Page last updated: 2024-11-11

mirabegron

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Description

mirabegron: a beta3-adrenergic receptor agonist; structure in first source [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

mirabegron : A monocarboxylic acid amide obtained by formal condensation of the carboxy group of 2-amino-1,3-thiazol-4-ylacetic acid with the anilino group of (1R)-2-{[2-(4-aminophenyl)ethyl]amino}-1-phenylethanol. Used for the treatment of overactive bladder syndrome. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID9865528
CHEMBL ID2095212
CHEBI ID65349
SCHEMBL ID904788
MeSH IDM0510156

Synonyms (68)

Synonym
HY-14773
D09535
223673-61-8
mirabegron (usan/jan)
myrbetriq (tn)
2-amino-n-[4-[2-[[(2r)-2-hydroxy-2-phenylethyl]amino]ethyl]phenyl]-4-thiazoleacetamide
ym 178;2-(2-aminothiazol-4-yl)-n-[4-[2-[[(2r)-2-hydroxy-2-phenyl-ethyl]amino]ethyl]phenyl]acetamide
A816162
2-(2-aminothiazol-4-yl)-4'-(2-((2-hydroxy-2-phenylethyl)amino)ethyl)acetanilide
betanis
ym 178
myrbetriq
4-thiazoleacetamide, 2-amino-n-(4-(2-(((2r)-2-hydroxy-2-phenylethyl)amino)ethyl)phenyl)-
unii-mvr3jl3b2v
ym178
ym-178
mirabegron
mirabegron [usan:inn]
mvr3jl3b2v ,
betmiga
CHEMBL2095212
S4009
mirabegron [jan]
mirabegron [inn]
2-(2-amino-1,3-thiazol-4-yl)-n-(4-(2-(((2r)-2-hydroxy-2-phenylethyl)amino)ethyl)phenyl)acetamide
mirabegron [mi]
mirabegron [usan]
mirabegron [mart.]
mirabegron [vandf]
mirabegron [who-dd]
2-(2-aminothiazol-4-yl)-n-[4-(2-{[(2r)-2-hydroxy-2-phenylethyl]amino}ethyl)phenyl]acetamide
mirabegron [orange book]
CS-0915
CHEBI:65349 ,
2-(2-amino-1,3-thiazol-4-yl)-n-[4-(2-{[(2r)-2-hydroxy-2-phenylethyl]amino}ethyl)phenyl]acetamide
AKOS016340341
2-(2-amino-1,3-thiazol-4-yl)-n-[4-[2-[[(2r)-2-hydroxy-2-phenylethyl]amino]ethyl]phenyl]acetamide
gtpl7445
DB08893
KS-1398
(r)-2-(2-aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetanilide
PBAPPPCECJKMCM-IBGZPJMESA-N
SCHEMBL904788
mirabegron (ym178)
(r)-2-(2-aminothiazol-4-yl)-n-(4-(2-(2-hydroxy-2-phenylethylamino)ethyl)phenyl)acetamide
(r)-2-(2-aminothiazol-4-yl)-n-(4-(2-((2-hydroxy-2-phenylethyl)amino)ethyl)phenyl)acetamide
AB01565808_02
2-(2-amino-1,3-thiazol-4-yl)-n-(4-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl}phenyl)acetamide
EX-A1050
mfcd11100356
HMS3714I09
SW220301-1
Q3702534
Z1980444597
AMY1800
AR-270/43507997
HMS3885M16
CCG-268611
NCGC00386239-01
2-(2-azanyl-1,3-thiazol-4-yl)-n-[4-[2-[[(2r)-2-oxidanyl-2-phenyl-ethyl]amino]ethyl]phenyl]ethanamide
h6u ,
DTXSID101021648
g04bd12
mirabegron (mart.)
2-(2-aminothiazol-4-yl)-n-(4-(2-(((2r)-2-hydroxy-2-phenylethyl)amino)ethyl)phenyl)acetamide
mirabegronum
2-(2-aminothiazol-4-yl)-n-(4-(2-(((2r)-2-hydroxy-2-phenylethyl)amino)ethyl)phenyl) acetamide
myrbetriq granules

Research Excerpts

Overview

Mirabegron is a beta-3 adrenergic receptor agonist that received FDA approval in 2021 to treat neurogenic detrusor overactivity (NDO) in children ages three years and older. The drug is effective for frequency, urgency urinary incontinence (UUI), but has interactions with cytochrome P450 enzymes (CYPs) and cardiovascular sequelae.

ExcerptReferenceRelevance
"Mirabegron is a promising drug to control OAB symptoms in patients with PD with an excellent safety profile."( The safety and effectiveness of mirabegron in Parkinson's disease patients with overactive bladder: a randomized controlled trial.
Chakra, MA; Dabboucy, B; Dellis, A; Fares, Y; Moussa, M; Papatsoris, A, 2022
)
2.45
"Mirabegron is a first-generation β3AR agonist that is effective for frequency, urgency urinary incontinence (UUI) and urgency, but has interactions with cytochrome P450 enzymes (CYPs) and cardiovascular sequelae."( Vibegron for the treatment of overactive bladder: a comprehensive update.
Dmochowski, R; Gleicher, S; Reynolds, WS; Sebesta, EM, 2022
)
1.44
"Mirabegron is a new drug acting by the ß3-adrenoceptor agonism."( Cost-effectiveness evaluation of mirabegron versus anti-muscarinics and third-line therapies: a systematic review.
Azadmehr, B; Mohammadnezhad, G; Yousefi, N, 2022
)
1.72
"Mirabegron is a selective beta-3 adrenergic receptor (β-3 AR) agonist used to treat an overactive bladder."( Mirabegron alleviates acetic acid-induced colitis in rats: Role of adiponectin and GSTM1/GSH detoxification pathway.
Abed El Baky, MF; Hafez, HM; Mohamed, MZ; Mokhemer, SA, 2023
)
3.07
"Mirabegron is a beta-3 adrenergic receptor agonist that received FDA approval in 2021 to treat neurogenic detrusor overactivity (NDO) in children ages three years and older. "( Cost analysis for mirabegron use in the treatment of children with neurogenic bladder.
Balthazar, A; Estrada, C; Sherlock, R; Xu, R, 2023
)
2.69
"Mirabegron appears to be an effective treatment in the management of neurogenic bladder unresponsive to antimuscarinics, particularly in patients presenting with storage symptoms. "( The use of mirabegron in neurogenic bladder: a systematic review.
Abi Tayeh, G; Chebel, R; El Helou, E; El Helou, J; Jalkh, G; Labaki, C; Nemr, E, 2020
)
2.39
"Mirabegron is a β3-agonist drug approved by the FDA for use in 2012 and administered in overactive bladder. "( Effect of Mirabegron on the Body's Exercise Capacity: A Review.
Baska, A; Gałązka, P; Leis, K; Mazur, E; Racinowski, M; Świerczyński, W, 2020
)
2.4
"Mirabegron is an effective drug to treat male OAB regardless of IPP grade."( Intravesical prostatic protrusion does not compromise the therapeutic effects of Mirabegron in male patients with overactive bladder.
Chen, CH; Chuang, YC; Lee, WC; Shen, YC; Wang, HJ, 2020
)
2.23
"Mirabegron is a safe and effective alternative therapy for females with OAB."( Mirabegron in female patients with overactive bladder syndrome: What's new? A systematic review and meta-analysis.
Athanasiou, S; Grigoriadis, T; Pitsouni, E; Salvatore, S; Serati, M; Zacharakis, D, 2020
)
2.72
"Mirabegron was judged to be an effective treatment for 990/1296 (76.4%) patients without BPH, 1935/2491 (77.7%) patients with BPH + treatment, and 421/538 (78.3%) patients with BPH + no treatment."( Safety and effectiveness of mirabegron in male patients with overactive bladder with or without benign prostatic hyperplasia: A Japanese post-marketing study.
Kato, D; Tabuchi, H; Takahashi, S; Uno, S, 2021
)
1.64
"Mirabegron is a well-tolerated add-on therapy to tamsulosin in Japanese and Korean males with residual overactive bladder symptoms."( Cardiovascular safety of mirabegron add-on therapy to tamsulosin for the treatment of overactive bladder in men with lower urinary tract symptoms: A post hoc analysis from the MATCH study.
Ishida, K; Jong, JJ; Kakizaki, H; Katoh, T; Katou, D; Lee, KS; Sumarsono, B; Uno, S; Yamaguchi, O; Yamamoto, O, 2021
)
1.65
"Mirabegron is an effective and safe treatment for men with OAB and BPH."( Efficacy and Safety of Mirabegron in Men with Overactive Bladder Symptoms and Benign Prostatic Hyperplasia.
Kaplan, SA; Mullen, GR, 2021
)
1.65
"Mirabegron is an effective treatment for patients with storage lower urinary tract symptoms/overactive bladder, providing a reduction of incontinence, urgency and frequency; an improvement of voided volume with a slight, but statistically, significant improvement of nocturia; with a good safety profile."( Systematic review and meta-analysis on the efficacy and tolerability of mirabegron for the treatment of storage lower urinary tract symptoms/overactive bladder: Comparison with placebo and tolterodine.
Chapple, C; Gacci, M; Gravas, S; Kaplan, SA; McVary, KT; Moncada, I; Morgia, G; Russo, GI; Sebastianelli, A; Serni, S, 2018
)
1.43
"Mirabegron is a novel medication for the treatment of OAB."( Therapeutic efficacy of low-dose (25 mg) mirabegron therapy for patients with mild to moderate overactive bladder symptoms due to central nervous system diseases.
Chen, SF; Kuo, HC, 2019
)
1.5
"Mirabegron is a β"( Mirabegron, a β
Alexandre, EM; Antunes, E; Lescano, CH; Mendes-Silvério, CB; Mónica, FZ, 2018
)
3.37
"Mirabegron is an established treatment alternative to antimuscarinic therapy for patients with overactive bladder (OAB), as shown by efficacy and tolerability data from phase III trials."( Efficacy and Tolerability of Mirabegron Compared with Antimuscarinic Monotherapy or Combination Therapies for Overactive Bladder: A Systematic Review and Network Meta-analysis.
Aballéa, S; Chapple, C; Hakimi, Z; Kelleher, C; Maman, K; Nazir, J; Siddiqui, E; Zur, R, 2018
)
2.21
"Mirabegron is a relatively new drug to treat overactive bladder (OAB). "( Efficacy and persistence of low-dose mirabegron (25 mg) in patients with overactive bladder: analysis in a real-world urological practice.
Chuang, YC; Shen, YC; Wang, HJ, 2018
)
2.2
"Mirabegron is a selective 3-adrenoreceptors agonist, which represent a new approach to the treatment of patients with overactive bladder."( [New approach to the treatment of patients with overactive bladder. Mirabegron: past, present and future].
Korshunova, ES, 2018
)
1.44
"Mirabegron is an effective first-line therapy for OAB, but has a persistence rate of 39.4% at 12 months. "( Effectiveness and persistence of mirabegron as a first-line treatment in patients with overactive bladder in real-life practice.
Choo, MS; Shin, JH, 2019
)
2.24
"Mirabegron is a kind of β3 adrenergic receptor agonist which is an effective drug for the treatment of overactive bladder. "( Determination of Mirabegron in rat plasma by UPLC-MS/MS after oral and intravenous administration.
Chen, L; Zhang, Y, 2019
)
2.3
"Mirabegron (Myrbetriq) is a β3-adrenoreceptor agonist approved for treating overactive bladder syndrome in human patients. "( Bladder drug mirabegron exacerbates atherosclerosis through activation of brown fat-mediated lipolysis.
Cao, Y; Chen, Y; Cheng, J; Dong, M; Jing, X; Li, H; Pan, H; Shi, W; Sui, W; Wang, X; Xue, F; Yang, Y; Zhang, C; Zhang, H; Zhang, M; Zhang, Y; Zhou, Q, 2019
)
2.33
"Mirabegron is a moderate CYP2D6 inhibitor and weak CYP3A inhibitor."( Physiologically Based Pharmacokinetic Modeling Suggests Limited Drug-Drug Interaction for Fesoterodine When Coadministered With Mirabegron.
Goosen, TC; Lin, J; Malhotra, B; Tse, S; Yamagami, H, 2019
)
1.44
"Mirabegron is a potent and selective β3-adrenoceptor agonist that may represent an alternative treatment option in place of antimuscarinics for patients with overactive bladder."( A phase II dose-ranging study of mirabegron in patients with overactive bladder.
Boerrigter, P; Bosman, B; Chapple, CR; Drogendijk, T; Dvorak, V; Radziszewski, P; Ridder, A; Van Der Putten-Slob, I; Van Kerrebroeck, P; Wyndaele, JJ; Yamaguchi, O, 2013
)
2.11
"Mirabegron is a β3-adrenoceptor agonist used for the treatment of overactive bladder. "( Effects of food intake on the pharmacokinetic properties of mirabegron oral controlled-absorption system: a single-dose, randomized, crossover study in healthy adults.
Grunenberg, N; Keirns, J; Kerbusch, V; Kowalski, D; Lee, J; Moy, S; Sawamoto, T; van Gelderen, M; Zhang, W, 2013
)
2.07
"Mirabegron is a new once-daily, oral treatment for management of overactive bladder (OAB) that is approved in USA, EU and Japan. "( The pharmacokinetic evaluation of mirabegron as an overactive bladder therapy option.
Kashyap, M; Tyagi, P, 2013
)
2.11
"Mirabegron is a first-in-class of β3 adrenoceptor agonists that could offer an alternative to antimuscarinics for OAB patients. "( The pharmacokinetic evaluation of mirabegron as an overactive bladder therapy option.
Kashyap, M; Tyagi, P, 2013
)
2.11
"Mirabegron is a β3-adrenoceptor agonist for the treatment of overactive bladder. "( Role of cytochrome p450 isoenzymes 3A and 2D6 in the in vivo metabolism of mirabegron, a β3-adrenoceptor agonist.
Keirns, J; Kerbusch, V; Kowalski, D; Krauwinkel, W; Lee, J; Marion, A; Meijer, J; Moy, S; Roy, M; Sawamoto, T; Takusagawa, S; van Gelderen, M, 2013
)
2.06
"Mirabegron is a potent and selective β3-adrenoceptor agonist developed for the treatment of overactive bladder. "( The effect of mirabegron, a potent and selective β3-adrenoceptor agonist, on the pharmacokinetics of CYP2D6 substrates desipramine and metoprolol.
Dickinson, J; Krauwinkel, W; Meijer, J; Schaddelee, M; Strabach, G; Tretter, R; van de Wetering, J; van Gelderen, M, 2014
)
2.21
"Mirabegron is a novel β3-adrenoceptor agonist developed for the treatment of overactive bladder. "( Pharmacological profile of the selective β3-adrenoceptor agonist mirabegron in cynomolgus monkeys.
Hatanaka, T; Masuda, N; Ohtake, A; Sato, S; Someya, A; Suzuki, M; Ueshima, K; Ukai, M; Watanabe, M, 2013
)
2.07
"Mirabegron is an efficacious drug which presents a statistically significant reduction in the number of incontinence episodes and in urinary frequency as of 4 weeks, with a higher percentage of dry patients and a higher percentage of patients with reduction ≥50% in the number of incontinence episodes than placebo. "( Evidence available on the use of the selective β3-adrenoceptor agonist mirabegron for the treatment of overactive bladder.
Angulo, JC; Khullar, V; Nitti, VW; Siddiqui, E,
)
1.81
"Mirabegron is a novel β3-adrenoceptor agonist recently approved by Japanese, American, and European authorities for overactive bladder (OAB) therapy. "( What do we know and not know about mirabegron, a novel β3 agonist, in the treatment of overactive bladder?
Caremel, R; Corcos, J; Loutochin, O, 2014
)
2.12
"Mirabegron is a β3-adrenoceptor agonist developed for the treatment of OAB, with a mechanism of action distinct from that of antimuscarinics."( Efficacy of mirabegron in patients with and without prior antimuscarinic therapy for overactive bladder: a post hoc analysis of a randomized European-Australian Phase 3 trial.
Angulo, JC; Blauwet, MB; Cambronero, J; Dorrepaal, C; Khullar, V; Martin, NE; Wooning, M, 2013
)
1.49
"Mirabegron appears to be a promising treatment in OAB patients by shifting its management from reducing detrusor over-activity to inducing relaxation. "( Mirabegron for overactive bladder: a novel, first-in-class β3-agonist therapy.
Imran, M; Najmi, AK; Tabrez, S, 2013
)
3.28
"Mirabegron is a human β3-adrenoceptor agonist for the treatment of overactive bladder. "( Pharmacokinetics of mirabegron, a β3-adrenoceptor agonist for treatment of overactive bladder, in healthy Japanese male subjects: results from single- and multiple-dose studies.
Amada, Y; Iitsuka, H; Katashima, M; Matsushima, H; Miyahara, H; Sawamoto, T; Takusagawa, S; Tanaka, T; Tokuno, T; van Gelderen, M, 2014
)
2.17
"Mirabegron is a first-in-class β3-adrenoceptor agonist licensed for the treatment of OAB and has shown to be well tolerated and effective in the treatment of OAB symptoms."( Comparative efficacy and safety of medical treatments for the management of overactive bladder: a systematic literature review and mixed treatment comparison.
Aballea, S; Desroziers, K; Hakimi, Z; Maman, K; Nazir, J; Neine, ME; Odeyemi, I; Siddiqui, E, 2014
)
1.12
"mirabegron is a β3-adrenoceptor agonist developed for the treatment of symptoms of overactive bladder (OAB). "( The efficacy and tolerability of the β3-adrenoceptor agonist mirabegron for the treatment of symptoms of overactive bladder in older patients.
Auerbach, S; Blauwet, MB; Cardozo, L; Castro-Diaz, D; Nitti, VW; Siddiqui, E; Wagg, A, 2014
)
2.09
"Mirabegron is a selective β3-adrenergic receptor agonist recently developed for the treatment of patients with overactive bladder (OAB), which offers an alternative pharmacological option to the well-established treatment with antimuscarinics (AMs)."( Mirabegron in the treatment of overactive bladder.
Candiani, M; Cardozo, L; Cola, A; Colacurci, N; Del Deo, F; Ferrero, S; Leone Roberti Maggiore, U; Salvatore, S; Sileo, F; Torella, M, 2014
)
3.29
"Mirabegron is a new beta 3 agonist for the treatment of overactive bladder (OAB). "( Third-line treatment for overactive bladder: should mirabegron be tried before intravesical botulinum toxin A therapy?
Balachandran, A; Basu, M; Curtiss, N; Duckett, J, 2015
)
2.11
"Mirabegron is a new selective β3-adrenoreceptor agonist licensed for the treatment of overactive bladder (OAB). "( The risk and severity of developing symptomatic palpitations when prescribed mirabegron for overactive bladder.
Balachandran, AA; Duckett, JR, 2015
)
2.09
"Mirabegron is a new treatment option for all patients with OAB and could solve an unmet need in patients still not satisfied, or where the antimuscarinic therapy is not indicated, is an alternative option for patients with OAB."( [Developments in the medical treatment of overactive bladder].
Alcántara Montero, A,
)
0.85
"Mirabegron is a treatment option for patients with overactive bladder. "( The efficacy and tolerability of mirabegron in a non-trial clinical setting.
Balachandran, A; Duckett, J, 2016
)
2.16
"Mirabegron has shown to be a drug with the better balance between efficacy and tolerability in women with OAB."( Comparison of Therapeutic Efficacy and Urodynamic Findings of Solifenacin Succinate versus Mirabegron in Women with Overactive Bladder Syndrome: Results of a Randomized Controlled Study.
Morosetti, C; Vecchioli Scaldazza, C, 2016
)
2.1
"Mirabegron is a β3-adrenoreceptor agonist developed for treatment of overactive bladder (OAB). "( The efficacy of mirabegron additional therapy for lower urinary tract symptoms after treatment with α1-adrenergic receptor blocker monotherapy: prospective analysis of elderly men.
Asai, A; Kakoki, K; Matsuo, T; Miyata, Y; Ohba, K; Sakai, H; Yuzuriha, M, 2016
)
2.22
"Mirabegron is a hydrophilic drug that exhibits pH-dependent solubility."( Oral Sustained Release of a Hydrophilic Drug Using the Lauryl Sulfate Salt/Complex.
Kasashima, Y; Namiki, N; Sako, K; Uchida, S; Yasuji, T; Yoshihara, K, 2016
)
1.16
"Mirabegron is a relatively new drug introduced to treat overactive bladder syndrome. "( Profile of mirabegron in the treatment of overactive bladder: place in therapy.
Hashim, H; Sharaf, A, 2017
)
2.29
"Mirabegron is a β(3)-adrenoceptor agonist developed to fulfill the need for a more convenient therapy and provide an improved safety/efficacy profile for OAB patients with advanced age and cognitive deficit. "( Mirabegron: a safety review.
Chancellor, M; Tyagi, P; Tyagi, V, 2011
)
3.25
"Mirabegron is a promising alternative to antimuscarinics."( Use of mirabegron in treating overactive bladder.
Bhide, AA; Digesu, GA; Fernando, R; Khullar, V, 2012
)
1.56
"Mirabegron is a potent and selective β3-adrenoceptor agonist in development for treatment of overactive bladder."( Single dose pharmacokinetics and absolute bioavailability of mirabegron, a β₃-adrenoceptor agonist for treatment of overactive bladder.
Drogendijk, T; Eltink, C; Grunenberg, N; Iitsuka, H; Kerbusch, V; Kowalski, D; Lee, J; Matsushima, H; Meijer, J; Moy, S; Sawamoto, T; Schaddelee, M; van Gelderen, M; van Marle, S; Zhang, W, 2012
)
2.06
"Mirabegron (YM178) is a β(3)-adrenoceptor agonist for the treatment of overactive bladder (OAB). "( Pharmacokinetic properties of mirabegron, a β3-adrenoceptor agonist: results from two phase I, randomized, multiple-dose studies in healthy young and elderly men and women.
Eltink, C; Kerbusch, V; Krauwinkel, W; Meijer, J; Schaddelee, M; Strabach, G; van Dijk, J; van Gelderen, M; van Marle, S, 2012
)
2.11

Effects

Mirabegron has an excellent safety profile and appears to be an effective treatment for overactive bladder symptoms in patients with PD. It may provide an improved benefit-to-risk ratio and therefore be considered as an alternative to antimuscarinics for older patients.

Mirabegron has been approved in Japan for the indication of urgency, urinary frequency and urge urinary incontinence associated with OAB. It was recently submitted for approval to U.S.

ExcerptReferenceRelevance
"Mirabegron has a similar efficacy profile to first-line antimuscarinics with favorable adverse effects profile. "( Are Beta 3 Adrenergic Agonists Now the Preferred Pharmacologic Management of Overactive Bladder?
Campeau, L; Fogaing, C; Mossa, AH, 2020
)
2
"Mirabegron has an excellent safety profile and appears to be an effective treatment for overactive bladder symptoms in patients with PD. "( Mirabegron in patients with Parkinson disease and overactive bladder symptoms: A retrospective cohort.
Biagioni, MC; Brucker, BM; Feigin, A; Frucht, S; Gilbert, R; Kaufmann, H; Malacarne, DR; Nitti, VW; Palma, JA; Palmerola, R; Peyronnet, B; Rosenblum, N; Sussman, RD; Vurture, G, 2018
)
3.37
"Mirabegron has a more favorable tolerability profile than antimuscarinics amongst older patients and may provide an improved benefit-to-risk ratio and therefore be considered as an alternative to antimuscarinics for older patients."( Oral pharmacotherapy for overactive bladder in older patients: mirabegron as a potential alternative to antimuscarinics.
Berner, T; Castro-Diaz, D; Kelleher, C; Nitti, VW; Siddiqui, E; Wagg, A, 2016
)
2.12
"Mirabegron has a favorable safety and tolerability profile, particularly compared with antimuscarinics, for dry mouth, constipation, and many CNS effects, which is maintained over 1 year."( Mirabegron for the treatment of overactive bladder: a review of efficacy, safety and tolerability with a focus on male, elderly and antimuscarinic poor-responder populations, and patients with OAB in Asia.
Chapple, CR; Siddiqui, E, 2017
)
2.62
"Mirabegron has been classified as a β"( The β
Kaumann, AJ; Lee, XW; Michel, MC; Mo, W; Molenaar, P, 2017
)
1.9
"Mirabegron has shown to be a drug with the better balance between efficacy and tolerability in women with OAB."( Comparison of Therapeutic Efficacy and Urodynamic Findings of Solifenacin Succinate versus Mirabegron in Women with Overactive Bladder Syndrome: Results of a Randomized Controlled Study.
Morosetti, C; Vecchioli Scaldazza, C, 2016
)
2.1
"Mirabegron has been approved in Japan for the indication of urgency, urinary frequency and urge urinary incontinence associated with OAB, and was recently submitted for approval to U.S."( Mirabegron for the treatment of overactive bladder.
Gras, J, 2012
)
2.54

Actions

Mirabegron's ability to increase adiponectin in serum and decrease glutathione, GSTM1, and catalase in the colon may account for its protective effects. MirabEGron may also cause a dose-dependent increase in blood pressure.

ExcerptReferenceRelevance
"Mirabegron's ability to increase adiponectin in serum and decrease glutathione, GSTM1, and catalase in the colon may account for its protective effects."( Mirabegron alleviates acetic acid-induced colitis in rats: Role of adiponectin and GSTM1/GSH detoxification pathway.
Abed El Baky, MF; Hafez, HM; Mohamed, MZ; Mokhemer, SA, 2023
)
3.07
"Mirabegron also had a lower adverse reaction rate (OR 0.9; 95% CI 0.8, 1.0; p = 0.04)."( The role of mirabegron in overactive bladder: a systematic review and meta-analysis.
Bu, SY; Cao, CX; Duan, X; Peng, CD; Wang, KJ; Wu, T, 2014
)
1.5
"Mirabegron may also cause a dose-dependent increase in blood pressure."( mirabegron (BETMIGA⁰). Poorly effective in urge urinary incontinence.
, 2016
)
2.6
"Mirabegron didn't produce significant inhibitory effects in any of the contractile elements in either species."( The actions of isoprenaline and mirabegron in the isolated whole rat and guinea pig bladder.
De Wachter, S; Eastham, J; Gillespie, J; Persyn, S; Wyndaele, JJ, 2016
)
1.44

Treatment

Mirabegron is a new treatment option for all patients with OAB. It could solve an unmet need in patients still not satisfied, or where the antimuscarinic therapy is not indicated. Mice treated with mira displayed significantly fewer voiding events compared to the stressed mice.

ExcerptReferenceRelevance
"Mirabegron is used for treatment of storage symptoms in overactive bladder (OAB) caused by spontaneous bladder smooth muscle contractions. "( Inhibition of Full Smooth Muscle Contraction in Isolated Human Detrusor Tissues by Mirabegron Is Limited to Off-Target Inhibition of Neurogenic Contractions.
Hennenberg, M; Huang, R; Stief, CG; Strittmatter, F; Tamalunas, A; Waidelich, R, 2022
)
2.39
"Mirabegron treatment significantly improved BOO-induced bladder dysfunction through the amelioration of bladder blood flow."( The effect of mirabegron on bladder blood flow in a rat model of bladder outlet obstruction.
Funahashi, Y; Gotoh, M; Kato, M; Majima, T; Matsukawa, Y; Yamamoto, T, 2020
)
2.36
"Mirabegron treatment was well-tolerated in older adults with OAB-wet. "( Safety and Tolerability Results from the PILLAR Study: A Phase IV, Double-Blind, Randomized, Placebo-Controlled Study of Mirabegron in Patients ≥ 65 years with Overactive Bladder-Wet.
Herschorn, S; Kristy, RM; Schermer, CR; Staskin, D; Wagg, A, 2020
)
2.21
"Mirabegron as adjuvant treatment in children with refractory neurogenic bladder increased bladder capacity, reduced intravesical pressure and helped achieve continence in more than two thirds of the sample population. "( Efficacy and safety of Mirabegron as adjuvant treatment in children with refractory neurogenic bladder dysfunction.
Burek, C; Corbetta, JP; Gomez, YR; Lopez Imizcoz, F; Ruiz, J; Sager, C; Sanmartino, M; Szklarz, T; Tessi, C; Vazquez Patiño, M; Weller, S, 2020
)
2.31
"Mirabegron treatment improved the IIEF-5 scores in five patients (38.4%) by 4 points or more, whereas IIEF-5 scores were not affected by Mirabegron treatment in eight patients (61.5%)."( Mirabegron improves erectile function in men with overactive bladder and erectile dysfunction: a 12-week pilot study.
Burnett, AL; Karakus, S; Musicki, B, 2022
)
2.89
"Most mirabegron treatment failures were because of treatment discontinuation (67%) versus switching to ACH therapy (14%)."( Adherence and persistence of mirabegron and anticholinergic therapies in patients with overactive bladder: a real-world claims data analysis.
Chaudhari, S; Kish, J; Kowalski, J; Lee, W; Murray, B; Sussman, D; Yehoshua, A, 2017
)
1.2
"Mirabegron treatment persistence was higher than has been previously reported, and was greater in patients aged ≥65 years compared with those aged <65 years."( Safety, efficacy, and persistence of long-term mirabegron treatment for overactive bladder in the daily clinical setting: Interim (1-year) report from a Japanese post-marketing surveillance study.
Kato, D; Tabuchi, H; Uno, S, 2019
)
1.49
"Mirabegron treatment was associated with longer median persistence compared with antimuscarinics (insurance claims: 44 [95% confidence intervals 37-56] vs 21 [14-28] to 30 [30-33] days, pharmacy claims: 105 [96-113] vs 62 [56-77] to 84 [77-86] days)."( Persistence and adherence to overactive bladder medications in Japan: A large nationwide real-world analysis.
Fan, A; Kato, D; Kimura, T; Uno, S; Van Schyndle, J, 2017
)
1.18
"Mirabegron treatment improved OABSS in terms of night-time frequency, urgency, and total score (P < .001). "( Efficacy of mirabegron for overactive bladder with human T cell lymphotropic virus-1 associated myelopathy.
Matsuo, T; Miyata, Y; Nakamura, T; Sakai, H; Satoh, K, 2019
)
2.34
"Mirabegron treatment significantly increased first desire to void and cystometric capacity with an average increment of 80 mL (P = 0.027) and 123 mL (P = 0.005), respectively. "( Video-urodynamic effects of mirabegron, a β3 -adrenoceptor agonist, in patients with low-compliance bladder.
Akiyama, Y; Fujimura, T; Fukuhara, H; Furuta, A; Homma, Y; Ichihara, K; Igawa, Y; Kamei, J; Kume, H; Niimi, A, 2015
)
2.15
"Mirabegron is a new treatment option for all patients with OAB and could solve an unmet need in patients still not satisfied, or where the antimuscarinic therapy is not indicated, is an alternative option for patients with OAB."( [Developments in the medical treatment of overactive bladder].
Alcántara Montero, A,
)
0.85
"Mirabegron is a treatment option for patients with overactive bladder. "( The efficacy and tolerability of mirabegron in a non-trial clinical setting.
Balachandran, A; Duckett, J, 2016
)
2.16
"Mirabegron treatment is associated with a satisfactory cardiovascular safety profile, as well as, significant symptomatic improvement also in a heterogeneous population of non-selected women with overactive bladder presenting in everyday clinical practice."( Safety and efficacy of mirabegron in daily clinical practice: a prospective observational study.
Altman, D; Christensson, AA; Elmér, C; Flam, B; Kallner, HK, 2016
)
2.19
"Mirabegron add-on treatment with tamsulosin has efficacy and safety because it improves storage symptom without impairment of bladder contractility during voiding in male patients with OAB."( Urodynamic Efficacy and Safety of Mirabegron Add-on Treatment with Tamsulosin for Japanese Male Patients with Overactive Bladder.
Hashizume, K; Iuchi, H; Kakizaki, H; Kita, M; Matsumoto, S; Wada, N, 2016
)
2.16
"Mice treated with mirabegron or solifenacin displayed significantly fewer voiding events compared to the stressed mice, and voiding frequency in drug-treated animals was comparable to unstressed controls."( Mirabegron and solifenacin are effective for the management of the increased urinary frequency induced by psychological stress in female mice.
Chess-Williams, R; McDermott, C; Sellers, DJ; West, EG, 2022
)
2.49
"Treatment with mirabegron resulted in significant changes in symptoms and urodynamic sensory markers in patients with URI."( Exploratory analysis of the effect of mirabegron on urodynamic sensation parameters and urethral pressure variations.
Egberts, J; Elzevier, HW; Groenendijk, PM; Kummeling, MTM; Putter, H; van Koeveringe, GA, 2021
)
1.23
"Treatment with mirabegron for 12 weeks did not contribute to drug-related cognitive side effects in patients aged ≥65 years, as measured by the MoCA. "( Effect of mirabegron on cognitive function in elderly patients with overactive bladder: MoCA results from a phase 4 randomized, placebo-controlled study (PILLAR).
Campbell, NL; Elsouda, D; Griebling, TL; Herschorn, S; Mangel, J; Schermer, CR; Staskin, D, 2020
)
1.31
"Treatment with mirabegron could generate savings of 80.74 ±4.61 € per patient per year compared to AM, assuming 100% probability of saving."( [Analysis of costs and consequences related to the persistence of Mirabegron and antimuscarinic treatments and their impact on quality of life in patients with overactive bladder in Spain: Results of a probabilistic model.]
Arlandis Guzmán, S; Blanco, N; Jiménez Cidre, MÁ; Landeira, M; Rubio-Rodríguez, D; Rubio-Terrés, C, 2020
)
1.13
"Treatment with mirabegron and desmopressin revealed both effectiveness and safety in patients with NDO and MS."( Effective treatment of neurogenic detrusor overactivity in multiple sclerosis patients using desmopressin and mirabegron.
Baltogiannis, D; Dimitriadis, F; Filiponi, M; Giannakis, J; Sofikitis, N; Takenaka, A; Tsounapi, P; Zachariou, A, 2017
)
1.02
"Treatment with mirabegron reduced the percentage of patients suffering from frequency after 6 weeks."( Does Pharmacological Treatment Reduce the Incidence of Lower Urinary Tract Symptoms (LUTS) after Transobturator Sling?
Bogusiewicz, M; Kulik-Rechberger, B; Miotla, P; Rechberger, E; Rechberger, T; Wrobel, A; Zietek, A, 2019
)
0.85
"Treatment with mirabegron 50 and 100 mg was noninferior to placebo based on the lower and upper limits of the 95% CI, respectively, for maximum urinary flow and detrusor pressure at maximum urinary flow. "( Urodynamics and safety of the β₃-adrenoceptor agonist mirabegron in males with lower urinary tract symptoms and bladder outlet obstruction.
Fakhoury, A; He, W; Martin, NE; Mitcheson, DH; Nitti, VW; Rosenberg, S, 2013
)
0.99

Toxicity

Mirabegron (25, 50 or 100 mg qd) was safe and well-tolerated in patients with OAB over 12-week (n = 2736) and 1-year.

ExcerptReferenceRelevance
" However, long-term adverse effects are not yet completely investigated."( Mirabegron: a safety review.
Chancellor, M; Tyagi, P; Tyagi, V, 2011
)
1.81
" The most commonly reported toxic effects of mirabegron are gastrointestinal adverse events and headache."( Mirabegron: a safety review.
Chancellor, M; Tyagi, P; Tyagi, V, 2011
)
2.07
" No treatment-emergent adverse event (AE) of glaucoma was reported."( Randomized, double-masked, placebo-controlled study to assess the ocular safety of mirabegron in healthy volunteers.
Hantsbarger, G; Lewis, RA; Martin, NE; Novack, GD; Rasmussen, S; Sheth, N; Swearingen, D; Vogel, R, 2013
)
0.61
"Mirabegron 100 mg orally once daily for 8 weeks of treatment does not increase the IOP, and was generally safe and well tolerated."( Randomized, double-masked, placebo-controlled study to assess the ocular safety of mirabegron in healthy volunteers.
Hantsbarger, G; Lewis, RA; Martin, NE; Novack, GD; Rasmussen, S; Sheth, N; Swearingen, D; Vogel, R, 2013
)
2.06
" The safety analysis included adverse event (AE) reporting, laboratory assessments, ECG, postvoid residual volume and vital signs (blood pressure, pulse rate)."( Mirabegron for the treatment of overactive bladder: a prespecified pooled efficacy analysis and pooled safety analysis of three randomised, double-blind, placebo-controlled, phase III studies.
Angulo, JC; Blauwet, MB; Cambronero, J; Dorrepaal, C; Herschorn, S; Khullar, V; Martin, NE; Nitti, VW; Siddiqui, E; van Kerrebroeck, P, 2013
)
1.83
" We evaluated adverse events and vital signs."( Urodynamics and safety of the β₃-adrenoceptor agonist mirabegron in males with lower urinary tract symptoms and bladder outlet obstruction.
Fakhoury, A; He, W; Martin, NE; Mitcheson, DH; Nitti, VW; Rosenberg, S, 2013
)
0.64
" The incidence of adverse events was similar for mirabegron and placebo."( Urodynamics and safety of the β₃-adrenoceptor agonist mirabegron in males with lower urinary tract symptoms and bladder outlet obstruction.
Fakhoury, A; He, W; Martin, NE; Mitcheson, DH; Nitti, VW; Rosenberg, S, 2013
)
0.89
" Statistically significant improvements vs placebo were demonstrated by mirabegron 50 mg in all patient-reported outcome scales with no increase in the incidence of treatment-emergent adverse events vs placebo."( A phase III, randomized, double-blind, parallel-group, placebo-controlled, multicentre study to assess the efficacy and safety of the β₃ adrenoceptor agonist, mirabegron, in patients with symptoms of overactive bladder.
Barkin, J; Castro-Diaz, D; Espuna-Pons, M; Frankel, JM; Gousse, AE; Gunther, A; Herschorn, S; Martin, N; Stölzel, M; Van Kerrebroeck, P, 2013
)
0.82
"This meta-analysis indicates that mirabegron to be an effective and safe treatment for OAB symptoms with a low occurrence of side effects."( The efficacy and safety of mirabegron in treating OAB: a systematic review and meta-analysis of phase III trials.
Cui, Y; Yan, H; Yang, C; Zhang, Y; Zong, H, 2014
)
0.98
" The most common adverse events (AEs) observed with mirabegron in clinical trials of up to 12 months were hypertension, nasopharyngitis, and urinary tract infection."( Mirabegron in overactive bladder: a review of efficacy, safety, and tolerability.
Cardozo, L; Chapple, CR; Michel, MC; Nitti, VW; Siddiqui, E, 2014
)
2.1
" This review included randomised controlled trials (RCTs) studying changes in symptoms (micturition frequency, incontinence, and urgency urinary incontinence [UUI] episodes) and incidence of the most frequently reported adverse events (dry mouth, constipation) associated with current OAB medications."( Comparative efficacy and safety of medical treatments for the management of overactive bladder: a systematic literature review and mixed treatment comparison.
Aballea, S; Desroziers, K; Hakimi, Z; Maman, K; Nazir, J; Neine, ME; Odeyemi, I; Siddiqui, E, 2014
)
0.4
"Mirabegron 50 mg had similar efficacy to most antimuscarinics and lower incidence of dry mouth, the most common adverse event reported with antimuscarinics and one of the main causes of discontinuation of treatment."( Comparative efficacy and safety of medical treatments for the management of overactive bladder: a systematic literature review and mixed treatment comparison.
Aballea, S; Desroziers, K; Hakimi, Z; Maman, K; Nazir, J; Neine, ME; Odeyemi, I; Siddiqui, E, 2014
)
1.85
" Safety assessments included treatment-emergent adverse events (TEAEs), blood pressure, pulse rate, postvoid residual (PVR) volume, and laboratory and electrocardiography (ECG) parameters."( Combination treatment with mirabegron and solifenacin in patients with overactive bladder: efficacy and safety results from a randomised, double-blind, dose-ranging, phase 2 study (Symphony).
Abrams, P; Kay, R; Kelleher, C; Martina, R; Newgreen, D; Paireddy, A; Rechberger, T; Ridder, A; Staskin, D; van Maanen, R, 2015
)
0.71
" Safety variables included the incidence and severity of treatment-emergent adverse events (TEAEs), vital signs and electrocardiogram data."( Safety and tolerability of the β3 -adrenoceptor agonist mirabegron, for the treatment of overactive bladder: results of a prospective pooled analysis of three 12-week randomised Phase III trials and of a 1-year randomised Phase III trial.
Auerbach, S; Blauwet, MB; Chapple, CR; Herschorn, S; Milsom, I; Nitti, VW; Radziszewski, P; Walters, C, 2014
)
0.65
"Mirabegron (25, 50 or 100 mg qd) was safe and well-tolerated in patients with OAB over 12-week (n = 2736) and 1-year (n = 1632) periods."( Safety and tolerability of the β3 -adrenoceptor agonist mirabegron, for the treatment of overactive bladder: results of a prospective pooled analysis of three 12-week randomised Phase III trials and of a 1-year randomised Phase III trial.
Auerbach, S; Blauwet, MB; Chapple, CR; Herschorn, S; Milsom, I; Nitti, VW; Radziszewski, P; Walters, C, 2014
)
2.09
" Safety assessments included adverse events (AEs), laboratory tests, vital signs, 12-lead electrocardiogram, QT corrected for heart rate using Fridericia's correction (QTcF) interval and post-void residual (PVR) volume."( Safety and efficacy of mirabegron as 'add-on' therapy in patients with overactive bladder treated with solifenacin: a post-marketing, open-label study in Japan (MILAI study).
Gotoh, M; Hamada, T; Homma, Y; Igawa, Y; Kakizaki, H; Kobayashi, A; Kuroishi, K; Nishizawa, O; Okitsu, A; Seki, N; Takeda, M; Yamaguchi, O; Yokoyama, O; Yoshida, M, 2015
)
0.73
" Safety was evaluated based on adverse events (AEs), laboratory findings, vital signs, electrocardiogram, and post-void residual volume."( Efficacy and Safety of the Selective β3 -Adrenoceptor Agonist Mirabegron in Japanese Patients with Overactive Bladder: A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study.
Igawa, Y; Ikeda, Y; Marui, E; Nishizawa, O; Ohkawa, S; Takeda, M; Yamaguchi, O, 2015
)
0.66
"Based on a systematic PubMed search, incidence of overall adverse events, hypertension, dry mouth, and constipation are comparable between mirabegron or solabegron and placebo."( Safety and tolerability of β3-adrenoceptor agonists in the treatment of overactive bladder syndrome - insight from transcriptosome and experimental studies.
Gravas, S; Michel, MC, 2016
)
0.64
" We propose that expression profiles and functional preclinical studies can be important tools in the prediction of adverse event profiles in first-in-class drugs."( Safety and tolerability of β3-adrenoceptor agonists in the treatment of overactive bladder syndrome - insight from transcriptosome and experimental studies.
Gravas, S; Michel, MC, 2016
)
0.43
" Antimuscarinics are currently the most widely prescribed drugs for OAB although persistence with medication is often limited due to lack of efficacy or intolerable adverse effects."( A drug safety evaluation of mirabegron in the management of overactive bladder.
Cardozo, L; Robinson, D; Thiagamoorthy, G, 2016
)
0.73
"The extensive clinical trial programme has shown mirabegron to be safe and efficacious in the treatment of OAB symptoms and the evidence would suggest that it offers an effective alternative to antimuscarinic therapy."( A drug safety evaluation of mirabegron in the management of overactive bladder.
Cardozo, L; Robinson, D; Thiagamoorthy, G, 2016
)
0.98
" Data on adverse events, cardiovascular outcomes, condition specific symptoms and drug discontinuation was collected at two months follow-up (FU)."( Safety and efficacy of mirabegron in daily clinical practice: a prospective observational study.
Altman, D; Christensson, AA; Elmér, C; Flam, B; Kallner, HK, 2016
)
0.74
" Safety assessments included adverse events, vital signs, post-void residual volume and patient-reported incidence, and severity of distinctive symptoms related to adverse events."( Comparison of mirabegron and imidafenacin for efficacy and safety in Japanese female patients with overactive bladder: A randomized controlled trial (COMFORT study).
Furuse, H; Kageyama, S; Kitagawa, M; Matsumoto, R; Nagae, H; Otsuka, A; Ozono, S; Suzuki, T, 2016
)
0.79
" The overall incidence of adverse events and the incidence of dry mouth were significantly higher in the imidafenacin group than in the mirabegron group."( Comparison of mirabegron and imidafenacin for efficacy and safety in Japanese female patients with overactive bladder: A randomized controlled trial (COMFORT study).
Furuse, H; Kageyama, S; Kitagawa, M; Matsumoto, R; Nagae, H; Otsuka, A; Ozono, S; Suzuki, T, 2016
)
1
"Treatment with 50 mg mirabegron once daily effectively relieves overactive bladder symptoms in women with fewer adverse events than treatment with antimuscarinics."( Comparison of mirabegron and imidafenacin for efficacy and safety in Japanese female patients with overactive bladder: A randomized controlled trial (COMFORT study).
Furuse, H; Kageyama, S; Kitagawa, M; Matsumoto, R; Nagae, H; Otsuka, A; Ozono, S; Suzuki, T, 2016
)
1.11
" Safety was evaluated based on vital signs, adverse events (AEs), laboratory findings, electrocardiogram and post-void residual volume."( Phase III Study to Assess Long-Term (52-Week) Safety and Efficacy of Mirabegron, a β
Ikeda, Y; Ohkawa, S; Yamaguchi, O, 2017
)
0.69
"Study the efficacy and adverse events of different pharmacological lines in the treatment of idiopathic overactive bladder (iOAB)."( [Efficacy and safety of available therapies in the management of idiopathic overactive bladder: A systematic review of the literature].
Legrand, F; Moyson, J; Quackels, T; Roumeguère, T; Vanden Bossche, M, 2017
)
0.46
"PubMed research on meta-analyses and randomized controlled trials (RCT) focused on the efficacy and adverse effects of anticholinergics, botulinum toxin and mirabegron since 2005."( [Efficacy and safety of available therapies in the management of idiopathic overactive bladder: A systematic review of the literature].
Legrand, F; Moyson, J; Quackels, T; Roumeguère, T; Vanden Bossche, M, 2017
)
0.65
" The most commonly reported side effect is dry mouth (30 % vs."( [Efficacy and safety of available therapies in the management of idiopathic overactive bladder: A systematic review of the literature].
Legrand, F; Moyson, J; Quackels, T; Roumeguère, T; Vanden Bossche, M, 2017
)
0.46
" Safety assessments included incidence and frequency of treatment-emergent adverse events (TEAEs), post-void residual (PVR) urine volume, and changes from baseline in laboratory parameters."( Efficacy and safety of combinations of mirabegron and solifenacin compared with monotherapy and placebo in patients with overactive bladder (SYNERGY study).
Abrams, P; Arlandis, S; Chapple, CR; Herschorn, S; Lee, KS; Mitcheson, D; Paireddy, A; Ridder, A; Robinson, D; Stoelzel, M; van Maanen, R, 2017
)
0.72
" CV safety assessments included frequency of CV-related treatment-emergent adverse events (TEAEs), change from baseline in vital signs (systolic blood pressure [SBP], diastolic blood pressure [DBP], pulse rate) and electrocardiogram (ECG) parameters."( Cardiovascular safety in refractory incontinent patients with overactive bladder receiving add-on mirabegron therapy to solifenacin (BESIDE).
Athanasiou, S; Cambronero Santos, J; Chapple, CR; Drake, MJ; Esen, A; Herschorn, S; Huang, M; MacDiarmid, S; Mitcheson, D; Siddiqui, E; Stoelzel, M, 2017
)
0.67
" Data were collected on adverse drug reactions (ADR), changes in OAB symptoms, changes in Overactive Bladder Symptom Score (OABSS), and treatment discontinuations."( Safety, efficacy, and persistence of long-term mirabegron treatment for overactive bladder in the daily clinical setting: Interim (1-year) report from a Japanese post-marketing surveillance study.
Kato, D; Tabuchi, H; Uno, S, 2019
)
0.77
" Despite evidence showing that the use of vaginal oestrogens is safe in those with a history of cancer, it is not fully supported by any health body."( Safety issues associated with using medication to treat overactive bladder.
Araklitis, G; Cardozo, L, 2017
)
0.46
"Incidence of adverse drug reactions (ADR) was assessed following 12 weeks' mirabegron treatment."( Safety and effectiveness of mirabegron in patients with overactive bladder aged ≥75 years: Analysis of a Japanese post-marketing study.
Kato, D; Kuroishi, K; Nozawa, Y; Tabuchi, H; Yoshida, M, 2019
)
1.04
" Safety assessments included monitoring the incidence and severity of adverse events."( Efficacy and safety of mirabegron for the treatment of neurogenic detrusor overactivity-Prospective, randomized, double-blind, placebo-controlled study.
Bílková, K; Borovička, V; Krhut, J; Míka, D; Mokriš, J; Sýkora, R; Zachoval, R, 2018
)
0.79
" Although most adverse events (AEs) were mild, patients with BOO had significantly higher AEs rate (18."( Mirabegron 25 mg Monotherapy Is Safe but Less Effective in Male Patients With Overactive Bladder and Bladder Outlet Obstruction.
Kuo, HC; Liao, CH, 2018
)
1.92
" Subjective symptom scores, uroflowmetry data, and adverse events (AEs) were recorded for all patients at baseline and after 1, 3, and 6 months treatment."( Efficacy and safety of mirabegron, a β
Kuo, HC; Lee, CL, 2019
)
0.82
"The primary objective was safety, measured as treatment-emergent adverse events (TEAEs)."( Long-term Safety and Efficacy of Mirabegron and Solifenacin in Combination Compared with Monotherapy in Patients with Overactive Bladder: A Randomised, Multicentre Phase 3 Study (SYNERGY II).
Abrams, P; Al-Shukri, S; Chapple, C; Gratzke, C; Herschorn, S; Mueller, ER; Paireddy, A; Rechberger, T; Ridder, A; Robinson, D; Stoelzel, M; van Maanen, R; Yoon, SJ, 2018
)
0.76
" Safety assessments included adverse events and post-void residual urine volume."( Safety and therapeutic efficacy of mirabegron 25 mg in older patients with overactive bladder and multiple comorbidities.
Kuo, HC; Lee, YK, 2018
)
0.76
" The younger patients experienced more minor adverse events than the older patients (41."( Safety and therapeutic efficacy of mirabegron 25 mg in older patients with overactive bladder and multiple comorbidities.
Kuo, HC; Lee, YK, 2018
)
0.76
"Mirabegron 25 mg once daily is a safe and effective treatment for older patients with overactive bladder."( Safety and therapeutic efficacy of mirabegron 25 mg in older patients with overactive bladder and multiple comorbidities.
Kuo, HC; Lee, YK, 2018
)
2.2
" Adverse drug reactions (ADRs), residual urine volume measurements, OAB symptoms, Overactive Bladder Symptom Scores (OABSS), and treatment discontinuations were evaluated prospectively."( Three-year safety, efficacy and persistence data following the daily use of mirabegron for overactive bladder in the clinical setting: A Japanese post-marketing surveillance study.
Kato, D; Tabuchi, H; Uno, S, 2019
)
0.74
" Safety assessments included treatment-emergent adverse events, blood pressure, pulse rate, postvoid residual volume, and maximum urinary flow rate."( Mirabegron as a treatment for overactive bladder symptoms in men (MIRACLE study): Efficacy and safety results from a multicenter, randomized, double-blind, placebo-controlled, parallel comparison phase IV study.
Bae, JH; Jeong, SJ; Joo, KJ; Kang, TW; Kim, HW; Kim, SW; Kim, YH; Koo, KC; Lee, YG; Shin, DG; Son, H; Song, SH; Woo, SH; Yoo, ES; Yoon, SJ, 2019
)
1.96
"A daily 50 mg dose of mirabegron for 12 weeks reduced OAB symptoms in men, and no significant adverse events compared to the placebo group were noted."( Mirabegron as a treatment for overactive bladder symptoms in men (MIRACLE study): Efficacy and safety results from a multicenter, randomized, double-blind, placebo-controlled, parallel comparison phase IV study.
Bae, JH; Jeong, SJ; Joo, KJ; Kang, TW; Kim, HW; Kim, SW; Kim, YH; Koo, KC; Lee, YG; Shin, DG; Son, H; Song, SH; Woo, SH; Yoo, ES; Yoon, SJ, 2019
)
2.27
" With regard to drug-related treatment-emergent adverse events (DR-TEAEs) and dry mouth, mirabegron showed better tolerance than solifenacin."( Meta-analysis of the efficacy and safety of mirabegron and solifenacin monotherapy for overactive bladder.
Cui, Y; Gao, Z; Li, Y; Wang, J; Wu, J; Yuan, H; Zhou, Z; Zhu, Z, 2019
)
1
"The therapeutic effect of mirabegron is similar to that of solifenacin, and mirabegron does not increase the risk of adverse events (AEs)."( Meta-analysis of the efficacy and safety of mirabegron and solifenacin monotherapy for overactive bladder.
Cui, Y; Gao, Z; Li, Y; Wang, J; Wu, J; Yuan, H; Zhou, Z; Zhu, Z, 2019
)
1.08
" Urodynamic parameters, including compliance, involuntary detrusor contraction, and maximum cystometric capacity, as well as patient-reported efficacy and adverse events, were measured."( Efficacy and safety of mirabegron, a β3-adrenoceptor agonist, for treating neurogenic bladder in pediatric patients with spina bifida: a retrospective pilot study.
Han, SW; Kim, SH; Kim, SW; Lee, CN; Lee, YS; Park, JS, 2019
)
0.82
" Safety assessments included treatment-emergent adverse events, vital signs, 12-lead electrocardiograms, post-void residual volume, and laboratory evaluations."( Long-term safety and efficacy of antimuscarinic add-on therapy in patients with overactive bladder who had a suboptimal response to mirabegron monotherapy: A multicenter, randomized study in Japan (MILAI II study).
Gotoh, M; Hamada, T; Homma, Y; Igawa, Y; Kakizaki, H; Kobayashi, A; Kuroishi, K; Nishizawa, O; Okitsu, A; Seki, N; Takeda, M; Yamaguchi, O; Yokoyama, O; Yoshida, M, 2019
)
0.72
"1% women, mean age 65 years) experienced at least one treatment-emergent adverse event, with similar rates for all treatments."( Long-term safety and efficacy of antimuscarinic add-on therapy in patients with overactive bladder who had a suboptimal response to mirabegron monotherapy: A multicenter, randomized study in Japan (MILAI II study).
Gotoh, M; Hamada, T; Homma, Y; Igawa, Y; Kakizaki, H; Kobayashi, A; Kuroishi, K; Nishizawa, O; Okitsu, A; Seki, N; Takeda, M; Yamaguchi, O; Yokoyama, O; Yoshida, M, 2019
)
0.72
" The OAB symptom score (OABSS), Vaginal Health Index Scale (VHIS), and occurrence of adverse effects were examined prior to and at 1 year following treatment initiation."( Efficacy and safety of non-ablative vaginal erbium:YAG laser treatment as a novel surgical treatment for overactive bladder syndrome: comparison with anticholinergics and β3-adrenoceptor agonists.
Okui, N, 2019
)
0.51
" Regarding safety, no adverse events were observed in the VEL group."( Efficacy and safety of non-ablative vaginal erbium:YAG laser treatment as a novel surgical treatment for overactive bladder syndrome: comparison with anticholinergics and β3-adrenoceptor agonists.
Okui, N, 2019
)
0.51
" CV safety was assessed using treatment-emergent adverse events (TEAEs), vital signs, and 12-lead electrocardiograms (ECGs)."( Cardiovascular safety of antimuscarinic add-on therapy in patients with overactive bladder who had a suboptimal response to mirabegron monotherapy: A post hoc analysis from the Japanese MILAI II study.
Hamada, T; Igawa, Y; Kato, D; Katoh, T; Kuroishi, K; Yamaguchi, O, 2020
)
0.76
" Safety was evaluated using the proportion of treatment-emergent adverse events."( Safety and Efficacy of Mirabegron: Analysis of a Large Integrated Clinical Trial Database of Patients with Overactive Bladder Receiving Mirabegron, Antimuscarinics, or Placebo.
Cardozo, L; Chapple, CR; Choudhury, N; Cruz, F; Heesakkers, J; Herschorn, S; Siddiqui, E; Staskin, D; Stoelzel, M, 2020
)
0.87
" Safety assessments included treatment emergent adverse events, and post-void residual volume, and maximum urinary flow measurements."( Efficacy and Safety of Mirabegron versus Placebo Add-On Therapy in Men with Overactive Bladder Symptoms Receiving Tamsulosin for Underlying Benign Prostatic Hyperplasia: A Randomized, Phase 4 Study (PLUS).
Cambronero Santos, J; Chapple, C; Choudhury, N; Foley, S; Hairston, J; Herschorn, S; Kaplan, SA; Kristy, RM; McVary, KT; Schermer, CR; Staskin, D, 2020
)
0.87
" Higher overall treatment emergent adverse event rates were observed with tamsulosin plus placebo, although higher rates of drug related treatment emergent adverse events were noted with tamsulosin plus mirabegron."( Efficacy and Safety of Mirabegron versus Placebo Add-On Therapy in Men with Overactive Bladder Symptoms Receiving Tamsulosin for Underlying Benign Prostatic Hyperplasia: A Randomized, Phase 4 Study (PLUS).
Cambronero Santos, J; Chapple, C; Choudhury, N; Foley, S; Hairston, J; Herschorn, S; Kaplan, SA; Kristy, RM; McVary, KT; Schermer, CR; Staskin, D, 2020
)
1.06
" Safety assessments that included treatment-emergent adverse events (odds ratio = 0."( The efficacy and safety of mirabegron on overactive bladder induced by benign prostatic hyperplasia in men receiving tamsulosin therapy: A systematic review and meta-analysis.
Chen, Z; Gao, Y; Liang, L; Lin, J; Liu, L; Su, S, 2020
)
0.86
"This analysis demonstrates that mirabegron is an effective and safe treatment for OAB symptoms induced by BPH in men receiving tamsulosin therapy with a low occurrence of side effects."( The efficacy and safety of mirabegron on overactive bladder induced by benign prostatic hyperplasia in men receiving tamsulosin therapy: A systematic review and meta-analysis.
Chen, Z; Gao, Y; Liang, L; Lin, J; Liu, L; Su, S, 2020
)
1.14
" Safety analyses were performed for adverse events (AEs) and vital signs on all randomized patients who received one or more dose of study drug."( Safety and Tolerability Results from the PILLAR Study: A Phase IV, Double-Blind, Randomized, Placebo-Controlled Study of Mirabegron in Patients ≥ 65 years with Overactive Bladder-Wet.
Herschorn, S; Kristy, RM; Schermer, CR; Staskin, D; Wagg, A, 2020
)
0.77
" Assessments included adverse drug reactions (ADRs), residual urine volume evaluations, and total Overactive Bladder Symptom Score (OABSS) and International Prostate Symptom Score-Quality of Life (IPSS-QoL) measurements."( Safety and effectiveness of mirabegron in male patients with overactive bladder with or without benign prostatic hyperplasia: A Japanese post-marketing study.
Kato, D; Tabuchi, H; Takahashi, S; Uno, S, 2021
)
0.92
" We did not observe any adverse effects."( Efficacy and safety of Mirabegron as adjuvant treatment in children with refractory neurogenic bladder dysfunction.
Burek, C; Corbetta, JP; Gomez, YR; Lopez Imizcoz, F; Ruiz, J; Sager, C; Sanmartino, M; Szklarz, T; Tessi, C; Vazquez Patiño, M; Weller, S, 2020
)
0.87
" Mirabegron was safe and well tolerated by children."( Efficacy and safety of Mirabegron as adjuvant treatment in children with refractory neurogenic bladder dysfunction.
Burek, C; Corbetta, JP; Gomez, YR; Lopez Imizcoz, F; Ruiz, J; Sager, C; Sanmartino, M; Szklarz, T; Tessi, C; Vazquez Patiño, M; Weller, S, 2020
)
1.78
"Cumulative exposure to one or more anticholinergic medications ("anticholinergic burden") is associated with an increased risk of adverse outcomes, particularly among older individuals."( Comparative Safety and Efficacy of Treatments for Overactive Bladder Among Older Adults: A Network Meta-analysis.
Hairston, JC; Harrigan, S; Johnston, K; Kristy, RM; Lozano-Ortega, G; Mickle, A; Rogula, B; Schermer, CR; Walker, DR, 2020
)
0.56
" In this older population, mirabegron was associated with a similar odds of experiencing adverse event-related treatment discontinuations relative to placebo (0."( Comparative Safety and Efficacy of Treatments for Overactive Bladder Among Older Adults: A Network Meta-analysis.
Hairston, JC; Harrigan, S; Johnston, K; Kristy, RM; Lozano-Ortega, G; Mickle, A; Rogula, B; Schermer, CR; Walker, DR, 2020
)
0.86
" The analysis focused on treatment-emergent adverse events relating to the cardiovascular system or blood pressure, and changes in vital signs during 12 weeks of follow-up."( Cardiovascular safety of mirabegron add-on therapy to tamsulosin for the treatment of overactive bladder in men with lower urinary tract symptoms: A post hoc analysis from the MATCH study.
Ishida, K; Jong, JJ; Kakizaki, H; Katoh, T; Katou, D; Lee, KS; Sumarsono, B; Uno, S; Yamaguchi, O; Yamamoto, O, 2021
)
0.92
"Cardiovascular-related treatment-emergent adverse events were reported by 6/566 patients, although only one serious treatment-emergent adverse event was related to treatment (unstable angina in the tamsulosin + placebo group)."( Cardiovascular safety of mirabegron add-on therapy to tamsulosin for the treatment of overactive bladder in men with lower urinary tract symptoms: A post hoc analysis from the MATCH study.
Ishida, K; Jong, JJ; Kakizaki, H; Katoh, T; Katou, D; Lee, KS; Sumarsono, B; Uno, S; Yamaguchi, O; Yamamoto, O, 2021
)
0.92
"Cardiovascular-related adverse events were uncommon in both treatment groups."( Cardiovascular safety of mirabegron add-on therapy to tamsulosin for the treatment of overactive bladder in men with lower urinary tract symptoms: A post hoc analysis from the MATCH study.
Ishida, K; Jong, JJ; Kakizaki, H; Katoh, T; Katou, D; Lee, KS; Sumarsono, B; Uno, S; Yamaguchi, O; Yamamoto, O, 2021
)
0.92
"Mirabegron is efficacious and safe in patients with NDO consequent to traumatic SCI."( Efficacy and safety of mirabegron for the treatment of neurogenic detrusor overactivity resulting from traumatic spinal cord injury: A prospective study.
Kumar, N; Prasad, V; Prashanth, YM; Saurav, K; Tyagi, V; Vasudeva, P; Yadav, S, 2021
)
2.37
"Numerous studies have shown mirabegron to be efficacious and safe in treating symptoms of OAB."( Efficacy and Safety of Mirabegron in Men with Overactive Bladder Symptoms and Benign Prostatic Hyperplasia.
Kaplan, SA; Mullen, GR, 2021
)
1.23
" A single cardiovascular study drug-related adverse event was recorded in a patient with cervical SCI (3."( Cardiovascular safety of mirabegron in individuals treated for spinal cord injury- or multiple sclerosis-induced neurogenic detrusor overactivity.
Bílková, K; Borovička, V; Cífková, R; Krhut, J; Kufová, E; Mokriš, J; Pudich, J; Sýkora, R; Wohlfahrt, P; Zachoval, R; Zvara, P, 2021
)
0.92
" Efficacy was evaluated using the OABS Score (OABSS), mean change in nocturnal frequency (NF), PVR and IPSS, while safety was assessed by recording treatment emergent adverse events (TEAE)."( Efficacy and safety of tamsulosin vs its combination with mirabegron in the management of lower urinary tract non-neurogenic overactive bladder symptoms (OABS) because of Benign Prostatic Enlargement (BPE)-An open label randomised controlled clinical stud
Behera, DP; Gupta, S; Singh, I; T K, A, 2021
)
0.87
"Mirabegron can be significantly efficacious and safe in ameliorating non-neurogenic OABS induced by BPE vs placebo by initiating combination therapy from the start as opposed to the usual 'add on therapy' protocol."( Efficacy and safety of tamsulosin vs its combination with mirabegron in the management of lower urinary tract non-neurogenic overactive bladder symptoms (OABS) because of Benign Prostatic Enlargement (BPE)-An open label randomised controlled clinical stud
Behera, DP; Gupta, S; Singh, I; T K, A, 2021
)
2.31
" Randomized controlled trials evaluating safety of mirabegron in overactive bladder were collected, and safety was assessed according to 15 adverse events."( Adverse events associated with mirabegron 50mg versus placebo: A systematic review and meta-analysis.
Du, H; Hou, J; Li, N; Xu, F, 2021
)
1.16
"Mirabegron 50mg is further confirmed to be nearly as safe as placebo, expect for nasopharyngitis."( Adverse events associated with mirabegron 50mg versus placebo: A systematic review and meta-analysis.
Du, H; Hou, J; Li, N; Xu, F, 2021
)
2.35
" Safety assessments including adverse events (P = ."( The efficacy and safety of mirabegron in treating ureteral stent-related symptoms: A systematic review and meta-analysis.
Chai, Y; Cui, Y; Li, Z; Zhang, Y, 2022
)
1.02
"The present meta-analysis shows that mirabegron is an effective and safe treatment for relieving ureteral stent-related symptoms with a low occurrence of adverse events."( The efficacy and safety of mirabegron in treating ureteral stent-related symptoms: A systematic review and meta-analysis.
Chai, Y; Cui, Y; Li, Z; Zhang, Y, 2022
)
1.29
" Eligible patients received either darifenacin or mirabegron for a period of 3 months and various parameters on the 3-day International Consultation on Incontinence Questionnaire (ICIQ) bladder diary, the Montreal Cognitive Assessment-Basic score (MoCA-B), and the adverse events at 3 months posttreatment were compared to that at the baseline."( Neurological safety and efficacy of darifenacin and mirabegron for the treatment of overactive bladder in patients with history of cerebrovascular accident: A prospective study.
Chaudhry, N; Kumar, A; Kumar, N; Nagendra Rao, S; Patel, S; Prasad, V; Vasudeva, P; Yadav, P; Yadav, S, 2021
)
1.13
" Both are safe and effective treatment options in patients with OAB post-CVA."( Neurological safety and efficacy of darifenacin and mirabegron for the treatment of overactive bladder in patients with history of cerebrovascular accident: A prospective study.
Chaudhry, N; Kumar, A; Kumar, N; Nagendra Rao, S; Patel, S; Prasad, V; Vasudeva, P; Yadav, P; Yadav, S, 2021
)
0.87
" Safety assessments included adverse events, electrocardiogram, QT corrected for heart rate using Fridericia's correction (QTcF) interval and blood pressure and pulse rate measurements."( The safety and effectiveness of mirabegron in Parkinson's disease patients with overactive bladder: a randomized controlled trial.
Chakra, MA; Dabboucy, B; Dellis, A; Fares, Y; Moussa, M; Papatsoris, A, 2022
)
1
" Adverse events were mild and the same in the two groups."( The safety and effectiveness of mirabegron in Parkinson's disease patients with overactive bladder: a randomized controlled trial.
Chakra, MA; Dabboucy, B; Dellis, A; Fares, Y; Moussa, M; Papatsoris, A, 2022
)
1
" Clinical and urodynamic parameters were pooled to evaluate the efficacy, and safety was measured by adverse events rate."( The efficacy and safety of mirabegron for adult and child patients with neurogenic lower urinary tract dysfunction: A systematic review and meta-analysis.
Boya, L; Chi, Z; Deyi, L; Liao, P; Yuanzhuo, C, 2022
)
1.02
"01), showed conspicuous improvements in adult and child patients' urodynamic parameters, while the incidence of adverse events (10."( The efficacy and safety of mirabegron for adult and child patients with neurogenic lower urinary tract dysfunction: A systematic review and meta-analysis.
Boya, L; Chi, Z; Deyi, L; Liao, P; Yuanzhuo, C, 2022
)
1.02
"This cohort study evaluates therapeutic efficacy and adverse events (AEs) of various overactive bladder (OAB) medications for patients with central nervous system (CNS) disorders."( Therapeutic efficacy and cognitive adverse events of overactive bladder medication in patients with central nervous system Disorders-A cohort study.
Chen, SF; Chuang, YC; Kuo, HC; Liao, CH; Wang, CC, 2022
)
0.72
" Aim of our study was to analyze real-life data of adverse events related to AMs and B3A reported on Eudra-Vigilance (EV) Database."( Adverse events related to antimuscarinics and beta-3-agonist: "real-life" data from the Eudra-Vigilance Database.
Cicione, A; DE Nunzio, C; DI Giacomo, F; Disabato, G; Franco, A; Gallo, G; Gravina, C; Lombardo, R; Nacchia, A; Rovesti, L; Trucchi, A; Tubaro, A; Turchi, B, 2022
)
0.72
"EV database is the system for managing and analyzing information on suspected adverse reactions to medicines which have been authorized or being studied in clinical trials in the European Economic Area (EEA)."( Adverse events related to antimuscarinics and beta-3-agonist: "real-life" data from the Eudra-Vigilance Database.
Cicione, A; DE Nunzio, C; DI Giacomo, F; Disabato, G; Franco, A; Gallo, G; Gravina, C; Lombardo, R; Nacchia, A; Rovesti, L; Trucchi, A; Tubaro, A; Turchi, B, 2022
)
0.72
" The incidence of drug-related adverse events in the solifenacin group was higher than that in the combination group, but there was no statistically significant difference (P > 0."( Efficacy and safety of combination of mirabegron and solifenacin in patients with double-J stent related overactive bladder: a prospective study.
Liu, YQ; Tang, QL; Tao, RZ; Wu, J; Zhou, S, 2022
)
0.99
" Safety outcomes for vibegron and mirabegron were similar to those in the placebo group, except for mirabegron, which had a higher risk of nasopharyngitis and cardiovascular adverse events than placebo."( Efficacy and safety of vibegron compared with mirabegron for overactive bladder: A systematic review and network meta-analysis.
He, W; Huang, G; Liu, X; Sun, Q; Tian, Y; Zhang, Y, 2023
)
1.45
"Medication was effective for OAB symptoms in patients with PD, and patients tolerated adverse events well."( The efficacy and safety of medication for treating overactive bladder in patients with Parkinson's disease: a meta-analysis and systematic review of randomized double-blind placebo-controlled trials.
Bao, Y; Cheng, B; Huang, Q; Huang, S; Zhou, Z, 2023
)
0.91
" The main secondary outcome was a composite measure of acute care encounters for anticholinergic related adverse events (AEs)."( Comparative safety of antimuscarinics versus mirabegron for overactive bladder in Parkinson disease.
Abraham, DS; Gray, SL; Hennessy, S; Leonard, CE; Liu, Q; Newcomb, CW; Pham Nguyen, TP; Weintraub, D; Willis, AW, 2023
)
1.17

Pharmacokinetics

Mirabegron OCAS exhibits similar single- and multiple-dose pharmacokinetic characteristics and deviations from dose proportionality in healthy Japanese male subjects compared with those observed in non-Japanese (primarily Caucasian) subjects. In Japanese subjects, a greater reduction in mirabEGron Cmax and AUC0-∞ was observed after a low-fat meal compared with a high- fat meal.

ExcerptReferenceRelevance
" To support the development of mirabegron, including pharmacokinetic studies, liquid chromatography/tandem mass spectrometry methods for mirabegron and eight metabolites (M5, M8, M11-M16) were developed and validated for heparinized human plasma containing sodium fluoride."( Development and validation of LC-MS/MS methods for the determination of mirabegron and its metabolites in human plasma and their application to a clinical pharmacokinetic study.
Beld, Cv; Gelderen, Mv; Meijer, J; Takusagawa, S; Teijlingen, Rv; Usui, T, 2012
)
0.9
" Mean half-life was around 40 h for both routes of administration."( Single dose pharmacokinetics and absolute bioavailability of mirabegron, a β₃-adrenoceptor agonist for treatment of overactive bladder.
Drogendijk, T; Eltink, C; Grunenberg, N; Iitsuka, H; Kerbusch, V; Kowalski, D; Lee, J; Matsushima, H; Meijer, J; Moy, S; Sawamoto, T; Schaddelee, M; van Gelderen, M; van Marle, S; Zhang, W, 2012
)
0.62
" As part of the clinical development program for mirabegron, 2 human volunteer studies were performed to derive detailed data on the multiple-dose pharmacokinetic (PK) properties of mirabegron."( Pharmacokinetic properties of mirabegron, a β3-adrenoceptor agonist: results from two phase I, randomized, multiple-dose studies in healthy young and elderly men and women.
Eltink, C; Kerbusch, V; Krauwinkel, W; Meijer, J; Schaddelee, M; Strabach, G; van Dijk, J; van Gelderen, M; van Marle, S, 2012
)
0.92
" Non-compartmental pharmacokinetic parameters were determined from plasma and urine concentration-time data of mirabegron and metabolites."( Effect of renal or hepatic impairment on the pharmacokinetics of mirabegron.
Dickinson, J; Keirns, J; Kerbusch, V; Kowalski, D; Krauwinkel, W; Kupčová, V; Lasseter, K; Lewand, M; Meijer, J; Morton, R; Moy, S; Riff, D; Sawamoto, T; Schaddelee, M; van Gelderen, M, 2013
)
0.84
" No clear relationship was evident between pharmacokinetic parameters and Child-Pugh scores."( Effect of renal or hepatic impairment on the pharmacokinetics of mirabegron.
Dickinson, J; Keirns, J; Kerbusch, V; Kowalski, D; Krauwinkel, W; Kupčová, V; Lasseter, K; Lewand, M; Meijer, J; Morton, R; Moy, S; Riff, D; Sawamoto, T; Schaddelee, M; van Gelderen, M, 2013
)
0.63
" Pharmacokinetic changes observed in subjects with mild or moderate renal impairment or mild hepatic impairment are of small magnitude and likely to be without clinical importance."( Effect of renal or hepatic impairment on the pharmacokinetics of mirabegron.
Dickinson, J; Keirns, J; Kerbusch, V; Kowalski, D; Krauwinkel, W; Kupčová, V; Lasseter, K; Lewand, M; Meijer, J; Morton, R; Moy, S; Riff, D; Sawamoto, T; Schaddelee, M; van Gelderen, M, 2013
)
0.63
"This study was designed to assess the effects of food on the pharmacokinetic properties of mirabegron OCAS in accordance with regulatory requirements to support dosing recommendations."( Effects of food intake on the pharmacokinetic properties of mirabegron oral controlled-absorption system: a single-dose, randomized, crossover study in healthy adults.
Grunenberg, N; Keirns, J; Kerbusch, V; Kowalski, D; Lee, J; Moy, S; Sawamoto, T; van Gelderen, M; Zhang, W, 2013
)
0.85
" Primary end points for the assessment of food effects were Cmax and AUC0-∞."( Effects of food intake on the pharmacokinetic properties of mirabegron oral controlled-absorption system: a single-dose, randomized, crossover study in healthy adults.
Grunenberg, N; Keirns, J; Kerbusch, V; Kowalski, D; Lee, J; Moy, S; Sawamoto, T; van Gelderen, M; Zhang, W, 2013
)
0.63
" With either fed condition or dose, the 90% CIs for the fed/fasted ratios of both Cmax and AUC0-∞ of mirabegron fell below the predetermined range for bioequivalence (80."( Effects of food intake on the pharmacokinetic properties of mirabegron oral controlled-absorption system: a single-dose, randomized, crossover study in healthy adults.
Grunenberg, N; Keirns, J; Kerbusch, V; Kowalski, D; Lee, J; Moy, S; Sawamoto, T; van Gelderen, M; Zhang, W, 2013
)
0.85
" The pharmacokinetic profile of mirabegron has been extensively characterized in healthy Caucasian subjects."( Pharmacokinetics of mirabegron, a β3-adrenoceptor agonist for treatment of overactive bladder, in healthy Japanese male subjects: results from single- and multiple-dose studies.
Amada, Y; Iitsuka, H; Katashima, M; Matsushima, H; Miyahara, H; Sawamoto, T; Takusagawa, S; Tanaka, T; Tokuno, T; van Gelderen, M, 2014
)
1.01
" Pharmacokinetic parameters were determined using non-compartmental methods."( Pharmacokinetics of mirabegron, a β3-adrenoceptor agonist for treatment of overactive bladder, in healthy Japanese male subjects: results from single- and multiple-dose studies.
Amada, Y; Iitsuka, H; Katashima, M; Matsushima, H; Miyahara, H; Sawamoto, T; Takusagawa, S; Tanaka, T; Tokuno, T; van Gelderen, M, 2014
)
0.73
"Mirabegron OCAS exhibits similar single- and multiple-dose pharmacokinetic characteristics and deviations from dose proportionality in healthy Japanese male subjects compared with those observed in non-Japanese (primarily Caucasian) subjects in previous studies."( Pharmacokinetics of mirabegron, a β3-adrenoceptor agonist for treatment of overactive bladder, in healthy Japanese male subjects: results from single- and multiple-dose studies.
Amada, Y; Iitsuka, H; Katashima, M; Matsushima, H; Miyahara, H; Sawamoto, T; Takusagawa, S; Tanaka, T; Tokuno, T; van Gelderen, M, 2014
)
2.17
"The objective of these studies was to evaluate the pharmacokinetic profile, safety, and tolerability of mirabegron, a β3-adrenoceptor agonist for the treatment of overactive bladder, including food effects (low- or high-fat meals) and sex, in healthy East Asian subjects."( Pharmacokinetics of Mirabegron, a β3-Adrenoceptor Agonist for Treatment of Overactive Bladder, in Healthy East Asian Subjects.
Iitsuka, H; Katashima, M; Sawamoto, T; Takusagawa, S; van Gelderen, M, 2015
)
0.95
"In total, 5 pharmacokinetic studies of mirabegron were conducted in healthy East Asian subjects."( Pharmacokinetics of Mirabegron, a β3-Adrenoceptor Agonist for Treatment of Overactive Bladder, in Healthy East Asian Subjects.
Iitsuka, H; Katashima, M; Sawamoto, T; Takusagawa, S; van Gelderen, M, 2015
)
1.01
" In Japanese subjects, a greater reduction in mirabegron Cmax and AUC0-∞ was observed after a low-fat meal compared with a high-fat meal."( Pharmacokinetics of Mirabegron, a β3-Adrenoceptor Agonist for Treatment of Overactive Bladder, in Healthy East Asian Subjects.
Iitsuka, H; Katashima, M; Sawamoto, T; Takusagawa, S; van Gelderen, M, 2015
)
1
" Furthermore, the effects of food on the pharmacokinetic profiles appeared to be similar among the 3 populations tested in our studies."( Pharmacokinetics of Mirabegron, a β3-Adrenoceptor Agonist for Treatment of Overactive Bladder, in Healthy East Asian Subjects.
Iitsuka, H; Katashima, M; Sawamoto, T; Takusagawa, S; van Gelderen, M, 2015
)
0.74
" Four phase 1 studies were conducted in healthy subjects to evaluate the potential for pharmacokinetic interactions between mirabegron and metformin, warfarin, digoxin, or a combination oral contraceptive (COC)."( Pharmacokinetic Interactions Between Mirabegron and Metformin, Warfarin, Digoxin or Combined Oral Contraceptives.
Groen-Wijnberg, M; Kerbusch, V; Krauwinkel, W; Meijer, J; Tretter, R; van Dijk, J; van Gelderen, M; Zhang, W, 2017
)
0.93
" Pharmacokinetic parameters were determined by non-compartmental methods."( Pharmacokinetic Interactions Between Mirabegron and Metformin, Warfarin, Digoxin or Combined Oral Contraceptives.
Groen-Wijnberg, M; Kerbusch, V; Krauwinkel, W; Meijer, J; Tretter, R; van Dijk, J; van Gelderen, M; Zhang, W, 2017
)
0.73
"This was the first study to construct a physiologically-based pharmacokinetic (PBPK) model for mirabegron which incorporates the overall elimination pathways of metabolism by cytochrome P450 (CYP) 3A4, uridine 5'-diphosphate-glucuronosyltransferase (UGT) 2B7, and butyrylcholinesterase (BChE) and renal excretion."( Physiologically-based pharmacokinetic modeling for mirabegron: a multi-elimination pathway mediated by cytochrome P450 3A4, uridine 5'-diphosphate-glucuronosyltransferase 2B7, and butyrylcholinesterase.
Konishi, K; Minematsu, T; Nagasaka, Y; Tabata, K, 2019
)
0.98
"We previously verified a physiologically based pharmacokinetic (PBPK) model for mirabegron in healthy subjects using the Simcyp Simulator by incorporating data on the inhibitory effect on cytochrome P450 (CYP) 2D6 and a multi-elimination pathway mediated by CYP3A4, uridine 5'-diphosphate-glucuronosyltransferase (UGT) 2B7 and butyrylcholinesterase (BChE)."( Application of a physiologically based pharmacokinetic model for the prediction of mirabegron plasma concentrations in a population with severe renal impairment.
Konishi, K; Minematsu, T; Nagasaka, Y; Tabata, K, 2019
)
0.97
" Potential drug-drug interactions (DDIs) following coadministration of these 2 overactive bladder treatments were estimated using physiologically based pharmacokinetic models, developed and verified by comparing predicted and observed pharmacokinetic profiles from clinical studies."( Physiologically Based Pharmacokinetic Modeling Suggests Limited Drug-Drug Interaction for Fesoterodine When Coadministered With Mirabegron.
Goosen, TC; Lin, J; Malhotra, B; Tse, S; Yamagami, H, 2019
)
0.72
" This work describes the development and verification of physiologically-based pharmacokinetic (PBPK) models for the CYP2D6-sensitive substrate, nebivolol and the index CYP2D6 inhibitors, mirabegron and cinacalcet."( Physiologically-Based Pharmacokinetic Models of CYP2D6 Substrate and Inhibitors Nebivolol, Cinacalcet and Mirabegron to Simulate Drug-Drug Interactions.
Gardner, I; Khoshaein, N; Kilford, P; Southall, R, 2022
)
1.13
"The exposure of nebivolol, cinacalcet and mirabegron predicted by the PBPK models was verified against pharmacokinetic data from 13, 3 and 9 clinical studies, respectively."( Physiologically-Based Pharmacokinetic Models of CYP2D6 Substrate and Inhibitors Nebivolol, Cinacalcet and Mirabegron to Simulate Drug-Drug Interactions.
Gardner, I; Khoshaein, N; Kilford, P; Southall, R, 2022
)
1.2

Compound-Compound Interactions

ExcerptReferenceRelevance
" In contrast to Spasmex, Mirabegron and Quercetin in combination with Testosterone and Estradiol contributed to stabilization of eNOS and nNOs expression already at early observation phases, and reduced the level of iNOS expression with its further disappearance in the later observation period."( MORPHOLOGICAL ASSESSMENT OF NO-SYNTHASE DISTRIBUTION IN OVERACTIVE BLADDER AND STRESS URINE INCONTINENCE IN ANIMAL MODELS ADMINISTERED WITH EXPERIMENTAL PHARMACOCORRECTION REGIMENS.
Iatsyna, O; Kostyev, F; Vernygorodskyi, S, 2018
)
0.78
" Potential drug-drug interactions (DDIs) following coadministration of these 2 overactive bladder treatments were estimated using physiologically based pharmacokinetic models, developed and verified by comparing predicted and observed pharmacokinetic profiles from clinical studies."( Physiologically Based Pharmacokinetic Modeling Suggests Limited Drug-Drug Interaction for Fesoterodine When Coadministered With Mirabegron.
Goosen, TC; Lin, J; Malhotra, B; Tse, S; Yamagami, H, 2019
)
0.72
" The performance of the PBPK models was verified by comparing the simulated results against reported human systemic exposure and clinical drug-drug interactions (DDIs) studies."( Physiologically-Based Pharmacokinetic Models of CYP2D6 Substrate and Inhibitors Nebivolol, Cinacalcet and Mirabegron to Simulate Drug-Drug Interactions.
Gardner, I; Khoshaein, N; Kilford, P; Southall, R, 2022
)
0.93

Bioavailability

Mirabegron extended release formulation shows dose-dependent oral bioavailability in humans. Saturation of intestinal efflux abilities leading to higher absorption with higher doses.

ExcerptReferenceRelevance
") and oral doses, absolute bioavailability (F), dose proportionality, sex differences and tolerability were assessed in 2 single-dose, open-label, randomized, parallel-group, cross-over studies in healthy men (exploratory Study 1, n = 12) and men and women (Study 2, n = 91)."( Single dose pharmacokinetics and absolute bioavailability of mirabegron, a β₃-adrenoceptor agonist for treatment of overactive bladder.
Drogendijk, T; Eltink, C; Grunenberg, N; Iitsuka, H; Kerbusch, V; Kowalski, D; Lee, J; Matsushima, H; Meijer, J; Moy, S; Sawamoto, T; Schaddelee, M; van Gelderen, M; van Marle, S; Zhang, W, 2012
)
0.62
" Involvement of saturable efflux transporters is indicated in oral bioavailability of mirabegron."( The pharmacokinetic evaluation of mirabegron as an overactive bladder therapy option.
Kashyap, M; Tyagi, P, 2013
)
0.89
" Mirabegron extended release formulation shows dose-dependent oral bioavailability in humans, which is likely attributable to saturation of intestinal efflux abilities leading to higher absorption with higher doses."( Intestinal absorption mechanism of mirabegron, a potent and selective β₃-adrenoceptor agonist: involvement of human efflux and/or influx transport systems.
Iwatsubo, T; Kerbusch, V; Li, Q; Miyashita, A; Nemoto, H; Takahashi, Y; Takusagawa, S; Ushigome, F; Usui, T, 2013
)
1.58
" Bioavailability studies were conducted in Wistar rats after oral administration of plain MBN dispersion, MBN-SLN, and MBN-PEG-SLN."( Development and Optimization of Mirabegron Solid Lipid Nanoparticles as an Oral Drug Delivery for Overactive Bladder.
Gambhire, M; Gambhire, V; Panchal, D; Raut, P, 2021
)
0.9
"Thus, the study established that the oral bioavailability of MBN could be improved by the administration of MBN-PEG-SLN."( Development and Optimization of Mirabegron Solid Lipid Nanoparticles as an Oral Drug Delivery for Overactive Bladder.
Gambhire, M; Gambhire, V; Panchal, D; Raut, P, 2021
)
0.9

Dosage Studied

The purpose of the study was to characterize the PK of mirabegron in pediatric patients with neurogenic detrusor overactivity or idiopathic OAB. It was also to provide a basis for a weight-based dosing algorithm, and to evaluate the safety, tolerability, and palatability/acceptability of the formulations.

ExcerptRelevanceReference
" dosing (7."( Single dose pharmacokinetics and absolute bioavailability of mirabegron, a β₃-adrenoceptor agonist for treatment of overactive bladder.
Drogendijk, T; Eltink, C; Grunenberg, N; Iitsuka, H; Kerbusch, V; Kowalski, D; Lee, J; Matsushima, H; Meijer, J; Moy, S; Sawamoto, T; Schaddelee, M; van Gelderen, M; van Marle, S; Zhang, W, 2012
)
0.62
" Excretion of unchanged mirabegron in urine over the 24-hour dosing interval (Ae(0-τ)%) increased from approximately 7% at 25 mg to 18% at 300 mg once daily in young subjects."( Pharmacokinetic properties of mirabegron, a β3-adrenoceptor agonist: results from two phase I, randomized, multiple-dose studies in healthy young and elderly men and women.
Eltink, C; Kerbusch, V; Krauwinkel, W; Meijer, J; Schaddelee, M; Strabach, G; van Dijk, J; van Gelderen, M; van Marle, S, 2012
)
0.97
"This study was designed to assess the effects of food on the pharmacokinetic properties of mirabegron OCAS in accordance with regulatory requirements to support dosing recommendations."( Effects of food intake on the pharmacokinetic properties of mirabegron oral controlled-absorption system: a single-dose, randomized, crossover study in healthy adults.
Grunenberg, N; Keirns, J; Kerbusch, V; Kowalski, D; Lee, J; Moy, S; Sawamoto, T; van Gelderen, M; Zhang, W, 2013
)
0.85
" Steady-state mirabegron pharmacokinetic parameters (50 and 100 mg mirabegron OCAS) were similar in 13 CYP2D6 poor, 40 intermediate, and 99 extensive metabolizers, whereas C max and AUC under the dosing interval τ of 24 h (AUCτ) were 30-47 % lower in 10 ultrarapid metabolizers."( Role of cytochrome p450 isoenzymes 3A and 2D6 in the in vivo metabolism of mirabegron, a β3-adrenoceptor agonist.
Keirns, J; Kerbusch, V; Kowalski, D; Krauwinkel, W; Lee, J; Marion, A; Meijer, J; Moy, S; Roy, M; Sawamoto, T; Takusagawa, S; van Gelderen, M, 2013
)
0.98
" Mirabegron accumulated twofold upon once-daily dosing relative to single-dose data."( Pharmacokinetics of mirabegron, a β3-adrenoceptor agonist for treatment of overactive bladder, in healthy Japanese male subjects: results from single- and multiple-dose studies.
Amada, Y; Iitsuka, H; Katashima, M; Matsushima, H; Miyahara, H; Sawamoto, T; Takusagawa, S; Tanaka, T; Tokuno, T; van Gelderen, M, 2014
)
1.64
" The secondary objective was to explore the dose-response relationship and the safety/tolerability compared with placebo and monotherapy."( Combination treatment with mirabegron and solifenacin in patients with overactive bladder: efficacy and safety results from a randomised, double-blind, dose-ranging, phase 2 study (Symphony).
Abrams, P; Kay, R; Kelleher, C; Martina, R; Newgreen, D; Paireddy, A; Rechberger, T; Ridder, A; Staskin, D; van Maanen, R, 2015
)
0.71
" Mirabegron accumulated 2- to 3-fold on once-daily dosing of multiple-dose relative to single-dose data."( Pharmacokinetics of Mirabegron, a β3-Adrenoceptor Agonist for Treatment of Overactive Bladder, in Healthy East Asian Subjects.
Iitsuka, H; Katashima, M; Sawamoto, T; Takusagawa, S; van Gelderen, M, 2015
)
1.65
" The dosage of mirabegron was 50 mg per day."( [Persistence in the treatment of overactive bladder (OAB) with Mirabegron in a multicentre clinical study].
Hanuš, T; Krhut, J; Martan, A; Mašata, J; Švabík, K, 2015
)
1.01
" The dosage of Mirabegron was 50 mg per day in 162 patients, though for 44 of the patients the treatment was changed."( [Cure effect and persistence of treatment with Mirabegron in patients with symptoms of overactive bladder: a multicentre clinical study].
Hanuš, T; Krhut, J; Martan, A; Mašata, J; Švabík, K; Zachoval, R,
)
0.74
" Tolterodine ER was dosed at 4 mg for 8 weeks and mirabegron was dosed at 25 mg for 4 weeks then increased to 50 mg for the next 4 weeks."( Patient-reported outcomes in patients with overactive bladder treated with mirabegron and tolterodine in a prospective, double-blind, randomized, two-period crossover, multicenter study (PREFER).
Fialkov, J; Gooch, K; Herschorn, S; Schermer, CR; Staskin, D; Tu, LM; Walsh, T, 2018
)
0.96
" We also found that increasing value of total payment and increasing frequency of payments were both independently associated with increased odds of prescribing with a dose-response effect."( The Receipt of Industry Payments is Associated With Prescribing Promoted Alpha-blockers and Overactive Bladder Medications.
Chang, SL; Dupree, JM; Kirk, PS; Modi, PK; Singer, EA; Wang, Y, 2018
)
0.48
" A dose-response study was conducted in 6 pigs to select the highest intravenous dose of mirabegron without significant detrimental hemodynamic effect."( Mirabegron, a Clinically Approved β3 Adrenergic Receptor Agonist, Does Not Reduce Infarct Size in a Swine Model of Reperfused Myocardial Infarction.
Fernández-Jiménez, R; Galán-Arriola, C; García-Álvarez, A; García-Prieto, J; García-Ruiz, JM; Ibanez, B; Lobo-Gonzalez, M; Piñero, A; Pizarro, G; Rossello, X; Sánchez-González, J; Sanz-Rosa, D; Vilchez, JP, 2018
)
2.15
" The OAB-q could detect dose-response relationships in some studies and demonstrated there were no significant differences across therapies from different drug classes."( Characterizing the Health-Related Quality of Life Burden of Overactive Bladder Using Disease-Specific Patient-Reported Outcome Measures: A Systematic Literature Review.
Johnston, KM; Lakzadeh, P; Walker, DR, 2019
)
0.51
"A phase IV study comparing flexibly dosed mirabegron versus placebo in elderly patients with OAB and urgency incontinence."( Efficacy, safety, and tolerability of mirabegron in patients aged ≥65yr with overactive bladder wet: a phase IV, double-blind, randomised, placebo-controlled study (PILLAR).
Engel, E; Herschorn, S; Kristy, RM; Schermer, CR; Staskin, D; Wagg, A, 2020
)
1.09
"The purpose of the study was to characterize the PK of mirabegron in pediatric patients with neurogenic detrusor overactivity or idiopathic OAB, to provide a basis for a weight-based dosing algorithm, and to evaluate the safety, tolerability, and palatability/acceptability of the formulations."( The pharmacokinetics, safety, and tolerability of mirabegron in children and adolescents with neurogenic detrusor overactivity or idiopathic overactive bladder and development of a population pharmacokinetic model-based pediatric dose estimation.
Baka-Ostrowska, M; Bosman, B; Kjaeer, B; Passier, P; Rittig, S; Stroosma, O; Tannenbaum, S; Tøndel, C; Walle, JV, 2020
)
1.06
" The finalized PK model used to characterize the pediatric PK of mirabegron will be utilized to develop a weight-based dosing algorithm."( The pharmacokinetics, safety, and tolerability of mirabegron in children and adolescents with neurogenic detrusor overactivity or idiopathic overactive bladder and development of a population pharmacokinetic model-based pediatric dose estimation.
Baka-Ostrowska, M; Bosman, B; Kjaeer, B; Passier, P; Rittig, S; Stroosma, O; Tannenbaum, S; Tøndel, C; Walle, JV, 2020
)
1.05
"The present review provides an insight into the mechanism, pharmacokinetics, toxicokinetics, clinical trials and the development of various conventional and modified-release dosage forms of mirabegron for the treatment of overactive bladder syndrome."( Potential of Mirabegron and its Extended-release Formulations for the Treatment of Overactive Bladder Syndrome.
Mandpe, P; Prabhakar, B; Shende, P, 2020
)
1.12
" The modified-release tablet dosage form of mirabegron appear to be a proficient and suitable replacement for antimuscarinics and revealed the tremendous potential to overcome the adverse effects of conventional antimuscarinic drugs like Oxybutyline chloride ER, Detrol LA, VESIcare, etc."( Potential of Mirabegron and its Extended-release Formulations for the Treatment of Overactive Bladder Syndrome.
Mandpe, P; Prabhakar, B; Shende, P, 2020
)
1.19
"We conducted this meta-analysis to explore the tolerance of monotherapy with mirabegron (50 mg) on an overactive bladder, compared with a common dosage of anticholinergic agents."( Monotherapy with mirabegron had a better tolerance than the anticholinergic agents on overactive bladder: A systematic review and meta-analysis.
Yang, J; Yang, Y; Yi, W, 2021
)
1.19
" This could be associated with fewer side effects due to drug dosage reduction."( Efficacy of overactive neurogenic bladder treatment: A systematic review of randomized controlled trials.
Bapir, R; Bhatti, KH; Buchholz, N; Eliwa, A; García-Perdomo, HA; Gherabi, N; Hennessey, D; Magri, V; Mourmouris, P; Ouattara, A; Perletti, G; Philipraj, J; Stamatiou, K; Trinchieri, A, 2022
)
0.72
"Green spectrofluorimetric methods have been adopted for the determination of Mirabegron (MG) in pure drug and pharmaceutical dosage form."( Spectrofluorimetric methods for the determination of mirabegron by quenching tyrosine and L-tryptophan fluorophores: Recognition of quenching mechanism by stern volmer relationship, evaluation of binding constants and binding sites.
Abdellatef, HE; Farid, NA; Sharaf, YA; Youssef, NF, 2023
)
1.39
" All women with OAB received daily dosage of 50 mg of mirabegron for 12 weeks."( Urinary beta 3-adrenoceptor as a diagnostic biomarker for overactive bladder in women.
Chou, YC; Hsieh, WC; Huang, JY; Huang, TX; Huang, YH; Liang, CC; Lo, TS, 2023
)
1.16
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (1)

RoleDescription
beta-adrenergic agonistAn agent that selectively binds to and activates beta-adrenergic receptors.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (4)

ClassDescription
1,3-thiazoles
aromatic amideAn amide in which the amide linkage is bonded directly to an aromatic system.
ethanolamines
monocarboxylic acid amideA carboxamide derived from a monocarboxylic acid.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Bioassays (40)

Assay IDTitleYearJournalArticle
AID1238586Cardiotoxicity in anesthetized Sprague-Dawley rat assessed as decrease in mean blood pressure at 1 mg/kg, iv measured for 30 mins relative to control2015Journal of medicinal chemistry, Aug-13, Volume: 58, Issue:15
Discovery of Novel Indazole Derivatives as Highly Potent and Selective Human β3-Adrenergic Receptor Agonists with the Possibility of Having No Cardiovascular Side Effects.
AID1218443Drug recovery in healthy human plasma at 160 mg, po as single dose measured at 2 hrs2012Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 40, Issue:4
Absorption, metabolism and excretion of [(14)C]mirabegron (YM178), a potent and selective β(3)-adrenoceptor agonist, after oral administration to healthy male volunteers.
AID1218445Drug recovery in healthy human plasma at 160 mg, po as single dose measured at 8 hrs2012Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 40, Issue:4
Absorption, metabolism and excretion of [(14)C]mirabegron (YM178), a potent and selective β(3)-adrenoceptor agonist, after oral administration to healthy male volunteers.
AID1276835Increase in circulating free fatty acid level in iv infused Sprague-Dawley rat after 45 mins by liquid chromatography-tandem mass spectrometric analysis2016Journal of medicinal chemistry, Jan-28, Volume: 59, Issue:2
Discovery of Vibegron: A Potent and Selective β3 Adrenergic Receptor Agonist for the Treatment of Overactive Bladder.
AID1218410Absolute oral bioavailability in rat at 30 mg/kg2012Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 40, Issue:4
Absorption, metabolism and excretion of [(14)C]mirabegron (YM178), a potent and selective β(3)-adrenoceptor agonist, after oral administration to healthy male volunteers.
AID1238584Cardiotoxicity in anesthetized Sprague-Dawley rat assessed as decrease in heart rate at 1 mg/kg, iv measured for 30 mins relative to control2015Journal of medicinal chemistry, Aug-13, Volume: 58, Issue:15
Discovery of Novel Indazole Derivatives as Highly Potent and Selective Human β3-Adrenergic Receptor Agonists with the Possibility of Having No Cardiovascular Side Effects.
AID1218441Drug recovery in healthy human urine at 160 mg, po as single dose measured up to 48 hrs2012Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 40, Issue:4
Absorption, metabolism and excretion of [(14)C]mirabegron (YM178), a potent and selective β(3)-adrenoceptor agonist, after oral administration to healthy male volunteers.
AID1218455Terminal elimination phase half life in healthy human urine at 160 mg, po as single dose2012Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 40, Issue:4
Absorption, metabolism and excretion of [(14)C]mirabegron (YM178), a potent and selective β(3)-adrenoceptor agonist, after oral administration to healthy male volunteers.
AID1238583Cardiotoxicity in anesthetized Sprague-Dawley rat assessed as increase in heart rate at 1 mg/kg, iv measured for 30 mins relative to control2015Journal of medicinal chemistry, Aug-13, Volume: 58, Issue:15
Discovery of Novel Indazole Derivatives as Highly Potent and Selective Human β3-Adrenergic Receptor Agonists with the Possibility of Having No Cardiovascular Side Effects.
AID1481944Cardiotoxicity in Sprague-Dawley rat assessed as increase in heart beat rate at 3 mg/kg, iv after 30 mins (Rvb = 1.8 +/- 0.9%)
AID1238588Cardiotoxicity in anesthetized Sprague-Dawley rat assessed as decrease in heart rate at 3 mg/kg, iv measured for 30 mins relative to control2015Journal of medicinal chemistry, Aug-13, Volume: 58, Issue:15
Discovery of Novel Indazole Derivatives as Highly Potent and Selective Human β3-Adrenergic Receptor Agonists with the Possibility of Having No Cardiovascular Side Effects.
AID1481946Cardiotoxicity in Sprague-Dawley rat assessed as increase in mean blood pressure at 3 mg/kg, iv after 30 mins (Rvb = 1 +/- 0.5%)
AID1218428Renal clearance in healthy human plasma at 160 mg, po as single dose2012Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 40, Issue:4
Absorption, metabolism and excretion of [(14)C]mirabegron (YM178), a potent and selective β(3)-adrenoceptor agonist, after oral administration to healthy male volunteers.
AID1218456Drug recovery in healthy human urine at 160 mg, po as single dose measured up to 408 hrs2012Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 40, Issue:4
Absorption, metabolism and excretion of [(14)C]mirabegron (YM178), a potent and selective β(3)-adrenoceptor agonist, after oral administration to healthy male volunteers.
AID1238592Cardiotoxicity in anesthetized Sprague-Dawley rat assessed as decrease in mean blood pressure at 1 mg/kg, iv measured for 30 mins relative to control in presence of 0.01 mg/kg, iv of alpha1A-AR antagonist silodosin2015Journal of medicinal chemistry, Aug-13, Volume: 58, Issue:15
Discovery of Novel Indazole Derivatives as Highly Potent and Selective Human β3-Adrenergic Receptor Agonists with the Possibility of Having No Cardiovascular Side Effects.
AID1481942Inhibition of CYP2D6 (unknown origin) at 10 uM relative to control
AID1276834Increase in circulating glycerol level in iv infused Sprague-Dawley rat after 45 mins by liquid chromatography-tandem mass spectrometric analysis2016Journal of medicinal chemistry, Jan-28, Volume: 59, Issue:2
Discovery of Vibegron: A Potent and Selective β3 Adrenergic Receptor Agonist for the Treatment of Overactive Bladder.
AID1218413Absolute oral bioavailability in dog at 1 mg/kg2012Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 40, Issue:4
Absorption, metabolism and excretion of [(14)C]mirabegron (YM178), a potent and selective β(3)-adrenoceptor agonist, after oral administration to healthy male volunteers.
AID1481945Cardiotoxicity in Sprague-Dawley rat assessed as decrease in heart beat rate at 3 mg/kg, iv after 30 mins (Rvb = 4.5 +/- 0.8%)
AID1218444Drug recovery in healthy human plasma at 160 mg, po as single dose measured at 4 hrs2012Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 40, Issue:4
Absorption, metabolism and excretion of [(14)C]mirabegron (YM178), a potent and selective β(3)-adrenoceptor agonist, after oral administration to healthy male volunteers.
AID1218426Apparent oral clearance in healthy human plasma at 160 mg, po as single dose2012Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 40, Issue:4
Absorption, metabolism and excretion of [(14)C]mirabegron (YM178), a potent and selective β(3)-adrenoceptor agonist, after oral administration to healthy male volunteers.
AID1481947Cardiotoxicity in Sprague-Dawley rat assessed as decrease in mean blood pressure at 3 mg/kg, iv after 30 mins (Rvb = 5.4 +/- 1.9%)
AID1218452Cmax in healthy human plasma at 160 mg, po as single dose2012Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 40, Issue:4
Absorption, metabolism and excretion of [(14)C]mirabegron (YM178), a potent and selective β(3)-adrenoceptor agonist, after oral administration to healthy male volunteers.
AID1218451Tmax in healthy human plasma at 160 mg, po as single dose2012Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 40, Issue:4
Absorption, metabolism and excretion of [(14)C]mirabegron (YM178), a potent and selective β(3)-adrenoceptor agonist, after oral administration to healthy male volunteers.
AID1218412Absolute oral bioavailability in dog at 0.5 mg/kg2012Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 40, Issue:4
Absorption, metabolism and excretion of [(14)C]mirabegron (YM178), a potent and selective β(3)-adrenoceptor agonist, after oral administration to healthy male volunteers.
AID1238587Cardiotoxicity in anesthetized Sprague-Dawley rat assessed as increase in heart rate at 3 mg/kg, iv measured for 30 mins relative to control2015Journal of medicinal chemistry, Aug-13, Volume: 58, Issue:15
Discovery of Novel Indazole Derivatives as Highly Potent and Selective Human β3-Adrenergic Receptor Agonists with the Possibility of Having No Cardiovascular Side Effects.
AID1218408Absolute oral bioavailability in rat at 3 mg/kg2012Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 40, Issue:4
Absorption, metabolism and excretion of [(14)C]mirabegron (YM178), a potent and selective β(3)-adrenoceptor agonist, after oral administration to healthy male volunteers.
AID1238589Cardiotoxicity in anesthetized Sprague-Dawley rat assessed as increase in mean blood pressure at 3 mg/kg, iv measured for 30 mins relative to control2015Journal of medicinal chemistry, Aug-13, Volume: 58, Issue:15
Discovery of Novel Indazole Derivatives as Highly Potent and Selective Human β3-Adrenergic Receptor Agonists with the Possibility of Having No Cardiovascular Side Effects.
AID1238590Cardiotoxicity in anesthetized Sprague-Dawley rat assessed as decrease in mean blood pressure at 3 mg/kg, iv measured for 30 mins relative to control2015Journal of medicinal chemistry, Aug-13, Volume: 58, Issue:15
Discovery of Novel Indazole Derivatives as Highly Potent and Selective Human β3-Adrenergic Receptor Agonists with the Possibility of Having No Cardiovascular Side Effects.
AID1218453AUC (infinity) in healthy human plasma at 160 mg, po as single dose2012Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 40, Issue:4
Absorption, metabolism and excretion of [(14)C]mirabegron (YM178), a potent and selective β(3)-adrenoceptor agonist, after oral administration to healthy male volunteers.
AID1238585Cardiotoxicity in anesthetized Sprague-Dawley rat assessed as increase in mean blood pressure at 1 mg/kg, iv measured for 30 mins relative to control2015Journal of medicinal chemistry, Aug-13, Volume: 58, Issue:15
Discovery of Novel Indazole Derivatives as Highly Potent and Selective Human β3-Adrenergic Receptor Agonists with the Possibility of Having No Cardiovascular Side Effects.
AID1238591Cardiotoxicity in anesthetized Sprague-Dawley rat assessed as increase in heart rate at 1 mg/kg, iv measured for 30 mins relative to control in presence of 0.01 mg/kg, iv of alpha1A-AR antagonist silodosin2015Journal of medicinal chemistry, Aug-13, Volume: 58, Issue:15
Discovery of Novel Indazole Derivatives as Highly Potent and Selective Human β3-Adrenergic Receptor Agonists with the Possibility of Having No Cardiovascular Side Effects.
AID1218411Absolute oral bioavailability in dog at 0.25 mg/kg2012Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 40, Issue:4
Absorption, metabolism and excretion of [(14)C]mirabegron (YM178), a potent and selective β(3)-adrenoceptor agonist, after oral administration to healthy male volunteers.
AID1218454Terminal elimination phase half life in healthy human plasma at 160 mg, po as single dose2012Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 40, Issue:4
Absorption, metabolism and excretion of [(14)C]mirabegron (YM178), a potent and selective β(3)-adrenoceptor agonist, after oral administration to healthy male volunteers.
AID1218409Absolute oral bioavailability in rat at 10 mg/kg2012Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 40, Issue:4
Absorption, metabolism and excretion of [(14)C]mirabegron (YM178), a potent and selective β(3)-adrenoceptor agonist, after oral administration to healthy male volunteers.
AID1218427Apparent volume of distribution during terminal phase in healthy human plasma at 160 mg, po as single dose2012Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 40, Issue:4
Absorption, metabolism and excretion of [(14)C]mirabegron (YM178), a potent and selective β(3)-adrenoceptor agonist, after oral administration to healthy male volunteers.
AID1218446Drug recovery in healthy human plasma at 160 mg, po as single dose measured at 12 hrs2012Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 40, Issue:4
Absorption, metabolism and excretion of [(14)C]mirabegron (YM178), a potent and selective β(3)-adrenoceptor agonist, after oral administration to healthy male volunteers.
AID1346250Human beta2-adrenoceptor (Adrenoceptors)2007The Journal of pharmacology and experimental therapeutics, May, Volume: 321, Issue:2
Effect of (R)-2-(2-aminothiazol-4-yl)-4'-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl} acetanilide (YM178), a novel selective beta3-adrenoceptor agonist, on bladder function.
AID1346297Human beta3-adrenoceptor (Adrenoceptors)2007The Journal of pharmacology and experimental therapeutics, May, Volume: 321, Issue:2
Effect of (R)-2-(2-aminothiazol-4-yl)-4'-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl} acetanilide (YM178), a novel selective beta3-adrenoceptor agonist, on bladder function.
AID1346260Human beta1-adrenoceptor (Adrenoceptors)2007The Journal of pharmacology and experimental therapeutics, May, Volume: 321, Issue:2
Effect of (R)-2-(2-aminothiazol-4-yl)-4'-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl} acetanilide (YM178), a novel selective beta3-adrenoceptor agonist, on bladder function.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (543)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's3 (0.55)29.6817
2010's342 (62.98)24.3611
2020's198 (36.46)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 113.23

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index113.23 (24.57)
Research Supply Index6.54 (2.92)
Research Growth Index6.91 (4.65)
Search Engine Demand Index204.92 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (113.23)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials131 (23.48%)5.53%
Reviews102 (18.28%)6.00%
Case Studies6 (1.08%)4.05%
Observational22 (3.94%)0.25%
Other297 (53.23%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (157)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Is Mirabegron 25 mg Safe and Effective in Treatment of Primary Nocturnal Enuresis as Regard Oral Desmopressin 120 mcg? [NCT05617664]150 participants (Anticipated)Interventional2022-11-23Recruiting
An Open-label, Randomized, 2-way Crossover Study to Evaluate the Pharmacokinetics of Mirabegron and Its Metabolites in Healthy Young and Elderly Male and Female Subjects [NCT01285596]Phase 175 participants (Actual)Interventional2009-03-31Completed
Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence [NCT05806164]Phase 4432 participants (Anticipated)Interventional2023-06-06Recruiting
Mirabegron for Treatment of Erectile Dysfunction in Patients With LUTS Secondry to BPH: A Randomized Study [NCT03600766]Phase 250 participants (Anticipated)Interventional2018-08-01Active, not recruiting
A Phase 1b, Randomized, Double-Masked, Parallel Group, Placebo Controlled Study to Assess Intraocular Pressure and Ocular Safety of the Beta-3 Agonist Mirabegron in Research Subjects [NCT01284309]Phase 1321 participants (Actual)Interventional2010-11-30Completed
A Phase 1, Randomized, Double-Blind, Placebo and Active Controlled, Parallel Crossover Study to Evaluate the Effect of Repeat Oral Doses of Mirabegron on Cardiac Repolarization in Healthy Male and Female Adult Subjects [NCT01199523]Phase 1352 participants (Actual)Interventional2010-05-31Completed
A Double-blind Two-sequence Crossover Study to Evaluate the Effect of Multiple Doses of YM178 on the Pharmacokinetics (PK) of an Ethinyl Estradiol and Levonorgestrel Containing Combined Oral Contraceptive (COC) [NCT01297179]Phase 130 participants (Actual)Interventional2008-10-31Completed
Far Eastern Memorial Hospital [NCT03695822]Phase 40 participants (Actual)Interventional2018-12-24Withdrawn(stopped due to I did not pass the 2018 Ministry of Science and Technology research project subsidy, so I applied for the project to close the case.)
Comparative Study of Solifenacin and Mirabegron in Treatment of Overactive Bladder Symptoms in Men After Transurethral Resection of the Prostate - A Randomized Prospective Study [NCT03632772]Phase 2130 participants (Anticipated)Interventional2018-08-01Recruiting
A Prospective, Non-interventional, Registry Study of Patients Initiating a Course of DrugTherapy for Overactive Bladder (OAB) [NCT02386072]1,524 participants (Actual)Observational2015-01-05Completed
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Comparison Clinical Study to Investigate the Efficacy and Safety of the β3 Adrenoceptor Agonist, Mirabegron With Overactive Bladder Symptoms in Men [NCT02361502]Phase 4462 participants (Anticipated)Interventional2015-02-28Recruiting
A Phase 1, Open-Label, Single Oral Dose Study to Assess the Safety, Pharmacokinetics and Effect of Food on the Pharmacokinetics of Mirabegron (YM178) in Healthy Volunteers [NCT01334905]Phase 112 participants (Actual)Interventional2011-03-31Completed
A Phase 1 Study to Evaluate the Effect of Steady State Solifenacin and Mirabegron on the Steady State Pharmacokinetics of Digoxin in Healthy Subjects [NCT02127034]Phase 126 participants (Actual)Interventional2014-03-31Completed
Treatment Persistence Among Patients With Overactive Bladder: A Retrospective Secondary Data Analysis in Asia Oceania [NCT03602508]5,589 participants (Actual)Observational2018-07-20Completed
An Open-label, One-sequence, Two-arm Study to Evaluate the Effect of Steady State Concentrations of Mirabegron on the Pharmacokinetics of Solifenacin and to Evaluate the Effect of Steady State Concentrations of Solifenacin on the Pharmacokinetics of Mirab [NCT01297192]Phase 141 participants (Actual)Interventional2009-03-31Completed
An Exploratory Study Into the Mechanism of Mirabegron-induced Cardiovascular Effects in Healthy Male Subjects. [NCT01284868]Phase 112 participants (Actual)Interventional2009-07-31Completed
A Randomized, Double-blind, Parallel Group, Proof of Concept Study of YM178 in Comparison With Placebo and Tolterodine in Patients With Symptomatic Overactive Bladder [NCT01604928]Phase 2260 participants (Actual)Interventional2004-04-30Completed
Comparisons of the Impact of Monotherapy With Mirabegron or Tolterodine Versus Combined Treatment With Mirabegron and Tolterodine on Autonomic Function and Bladder Blow Flow in Women With Overactive Bladder Syndrome: a Randomized Controlled Study [NCT05946902]Phase 4150 participants (Anticipated)Interventional2023-09-12Recruiting
Mirabegron, Propevirine, Solifenacin for Treatment of Lower Urinary Tract Symptoms During Intravesical BCG Instillation: Prospective Randomized Controlled Trial [NCT05490082]Phase 3100 participants (Anticipated)Interventional2022-03-01Recruiting
Effects of Sympathicomimetic Agonists on the Disease Course and Mutant Allele Burden in Patients With JAK2-mutated Myeloproliferative Neoplasms. A Multicenter Phase II Trial. [NCT02311569]Phase 239 participants (Actual)Interventional2015-04-30Completed
Effect of Mirabegron on Bladder Compliance ; a Prospective Paired Comparison of Mirabegron and Anticholinergics in Patients With Low Bladder Compliance [NCT05745584]15 participants (Anticipated)Interventional2016-01-12Active, not recruiting
Non-Interventional Study Assessing Quality of Life, Treatment Satisfaction, Resource Utilisation, and Persistence With Treatment in Overactive Bladder (OAB) Patients Prescribed Betmiga® - A Multicenter Non-interventional Post Authorisation Study (PAS) [NCT02320773]863 participants (Actual)Observational2014-11-25Completed
Treatment of Spinal Cord Injury Patients for Neurogenic Bladder: an Open Label Pilot Study of Anticholinergic Agent vs. Mirabegron (MYRBETRIQ ®) to Evaluate Cognitive Impact and Efficacy [NCT03612401]Early Phase 120 participants (Actual)Interventional2018-12-05Completed
Mirabegron For Erectile Dysfunction [NCT02916693]Phase 1/Phase 220 participants (Actual)Interventional2017-08-01Completed
A Randomized, Double-Blind, Parallel Group, Active Controlled, Multi-center Long-term Study to Assess the Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) 50 mg qd and 100 mg qd in Subjects With Symptoms of Overactive Bladder [NCT00688688]Phase 32,792 participants (Actual)Interventional2008-04-25Completed
A Phase 2, Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi-center Study to Evaluate the Urodynamics and Safety of YM178 in Male Subjects With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO) [NCT00410514]Phase 2200 participants (Actual)Interventional2006-12-31Completed
A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men With Overactive Bladder (OAB) Symptoms While Taking the Alpha Blocker Tamsulosin Hydrochloride for Lower Ur [NCT02757768]Phase 4715 participants (Actual)Interventional2016-06-13Completed
Therapeutic Efficacy and Safety of Mirabegron , a β3-Adrenoceptor Agonist, Treatment on Patients With Overactive Bladder Syndrome in Taiwan - Predictive Factors for the First Line Use and the Dose Effectiveness Relationship [NCT03059134]Phase 3168 participants (Actual)Interventional2015-04-28Completed
Identifying Responsible Signaling Pathway for Adrenergic Beta-3 Receptor Regulation in Human Subcutaneous White Adipose Tissue [NCT05634174]Phase 140 participants (Anticipated)Interventional2023-09-01Not yet recruiting
Mirabegron and Physiological Function in Cold Environments - Aim 1 [NCT04766021]Phase 1/Phase 230 participants (Actual)Interventional2021-11-30Completed
Phase II Trial of the Combination of Alpha-lipoic Acid and Mirabegron in Women and in Men With Obesity [NCT05713799]Phase 260 participants (Anticipated)Interventional2024-01-03Not yet recruiting
Ureteral Stent-related Pain and Mirabegron (SPAM) Trial [NCT02095665]Phase 422 participants (Actual)Interventional2014-01-01Completed
Effectiveness of a Structured Intervention to Optimize Both the Use of Mirabegron, a β3 Receptor Agonist, and Facilitate Its Discontinuation: a Quasi-experimental Study [NCT03536494]1,932 participants (Actual)Interventional2017-01-01Completed
Predictors Affecting Long-term Use of Solifenacin or Mirabegron in Women With Overactive Bladder Syndrome [NCT05040984]500 participants (Anticipated)Observational2021-04-30Recruiting
Mirabegron for Female Patients With Overactive Bladder Syndrome: Comparison of Daytime and Nighttime Dosing [NCT03251300]Phase 4120 participants (Anticipated)Interventional2017-08-01Recruiting
Comparative Effectiveness of Pelvic Floor Muscle Training, Mirabegron, and Trospium Among Older Women With Urgency Urinary Incontinence and High Fall Risk: a Feasibility Randomized Clinical Study [NCT05880862]Early Phase 148 participants (Anticipated)Interventional2023-09-28Recruiting
Sequencing and Combination of Mirabegron and Transcutaneous Tibial Nerve Stimulation (TTNS) in Overactive Bladder Syndrome: a Multicenter, Randomized, Open-label, Crossover Trial [NCT05188742]Phase 4180 participants (Anticipated)Interventional2021-11-10Recruiting
A Multicentre, Open-Label, Single Dose, Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron Oral Suspension in Pediatric Subjects From 3 to Less Than 12 Years of Age With Neurogenic Detrusor Overactivity (NDO) or Overacti [NCT02526979]Phase 19 participants (Actual)Interventional2015-12-17Completed
The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics [NCT05051436]Phase 496 participants (Anticipated)Interventional2021-12-13Recruiting
A Phase 1, Open-Label, Randomized, Single Oral Dose, Three-Way Crossover Study to Assess the Effect of Food on the Pharmacokinetics of Mirabegron [NCT00939757]Phase 176 participants (Actual)Interventional2009-05-31Completed
Impact of Beta 3 Agonist Mirabegron on Erectile Function on Patients With Benign Prostate Hyperplasia [NCT04503850]100 participants (Anticipated)Observational2020-10-01Not yet recruiting
Higher Neural and Cognitive Changes Following Anticholinergic Versus Beta 3 Agonist Versus Placebo Treatments in Female Patients With Overactive Bladder: a Multicenter Randomized Controlled Pilot Trial [NCT03817931]Phase 430 participants (Anticipated)Interventional2019-08-05Recruiting
A Pharmacokinetic Study in Healthy Non-elderly Male and Female Volunteers to Investigate the Effect of Food on the Pharmacokinetics of YM178 [NCT00965926]Phase 172 participants (Actual)Interventional2009-07-31Completed
Protocol for Specified Drug Use-results Survey of Betanis Tablets (for Patients With Coexisting Cardiovascular Disease) [NCT02570035]316 participants (Actual)Observational2012-12-31Completed
A Multi-centre Randomized, Placebo-controlled Trial of Mirabegron, a New beta3-adrenergic Receptor Agonist on Left Ventricular Mass and Diastolic Function in Patients With Structural Heart Disease [NCT02599480]Phase 2296 participants (Actual)Interventional2016-04-30Active, not recruiting
Phase 4 Study of Cardiovascular Morbidity and Safety in Women Treated With Mirabegron for Overactive Bladder [NCT02622555]221 participants (Actual)Observational2013-08-31Completed
A Clinical Trial of Mirabegron for Overactive Bladder Symptoms in Patients With Parkinson Disease and Impaired Cognition [NCT02536976]Phase 47 participants (Actual)Interventional2015-12-31Completed
A Phase 1 Study to Evaluate the Effect of Steady State Solifenacin and Mirabegron on the Steady State Pharmacokinetics of Tamsulosin HCl in Healthy Male Subjects [NCT02169713]Phase 120 participants (Actual)Interventional2014-05-31Completed
THE EFFECTS OF MIRABEGRON AND TAMSULOSIN FOR PATIENTS WITH URETERAL STENTS [NCT06124066]Phase 442 participants (Actual)Interventional2022-07-01Completed
Efficacy and Safety of Mirabegron Compared With Solifenacin in Treatment of Overactive Bladder [NCT03558919]Phase 481 participants (Actual)Interventional2017-01-01Completed
A Prospective, Non-interventional, Registry Study of Patients Initiating Pharmacologic Therapy for Overactive Bladder in Taiwan, Korea and China [NCT03572231]805 participants (Actual)Observational2018-07-19Completed
An Open Label, One-sequence, 3-period Study to Evaluate Drug-drug Interactions Between BR9006-1 and BR9006-2 in Healthy Male Volunteers. [NCT04485585]Phase 136 participants (Actual)Interventional2020-07-20Completed
Therapeutic Efficacy and Safety of Mirabegron , a β3-Adrenoceptor Agonist, Treatment on Patients With Overactive Bladder Syndrome in Taiwan - Comparison of Therapeutic Efficacy and Safety Between 25mg and 50mg [NCT03044912]Phase 3574 participants (Anticipated)Interventional2015-11-16Recruiting
Mirabegron and Physiological Function in Cold Environments - Aim 1 [NCT05990387]Phase 1/Phase 230 participants (Anticipated)Interventional2023-07-19Recruiting
A Pilot Study of the Effects of Mirabegron on Symptoms in Patients With Interstitial Cystitis [NCT02787083]Phase 39 participants (Actual)Interventional2016-08-31Terminated(stopped due to Low enrollment)
Phase 2a Exploratory, Randomized, Double-blind, Parallel-group Study of ONO-8577 Compared to Combination of Solifenacin Succinate/ Mirabegron for Overactive Bladder [NCT03106623]Phase 2207 participants (Actual)Interventional2017-04-07Completed
An Open-label, 2-Part, Phase 1 Clinical Trial to Evaluate Drug Interactions When DA-8010 is Co-administered With Paroxetine or Mirabegron in Healthy Adults [NCT05992428]Phase 136 participants (Anticipated)Interventional2023-08-22Recruiting
An Open-label, Baseline-controlled, Multicenter, Phase 3 Dose-titration Study Followed by a Fixed-dose Observation Period to Evaluate Efficacy, Safety and Pharmacokinetics of Mirabegron in Children and Adolescents From 3 to Less Than 18 Years of Age With [NCT02751931]Phase 391 participants (Actual)Interventional2016-06-17Completed
Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Multiple Sclerosis (MIRROR) [NCT02086188]Phase 428 participants (Actual)Interventional2014-05-31Completed
Using Mirabegron to Increase Blood Pressure in Patients With Postural Orthostatic Tachycardia Syndrome [NCT06133075]Phase 220 participants (Anticipated)Interventional2023-11-22Not yet recruiting
The Effects of Normalizing Blood Pressure on Cerebral Blood Flow in Hypotensive Individuals With Spinal Cord Injury [NCT02893553]Phase 241 participants (Actual)Interventional2016-12-31Completed
A Phase III, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of Mirabegron in Subjects With Symptoms of Overactive Bladder [NCT00662909]Phase 32,149 participants (Actual)Interventional2008-03-28Completed
Comparisons of the Effects of Solifenacin Versus Mirabegron on Autonomic System, Arterial Stiffness and Psychosomatic Distress and Clinical Outcomes: A Prospective Randomized Controlled Trial [NCT02540707]Phase 4113 participants (Actual)Interventional2015-09-08Completed
Beta3 Adrenergic Agonist Treatment in Chronic Pulmonary Hypertension Secondary to Heart Failure [NCT02775539]Phase 280 participants (Anticipated)Interventional2016-06-30Not yet recruiting
A Phase 1, Open-Label, Randomized, Parallel Dose Group Study to Assess the Pharmacokinetics of Mirabegron OCAS Formulations With Different Release Rates Versus IV Infusion in Healthy Volunteers [NCT00940121]Phase 191 participants (Actual)Interventional2009-04-30Completed
Beta 3 Agonist Treatment in Heart Failure-2 [NCT03926754]Phase 2/Phase 356 participants (Actual)Interventional2017-01-23Completed
A Randomized, Double-Blind, Parallel Group, Placebo and Active Controlled, Multicenter Study to Assess the Efficacy and Safety of Mirabegron in Subjects With Symptoms of Overactive Bladder [NCT00689104]Phase 32,336 participants (Actual)Interventional2008-04-28Completed
A Phase III, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (25 mg qd and 50 mg qd) in Subjects With Symptoms of Overactive Bladder [NCT00912964]Phase 32,030 participants (Actual)Interventional2009-04-28Completed
An Open-label, One-sequence Crossover Study to Evaluate the Effect of Multiple Doses of YM178 on the Pharmacokinetics of Warfarin in Healthy Subjects [NCT00856570]Phase 124 participants (Actual)Interventional2008-09-30Completed
A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain [NCT05658874]Phase 380 participants (Anticipated)Interventional2022-12-01Recruiting
Long-term Study of YM178: Long Term Study of YM178 in Subjects With Overactive Bladder [NCT00840645]Phase 3204 participants (Actual)Interventional2008-12-31Completed
A Phase 4, Open-label, Randomized, Prospective, Interventional Post-authorization Efficacy and Safety Study of Mirabegron 50 mg and 25 mg for the Treatment of Overactive Bladder in Chinese Subjects [NCT04562090]Phase 4249 participants (Actual)Interventional2021-01-06Completed
Sympathomimetics and Sympatholytics in Type 2 Diabetes: Teaching Old Drugs New Tricks [NCT04823442]9 participants (Actual)Interventional2021-01-21Completed
The Activation of Brown and Beige Fat and Role in Insulin Sensitivity [NCT02919176]Early Phase 139 participants (Actual)Interventional2016-09-01Completed
Title: A Randomized Clinical Trial Comparing Percutaneous Tibial Nerve Stimulation in Combination With Mirabegron to Percutaneous Tibial Nerve Stimulation Plus Placebo in Women With Refractory OAB Symptoms [NCT04907032]Phase 454 participants (Actual)Interventional2021-10-01Completed
Phase III Study of YM178 - A Placebo-controlled, Double-blind, Group Comparison Study in Patients With Overactive Bladder [NCT00966004]Phase 31,139 participants (Actual)Interventional2009-07-31Completed
A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Assess the Effect of Mild, Moderate and Severe Renal Impairment on the Pharmacokinetics of YM178 [NCT00750620]Phase 133 participants (Actual)Interventional2008-09-30Completed
A Phase 1, Open-Label, Drug Interaction Study to Evaluate the Effect of Repeat Doses of Rifampin on the Single-Dose Pharmacokinetics of Mirabegron (YM178) [NCT00776516]Phase 124 participants (Actual)Interventional2008-10-31Completed
A Phase 3, Double-blind, Randomized, Multicenter, Parallel Group, Placebo-controlled Sequential Dose Titration Study to Evaluate Efficacy, Safety and Pharmacokinetics of Mirabegron in Pediatric Subjects From 5 to < 18 Years of Age With Overactive Bladder [NCT04641975]Phase 326 participants (Actual)Interventional2021-03-15Terminated(stopped due to Termination due to operational futility)
Long-Term Specified Drug Use-results Survey of Betanis Tablets [NCT01901120]1,263 participants (Actual)Observational2012-10-31Completed
To Explore the Effect of beta3-adrenoceptor Agonist on Patients With Overactive Bladder and Develop Its Urinary Biomarker [NCT04693897]400 participants (Anticipated)Observational [Patient Registry]2021-03-01Not yet recruiting
Phase III Study of YM178: A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multi-center Study in Subjects With Symptoms of Overactive Bladder [NCT01043666]Phase 31,126 participants (Actual)Interventional2009-12-31Completed
Beta 3 Agonist Treatment in Heart Failure [NCT01876433]Phase 270 participants (Actual)Interventional2013-09-30Completed
Drug Use-Results Survey of Betanis Tablets 25 and 50 mg [NCT01919047]10,711 participants (Actual)Observational2012-04-30Completed
Post-Marketing Study of Mirabegron - A Pharmacokinetic Study to Assess Drug-Drug Interaction Between Mirabegron and Tolterodine - [NCT01964183]Phase 424 participants (Actual)Interventional2013-06-30Completed
Evaluation of the Efficacy and Urodynamic Outcomes Between Intradetrusor onabotulinumtoxinA Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity [NCT05968885]Phase 4300 participants (Anticipated)Interventional2021-10-01Recruiting
An Open-label, Parallel Group, Randomized, Two-sequence, Three-way Crossover Study to Assess the Relative Bioavailability of Solifenacin Succinate and Mirabegron Fixed-dose Combination Tablets Compared to Co-administration of Single Entity Tablets at Thre [NCT02010944]Phase 172 participants (Actual)Interventional2012-09-30Completed
Cognitive, Urinary, and Functional Trajectories of Older Women Using Pharmacologic Treatment Strategies for Urgency Incontinence [NCT05362292]Phase 4270 participants (Anticipated)Interventional2022-10-04Recruiting
A Multicentre, Open-label, Single Ascending Dose Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS Tablets in Pediatric Subjects From 5 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity (NDO) or Ov [NCT02211846]Phase 134 participants (Actual)Interventional2014-09-21Completed
Predictor for Re-treatment of Overactive Bladder Syndrome After Discontinuation of Mirabegron Treatment for Female Overactive Bladder Syndrome [NCT04550702]120 participants (Actual)Observational2015-01-01Completed
An Exploratory Open Label, Three-way Crossover Study to Compare the Pharmacokinetic Profiles of Three Different YM178 Modified Release (OCAS) Formulations Under Fasted and Fed Conditions With YM178 Immediate Release (IR) Formulation Under Fasted Condition [NCT01646294]Phase 134 participants (Actual)Interventional2005-01-31Completed
EFFICACY AND SAFETY OF COMBINATION THERAPY WITH β3-ADRENOCEPTOR AGONIST (MIRABEGRON) AND α-ADRENOCEPTOR ANTAGONIST (TAMSULOSIN) FOR TREATMENT OF OVERACTIVE BLADDER IN MALE PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA. [NCT02279615]Phase 4200 participants (Anticipated)Interventional2021-12-31Not yet recruiting
A Randomized, Double-Blind, Factorial, Parallel-Group, Active and Placebo-Controlled, Multicenter Dose-Ranging Study to Evaluate the Efficacy, Safety and Tolerability of Six Dose Combinations of Solifenacin Succinate and Mirabegron Compared to Mirabegron [NCT01340027]Phase 21,307 participants (Actual)Interventional2011-03-29Completed
Effect of Mirabegron on Promoting Brown Adipose Tissue Activation [NCT05779514]20 participants (Anticipated)Interventional2022-08-18Recruiting
Mirabegron And Ureteral Stent-related Pain (MAP) Trial [NCT04286152]Phase 3142 participants (Anticipated)Interventional2020-02-03Recruiting
Pharmacological or Cold-induced Activation of Brown Adipose Tissue Metabolism [NCT02811289]22 participants (Actual)Interventional2016-08-05Completed
Assessment of Efficacy of Mirabegron, Solifenacin, Tadalafil 5mg and Combination Therapy in Female Patients With Overactive Bladder: A Double Blinded Prospective Randomized Placebo -Controlled Trial [NCT06184334]300 participants (Actual)Interventional2022-09-14Completed
A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multicenter Dose Ranging Study With the Beta-3 Agonist YM178 in Patients With Symptomatic Overactive Bladder [NCT00337090]Phase 21,108 participants (Actual)InterventionalCompleted
Comparative Study Between Behavior Therapy and Behavior Therapy Plus Mirabegron 50mg in Sexually Active Men With Bothersome Overactive Bladder Symptoms - A Multicenter, Randomized Study [NCT04420533]150 participants (Actual)Interventional2020-06-05Completed
Mirabegron Combined With Behavioral Intervention for Overactive Bladder:a Prospective Multicenter Randomized Controlled Clinical Study [NCT05452434]Phase 4600 participants (Anticipated)Interventional2022-07-15Not yet recruiting
Efficacy of Mirabegron Versus Tamsulosin Versus Solifenacin for Treatment of Ureteral Stents-Related Symptoms: a Randomized Controlled Trial [NCT04325880]Phase 3240 participants (Anticipated)Interventional2021-12-01Recruiting
A Study to Evaluate Cardiovascular Interactions Between Mirabegron and Tamsulosin [NCT01489696]Phase 148 participants (Actual)Interventional2010-08-31Completed
A Randomized, Double-blind, Parallel-group, Placebo-controlled Study in Patients With Symptomatic Overactive Bladder [NCT00527033]Phase 2842 participants (Actual)Interventional2007-09-30Completed
An Open-Label, Single and Multiple Dose Study to Assess the Safety and Pharmacokinetics of YM178 OCAS Tablet (Mirabegron) in Healthy Chinese Volunteers [NCT01720212]Phase 124 participants (Actual)Interventional2012-05-31Completed
An Open Label Randomized, Single Dose, Three-way, Partial Replicate Bioequivalence Study to Determine the Bioequivalence of Solifenacin Succinate & Mirabegron From Mirfenacin MR 5/50 mg Extended Release Tablets (Hikma Pharma, Egypt) Versus Vesicare 5 mg F [NCT05767632]Phase 130 participants (Actual)Interventional2022-05-30Completed
A Phase 1, Open-Label, Two-Period, One-Sequence Crossover Study to Assess Pharmacokinetic Interaction of Multiple Dose Ketoconazole on Single Dose YM178 Oral Controlled Absorption System (OCAS) in Healthy Male and Female Adult Volunteers [NCT01476800]Phase 124 participants (Actual)Interventional2006-07-31Completed
An Open Label, One-sequence, Parallel Study to Compare the Single Dose Pharmacokinetics of YM178 in Healthy Poor or Extensive Metabolisers for CYP2D6 and to Assess the Effect of Multiple Doses of YM178 on the Metabolism of the Model Substrate Metoprolol [NCT01478490]Phase 128 participants (Actual)Interventional2002-09-30Completed
Double-blind, Randomized, Placebo-controlled, Dose-escalating, Exploratory Study to Investigate the Pharmacokinetics, Safety and Tolerability of Multiple Doses of YM178 OCAS-M in Healthy Young Male and Female Subjects and Healthy Elderly Male and Female S [NCT01478503]Phase 196 participants (Actual)Interventional2005-05-31Completed
A Single Dose, Open Label, Randomized, Two-period Cross Over Study in Healthy Male Subjects to Assess the Absolute Bioavailability of YM178 OCAS-M Formulation [NCT01478529]Phase 112 participants (Actual)Interventional2006-02-28Completed
An Open-label, One-sequence Crossover Study to Evaluate the Effect of Multiple Doses of YM178 on the Pharmacokinetics of the CYP2D6 Substrate Desipramine in Healthy Subjects [NCT01478568]Phase 128 participants (Actual)Interventional2008-10-31Completed
The Effect of Mirabegron on Brown Adipose Tissue in Healthy Young White Caucasian and South Asian Men [NCT03012113]Phase 420 participants (Anticipated)Interventional2016-06-30Recruiting
Comparisons of the Impact of Beta-3 Agonist Versus Antimuscarinics on Psychological Distress, Sexual Function, Bladder Wall Thickness and Blood Flow in Women With Overactive Bladder Syndrome: a Randomized Controlled Study. [NCT04023253]Phase 3120 participants (Anticipated)Interventional2019-08-01Recruiting
A 8 Weeks, Randomized, Open Label, Parallel Group, Active Control Trial Evaluating the Clinical Efficacy and Safety of Hibero SR (Mirabegron) 50 mg and Ditropan (Oxybutynin Chloride) 10 mg in Children Between 5 and 18 Years With Overactive Bladder (OAB) [NCT06181591]Phase 244 participants (Anticipated)Interventional2024-01-15Not yet recruiting
Acupuncture Combined With Mirabegron in the Treatment of Overactive Bladder Syndrome: A Prospective Randomized Controlled Trial [NCT06181019]Phase 175 participants (Actual)Interventional2021-12-01Active, not recruiting
Mirabegron for Treatment of Overactive Bladder Symptoms in Patients With Parkinson's Disease: a Double-blind, Randomized Placebo-controlled Trial [NCT03412513]Phase 4144 participants (Anticipated)Interventional2017-07-17Recruiting
The Therapeutic Effect of Beta-3 Agonist and Anti-muscarinic Agent on Overactive Bladder Among Sjogren's Syndrome Patient [NCT04909255]Phase 450 participants (Anticipated)Interventional2021-03-23Recruiting
[NCT02436889]Phase 423 participants (Actual)Interventional2016-02-29Completed
A Double Blind Placebo Control Trial of Mirabegron for Medical Expulsive Therapy and to Manage Stent Pain for Ureteral Stones(Protocol # 01-16-20-02) [NCT02744430]Phase 233 participants (Actual)Interventional2017-07-22Completed
Effects of b3-Adrenergic Receptor Agonists on Brown Adipose Tissue [NCT01783470]Phase 215 participants (Actual)Interventional2013-02-28Completed
Pilot Study: Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women, an Open Label Study With Dose Escalation [NCT02981459]Phase 40 participants (Actual)Interventional2017-12-08Withdrawn(stopped due to Withdrawn by Sponsor)
A Phase 3, Open Label, Multicenter, Baseline-Controlled Sequential Dose Titration Study Followed by a Fixed Dose Observation Period to Evaluate Pharmacokinetics, Efficacy and Safety of Mirabegron Prolonged-Release Microgranula-Based Suspension in Children [NCT05621616]Phase 310 participants (Anticipated)Interventional2023-06-26Recruiting
An Open-label Study to Evaluate the Pharmacokinetics of YM178 After Single Oral Administration of 14C-labeled YM178 in Healthy Male Volunteers [NCT01651312]Phase 14 participants (Actual)Interventional2003-01-31Completed
An Open-label, One-sequence Crossover Study to Evaluate the Effect of Multiple Doses of YM178 on the Pharmacokinetics of Digoxin in Healthy Subjects [NCT01663961]Phase 125 participants (Actual)Interventional2008-09-30Completed
A Study to Evaluate Pharmacokinetics of Mirabegron After Single and Multiple Oral Administration to Healthy Non-elderly Male and Female Chinese Subjects [NCT01747564]Phase 124 participants (Actual)Interventional2012-08-31Completed
The Physiological Responses and Adaptation of Brown Adipose Tissue to Chronic Treatment With Beta3-Adrenergic Receptor Agonists [NCT03049462]Phase 1100 participants (Anticipated)Interventional2017-03-13Recruiting
The Mechanism of Human Non-Shivering Thermogenesis and Basal Metabolic Rate [NCT01950520]Phase 2134 participants (Anticipated)Interventional2014-02-07Recruiting
An Open Label Randomized, Single Dose, Three Way Three Sequence Two Treatment Partial Replicate Crossover Bioequivalence Study to Determine the Bioequivalence of Mirabegron From Bladogra 25 mg Extended Release Tablets (Multi-Apex for Pharmaceutical Indust [NCT04476966]Phase 129 participants (Actual)Interventional2020-01-20Completed
A Phase 4 Open-label, Randomized, Single Oral Dose, Two-way Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of Mirabegron in Healthy Chinese Subjects [NCT04501640]Phase 424 participants (Actual)Interventional2020-09-21Completed
A Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Parkinson's Disease. (MAESTRO) [NCT02092181]Phase 430 participants (Actual)Interventional2014-03-31Completed
An Open Label Single Dose Study to Investigate the Effect of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of YM178 Compared With Healthy Subjects [NCT01579461]Phase 132 participants (Actual)Interventional2008-11-30Completed
Mechanisms for Activation of Beige Adipose Tissue in Humans [NCT04666636]Phase 265 participants (Anticipated)Interventional2020-12-07Recruiting
Mirabegron in Achalasia: A Clinical and Manometric Proof of Concept Pilot Study [NCT03411252]Early Phase 15 participants (Actual)Interventional2018-02-15Terminated(stopped due to inability to enroll)
Mirabegron and Urinary Urgency Incontinence: The Clinical Response and the Female Urinary Microbiome [NCT02495389]Phase 484 participants (Actual)Interventional2015-01-28Completed
Add-on Mirabegron in Pediatric Patients With Refractory Overactive Bladder [NCT02476175]Phase 335 participants (Actual)Interventional2013-04-30Completed
A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Multi-center Study to Evaluate the Long-Term Safety and Efficacy of Combination of Solifenacin Succinate With Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in Subject [NCT02045862]Phase 31,829 participants (Actual)Interventional2014-03-17Completed
Efficacy and Safety of Mirabegron in Intracerebral Hemorrhage [NCT05369351]Phase 266 participants (Anticipated)Interventional2023-01-10Not yet recruiting
Effect of Behavioral Sleep Intervention on Lower Urinary Tract Symptoms in Older Women [NCT05604222]Phase 4120 participants (Anticipated)Interventional2023-03-01Recruiting
A Double-Blind, Randomized, Parallel Group, Multi-Centre Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Subjects With Overactive Bladder (OAB) Treated With Antimuscarinics and Dissatisfied Due to Lack of Efficacy [NCT01638000]Phase 31,887 participants (Actual)Interventional2012-06-12Completed
Comparison of Electroacupuncture to Mirabegron on Symptoms of Overactive Bladder in Women Who Have Failed Anti-Cholinergic Therapy [NCT03087578]0 participants (Actual)Interventional2017-07-01Withdrawn(stopped due to Study never started)
A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB) [NCT02216214]Phase 4888 participants (Actual)Interventional2014-10-07Completed
A Multicenter Prospective Study for Patient Perception of Treatment Satisfaction After Switching to Mirabegron in Patients With Overactive Bladder Who Were Unsatisfied With Efficacy of Antimuscarinic Therapy or Adverse Event. [NCT02468375]Phase 4434 participants (Actual)Interventional2015-06-30Completed
A Double Blind, Randomized Placebo Controlled Trial Evaluating the Urodynamic and Clinical Efficacy of Mirabegron Among Neurogenic Bladder Patients [NCT02044510]Phase 2/Phase 332 participants (Actual)Interventional2014-07-31Terminated(stopped due to Slow recruitment and small observed effect size)
Efficacy of Pharmacological Stimulation of Brown and White Fat in Lean and Obese Young Adults [NCT02354807]Phase 220 participants (Anticipated)Interventional2015-10-31Recruiting
Efficacy and Tolerability of Mirabegron Compared to Oxybutynin Chloride Immediate Release for Neurogenic Detrusor Overactivity in Persons With Chronic Spinal Cord Injury: A Randomized, Double-Blind, Controlled, Cross-Over Clinical Trial [NCT03187795]Phase 262 participants (Anticipated)Interventional2019-04-03Recruiting
Myrbetriq™ (Mirabegron) to Improve Disordered Sleep in Subjects With Lower Urinary Tract Symptoms (LUTS) [NCT02410135]34 participants (Actual)Observational2015-04-30Completed
Specified Drug Use-results Survey of Betanis Tablets in OAB Patients With Coexisting Glaucoma [NCT01898624]300 participants (Actual)Observational2012-12-04Completed
A Randomized, Double-Blind, Multi-Centre Study to Evaluate the Efficacy and Safety of Adding Mirabegron to Solifenacin in Incontinent OAB Subjects Who Have Received Solifenacin for 4 Weeks and Warrant Additional Relief for Their OAB Symptoms [NCT01908829]Phase 32,174 participants (Actual)Interventional2013-07-10Completed
Postmarketing Study of Mirabegron in Japan: Long-term Add-on Therapy With Antimuscarinics in Patients With Overactive Bladder Treated With Mirabegron [NCT02294396]Phase 4649 participants (Actual)Interventional2014-10-28Completed
A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multi-center Study to Evaluate the Efficacy, Safety and Tolerability of Combinations of Solifenacin Succinate and Mirabegron Compared to Solifenacin Succinate and Mirabegron Monot [NCT01972841]Phase 33,527 participants (Actual)Interventional2013-11-05Completed
The Effects of Extracorporeal Magnetic Innervation in Combination With Mirabegron in the Treatment of Urinary Frequency, Urgency and Urge Incontinence [NCT06123364]56 participants (Actual)Interventional2019-10-14Completed
A Prospective, Double-Blind, Randomized, Two-Period Crossover, Multi-Center Study to Evaluate the Tolerability and Patient Preference Between Myrbetriq® and Detrol® LA in Subjects With Overactive Bladder (OAB) [NCT02138747]Phase 4376 participants (Actual)Interventional2014-07-24Completed
Myrbetriq™ (Mirabegron) to Reduce Pain and Discomfort Following Ureteral Stent Placement [NCT02462837]Phase 211 participants (Actual)Interventional2015-05-31Terminated(stopped due to insufficient rate of accrual)
Safety and Efficacy of Mirabegron as Add-on Therapy in Patients With Overactive Bladder Treated With Solifenacin: A Postmarketing Open-label Study in Japan [NCT01745094]Phase 4223 participants (Actual)Interventional2012-10-01Completed
A Phase 4, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Mirabegron in Japanese and Korean Male Patients With Overactive Bladder Under Treatment With the α-Blocker Tamsulosin for Benign Prostatic Hyp [NCT02656173]Phase 4568 participants (Actual)Interventional2016-01-25Completed
Does Mirabegron Increase the Body Heat Generated by the Nervous System [NCT06011265]Early Phase 115 participants (Anticipated)Interventional2023-04-27Recruiting
Prospective Pilot Study of Mirabegron in Pediatric Patients With Overactive Bladder [NCT02468830]Phase 358 participants (Actual)Interventional2013-04-30Completed
Vaginal Estradiol vs Oral Beta-3 Agonist for Treatment of Overactive Bladder Syndrome: A Single-Therapy, Double-Blind, Randomized Controlled Trial [NCT05221021]Phase 4152 participants (Anticipated)Interventional2022-10-01Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00410514 (18) [back to overview]Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Total Score
NCT00410514 (18) [back to overview]Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Storage Symptom Score
NCT00410514 (18) [back to overview]Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
NCT00410514 (18) [back to overview]Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)
NCT00410514 (18) [back to overview]Change From Baseline to End of Treatment in Bladder Voiding Efficiency (BVE)
NCT00410514 (18) [back to overview]Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests
NCT00410514 (18) [back to overview]Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score
NCT00410514 (18) [back to overview]Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Bother Score
NCT00410514 (18) [back to overview]Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score
NCT00410514 (18) [back to overview]Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Urgency Episodes With Urgency Severity ≥ 3 Per 24 Hours
NCT00410514 (18) [back to overview]Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Overall Symptom Interference of Life Score
NCT00410514 (18) [back to overview]Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Postvoid Residual Volume (PVR)
NCT00410514 (18) [back to overview]Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Patient Perception of Bladder Condition (PPBC)
NCT00410514 (18) [back to overview]Change From Baseline to End of Treatment in Bladder Contractile Index (BCI)
NCT00410514 (18) [back to overview]Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Voided Volume Per Micturition
NCT00410514 (18) [back to overview]Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Micturitions Per 24 Hours
NCT00410514 (18) [back to overview]Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
NCT00410514 (18) [back to overview]Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Voiding Score
NCT00662909 (31) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score
NCT00662909 (31) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency
NCT00662909 (31) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours
NCT00662909 (31) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours
NCT00662909 (31) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours
NCT00662909 (31) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
NCT00662909 (31) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician
NCT00662909 (31) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score
NCT00662909 (31) [back to overview]Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
NCT00662909 (31) [back to overview]Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
NCT00662909 (31) [back to overview]Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
NCT00662909 (31) [back to overview]Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
NCT00662909 (31) [back to overview]Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
NCT00662909 (31) [back to overview]Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)
NCT00662909 (31) [back to overview]Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS)
NCT00662909 (31) [back to overview]Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment
NCT00662909 (31) [back to overview]Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working
NCT00662909 (31) [back to overview]Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment
NCT00662909 (31) [back to overview]Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed
NCT00662909 (31) [back to overview]Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition
NCT00662909 (31) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
NCT00662909 (31) [back to overview]Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours
NCT00662909 (31) [back to overview]Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours
NCT00662909 (31) [back to overview]Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours
NCT00662909 (31) [back to overview]Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit
NCT00662909 (31) [back to overview]Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit
NCT00662909 (31) [back to overview]Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit
NCT00662909 (31) [back to overview]Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours
NCT00662909 (31) [back to overview]Change From Baseline to Final Visit in Mean Volume Voided Per Micturition
NCT00662909 (31) [back to overview]Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours
NCT00662909 (31) [back to overview]Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours
NCT00688688 (28) [back to overview]Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
NCT00688688 (28) [back to overview]Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
NCT00688688 (28) [back to overview]Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
NCT00688688 (28) [back to overview]Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score
NCT00688688 (28) [back to overview]Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
NCT00688688 (28) [back to overview]Change From Baseline to Month 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)
NCT00688688 (28) [back to overview]Change From Baseline to Month 12 and Final Visit in Treatment Satisfaction-visual Analog Scale (TS-VAS)
NCT00688688 (28) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score
NCT00688688 (28) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency
NCT00688688 (28) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours
NCT00688688 (28) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours
NCT00688688 (28) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours
NCT00688688 (28) [back to overview]Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed
NCT00688688 (28) [back to overview]Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment
NCT00688688 (28) [back to overview]Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment
NCT00688688 (28) [back to overview]Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working
NCT00688688 (28) [back to overview]Change From Baseline to Months 3, 6, 12 and Final Visit in Number of Non-study Related Visits to Physician
NCT00688688 (28) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours
NCT00688688 (28) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
NCT00688688 (28) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score
NCT00688688 (28) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition
NCT00688688 (28) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
NCT00688688 (28) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
NCT00688688 (28) [back to overview]Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit
NCT00688688 (28) [back to overview]Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC)
NCT00688688 (28) [back to overview]Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit
NCT00688688 (28) [back to overview]Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram
NCT00688688 (28) [back to overview]Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs)
NCT00689104 (31) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score
NCT00689104 (31) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency
NCT00689104 (31) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours
NCT00689104 (31) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours
NCT00689104 (31) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours
NCT00689104 (31) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
NCT00689104 (31) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician
NCT00689104 (31) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score
NCT00689104 (31) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
NCT00689104 (31) [back to overview]Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours
NCT00689104 (31) [back to overview]Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours
NCT00689104 (31) [back to overview]Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit
NCT00689104 (31) [back to overview]Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit
NCT00689104 (31) [back to overview]Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours
NCT00689104 (31) [back to overview]Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours
NCT00689104 (31) [back to overview]Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit
NCT00689104 (31) [back to overview]Change From Baseline to Final Visit in Mean Volume Voided Per Micturition
NCT00689104 (31) [back to overview]Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours
NCT00689104 (31) [back to overview]Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours
NCT00689104 (31) [back to overview]Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
NCT00689104 (31) [back to overview]Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
NCT00689104 (31) [back to overview]Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
NCT00689104 (31) [back to overview]Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
NCT00689104 (31) [back to overview]Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score
NCT00689104 (31) [back to overview]Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)
NCT00689104 (31) [back to overview]Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS)
NCT00689104 (31) [back to overview]Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment
NCT00689104 (31) [back to overview]Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working
NCT00689104 (31) [back to overview]Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment
NCT00689104 (31) [back to overview]Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed
NCT00689104 (31) [back to overview]Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition
NCT00912964 (39) [back to overview]Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours
NCT00912964 (39) [back to overview]Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
NCT00912964 (39) [back to overview]Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
NCT00912964 (39) [back to overview]Percentage of Responders for Number of Grade 3 or 4 Urgency Episodes
NCT00912964 (39) [back to overview]Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours
NCT00912964 (39) [back to overview]Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours
NCT00912964 (39) [back to overview]Change From Baseline to End of Treatment (Final Visit) in Mean Volume Voided Per Micturition
NCT00912964 (39) [back to overview]Change From Baseline to End of Treatment (Final Visit) in Mean Number of Urgency Incontinence Episodes Per 24 Hours
NCT00912964 (39) [back to overview]Change From Baseline to End of Treatment (Final Visit) in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours
NCT00912964 (39) [back to overview]Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours
NCT00912964 (39) [back to overview]Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours
NCT00912964 (39) [back to overview]Change From Baseline to Week 4, Week 8 and Week 12 in Mean Number of Urgency Incontinence Episodes Per 24 Hours
NCT00912964 (39) [back to overview]Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition
NCT00912964 (39) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score
NCT00912964 (39) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours
NCT00912964 (39) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours
NCT00912964 (39) [back to overview]Percentage of Responders for Mean Level of Urgency
NCT00912964 (39) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician
NCT00912964 (39) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score
NCT00912964 (39) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
NCT00912964 (39) [back to overview]Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours
NCT00912964 (39) [back to overview]Change From Baseline to End of Treatment (Final Visit) in Mean Level of Urgency
NCT00912964 (39) [back to overview]Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit
NCT00912964 (39) [back to overview]Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit
NCT00912964 (39) [back to overview]Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit
NCT00912964 (39) [back to overview]Summary of Baseline, Week 12 and Final Visit Change in Bladder Symptoms on the Clinician Global Impression Scale
NCT00912964 (39) [back to overview]Summary of Baseline, Week 12 and Final Visit Change in Bladder Symptoms on the Patient Global Impression Scale
NCT00912964 (39) [back to overview]Change From Baseline to Week 4, Week 8 and Week 12 in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours
NCT00912964 (39) [back to overview]Change From Baseline to Week 4, Week 8 and Week 12 in Mean Level of Urgency
NCT00912964 (39) [back to overview]Summary of Baseline, Week 12 and Final Visit Change in Overall Condition on the Patient Global Impression Scale
NCT00912964 (39) [back to overview]Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed
NCT00912964 (39) [back to overview]Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment
NCT00912964 (39) [back to overview]Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working
NCT00912964 (39) [back to overview]Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment
NCT00912964 (39) [back to overview]Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS)
NCT00912964 (39) [back to overview]Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)
NCT00912964 (39) [back to overview]Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
NCT00912964 (39) [back to overview]Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score
NCT00912964 (39) [back to overview]Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
NCT01340027 (30) [back to overview]Percentage of Participants With a Health-related Quality of Life Total Score Response
NCT01340027 (30) [back to overview]Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS)
NCT01340027 (30) [back to overview]Change From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score
NCT01340027 (30) [back to overview]Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
NCT01340027 (30) [back to overview]Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition
NCT01340027 (30) [back to overview]Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC)
NCT01340027 (30) [back to overview]Percentage of Participants With Deterioration in PPBC
NCT01340027 (30) [back to overview]Percentage of Participants With Improvement in PPBC
NCT01340027 (30) [back to overview]Percentage of Participants With Major Improvement in PPBC
NCT01340027 (30) [back to overview]Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
NCT01340027 (30) [back to overview]Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
NCT01340027 (30) [back to overview]Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
NCT01340027 (30) [back to overview]Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
NCT01340027 (30) [back to overview]Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
NCT01340027 (30) [back to overview]Change From Baseline to Each Visit in Mean Level of Urgency
NCT01340027 (30) [back to overview]Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours
NCT01340027 (30) [back to overview]Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours
NCT01340027 (30) [back to overview]Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours
NCT01340027 (30) [back to overview]Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours
NCT01340027 (30) [back to overview]Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
NCT01340027 (30) [back to overview]Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
NCT01340027 (30) [back to overview]Change From Baseline to Each Visit in Mean Volume Voided Per Micturition
NCT01340027 (30) [back to overview]Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI)
NCT01340027 (30) [back to overview]Percentage of Participants With 50% Reduction in Incontinence Episodes
NCT01340027 (30) [back to overview]Percentage of Participants With Zero Incontinence Episodes Post-baseline
NCT01340027 (30) [back to overview]Percentage of Participants With a Symptom Bother Response
NCT01340027 (30) [back to overview]Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)
NCT01340027 (30) [back to overview]Percentage of Participants With a Micturition Response
NCT01340027 (30) [back to overview]Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
NCT01340027 (30) [back to overview]Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
NCT01638000 (47) [back to overview]Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit
NCT01638000 (47) [back to overview]Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit
NCT01638000 (47) [back to overview]Percentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final Visit
NCT01638000 (47) [back to overview]Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12
NCT01638000 (47) [back to overview]Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit
NCT01638000 (47) [back to overview]Percentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final Visit
NCT01638000 (47) [back to overview]Percentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final Visit
NCT01638000 (47) [back to overview]Percentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final Visit
NCT01638000 (47) [back to overview]Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit
NCT01638000 (47) [back to overview]Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period
NCT01638000 (47) [back to overview]Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit
NCT01638000 (47) [back to overview]Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit
NCT01638000 (47) [back to overview]Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit
NCT01638000 (47) [back to overview]Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)
NCT01638000 (47) [back to overview]Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC)
NCT01638000 (47) [back to overview]Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
NCT01638000 (47) [back to overview]Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
NCT01638000 (47) [back to overview]Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
NCT01638000 (47) [back to overview]Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire
NCT01638000 (47) [back to overview]Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
NCT01638000 (47) [back to overview]Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
NCT01638000 (47) [back to overview]Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
NCT01638000 (47) [back to overview]Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
NCT01638000 (47) [back to overview]Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire
NCT01638000 (47) [back to overview]Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
NCT01638000 (47) [back to overview]Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
NCT01638000 (47) [back to overview]Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
NCT01638000 (47) [back to overview]Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
NCT01638000 (47) [back to overview]Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire
NCT01638000 (47) [back to overview]Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
NCT01638000 (47) [back to overview]Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours
NCT01638000 (47) [back to overview]Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment
NCT01638000 (47) [back to overview]Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment
NCT01638000 (47) [back to overview]Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency
NCT01638000 (47) [back to overview]Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours
NCT01638000 (47) [back to overview]Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
NCT01638000 (47) [back to overview]Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours
NCT01638000 (47) [back to overview]Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit
NCT01638000 (47) [back to overview]Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours
NCT01638000 (47) [back to overview]Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
NCT01638000 (47) [back to overview]Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire
NCT01638000 (47) [back to overview]Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
NCT01638000 (47) [back to overview]Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
NCT01638000 (47) [back to overview]Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
NCT01638000 (47) [back to overview]Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS)
NCT01638000 (47) [back to overview]Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert Scale
NCT01638000 (47) [back to overview]Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q
NCT01745094 (15) [back to overview]Number for Participants Who Achieved Normalization of the Number of Incontinence Episodes Per 24 Hours
NCT01745094 (15) [back to overview]Change From Baseline in Postvoid Residual (PVR) Volume
NCT01745094 (15) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
NCT01745094 (15) [back to overview]Number for Participants Who Achieved Normalization of the Number of Micturitions Per 24 Hours
NCT01745094 (15) [back to overview]Number for Participants Who Achieved Normalization of the Number of Urgency Episodes Per 24 Hours
NCT01745094 (15) [back to overview]Change From Baseline in OAB-q SF Total HRQL Score
NCT01745094 (15) [back to overview]Change From Baseline in OABSS Total Score
NCT01745094 (15) [back to overview]Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Severity Score
NCT01745094 (15) [back to overview]Number of Participants Who Achieved Normalization for OABSS Total Score
NCT01745094 (15) [back to overview]Change From Baseline in the Number of Incontinence Episodes Per 24 Hours
NCT01745094 (15) [back to overview]Change From Baseline in the Number of Micturitions Per 24 Hours
NCT01745094 (15) [back to overview]Change From Baseline in the Number of Nocturia Episodes Per Night
NCT01745094 (15) [back to overview]Change From Baseline in the Number of Urge Incontinence Episodes Per 24 Hours
NCT01745094 (15) [back to overview]Change From Baseline in the Number of Urgency Episodes Per 24 Hours
NCT01745094 (15) [back to overview]Change From Baseline in the Volume Voided Per Micturition
NCT01783470 (1) [back to overview]BAT Activity as Measured by 18F-FDG PET/CT
NCT01908829 (36) [back to overview]Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score
NCT01908829 (36) [back to overview]Change From Baseline in Patient Perception Bladder Control (PPBC) Score
NCT01908829 (36) [back to overview]Change From Baseline in Post Void Residual (PVR) Volume
NCT01908829 (36) [back to overview]Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score
NCT01908829 (36) [back to overview]Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours
NCT01908829 (36) [back to overview]Number of Incontinence Episodes Reported During the 3-Day Diary
NCT01908829 (36) [back to overview]Number of Nocturia Episodes Reported Over 3-Day Diary
NCT01908829 (36) [back to overview]Number of Pads Used During the 3-Day Diary
NCT01908829 (36) [back to overview]Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC)
NCT01908829 (36) [back to overview]Number of Participants With Adverse Events (AEs)
NCT01908829 (36) [back to overview]Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression
NCT01908829 (36) [back to overview]Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort
NCT01908829 (36) [back to overview]Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care
NCT01908829 (36) [back to overview]Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities
NCT01908829 (36) [back to overview]Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility
NCT01908829 (36) [back to overview]Number of UI Episodes Reported During the 3-Day Diary
NCT01908829 (36) [back to overview]Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline
NCT01908829 (36) [back to overview]Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC
NCT01908829 (36) [back to overview]Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score
NCT01908829 (36) [back to overview]Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score
NCT01908829 (36) [back to overview]Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC
NCT01908829 (36) [back to overview]Percentage of Participants With Zero Incontinence Episodes Postbaseline
NCT01908829 (36) [back to overview]Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours
NCT01908829 (36) [back to overview]Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours
NCT01908829 (36) [back to overview]Change From Baseline to EoT in Corrected Micturition Frequency (CMF)
NCT01908829 (36) [back to overview]Change From Baseline in Mean Number of Micturitions Per 24 Hours
NCT01908829 (36) [back to overview]Change From Baseline in Mean Number of Nocturia Episodes
NCT01908829 (36) [back to overview]Change From Baseline in Mean Number of Pads Per 24 Hours
NCT01908829 (36) [back to overview]Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
NCT01908829 (36) [back to overview]Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours
NCT01908829 (36) [back to overview]Change From Baseline in Mean Volume Voided (MVV) Per Micturition
NCT01908829 (36) [back to overview]Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score
NCT01908829 (36) [back to overview]Change From Baseline in OAB-q HRQL Subscale Score: Concern
NCT01908829 (36) [back to overview]Change From Baseline in OAB-q HRQL Subscale Score: Coping
NCT01908829 (36) [back to overview]Change From Baseline in OAB-q HRQL Subscale Score: Sleep
NCT01908829 (36) [back to overview]Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction
NCT01972841 (70) [back to overview]Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment
NCT01972841 (70) [back to overview]Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working
NCT01972841 (70) [back to overview]Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment
NCT01972841 (70) [back to overview]Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference
NCT01972841 (70) [back to overview]Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)
NCT01972841 (70) [back to overview]Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)
NCT01972841 (70) [back to overview]Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)
NCT01972841 (70) [back to overview]Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window
NCT01972841 (70) [back to overview]Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window
NCT01972841 (70) [back to overview]Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window
NCT01972841 (70) [back to overview]Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference
NCT01972841 (70) [back to overview]Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference
NCT01972841 (70) [back to overview]Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours
NCT01972841 (70) [back to overview]Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours
NCT01972841 (70) [back to overview]Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition
NCT01972841 (70) [back to overview]Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score
NCT01972841 (70) [back to overview]Change From Baseline to Weeks 4, 8 and 12 in TS-VAS
NCT01972841 (70) [back to overview]Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours
NCT01972841 (70) [back to overview]Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours
NCT01972841 (70) [back to overview]Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours
NCT01972841 (70) [back to overview]Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours
NCT01972841 (70) [back to overview]Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes
NCT01972841 (70) [back to overview]Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes
NCT01972841 (70) [back to overview]Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used
NCT01972841 (70) [back to overview]Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes
NCT01972841 (70) [back to overview]Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score
NCT01972841 (70) [back to overview]Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern
NCT01972841 (70) [back to overview]Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT
NCT01972841 (70) [back to overview]Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep
NCT01972841 (70) [back to overview]Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social
NCT01972841 (70) [back to overview]Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)
NCT01972841 (70) [back to overview]Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume
NCT01972841 (70) [back to overview]Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT
NCT01972841 (70) [back to overview]Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT
NCT01972841 (70) [back to overview]Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT
NCT01972841 (70) [back to overview]Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT
NCT01972841 (70) [back to overview]Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT
NCT01972841 (70) [back to overview]Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT
NCT01972841 (70) [back to overview]Number of Pads Used at Weeks 4, 8, 12 and EoT
NCT01972841 (70) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
NCT01972841 (70) [back to overview]Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT
NCT01972841 (70) [back to overview]Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT
NCT01972841 (70) [back to overview]Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT
NCT01972841 (70) [back to overview]Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT
NCT01972841 (70) [back to overview]Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT
NCT01972841 (70) [back to overview]Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT
NCT01972841 (70) [back to overview]Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT
NCT01972841 (70) [back to overview]Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT
NCT01972841 (70) [back to overview]Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT
NCT01972841 (70) [back to overview]Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT
NCT01972841 (70) [back to overview]Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT
NCT01972841 (70) [back to overview]Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT
NCT01972841 (70) [back to overview]Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT
NCT01972841 (70) [back to overview]Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT
NCT01972841 (70) [back to overview]PGIC Scale: Impression in General Health at Week 12 and EoT
NCT01972841 (70) [back to overview]Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT
NCT01972841 (70) [back to overview]Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT
NCT01972841 (70) [back to overview]Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours
NCT01972841 (70) [back to overview]Change From Baseline to EoT in Corrected Micturition Frequency
NCT01972841 (70) [back to overview]Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours
NCT01972841 (70) [back to overview]Change From Baseline to EoT in Mean Volume Voided Per Micturition
NCT01972841 (70) [back to overview]Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
NCT01972841 (70) [back to overview]Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS)
NCT01972841 (70) [back to overview]Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression
NCT01972841 (70) [back to overview]Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort
NCT01972841 (70) [back to overview]Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care
NCT01972841 (70) [back to overview]Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities
NCT01972841 (70) [back to overview]Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility
NCT01972841 (70) [back to overview]Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed
NCT01972841 (70) [back to overview]Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping
NCT02044510 (1) [back to overview]Bladder Capacity
NCT02045862 (53) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours
NCT02045862 (53) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours
NCT02045862 (53) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep
NCT02045862 (53) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping
NCT02045862 (53) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern
NCT02045862 (53) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social
NCT02045862 (53) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score
NCT02045862 (53) [back to overview]Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT
NCT02045862 (53) [back to overview]Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT
NCT02045862 (53) [back to overview]Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT
NCT02045862 (53) [back to overview]Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT
NCT02045862 (53) [back to overview]Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT
NCT02045862 (53) [back to overview]Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT
NCT02045862 (53) [back to overview]Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT
NCT02045862 (53) [back to overview]Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT
NCT02045862 (53) [back to overview]Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT
NCT02045862 (53) [back to overview]Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Months 1, 3, 6, 9, 12 and EoT
NCT02045862 (53) [back to overview]Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Months 1, 3, 6, 9, 12 and EoT
NCT02045862 (53) [back to overview]Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT
NCT02045862 (53) [back to overview]Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT
NCT02045862 (53) [back to overview]Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT
NCT02045862 (53) [back to overview]Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT
NCT02045862 (53) [back to overview]Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
NCT02045862 (53) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
NCT02045862 (53) [back to overview]Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit
NCT02045862 (53) [back to overview]Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit
NCT02045862 (53) [back to overview]Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit
NCT02045862 (53) [back to overview]Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS
NCT02045862 (53) [back to overview]Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score
NCT02045862 (53) [back to overview]Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit
NCT02045862 (53) [back to overview]Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours
NCT02045862 (53) [back to overview]Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours
NCT02045862 (53) [back to overview]Change From Baseline to EoT in the Patient's Assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS)
NCT02045862 (53) [back to overview]Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
NCT02045862 (53) [back to overview]Change From Baseline to EoT in Mean Volume Voided Per Micturition
NCT02045862 (53) [back to overview]Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours
NCT02045862 (53) [back to overview]Change From Baseline to EoT in Corrected Micturition Frequency
NCT02045862 (53) [back to overview]Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours
NCT02045862 (53) [back to overview]Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
NCT02045862 (53) [back to overview]Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)
NCT02045862 (53) [back to overview]Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment
NCT02045862 (53) [back to overview]Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment
NCT02045862 (53) [back to overview]Change From Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working
NCT02045862 (53) [back to overview]Change From Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed
NCT02045862 (53) [back to overview]Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition
NCT02045862 (53) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume
NCT02045862 (53) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)
NCT02045862 (53) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
NCT02045862 (53) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit
NCT02045862 (53) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
NCT02045862 (53) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
NCT02045862 (53) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours
NCT02045862 (53) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours
NCT02086188 (7) [back to overview]Mean # of Incontinence Episodes/Day
NCT02086188 (7) [back to overview]Subject Global Impression (Single Question)
NCT02086188 (7) [back to overview]Qualiveen Questionnaire
NCT02086188 (7) [back to overview]Overactive Bladder Symptom Composite Score (OAB-SCS) at Baseline vs. Titration Visit
NCT02086188 (7) [back to overview]Overactive Bladder Symptom Composite Score (OAB-SCS) at Baseline vs. Final Visit
NCT02086188 (7) [back to overview]Mean Volume Voided/Micturition
NCT02086188 (7) [back to overview]Mean # of Micturitions/Day Based on Voiding Diaries
NCT02092181 (7) [back to overview]Change in Mean Daily OAB-SCS Visit 3 vs Baseline
NCT02092181 (7) [back to overview]Change in the Mean Daily Overactive Bladder-Symptom Composite Score.
NCT02092181 (7) [back to overview]Change in Mean Number of Incontinence Episodes Per 24 Hours
NCT02092181 (7) [back to overview]Non- Motor Symptoms Scale (NMSS)
NCT02092181 (7) [back to overview]Overactive Bladder Questionnaire Symptom Severity Scale( OAB-q)
NCT02092181 (7) [back to overview]Patient Perception of Bladder Condition
NCT02092181 (7) [back to overview]Subjects Global Impression of Change
NCT02138747 (13) [back to overview]Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Participant's Fulfillment of OAB Medication Expectations
NCT02138747 (13) [back to overview]Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Interruption of Day-to-Day Life Due to OAB
NCT02138747 (13) [back to overview]Change From Baseline to End of Treatment (EOT) in Mean Number of Incontinence Episodes Per 24 Hours
NCT02138747 (13) [back to overview]Change From Baseline to End of Treatment (EOT) in Number of Micturitions Per 24 Hours
NCT02138747 (13) [back to overview]Participants Tolerability Assessed by the Medication Tolerability Scale of the Overactive Bladder-Satisfaction (OAB-S) Questionnaire at the End of Treatment (EOT)
NCT02138747 (13) [back to overview]Scale of the OAB-S Questionnaire at the End of Treatment Period: Impact on Daily Living With OAB.
NCT02138747 (13) [back to overview]Scale of the OAB-S Questionnaire at the End of Treatment Period: OAB Control
NCT02138747 (13) [back to overview]Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Improvement in Day-to-Day Life Due to OAB Medication
NCT02138747 (13) [back to overview]Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Willingness to Continue OAB Medication
NCT02138747 (13) [back to overview]Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Satisfaction With OAB Medication
NCT02138747 (13) [back to overview]Scale of the OAB-S Questionnaire at the End of Treatment Period: Satisfaction With OAB Control
NCT02138747 (13) [back to overview]Number of Participants With Adverse Events
NCT02138747 (13) [back to overview]Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods.
NCT02216214 (25) [back to overview]Change From Baseline in Post-void Residual Volume (PVR)
NCT02216214 (25) [back to overview]Change From Baseline to End of Treatment (EOT) in Mean Number of Micturitions Per 24 Hours
NCT02216214 (25) [back to overview]Change From Baseline to EOT in Barthel Index of Daily Living Score
NCT02216214 (25) [back to overview]Change From Baseline to EOT in Mean Number of Incontinence Episodes Per 24 Hours
NCT02216214 (25) [back to overview]Change From Baseline to EOT in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
NCT02216214 (25) [back to overview]Change From Baseline to EOT in OAB-q HRQL Subscale Scores
NCT02216214 (25) [back to overview]Change From Baseline to EOT in Mean Volume Voided Per Micturition
NCT02216214 (25) [back to overview]Change From Baseline to EOT in Montreal Cognitive Assessment (MoCA) Score
NCT02216214 (25) [back to overview]Change From Baseline to EOT in OAB-q: Health Related Quality of Life (HRQL) Total Score
NCT02216214 (25) [back to overview]Change From Baseline to EOT in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score
NCT02216214 (25) [back to overview]Change From Baseline to EOT in Patient Perception of Bladder Condition (PPBC)
NCT02216214 (25) [back to overview]Change From Baseline to EOT in PPIUS
NCT02216214 (25) [back to overview]Change From Baseline to EOT in Treatment Satisfaction Visual Analog Scale (TS-VAS)
NCT02216214 (25) [back to overview]Change From Baseline to EOT in University of Alabama, Birmingham - Life Space Assessment (UAB-LSA)
NCT02216214 (25) [back to overview]Change From Baseline to EOT in Vulnerable Elder Survey-13 (VES-13) Score
NCT02216214 (25) [back to overview]Change From to EOT in Mean Number of Nocturia Episodes Per 24 Hours
NCT02216214 (25) [back to overview]Percentage of Participants Major (≥ 2-Point) Improvement From Baseline in PPBC
NCT02216214 (25) [back to overview]Percentage of Participants Who Achieved Micturition Frequency Normalization
NCT02216214 (25) [back to overview]Percentage of Participants With ≥ 10-Point Improvement From Baseline in OAB-q HRQL Subscales
NCT02216214 (25) [back to overview]Number of Participants With Adverse Events (AEs)
NCT02216214 (25) [back to overview]Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours
NCT02216214 (25) [back to overview]Percentage of Participants With ≥ 1-Point Improvement From Baseline in PPBC
NCT02216214 (25) [back to overview]Percentage of Participants With Zero Incontinence Episodes Per 24 Hours
NCT02216214 (25) [back to overview]Change From Baseline in Number of Incontinence Episodes Reported During 3-Day Diary Prior to Each Visit
NCT02216214 (25) [back to overview]Change From Baseline to EOT in Mean Number of Urgency Incontinence Episodes Per 24 Hours
NCT02294396 (16) [back to overview]Change From Baseline in the Mean Number of Incontinence Episodes Per 24 Hours
NCT02294396 (16) [back to overview]Change From Baseline in the Mean Number of Micturitions Per 24 Hours
NCT02294396 (16) [back to overview]Change From Baseline in the Mean Number of Nocturia Episodes Per Night
NCT02294396 (16) [back to overview]Change From Baseline in the Mean Number of Urgency Episodes Per 24 Hours
NCT02294396 (16) [back to overview]Change From Baseline in the Mean Volume Voided Per Micturition
NCT02294396 (16) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
NCT02294396 (16) [back to overview]Change From Baseline in the Mean Number of Urge Incontinence Episodes Per 24 Hours
NCT02294396 (16) [back to overview]Number for Participants Who Achieved Normalization of the Mean Number of Incontinence Episodes Per 24 Hours
NCT02294396 (16) [back to overview]Number for Participants Who Achieved Normalization of the Mean Number of Micturitions Per 24 Hours
NCT02294396 (16) [back to overview]Number for Participants Who Achieved Normalization of the Mean Number of Urgency Episodes Per 24 Hours
NCT02294396 (16) [back to overview]Number of Participants Who Achieved Normalization for OABSS Total Score
NCT02294396 (16) [back to overview]Number of Participants Who Achieved Normalization of the Mean Number of Nocturia Episodes Per 24 Hours
NCT02294396 (16) [back to overview]Change From Baseline in OAB-q SF Total HRQL Score
NCT02294396 (16) [back to overview]Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Symptom Severity Score
NCT02294396 (16) [back to overview]Change From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score
NCT02294396 (16) [back to overview]Change From Baseline in Postvoid Residual (PVR) Volume
NCT02436889 (5) [back to overview]Change From Baseline in Trail Making Test, Trail A Score at 8 Weeks
NCT02436889 (5) [back to overview]Change From Baseline in Urge Incontinence Episodes Per Day on a Voiding Diary at 8 Weeks.
NCT02436889 (5) [back to overview]Change From Baseline in California Verbal Learning Test (CVLT) Score at 8 Weeks
NCT02436889 (5) [back to overview]Change From Baseline in Short Physical Performance Battery (SPPB) Score at 8 Weeks
NCT02436889 (5) [back to overview]Change From Baseline in Total Urinary Incontinence Frequency Measured by a Voiding Diary at 8 Weeks
NCT02462837 (6) [back to overview]Improvement From Baseline in the Incontinence Symptom Severity Index (ISSI) in the Myrbetriq™ Group at the 1 Week Follow-up Compared to Placebo Group.
NCT02462837 (6) [back to overview]Improvement From Baseline in the Incontinence Symptom Severity Index (ISSI) in the Myrbetriq™ Group at the 2 Week Follow-up Compared to Placebo Group.
NCT02462837 (6) [back to overview]Improvement From Baseline on the Patient Global Impression of Severity (PGI-S) at the 2 Week Follow-up.
NCT02462837 (6) [back to overview]Reduction in Pain Medicine Intake at the 2 Week Follow-up
NCT02462837 (6) [back to overview]Reduction in Pain Medicine Intake at the 2 Week Follow-up
NCT02462837 (6) [back to overview]Improvement in Pain and Discomfort Perception Using a 10 Point Visual Analog Scale for Pain Assessment (VAS) at the 1 and 2 Week Follow-up.
NCT02468830 (5) [back to overview]Improved Overactive Bladder Symptoms as a Measure of Efficacy of Mirabegron
NCT02468830 (5) [back to overview]Improved Overactive Bladder Symptoms as a Measure of Efficacy of Mirabegron
NCT02468830 (5) [back to overview]Improved Quality of Life Using the Patient Perception of Bladder Condition (PPBC) Scale
NCT02468830 (5) [back to overview]Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Mirabegron
NCT02468830 (5) [back to overview]Number of Participants With Cardio Vascular Safety
NCT02476175 (5) [back to overview]Number of Participants With Grade 2 or 3 Urgency Episodes as a Measure of Efficacy
NCT02476175 (5) [back to overview]Response to Urinary Incontinence as a Composite Measure of Efficacy of add-on Mirabegron
NCT02476175 (5) [back to overview]Number of Participants Showing Improved Quality of Life Using the Patient Perception of Bladder Condition Scale and Voiding Diaries
NCT02476175 (5) [back to overview]Number of Participants Without Variation in Heart Rate
NCT02476175 (5) [back to overview]Number of Participants With Cardio Vascular Safety
NCT02495389 (4) [back to overview]Change in Urinary Distress Inventory (UDI)
NCT02495389 (4) [back to overview]Change in Pelvic Organ Prolapse Distress Inventory (POPDI) Score
NCT02495389 (4) [back to overview]Change in Overactive Bladder Questionnaire (OAB-q) Health Related Quality of Life (HRQL)
NCT02495389 (4) [back to overview]Change in Colo-Rectal-Anal Distress Inventory (CRADI)
NCT02536976 (3) [back to overview]Change in Montreal Cognitive Assessment Total Score
NCT02536976 (3) [back to overview]Change in Unified Parkinson's Disease Rating Scale
NCT02536976 (3) [back to overview]Change in Overactive Bladder Questionnaire Subscale Scores
NCT02656173 (16) [back to overview]Change From Baseline to EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours
NCT02656173 (16) [back to overview]Change From Baseline to EoT in Total International Prostate Symptom Score (IPSS)
NCT02656173 (16) [back to overview]Change From Baseline to EoT in Total Health-Related QoL (HRQoL) Scores as Assessed by the OAB-q
NCT02656173 (16) [back to overview]Change From Baseline to EoT in Symptom Bother as Assessed by the Overactive Bladder Questionnaire (OAB-q)
NCT02656173 (16) [back to overview]Change From Baseline to EoT in Postvoid Residual (PVR) Volume
NCT02656173 (16) [back to overview]Change From Baseline to EoT in Mean Volume Voided Per Micturition
NCT02656173 (16) [back to overview]Change From Baseline to EoT in Mean Number of Urgency Episodes Per 24 Hours
NCT02656173 (16) [back to overview]Change From Baseline to EoT in Mean Number of Nocturia Episodes
NCT02656173 (16) [back to overview]Change From Baseline to EoT in Mean Number of Incontinence Episodes Per 24 Hours
NCT02656173 (16) [back to overview]Change From Baseline to EoT in Total Overactive Bladder Symptom Score (OABSS)
NCT02656173 (16) [back to overview]Change From Baseline to EoT in Maximum Urine Flow Rate (Qmax)
NCT02656173 (16) [back to overview]Change From Baseline to End of Treatment (EoT) in Mean Number of Micturitions Per 24 Hours
NCT02656173 (16) [back to overview]Change From Baseline to EoT in IPSS Subscale Scores
NCT02656173 (16) [back to overview]Change From Baseline to EoT in OABSS Subscale Scores
NCT02656173 (16) [back to overview]Change From Baseline to Weeks 4, 8, 12 in Mean Number of Micturitions Per 24 Hours
NCT02656173 (16) [back to overview]Number of Participants With Adverse Events
NCT02744430 (2) [back to overview]Spontaneous Stone Passage Using Fisher's Exact Test
NCT02744430 (2) [back to overview]Comparison of Pain Levels Between Treatment Groups Using the Wong-Baker Pain Rating Scale
NCT02751931 (31) [back to overview]Number of Participants With Study Drug Acceptability for Oral Suspension at Week 24
NCT02751931 (31) [back to overview]Number of Participants With Study Drug Acceptability for Oral Suspension at Week 52
NCT02751931 (31) [back to overview]Number of Participants With Study Drug Acceptability for Tablets at Week 24
NCT02751931 (31) [back to overview]Number of Participants With Study Drug Acceptability for Tablets at Week 4
NCT02751931 (31) [back to overview]Number of Participants With Study Drug Acceptability for Tablets at Week 52
NCT02751931 (31) [back to overview]Apparent Volume of Distribution After Non-intravenous Administration (Vz/F) of Mirabegron
NCT02751931 (31) [back to overview]Change From Baseline in Maximum Cystometric Capacity (MCC) at Week 24
NCT02751931 (31) [back to overview]Change From Baseline in Maximum Cystometric Capacity at Week 4
NCT02751931 (31) [back to overview]Maximum Plasma Concentration (Cmax) of Mirabegron
NCT02751931 (31) [back to overview]Plasma Concentration of Mirabegron at the End of a Dosing Interval at Steady State (Ctrough)
NCT02751931 (31) [back to overview]Time to Reach Maximum Plasma Concentration of Mirabegron Following Drug Administration (Tmax)
NCT02751931 (31) [back to overview]Change From Baseline in Average Catheterized Volume Per Catheterization
NCT02751931 (31) [back to overview]Change From Baseline in Average Morning Catheterized Volume
NCT02751931 (31) [back to overview]Change From Baseline in Bladder Compliance (ΔV/ΔP)
NCT02751931 (31) [back to overview]Change From Baseline in Detrusor Pressure at End of Filling
NCT02751931 (31) [back to overview]Change From Baseline in Filling Bladder Volume Until First Overactive Detrusor Contraction (> 15 cm H20)
NCT02751931 (31) [back to overview]Change From Baseline in Filling Bladder Volume Until First Overactive Detrusor Contraction (> 15 cm H20): Paired T-test
NCT02751931 (31) [back to overview]Change From Baseline in Filling Bladder Volume Until First Overactive Detrusor Contraction (> 15 cm H20): Wilcoxon Signed-rank Test Updated Analysis
NCT02751931 (31) [back to overview]Change From Baseline in Maximum Catheterized Daytime Volume (MCDV)
NCT02751931 (31) [back to overview]Change From Baseline in Maximum Catheterized Volume
NCT02751931 (31) [back to overview]Change From Baseline in Mean Number of Leakage Episodes Per Day
NCT02751931 (31) [back to overview]Change From Baseline in Mean Number of Leakage Episodes Per Day: Updated Analysis
NCT02751931 (31) [back to overview]Change From Baseline in Number of Dry Days Per 7 Days (Day and Night Time)
NCT02751931 (31) [back to overview]Change From Baseline in Number of Overactive Detrusor Contractions (> 15 cm H20) Until End of Filling
NCT02751931 (31) [back to overview]Change From Baseline in Patient Global Impression of Severity Scale (PGI-S)
NCT02751931 (31) [back to overview]Change From Baseline in Pediatric Incontinence Questionnaire (PIN-Q) Score
NCT02751931 (31) [back to overview]Apparent Total Clearance of Mirabegron From Plasma After Oral Administration (CL/F)
NCT02751931 (31) [back to overview]Number of Participants With Study Drug Acceptability for Oral Suspension at Week 4
NCT02751931 (31) [back to overview]Number of Participants With Adverse Events (AEs)
NCT02751931 (31) [back to overview]Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC24) for Mirabegron
NCT02751931 (31) [back to overview]Number of Participants With Clinician Global Impression of Change (CGI-C)
NCT02757768 (21) [back to overview]Change From Baseline to End of Treatment (EoT) in Mean Number of Micturitions Per Day
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in Total Urgency and Frequency Score (TUFS)
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in Treatment Satisfaction Visual Analog Scale (TS-VAS)
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, and Week 12 in Mean Number of Micturitions Per Day
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in European Quality of Life in 5 Dimensions and 5 Levels (EQ-5D-5L Questionnaire) Utilities
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Coping Score
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Sleep Score
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Social Interaction Score
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in International Prostate Symptom Score (IPSS) Total Score
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in IPSS Subscale Quality of Life (QoL) Score
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in IPSS Subscale Voiding Score
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Incontinence Episodes Per Day
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per Day
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12, and EoT in IPSS Subscale Storage Score
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Concern Score
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in Total Health Related Quality of Life (HRQL) Score
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in Symptom Bother Score
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in Patient Perception of Bladder Condition (PPBC)
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Volume Voided Per Micturition
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Urgency Incontinence Episodes Per Day
NCT02787083 (2) [back to overview]Number of Participants With Interstitial Cystitis Symptom Improvement
NCT02787083 (2) [back to overview]Number of Participants With Improvement in Incontinence Episodes
NCT02916693 (10) [back to overview]Health Related Quality of Life as Assessed by the OAB Questionnaire
NCT02916693 (10) [back to overview]Health Related Quality of Life as Assessed by the OAB Questionnaire
NCT02916693 (10) [back to overview]Health Related Quality of Life as Assessed by the OAB Questionnaire
NCT02916693 (10) [back to overview]Health Related Quality of Life as Assessed by the OAB Questionnaire
NCT02916693 (10) [back to overview]Erectile Function Assessed by IIEF Questionnaire
NCT02916693 (10) [back to overview]Health Related Quality of Life as Assessed by the OAB Questionnaire
NCT02916693 (10) [back to overview]Erectile Function Assessed by IIEF Questionnaire
NCT02916693 (10) [back to overview]Erectile Function Assessed by IIEF Questionnaire
NCT02916693 (10) [back to overview]Erectile Function Assessed by IIEF Questionnaire
NCT02916693 (10) [back to overview]Erectile Function Assessed by IIEF Questionnaire
NCT04501640 (4) [back to overview]Maximum Concentration (Cmax) For Mirabegron
NCT04501640 (4) [back to overview]Number of Participants With Adverse Events (AE)
NCT04501640 (4) [back to overview]Area Under The Concentration-Time Curve (AUC) From The Time of Dosing Extrapolated to Time Infinity (AUCinf) For Mirabegron
NCT04501640 (4) [back to overview]Area Under The Concentration-Time Curve (AUC) From The Time of Dosing to The Last Measurable Concentration (AUClast) For Mirabegron
NCT04562090 (9) [back to overview]Change From Baseline (CFB) to the End of 12-Week Treatment Period in Mean Number of Micturition/24 Hours in Mirabegron 50 mg Group
NCT04562090 (9) [back to overview]Change From Baseline to Week 12 in Post Void Residual (PVR) Volume
NCT04562090 (9) [back to overview]Number of Participants With Treatment Emergent Adverse Events
NCT04562090 (9) [back to overview]Change From Baseline in Mean Number of Daytime Incontinence Episodes Per 24 Hours
NCT04562090 (9) [back to overview]Change From Baseline in Mean Number of Grade 3 or 4 Patient Perception of Intensity of Urgency Scale (PPIUS) Urgency Episodes Per 24 Hours
NCT04562090 (9) [back to overview]Change From Baseline in Mean Number of Micturition Per 24 Hours
NCT04562090 (9) [back to overview]Change From Baseline in Mean Number of Nighttime Incontinence Episodes Per 24 Hours
NCT04562090 (9) [back to overview]Change From Baseline in Mean Number of Urge Incontinence Episodes Per 24 Hours
NCT04562090 (9) [back to overview]Change From Baseline in OAB Symptom Score (OABSS)
NCT04641975 (14) [back to overview]Change From Baseline to Week 12/EoT in Mean Number of Micturitions Per 24 Hours for Age Group 5 to <12 Years
NCT04641975 (14) [back to overview]Change From Baseline in Post Void Residual (PVR) Volume
NCT04641975 (14) [back to overview]Change From Baseline in Post Void Residual (PVR) Volume
NCT04641975 (14) [back to overview]Change From Baseline to Week 12/EoT in Maximum Volume Voided (MVV) for Age Group 5 to <12 Years
NCT04641975 (14) [back to overview]Change From Baseline to Week 12/EoT in Mean Number of Daytime Incontinence Episodes Per 24 Hours for Age Group 5 to <12 Years
NCT04641975 (14) [back to overview]Change From Baseline to Week 12/EoT in Mean Number of Daytime Micturitions Per 24 Hours for Age Group 5 to <12 Years
NCT04641975 (14) [back to overview]Change From Baseline to Week 12/EoT in Mean Number of Nighttime Incontinence Episodes Per 24 Hours for Age Group 5 to <12 Years
NCT04641975 (14) [back to overview]Change From Baseline to Week 12/EoT in Mean Volume Voided Per 24 Hours for Age Group 5 to <12 Years
NCT04641975 (14) [back to overview]Change From Baseline to Week 12/EoT in Number of Dry (Incontinence-free) Days Per 7 Days for Age Group 5 to <12 Years
NCT04641975 (14) [back to overview]Number of Participants With Study Drug Acceptability and Palatability for Oral Suspension
NCT04641975 (14) [back to overview]Number of Participants With Study Drug Acceptability and Palatability for Tablets
NCT04641975 (14) [back to overview]Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
NCT04641975 (14) [back to overview]PK of Mirabegron in Plasma: Concentration Immediately Prior to Dosing (Ctrough)
NCT04641975 (14) [back to overview]PK of Mirabegron in Plasma: Concentration Immediately Prior to Dosing (Ctrough)
NCT04907032 (4) [back to overview]Change in Symptom Distress as Measured by the Urinary Distress Index (UDI-6) Questionnaire Pre- (Baseline Measure) vs. Post-treatment (Post-trial Measure)
NCT04907032 (4) [back to overview]Change in the Number of UUI Episodes Over a 3-day Voiding Diary Pre- vs. Post-treatment. This Includes a Baseline Measure Pre-trial and a Pos-trial Measure in 12 Weeks
NCT04907032 (4) [back to overview]Change in UUI (Urge Urinary Incontinence)/OAB (Overactive Bladder) Quality of Life as Measured by the Incontinence Impact Questionnaire Short Form (IIQ-7) Questionnaire Pre- (Baseline Measure) vs. Post-treatment (Post-trial Measure in 12 Weeks)
NCT04907032 (4) [back to overview]Change in UUI (Urge Urinary Incontinence)/OAB (Overactive Bladder) Quality of Life as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF) Questionnaire Pre- (Baseline Measure) vs. Post-treatment (Post-trial Measure)

Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Total Score

"The IPSS is a validated global questionnaire used to assess the degree of bother from benign prostatic hyperplasia symptoms and is based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Weeks 1, 4, 8 and 12

,,
Interventionscores on a scale (Least Squares Mean)
Change from Baseline at Week 1 [N=63; 63; 57]Change from Baseline at Week 4 [N=63; 62; 58]Change from Baseline at Week 8 [N=62; 63; 56]Change from Baseline at Week 12 [N=58; 61; 52]Change from Baseline at EOT [N=63; 64; 58]
Mirabegron 100 mg-1.6-4.4-5.3-4.8-4.8
Mirabegron 50 mg-2.4-5.2-6.3-6.3-6.2
Placebo-1.7-4.0-5.0-5.2-5.0

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Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Storage Symptom Score

"The IPSS is a validated global questionnaire used to assess the degree of bother from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 questions relating to storage symptoms (frequency, urgency and nocturia) and ranges from 0 to 15 (asymptomatic to very symptomatic).~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Weeks 1, 4, 8 and 12

,,
Interventionscores on a scale (Least Squares Mean)
Change from Baseline at Week 1 [N=63; 63; 57]Change from Baseline at Week 4 [N=63; 62; 58]Change from Baseline at Week 8 [N=62; 63; 57]Change from Baseline at Week 12 [N=59; 61; 52]Change from Baseline at EOT [N=63; 64; 58]
Mirabegron 100 mg-1.0-2.3-2.6-2.5-2.5
Mirabegron 50 mg-1.4-2.6-3.2-3.4-3.3
Placebo-0.7-1.7-2.1-2.2-2.2

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Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)

"Maximum urinary flow rate (Qmax) was measured by the Investigator using cystometry and was sent to an independent central reading center for review and interpretation.~Least squares means (LSM) were derived from an analysis of covariance (ANCOVA) model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Week 12

InterventionmL/sec (Least Squares Mean)
Placebo-0.33
Mirabegron 50 mg0.07
Mirabegron 100 mg0.30

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Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)

"Detrusor pressure at maximum urinary flow rate (PdetQmax) was measured by the Investigator using cystometry and was sent to an independent central reading center for review and interpretation.~Least squares means (LSM) were derived from an analysis of covariance (ANCOVA) model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Week 12

InterventioncmH2O (Least Squares Mean)
Placebo2.92
Mirabegron 50 mg-3.03
Mirabegron 100 mg1.53

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Change From Baseline to End of Treatment in Bladder Voiding Efficiency (BVE)

"Bladder Voiding Efficiency (BVE) is a product of bladder contractility against the urethral resistance and is measured according to the degree of bladder emptying. BVE is expressed as a percentage and is calculated using the formula:~Bladder Voiding efficiency = (Voided volume x 100)/maximum cystometric capacity.~A higher number indicates a higher voiding efficiency. Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Week 12

InterventionPercent voiding efficiency (Least Squares Mean)
Placebo-3.01
Mirabegron 50 mg-5.49
Mirabegron 100 mg2.06

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Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests

Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild, moderate or severe and for causal relationship to study drug. (NCT00410514)
Timeframe: From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).

,,
Interventionparticipants (Number)
Adverse eventsMild intensity adverse eventsModerate intensity adverse eventsSevere intensity adverse eventsDrug-related adverse eventsSerious adverse eventsAEs leading to study drug discontinuationDeaths
Mirabegron 100 mg342014011020
Mirabegron 50 mg28161025010
Placebo2817748020

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Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score

"Male lower urinary tract symptoms were assessed by the ICIQ MaleLUTS questionnaire which consists of 13 questions each on a 0-4 scale (larger scores correspond to worse conditions). The total symptom score ranges from 0 to 52.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
Interventionscores on a scale (Least Squares Mean)
Change from Baseline at Week 4 [N=60; 60; 58]Change from Baseline at Week 8 [N=61; 61; 56]Change from Baseline at Week 12 [N=58; 60; 53]Change from Baseline at EOT [N=62; 61; 58]
Mirabegron 100 mg-3.5-4.9-5.4-5.5
Mirabegron 50 mg-4.0-5.1-4.9-4.8
Placebo-2.8-3.9-4.2-3.9

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Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Bother Score

"The degree to which urinary symptoms bothered participants was assessed by the ICIQ MaleLUTS questionnaire which consists of 13 symptom bother questions each on a 0-10 scale (larger scores correspond to worse outcomes). The total bother score ranges from 0 to 130.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
Interventionscores on a scale (Least Squares Mean)
Change from Baseline at Week 4 [N=58; 53; 56]Change from Baseline at Week 8 [N=57; 57; 53]Change from Baseline at Week 12 [N=54; 53; 51]Change from Baseline at EOT [N=60; 57; 58]
Mirabegron 100 mg-10.0-19.3-17.4-18.6
Mirabegron 50 mg-13.6-21.9-19.3-20.1
Placebo-7.5-11.6-15.1-14.0

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Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score

"Quality of life was assessed by the ICIQ-LUTSqol questionnaire which consists of 19 questions each on a 1-4 scale (larger scores correspond to less quality of life). The total symptom score ranges from 19 - 76.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
Interventionscores on a scale (Least Squares Mean)
Change from Baseline at Week 4 [N=41; 37; 33]Change from Baseline at Week 8 [N=39; 36; 31]Change from Baseline at Week 12 [N=40; 30;26]Change from Baseline at EOT [N=47; 40; 36]
Mirabegron 100 mg-3.1-5.7-5.7-5.0
Mirabegron 50 mg-4.1-6.4-6.9-6.9
Placebo-3.2-4.8-4.7-4.8

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Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Urgency Episodes With Urgency Severity ≥ 3 Per 24 Hours

"For each micturition and/or incontinence episode in the 3 days preceding the clinic visit, participants rated the degree of associated urgency (the sudden compelling desire to pass urine, which is difficult to defer) according to the following scale: 0: No Urgency, felt no need to empty my bladder but did so for another reason; 1: Mild Urgency, could postpone passing water for as long as necessary; 2: Moderate Urgency, could postpone passing water for a short while; 3: Severe Urgency, could not postpone passing water; 4: Urge Incontinence, leaked before reaching the toilet.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Weeks 1, 4, 8 and 12

,,
InterventionUrgency episodes (Least Squares Mean)
Change from Baseline at Week 1 [N=63; 64; 57]Change from Baseline at Week 4 [N=63; 64; 58]Change from Baseline at Week 8 [N=62; 63; 57]Change from Baseline at Week 12 [N=62; 63; 54]Change from Baseline at EOT [N=63; 64; 58]
Mirabegron 100 mg-0.60-0.95-0.98-0.90-0.93
Mirabegron 50 mg-0.81-1.13-1.43-1.65-1.60
Placebo0.09-0.11-0.35-0.33-0.33

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Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Overall Symptom Interference of Life Score

"Participants were asked to rate how much their urinary symptoms interfered overall with their everyday life on a scale from 0 (not at all) to 10 (a great deal).~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
Interventionscores on a scale (Least Squares Mean)
Change from Baseline at Week 4 [N=61; 62; 58]Change from Baseline at Week 8 [N=60; 63; 57]Change from Baseline at Week 12 [N=59; 61; 53]Change from Baseline at EOT [N=62; 63; 58]
Mirabegron 100 mg-1.0-1.7-1.9-1.9
Mirabegron 50 mg-1.2-1.7-2.1-2.0
Placebo-0.4-0.9-1.1-1.1

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Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Postvoid Residual Volume (PVR)

"Healthy micturitions (urinations) result in complete emptying of the bladder. Post Void Residual (PVR) is the volume of urine retained after voiding and was assessed using abdominal ultrasound. An increasing PVR over time is an indicator of abnormal bladder function or detrusor decompensation.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Weeks 1, 4, 8 and 12

,,
InterventionmL (Least Squares Mean)
Change from Baseline at Week 1 [N=63; 66; 63]Change from Baseline at Week 4 [N=63; 67; 63]Change from Baseline at Week 8 [N=62; 67; 61]Change from Baseline at Week 12 [N=59; 63; 57]Change from Baseline at EOT [N=64; 70; 65]
Mirabegron 100 mg0.518.63-3.7133.2230.77
Mirabegron 50 mg-2.93-1.035.1121.1317.89
Placebo-8.101.08-9.924.650.55

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Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Patient Perception of Bladder Condition (PPBC)

"The patient perception of bladder condition (PPBC) asks participants to assess their bladder condition using a 6-point validated Likert scale which ranges from 1 (does not cause me any problems at all) to 6 (causes me many severe problems).~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Weeks 1, 4, 8 and 12

,,
Interventionscores on a scale (Least Squares Mean)
Change from Baseline at Week 1 [N=63; 63; 57]Change from Baseline at Week 4 [N=63; 62; 58]Change from Baseline at Week 8 [N=62; 63; 57]Change from Baseline at Week 12 [N=60; 61; 53]Change from Baseline at EOT [N=63; 64; 58]
Mirabegron 100 mg-0.6-0.6-0.9-0.9-0.8
Mirabegron 50 mg-0.3-0.5-0.7-0.9-0.9
Placebo-0.2-0.3-0.5-0.6-0.6

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Change From Baseline to End of Treatment in Bladder Contractile Index (BCI)

"The Bladder Contractile Index (BCI) is a value used to measure the degree of contractility. BCI was calculated using the following formula:~BCI = pdetQmax + 5Qmax.~Strong contractility is a BCI > 150, normal contractility is a BCI of 100-150 and weak contractility is a BCI of < 100.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Week 12

InterventionScores on a scale (Least Squares Mean)
Placebo1.25
Mirabegron 50 mg-2.60
Mirabegron 100 mg2.51

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Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Voided Volume Per Micturition

"The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Weeks 1, 4, 8 and 12

,,
InterventionmL (Least Squares Mean)
Change from Baseline at Week 1 [N=63; 64; 57]Change from Baseline at Week 4 [N=63; 64; 58]Change from Baseline at Week 8 [N=62; 63; 57]Change from Baseline at Week 12 [N=62; 63; 54]Change from Baseline at EOT [N=63; 64; 58]
Mirabegron 100 mg10.3818.3122.8316.2015.80
Mirabegron 50 mg6.7112.5514.5216.6215.82
Placebo2.7510.254.534.495.40

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Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Micturitions Per 24 Hours

"A micturition is any voluntary urination, excluding episodes of incontinence only. The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Weeks 1, 4, 8 and 12

,,
Interventionmicturitions (Least Squares Mean)
Change from Baseline at Week 1 [N=63; 64; 57]Change from Baseline at Week 4 [N=63; 64; 58]Change from Baseline at Week 8 [N=62; 63; 57]Change from Baseline at Week 12 [N=62; 63; 54]Change from Baseline at EOT [N=63; 64; 58]
Mirabegron 100 mg-0.48-1.36-1.41-1.23-1.37
Mirabegron 50 mg-0.58-0.90-1.32-1.33-1.35
Placebo-0.15-0.36-0.61-0.27-0.31

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Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours

"The mean number of incontinence episodes (the involuntary leakage of urine) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Weeks 1, 4, 8 and 12

,,
InterventionIncontinence episodes (Least Squares Mean)
Change from Baseline at Week 1 [N=9; 18; 13]Change from Baseline at Week 4 [N=9; 18; 13Change from Baseline at Week 8 [N=9; 17; 13]Change from Baseline at Week 12 [N=9; 17; 13]Change from Baseline at EOT [N=9; 18; 13]
Mirabegron 100 mg-0.97-1.60-2.31-2.03-1.98
Mirabegron 50 mg-0.18-0.42-0.70-0.91-0.89
Placebo-1.16-0.99-0.77-0.98-0.96

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Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Voiding Score

"The IPSS is a validated global questionnaire used to assess the degree of bother from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 questions relating to urination (incomplete emptying, intermittency, weak stream and straining) and ranges from 0 to 20 (asymptomatic to very symptomatic).~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Weeks 1, 4, 8 and 12

,,
Interventionscores on a scale (Least Squares Mean)
Change from Baseline at Week 1 [N=63; 63; 57]Change from Baseline at Week 4 [N=63; 62; 58]Change from Baseline at Week 8 [N=62; 63; 56]Change from Baseline at Week 12 [N=58; 61; 52]Change from Baseline at EOT [N=63; 64; 58]
Mirabegron 100 mg-0.5-2.1-2.7-2.3-2.4
Mirabegron 50 mg-1.0-2.5-3.1-2.9-2.9
Placebo-0.9-2.3-3.0-3.0-2.8

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Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency

Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00662909)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
InterventionScores on a scale (Least Squares Mean)
Week 4 [N= 430; 421; 408]Week 8 [N= 393; 393; 389]Week 12 [N= 382; 377; 374]Final Visit (LOCF) [N= 432; 425; 411]
Mirabegron 100 mg-0.18-0.21-0.21-0.21
Mirabegron 50 mg-0.12-0.17-0.18-0.19
Placebo-0.08-0.10-0.09-0.08

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Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours

"Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate." (NCT00662909)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
InterventionNocturia episodes (Least Squares Mean)
Week 4 [N= 366; 345; 353]Week 8 [N= 333; 324; 340]Week 12 [N= 323; 311; 328]Final Visit (LOCF) [N= 366; 348; 356]
Mirabegron 100 mg-0.40-0.55-0.58-0.57
Mirabegron 50 mg-0.43-0.54-0.59-0.57
Placebo-0.29-0.24-0.32-0.38

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Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours

"The average number of times a patient records a new pad used per day during the 3-day micturition diary period.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate." (NCT00662909)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
Interventionpads (Least Squares Mean)
Week 4 [N= 176; 165; 156]Week 8 [N= 159; 154; 152]Week 12 [N= 152; 145; 147]Final Visit (LOCF) [N= 176; 166; 159]
Mirabegron 100 mg-0.76-1.03-1.09-1.06
Mirabegron 50 mg-0.77-0.96-1.04-1.03
Placebo-0.40-0.56-0.63-0.63

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Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours

The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00662909)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
InterventionUrgency episodes (Least Squares Mean)
Week 4 [N= 430; 420; 408]Week 8 [N= 393; 392; 389]Week 12 [N= 382; 376; 374]Final Visit (LOCF) [N= 432; 424; 411]
Mirabegron 100 mg-1.45-1.80-1.79-1.76
Mirabegron 50 mg-1.03-1.58-1.63-1.57
Placebo-0.75-0.91-0.86-0.82

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Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours

The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00662909)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
InterventionUrgency incontinence episodes (Least Squares Mean)
Week 4 [N=319; 294; 288]Week 8 [N=291; 273; 278]Week 12 [N= 278; 264; 265]Final Visit (LOCF) [N= 319; 297; 291]
Mirabegron 100 mg-1.05-1.44-1.45-1.45
Mirabegron 50 mg-1.09-1.23-1.32-1.32
Placebo-0.62-0.81-0.94-0.89

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Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score

"Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate." (NCT00662909)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
InterventionScores on a scale (Least Squares Mean)
Week 4 [ N= 354; 346; 335]Week 8 [N= 325; 321; 323]Week 12 [N=315; 308; 317]Final Visit (LOCF) [N= 356; 350; 344]
Mirabegron 100 mg-16.1-20.3-20.7-20.2
Mirabegron 50 mg-13.5-16.0-17.4-17.0
Placebo-9.7-11.6-11.3-10.8

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Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score

"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00662909)
Timeframe: Baseline and Week 12

,,
Interventionparticipants (Number)
Not anxious -> Not anxiousNot anxious -> Moderately anxiousNot anxious -> Extremely anxiousNot anxious -> Missing dataModerately anxious -> Not anxiousModerately anxious -> Moderately anxiousModerately anxious -> Extremely anxiousModerately anxious -> Missing dataExtremely anxious -> Not anxiousExtremely anxious -> Moderately anxiousExtremely anxious -> Extremely anxiousExtremely anxious -> Missing dataMissing data -> Not anxiousMissing data -> Moderately anxiousMissing data -> Extremely anxiousMissing data -> Missing data
Mirabegron 100 mg250330146750022201000
Mirabegron 50 mg250361148711229004000
Placebo239302458767315701000

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Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score

"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems in walking about; I have some problems in walking about; I am confined to bed.~In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00662909)
Timeframe: Baseline and Week 12

,,
Interventionparticipants (Number)
No problem -> No problemNo problem -> Some problemsNo problem -> Confined to bedNo problem -> Missing dataSome problems -> No problemsSome problems -> Some problemsSome problems -> Confined to bedSome problems -> Missing dataConfined -> No problemsConfined -> Some problemsConfined -> Confined to bedConfined -> Missing dataMissing data -> No problemsMissing data -> Some problemsMissing data -> Confined to bedMissing data -> Missing data
Mirabegron 100 mg291240141540000001000
Mirabegron 50 mg304170237580110103100
Placebo318150641490110002000

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Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score

"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00662909)
Timeframe: Baseline and Week 12

,,
Interventionparticipants (Number)
No pain -> No painNo pain -> Moderate painNo pain -> Extreme painNo pain -> Missing dataModerate pain -> No painModerate pain -> Moderate painModerate pain -> Extreme painModerate pain -> Missing dataExtreme pain -> No painExtreme pain -> Moderate painExtreme pain -> Extreme painExtreme pain -> Missing dataMissing data -> No painMissing data -> Moderate painMissing data -> Extreme painMissing data -> Missing data
Mirabegron 100 mg204311157958035601000
Mirabegron 50 mg198321279849128602100
Placebo201341376923337811000

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Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score

"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00662909)
Timeframe: Baseline and Week 12

,,
Interventionparticipants (Number)
No problem -> No problemNo problem -> Some problemsNo problem -> Unable to wash or dress myselfNo problem -> Missing dataSome problems -> No problemsSome problems -> Some problemsSome problems -> Unable to wash or dress myselfSome problems -> Missing dataUnable to wash or dress myself -> No problemsUnable to wash or dress myself -> Some problemsUnable to wash or dress -> Unable to wash or dressUnable to wash or dress myself -> Missing dataMissing data -> No problemsMissing data -> Some problemsMissing data -> Unable to wash or dress myselfMissing data -> Missing data
Mirabegron 100 mg386612850000004000
Mirabegron 50 mg3929038100000003000
Placebo3981016750121002000

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Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score

The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit. (NCT00662909)
Timeframe: Baseline and Week 12

,,
Interventionparticipants (Number)
No problem -> No problemNo problem -> Some problemsNo problem -> UnableNo problem -> Missing dataSome problems -> No problemsSome problems -> Some problemsSome problems -> UnableSome problems -> Missing dataUnable -> No problemsUnable -> Some problemsUnable -> UnableUnable -> Missing dataMissing data -> No problemsMissing data -> Some problemsMissing data -> UnableMissing data -> Missing data
Mirabegron 100 mg287191150482010201000
Mirabegron 50 mg297191245501105102100
Placebo303220647520101001000

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Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)

The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A negative change from Baseline score indicates improvement. (NCT00662909)
Timeframe: Baseline and Week 12

,,
InterventionScores on a scale (Least Squares Mean)
Week 12 [N=373; 376; 371]Final Visit (LOCF) [N=392; 388; 377]
Mirabegron 100 mg-0.8-0.8
Mirabegron 50 mg-0.7-0.7
Placebo-0.6-0.5

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Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS)

The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A positive change from baseline indicates improvement. (NCT00662909)
Timeframe: Baseline and Week 12

,,
InterventionScores on a scale (Least Squares Mean)
Week 12 [N= 371; 375; 368]Final Visit (LOCF) [N= 390; 387; 373]
Mirabegron 100 mg2.092.09
Mirabegron 50 mg1.571.55
Placebo0.720.70

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Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment

The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment. A negative change from baseline indicates improvement. (NCT00662909)
Timeframe: Baseline and Week 12

,,
Interventionpercent activity impairment (Mean)
Week 12 [N= 368; 368; 363]Final Visit (LOCF) [N= 386; 380; 368]
Mirabegron 100 mg-10.8-10.7
Mirabegron 50 mg-12.9-12.3
Placebo-7.5-6.7

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Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working

The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. (NCT00662909)
Timeframe: Baseline and Week 12

,,
Interventionpercent impairment while working (Mean)
Week 12 [N= 142; 143; 137]Final Visit (LOCF) [N= 147; 146; 137]
Mirabegron 100 mg-8.2-8.2
Mirabegron 50 mg-8.5-8.6
Placebo-7.1-6.2

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Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment

The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. (NCT00662909)
Timeframe: Baseline and Week 12

,,
Interventionpercent overall work impairment (Mean)
Week 12 [ N= 135; 138; 130]Final Visit (LOCF) [N= 140; 140; 130]
Mirabegron 100 mg-8.7-8.7
Mirabegron 50 mg-8.2-8.2
Placebo-7.1-6.1

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Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed

The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement. (NCT00662909)
Timeframe: Baseline and Week12

,,
Interventionpercent work time missed (Mean)
Week 12 [N= 136; 138; 131]Final Visit (LOCF) [N= 141; 140; 131]
Mirabegron 100 mg-1.3-1.3
Mirabegron 50 mg-0.2-0.2
Placebo0.030.3

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Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition

The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 4, 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00662909)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
InterventionmL (Least Squares Mean)
Week 4 [N=433; 421; 409]Week 8 [N=394; 394; 391]Week 12 [N=382; 378; 376]
Mirabegron 100 mg19.219.418.7
Mirabegron 50 mg15.219.019.7
Placebo7.15.47.2

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Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)

The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement. (NCT00662909)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
InterventionScores on a scale (Mean)
Week 4 [N= 413; 406; 396]Week 8 [N= 385; 385; 387]Week 12 [N= 377; 369; 378]Final Visit (LOCF) [N=424; 417; 410]
Mirabegron 100 mg0.522.343.893.52
Mirabegron 50 mg0.852.173.603.04
Placebo-0.571.151.921.46

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Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours

The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00662909)
Timeframe: Baseline and Week 12 (Final Visit)

InterventionIncontinence episodes (Least Squares Mean)
Placebo-1.13
Mirabegron 50 mg-1.47
Mirabegron 100 mg-1.63

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Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours

The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00662909)
Timeframe: Baseline and Weeks 8 and 12

,,
InterventionIncontinence episodes (Least Squares Mean)
Week 8 [N= 296; 288; 279]Week 12 [N=283; 278; 267]
Mirabegron 100 mg-1.61-1.60
Mirabegron 50 mg-1.32-1.45
Placebo-0.93-1.13

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Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours

The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00662909)
Timeframe: Baseline and Weeks 8 and 12

,,
InterventionMicturitions (Least Squares Mean)
Week 8 [N=394; 394; 391]Week 12 [N=382; 379; 376]
Mirabegron 100 mg-1.74-1.72
Mirabegron 50 mg-1.52-1.71
Placebo-0.94-1.02

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Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit

The percentage of participants with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary. (NCT00662909)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
InterventionPercentage of participants (Number)
Week 4 [N= 325; 309; 293]Week 8 [N= 296; 288; 279]Week 12 [N= 283; 278; 267]Final Visit (LOCF) [N= 325; 312; 296]
Mirabegron 100 mg59.073.874.573.3
Mirabegron 50 mg56.661.868.766.7
Placebo48.052.061.559.4

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Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit

The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1 point improvement from Baseline to post-baseline and a major improvement was defined as at least a 2 point improvement from Baseline to post-baseline in PPBC score. (NCT00662909)
Timeframe: Baseline and Week 12

,,
InterventionPercentage of participants (Number)
Improvement at Week 12 [N= 373; 376; 371]Improvement at Final Visit [N= 392; 388; 377]Major Improvement at Week 12 [N= 373; 376; 371]Major Improvement at Final Visit [N=392; 388; 377]
Mirabegron 100 mg57.156.827.827.3
Mirabegron 50 mg50.850.818.618.6
Placebo48.347.417.717.3

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Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit

The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient. (NCT00662909)
Timeframe: Weeks 4, 8 and 12

,,
InterventionPercentage of participants (Number)
Week 4 [N= 325; 309; 293]Week 8 [N= 296; 288; 279]Week 12 [N=283; 278; 267]Final Visit (LOCF) [N= 325; 312; 296]
Mirabegron 100 mg32.843.448.749.0
Mirabegron 50 mg30.135.442.840.7
Placebo26.829.435.033.8

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Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours

The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00662909)
Timeframe: Baseline and Week 12

InterventionMicturitions (Least Squares Mean)
Placebo-1.05
Mirabegron 50 mg-1.66
Mirabegron 100 mg-1.75

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Change From Baseline to Final Visit in Mean Volume Voided Per Micturition

The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00662909)
Timeframe: Baseline and Week 12

InterventionmL (Least Squares Mean)
Placebo7.0
Mirabegron 50 mg18.2
Mirabegron 100 mg18.0

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Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours

The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00662909)
Timeframe: Baseline and Week 4

InterventionIncontinence episodes (Least Squares Mean)
Placebo-0.72
Mirabegron 50 mg-1.20
Mirabegron 100 mg-1.18

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Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours

The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00662909)
Timeframe: Baseline and Week 4

InterventionMicturitions (Least Squares Mean)
Placebo-0.77
Mirabegron 50 mg-1.19
Mirabegron 100 mg-1.37

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Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score

"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00688688)
Timeframe: Baseline and Month 12

,,
Interventionparticipants (Number)
Not anxious -> Not anxiousNot anxious -> Moderately anxiousNot anxious -> Extremely anxiousNot anxious -> Missing dataModerately anxious -> Not anxiousModerately anxious -> Moderately anxiousModerately anxious -> Extremely anxiousModerately anxious -> Missing dataExtremely anxious -> Not anxiousExtremely anxious -> Moderately anxiousExtremely anxious -> Extremely anxiousExtremely anxious -> Missing dataMissing data -> Not anxiousMissing data -> Moderately anxiousMissing data -> Extremely anxiousMissing data -> Missing data
Mirabegron 100 mg4533431991819259500100
Mirabegron 50 mg413433310817471381507400
Tolterodine ER 4 mg4294312105169112314603210

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Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score

"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and evaluating health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems in walking about; I have some problems in walking about; I am confined to bed.~In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00688688)
Timeframe: Baseline and Month 12

,,
Interventionparticipants (Number)
No problem -> No problemNo problem -> Some problemsNo problem -> Confined to bedNo problem -> Missing dataSome problems -> No problemsSome problems -> Some problemsSome problems -> Confined to bedSome problems -> Missing dataConfined to bed -> No problemsConfined to bed -> Some problemsConfined to bed -> Confined to bedConfined to bed -> Missing dataMissing data -> No problemMissing data -> Some problemsMissing data -> Confined to bedMissing data -> Missing data
Mirabegron 100 mg601421355970110001000
Mirabegron 50 mg56736146410510000011000
Tolterodine ER 4 mg5733902621060200007000

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Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score

"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and evaluating health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00688688)
Timeframe: Baseline and Month 12

,,
Interventionparticipants (Number)
No pain -> No painNo pain -> Moderate painNo pain -> Extreme painNo pain -> Missing dataModerate pain -> No painModerate pain -> Moderate painModerate pain -> Extreme painModerate pain -> Missing dataExtreme pain -> No painExtreme pain -> Moderate painExtreme pain -> Extreme painExtreme pain -> Missing dataMissing data-> No painMissing data -> Moderate painMissing data -> Extreme painMissing data -> Missing data
Mirabegron 100 mg396692210719652461003000
Mirabegron 50 mg39854441041731413131008300
Tolterodine ER 4 mg39863421051828249806000

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Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score

"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and evaluating health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00688688)
Timeframe: Baseline and Month 12

,,
Interventionparticipants (Number)
No problem -> No problemNo problem -> Some problemsNo problem -> Unable to wash or dress myselfNo problem -> Missing dataSome problems -> No problemsSome problems -> Some problemsSome problems -> Unable to wash or dress myselfSome problems -> Missing dataUnable to wash or dress myself -> No problemsUnable to wash or dress myself -> Some problemsUnable to wash or dress -> Unable to wash or dressUnable to wash or dress myself -> Missing dataMissing data -> No problemMissing data -> Some problemsMissing data -> Unable to wash or dress myselfMissing data -> Missing data
Mirabegron 100 mg735150419250021001000
Mirabegron 50 mg7181614191800000013000
Tolterodine ER 4 mg720233413200000008000

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Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score

The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit. (NCT00688688)
Timeframe: Baseline and Month 12

,,
Interventionparticipants (Number)
No problem -> No problemNo problem -> Some problemsNo problem -> Unable to perform usual activitiesNo problem -> Missing dataSome problems -> No problemsSome problems -> Some problemsSome problems-> Unable to perform usual activitiesSome problems -> Missing dataUnable to perform usual activities -> No problemsUnable to perform usual activities-> Some problemsUnable to perform -> Unable to performUnable to perform usual activities -> Missing dataMissing data -> No problemMissing data -> Some problemsMissing data -> Unable to perform usual activitiesMissing data -> Missing data
Mirabegron 100 mg569551188762224020000
Mirabegron 50 mg5364023979411022101000
Tolterodine ER 4 mg542532196791305171000

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Change From Baseline to Month 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)

"The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement.~LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate." (NCT00688688)
Timeframe: Baseline and Month 12

,,
Interventionscores on a scale (Least Squares Mean)
Month 12 [N=601; 616; 611]Final Visit (LOCF) [N=655; 673; 673]
Mirabegron 100 mg-0.9-0.9
Mirabegron 50 mg-0.8-0.8
Tolterodine ER 4 mg-0.9-0.8

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Change From Baseline to Month 12 and Final Visit in Treatment Satisfaction-visual Analog Scale (TS-VAS)

The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). A positive change from baseline indicates improvement. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. (NCT00688688)
Timeframe: Baseline and Month 12

,,
Interventionscores on a scale (Least Squares Mean)
Month 12 [N=599; 620; 613]Final Visit (LOCF) [N=654; 676; 676]
Mirabegron 100 mg2.272.11
Mirabegron 50 mg2.272.08
Tolterodine ER 4 mg2.522.27

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Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency

Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS means are generated from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12

,,
Interventionscores on a scale (Least Squares Mean)
Month 1 [N=784; 793; 780]Month 3 [N=739; 738; 733]Month 6 [N=684; 702; 680]Month 9 [N=654; 666; 643]Month 12 [N=622; 638; 621]Final Visit (LOCF) [N=789; 801; 788]
Mirabegron 100 mg-0.19-0.28-0.32-0.30-0.31-0.29
Mirabegron 50 mg-0.18-0.21-0.29-0.30-0.33-0.29
Tolterodine ER 4 mg-0.17-0.24-0.27-0.31-0.32-0.27

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Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours

The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. Least squares (LS) means were generated from the analysis of covariance (ANCOVA) model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate. (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12

,,
Interventionincontinence episodes (Least Squares Mean)
Month 1 [N=478; 479; 485]Month 3 [N=447; 443; 452]Month 6 [N=409; 428; 418]Month 9 [N=387; 402; 391]Month 12 [N=370; 387; 379]Final Visit (LOCF) [N=479; 483; 488]
Mirabegron 100 mg-1.03-1.28-1.27-1.32-1.19-1.24
Mirabegron 50 mg-0.94-1.10-1.11-1.17-1.14-1.01
Tolterodine ER 4 mg-0.96-1.09-1.17-1.26-1.36-1.26

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Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours

The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. Least squares (LS) means were generated from the analysis of covariance (ANCOVA) model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate. (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12

,,
Interventionmicturitions (Least Squares Mean)
Month 1 [N=786; 797; 786]Month 3 [N=742; 741; 735]Month 6 [N=684; 705; 684]Month 9 [N=656; 667; 645]Month 12 [N=627; 642; 623]Final Visit (LOCF) [N=789; 802; 791]
Mirabegron 100 mg-1.10-1.46-1.43-1.37-1.46-1.41
Mirabegron 50 mg-0.94-1.13-1.25-1.33-1.30-1.27
Tolterodine ER 4 mg-1.02-1.27-1.30-1.38-1.50-1.39

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Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours

"Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary.~LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate." (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12

,,
Interventionnocturia episodes (Least Squares Mean)
Month 1 [N=690; 698; 690]Month 3 [N=654; 651; 643]Month 6 [N=604; 618; 602]Month 9 [N=580; 583; 567]Month 12 [N=554; 562; 550]Final Visit (LOCF) [N=693; 703; 693]
Mirabegron 100 mg-0.29-0.45-0.38-0.41-0.40-0.39
Mirabegron 50 mg-0.26-0.41-0.42-0.50-0.48-0.46
Tolterodine ER 4 mg-0.29-0.37-0.35-0.39-0.46-0.43

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Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed

The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement. (NCT00688688)
Timeframe: Baseline and Months 3, 6 and 12

,,
InterventionPercent work time missed (Mean)
Month 3 [N=215; 217; 211]Month 6 [N=183; 203; 200]Month 12 [N=181; 185; 188]Final Visit (LOCF) [N=245; 256; 249]
Mirabegron 100 mg-1.0-1.5-0.8-0.9
Mirabegron 50 mg-0.06-1.3-0.5-0.5
Tolterodine ER 4 mg-0.6-0.7-1.2-0.8

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Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment

The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. (NCT00688688)
Timeframe: Baseline and Months 3, 6 and 12

,,
InterventionPercent overall work impairment (Mean)
Month 3 [N=208; 208; 204]Month 6 [N=181; 195; 193]Month 12 [N=175; 177; 183]Final Visit (LOCF) [N=240; 250; 244]
Mirabegron 100 mg-10.9-13.0-14.1-12.4
Mirabegron 50 mg-11.4-12.4-11.5-11.2
Tolterodine ER 4 mg-11.0-11.1-13.6-11.5

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Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment

The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. (NCT00688688)
Timeframe: Baseline and Months 3, 6 and 12

,,
InterventionPercent activity impairment (Mean)
Month 3 [N=691; 690; 692]Month 6 [N=640; 663; 651]Month 12 [N=582; 603; 598]Final Visit (LOCF) [N=728; 737; 733]
Mirabegron 100 mg-13.7-15.6-15.2-13.9
Mirabegron 50 mg-12.0-14.0-13.3-12.5
Tolterodine ER 4 mg-12.3-13.4-15.0-12.8

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Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working

The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. (NCT00688688)
Timeframe: Baseline and Months 3, 6 and 12

,,
InterventionPercent impairment while working (Mean)
Month 3 [N=233; 236; 231]Month 6 [N=207; 216; 213]Month 12 [N=194; 196; 201]Final Visit (LOCF) [N=261; 272; 265]
Mirabegron 100 mg-9.9-11.9-14.4-11.8
Mirabegron 50 mg-10.6-13.0-11.9-10.9
Tolterodine ER 4 mg-10.9-11.1-12.3-10.6

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Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours

"The average number of times a patient records a new pad used per day during the 3-day micturition diary period.~LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate." (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12

,,
Interventionpads (Least Squares Mean)
Month 1 [N=324; 305; 313]Month 3 [N=307; 280; 286]Month 6 [N=277; 271; 264]Month 9 [N=264; 255; 250]Month 12 [N=254; 247; 241]Final Visit (LOCF) [N=325; 307; 314]
Mirabegron 100 mg-0.79-0.94-0.94-0.96-0.92-0.88
Mirabegron 50 mg-0.75-0.80-0.88-0.99-0.87-0.81
Tolterodine ER 4 mg-0.79-0.95-0.99-0.99-1.13-1.02

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Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)

The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from Baseline indicates improvement. (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12

,,
Interventionscores on a scale (Mean)
Month 1 [N=767; 787; 770]Month 3 [N=734; 740; 731]Month 6 [N=676; 697; 678]Month 9 [N=645; 665; 637]Month 12 [N=615; 637; 612]Final Visit (LOCF) [N=776; 797; 777]
Mirabegron 100 mg3.95.46.46.56.85.9
Mirabegron 50 mg3.85.06.56.68.26.8
Tolterodine ER 4 mg3.14.35.26.37.96.0

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Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score

"Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the patient on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.~LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate." (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12

,,
Interventionscores on a scale (Least Squares Mean)
Month 1 [N=775; 784; 771]Month 3 [N=736; 733; 739]Month 6 [N=680; 699; 682]Month 9 [N=649; 661; 639]Month 12 [N=622; 636; 612]Final Visit (LOCF) [N=779; 795; 781]
Mirabegron 100 mg-12.5-16.1-16.5-15.6-15.7-14.8
Mirabegron 50 mg-10.5-13.4-14.5-14.2-14.1-13.1
Tolterodine ER 4 mg-11.5-13.5-14.6-14.3-16.3-14.3

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Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition

The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. LS means were generated from the ANCOVA model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate. (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12

,,
InterventionmL (Least Squares Mean)
Month 1 [N=785; 797; 786]Month 3 [N=741; 741; 735]Month 6 [N=684; 705; 684]Month 9 [N=655; 667; 645]Month 12 [N=626; 642; 623]Final Visit (LOCF) [N=789; 802; 791]
Mirabegron 100 mg16.720.423.023.524.321.5
Mirabegron 50 mg12.114.818.620.518.517.5
Tolterodine ER 4 mg16.017.418.817.918.918.1

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Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours

The involuntary leakage of urine accompanied or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0=No urgency; 1=Mild urgency; 2=Moderate urgency, could postpone voiding a short time; 3=Severe urgency, could not postpone voiding; 4=Urge incontinence, leaked before arriving to toilet. LS means are from the ANCOVA model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate. (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12

,,
Interventionurgency incontinence episodes (Least Squares Mean)
Month 1 [N=471; 467; 471]Month 3 [N=441; 432; 440]Month 6 [N=404; 417; 408]Month 9 [N=382; 392; 382]Month 12 [N=366; 377; 371]Final Visit (LOCF) [N=472; 471; 474]
Mirabegron 100 mg-1.04-1.23-1.32-1.33-1.20-1.23
Mirabegron 50 mg-0.92-1.05-1.13-1.13-1.17-1.01
Tolterodine ER 4 mg-0.95-1.06-1.11-1.25-1.29-1.21

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Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours

The average number of urgency episodes (the sudden, compelling desire to pass urine that is difficult to defer) derived from episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0=No urgency; 1=Mild urgency; 2=Moderate urgency, could delay voiding a short time; 3=Severe urgency, could not delay voiding; 4=Urge incontinence, leaked before arriving to the toilet. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12

,,
Interventionurgency episodes (Least Squares Mean)
Month 1 [N=783; 791; 780]Month 3 [N=738; 737; 733]Month 6 [N=683; 701; 680]Month 9 [N=653; 665; 643]Month 12 [N=621; 637; 621]Final Visit (LOCF) [N=788; 799; 788]
Mirabegron 100 mg-1.31-1.83-1.95-1.71-1.79-1.80
Mirabegron 50 mg-1.30-1.37-1.75-1.77-1.81-1.62
Tolterodine ER 4 mg-1.11-1.55-1.63-1.78-1.89-1.63

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Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit

The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient. (NCT00688688)
Timeframe: Months 1, 3, 6, 9 and 12

,,
Interventionpercentage of participants (Number)
Month 1 [N=478; 479; 485]Month 3 [N=447; 443; 452]Month 6 [N=409; 428; 418]Month 9 [N=387; 402; 391]Month 12 [N=370; 387; 379]Final Visit (LOCF) [N=479; 483; 488]
Mirabegron 100 mg36.745.445.146.847.545.8
Mirabegron 50 mg35.440.943.347.547.843.4
Tolterodine ER 4 mg33.439.243.544.249.145.1

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Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC)

The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a one point improvement from Baseline to post-baseline and a major improvement was defined as at least a two point improvement from Baseline to post-baseline in PPBC score. (NCT00688688)
Timeframe: Baseline and Month 12

,,
Interventionpercentage of participants (Number)
Improvement: Month12 [N=616; 630; 620]Improvement: Final Visit [N=671; 688; 684]Major Improvement: Month 12 [N=616; 630; 620]Major Improvement: Final Visit [N=671; 688; 684]
Mirabegron 100 mg60.659.629.728.2
Mirabegron 50 mg55.752.927.426.2
Tolterodine ER 4 mg56.654.428.226.6

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Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit

The percentage of participants with at least a 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary. (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12

,,
Interventionpercentage of participants (Number)
Month 1 [N=478; 479; 485]Month 3 [N=447; 443; 452]Month 6 [N=409; 428; 418]Month 9 [N=387; 402; 391]Month 12 [N=370; 387; 379]Final Visit (LOCF) [N=479; 483; 488]
Mirabegron 100 mg57.066.166.867.268.566.3
Mirabegron 50 mg58.261.765.565.667.663.7
Tolterodine ER 4 mg56.361.563.966.071.266.8

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Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram

"An abnormality identified during a medical test was defined as an AE if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant. The Investigator assessed each AE for causal relationship (not related, possible or probable) to study drug. A serious AE (SAE) was any untoward medical occurrence that: resulted in death, was life-threatening, resulted in significant disability/incapacity or congenital anomaly/birth defect, required or prolonged hospitalization or was a medically important event.~The data reported represent the number of participants with adverse events in each category." (NCT00688688)
Timeframe: From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months.

,,
Interventionparticipants (Number)
Adverse eventsTreatment-related adverse events (TRAEs)DeathsSerious adverse events (SAEs)Treatment-related serious adverse eventsAEs leading to study drug discontinuationTRAEs leading to study drug discontinuation
Mirabegron 100 mg50319205145029
Mirabegron 50 mg485213242104835
Tolterodine ER 4 mg50822424454631

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Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs)

"An adverse event (AE) was defined as any untoward medical occurrence in a patient administered a study drug and which did not necessarily have a causal relationship with the treatment. The investigator assessed the severity of each AE, including abnormal laboratory values, as follows:~Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities." (NCT00688688)
Timeframe: From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months.

,,
Interventionparticipants (Number)
Mild adverse eventsModerate adverse eventsSevere adverse events
Mirabegron 100 mg24021152
Mirabegron 50 mg22221251
Tolterodine ER 4 mg25121839

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Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency

Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Weeks 4, 8 and 12

,,,
InterventionScores on a scale (Least Squares Mean)
Week 4 [N=476; 469; 472; 471]Week 8 [N=460; 447; 451; 456]Week 12 [N=450; 434; 442; 434]Final Visit (LOCF) [N=480; 472; 475; 473]
Mirabegron 100 mg-0.21-0.27-0.31-0.30
Mirabegron 50 mg-0.19-0.26-0.33-0.31
Placebo-0.08-0.16-0.22-0.22
Tolterodine SR 4 mg-0.21-0.25-0.30-0.29

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Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours

"Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate." (NCT00689104)
Timeframe: Baseline and Weeks 4, 8 and 12

,,,
Interventionnocturia episodes (Least Squares Mean)
Week 4 [N=428; 422; 422; 432]Week 8 [N=414; 404; 403; 419]Week 12 [N=404; 393; 395; 399]Final Visit (LOCF) [N=428; 423; 422; 433]
Mirabegron 100 mg-0.34-0.48-0.47-0.50
Mirabegron 50 mg-0.27-0.41-0.57-0.56
Placebo-0.25-0.30-0.41-0.41
Tolterodine SR 4 mg-0.29-0.39-0.44-0.45

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Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours

"The average number of times a patient records a new pad used per day during the 3-day micturition diary period.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate." (NCT00689104)
Timeframe: Baseline and Weeks 4, 8 and 12

,,,
Interventionpads (Least Squares Mean)
Week 4 [N=209; 183; 195; 181]Week 8 [N=204; 176; 183; 177]Week 12 [N=200; 172; 181; 165]Final Visit (LOCF) [N=209; 183; 195; 181]
Mirabegron 100 mg-0.81-1.03-1.11-1.12
Mirabegron 50 mg-0.73-1.02-1.26-1.17
Placebo-0.45-0.72-0.99-0.95
Tolterodine SR 4 mg-0.67-0.77-0.95-0.95

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Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours

The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Weeks 4, 8 and 12

,,,
InterventionUrgency episodes (Least Squares Mean)
Week 4 [N=475; 469; 471; 470]Week 8 [N=460; 446; 450; 456]Week 12 [N=450; 433; 441; 434]Final Visit (LOCF) [N=479; 470; 474; 472]
Mirabegron 100 mg-1.54-1.90-2.00-1.96
Mirabegron 50 mg-1.39-1.90-2.35-2.25
Placebo-0.89-1.28-1.65-1.65
Tolterodine SR 4 mg-1.63-1.91-2.16-2.07

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Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours

The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Weeks 4, 8 and 12

,,,
InterventionUrgency incontinence episodes (Least Squares Mean)
Week 4 [N=283; 286; 276; 288]Week 8 [N=273; 272; 263; 281]Week 12 [N=269; 267; 257; 265]Final Visit (LOCF) [N=283; 286; 276; 289]
Mirabegron 100 mg-1.00-1.32-1.32-1.33
Mirabegron 50 mg-0.98-1.27-1.52-1.46
Placebo-0.63-0.94-1.12-1.11
Tolterodine SR 4 mg-1.01-0.99-1.19-1.18

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Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score

"Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate." (NCT00689104)
Timeframe: Baseline and Weeks 4, 8 and 12

,,,
InterventionScores on a scale (Least Squares Mean)
Week 4 [N=472; 460; 470; 467]Week 8 [N=455; 441; 450; 451]Week 12 [N=445; 424; 435; 433]Final Visit (LOCF) [N=475; 465; 473; 469]
Mirabegron 100 mg-13.8-17.6-20.0-19.9
Mirabegron 50 mg-13.0-17.8-20.3-19.6
Placebo-9.7-13.3-15.3-14.9
Tolterodine SR 4 mg-13.8-17.1-18.5-18.4

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Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)

The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement. (NCT00689104)
Timeframe: Baseline and Weeks 4, 8 and 12

,,,
InterventionScores on a scale (Mean)
Week 4 [N=466; 459; 468; 461]Week 8 [N=451; 443; 447; 447]Week 12 [N=443; 423; 437; 429]Final Visit (LOCF) [N=470; 466; 472; 467]
Mirabegron 100 mg4.46.88.28.1
Mirabegron 50 mg3.35.57.16.5
Placebo3.14.56.76.4
Tolterodine SR 4 mg3.26.06.96.4

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Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours

The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Weeks 8 and 12

,,,
InterventionIncontinence episodes (Least Squares Mean)
Week 8 [N=280; 277; 268; 292]Week 12 [N=275; 272; 262; 276]
Mirabegron 100 mg-1.40-1.45
Mirabegron 50 mg-1.29-1.62
Placebo-1.00-1.18
Tolterodine SR 4 mg-1.02-1.27

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Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours

The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Weeks 8 and 12

,,,
Interventionmicturitions (Least Squares Mean)
Week 8 [N=463; 450; 455; 461]Week 12 [N=452; 437; 447; 438]
Mirabegron 100 mg-1.66-1.78
Mirabegron 50 mg-1.64-2.02
Placebo-1.15-1.33
Tolterodine SR 4 mg-1.43-1.60

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Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit

The percentage of participants with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary. (NCT00689104)
Timeframe: Baseline and Weeks 4, 8 and 12

,,,
Interventionpercentage of participants (Number)
Week 4 [N=291; 293; 281; 299]Week 8 [N=280; 277; 268; 292]Week 12 [N=275; 272; 262; 276]Final Visit (LOCF) [N=291; 293; 281; 300]
Mirabegron 100 mg54.468.367.967.6
Mirabegron 50 mg57.367.973.572.2
Placebo46.053.961.560.1
Tolterodine SR 4 mg56.564.469.668.3

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Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit

The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1 point improvement from Baseline to post-baseline and a major improvement was defined as at least a 2 point improvement from Baseline to post-baseline in PPBC score. (NCT00689104)
Timeframe: Baseline and Week 12

,,,
Interventionpercentage of participants (Number)
Improvement: Week 12 [N=425; 410;421; 417]Improvement: Final Visit [N=433; 416; 429; 426]Major Improvement: Week 12 [N=425; 410; 421; 417]Major Improvement: Final Visit [N=433;416;429;426]
Mirabegron 100 mg62.762.234.033.6
Mirabegron 50 mg61.561.329.529.1
Placebo56.956.628.528.2
Tolterodine SR 4 mg65.265.031.731.5

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Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours

The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Week 12

Interventionmicturitions (Least Squares Mean)
Placebo-1.34
Mirabegron 50 mg-1.93
Mirabegron 100 mg-1.77
Tolterodine SR 4 mg-1.59

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Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours

The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Week 12 (final visit)

InterventionIncontinence episodes (Least Squares Mean)
Placebo-1.17
Mirabegron 50 mg-1.57
Mirabegron 100 mg-1.46
Tolterodine SR 4 mg-1.27

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Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit

The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient. (NCT00689104)
Timeframe: Weeks 4, 8 and 12

,,,
Interventionpercentage of participants (Number)
Week 4 [N=291; 293; 281; 299]Week 8 [N=280; 277; 268; 292]Week 12 [N=275; 272; 262; 276]Final Visit (LOCF) [N=291; 293; 281; 300]
Mirabegron 100 mg32.045.143.943.8
Mirabegron 50 mg32.142.646.345.1
Placebo28.934.341.140.5
Tolterodine SR 4 mg33.441.848.647.3

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Change From Baseline to Final Visit in Mean Volume Voided Per Micturition

The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Week 12

InterventionmL (Least Squares Mean)
Placebo12.3
Mirabegron 50 mg24.2
Mirabegron 100 mg25.6
Tolterodine SR 4 mg25.0

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Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours

The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Week 4

InterventionIncontinence episodes (Least Squares Mean)
Placebo-0.65
Mirabegron 50 mg-1.04
Mirabegron 100 mg-1.03
Tolterodine SR 4 mg-1.00

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Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours

The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Week 4

Interventionmicturitions (Least Squares Mean)
Placebo-0.77
Mirabegron 50 mg-1.16
Mirabegron 100 mg-1.29
Tolterodine SR 4 mg-1.10

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Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score

"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems in walking about; I have some problems in walking about; I am confined to bed.~In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00689104)
Timeframe: Baseline and Week 12

,,,
Interventionparticipants (Number)
No problem -> No problemNo problem -> Some problemsNo problem -> Confined to bedNo problem -> Missing dataSome problems -> No problemsSome problems -> Some problemsSome problems -> Confined to bedSome problems -> Missing dataConfined -> No problemsConfined -> Some problemsConfined -> Confined to bedConfined -> Missing dataMissing data -> No problemMissing data -> Some problemsMissing data -> Confined to bedMissing data -> Missing data
Mirabegron 100 mg334180140820100002000
Mirabegron 50 mg340261244590000001000
Placebo334270237780000002000
Tolterodine SR 4 mg330280138731000003100

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Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score

"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00689104)
Timeframe: Baseline and Week 12

,,,
Interventionparticipants (Number)
No pain -> No painNo pain -> Moderate painNo pain -> Extreme painNo pain -> Missing dataModerate pain -> No painModerate pain -> Moderate painModerate pain -> Extreme painModerate pain ->Missing dataExtreme pain -> No painExtreme pain -> Moderate painExtreme pain -> Extreme painExtreme pain -> Missing dataMissing data -> No painMissing data -> Moderate painMissing data -> Extreme painMissing data -> Missing data
Mirabegron 100 mg20950217611451112501100
Mirabegron 50 mg21132227112880212401000
Placebo210364070129223131000100
Tolterodine SR 4 mg19737216913270412903110

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Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score

"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00689104)
Timeframe: Baseline and Week 12

,,,
Interventionparticipants (Number)
No problem -> No problemNo problem -> Some problemsNo problem -> Unable to wash or dress myselfNo problem -> Missing dataSome problems -> No problemsSome problems -> Some problemsSome problems -> Unable to wash or dress myselfSome problems -> Missing dataUnable to wash or dress myself -> No problemsUnable to wash or dress myself -> Some problemsUnable to wash or dress -> Unable to wash or dressUnable to wash or dress myself -> Missing dataMissing data -> No problemMissing data -> Some problemsMissing data -> Unable to wash or dress myselfMissing data -> Missing data
Mirabegron 100 mg43917028100001001000
Mirabegron 50 mg445902960001001000
Placebo43770218140010001000
Tolterodine SR 4 mg43212119150000004100

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Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score

The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit. (NCT00689104)
Timeframe: Baseline and Week 12

,,,
Interventionparticipants (Number)
No problem -> No problemNo problem -> Some problemsNo problem -> Unable to perform usual activitiesNo problem -> Missing dataSome problems -> No problemsSome problems -> Some problemsSome problems-> Unable to perform usual activitiesSome problems -> Missing dataUnable to perform usual activities -> No problemsUnable to perform usual activities-> Some problemsUnable to perform -> Unable to performUnable to perform usual activities -> Missing dataMissing data -> No problemMissing data -> Some problemsMissing data -> Unable to perform usual activitiesMissing data -> Missing data
Mirabegron 100 mg327253151630113201000
Mirabegron 50 mg316182182480111102000
Placebo298250273752002002100
Tolterodine SR 4 mg283390168730023104100

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Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score

"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00689104)
Timeframe: Baseline and Week 12

,,,
Interventionparticipants (Number)
Not anxious -> Not anxiousNot anxious -> Moderately anxiousNot anxious -> Extremely anxiousNot anxious -> Missing dataModerately anxious -> Not anxiousModerately anxious -> Moderately anxiousModerately anxious -> Extremely anxiousModerately anxious -> Missing dataExtremely anxious -> Not anxiousExtremely anxious -> Moderately anxiousExtremely anxious -> Extremely anxiousExtremely anxious -> Missing dataMissing data -> Not anxiousMissing data -> Moderately anxiousMissing data -> Extremely anxiousMissing data -> Missing data
Mirabegron 100 mg232191288105100111801000
Mirabegron 50 mg22430107411151412911000
Placebo21937217610891312902100
Tolterodine SR 4 mg217213071122121418203100

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Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)

The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A negative change from Baseline score indicates improvement. (NCT00689104)
Timeframe: Baseline and Week 12

,,,
InterventionScores on a scale (Least Squares Mean)
Week 12 [N=425; 410; 421; 417]Final Visit (LOCF) [N=433; 416; 429; 426]
Mirabegron 100 mg-0.1-1.1
Mirabegron 50 mg-1.1-1.0
Placebo-0.8-0.8
Tolterodine SR 4 mg-1.0-1.0

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Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS)

The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A positive change from baseline indicates improvement. (NCT00689104)
Timeframe: Baseline and Week 12

,,,
InterventionScores on a scale (Least Squares Mean)
Week 12 [N=421; 410; 420; 416]Final Visit (LOCF) [N=428; 414; 427; 425]
Mirabegron 100 mg2.672.66
Mirabegron 50 mg2.572.55
Placebo1.921.89
Tolterodine SR 4 mg2.442.44

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Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment

The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment. A negative change from baseline indicates improvement. (NCT00689104)
Timeframe: Baseline and Week 12

,,,
Interventionpercent activity impairment (Mean)
Week 12 [N=409; 395; 409; 400]Final Visit (LOCF) [N=419; 400; 417; 409]
Mirabegron 100 mg-14.5-14.4
Mirabegron 50 mg-15.0-14.9
Placebo-11.2-11.0
Tolterodine SR 4 mg-14.7-14.3

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Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working

The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. (NCT00689104)
Timeframe: Baseline and Week 12

,,,
Interventionpercent impairment while working (Mean)
Week 12 [N=116; 128; 104; 114]Final Visit (LOCF) [N=118; 130; 106; 115]
Mirabegron 100 mg-10.8-10.8
Mirabegron 50 mg-12.5-12.8
Placebo-8.3-8.1
Tolterodine SR 4 mg-6.7-6.6

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Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment

The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. (NCT00689104)
Timeframe: Baseline and Week 12

,,,
Interventionpercent overall work impairment (Mean)
Week 12 [N=104; 117; 98; 104]Final Visit (LOCF) [N=106; 119; 99; 105]
Mirabegron 100 mg-11.6-11.5
Mirabegron 50 mg-13.2-13.6
Placebo-7.9-7.7
Tolterodine SR 4 mg-5.8-5.8

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Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed

The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement. (NCT00689104)
Timeframe: Baseline and Week 12

,,,
Interventionpercent work time missed (Mean)
Week 12 [N=111; 120; 109; 113]Final Visit (LOCF) [N=113; 122; 110; 114]
Mirabegron 100 mg-1.7-1.7
Mirabegron 50 mg-1.9-1.8
Placebo-0.2-0.2
Tolterodine SR 4 mg-1.2-1.2

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Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition

The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 4, 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Weeks 4, 8 and 12

,,,
InterventionmL (Least Squares Mean)
Week 4 [N=479; 470; 477; 474]Week 8 [N=463; 449; 455; 461]Week 12 [N=452; 437; 447; 438]
Mirabegron 100 mg20.325.325.7
Mirabegron 50 mg20.120.725.3
Placebo9.811.711.9
Tolterodine SR 4 mg21.425.925.8

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Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours

The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00912964)
Timeframe: Baseline and Weeks 8 and 12

,,
Interventionmicturitions (Least Squares Mean)
Week 8 [N= 377; 395; 399]Week 12 [N= 366; 387; 386]
Mirabegron 25 mg-1.52-1.68
Mirabegron 50 mg-1.53-1.69
Placebo-1.09-1.47

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Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score

"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems in walking about; I have some problems in walking about; I am confined to bed.~In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00912964)
Timeframe: Baseline and Week 12

,,
Interventionparticipants (Number)
No problem -> No problemNo problem -> Some problemsNo problem -> Confined to bedNo problem -> Missing dataSome problems -> No problemsSome problems -> Some problemsSome problems -> Confined to bedSome problems -> Missing dataConfined -> No problemsConfined -> Some problemsConfined -> Confined to bedConfined -> Missing dataMissing data -> No problemMissing data -> Some problemsMissing data -> Confined to bedMissing data -> Missing data
Mirabegron 25 mg310200131450000003000
Mirabegron 50 mg304330236481200000000
Placebo327160622390110003000

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Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score

"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00912964)
Timeframe: Baseline and Week 12

,,
Interventionparticipants (Number)
Not anxious -> Not anxiousNot anxious -> Moderately anxiousNot anxious -> Extremely anxiousNot anxious -> Missing dataModerately anxious -> Not anxiousModerately anxious -> Moderately anxiousModerately anxious -> Extremely anxiousModerately anxious -> Missing dataExtremely anxious -> Not anxiousExtremely anxious -> Moderately anxiousExtremely anxious -> Extremely anxiousExtremely anxious -> Missing dataMissing data -> Not anxiousMissing data -> Moderately anxiousMissing data -> Extremely anxiousMissing data -> Missing data
Mirabegron 25 mg243291050742015112100
Mirabegron 50 mg225333458893026300000
Placebo239201352774416403100

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Percentage of Responders for Number of Grade 3 or 4 Urgency Episodes

Percentage of participants with a decrease from baseline to final visit in mean number of urgency episodes (grade 3 or 4) at least as large as the pre-specified minimally important difference (MID). The MID was determined to be 1.54 for mean number of urgency episodes (grade 3 or 4). The mean number of urgency episodes was derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale where a score 3=severe urgency and 4=urge incontinence. (NCT00912964)
Timeframe: Baseline and Week 12

Interventionpercentage of participants (Number)
Placebo44.6
Mirabegron 25 mg47.1
Mirabegron 50 mg57.7

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Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours

The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00912964)
Timeframe: Baseline and Week 4

Interventionmicturitions (Least Squares Mean)
Placebo-0.78
Mirabegron 25 mg-0.96
Mirabegron 50 mg-1.14

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Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours

The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00912964)
Timeframe: Baseline and Week 4

InterventionIncontinence episodes (Least Squares Mean)
Placebo-0.62
Mirabegron 25 mg-0.96
Mirabegron 50 mg-1.13

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Change From Baseline to End of Treatment (Final Visit) in Mean Volume Voided Per Micturition

The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00912964)
Timeframe: Baseline and Week 12

InterventionmL (Least Squares Mean)
Placebo8.3
Mirabegron 25 mg12.8
Mirabegron 50 mg20.7

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Change From Baseline to End of Treatment (Final Visit) in Mean Number of Urgency Incontinence Episodes Per 24 Hours

The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00912964)
Timeframe: Baseline and Week 12

Interventionurgency incontinence episodes (Least Squares Mean)
Placebo-0.95
Mirabegron 25 mg-1.31
Mirabegron 50 mg-1.33

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Change From Baseline to End of Treatment (Final Visit) in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours

The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00912964)
Timeframe: Baseline and Week 12

Interventionurgency episodes (Least Squares Mean)
Placebo-1.35
Mirabegron 25 mg-1.68
Mirabegron 50 mg-1.94

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Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours

The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00912964)
Timeframe: Baseline and Week 12

Interventionmicturitions (Least Squares Mean)
Placebo-1.18
Mirabegron 25 mg-1.65
Mirabegron 50 mg-1.60

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Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours

The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00912964)
Timeframe: Baseline and Week 12

InterventionIncontinence episodes (Least Squares Mean)
Placebo-0.96
Mirabegron 25 mg-1.36
Mirabegron 50 mg-1.38

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Change From Baseline to Week 4, Week 8 and Week 12 in Mean Number of Urgency Incontinence Episodes Per 24 Hours

The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00912964)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
InterventionUrgency incontinence episodes (Least Squares Mean)
Week 4 [N=256; 247; 249]Week 8 [N=231; 237; 236]Week 12 [N=226; 232; 227]
Mirabegron 25 mg-0.98-1.33-1.32
Mirabegron 50 mg-1.12-1.39-1.39
Placebo-0.63-1.02-1.06

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Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition

The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 4, 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00912964)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
InterventionmL (Least Squares Mean)
Week 4 [N=415; 410; 424]Week 8 [N=377; 395; 399]Week 12 [N=366; 387; 386]
Mirabegron 25 mg10.615.713.6
Mirabegron 50 mg17.817.922.5
Placebo7.69.88.2

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Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours

"Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate." (NCT00912964)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
Interventionnocturia episodes (Least Squares Mean)
Week 4 [N=362; 362; 376]Week 8 [N=329; 349; 354]Week 12 [N=321; 342; 344]Final Visit (LOCF) [N=362; 362; 378]
Mirabegron 25 mg-0.27-0.41-0.50-0.49
Mirabegron 50 mg0.38-0.44-0.52-0.52
Placebo-0.30-0.45-0.54-0.48

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Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours

"The average number of times a patient records a new pad used per day during the 3-day micturition diary period.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate." (NCT00912964)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
Interventionpads (Least Squares Mean)
Week 4 [N=145; 136; 136]Week 8 [N=131; 131; 128]Week 12 [N=129; 129; 124]Final Visit (LOCF) [N=145; 136; 137]
Mirabegron 25 mg-0.59-0.79-0.89-0.83
Mirabegron 50 mg-0.81-1.16-1.17-1.16
Placebo-0.72-0.97-1.06-0.99

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Percentage of Responders for Mean Level of Urgency

Percentage of participants with a decrease from Baseline to Final Visit in mean level of urgency at least as large as the pre-specified minimally important difference (MID). The MID was determined to be 0.24 for mean level of urgency. Mean level of urgency was derived from the average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale which ranged from 0 (No urgency) to 4 (Urge incontinence). (NCT00912964)
Timeframe: Baseline and Week 12

Interventionpercentage of participants (Number)
Placebo36.6
Mirabegron 25 mg40.5
Mirabegron 50 mg44.8

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Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score

"Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate." (NCT00912964)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
Interventionscores on a scale (Least Squares Mean)
Week 4 [N=402; 406; 418]Week 8 [N=376; 389; 391]Week 12 [N=360; 380; 378]Final Visit (LOCF) [N=405; 407; 422]
Mirabegron 25 mg-13.7-17.4-18.0-17.9
Mirabegron 50 mg-12.7-18.5-19.6-18.8
Placebo-12.2-15.1-17.5-16.0

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Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)

The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement. (NCT00912964)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
Interventionscores on a scale (Mean)
Week 4 [N=399; 401; 411]Week 8 [N=368; 386; 383]Week 12 [N=359; 379; 375]Final Visit (LOCF) [N=404; 406; 419]
Mirabegron 25 mg2.433.954.404.12
Mirabegron 50 mg1.674.135.594.96
Placebo0.383.144.263.43

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Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours

The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00912964)
Timeframe: Baseline and Weeks 8 and 12

,,
InterventionIncontinence episodes (Least Squares Mean)
Week 8 [N= 236; 244; 241]Week 12 [N= 231; 239; 232]
Mirabegron 25 mg-1.38-1.36
Mirabegron 50 mg-1.39-1.43
Placebo-1.04-1.08

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Change From Baseline to End of Treatment (Final Visit) in Mean Level of Urgency

Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00912964)
Timeframe: Baseline and Week 12

Interventionscores on a scale (Least Squares Mean)
Placebo-0.15
Mirabegron 25 mg-0.22
Mirabegron 50 mg-0.29

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Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit

The percentage of participants with at least a 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary. (NCT00912964)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
Interventionpercentage of participants (Number)
Week 4 [N=262; 254; 255]Week 8 [N=236; 244; 241]Week 12 [N=231; 239; 232]Final Visit (LOCF) [N=262; 254; 257]
Mirabegron 25 mg54.771.774.172.8
Mirabegron 50 mg61.671.471.170.0
Placebo46.662.761.559.2

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Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit

The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a one point improvement from Baseline to post-baseline and a major improvement was defined as at least a two point improvement from Baseline to post-baseline in PPBC score. (NCT00912964)
Timeframe: Baseline and Week 12

,,
Interventionpercentage of participants (Number)
Improvement: Week 12 [N=357; 381; 378]Improvement: Final Visit [N=376; 391; 395]Major Improvement: Week 12 [N=357; 381; 378]Major Improvement: Final Visit [N=376; 391; 395]
Mirabegron 25 mg52.852.723.623.0
Mirabegron 50 mg55.855.225.725.6
Placebo56.055.122.121.5

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Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit

The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient. (NCT00912964)
Timeframe: Weeks 4, 8 and 12

,,
Interventionpercentage of participants (Number)
Week 4 [N=262; 254; 255]Week 8 [N=236; 244; 241]Week 12 [N=231; 239; 232]Final Visit (LOCF) [N=262; 254; 257]
Mirabegron 25 mg31.544.746.945.7
Mirabegron 50 mg36.541.947.447.1
Placebo28.241.942.039.7

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Summary of Baseline, Week 12 and Final Visit Change in Bladder Symptoms on the Clinician Global Impression Scale

The Clinician Global Impression Scale (CGI) assessed the change in the patient's bladder symptoms since the start of the study and was completed by the physician at Baseline and at Week 12/end of treatment. The degree of change was categorized as one of the following: 'Very much improved', 'Much improved', 'Minimally improved', 'No change', 'Minimally worse', 'Much worse', or 'Very much worse'. (NCT00912964)
Timeframe: Baseline and Week 12

,,
Interventionparticipants (Number)
Baseline: TotalBaseline: Very Much ImprovedBaseline: Much ImprovedBaseline: Minimally ImprovedBaseline: No ChangeBaseline: Minimally WorseBaseline: Much WorseBaseline: Very Much WorseWeek 12: TotalWeek 12: Very Much ImprovedWeek 12: Much ImprovedWeek 12: Minimally ImprovedWeek 12: No ChangeWeek 12: Minimally WorseWeek 12: Much WorseWeek 12: Very Much WorseFinal Visit: TotalFinal Visit: Very Much ImprovedFinal Visit: Much ImprovedFinal Visit: Minimally ImprovedFinal Visit: No ChangeFinal Visit: Minimally WorseFinal Visit: Much WorseFinal Visit: Very Much Worse
Mirabegron 25 mg18826321349501752252593741018322546041420
Mirabegron 50 mg19603331488401712858424120018530604844210
Placebo182063112613331581348533265117113495838661

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Summary of Baseline, Week 12 and Final Visit Change in Bladder Symptoms on the Patient Global Impression Scale

The patient global impression (PGI) scale assessed the change in bladder symptoms since the start of the study and was completed by the patient at Baseline and at Week 12/end of treatment. The degree of change was categorized as one of the following: 'Very much improved', 'Much improved', 'Minimally improved', 'No change', 'Minimally worse', 'Much worse', or 'Very much worse'. (NCT00912964)
Timeframe: Baseline and Week 12

,,
Interventionparticipants (Number)
Baseline: TotalBaseline: Very Much ImprovedBaseline: Much ImprovedBaseline: Minimally ImprovedBaseline: No ChangeBaseline: Minimally WorseBaseline: Much WorseBaseline: Very Much WorseWeek 12: TotalWeek 12: Very Much ImprovedWeek 12: Much ImprovedWeek 12: Minimally ImprovedWeek 12: No ChangeWeek 12: Minimally WorseWeek 12: Much WorseFinal Visit: TotalFinal Visit: Very Much ImprovedFinal Visit: Much ImprovedFinal Visit: Minimally ImprovedFinal Visit: No ChangeFinal Visit: Minimally WorseFinal Visit: Much Worse
Mirabegron 25 mg19441552105115217623575733511852360573672
Mirabegron 50 mg20221242124139017437484542111883951494513
Placebo1884144810565616018544926581731854523568

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Change From Baseline to Week 4, Week 8 and Week 12 in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours

The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00912964)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
InterventionUrgency episodes (Least Squares Mean)
Week 4 [N=412; 409; 423]Week 8 [N=377; 393; 398]Week 12 [N=364; 385; 385]
Mirabegron 25 mg-0.97-1.51-1.72
Mirabegron 50 mg-1.47-1.73-1.99
Placebo-0.90-1.17-1.60

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Change From Baseline to Week 4, Week 8 and Week 12 in Mean Level of Urgency

Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00912964)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
Interventionscores on a scale (Least Squares Mean)
Week 4 [N=412; 409; 423]Week 8 [N=377; 393; 398]Week 12 [N=364; 385; 385]
Mirabegron 25 mg-0.12-0.19-0.23
Mirabegron 50 mg-0.20-0.26-0.30
Placebo-0.10-0.15-0.19

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Summary of Baseline, Week 12 and Final Visit Change in Overall Condition on the Patient Global Impression Scale

The patient global impression (PGI) scale assessed the change in the patient's overall condition since the start of the study and was completed by the patient at Baseline and at Week 12/end of treatment. The degree of change was categorized as one of the following: 'Very much improved', 'Much improved', 'Minimally improved', 'No change', 'Minimally worse', 'Much worse', or 'Very much worse'. (NCT00912964)
Timeframe: Baseline and Week 12

,,
Interventionparticipants (Number)
Baseline: TotalBaseline: Very Much ImprovedBaseline: Much ImprovedBaseline: Minimally ImprovedBaseline: No ChangeBaseline: Minimally WorseBaseline: Much WorseBaseline: Very Much WorseWeek 12: TotalWeek 12: Very Much ImprovedWeek 12: Much ImprovedWeek 12: Minimally ImprovedWeek 12: No ChangeWeek 12: Minimally WorseWeek 12: Much WorseFinal Visit: TotalFinal Visit: Very Much ImprovedFinal Visit: Much ImprovedFinal Visit: Minimally ImprovedFinal Visit: No ChangeFinal Visit: Minimally WorseFinal Visit: Much Worse
Mirabegron 25 mg19451247115121217619605439311851962544352
Mirabegron 50 mg20221141132115017436514738201883854494331
Placebo1883134611263516019475033471731947534248

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Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed

The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement. (NCT00912964)
Timeframe: Baseline and Week 12

,,
Interventionpercent work time missed (Mean)
Week 12 [N=112; 118; 118]Final Visit (LOCF) [N=119; 122; 123]
Mirabegron 25 mg0.70.7
Mirabegron 50 mg-1.5-1.3
Placebo0.60.6

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Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment

The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. (NCT00912964)
Timeframe: Baseline and Week 12

,,
Interventionpercent overall work impairment (Mean)
Week 12 [N=110; 115; 118]Final Visit (LOCF) [N=117; 119; 123]
Mirabegron 25 mg-11.0-10.8
Mirabegron 50 mg-13.3-13.3
Placebo-14.1-13.8

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Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working

The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. (NCT00912964)
Timeframe: Baseline and Week 12

,,
Interventionpercent impairment while working (Mean)
Week 12 [N=123; 130; 128]Final Visit (LOCF) [N=130; 135; 134]
Mirabegron 25 mg-10.2-10.1
Mirabegron 50 mg-13.0-13.1
Placebo-11.6-11.5

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Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment

The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment. A negative change from baseline indicates improvement. (NCT00912964)
Timeframe: Baseline and Week 12

,,
Interventionpercent activity impairment (Mean)
Week 12 [N=353; 366; 362]Final Visit (LOCF) [N=373; 376; 378]
Mirabegron 25 mg-12.3-11.9
Mirabegron 50 mg-13.1-13.3
Placebo-11.4-11.0

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Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS)

The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A positive change from baseline indicates improvement. (NCT00912964)
Timeframe: Baseline and Week 12

,,
Interventionscores on a scale (Least Squares Mean)
Week 12 [N=357; 379; 371]Final Visit (LOCF) [N=377; 389; 388]
Mirabegron 25 mg1.581.54
Mirabegron 50 mg1.941.88
Placebo1.181.05

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Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)

The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A negative change from Baseline score indicates improvement. (NCT00912964)
Timeframe: Baseline and Week 12

,,
Interventionscores on a scale (Least Squares Mean)
Week 12 [N=357; 381; 378]Final Visit (LOCF) [N=376; 391; 395]
Mirabegron 25 mg-0.8-0.8
Mirabegron 50 mg-0.8-0.7
Placebo-0.7-0.7

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Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score

The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit. (NCT00912964)
Timeframe: Baseline and Week 12

,,
Interventionparticipants (Number)
No problem -> No problemNo problem -> Some problemsNo problem -> Unable to perform usual activitiesNo problem -> Missing dataSome problems -> No problemsSome problems -> Some problemsSome problems->Unable to perform usual activitiesSome problems -> Missing dataUnable to perform usual activities -> No problemsUnable to perform usual activities-> Some problemsUnable to perform -> Unable to performUnable to perform usual activities -> Missing dataMissing data -> No problemMissing data -> Some problemsMissing data -> Unable to perform usual activitiesMissing data -> Missing data
Mirabegron 25 mg303271038351001012100
Mirabegron 50 mg293310451441001100000
Placebo313270635300100003000

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Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score

"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00912964)
Timeframe: Baseline and Week 12

,,
Interventionparticipants (Number)
No problem -> No problemNo problem -> Some problemsNo problem -> Unable to wash or dress myselfNo problem -> Missing dataSome problems -> No problemsSome problems -> Some problemsSome problems -> Unable to wash or dress myselfSome problems -> Missing dataUnable to wash or dress myself -> No problemsUnable to wash or dress myself -> Some problemsUnable to wash or dress -> Unable to wash or dressUnable to wash or dress myself -> Missing dataMissing data -> No problemMissing data -> Some problemsMissing data -> Unable to wash or dress myselfMissing data -> Missing data
Mirabegron 25 mg3851001380000003000
Mirabegron 50 mg403614290001000000
Placebo389507560000003000

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Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score

"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00912964)
Timeframe: Baseline and Week 12

,,
Interventionparticipants (Number)
No pain -> No painNo pain -> Moderate painNo pain -> Extreme painNo pain -> Missing dataModerate pain -> No painModerate pain -> Moderate painModerate pain -> Extreme painModerate pain ->Missing dataExtreme pain -> No painExtreme pain -> Moderate painExtreme pain -> Extreme painExtreme pain -> Missing dataMissing data-> No painMissing data -> Moderate painMissing data -> Extreme painMissing data -> Missing data
Mirabegron 25 mg200364065920004511200
Mirabegron 50 mg1854133758770513511000
Placebo209342458855309202200

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Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS)

The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). A positive change from Baseline indicates improvement. (NCT01340027)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo2.44
Mirabegron 25 mg2.61
Mirabegron 50 mg3.17
Solifenacin 2.5 mg3.10
Solifenacin 5 mg2.78
Solifenacin 10 mg2.96
Solifenacin 2.5 mg + Mirabegron 25 mg2.96
Solifenacin 2.5 mg + Mirabegron 50 mg3.24
Solifenacin 5 mg + Mirabegron 25 mg3.47
Solifenacin 5 mg + Mirabegron 50 mg3.24
Solifenacin 10 mg + Mirabegron 25 mg3.51
Solifenacin 10 mg + Mirabegron 50 mg3.72

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Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)

The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement. (NCT01340027)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Placebo13.1
Mirabegron 25 mg5.8
Mirabegron 50 mg14.3
Solifenacin 2.5 mg11.1
Solifenacin 5 mg11.9
Solifenacin 10 mg13.3
Solifenacin 2.5 mg + Mirabegron 25 mg11.6
Solifenacin 2.5 mg + Mirabegron 50 mg12.5
Solifenacin 5 mg + Mirabegron 25 mg11.8
Solifenacin 5 mg + Mirabegron 50 mg15.9
Solifenacin 10 mg + Mirabegron 25 mg15.3
Solifenacin 10 mg + Mirabegron 50 mg11.1

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Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition

The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. (NCT01340027)
Timeframe: Baseline and Week 12

InterventionmL (Least Squares Mean)
Placebo14.0
Mirabegron 25 mg24.9
Mirabegron 50 mg34.5
Solifenacin 2.5 mg36.4
Solifenacin 5 mg36.0
Solifenacin 10 mg36.2
Solifenacin 2.5 mg + Mirabegron 25 mg39.4
Solifenacin 2.5 mg + Mirabegron 50 mg41.9
Solifenacin 5 mg + Mirabegron 25 mg53.6
Solifenacin 5 mg + Mirabegron 50 mg54.2
Solifenacin 10 mg + Mirabegron 25 mg57.6
Solifenacin 10 mg + Mirabegron 50 mg62.3

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Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC)

The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement. (NCT01340027)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-1.4
Mirabegron 25 mg-1.4
Mirabegron 50 mg-1.5
Solifenacin 2.5 mg-1.5
Solifenacin 5 mg-1.3
Solifenacin 10 mg-1.5
Solifenacin 2.5 mg + Mirabegron 25 mg-1.4
Solifenacin 2.5 mg + Mirabegron 50 mg-1.7
Solifenacin 5 mg + Mirabegron 25 mg-1.7
Solifenacin 5 mg + Mirabegron 50 mg-1.8
Solifenacin 10 mg + Mirabegron 25 mg-1.8
Solifenacin 10 mg + Mirabegron 50 mg-1.6

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Percentage of Participants With Deterioration in PPBC

The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Deterioration was defined as at least a 1 point increase from Baseline in PPBC score. (NCT01340027)
Timeframe: Baseline and Week 12

Interventionpercentage of participants (Number)
Placebo6.4
Mirabegron 25 mg4.1
Mirabegron 50 mg5.3
Solifenacin 2.5 mg4.0
Solifenacin 5 mg4.8
Solifenacin 10 mg2.7
Solifenacin 2.5 mg + Mirabegron 25 mg4.3
Solifenacin 2.5 mg + Mirabegron 50 mg2.8
Solifenacin 5 mg + Mirabegron 25 mg2.9
Solifenacin 5 mg + Mirabegron 50 mg1.4
Solifenacin 10 mg + Mirabegron 25 mg1.3
Solifenacin 10 mg + Mirabegron 50 mg6.4

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Percentage of Participants With Improvement in PPBC

The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1-point improvement (decrease) from Baseline in PPBC score. (NCT01340027)
Timeframe: Baseline and Week 12

Interventionpercentage of participants (Number)
Placebo69.2
Mirabegron 25 mg76.7
Mirabegron 50 mg78.9
Solifenacin 2.5 mg68.0
Solifenacin 5 mg72.8
Solifenacin 10 mg84.9
Solifenacin 2.5 mg + Mirabegron 25 mg74.5
Solifenacin 2.5 mg + Mirabegron 50 mg83.2
Solifenacin 5 mg + Mirabegron 25 mg77.9
Solifenacin 5 mg + Mirabegron 50 mg82.6
Solifenacin 10 mg + Mirabegron 25 mg82.9
Solifenacin 10 mg + Mirabegron 50 mg75.6

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Percentage of Participants With Major Improvement in PPBC

The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Major improvement was defined as at least a 2-point improvement (decrease) from Baseline in PPBC score. (NCT01340027)
Timeframe: Baseline and Week 12

Interventionpercentage of participants (Number)
Placebo39.7
Mirabegron 25 mg42.5
Mirabegron 50 mg38.2
Solifenacin 2.5 mg44.0
Solifenacin 5 mg42.2
Solifenacin 10 mg46.6
Solifenacin 2.5 mg + Mirabegron 25 mg48.2
Solifenacin 2.5 mg + Mirabegron 50 mg52.4
Solifenacin 5 mg + Mirabegron 25 mg54.4
Solifenacin 5 mg + Mirabegron 50 mg54.9
Solifenacin 10 mg + Mirabegron 25 mg57.9
Solifenacin 10 mg + Mirabegron 50 mg50.0

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Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score

"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category." (NCT01340027)
Timeframe: Baseline and Week 12

,,,,,,,,,,,
Interventionparticipants (Number)
No anxiety → No anxietyNo anxiety → Moderate anxietyNo anxiety → Extreme anxietyNo anxiety → Missing dataModerate anxiety → No anxietyModerate anxiety → Moderate anxietyModerate anxiety → Extreme anxietyModerate anxiety → Missing dataExtreme anxiety → No anxietyExtreme anxiety → Moderate anxietyExtreme anxiety → Extreme anxietyExtreme anxiety → Missing dataMissing data → No anxietyMissing data → Moderate anxietyMissing data → Extreme anxietyMissing data → Missing data
Mirabegron 25 mg388009180101100000
Mirabegron 50 mg3970015141100000000
Placebo4151017130002010000
Solifenacin 10 mg3660019121101000000
Solifenacin 10 mg + Mirabegron 25 mg445001580031200000
Solifenacin 10 mg + Mirabegron 50 mg3660214191020000000
Solifenacin 2.5 mg424002190000100000
Solifenacin 2.5 mg + Mirabegron 25 mg8170125211017101000
Solifenacin 2.5 mg + Mirabegron 50 mg7851135220021100010
Solifenacin 5 mg76111024332020100000
Solifenacin 5 mg + Mirabegron 25 mg7690128191124000000
Solifenacin 5 mg + Mirabegron 50 mg8030133261121002000

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Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score

"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems in walking about; I have some problems in walking about; I am confined to bed.~In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category." (NCT01340027)
Timeframe: Baseline and Week 12

,,,,,,,,,,,
Interventionparticipants (Number)
No problem → No problemNo problem → Some problemsNo problem → Confined to bedNo problem → Missing dataSome problems → No problemsSome problems → Some problemsSome problems → Confined to bedSome problems → Missing dataConfined → No problemsConfined → Some problemsConfined → Confined to bedConfined → Missing dataMissing data → No problemMissing data → Some problemsMissing data → Confined to bedMissing data → Missing data
Mirabegron 25 mg581016100000000000
Mirabegron 50 mg63401630000000000
Placebo60601580000000000
Solifenacin 10 mg54401890000000000
Solifenacin 10 mg + Mirabegron 25 mg590001180000000000
Solifenacin 10 mg + Mirabegron 50 mg56502890000000000
Solifenacin 2.5 mg594004100000000000
Solifenacin 2.5 mg + Mirabegron 25 mg9490121200000001000
Solifenacin 2.5 mg + Mirabegron 50 mg11350115120000000100
Solifenacin 5 mg11860011150000000000
Solifenacin 5 mg + Mirabegron 25 mg10290113150100000000
Solifenacin 5 mg + Mirabegron 50 mg12010114110100002000

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Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score

"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of participants in that category." (NCT01340027)
Timeframe: Baseline and Week 12

,,,,,,,,,,,
Interventionparticipants (Number)
No pain → No painNo pain → Moderate painNo pain → Extreme painNo pain → Missing dataModerate pain → No painModerate pain → Moderate painModerate pain → Extreme painModerate pain → Missing dataExtreme pain → No painExtreme pain → Moderate painExtreme pain → Extreme painExtreme pain → Missing dataMissing data → No painMissing data → Moderate painMissing data → Extreme painMissing data → Missing data
Mirabegron 25 mg33120014151000010000
Mirabegron 50 mg4060010190000110000
Placebo3890012161112000000
Solifenacin 10 mg3531113180020300000
Solifenacin 10 mg + Mirabegron 25 mg3980014121003100000
Solifenacin 10 mg + Mirabegron 50 mg3260220182000000000
Solifenacin 2.5 mg3840012191011100000
Solifenacin 2.5 mg + Mirabegron 25 mg6761124374032000100
Solifenacin 2.5 mg + Mirabegron 50 mg61110134331012200100
Solifenacin 5 mg70150024370011200000
Solifenacin 5 mg + Mirabegron 25 mg66140028270212100000
Solifenacin 5 mg + Mirabegron 50 mg7370136250114002000

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Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score

"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself.~In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category." (NCT01340027)
Timeframe: Baseline and Week 12

,,,,,,,,,,,
Interventionparticipants (Number)
No problem → No problemNo problem → Some problemsNo problem → UnableNo problem → Missing dataSome problems → No problemsSome problems → Some problemsSome problems → UnableSome problems → Missing dataUnable → No problemsUnable → Some problemsUnable → UnableUnable → Missing dataMissing data → No problemMissing data → Some problemsMissing data → UnableMissing data → Missing data
Mirabegron 25 mg69100410100000000
Mirabegron 50 mg73301000000000000
Placebo76001120000000000
Solifenacin 10 mg68211310000000000
Solifenacin 10 mg + Mirabegron 25 mg74100120000000000
Solifenacin 10 mg + Mirabegron 50 mg72002240000000000
Solifenacin 2.5 mg72200120000000000
Solifenacin 2.5 mg + Mirabegron 25 mg128501830000001000
Solifenacin 2.5 mg + Mirabegron 50 mg138201320000000100
Solifenacin 5 mg138210630000000000
Solifenacin 5 mg + Mirabegron 25 mg130102341000000000
Solifenacin 5 mg + Mirabegron 50 mg141102220000002000

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Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score

"The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities.~In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category." (NCT01340027)
Timeframe: Baseline and Week 12

,,,,,,,,,,,
Interventionparticipants (Number)
No problem → No problemNo problem → Some problemsNo problem → UnableNo problem → Missing dataSome problems → No problemsSome problems → Some problemsSome problems → UnableSome problems → Missing dataUnable → No problemsUnable → Some problemsUnable → UnableUnable → Missing dataMissing data → No problemMissing data → Some problemsMissing data → UnableMissing data → Missing data
Mirabegron 25 mg5220011100100000000
Mirabegron 50 mg58301860001000000
Placebo622001140100000000
Solifenacin 10 mg57411760000000000
Solifenacin 10 mg + Mirabegron 25 mg571001441001000000
Solifenacin 10 mg + Mirabegron 50 mg485121480002000000
Solifenacin 2.5 mg602001140000000000
Solifenacin 2.5 mg + Mirabegron 25 mg8980129180000001000
Solifenacin 2.5 mg + Mirabegron 50 mg1103012480000000100
Solifenacin 5 mg11530016132010000000
Solifenacin 5 mg + Mirabegron 25 mg10690112110110000000
Solifenacin 5 mg + Mirabegron 50 mg10940221120000002000

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Change From Baseline to Each Visit in Mean Level of Urgency

Average of participants' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in the 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. (NCT01340027)
Timeframe: Baseline and Weeks 2, 4, 8 and 12

,,,,,,,,,,,
Interventionunits on a scale (Least Squares Mean)
Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73EOT; n=80,76,77,77,150,76,146,147,141,150,78,80
Mirabegron 25 mg-0.19-0.28-0.30-0.35-0.33
Mirabegron 50 mg-0.15-0.26-0.36-0.44-0.41
Placebo-0.24-0.32-0.42-0.48-0.46
Solifenacin 10 mg-0.21-0.35-0.44-0.49-0.47
Solifenacin 10 mg + Mirabegron 25 mg-0.31-0.41-0.53-0.61-0.59
Solifenacin 10 mg + Mirabegron 50 mg-0.20-0.31-0.43-0.49-0.47
Solifenacin 2.5 mg-0.25-0.33-0.45-0.42-0.45
Solifenacin 2.5 mg + Mirabegron 25 mg-0.19-0.32-0.39-0.43-0.42
Solifenacin 2.5 mg + Mirabegron 50 mg-0.26-0.35-0.41-0.54-0.50
Solifenacin 5 mg-0.14-0.23-0.30-0.33-0.33
Solifenacin 5 mg + Mirabegron 25 mg-0.26-0.35-0.45-0.50-0.48
Solifenacin 5 mg + Mirabegron 50 mg-0.28-0.37-0.46-0.54-0.55

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Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours

The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit. (NCT01340027)
Timeframe: Baseline and Weeks 2, 4, 8 and 12

,,,,,,,,,,,
Interventionincontinence episodes (Least Squares Mean)
Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20
Mirabegron 25 mg-0.43-0.48-0.65-0.59
Mirabegron 50 mg-0.85-0.89-0.92-0.89
Placebo-0.83-0.87-0.82-0.93
Solifenacin 10 mg-0.71-0.84-1.04-0.95
Solifenacin 10 mg + Mirabegron 25 mg-1.14-1.18-0.93-0.27
Solifenacin 10 mg + Mirabegron 50 mg-0.77-0.71-0.91-0.96
Solifenacin 2.5 mg-0.98-1.20-1.12-1.21
Solifenacin 2.5 mg + Mirabegron 25 mg-0.49-0.73-0.78-0.74
Solifenacin 2.5 mg + Mirabegron 50 mg-0.64-0.67-0.82-0.88
Solifenacin 5 mg-0.67-0.80-0.72-0.84
Solifenacin 5 mg + Mirabegron 25 mg-0.70-0.81-1.01-1.20
Solifenacin 5 mg + Mirabegron 50 mg-0.65-0.88-0.95-1.11

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Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours

The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit. (NCT01340027)
Timeframe: Baseline and Weeks 2, 4, 8 and 12

,,,,,,,,,,,
Interventionmicturitions (Least Squares Mean)
Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73
Mirabegron 25 mg-1.69-2.02-2.27-2.51
Mirabegron 50 mg-1.60-1.99-2.42-2.67
Placebo-1.18-1.68-2.27-2.59
Solifenacin 10 mg-1.32-2.25-2.97-3.31
Solifenacin 10 mg + Mirabegron 25 mg-1.74-2.55-3.04-3.47
Solifenacin 10 mg + Mirabegron 50 mg-2.35-2.69-3.49-3.63
Solifenacin 2.5 mg-1.49-2.10-2.46-2.38
Solifenacin 2.5 mg + Mirabegron 25 mg-1.52-2.03-2.58-2.64
Solifenacin 2.5 mg + Mirabegron 50 mg-1.95-2.11-2.66-3.02
Solifenacin 5 mg-1.16-1.80-2.22-2.58
Solifenacin 5 mg + Mirabegron 25 mg-1.68-2.29-2.43-2.64
Solifenacin 5 mg + Mirabegron 50 mg-2.21-2.77-3.20-3.35

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Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours

Nocturia is defined as waking at night one or more times to void. The average number of times a participant urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day micturition diary. (NCT01340027)
Timeframe: Baseline and Weeks 2, 4, 8 and 12

,,,,,,,,,,,
Interventionnocturia episodes (Least Squares Mean)
Week 2; n=78,69,75,72,144,71,142,138,133,138,74,73Week 4; n=77,69,74,74,143,71,138,135,134,141,74,71Week 8; n=75,67,73,73,143,72,140,135,130,142,74,70Week 12;n=73,66,73,71,140,71,135,131,130,141,72,69EOT; n=78,73,76,75,146,74,143,140,137,147,75,76
Mirabegron 25 mg-0.37-0.60-0.65-0.69-0.69
Mirabegron 50 mg-0.60-0.71-0.68-0.84-0.82
Placebo-0.33-0.50-0.64-0.79-0.74
Solifenacin 10 mg-0.45-0.74-1.01-0.99-0.95
Solifenacin 10 mg + Mirabegron 25 mg-0.43-0.67-0.81-0.98-0.94
Solifenacin 10 mg + Mirabegron 50 mg-0.53-0.75-0.91-1.03-0.96
Solifenacin 2.5 mg-0.38-0.55-0.80-0.59-0.68
Solifenacin 2.5 mg + Mirabegron 25 mg-0.43-0.59-0.76-0.75-0.73
Solifenacin 2.5 mg + Mirabegron 50 mg-0.51-0.54-0.79-0.81-0.77
Solifenacin 5 mg-0.30-0.47-0.65-0.70-0.69
Solifenacin 5 mg + Mirabegron 25 mg-0.49-0.69-0.76-0.80-0.77
Solifenacin 5 mg + Mirabegron 50 mg-0.61-0.80-0.98-1.05-1.04

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Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours

The average number of times a participant recorded a new pad used per day during the 3-day micturition diary period. (NCT01340027)
Timeframe: Baseline and Weeks 2, 4, 8 and 12

,,,,,,,,,,,
Interventionpads (Least Squares Mean)
Week 2; n=33,33,34,31,74,23,62,55,62,62,45,30Week 4; n=32,31,35,31,75,23,61,52,64,62,45,30Week 8; n=30,31,34,31,74,24,63,52,64,61,45,30Week 12; n=30,31,34,29,72,23,60,52,63,62,45,31EOT; n=33,34,35,32,76,24,63,56,64,65,46,32
Mirabegron 25 mg-0.87-0.93-0.90-0.97-1.04
Mirabegron 50 mg-0.88-0.70-1.11-0.93-0.95
Placebo-0.81-0.76-0.97-0.92-0.63
Solifenacin 10 mg-0.91-1.23-1.53-1.75-1.73
Solifenacin 10 mg + Mirabegron 25 mg-1.13-1.35-1.37-1.60-1.59
Solifenacin 10 mg + Mirabegron 50 mg-1.31-1.36-1.56-1.60-1.63
Solifenacin 2.5 mg-1.31-1.62-1.47-1.35-1.44
Solifenacin 2.5 mg + Mirabegron 25 mg-0.86-0.94-1.10-1.02-1.04
Solifenacin 2.5 mg + Mirabegron 50 mg-0.96-1.09-1.39-1.44-1.38
Solifenacin 5 mg-0.92-1.26-1.25-1.39-1.38
Solifenacin 5 mg + Mirabegron 25 mg-0.89-1.24-1.29-1.45-1.46
Solifenacin 5 mg + Mirabegron 50 mg-1.02-1.30-1.51-1.63-1.63

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Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours

The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the participant in the 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. (NCT01340027)
Timeframe: Baseline and Weeks 2, 4, 8 and 12

,,,,,,,,,,,
Interventionurgency episodes (Least Squares Mean)
Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73EOT; n=80,76,77,77,150,76,146,147,141,150,78,80
Mirabegron 25 mg-2.06-2.70-2.86-3.31-3.23
Mirabegron 50 mg-1.91-2.70-3.27-3.65-3.44
Placebo-2.07-2.55-3.42-3.69-3.53
Solifenacin 10 mg-1.97-3.02-3.63-4.15-3.98
Solifenacin 10 mg + Mirabegron 25 mg-2.35-3.04-3.53-3.76-3.71
Solifenacin 10 mg + Mirabegron 50 mg-2.23-2.81-3.63-3.93-3.91
Solifenacin 2.5 mg-2.49-3.16-3.61-3.54-3.62
Solifenacin 2.5 mg + Mirabegron 25 mg-1.84-2.64-3.34-3.26-3.21
Solifenacin 2.5 mg + Mirabegron 50 mg-2.59-3.14-3.60-4.24-3.97
Solifenacin 5 mg-1.63-2.24-2.67-2.71-2.73
Solifenacin 5 mg + Mirabegron 25 mg-2.30-3.08-3.60-3.98-3.86
Solifenacin 5 mg + Mirabegron 50 mg-2.57-3.17-3.85-4.09-4.10

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Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours

Urgency incontinence is the involuntary leakage of urine accompanied by or immediately preceded by urgency, and was derived from the number of incontinence episodes classified by the participant in a 3-day micturition diary as Grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. (NCT01340027)
Timeframe: Baseline and Weeks 2, 4, 8 and 12

,,,,,,,,,,,
Interventionurgency incontinence episodes (Least Squares Mean)
Week 2; n=14,13,17,15,33,12,29,33,31,21,24,18Week 4; n=14,10,17,15,34,12,28,30,31,22,24,18Week 8; n=14,10,17,14,34,13,29,30,31,21,24,19Week 12; n=14,10,17,13,34,12,28,30,29,22,24,19EOT; n=14,13,17,15,35,13,29,33,31,23,24,19
Mirabegron 25 mg-0.59-0.48-0.65-0.54-0.80
Mirabegron 50 mg-0.83-0.93-1.00-0.87-0.88
Placebo-0.80-0.83-0.86-0.84-0.86
Solifenacin 10 mg-0.77-1.00-1.16-1.13-1.13
Solifenacin 10 mg + Mirabegron 25 mg-1.12-1.20-0.91-0.28-0.28
Solifenacin 10 mg + Mirabegron 50 mg-0.76-0.68-0.88-0.93-0.94
Solifenacin 2.5 mg-0.96-1.13-1.04-1.13-1.17
Solifenacin 2.5 mg + Mirabegron 25 mg-0.52-0.73-0.86-0.81-0.81
Solifenacin 2.5 mg + Mirabegron 50 mg-0.68-0.70-0.84-0.91-0.87
Solifenacin 5 mg-0.66-0.77-0.76-0.83-0.86
Solifenacin 5 mg + Mirabegron 25 mg-0.68-0.81-0.99-1.19-1.20
Solifenacin 5 mg + Mirabegron 50 mg-0.64-0.86-0.89-1.06-1.08

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Change From Baseline to Each Visit in Mean Volume Voided Per Micturition

The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and each post-baseline clinic visit. (NCT01340027)
Timeframe: Baseline and Weeks 2, 4, 8 and 12

,,,,,,,,,,,
InterventionmL (Least Squares Mean)
Week 2; n=80,71,76,74,148,73,145,145,136,141,76,77Week 4; n=79,72,74,76,146,72,141,142,138,144,77,75Week 8; n=77,70,73,75,147,73,143,142,134,143,76,74Week 12;n=75,68,73,73,144,72,138,138,133,140,72,73
Mirabegron 25 mg14.316.824.623.0
Mirabegron 50 mg26.029.435.435.5
Placebo8.710.213.514.7
Solifenacin 10 mg16.128.337.735.8
Solifenacin 10 mg + Mirabegron 25 mg29.545.755.859.8
Solifenacin 10 mg + Mirabegron 50 mg42.154.568.566.2
Solifenacin 2.5 mg22.724.828.336.9
Solifenacin 2.5 mg + Mirabegron 25 mg22.529.235.638.6
Solifenacin 2.5 mg + Mirabegron 50 mg29.236.542.343.7
Solifenacin 5 mg23.129.630.134.6
Solifenacin 5 mg + Mirabegron 25 mg29.942.749.754.7
Solifenacin 5 mg + Mirabegron 50 mg32.344.552.256.6

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Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI)

This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant's assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant's assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicates improvement. (NCT01340027)
Timeframe: Baseline and Week 12

,,,,,,,,,,,
Interventionunits on a scale (Mean)
Percent work time missedPercent impairment while workingPercent overall work impairmentPercent activity impairment
Mirabegron 25 mg0.53-16.13-16.32-14.52
Mirabegron 50 mg-0.24-10.00-9.91-13.95
Placebo-2.44-7.50-9.50-9.62
Solifenacin 10 mg-0.28-10.00-9.95-17.12
Solifenacin 10 mg + Mirabegron 25 mg0.79-18.00-17.69-19.34
Solifenacin 10 mg + Mirabegron 50 mg-1.12-9.29-10.32-19.74
Solifenacin 2.5 mg-2.85-16.67-17.88-13.73
Solifenacin 2.5 mg + Mirabegron 25 mg-0.55-8.43-8.59-14.11
Solifenacin 2.5 mg + Mirabegron 50 mg-0.83-17.72-17.16-25.31
Solifenacin 5 mg-1.29-17.33-17.26-14.38
Solifenacin 5 mg + Mirabegron 25 mg-0.84-13.85-14.00-17.43
Solifenacin 5 mg + Mirabegron 50 mg-1.65-13.39-14.18-20.42

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Percentage of Participants With 50% Reduction in Incontinence Episodes

The percentage of participants with at least a 50% decrease from Baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the participant's micturition diary. (NCT01340027)
Timeframe: Baseline and Weeks 2, 4, 8 and 12

,,,,,,,,,,,
Interventionpercentage of participants (Number)
Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20EOT; n=17,13,18,15,35,15,35,33,32,24,24,20
Mirabegron 25 mg30.840.060.070.061.5
Mirabegron 50 mg66.772.277.877.877.8
Placebo64.782.476.594.194.1
Solifenacin 10 mg57.178.686.764.366.7
Solifenacin 10 mg + Mirabegron 25 mg91.795.891.795.895.8
Solifenacin 10 mg + Mirabegron 50 mg68.468.475.090.090.0
Solifenacin 2.5 mg73.386.785.784.686.7
Solifenacin 2.5 mg + Mirabegron 25 mg51.464.782.966.768.6
Solifenacin 2.5 mg + Mirabegron 50 mg66.763.373.380.075.8
Solifenacin 5 mg57.676.558.873.574.3
Solifenacin 5 mg + Mirabegron 25 mg71.975.090.696.796.9
Solifenacin 5 mg + Mirabegron 50 mg66.778.381.895.795.8

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Percentage of Participants With Zero Incontinence Episodes Post-baseline

The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the participant. (NCT01340027)
Timeframe: Weeks 2, 4, 8 and 12

,,,,,,,,,,,
Interventionpercentage of participants (Number)
Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20EOT; n=17,13,18,15,35,15,35,33,32,24,24,20
Mirabegron 25 mg23.120.050.050.046.2
Mirabegron 50 mg44.455.661.161.161.1
Placebo47.164.758.882.482.4
Solifenacin 10 mg50.071.473.357.153.3
Solifenacin 10 mg + Mirabegron 25 mg70.879.279.279.279.2
Solifenacin 10 mg + Mirabegron 50 mg52.652.665.075.075.0
Solifenacin 2.5 mg40.073.371.469.266.7
Solifenacin 2.5 mg + Mirabegron 25 mg40.055.954.351.554.3
Solifenacin 2.5 mg + Mirabegron 50 mg51.546.750.063.360.6
Solifenacin 5 mg45.564.750.058.860.0
Solifenacin 5 mg + Mirabegron 25 mg65.662.571.986.787.5
Solifenacin 5 mg + Mirabegron 50 mg52.452.277.387.087.5

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Percentage of Participants With a Symptom Bother Response

Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. Symptom bother response is defined as improvement (decrease) of at least 10 points from Baseline. (NCT01340027)
Timeframe: Baseline and Week 12

Interventionpercentage of participants (Number)
Placebo73.4
Mirabegron 25 mg84.0
Mirabegron 50 mg78.9
Solifenacin 2.5 mg85.7
Solifenacin 5 mg81.3
Solifenacin 10 mg85.3
Solifenacin 2.5 mg + Mirabegron 25 mg82.6
Solifenacin 2.5 mg + Mirabegron 50 mg85.5
Solifenacin 5 mg + Mirabegron 25 mg85.6
Solifenacin 5 mg + Mirabegron 50 mg88.4
Solifenacin 10 mg + Mirabegron 25 mg88.5
Solifenacin 10 mg + Mirabegron 50 mg83.3

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Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)

Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements. (NCT01340027)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-25.5
Mirabegron 25 mg-27.1
Mirabegron 50 mg-27.5
Solifenacin 2.5 mg-29.8
Solifenacin 5 mg-26.8
Solifenacin 10 mg-29.9
Solifenacin 2.5 mg + Mirabegron 25 mg-28.0
Solifenacin 2.5 mg + Mirabegron 50 mg-31.7
Solifenacin 5 mg + Mirabegron 25 mg-32.0
Solifenacin 5 mg + Mirabegron 50 mg-33.5
Solifenacin 10 mg + Mirabegron 25 mg-33.6
Solifenacin 10 mg + Mirabegron 50 mg-31.4

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Percentage of Participants With a Micturition Response

A responder is defined as a participant with at most 8 micturitions per 24 hours post-baseline and a negative change (i.e. an improvement) from Baseline. (NCT01340027)
Timeframe: Baseline and Weeks 2, 4, 8 and 12

,,,,,,,,,,,
Interventionpercentage of participants (Number)
Week 2; n=79,70,75,71,144,72,143,143,135,137,77,76Week 4; n=78,72,73,73,144,72,139,140,137,140,77,74Week 8; n=76,70,73,72,145,73,141,140,133,142,77,73Week 12;n=74,69,72,69,142,72,136,136,132,142,75,72EOT; n=79,75,76,73,146,75,144,145,140,146,78,79
Mirabegron 25 mg25.727.835.746.442.7
Mirabegron 50 mg37.343.850.747.247.4
Placebo27.842.353.955.453.2
Solifenacin 10 mg34.744.456.255.654.7
Solifenacin 10 mg + Mirabegron 25 mg36.448.157.165.365.4
Solifenacin 10 mg + Mirabegron 50 mg46.141.964.461.158.2
Solifenacin 2.5 mg29.635.643.153.654.8
Solifenacin 2.5 mg + Mirabegron 25 mg36.445.346.855.154.2
Solifenacin 2.5 mg + Mirabegron 50 mg38.542.154.355.153.1
Solifenacin 5 mg26.434.040.047.947.9
Solifenacin 5 mg + Mirabegron 25 mg34.148.249.653.852.1
Solifenacin 5 mg + Mirabegron 50 mg36.556.456.362.061.6

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Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours

The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits. (NCT01340027)
Timeframe: Baseline and Week 12

Interventionmicturitions (Least Squares Mean)
Placebo-2.43
Mirabegron 25 mg-2.48
Mirabegron 50 mg-2.56
Solifenacin 2.5 mg-2.44
Solifenacin 5 mg-2.54
Solifenacin 10 mg-3.22
Solifenacin 2.5 mg + Mirabegron 25 mg-2.58
Solifenacin 2.5 mg + Mirabegron 50 mg-2.93
Solifenacin 5 mg + Mirabegron 25 mg-2.56
Solifenacin 5 mg + Mirabegron 50 mg-3.34
Solifenacin 10 mg + Mirabegron 25 mg-3.42
Solifenacin 10 mg + Mirabegron 50 mg-3.52

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Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours

The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits. (NCT01340027)
Timeframe: Baseline and Week 12

Interventionincontinence episodes (Least Squares Mean)
Placebo-0.95
Mirabegron 25 mg-0.74
Mirabegron 50 mg-0.90
Solifenacin 2.5 mg-1.26
Solifenacin 5 mg-0.88
Solifenacin 10 mg-0.97
Solifenacin 2.5 mg + Mirabegron 25 mg-0.75
Solifenacin 2.5 mg + Mirabegron 50 mg-0.85
Solifenacin 5 mg + Mirabegron 25 mg-1.22
Solifenacin 5 mg + Mirabegron 50 mg-1.14
Solifenacin 10 mg + Mirabegron 25 mg-0.27
Solifenacin 10 mg + Mirabegron 50 mg-0.97

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Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit

A responder is defined as a participant who reported incontinence episodes at baseline and reported no incontinence episodes during the treatment period at specified visit. (NCT01638000)
Timeframe: Week 4, Week 8, Week 12

,
Interventionpercentage of participants (Number)
Week 4 [N=404,410]Week 8 [N=387,397]Week 12 [N=381,387]Final visit [N=404,413]
Mirabegron 50 mg47.364.369.067.3
Solifenacin 5 mg52.063.269.568.5

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Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit

A responder is defined as a participant who has ≥8 micturitions at baseline and has <8 micturitions per 24 hours during the treatment period at each specified visit, where change from baseline is <0. (NCT01638000)
Timeframe: Week 4, Week 8, Week 12

,
Interventionpercentage of participants (Number)
Week 4 [N=916,906]Week 8 [N=888,876]Week 12 [N=870,856]Final visit [N=920,910]
Mirabegron 50 mg32.341.244.844.2
Solifenacin 5 mg33.946.949.348.8

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Percentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final Visit

A responder is defined as a participant with ≥2 point improvement in PPBC from baseline. (NCT01638000)
Timeframe: Baseline to Week 12

,
Interventionpercentage of participants (Number)
Week 12 [N=865,858]Final visit [N=906,897]
Mirabegron 50 mg47.646.2
Solifenacin 5 mg52.651.1

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Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12

A responder is defined as a participant with ≥1, ≥2, ≥3, ≥4, ≥5 or 6-point improvement from baseline in TS-Likert scale. (NCT01638000)
Timeframe: Baseline to Week 12

,
Interventionpercentage of participants (Number)
≥1 point improvement≥2 point improvement≥3 point improvement≥4 point improvement≥5 point improvement6 point improvement
Mirabegron 50 mg86.480.367.744.415.62.5
Solifenacin 5 mg90.483.671.947.515.42.9

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Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit

A responder is defined as a participant with >=1 or >=2 or >=3 or >=4 or >=5 or 6-point improvement from baseline in TS-Likert scale. (NCT01638000)
Timeframe: Baseline to final visit (up to Week 12)

,
Interventionpercentage of participants (Number)
≥1 point improvement≥2 point improvement≥3 point improvement≥4 point improvement≥5 point improvement6 point improvement
Mirabegron 50 mg85.679.066.743.815.42.5
Solifenacin 5 mg89.482.670.846.615.12.8

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Percentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final Visit

A responder is defined as a participant with ≥10 points improvement in symptom bother from baseline. (NCT01638000)
Timeframe: Baseline to Week 12

,
Interventionpercentage of participants (Number)
Week 12 [N=865,859]Final visit [N=906,897]
Mirabegron 50 mg77.576.2
Solifenacin 5 mg82.481.2

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Percentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final Visit

A responder is defined as a participant with ≥1 point improvement in PPBC from baseline. (NCT01638000)
Timeframe: Baseline to Week 12

,
Interventionpercentage of participants (Number)
Week 12 [N=865,858]Final visit [N=906,897]
Mirabegron 50 mg73.171.9
Solifenacin 5 mg76.774.9

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Percentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final Visit

A responder is defined as a participant with >=10 points improvement in the total HRQL score from baseline. (NCT01638000)
Timeframe: Baseline to Week 12

,
Interventionpercentage of participants (Number)
Week 12 [N=865,859]Final visit [N=906,897]
Mirabegron 50 mg69.267.5
Solifenacin 5 mg72.671.0

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Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit

A responder is defined as a participant with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the treatment period at specified visit. (NCT01638000)
Timeframe: Week 4, Week 8, Week 12

,
Interventionpercentage of participants (Number)
Week 4 [N=404,410]Week 8 [N=387,397]Week 12 [N=381,387]Final visit [N=404,413]
Mirabegron 50 mg75.585.586.185.1
Solifenacin 5 mg77.386.989.188.1

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Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period

A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE; defined as any untoward medical occurrence in a patient administered a study drug) that started or worsened in the period from the first double-blind medication intake until 30 days after the last double-blind medication intake. The following TEAEs were selected for inclusion in the analysis: Dry mouth (aptyalism, dry mouth, dry throat), constipation (constipation), blurred vision (vision blurred, myopia, refraction disorder, accommodation disorder). (NCT01638000)
Timeframe: From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks)

,
Interventionpercentage of participants (Number)
OverallDry mouthDry throatBlurred visionConstipation
Mirabegron 50 mg53.10.10.62.2
Solifenacin 5 mg7.45.80.10.42.5

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Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit

The total number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit. (NCT01638000)
Timeframe: Week 4, Week 8, Week 12

,
Interventionpads (Mean)
Week 4 [N=574,563]Week 8 [N=551,543]Week 12 [N=543,532]Final visit [N=576,565]
Mirabegron 50 mg4.253.333.193.32
Solifenacin 5 mg4.263.273.043.19

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Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit

A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The total number of nocturia episodes were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit. (NCT01638000)
Timeframe: Week 4, Week 8, Week 12

,
Interventionnocturia episodes (Mean)
Week 4 [N=877,871]Week 8 [N=850, 844]Week 12 [N=831,828]Final Visit [N=879,875]
Mirabegron 50 mg4.784.263.944.05
Solifenacin 5 mg5.124.414.064.13

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Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit

An incontinence episode is any involuntary leakage of urine. The total number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit. (NCT01638000)
Timeframe: Week 4, Week 8, Week 12

,
Interventionincontinence episodes (Mean)
Week 4 [N=404,410]Week 8 [N=387,397]Week 12 [N=381,387]Final visit [N=404,413]
Mirabegron 50 mg2.642.192.072.13
Solifenacin 5 mg2.251.281.081.29

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Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)

The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, scored from 1 to 6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement. (NCT01638000)
Timeframe: Baseline and Week 4, Week 8, Week 12

,
Interventionunits on a scale (Least Squares Mean)
Week 4 [N=905,896]Week 8 [N=882,875]Week 12 [N=865,859]Final visit [N=906,897]
Mirabegron 50 mg-20.51-25.96-29.74-28.89
Solifenacin 5 mg-22.20-27.76-31.84-30.76

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Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC)

The Patient Perception of Bladder Condition (PPBC) questionnaire is a single-item questionnare used to assess participants' perceptions and impressions of their bladder condition. Participants assessed their bladder condition using a 6-point categorical scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. (NCT01638000)
Timeframe: Baseline and Week 4, Week 8, Week 12

,
Interventionunits on a scale (Least Squares Mean)
Week 4 [N=905,896]Week 8 [N=882,875]Week 12 [N=865,858]Final visit [N=906,897]
Mirabegron 50 mg-0.91-1.30-1.58-1.53
Solifenacin 5 mg-1.00-1.46-1.73-1.67

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Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 8

,
Interventionparticipants (Number)
No problems -> no problemsNo problems -> slight problemsNo problems -> moderate problemsNo problems -> severe problemsNo problems -> extreme problemsNo problems -> no dataSlight problems -> no problemsSlight problems -> slight problemsSlight problems -> moderate problemsSlight problems -> severe problemsSlight problems -> extreme problemsSlight problems -> no dataModerate problems -> no problemsModerate problems -> slight problemsModerate problems -> moderate problemsModerate problems -> severe problemsModerate problems -> extreme problemsModerate problems -> no dataSevere problems -> no problemsSevere problems -> slight problemsSevere problems -> moderate problemsSevere problems -> severe problemsSevere problems -> extreme problemsSevere problems -> no dataExtreme problems -> no problemsExtreme problems -> slight problemsExtreme problems -> moderate problemsExtreme problems -> severe problemsExtreme problems -> extreme problemsExtreme problems -> no dataNo data -> no problemsNo data -> slight problemsNo data -> moderate problemsNo data -> severe problemsNo data -> extreme problemsNo data -> no data
Mirabegron 50 mg4304815201610145163136157261016132312702522201350003
Solifenacin 5 mg426491130131095012204535320616163215305453020410004

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Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 8

,
Interventionparticipants (Number)
No problems -> no problemsNo problems -> slight problemsNo problems -> moderate problemsNo problems -> severe problemsNo problems -> extreme problemsNo problems -> no dataSlight problems -> no problemsSlight problems -> slight problemsSlight problems -> moderate problemsSlight problems -> severe problemsSlight problems -> exteme problemsSlight problems -> no dataModerate problems -> no problemsModerate problems -> slight problemsModerate problems -> moderate problemsModerate problems -> severe problemsModerate problems -> extreme problemsModerate problems -> no dataSevere problems -> no problemsSevere problems -> slight problemsSevere problems -> moderate problemsSevere problems -> severe problemsSevere problems -> extreme problemsSevere problems -> no dataExtreme problems -> no problemsExtreme problems -> slight problemsExtreme problems -> moderate problemsExtreme problems -> severe problemsExtreme problems -> extreme problemsExtreme problems -> no dataNo data -> no problemsNo data -> slight problemsNo data -> moderate problemsNo data -> severe problemsNo data -> extreme problemsNo data -> no data
Mirabegron 50 mg672357112042199103341752021794201140002620003
Solifenacin 5 mg6733821121332090023416620213158002220001500004

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Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 8

,
Interventionparticipants (Number)
No problems -> no problemsNo problems -> slight problemsNo problems -> moderate problemsNo problems -> severe problemsNo problems -> extreme problemsNo problems -> no dataSlight problems -> no problemsSlight problems -> slight problemsSlight problems -> moderate problemsSlight problems -> severe problemsSlight problems -> extreme problemsSlight problems -> no dataModerate problems -> no problemsModerate problems -> slight problemsModerate problems -> moderate problemsModerate problems -> severe problemsModerate problems -> extreme problemsModerate problems -> no dataSevere problems -> no problemsSevere problems -> slight problemsSevere problems -> moderate problemsSevere problems -> severe problemsSevere problems -> extreme problemsSevere problems -> no dataExtreme problems -> no problemsExtreme problems -> slight problemsExtreme problems -> moderate problemsExtreme problems -> severe problemsExtreme problems -> extreme problemsExtreme problems -> no dataNo data -> no problemsNo data -> slight problemsNo data -> moderate problemsNo data -> severe problemsNo data -> extreme problemsNo data -> no data
Mirabegron 50 mg291521341101031112560759664610181737121822142011440003
Solifenacin 5 mg286661600109610330105617857418162515714344101230004

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Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 8

,
Interventionparticipants (Number)
No problems -> no problemsNo problems -> slight problemsNo problems -> moderate problemsNo problems -> severe problemsNo problems -> extreme problemsNo problems -> no dataSlight problems -> no problemsSlight problems -> slight problemsSlight problems -> moderate problemsSlight problems -> severe problemsSlight problems -> extreme problemsSlight problems -> no dataModerate problems -> no problemsModerate problems -> slight problemsModerate problems -> modrate problemsModerate problems -> severe problemsModerate problems -> extreme problemsModerate problems -> no dataSevere problems -> no problemsSevere problems -> slight problemsSevere problems -> moderate problemsSevere problems -> severe problemsSevere problems -> extreme problemsSevere problems -> no dataExtreme problems -> no problemsExtreme problems -> slight problemsExtreme problems -> moderate problemsExtreme problems -> severe problemsExtreme problems -> extreme problemsExtreme problems -> no dataNo data -> no problemsNo data -> slight problemsNo data -> moderate problemsNo data -> severe problemsNo data -> extreme problemsNo data -> no data
Mirabegron 50 mg445382031147046193065141318143030212014111000431003
Solifenacin 5 mg44631233111784412306475240604224115807010110410004

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Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 8

,
Interventionparticipants (Number)
No problems -> no problemsNo problems -> slight problemsNo problems -> moderate problemsNo problems -> severe problemsNo problems -> extreme problemsNo problems -> no dataSlight problems -> no problemsSlight problems -> slight problemsSlight problems -> moderate problemsSlight problems -> severe problemsSlight problems -> extreme problemsSlight problems -> no dataModerate problems -> no problemsModerate problems -> slight problemsModerate problems -> moderate problemsModerate problems -> severe problemsModerate problems -> extreme problemsModerate problems -> no dataSevere problems -> no problemsSevere problems -> slight problemsSevere problems -> moderate problemsSevere problems -> severe problemsSevere problems -> extreme problemsSevere problems -> no dataExtreme problems -> no problemsExtreme problems -> slight problemsExtreme problems -> moderate problemsExtreme problems -> severe problemsExtreme problems -> extreme problemsExtreme problems -> no dataNo data -> no problemsNo data -> slight problemsNo data -> moderate problemsNo data -> severe problemsNo data -> extreme problemsNo data -> no data
Mirabegron 50 mg3255215201012294264364250311107233911714972331530003
Solifenacin 5 mg3346581013116792032449593440513371263611104140221004

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Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 4

,
Interventionparticipants (Number)
No problems -> no problemsNo problems -> slight problemsNo problems -> moderate problemsNo problems -> severe problemsNo problems -> extreme problemsNo problems -> no dataSlight problems -> no problemsSlight problems -> slight problemsSlight problems -> moderate problemsSlight problems -> severe problemsSlight problems -> extreme problemsSlight problems -> no dataModerate problems -> no problemsModerate problems -> slight problemsModerate problems -> moderate problemsModerate problems -> severe problemsModerate problems -> extreme problemsModerate problems -> no dataSevere problems -> no problemsSevere problems -> slight problemsSevere problems -> moderate problemsSevere problems -> severe problemsSevere problems -> extreme problemsSevere problems -> no dataExtreme problems -> no problemsExtreme problems -> slight problemsExtreme problems -> moderate problemsExtreme problems -> severe problemsExtreme problems -> extreme problemsExtreme problems -> no dataNo data -> no problemsNo data -> slight problemsNo data -> moderate problemsNo data -> severe problemsNo data -> extreme problemsNo data -> no data
Mirabegron 50 mg42161204141024914211475945910172111710035310021008
Solifenacin 5 mg42263103041015816110345939700281913713453110200007

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Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 4

,
Interventionparticipants (Number)
No problems -> No problemsNo problems -> slight problemsNo problems -> moderate problemsNo problems -> severe problemsNo problems -> extreme problemsNo problems -> no dataSlight problems -> No problemsSlight problems -> slight problemsSlight problems -> moderate problemsSlight problems -> severe problemsSlight problems -> extreme problemsSlight problems -> no dataModerate problems -> no problemsModerate problems -> slight problemsModerate problems -> moderate problemsModerate problems -> severe problemsModerate problems -> extreme problemsModerate problems -> no dataSevere problems -> no problemsSevere problems -> slight problemsSevere problems -> moderate problemsSevere problems -> severe problemsSevere problems -> extreme problemsSevere problems -> no dataExtreme problems -> no problemsExtreme problems -> slight problemsExtreme problems -> moderate problemsExtreme problems -> severe problemsExtreme problems -> extreme problemsExtreme problems -> no dataNo data -> no problemsNo data -> slight problemsNo data -> moderate problemsNo data -> severe problemsNo data -> extreme problemsNo data -> no data
Mirabegron 50 mg6932612005372881002418171009137400411010111008
Solifenacin 5 mg7032340154116520017281500015156011110201200007

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Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 4

,
Interventionparticipants (Number)
No problems -> no problemsNo problems -> slight problemsNo problems -> moderate problemsNo problems -> severe problemsNo problems -> extreme problemsNo problems -> no dataSlight problems -> no problemsSlight problems -> slight problemsSlight problems -> moderate problemsSlight problems -> severe problemsSlight problems -> extreme problemsSlight problems -> no dataModerate problems -> no problemsModerate problems -> slight problemsModerate problems -> moderate problemsModerate problems -> severe problemsModerate problems -> extrme problemsModerate problems -> no dataSevere problems -> no problemsSevere problems -> slight problemsSevere problems -> moderate problemsSevere problems -> severe problemsSevere problems -> extreme problemsSevere problems -> no dataExtreme problems -> no problemsExtreme problems -> slight problemsExtreme problems -> moderate problemsExtreme problems -> severe problemsExtreme problems -> extreme problemsExtreme problems -> no dataNo data -> no problemsNo data -> slight problemsNo data -> moderate problemsNo data -> severe problemsNo data -> extreme problemsNo data -> no data
Mirabegron 50 mg29957111121011163220151606610122122192060123120102008
Solifenacin 5 mg285671750497109254004486651211192517601163201110007

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Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 12

,
Interventionparticipants (Number)
No problems -> no problemsNo problems -> slight problemsNo problems -> moderate problemsNo problems -> severe problemsNo problems -> extreme problemsNo problems -> no dataSlight problems -> no problemsSlight problems -> slight problemsSlight problems -> moderate problemsSlight problems -> severe problemsSlight problems -> extreme problemsSlight problems -> no dataModerate problems -> no problemsModerate problems -> slight problemsModerate problems -> moderate problemsModerate problems -> severe problemsModerate problems -> extreme problemsModerate problems -> no dataSevere problems -> no problemsSevere problems -> slight problemsSevere problems -> moderate problemsSevere problems -> severe problemsSevere problems -> extreme problemsSevere problems -> no dataExtreme problems -> no problemsExtreme problems -> slight problemsExtreme problems -> moderate problemsExtreme problems -> severe problemsExtreme problems -> extreme problemsExtreme problems -> no dataNo data -> no problemsNo data -> slight problemsNo data -> moderate problemsNo data -> severe problemsNo data -> extreme problemsNo data -> no data
Mirabegron 50 mg442361061267743152075731357065315151805200001253001
Solifenacin 5 mg459251050168232162011634330409511778010110010900000

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Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 12

,
Interventionparticipants (Number)
No problems -> no problemsNo problems -> slight problemsNo problems -> moderate problemsNo problems -> severe problemsNo problems -> extreme problemsNo problems -> no dataSlight problems -> no problemsSlight problems -> slight problemsSlight problems -> moderate problemsSlight problems -> severe problemsSlight problems -> extreme problemsSlight problems -> no dataModerate problems -> no problemsModerate problems -> slight problemsModerate problems -> moderate problemsModerate problems -> severe problemsModerate problems -> extreme problemsModerate problems -> no dataSevere problems -> no problemsSevere problems -> slight problemsSevere problems -> moderate problemsSevere problems -> severe problemsSevere problems -> extreme problemsSevere problems -> no dataExtreme problems -> no problemsExtreme problems -> slight problemsExtreme problems -> moderate problemsExtreme problems -> severe problemsExtreme problems -> extreme problemsExtreme problems -> no dataNo data -> no problemsNo data -> slight problemsNo data -> moderate problemsNo data -> severe problemsNo data -> extreme problemsNo data -> no data
Mirabegron 50 mg2875015201711297292012794942100103914161225421101721001
Solifenacin 5 mg29949114015116871840108071386113341312117523111540000

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Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 12

,
Interventionparticipants (Number)
No problems -> no problemsNo problems -> slight problemsNo problems -> moderate problemsNo problems -> severe problemsNo problems -> extreme problemsNo problems -> no dataSlight problems -> no problemsSlight problems -> slight problemsSlight problems -> moderate problemsSlight problems -> severe problemsSlight problems -> extreme problemsSlight problems -> no dataModerate problems -> no problemsModerate problems -> slight problemsModerate problems -> moderate problemsModerate problems -> severe problemsModerate problems -> extreme problemsModerate problems -> no dataSevere problems -> no problemsSevere problems -> slight problemsSevere problems -> moderate problemsSevere problems -> severe problemsSevere problems -> extreme problemsSevere problems -> no dataExtreme problems -> no problemsExtreme problems -> slight problemsExtreme problems -> moderate problemsExtreme problems -> severe problemsExtreme problems -> extreme problemsExtreme problems -> no dataNo data -> no problemsNo data -> slight problemsNo data -> moderate problemsNo data -> severe problemsNo data -> extreme problemsNo data -> no data
Mirabegron 50 mg667265113643131410344851022540301400003820001
Solifenacin 5 mg67023610364212510446660022572103400001900000

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Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 12

,
Interventionparticipants (Number)
No problems -> no problemsNo problems -> slight problemsNo problems -> moderate problemsNo problems -> severe problemsNo problems -> extreme problemsNo problems -> no dataSlight problems -> no problemsSlight problems -> slight problemsSlight problems -> moderate problemsSlight problems -> severe problemsSlight problems -> extreme problemsSlight problems -> no dataModerate problems -> no problemsModerate problems -> slight problemsModerate problems -> moderate problemsModerate problems -> severe problemsModerate problems -> extreme problemsModerate problems -> no dataSevere problems -> no problemsSevere problems -> slight problemsSevere problems -> moderate problemsSevere problems -> severe problemsSevere problems -> extreme problemsSevere problems -> no dataExtreme problems -> no problemsExtreme problems -> slight problemsExtreme problems -> moderate problemsExtreme problems -> severe problemsExtreme problems -> extreme problemsExtreme problems -> no dataNo data -> no problemsNo data -> slight problemsNo data -> moderate problemsNo data -> severe problemsNo data -> extreme problemsNo data -> no data
Mirabegron 50 mg32353101116132842630105251188210382579151053214910001
Solifenacin 5 mg3414810202011880152096744285163517142091527222720000

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Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 4

,
Interventionparticipants (Number)
No problems -> no problemsNo problems -> slight problemsNo problems -> moderate problemsNo problems -> severe problemsNo problems -> extreme problemsNo problems -> no dataSlight problems -> no problemsSlight problems -> slight problemsSlight problems -> moderate problemsSlight problems -> severe problemsSlight problems -> extreme problemsSlight problems -> no dataModerate problems -> no problemsModerate problems -> slight problemsModerate problems -> moderate problemsModerate problems -> severe problemsModerate problems -> extreme problemsModerate problems -> no dataSevere problems -> no problemsSevere problems -> slight problemsSevere problems -> moderate problemsSevere problems -> severe problemsSevere problems -> extreme problemsSevere problems -> no dataExtreme problems -> no problemsExtreme problems -> slight problemsExtreme problems -> moderate problemsExtreme problems -> severe problemsExtreme problems -> extreme problemsExtreme problems -> no dataNo data -> no problemsNo data -> slight problemsNo data -> moderate problemsNo data -> severe problemsNo data -> extreme problemsNo data -> no data
Mirabegron 50 mg3285911204981222951025643712301232261221783430120008
Solifenacin 5 mg3396511222102942530033654010121729199031245450110007

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Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire

The European Quality of Life 5-Dimensions Questionnaire (EQ-5D-5L) is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 4

,
Interventionparticipants (Number)
No problems -> No problemsNo problems -> Slight problemsNo problems -> Moderate problemsNo problems -> Severe problemsNo problems -> Extreme problemsNo problems -> no dataSlight problems -> no problemsSlight problems -> slight problemsSlight problems -> moderate problemsSlight problems -> severe problemsSlight problems -> extreme problemsSlight problems -> no dataModerate problems -> no problemsModerate problems -> slight problemsModerate problems -> moderate problemsModerate problems -> severe problemsModerate problems -> extreme problemsModerate problems -> no dataSevere problems -> no problemsSevere problems -> slight problemsSevere problems -> moderate problemsSevere problems -> severe problemsSevere problems -> extreme problemsSevere problems -> no dataExtreme problems -> no problemsExtreme problems -> slight problemsExtreme problems -> moderate problemsExtreme problems -> severe problemsExtreme problems -> extreme problemsExtreme problems -> no dataNo data -> no problemsNo data -> slight problemsNo data -> moderate problemsNo data -> severe problemsNo data -> extreme problemsNo data -> no data
Mirabegron 50 mg44745232046647246013939507102024451610210000111008
Solifenacin 5 mg44343196138047113115145466011634291202110010110007

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Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 12

,
Interventionparticipants (Number)
No problems -> no problemsNo problems -> slight problemsNo problems -> moderate problemsNo problems -> severe problemsNo problems -> extreme problemsNo problems -> no dataSlight problems -> no problemsSlight problems -> slight problemsSlight problems -> moderate problemsSlight problems -> severe problemsSlight problems -> extreme problemsSlight problems -> no dataModerate problems -> no problemsModerate problems -> slight problemsModerate problems -> moderate problemsModerate problems -> severe problemsModerate problems -> extreme problemsModerate problems -> no dataSevere problems -> no problemsSevere problems -> slight problemsSevere problems -> moderate problemsSevere problems -> severe problemsSevere problems -> extreme problemsSevere problems -> no dataExtreme problems -> no problemsExtreme problems -> slight problemsExtreme problems -> moderate problemsExtreme problems -> severe problemsExtreme problems -> extreme problemsExtreme problems -> no dataNo data -> no problemsNo data -> slight problemsNo data -> moderate problemsNo data -> severe problemsNo data -> extreme problemsNo data -> no data
Mirabegron 50 mg4254314202710345123068141256083176913712101730001
Solifenacin 5 mg426457202210753910779311550940136507723101810000

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Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours

A micturition is any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. (NCT01638000)
Timeframe: Baseline and final visit (up to Week 12)

Interventionmicturitions (Least Squares Mean)
Mirabegron 50 mg-2.95
Solifenacin 5 mg-3.13

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Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment

A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. (NCT01638000)
Timeframe: Baseline and Week 4, Week 8, Week 12

,
Interventionnocturia episodes (Least Squares Mean)
Week 4 [N=877,871]Week 8 [N=850,844]Week 12 [N=831,828]
Mirabegron 50 mg-0.72-0.90-0.98
Solifenacin 5 mg-0.63-0.87-0.97

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Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment

The mean number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. (NCT01638000)
Timeframe: Baseline and Week 4, Week 8 , Week 12

,
Interventionpads (Least Squares Mean)
Week 4 [M=574,563]Week 8 [N=551,543]Week 12 [N=543,532]
Mirabegron 50 mg-1.80-2.10-2.14
Solifenacin 5 mg-1.82-2.14-2.20

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Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency

Urgency level was rated by the participant during the 3-day micturition diary period using the PPIUS 5-point categorical scale: 0. No urgency; 1. Mild urgency; 2. Moderate urgency; 3. Severe urgency; 4. Urgency incontinence. (NCT01638000)
Timeframe: Baseline and Week 4, Week 8, Week 12

,
Interventionunits on a scale (Least Squares Mean)
Week 4 [N=916,906]Week 8 [N=888,876]Week 12 [N=870,856]Final visit [N=920,910]
Mirabegron 50 mg-0.36-0.50-0.60-0.58
Solifenacin 5 mg-0.36-0.52-0.60-0.57

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Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours

An urgency episode is a sudden compelling desire to pass urine immediately followed by an incontinent event or the patient having to rush to the toilet and make it in time; severity recorded as 3 (severe urgency) or 4 (urgency incontinence) on the Patient Perception of the Intensity of Urgency Scale (PPIUS) validated scale. The mean number of urgency episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. (NCT01638000)
Timeframe: Baseline and Week 4, Week 8, Week 12

,
Interventionurgency episodes (Least Squares Mean)
Week 4 [N=915,905]Week 8 [N=887,875]Week 12 [N=869,855]Final Visit [N=919,909]
Mirabegron 50 mg-3.75-4.44-4.67-4.61
Solifenacin 5 mg-3.88-4.79-4.99-4.84

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Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours

An incontinence episode is any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. (NCT01638000)
Timeframe: Baseline and Week 4, Week 8, Week 12

,
Interventionincontinence episodes (Least Squares Mean)
Week 4 [N=404,410]Week 8 [N=387,397]Week 12 [N=381,387]
Mirabegron 50 mg-1.22-1.37-1.41
Solifenacin 5 mg-1.30-1.59-1.66

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Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours

(NCT01638000)
Timeframe: Baseline and Week 4, Week 8, Week 12

,
Interventionmicturitions (Least Squares Mean)
Week 4 [N=916,906]Week 8 [N=888,876]Week 12 [N=870,856]
Mirabegron 50 mg-2.37-2.77-3.02
Solifenacin 5 mg-2.33-3.00-3.21

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Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit

An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The total number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit. (NCT01638000)
Timeframe: Week 4, Week 8, Week 12

,
Interventionurgency incontinence episodes (Mean)
Week 4 [N=395,399]Week 8 [N=379,386]Week 12 [N=373,377]Final visit [N=395,402]
Mirabegron 50 mg2.271.741.441.51
Solifenacin 5 mg2.161.131.031.23

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Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours

An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The mean number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. (NCT01638000)
Timeframe: Baseline and Week 4, Week 8, Week 12

,
Interventionurgency incontinence episodes (Least Squares Mean)
Week 4 [N=395,399]Week 8 [N=379,386]Week 12 [N=373,377]
Mirabegron 50 mg-1.22-1.39-1.49
Solifenacin 5 mg-1.24-1.56-1.59

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Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and final visit (up to Week 12)

,
Interventionparticipants (Number)
No problems -> no problemsNo problems -> slight problemsNo problems -> moderate problemsNo problems -> severe problemsNo problems -> extreme problemsNo problems -> no dataSlight problems -> no problemsSlight problems -> slight problemsSlight problems -> moderate problemsSlight problems -> severe problemsSlight problems -> extreme problemsSlight problems -> no dataModerate problems -> no problemsModerate problems -> slight problemsModerate problems -> moderate problemsModerate problems -> severe problemsModerate problems -> extreme problemsModerate problems -> no dataSevere problems -> no problemsSevere problems -> slight problemsSevere problems -> moderate problemsSevere problems -> severe problemsSevere problems -> extreme problemsSevere problems -> no dataExtreme problems -> no problemsExtreme problems -> slight problemsExtreme problems -> moderate problemsExtreme problems -> severe problemsExtreme problems -> extreme problemsExtreme problems -> no dataNo data -> no problemsNo data -> slight problemsNo data -> moderate problemsNo data -> severe problemsNo data -> extreme problemsNo data -> no data
Mirabegron 50 mg3325511213133922640055522210203825812111063330910001
Solifenacin 5 mg356521020112183172106845296123518156031527330720000

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Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and final visit (up to Week 12)

,
Interventionparticipants (Number)
No problems -> no problemsNo problems -> slight problemsNo problems -> moderate problemsNo problems -> severe problemsNo problems -> extreme problemsNo problems -> no dataSlight problems -> no problemsSlight problems -> slight problemsSlight problems -> moderate problemsSlight problems -> severe problemsSlight problems -> extreme problemsSlight problems -> no dataModerate problems -> no problemsModerate problems -> slight problemsModerate problems -> moderate problemsModerate problems -> severe problemsModerate problems -> extreme problemsModerate problems -> no dataSevere problems -> no problemsSevere problems -> slight problemsSevere problems -> moderate problemsSevere problems -> severe problemsSevere problems -> extreme problemsSevere problems -> no dataExtreme problems -> no problemsExtreme problems -> slight problemsExtreme problems -> moderate problemsExtreme problems -> severe problemsExtreme problems -> extreme problemsExtreme problems -> no dataNo data -> no problemsNo data -> slight problemsNo data -> moderate problemsNo data -> severe problemsNo data -> extreme problemsNo data -> no data
Mirabegron 50 mg46037146138045162016033367005315172010210000253001
Solifenacin 5 mg47125125028834182016746314015217111102110010900000

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Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and final visit (up to Week 12)

,
Interventionparticipants (Number)
No problems -> no problemsNo problems -> slight problemsNo problems -> moderate problemsNo problems -> severe problemsNo problems -> extreme problemsNo problems -> no dataSlight problems -> no problemsSlight problems -> slight problemsSlight problems -> moderate problemsSlight problems -> severe problemsSlight problems -> extreme problemsSlight problems -> no dataModerate problems -> no problemsModerate problems -> slight problemsModerate problems -> moderate problemsModerate problems -> severe problemsModerate problems -> extreme problemsModerate problems -> no dataSevere problems -> no problemsSevere problems -> slight problemsSevere problems -> moderate problemsSevere problems -> severe problemsSevere problems -> extreme problemsSevere problems -> no dataExtreme problems -> no problemsExtreme problems -> slight problemsExtreme problems -> moderate problemsExtreme problems -> severe problemsExtreme problems -> extreme problemsExtreme problems -> no dataNo data -> no problemsNo data -> slight problemsNo data -> moderate problemsNo data -> severe problemsNo data -> extreme problemsNo data -> no data
Mirabegron 50 mg29755152021161033020180514810013916161520421110721001
Solifenacin 5 mg30652134031189320400837244721341415311523111540000

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Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and final visit (up to Week 12)

,
Interventionparticipants (Number)
No problems -> no problemsNo problems -> slight problemsNo problems -> moderate problemsNo problems -> severe problemsNo problems -> extreme problemsNo problems -> no dataSlight problems -> no problemsSlight problems -> slight problemsSlight problems -> moderate problemsSlight problems -> severe problemsSlight problems -> extreme problemsSlight problems -> no dataModerate problems -> no problemsModerate problems -> slight problemsModerate problems -> moderate problemsModerate problems -> severe problemsModerate problems -> extreme problemsModerate problems -> no dataSevere problems -> no problemsSevere problems -> slight problemsSevere problems -> moderate problemsSevere problems -> severe problemsSevere problems -> extreme problemsSevere problems -> no dataExtreme problems -> no problemsExtreme problems -> slight problemsExtreme problems -> moderate problemsExtreme problems -> severe problemsExtreme problems -> extreme problemsExtreme problems -> no dataNo data -> no problemsNo data -> slight problemsNo data -> moderate problemsNo data -> severe problemsNo data -> extreme dataNo data -> no data
Mirabegron 50 mg69727512443151510045861002540400510010820001
Solifenacin 5 mg6992661044314610046680002574101400001900000

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Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and final visit (up to Week 12)

,
Interventionparticipants (Number)
No problems -> no problemsNo problems -> slight problemsNo problems -> moderate problemsNo problems -> severe problemsNo problems -> extreme problemsNo problems -> no dataSlight problems -> no problemsSlight problems -> slight problemsSlight problems -> moderate problemsSlight problems -> severe problemsSlight problems -> extreme problemsSlight problems -> no dataModerate problems -> no problemsModerate problems -> slight problemsModerate problems -> moderate problemsModerate problems -> severe problemsModerate problems -> extreme problemsModerate problems -> no dataSevere problems -> no problemsSevere problems -> slight problemsSevere problems -> moderate problemsSevere problems -> severe problemsSevere problems -> extreme problemsSevere problems -> no dataExtreme problems -> no problemsExtreme problems -> slight problemExtreme problems -> moderate problemExtreme problems -> severe problemExtreme problems -> extreme problemExtreme problems -> no dataNo data -> no problemsNo data -> slight problemsNo data -> moderate problemsNo data -> severe problemsNo data -> extreme problemsNo data -> no data
Mirabegron 50 mg4444615204106451530083422970031961010712110730001
Solifenacin 5 mg44049820311354910079342060041148503723110810000

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Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS)

"The Treatment Satisfaction (TS)-Visual Analogue Scale (VAS) was a self-rated scale with the participant answering the question Are you satisfied with your treatment? and placing a vertical mark on a line from 0 (No, not at all) to 10 (Yes, completely)." (NCT01638000)
Timeframe: Baseline and Week 12

,
Interventionunits on a scale (Least Squares Mean)
Week 12 [N=865,857]Final visit [N=891,876]
Mirabegron 50 mg3.513.44
Solifenacin 5 mg3.933.86

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Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert Scale

"The Treatment Satisfaction (TS)-Likert Scale was a self-rated scale with the participant answering the question How satisfied were you with your treatment? with on a scale from 1 (extremely dissatisfied) to 7 (extremely satisfied)." (NCT01638000)
Timeframe: Baseline and Week 12

,
Interventionunits on a scale (Least Squares Mean)
Week 12 [N=876,871]Final visit [N=897,889]
Mirabegron 50 mg2.922.88
Solifenacin 5 mg3.073.03

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Number for Participants Who Achieved Normalization of the Number of Incontinence Episodes Per 24 Hours

Normalization for the mean number of incontinence episodes per 24 hours was defined as no incontinence episode per 24 hours. (NCT01745094)
Timeframe: Week 16

InterventionParticipants (Count of Participants)
Solifenacin 2.5 mg + Mirabegron 25 mg10
Solifenacin 2.5 mg + Mirabegron 50 mg21
Solifenacin 5 mg + Mirabegron 25 mg19
Solifenacin 5 mg + Mirabegron 50 mg46

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Change From Baseline in Postvoid Residual (PVR) Volume

Measurement of PVR volume was made using either ultrasonography or urethral catheterization, provided that the same method was used for the same participant throughout the study. (NCT01745094)
Timeframe: Baseline and week 4, 8, 12, 16

,,,
InterventionmL (Mean)
Week 4Week 8Week 12Week 16Week 16 (LOCF)
Solifenacin 2.5 mg + Mirabegron 25 mg-4.95-2.83-2.530.63-0.42
Solifenacin 2.5 mg + Mirabegron 50 mg5.885.075.293.963.96
Solifenacin 5 mg + Mirabegron 25 mg13.7811.056.517.318.00
Solifenacin 5 mg + Mirabegron 50 mg4.361.871.173.603.17

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Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

TEAEs were defined as AEs observed after the first administration of the study drugs for the treatment period. The investigator assessed the severity of AEs, including abnormal clinical laboratory values, Electrocardiogram (ECG), vital signs, as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator. (NCT01745094)
Timeframe: From first dose of study drug up to weeks 16

,,,
InterventionParticipants (Count of Participants)
Any TEAEsMildModerateSevereDrug-related TEAEsDeathsSerious TEAEsDrug-related Serious TEAEsTEAEs leading to permanent discontinuation (PD)Drug-related TEAEs leading to PD
Solifenacin 2.5 mg + Mirabegron 25 mg232210601000
Solifenacin 2.5 mg + Mirabegron 50 mg212010601000
Solifenacin 5 mg + Mirabegron 25 mg4240111205132
Solifenacin 5 mg + Mirabegron 50 mg6967202804011

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Number for Participants Who Achieved Normalization of the Number of Micturitions Per 24 Hours

Normalization for the mean number of micturitions per 24 hours was defined as < 8 micturitions per 24 hours. (NCT01745094)
Timeframe: Week 16

InterventionParticipants (Count of Participants)
Solifenacin 2.5 mg + Mirabegron 25 mg10
Solifenacin 2.5 mg + Mirabegron 50 mg17
Solifenacin 5 mg + Mirabegron 25 mg23
Solifenacin 5 mg + Mirabegron 50 mg40

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Number for Participants Who Achieved Normalization of the Number of Urgency Episodes Per 24 Hours

Normalization for the mean number of urgency episodes per 24 hours was defined as no urgency episode per 24 hours. (NCT01745094)
Timeframe: Week 16

InterventionParticipants (Count of Participants)
Solifenacin 2.5 mg + Mirabegron 25 mg16
Solifenacin 2.5 mg + Mirabegron 50 mg13
Solifenacin 5 mg + Mirabegron 25 mg31
Solifenacin 5 mg + Mirabegron 50 mg38

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Change From Baseline in OAB-q SF Total HRQL Score

The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the HRQL. The HRQL section included 13 questions. For each participant, the total HRQL score was derived as a sum of scores for Questions 7 to 19. The total score ranges from 13 to 78 with higher total HRQL score indicating greater HRQL. OAB-q SF data obtained at week 0 visit were used as baseline. (NCT01745094)
Timeframe: Baseline and week 8, 16

,,,
Interventionunits on a scale (Mean)
Week 8Week 16Week 16 (LOCF)
Solifenacin 2.5 mg + Mirabegron 25 mg15.1417.5417.34
Solifenacin 2.5 mg + Mirabegron 50 mg9.3116.7216.72
Solifenacin 5 mg + Mirabegron 25 mg12.4314.7213.88
Solifenacin 5 mg + Mirabegron 50 mg6.1412.7212.56

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Change From Baseline in OABSS Total Score

The OABSS questionnaire was a questionnaire completed by participants with 4 questions regarding their OAB symptoms. For each participant, the OABSS total score was calculated from the sum total of the score of each question. The total score ranges from 0 to 15 with higher score indicating more symptoms. The OABSS data obtained at week 0 were used as baseline. (NCT01745094)
Timeframe: Baseline and week 8, 16

,,,
Interventionunits on a scale (Mean)
Week 8Week 16Week 16 (LOCF)
Solifenacin 2.5 mg + Mirabegron 25 mg-3.5-3.5-3.4
Solifenacin 2.5 mg + Mirabegron 50 mg-2.1-3.9-3.9
Solifenacin 5 mg + Mirabegron 25 mg-3.5-3.6-3.6
Solifenacin 5 mg + Mirabegron 50 mg-2.5-4.0-4.0

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Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Severity Score

The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the Health-related Quality of Life (HRQL). The Severity Symptom section included 6 questions. For each participant, the symptom severity score was derived as a sum of scores for Questions 1 to 6. The total score ranges from 6 to 36 with higher symptom severity score indicating greater symptom bother. OAB-q SF data obtained at week 0 visit were used as baseline. (NCT01745094)
Timeframe: Baseline and week 8, 16

,,,
Interventionunits on a scale (Mean)
Week 8Week 16Week 16 (LOCF)
Solifenacin 2.5 mg + Mirabegron 25 mg-19.46-21.00-21.21
Solifenacin 2.5 mg + Mirabegron 50 mg-12.52-22.25-22.25
Solifenacin 5 mg + Mirabegron 25 mg-15.29-17.68-17.55
Solifenacin 5 mg + Mirabegron 50 mg-10.39-16.56-16.31

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Number of Participants Who Achieved Normalization for OABSS Total Score

Normalization for OABSS Total Score was defined as OABSS total score ≤ 2 or OABSS Question 3 score ≤ 1. (NCT01745094)
Timeframe: Week 8 and 16

,,,
InterventionParticipants (Count of Participants)
Week 8Week 16Week 16 (LOCF)
Solifenacin 2.5 mg + Mirabegron 25 mg191819
Solifenacin 2.5 mg + Mirabegron 50 mg81616
Solifenacin 5 mg + Mirabegron 25 mg282729
Solifenacin 5 mg + Mirabegron 50 mg264849

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Change From Baseline in the Number of Incontinence Episodes Per 24 Hours

"Participants completed the patient diary (paper document) for 3 days immediately before each visit. An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urinary incontinence' was indicated, divided by the number of days on which episodes were recorded. Only participants who had an incontinence episode at baseline was included in the analysis." (NCT01745094)
Timeframe: Baseline and week 4, 8, 12, 16

,,,
Interventionincontinence episodes (Mean)
Week 4Week 8Week 12Week 16Week 16 (LOCF)
Solifenacin 2.5 mg + Mirabegron 25 mg-0.85-1.06-1.31-1.22-1.07
Solifenacin 2.5 mg + Mirabegron 50 mg-0.55-0.73-1.04-1.08-1.08
Solifenacin 5 mg + Mirabegron 25 mg-1.12-1.26-1.03-1.32-1.32
Solifenacin 5 mg + Mirabegron 50 mg-0.64-0.76-0.93-1.08-1.06

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Change From Baseline in the Number of Micturitions Per 24 Hours

"Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean number of micturitions per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urinated was indicated, divided by the number of days on which episodes were recorded." (NCT01745094)
Timeframe: Baseline and week 4, 8, 12, 16

,,,
Interventionmicturitions (Mean)
Week 4Week 8Week 12Week 16Week 16 (LOCF)
Solifenacin 2.5 mg + Mirabegron 25 mg-0.34-1.69-1.98-2.06-1.89
Solifenacin 2.5 mg + Mirabegron 50 mg-0.98-1.31-2.40-2.36-2.36
Solifenacin 5 mg + Mirabegron 25 mg-1.33-1.74-1.50-1.90-1.94
Solifenacin 5 mg + Mirabegron 50 mg-1.02-1.32-1.75-2.13-2.12

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Change From Baseline in the Number of Nocturia Episodes Per Night

"Participants completed the patient diary (paper document) for 3 days immediately before each visit. A nocturia episode was defined as waking at night 1 or more times to void. Night time was defined as the period between bedtime and the wake-up time the following day (micturitions at the same time as the wake-up time were excluded). The mean number of nocturia episodes per night was calculated by taking the sum of nocturia episodes in the patient diary where the variable urinated was indicated during the night time, divided by the number of nights. Only participants who had a nocturia episode at baseline was included in the analysis." (NCT01745094)
Timeframe: Baseline and week 4, 8, 12, 16

,,,
Interventionnocturia episodes (Mean)
Week 4Week 8Week 12Week 16Week 16 (LOCF)
Solifenacin 2.5 mg + Mirabegron 25 mg0.17-0.38-0.35-0.38-0.43
Solifenacin 2.5 mg + Mirabegron 50 mg-0.07-0.21-0.48-0.31-0.31
Solifenacin 5 mg + Mirabegron 25 mg-0.45-0.37-0.29-0.44-0.44
Solifenacin 5 mg + Mirabegron 50 mg-0.27-0.44-0.58-0.61-0.60

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Change From Baseline in the Number of Urge Incontinence Episodes Per 24 Hours

"Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urge incontinence episode was defined as any episode when both urgency and incontinence occurred concurrently. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urgency and urinary incontinence' were indicated, divided by the number of days on which episodes were recorded. Only participants who had an urge incontinence episode at baseline was included in the analysis." (NCT01745094)
Timeframe: Baseline and week 4, 8, 12, 16

,,,
Interventionurge incontinence episodes (Mean)
Week 4Week 8Week 12Week 16Week 16 (LOCF)
Solifenacin 2.5 mg + Mirabegron 25 mg-0.87-1.17-1.30-1.07-0.97
Solifenacin 2.5 mg + Mirabegron 50 mg-0.50-0.65-0.94-1.00-1.00
Solifenacin 5 mg + Mirabegron 25 mg-0.77-1.07-0.84-1.11-1.04
Solifenacin 5 mg + Mirabegron 50 mg-0.82-0.72-0.91-0.96-0.94

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Change From Baseline in the Number of Urgency Episodes Per 24 Hours

"Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urgency episode was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urgency was indicated, divided by the number of days on which episodes were recorded. Only participants who had an urgency episode at baseline was included in the analysis." (NCT01745094)
Timeframe: Baseline and week 4, 8, 12, 16

,,,
Interventionurgency episodes (Mean)
Week 4Week 8Week 12Week 16Week 16 (LOCF)
Solifenacin 2.5 mg + Mirabegron 25 mg-1.15-1.77-1.95-1.77-1.57
Solifenacin 2.5 mg + Mirabegron 50 mg-1.26-1.49-2.55-2.59-2.59
Solifenacin 5 mg + Mirabegron 25 mg-1.45-1.76-1.89-1.93-1.93
Solifenacin 5 mg + Mirabegron 50 mg-1.43-1.37-1.88-2.06-2.02

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Change From Baseline in the Volume Voided Per Micturition

"Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean volume per micturition was calculated by taking the sum of the urinary volumes where the volume voided was > 0 and where urinary incontinence was not indicated in the patient diary, divided by the number of micturitions where the volume voided was > 0 and where urinary incontinence was not indicated. Only participants who had volume voided was > 0 at baseline was included in the analysis." (NCT01745094)
Timeframe: Baseline and week 8, 16

,,,
InterventionmL (Mean)
Week 8Week16Week 16 (LOCF)
Solifenacin 2.5 mg + Mirabegron 25 mg22.12028.53229.865
Solifenacin 2.5 mg + Mirabegron 50 mg19.38033.03133.031
Solifenacin 5 mg + Mirabegron 25 mg33.78135.78034.118
Solifenacin 5 mg + Mirabegron 50 mg24.82136.92136.957

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BAT Activity as Measured by 18F-FDG PET/CT

difference in BAT metabolic activity measured in placebo and active drug arms. The BAT metabolic activity represents the amount of FDG tracer retained within the tissue. Retained FDG is a biomarker for tissue oxygen consumption and hence energy expenditure by the tissue. (NCT01783470)
Timeframe: 60 min after FDG administration

InterventionmL*SUVmean*g/mL (Median)
Placebo0.92
beta3-adrenergic Receptor (AR)132

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Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score

The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). Symptom Bother score ranges from 0 (least severity) to 100 (worst severity). (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12

,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12EoT
Combination (Solifenacin + Mirabegron)-16.68-22.86-27.90-26.89
Solifenacin 10 mg-15.82-19.34-24.09-23.59
Solifenacin 5 mg-13.79-18.36-22.31-21.93

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Change From Baseline in Patient Perception Bladder Control (PPBC) Score

The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. PPBC score: 1-no problem, 2- some very minor problems, 3-some minor problems, 4-moderate problems, 5-severe problems, 6-many severe problems. (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12

,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12EoT
Combination (Solifenacin + Mirabegron)-0.9-1.2-1.5-1.5
Solifenacin 10 mg-0.7-1.0-1.3-1.3
Solifenacin 5 mg-0.6-1.0-1.2-1.2

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Change From Baseline in Post Void Residual (PVR) Volume

PVR Volume was assessed by bladder scan. (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12

,,
InterventionmL (Mean)
Week 4Week 8Week 12EoT
Combination (Solifenacin + Mirabegron)1.5452.2456.3565.478
Solifenacin 10 mg7.3087.2326.5527.354
Solifenacin 5 mg2.8211.1172.3373.046

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Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score

The TS-VAS rated participant satisfaction with treatment on a scale from 0 (No, not at all) to 10 (Yes, completely). (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12

,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12EoT
Combination (Solifenacin + Mirabegron)1.21.51.91.8
Solifenacin 10 mg1.11.31.61.6
Solifenacin 5 mg0.81.21.41.4

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Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours

The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12

,,
Interventionincontinence episodes (Least Squares Mean)
Week 4Week 8Week 12
Combination (Solifenacin + Mirabegron)-1.24-1.68-1.81
Solifenacin 10 mg-1.12-1.49-1.67
Solifenacin 5 mg-0.91-1.29-1.57

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Number of Incontinence Episodes Reported During the 3-Day Diary

The number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from total number of incontinence episodes on valid diary days recorded during the 3-day micturition diary period. (NCT01908829)
Timeframe: Weeks 4, 8 and 12

,,
Interventionincontinence episodes (Mean)
Week 4Week 8Week 12EoT
Combination (Solifenacin + Mirabegron)5.814.554.034.25
Solifenacin 10 mg6.415.284.624.72
Solifenacin 5 mg6.685.434.564.87

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Number of Nocturia Episodes Reported Over 3-Day Diary

The number of nocturia episodes was defined as the number of times a participant urinated (excluding incontinence only episodes) during sleeping time during the 3-day micturition diary period. This was calculated using the sum of each nocturia episode recorded on valid diary days during the 3-day micturition diary period. (NCT01908829)
Timeframe: Weeks 4, 8 and 12

,,
Interventionnocturia episodes (Mean)
Week 4Week 8Week 12EoT
Combination (Solifenacin + Mirabegron)3.633.333.123.16
Solifenacin 10 mg3.583.323.233.19
Solifenacin 5 mg3.593.353.263.28

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Number of Pads Used During the 3-Day Diary

The number of pads used was defined as the number of times a participant recorded a new pad used during the 3-day micturition diary period. This was calculated using the sum of each record with new pad checked. Only records with new pad checked on a valid diary day were counted. (NCT01908829)
Timeframe: Weeks 4, 8 and 12

,,
Interventionpads (Mean)
Week 4Week 8Week 12EoT
Combination (Solifenacin + Mirabegron)4.803.643.233.29
Solifenacin 10 mg5.414.504.074.17
Solifenacin 5 mg5.694.714.134.27

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Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC)

The PGIC was a 2-part questionnaire, assessing both the change in the participant's overall condition (Patient Impression in General Health (PIBS)) and change in bladder condition since the start of the study (Patient Impression in General Health (PIGH)) (from very much worse to very much improved). The CGIC was a single questionnaire assessing the participant's change in bladder condition since the beginning of the study (Clinician Impression in Bladder Symptoms (CIBS)). (NCT01908829)
Timeframe: End of treatment (up to 12 weeks)

,,
Interventionparticipants (Number)
PIBS Very Much ImprovedPIBS Much ImprovedPIBS Minimally ImprovedPIBS No ChangePIBS Minimally WorsePIBS Much WorsePIBS Very Much WorsePIGH Very Much ImprovedPIGH Much ImprovedPIGH Minimally ImprovedPIGH No ChangePIGH Minimally WorsePIGH Much WorsePIGH Very Much WorseCIBS Very Much ImprovedCIBS Much ImprovedCIBS Minimally ImprovedCIBS No ChangeCIBS Minimally WorseCIBS Much WorseCIBS Very Much Worse
Combination (Solifenacin + Mirabegron)22725713525740144239143113141118431114123443
Solifenacin 10 mg17128415256461108244146160104214132915540554
Solifenacin 5 mg152264170551141104236147142234111831616456833

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Number of Participants With Adverse Events (AEs)

AE was defined as any untoward medical occurrence in a participant administered a study drug or has undergone study procedures & which does not necessarily have a causal relationship with this treatment. Treatment-Emergent Adverse Event (TEAE) referred to an adverse event which started or worsened in the period from first double-blind medication intake until 30 days after the last double-blind medication intake. (NCT01908829)
Timeframe: From first dose of double blind treatment until 30 days after last dose (up to 16 weeks)

,,
InterventionParticipants (Count of Participants)
AEsDrug-related AEsSerious Adverse Events (SAEs)Drug-related SAEsAEs Leading to Perm. Disc. of Study DrugDrug-related AEs Leading to Perm. Disc. of DrugDeaths
Combination (Solifenacin + Mirabegron)2601411311190
Solifenacin 10 mg2831611531190
Solifenacin 5 mg24112510011100

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Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression

The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity. (NCT01908829)
Timeframe: Baseline and EoT (up to 12 weeks)

,,
Interventionparticipants (Number)
Not anxious -> not anxiousNot anxious -> slightly anxiousNot anxious -> moderately anxiousNot anxious -> severely anxiousNot anxious-> extremely anxiousNot anxious -> no dataSlightly anxious -> not anxiousSlightly anxious -> slightly anxiousSlightly anxious -> moderately anxiousSlightly anxious -> severely anxiousSlightly anxious -> extremely anxiousSlightly anxious -> no dataModerately anxious -> not anxiousModerately anxious -> slightly anxiousModerately anxious -> moderately anxiousModerately anxious -> severely anxiousModerately anxious -> extremely anxiousModerately anxious -> no dataSeverely anxious -> not anxiousSeverely anxious -> slightly anxiousSeverely anxious -> moderately anxiousSeverely anxious -> severely anxiousSeverely anxious -> extremely anxiousSeverely anxious -> no dataExtremely anxious -> not anxiousExtremely anxious -> slightly anxiousExtremely anxious -> moderately anxiousExtremely anxious -> severely anxiousExtremely anxious -> extremely anxiousExtremely anxious -> no dataNo data -> not anxiousNo data -> slightly anxiousNo data -> moderately anxiousNo data -> severely anxiousNo data -> extremely anxiousNo data -> no data
Combination (Solifenacin + Mirabegron)322431120410756131013636223001096500124411501001
Solifenacin 10 mg307431530390692320234331711085117001131101151000
Solifenacin 5 mg30039172039960112023840267308568304121201321000

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Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort

The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity. (NCT01908829)
Timeframe: Baseline and EoT (up to 12 weeks)

,,
Interventionparticipants (Number)
No pain -> no painNo pain -> slight painNo pain -> moderate painNo pain -> severe painNo pain -> extreme painNo pain -> no dataSlight pain -> no painSlight pain -> slight painSlight pain -> moderate painSlight pain -> severe painSlight pain -> extreme painSlight pain -> no dataModerate pain -> no painModerate pain -> slight painModerate pain -> moderate painModerate pain -> severe painModerate pain -> extreme painModerate pain -> no dataSevere pain -> no painSevere pain -> slight painSevere pain -> moderate painSevere pain -> severe painSevere pain -> extreme painSevere pain -> no dataExtreme pain -> no painExtreme pain -> slight painExtreme pain -> moderate painExtreme pain -> severe painExtreme pain -> extreme painExtreme pain -> no dataNo data -> no painNo data -> slight painNo data -> moderate painNo data -> severe painNo data -> extreme painNo data -> no data
Combination (Solifenacin + Mirabegron)2994512304795828010393734702712111000401610411001
Solifenacin 10 mg2835117213815531502213939800104169100111001142000
Solifenacin 5 mg29062149048264172203636304114716410110100835000

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Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care

The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity. (NCT01908829)
Timeframe: Baseline and EoT (up to 12 weeks)

,,
Interventionparticipants (Number)
No problems -> no problemsNo problems -> slight problemsNo problems -> moderate problemsNo problems -> severe problemsNo problems -> extreme problemsNo problems -> no dataSlight problems -> no problemsSlight problems -> slight problemsSlight problems -> moderate problemsSlight problems -> severe problemsSlight problems -> extreme problemsSlight problems -> no dataModerate problems -> no problemsModerate problems -> slight problemsModerate problems -> moderate problemsModerate problems -> severe problemsModerate problems -> extreme problemsModerate problems -> no dataSevere problems -> no problemsSevere problems -> slight problemsSevere problems -> moderate problemsSevere problems -> severe problemsSevere problems -> extreme problemsSevere problems -> no dataExtreme problems -> no problemsExtreme problems -> slight problemsExtreme problems -> moderate problemsExtreme problems -> severe problemsExtreme problems -> extreme problemsExtreme problems -> no dataNo data -> no problemsNo data -> slight problemsNo data -> moderate problemsNo data -> severe problemsNo data -> extreme problemsNo data -> no data
Combination (Solifenacin + Mirabegron)5482803063723910012911000722100000100600001
Solifenacin 10 mg5482572043222900175122000221000000001700000
Solifenacin 5 mg54126140052524700016972005214000100001420000

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Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities

The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity. (NCT01908829)
Timeframe: Baseline and EoT (up to 12 weeks)

,,
Interventionparticipants (Number)
No problems -> no problemsNo problems -> slight problemsNo problems -> moderate problemsNo problems -> severe problemsNo problems -> extreme problemsNo problems -> no dataSlight problems -> no problemsSlight problems -> slight problemsSlight problems -> moderate problemsSlight problems -> severe problemsSlight problems -> extreme problemsSlight problems -> no dataModerate problems -> no problemsModerate problems -> slight problemsModerate problems -> moderate problemsModerate problems -> severe problemsModerate problems -> extreme problemsModerate problems -> no dataSevere problems -> no problemsSevere problems -> slight problemsSevere problems -> moderate problemsSevere problems -> severe problemsSevere problems -> extreme problemsSevere problems -> no dataExtreme problems -> no problemsExtreme problems -> slight problemsExtreme problems -> moderate problemsExtreme problems -> severe problemsExtreme problems -> extreme problemsExtreme problems -> no dataNo data -> no problemsNo data -> slight problemsNo data -> moderate problemsNo data -> severe problemsNo data -> extreme problemsNo data -> no data
Combination (Solifenacin + Mirabegron)3973812104754612100292222312977500213100510001
Solifenacin 10 mg379421111378371530225282140012199000000001511000
Solifenacin 5 mg38430194038145161113520183018567000010001141000

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Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility

The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity. (NCT01908829)
Timeframe: Baseline and EoT (up to 12 weeks)

,,
Interventionparticipants (Number)
No problems -> no problemsNo problems -> slight problemsNo problems -> moderate problemsNo problems -> severe problemsNo problems -> extreme problemsNo problems -> no dataSlight problems -> no problemsSlight problems -> slight problemsSlight problems -> moderate problemsSlight problems -> severe problemsSlight problems -> extreme problemsSlight problems -> no dataModerate problems -> no problemsModerate problems -> slight problemsModerate problems -> moderate problemsModerate problems -> severe problemsModerate problems -> extreme problemsModerate problems -> no dataSevere problems -> no problemsSevere problems -> slight problemsSevere problems -> moderate problemsSevere problems -> severe problemsSevere problems -> extreme problemsSevere problems -> no dataExtreme problems -> no problemsExtreme problems -> slight problemsExtreme problems -> moderate problemsExtreme problems -> severe problemsExtreme problems -> extreme problemsExtreme problems -> no dataNo data -> no problemsNo data -> slight problemsNo data -> moderate problemsNo data -> severe problemsNo data -> extreme problemsNo data -> no data
Combination (Solifenacin + Mirabegron)409331400252431510224252820176171201311100420001
Solifenacin 10 mg3743611405604016300252340700271114002010001313000
Solifenacin 5 mg370351171458462830036182831087111001201000943000

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Number of UI Episodes Reported During the 3-Day Diary

Number of UI episodes was calculated using the number of UI episodes recorded on valid diary days during the 3-day micturition diary period. NOTE: Only urgency incontinence episodes recorded on a valid diary day were counted. (NCT01908829)
Timeframe: Weeks 4, 8 and 12

,,
InterventionUI episodes (Mean)
Week 4Week 8Week 12EoT
Combination (Solifenacin + Mirabegron)4.963.553.103.33
Solifenacin 10 mg5.504.503.913.96
Solifenacin 5 mg5.864.763.784.00

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Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline

Micturitions were defined as voluntary urinations (excluding incontinence only episodes). (NCT01908829)
Timeframe: Weeks 4, 8 and 12

,,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12EoT
Combination (Solifenacin + Mirabegron)21.028.131.430.2
Solifenacin 10 mg20.226.328.027.7
Solifenacin 5 mg18.722.424.825.0

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Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC

The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. (NCT01908829)
Timeframe: Weeks 4, 8 and 12

,,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12EoT
Combination (Solifenacin + Mirabegron)61.170.177.976.5
Solifenacin 10 mg56.364.672.771.9
Solifenacin 5 mg52.162.170.469.5

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Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score

HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life). (NCT01908829)
Timeframe: Weeks 4, 8 and 12

,,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12EoT
Combination (Solifenacin + Mirabegron)52.663.670.568.6
Solifenacin 10 mg48.153.860.460.1
Solifenacin 5 mg44.554.860.860.6

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Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score

The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). Symptom Bother score ranges from 0 (least severity) to 100 (worst severity). (NCT01908829)
Timeframe: Weeks 4, 8 and 12

,,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12EoT
Combination (Solifenacin + Mirabegron)67.977.283.581.7
Solifenacin 10 mg61.969.175.474.6
Solifenacin 5 mg58.266.472.171.7

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Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC

The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. (NCT01908829)
Timeframe: Weeks 4, 8 and 12

,,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12EoT
Combination (Solifenacin + Mirabegron)26.639.551.849.8
Solifenacin 10 mg21.631.843.843.2
Solifenacin 5 mg21.631.539.839.1

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Percentage of Participants With Zero Incontinence Episodes Postbaseline

Incontinence was defined as any involuntary leakage of urine. (NCT01908829)
Timeframe: Weeks 4, 8 and 12

,,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12EoT
Combination (Solifenacin + Mirabegron)23.540.447.346.0
Solifenacin 10 mg22.134.340.740.2
Solifenacin 5 mg20.031.639.537.9

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Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours

Incontinence was defined as any involuntary leakage of urine. (NCT01908829)
Timeframe: Weeks 4, 8 and 12

,,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12EoT
Combination (Solifenacin + Mirabegron)52.566.972.471.2
Solifenacin 10 mg49.061.866.966.6
Solifenacin 5 mg43.357.664.063.1

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Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours

The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. The analysis population consisted of the Full Analysis Set (FAS) which comprised of all the Randomized Analysis Set's (RAS) participants who met the following criteria: took at least 1 dose of double-blind study drug after randomization, reported at least 1 micturition in the baseline diary & at least 1 micturition postbaseline & reported at least 1 incontinence episode in the baseline diary. For participants who withdrew before EoT (week 12) and have no measurement available for that diary period, the Last Observation Carried Forward (LOCF) value during the double-blind study period was used as EoT value to derive the primary variable. (NCT01908829)
Timeframe: Baseline and end of treatment (up to 12 weeks)

Interventionincontinence episodes (Least Squares Mean)
Combination (Solifenacin + Mirabegron)-1.8
Solifenacin 5 mg-1.53
Solifenacin 10 mg-1.67

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Change From Baseline to EoT in Corrected Micturition Frequency (CMF)

CMF was defined as the mean number of micturitions per 24 hours that participants would have at EoT if their fluid intake had remained unchanged since baseline. This was calculated by the MVV per Micturition at baseline multiplied by the mean number of micturitions per 24 hours at baseline divided by the MVV per micturition at EoT. (NCT01908829)
Timeframe: Baseline and EoT (up to 12 weeks)

Interventionmicturitions (Least Squares Mean)
Combination (Solifenacin + Mirabegron)-0.96
Solifenacin 5 mg-0.52
Solifenacin 10 mg-0.71

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Change From Baseline in Mean Number of Micturitions Per 24 Hours

The average number of micturitions (voluntary urinations (excluding incontinence only episodes)) per 24 hours was derived from number of micturitions recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period (excluding incontinence only episodes). (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12

,,
Interventionmicturitions (Least Squares Mean)
Week 4Week 8Week 12EoT
Combination (Solifenacin + Mirabegron)-0.95-1.36-1.63-1.59
Solifenacin 10 mg-0.79-1.00-1.11-1.12
Solifenacin 5 mg-0.69-0.94-1.16-1.14

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Change From Baseline in Mean Number of Nocturia Episodes

Mean number of nocturia episodes was defined as the number of times a participant urinated (excluding incontinence only episodes) while sleeping during the 3-day diary period, divided by the number of valid diary days during the diary period. Night time episode of incontinence only was not considered a nocturia episode. Nocturia episodes were counted for each micturition record which occurred between the date/time of going to bed with intention to sleep and the date/time of getting up with intention to stay awake on a valid diary day & which was accompanied by a sleep interruption. Nocturia only determined for those who were not night-shift workers. (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12

,,
Interventionnocturia episodes (Least Squares Mean)
Week 4Week 8Week 12EoT
Combination (Solifenacin + Mirabegron)-0.28-0.37-0.46-0.43
Solifenacin 10 mg-0.29-0.37-0.41-0.41
Solifenacin 5 mg-0.27-0.35-0.38-0.37

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Change From Baseline in Mean Number of Pads Per 24 Hours

The mean number of pads per 24 hours was defined as the average number of times a participant recorded a new pad used per day during the 3-day micturition diary period. This was calculated using the number of new pads used during valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12

,,
Interventionpads (Least Squares Mean)
Week 4Week 8Week 12EoT
Combination (Solifenacin + Mirabegron)-1.12-1.50-1.65-1.66
Solifenacin 10 mg-1.04-1.36-1.43-1.43
Solifenacin 5 mg-0.86-1.17-1.38-1.35

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Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours

An urgency episode was defined as the complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes (severity of 3 or 4) per 24 hours was defined as the average number of times a participant recorded an urgency episode (severity of 3 or 4) with or without incontinence per day during the 3-day micturition diary period. Measured using the PPIUS scale. This was calculated using the sum of each record with an urgency episode (severity of 3 or 4) recorded on a valid diary day divided by the number of valid diary days during the 3-day micturition diary period. (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12

,,
Interventionurgency episodes (Least Squares Mean)
Week 4Week 8Week 12EoT
Combination (Solifenacin + Mirabegron)-1.84-2.64-2.97-2.95
Solifenacin 10 mg-1.74-2.29-2.55-2.54
Solifenacin 5 mg-1.39-2.00-2.44-2.41

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Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours

UI was defined as the complaint of involuntary urine leakage accompanied by or immediately preceded by urgency. UI was measured using the Patient Perception of Intensity of Urgency Scale (PPIUS), a patient reported outcome validated 5-point categorical scale rating the degree of associated urinary urgency severity (0=No urgency, I felt no need to empty my bladder, but did so for other reasons. 1=Mild, I could postpone voiding as long as necessary, without fear of wetting myself. 2= Moderate, I could postpone voiding for a short while, without fear of wetting myself. 3=Severe, I could not postpone voiding, but had to rush to the toilet in order not to wet myself. 4=Urgency incontinence, I leaked before arriving to the toilet). One urgency incontinence episode was counted for each record of the diary in which the following occurred: incontinence episode or 'both' was recorded & severity of urinary urgency recorded was 3 or 4. (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12

,,
InterventionUI episodes (Least Squares Mean)
Week 4Week 8Week 12EoT
Combination (Solifenacin + Mirabegron)-1.26-1.70-1.84-1.82
Solifenacin 10 mg-1.14-1.45-1.62-1.63
Solifenacin 5 mg-0.91-1.25-1.58-1.54

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Change From Baseline in Mean Volume Voided (MVV) Per Micturition

MVV per micturition was defined as MVV (mL) per micturition during last 3 days of the 3-day micturition diary period. MVV per micturition was calculated as the sum of each volume voided for each record with volume voided > 0 on valid diary days divided by the total number of records with a volume voided > 0 on valid diary days during the 3-day micturition diary period. (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12

,,
InterventionmL (Least Squares Mean)
Week 4Week 8Week 12EoT
Combination (Solifenacin + Mirabegron)15.0625.2129.5428.05
Solifenacin 10 mg14.9921.0820.9920.30
Solifenacin 5 mg11.2014.0217.1616.52

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Change From Baseline in OAB-q HRQL Subscale Score: Concern

The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life). (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12

,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12Week EoT
Combination (Solifenacin + Mirabegron)13.7918.8722.8522.28
Solifenacin 10 mg13.8215.8819.6719.28
Solifenacin 5 mg11.8516.3619.2419.00

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Change From Baseline in OAB-q HRQL Subscale Score: Coping

The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life). (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12

,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12EoT
Combination (Solifenacin + Mirabegron)15.1720.8225.1624.48
Solifenacin 10 mg14.2516.8720.2019.90
Solifenacin 5 mg12.2717.4720.4520.19

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Change From Baseline in OAB-q HRQL Subscale Score: Sleep

The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life). (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12

,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12Week EoT
Combination (Solifenacin + Mirabegron)11.5816.1820.0019.16
Solifenacin 10 mg11.1613.7216.8416.55
Solifenacin 5 mg11.0414.5717.7417.30

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Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction

The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life). (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12

,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12EoT
Combination (Solifenacin + Mirabegron)9.5811.9314.7014.39
Solifenacin 10 mg8.9510.1611.9811.72
Solifenacin 5 mg7.8510.8412.0811.91

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Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment

(NCT01972841)
Timeframe: Baseline and week 12 and EoT (up to 12 weeks)

,,,,,
Interventionpercentage of activity impairment (Mean)
Week 12End of treatment
Mirabegron 25 mg-16.89-16.72
Mirabegron 50 mg-14.99-15.05
Placebo-11.49-11.55
Solifenacin 5 mg-16.19-16.05
Solifenacin 5 mg + Mirabegron 25 mg-19.60-19.45
Solifenacin 5 mg + Mirabegron 50 mg-18.92-18.76

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Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working

(NCT01972841)
Timeframe: Baseline and week 12 and EoT (up to 12 weeks)

,,,,,
Interventionpercentage of impairment while working (Mean)
Week 12End of treatment
Mirabegron 25 mg-14.96-14.96
Mirabegron 50 mg-12.25-12.37
Placebo-11.27-11.18
Solifenacin 5 mg-10.85-10.98
Solifenacin 5 mg + Mirabegron 25 mg-14.69-14.58
Solifenacin 5 mg + Mirabegron 50 mg-13.07-12.87

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Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment

(NCT01972841)
Timeframe: Baseline and week 12 and EoT (up to 12 weeks)

,,,,,
Interventionpercentage of overall work impairment (Mean)
Week 12End of treatment
Mirabegron 25 mg-15.70-15.70
Mirabegron 50 mg-12.92-13.05
Placebo-12.23-12.14
Solifenacin 5 mg-12.31-12.42
Solifenacin 5 mg + Mirabegron 25 mg-16.31-16.07
Solifenacin 5 mg + Mirabegron 50 mg-13.97-13.76

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Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference

Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

,,,,,
InterventionnnHg (Least Squares Mean)
Week 4Week 12End of treatment
Mirabegron 25 mg-1.080.150.27
Mirabegron 50 mg-0.20-1.90-0.96
Placebo-0.760.530.87
Solifenacin 5 mg-1.60-0.66-1.67
Solifenacin 5 mg + Mirabegron 25 mg0.39-1.24-0.98
Solifenacin 5 mg + Mirabegron 50 mg-0.560.460.52

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Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)

Vital signs (blood pressure and pulse rate) were monitored using ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

,,,,,
InterventionmmHg (Least Squares Mean)
Week 4: 24-hour meanWeek 4: mean daytimeWeek 4: mean nighttimeWeek 12: 24-hour meanWeek 12: mean daytimeWeek 12: mean nighttimeEnd of treatment: 24-hour meanEnd of treatment: mean daytimeEnd of treatment: mean nighttime
Mirabegron 25 mg-0.86-0.36-0.97-0.93-0.54-1.39-1.41-0.98-2.00
Mirabegron 50 mg0.22-0.330.40-0.19-0.40-0.03-0.11-0.690.08
Placebo-0.70-1.25-0.12-0.80-0.85-0.49-0.96-1.17-0.41
Solifenacin 5 mg0.25-0.770.480.43-0.330.920.05-0.790.71
Solifenacin 5 mg + Mirabegron 25 mg0.03-0.400.93-0.37-0.060.23-0.02-0.180.56
Solifenacin 5 mg + Mirabegron 50 mg0.380.070.470.31-0.180.490.25-0.360.61

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Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)

Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

,,,,,
Interventionbeats per minute (bpm) (Least Squares Mean)
Week 4: 24-hour meanWeek 4: mean daytimeWeek 4: mean nighttimeWeek 12: 24-hour meanWeek 12: mean daytimeWeek 12: mean nighttimeEnd of treatment: 24-hour meanEnd of treatment: mean daytimeEnd of treatment: mean nighttime
Mirabegron 25 mg1.141.190.980.380.250.210.630.370.82
Mirabegron 50 mg2.323.521.771.192.120.191.672.640.75
Placebo-0.83-0.70-0.720.700.890.340.410.450.39
Solifenacin 5 mg0.360.371.090.12-0.130.060.02-0.070.45
Solifenacin 5 mg + Mirabegron 25 mg0.40-0.050.860.940.840.760.850.321.21
Solifenacin 5 mg + Mirabegron 50 mg0.690.610.861.441.361.521.521.241.64

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Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)

Vital signs (blood pressure and pulse rate) were monitored using an ambulatory blood pressure monitoring (ABPM) device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

,,,,,
InterventionmmHg (Least Squares Mean)
Week 4: 24-hour meanWeek 4: mean daytimeWeek 4: mean nighttimeWeek 12: 24-hour meanWeek 12: mean daytimeWeek 12: mean nighttimeEnd of treatment: 24-hour meanEnd of treatment: mean daytimeEnd of treatment: mean nighttime
Mirabegron 25 mg-2.04-1.19-1.14-2.70-2.53-2.81-3.44-3.29-3.48
Mirabegron 50 mg0.96-0.671.42-1.75-2.14-0.77-1.14-1.92-0.60
Placebo-1.00-1.55-0.51-1.97-2.22-1.03-1.73-2.01-1.00
Solifenacin 5 mg1.03-1.130.410.40-2.091.310.37-2.171.42
Solifenacin 5 mg + Mirabegron 25 mg-0.85-1.631.14-0.71-0.390.11-0.52-0.680.41
Solifenacin 5 mg + Mirabegron 50 mg0.31-0.530.540.40-0.710.79-0.08-1.280.91

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Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window

Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

,,,,,
InterventionmmHg (Least Squares Mean)
Week 4Week 12End of treatment
Mirabegron 25 mg0.09-0.45-0.71
Mirabegron 50 mg-0.65-0.31-0.71
Placebo-1.24-1.74-1.85
Solifenacin 5 mg-0.48-1.49-1.22
Solifenacin 5 mg + Mirabegron 25 mg-0.220.480.44
Solifenacin 5 mg + Mirabegron 50 mg-0.71-0.03-0.80

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Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window

Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

,,,,,
Interventionbpm (Least Squares Mean)
Week 4Week 12End of treatment
Mirabegron 25 mg2.391.220.82
Mirabegron 50 mg3.681.873.41
Placebo0.020.10-0.43
Solifenacin 5 mg0.470.37-1.25
Solifenacin 5 mg + Mirabegron 25 mg-0.910.150.34
Solifenacin 5 mg + Mirabegron 50 mg0.671.391.25

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Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window

Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax (time to maximum concentration) window of mirabegron and solifenacin was from 4-6 hours postdose. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

,,,,,
InterventionmmHg (Least Squares Mean)
Week 4Week 12End of treatment
Mirabegron 25 mg0.34-2.13-2.19
Mirabegron 50 mg-1.03-1.64-1.94
Placebo-2.71-4.86-4.40
Solifenacin 5 mg-1.77-3.15-3.64
Solifenacin 5 mg + Mirabegron 25 mg-1.55-0.26-0.61
Solifenacin 5 mg + Mirabegron 50 mg-1.470.60-0.98

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Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference

Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

,,,,,
Interventionbpm (Least Squares Mean)
Week 4Week 12End of treatment
Mirabegron 25 mg0.46-0.040.45
Mirabegron 50 mg1.541.151.14
Placebo1.163.352.48
Solifenacin 5 mg0.783.493.16
Solifenacin 5 mg + Mirabegron 25 mg-0.68-0.53-0.02
Solifenacin 5 mg + Mirabegron 50 mg-0.511.481.80

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Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference

Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

,,,,,
InterventionmmHg (Least Squares Mean)
Week 4Week 12End of treatment
Mirabegron 25 mg0.14-2.45-1.38
Mirabegron 50 mg-0.69-4.55-2.30
Placebo-0.711.181.15
Solifenacin 5 mg0.85-1.63-0.97
Solifenacin 5 mg + Mirabegron 25 mg-1.610.680.25
Solifenacin 5 mg + Mirabegron 50 mg0.410.620.68

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Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours

(NCT01972841)
Timeframe: Baseline and weeks 4, 8 and 12

,,,,,
Interventionincontinence episodes (Least Squares Mean)
Week 4Week 8Week 12
Mirabegron 25 mg-1.07-1.51-1.76
Mirabegron 50 mg-1.24-1.57-1.81
Placebo-0.74-1.20-1.30
Solifenacin 5 mg-1.24-1.66-1.80
Solifenacin 5 mg + Mirabegron 25 mg-1.38-1.79-2.08
Solifenacin 5 mg + Mirabegron 50 mg-1.50-1.84-1.98

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Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours

(NCT01972841)
Timeframe: Baseline and weeks 4, 8 and 12

,,,,,
Interventionmicturitions (Least Squares Mean)
Week 4Week 8Week 12
Mirabegron 25 mg-1.46-1.95-2.01
Mirabegron 50 mg-1.44-1.89-2.03
Placebo-1.02-1.43-1.51
Solifenacin 5 mg-1.39-1.84-2.22
Solifenacin 5 mg + Mirabegron 25 mg-1.67-2.23-2.47
Solifenacin 5 mg + Mirabegron 50 mg-1.91-2.42-2.60

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Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition

(NCT01972841)
Timeframe: Baseline and weeks 4, 8 and 12

,,,,,
InterventionmL (Least Squares Mean)
Week 4Week 8Week 12
Mirabegron 25 mg10.0810.9612.88
Mirabegron 50 mg15.5217.7322.40
Placebo6.959.008.70
Solifenacin 5 mg24.2327.5531.89
Solifenacin 5 mg + Mirabegron 25 mg25.5432.9435.52
Solifenacin 5 mg + Mirabegron 50 mg28.9936.5141.28

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Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score

The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion in the OAB-q (seen in this outcome measure) consisted of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement. (NCT01972841)
Timeframe: Baseline and weeks 4, 8 and 12

,,,,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12
Mirabegron 25 mg-17.05-22.79-24.44
Mirabegron 50 mg-18.98-23.54-26.80
Placebo-13.84-17.35-19.94
Solifenacin 5 mg-19.53-24.69-26.72
Solifenacin 5 mg + Mirabegron 25 mg-23.46-29.10-31.70
Solifenacin 5 mg + Mirabegron 50 mg-25.19-30.04-33.15

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Change From Baseline to Weeks 4, 8 and 12 in TS-VAS

The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement. (NCT01972841)
Timeframe: Baseline and week 4, 8 and 12

,,,,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12
Mirabegron 25 mg1.682.162.24
Mirabegron 50 mg1.772.092.23
Placebo1.141.501.47
Solifenacin 5 mg1.822.202.32
Solifenacin 5 mg + Mirabegron 25 mg2.062.482.58
Solifenacin 5 mg + Mirabegron 50 mg2.132.482.63

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Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours

The mean number of nocturia episodes per 24hr was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit. (NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

,,,,,
Interventionnocturia episodes (Least Squares Mean)
Week 4Week 8Week 12End of treatmemt
Mirabegron 25 mg-0.31-0.37-0.38-0.40
Mirabegron 50 mg-0.25-0.35-0.39-0.39
Placebo-0.17-0.27-0.26-0.27
Solifenacin 5 mg-0.24-0.36-0.41-0.39
Solifenacin 5 mg + Mirabegron 25 mg-0.33-0.44-0.49-0.48
Solifenacin 5 mg + Mirabegron 50 mg-0.35-0.50-0.56-0.56

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Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours

The mean number of pads used per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit. (NCT01972841)
Timeframe: Baseline and weeks 4, 8 and 12 (up to 12 weeks)

,,,,,
Interventionpads (Least Squares Mean)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg-0.81-1.20-1.30-1.26
Mirabegron 50 mg-1.12-1.24-1.37-1.41
Placebo-0.52-0.82-0.92-0.94
Solifenacin 5 mg-1.19-1.53-1.56-1.53
Solifenacin 5 mg + Mirabegron 25 mg-1.09-1.36-1.54-1.53
Solifenacin 5 mg + Mirabegron 50 mg-1.23-1.51-1.59-1.58

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Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours

An urgency episode was a complaint of a sudden, compelling desire to pass urine, which was difficult to defer; it was recorded when a micturition or incontinence episode was recorded and the severity of urinary urgency recorded was 3 (severe urgency) or 4 (urgency incontinence) according to the Patient Perception of Intensity of Urgency Scale (PPIUS). The mean number of urgency episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit. (NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

,,,,,
Interventionurgency episodes (Least Squares Mean)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg-1.95-2.54-2.85-2.74
Mirabegron 50 mg-1.91-2.43-2.70-2.63
Placebo-1.34-1.85-2.05-2.06
Solifenacin 5 mg-2.14-2.90-3.11-3.05
Solifenacin 5 mg + Mirabegron 25 mg-2.42-3.13-3.45-3.38
Solifenacin 5 mg + Mirabegron 50 mg-2.66-3.28-3.50-3.51

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Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours

The mean number of urgency incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit. (NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

,,,,,
Interventionurgency incontinence episodes (Least Squares Mean)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg-1.00-1.43-1.63-1.58
Mirabegron 50 mg-1.15-1.44-1.67-1.62
Placebo-0.78-1.15-1.29-1.33
Solifenacin 5 mg-1.19-1.56-1.72-1.71
Solifenacin 5 mg + Mirabegron 25 mg-1.35-1.74-1.99-1.95
Solifenacin 5 mg + Mirabegron 50 mg-1.47-1.79-1.93-1.94

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Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes

(NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

,,,,,
Interventionincontinence episodes (Least Squares Mean)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg-7.59-10.57-12.33-11.93
Mirabegron 50 mg-8.99-10.97-12.58-12.39
Placebo-5.23-8.79-9.05-9.42
Solifenacin 5 mg-8.92-11.89-12.75-12.65
Solifenacin 5 mg + Mirabegron 25 mg-9.62-12.53-14.50-14.29
Solifenacin 5 mg + Mirabegron 50 mg-10.51-12.78-13.94-13.98

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Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes

(NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12, and EoT (up to 12 weeks)

,,,,,
Interventionnocturia episodes (Least Squares Mean)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg-2.25-2.70-2.77-2.91
Mirabegron 50 mg-1.80-2.41-2.73-2.75
Placebo-1.27-1.94-1.95-2.05
Solifenacin 5 mg-1.79-2.60-2.89-2.81
Solifenacin 5 mg + Mirabegron 25 mg-2.39-3.13-3.49-3.42
Solifenacin 5 mg + Mirabegron 50 mg-2.50-3.48-3.96-3.96

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Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used

(NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12 and EOT (up to 12 weeks)

,,,,,
Interventionpads (Least Squares Mean)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg-5.68-8.44-9.06-8.76
Mirabegron 50 mg-7.83-8.43-9.41-9.80
Placebo-3.69-6.24-6.29-6.60
Solifenacin 5 mg-8.23-10.67-10.80-10.63
Solifenacin 5 mg + Mirabegron 25 mg-7.61-9.49-10.66-10.67
Solifenacin 5 mg + Mirabegron 50 mg-8.58-10.59-11.23-11.21

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Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes

(NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

,,,,,
Interventionurgency incontinence episodes (Least Squares Mean)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg-7.07-9.93-11.39-11.03
Mirabegron 50 mg-8.39-10.07-11.66-11.44
Placebo-5.49-8.30-8.96-9.26
Solifenacin 5 mg-8.53-11.10-12.10-12.03
Solifenacin 5 mg + Mirabegron 25 mg-9.44-12.18-13.87-13.64
Solifenacin 5 mg + Mirabegron 50 mg-10.23-12.18-13.53-13.64

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Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern

The Concern score was calculated by adding 7 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

,,,,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg15.8920.6322.3721.55
Mirabegron 50 mg17.3920.5523.6223.07
Placebo11.2416.1017.5316.98
Solifenacin 5 mg17.1820.9623.1922.65
Solifenacin 5 mg + Mirabegron 25 mg20.4825.2627.5326.89
Solifenacin 5 mg + Mirabegron 50 mg21.0925.6528.2427.47

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Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT

The number of incontinence-free days was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)

,,,,,
Interventionincontinence-free days (Mean)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg2.483.173.693.51
Mirabegron 50 mg2.983.633.963.89
Placebo2.252.923.193.16
Solifenacin 5 mg2.743.313.683.61
Solifenacin 5 mg + Mirabegron 25 mg3.083.884.334.20
Solifenacin 5 mg + Mirabegron 50 mg3.374.014.254.23

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Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep

The Sleep score was calculated by adding 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

,,,,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg12.7016.3918.0417.51
Mirabegron 50 mg13.8017.3319.1619.11
Placebo9.2813.5814.4014.17
Solifenacin 5 mg13.0816.4318.3517.97
Solifenacin 5 mg + Mirabegron 25 mg15.9720.2922.9722.39
Solifenacin 5 mg + Mirabegron 50 mg16.6620.4922.7622.39

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Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social

The Social score was calculated by adding 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)

,,,,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg9.0411.5013.4313.04
Mirabegron 50 mg10.1912.3415.3514.87
Placebo7.0710.6510.8410.56
Solifenacin 5 mg9.8912.0213.7413.57
Solifenacin 5 mg + Mirabegron 25 mg11.5514.8916.1615.84
Solifenacin 5 mg + Mirabegron 50 mg11.2514.7316.0815.82

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Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)

The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. (NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12, EoT (up to 12 weeks)

,,,,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg-0.72-1.07-1.23-1.18
Mirabegron 50 mg-0.83-1.12-1.34-1.31
Placebo-0.54-0.80-0.95-0.91
Solifenacin 5 mg-0.81-1.18-1.32-1.27
Solifenacin 5 mg + Mirabegron 25 mg-0.99-1.32-1.57-1.53
Solifenacin 5 mg + Mirabegron 50 mg-1.07-1.48-1.72-1.66

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Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume

PVR volume was assessed by ultrasonography or a bladder scanner. (NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

,,,,,
InterventionmL (Mean)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg1.6-0.41.00.7
Mirabegron 50 mg-2.1-0.60.0-0.8
Placebo-0.8-1.9-1.0-1.0
Solifenacin 5 mg5.85.44.74.8
Solifenacin 5 mg + Mirabegron 25 mg7.27.07.99.0
Solifenacin 5 mg + Mirabegron 50 mg10.69.99.611.0

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Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT

Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

,,,,,
InterventionmmHg (Least Squares Mean)
Week 4Week 12End of treatment
Mirabegron 25 mg19.1519.5219.29
Mirabegron 50 mg20.4120.4120.71
Placebo18.7819.6820.29
Solifenacin 5 mg20.0221.1820.47
Solifenacin 5 mg + Mirabegron 25 mg20.7419.2620.29
Solifenacin 5 mg + Mirabegron 50 mg20.2720.0120.36

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Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT

Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

,,,,,
Interventionbpm (Least Squares Mean)
Week 4Week 12End of treatment
Mirabegron 25 mg23.8623.5424.12
Mirabegron 50 mg25.1226.0326.23
Placebo22.3422.6323.01
Solifenacin 5 mg24.2823.5223.33
Solifenacin 5 mg + Mirabegron 25 mg21.4822.6022.66
Solifenacin 5 mg + Mirabegron 50 mg21.8024.0824.14

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Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT

Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

,,,,,
InterventionmmHg (Least Squares Mean)
Week 4Week 12End of treatment
Mirabegron 25 mg31.1430.6830.65
Mirabegron 50 mg38.2032.8833.53
Placebo34.0533.2134.98
Solifenacin 5 mg35.1635.1134.95
Solifenacin 5 mg + Mirabegron 25 mg32.8833.5334.70
Solifenacin 5 mg + Mirabegron 50 mg32.8032.8232.55

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Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT

The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)

,,,,,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg27.944.751.748.5
Mirabegron 50 mg37.750.154.953.9
Placebo23.235.640.640.9
Solifenacin 5 mg34.551.356.956.0
Solifenacin 5 mg + Mirabegron 25 mg39.953.862.059.9
Solifenacin 5 mg + Mirabegron 50 mg42.957.765.463.8

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Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT

The number of incontinence-free days with < 8 micturitions per day was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded and with < 8 micturitions per day. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)

,,,,,
Interventiondays (Mean)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg0.841.201.471.40
Mirabegron 50 mg0.871.231.501.47
Placebo0.640.850.981.01
Solifenacin 5 mg0.911.311.601.59
Solifenacin 5 mg + Mirabegron 25 mg1.211.752.122.04
Solifenacin 5 mg + Mirabegron 50 mg1.321.892.152.12

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Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT

A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant went to bed with the intention to sleep until the time the patients got up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode on valid diary days during the 7-day micturition diary period prior to each visit. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)

,,,,,
Interventionnocturia episodes (Mean)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg8.468.077.997.79
Mirabegron 50 mg9.118.618.348.14
Placebo9.628.998.918.83
Solifenacin 5 mg9.228.378.178.12
Solifenacin 5 mg + Mirabegron 25 mg8.407.637.267.33
Solifenacin 5 mg + Mirabegron 50 mg8.097.116.676.67

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Number of Pads Used at Weeks 4, 8, 12 and EoT

The number of pads used was the number of times a participant recorded a new pad used on valid diary days during the 7-day micturition diary period prior to each visit. (NCT01972841)
Timeframe: Weeks 4, 8 and 12 (up to 12 weeks)

,,,,,
Interventionpads (Mean)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg13.4610.799.6510.15
Mirabegron 50 mg10.059.538.448.16
Placebo15.6212.7512.6212.29
Solifenacin 5 mg11.418.458.218.53
Solifenacin 5 mg + Mirabegron 25 mg9.718.076.607.04
Solifenacin 5 mg + Mirabegron 50 mg9.347.586.646.80

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Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

A TEAE refered to an adverse event (AE; defined as any untoward medical occurrence in a participant administered a study drug or who had undergone study procedures and did not necessarily have a causal relationship with this treatment) which started or worsened in the period from first double-blind medication intake until 14 days after the last double-blind medication intake. Serious TEAEs with a start date reported until 30 days after the last double-blind medication intake were also summarized as TEAEs, and also included serious TEAEs upgraded by the sponsor based on review of the sponsor's list of Always Serious terms if any upgrade was done. Drug-related TEAEs may be possible or probable, as assessed by the investigator, or records where relationship is missing. (NCT01972841)
Timeframe: From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 16 weeks)

,,,,,
InterventionParticipants (Count of Participants)
Any TEAEDrug-related TEAEsDeathsSerious TEAEsDrug-related serious TEAEsTEAEs leading to discontinuationDrug-related TEAEs leading to discontinuation
Mirabegron 25 mg1353706174
Mirabegron 50 mg14752051106
Placebo1454508097
Solifenacin 5 mg1496303075
Solifenacin 5 mg + Mirabegron 25 mg34515701222017
Solifenacin 5 mg + Mirabegron 50 mg31415001932219

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Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT

An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The number of urgency incontinence episodes was the number of times a participant recorded an urgency incontinence episode on valid diary days during the 7-day micturition diary period prior to each visit. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)

,,,,,
Interventionurgency incontinence episodes (Mean)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg13.3610.658.849.37
Mirabegron 50 mg11.4610.098.328.63
Placebo15.7612.7712.0011.69
Solifenacin 5 mg13.1910.419.299.29
Solifenacin 5 mg + Mirabegron 25 mg10.227.585.866.25
Solifenacin 5 mg + Mirabegron 50 mg9.337.316.276.15

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Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT

The PGIC was a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved). (NCT01972841)
Timeframe: Week 12 and EoT (up to 12 weeks)

,,,,,
Interventionpercentage of participants (Number)
Week 12: Very much improvedWeek 12: Much improvedWeek 12: Minimally improvedWeek 12: No changeWeek 12: Minimally worseWeek 12: Much worseWeek 12: Very much worseEoT: Very much improvedEoT: Much improvedEoT: Minimally improvedEoT: No changeEoT: Minimally worseEoT: Much worseEoT: Very much worse
Mirabegron 25 mg13.932.926.812.91.51.00.513.933.226.813.41.51.00.5
Mirabegron 50 mg15.134.826.59.72.21.20.715.134.827.010.22.21.20.7
Placebo8.429.729.717.54.11.00.58.430.429.918.24.11.00.5
Solifenacin 5 mg13.540.525.88.91.70.50.513.541.026.39.61.70.70.5
Solifenacin 5 mg + Mirabegron 25 mg19.839.822.27.70.80.20.220.040.022.67.90.80.40.2
Solifenacin 5 mg + Mirabegron 50 mg27.134.020.77.30.800.527.134.621.37.40.800.6

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Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT

The percentage of participants with micturition frequency normalization was defined as any participant who had ≥ 8 micturitions/24 hours at baseline and < 8 micturitions/24 h postbaseline at weeks 4, 8, 12 and EoT. (NCT01972841)
Timeframe: Weeks 4, 8 , 12 and EoT (up to 12 weeks)

,,,,,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg30.837.942.342.1
Mirabegron 50 mg25.434.540.740.1
Placebo24.128.729.731.1
Solifenacin 5 mg31.137.044.945.0
Solifenacin 5 mg + Mirabegron 25 mg36.045.350.851.3
Solifenacin 5 mg + Mirabegron 50 mg37.749.053.152.6

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Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT

The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by ≥ 10 points) on the OAB-q HRQL total score at weeks 4, 8, 12 and EoT. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)

,,,,,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg28.343.248.346.0
Mirabegron 50 mg39.846.153.552.9
Placebo23.232.939.239.1
Solifenacin 5 mg37.748.454.854.0
Solifenacin 5 mg + Mirabegron 25 mg40.454.161.659.0
Solifenacin 5 mg + Mirabegron 50 mg40.553.059.258.2

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Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT

The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by ≥ 10 points) on the OAB-q Symptom Bother score at weeks 4, 8, 12 and EoT. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)

,,,,,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg34.850.055.754.0
Mirabegron 50 mg45.751.559.458.2
Placebo28.639.845.045.2
Solifenacin 5 mg44.956.563.162.6
Solifenacin 5 mg + Mirabegron 25 mg47.863.166.765.2
Solifenacin 5 mg + Mirabegron 50 mg52.363.569.568.2

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Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT

The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per24 hours compared to baseline, minimal important difference reached (improvement by ≥ 10 points) on the HRQL total score, and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)

,,,,,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg20.636.942.039.1
Mirabegron 50 mg30.038.945.644.8
Placebo15.224.933.333.3
Solifenacin 5 mg28.643.049.949.2
Solifenacin 5 mg + Mirabegron 25 mg32.746.354.551.6
Solifenacin 5 mg + Mirabegron 50 mg33.446.854.252.8

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Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT

The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline, minimal important difference reached (improvement by ≥ 10 points) on the OAB-q Symptom Bother score, and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)

,,,,,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg24.041.347.745.0
Mirabegron 50 mg33.643.249.648.4
Placebo17.829.735.836.1
Solifenacin 5 mg31.447.854.553.3
Solifenacin 5 mg + Mirabegron 25 mg37.551.658.256.3
Solifenacin 5 mg + Mirabegron 50 mg40.254.762.060.3

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Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT

The percentage of participants with ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)

,,,,,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12End of treaetment
Mirabegron 25 mg52.865.366.965.4
Mirabegron 50 mg60.369.773.872.4
Placebo48.956.459.859.8
Solifenacin 5 mg58.172.774.171.9
Solifenacin 5 mg + Mirabegron 25 mg63.171.676.675.7
Solifenacin 5 mg + Mirabegron 50 mg62.775.480.078.4

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Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT

The percentage of participants with ≥ 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT). (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)

,,,,,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg52.862.262.461.0
Mirabegron 50 mg59.765.369.168.3
Placebo45.351.257.756.8
Solifenacin 5 mg61.766.271.771.2
Solifenacin 5 mg + Mirabegron 25 mg62.971.576.374.5
Solifenacin 5 mg + Mirabegron 50 mg61.369.371.871.1

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Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT

The percentage of participants with ≥ 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT). (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)

,,,,,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg62.671.672.171.2
Mirabegron 50 mg69.973.478.477.1
Placebo56.462.266.065.3
Solifenacin 5 mg73.979.282.481.2
Solifenacin 5 mg + Mirabegron 25 mg73.983.983.582.8
Solifenacin 5 mg + Mirabegron 50 mg75.882.885.184.3

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Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT

The percentage of participants with ≥ 50% decrease from baseline in mean number of incontinence episodes per 24 hours at each time point (weeks 4, 8, 12 and EoT). (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)

,,,,,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg45.361.866.464.5
Mirabegron 50 mg56.763.770.269.0
Placebo41.154.958.659.5
Solifenacin 5 mg53.265.371.070.5
Solifenacin 5 mg + Mirabegron 25 mg57.269.875.974.5
Solifenacin 5 mg + Mirabegron 50 mg60.670.676.175.7

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Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT

The percentage of participants with a major (≥ 2 points) improvement from baseline in PPBC at weeks 4, 8, 12 and EoT. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)

,,,,,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg20.633.339.037.2
Mirabegron 50 mg22.435.042.340.7
Placebo15.927.029.629.5
Solifenacin 5 mg27.440.544.542.6
Solifenacin 5 mg + Mirabegron 25 mg31.142.750.749.7
Solifenacin 5 mg + Mirabegron 50 mg31.146.452.951.2

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Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT

The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 3 days prior to weeks 4, 8, 12 and EoT. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)

,,,,,
Interventionpercentage of particpants (Number)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg24.935.342.540.6
Mirabegron 50 mg27.640.747.446.3
Placebo23.228.738.037.6
Solifenacin 5 mg28.938.342.742.9
Solifenacin 5 mg + Mirabegron 25 mg35.145.352.350.7
Solifenacin 5 mg + Mirabegron 50 mg37.348.252.752.2

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Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT

The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 7 days prior to weeks 4, 8, 12 and EoT. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)

,,,,,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg13.124.432.230.6
Mirabegron 50 mg16.729.835.034.0
Placebo12.819.129.128.6
Solifenacin 5 mg17.728.231.931.5
Solifenacin 5 mg + Mirabegron 25 mg23.936.642.440.9
Solifenacin 5 mg + Mirabegron 50 mg26.038.443.743.1

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PGIC Scale: Impression in General Health at Week 12 and EoT

The PGIC was a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved). (NCT01972841)
Timeframe: Week 12 and EoT (up to 12 weeks)

,,,,,
Interventionpercentage of participants (Number)
Week 12: Very much improvedWeek 12: Much improvedWeek 12: Minimally improvedWeek 12: No changeWeek 12: Minimally worseWeek 12: Much worseWeek 12: Very much worseEnd of treatment: Very much improvedEnd of treatment: Much improvedEnd of treatment: Minimally improvedEnd of treatment:No changeEnd of treatment: Minimally worseEnd of treatment: Much worseEnd of treatment: Very much worse
Mirabegron 25 mg8.028.021.527.82.90.70.58.028.021.528.32.90.70.7
Mirabegron 50 mg7.329.222.427.52.21.20.57.329.222.927.72.41.20.5
Placebo4.823.923.931.84.31.70.24.824.224.432.34.31.90.5
Solifenacin 5 mg7.731.824.125.31.40.50.57.731.824.126.51.90.50.7
Solifenacin 5 mg + Mirabegron 25 mg10.333.420.123.92.50.50.210.333.620.224.32.80.50.2
Solifenacin 5 mg + Mirabegron 50 mg14.630.220.921.62.20.10.614.630.421.321.92.70.20.7

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Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT

The number of incontinence episodes was calculated as the total number of incontinence episodes on valid diary days recorded during the 7-day micturition diary period. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)

,,,,,
Interventionincontinence episodes (Mean)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg15.6512.8410.6011.19
Mirabegron 50 mg12.9011.319.509.79
Placebo18.0914.4514.0613.70
Solifenacin 5 mg15.3112.1911.2511.21
Solifenacin 5 mg + Mirabegron 25 mg12.519.707.628.02
Solifenacin 5 mg + Mirabegron 50 mg11.449.338.218.18

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Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT

The number of days with < 8 micturitions was the number of valid diary days during the 7-day micturition diary period with less than 8 micturitions per day. (NCT01972841)
Timeframe: Weeks 4, 8,12 and EoT (up to 12 weeks)

,,,,,
Interventiondays (Mean)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg1.742.082.312.28
Mirabegron 50 mg1.551.992.252.22
Placebo1.491.691.761.80
Solifenacin 5 mg1.862.222.492.49
Solifenacin 5 mg + Mirabegron 25 mg2.072.592.872.84
Solifenacin 5 mg + Mirabegron 50 mg2.112.702.952.92

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Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours

An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period. (NCT01972841)
Timeframe: Baseline and EoT (up to 12 weeks)

Interventionincontinence episodes (Least Squares Mean)
Placebo-1.34
Mirabegron 25 mg-1.70
Mirabegron 50 mg-1.76
Solifenacin 5 mg-1.79
Solifenacin 5 mg + Mirabegron 25 mg-2.04
Solifenacin 5 mg + Mirabegron 50 mg-1.98

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Change From Baseline to EoT in Corrected Micturition Frequency

Corrected micturition frequency was defined as the mean number of micturitions per 24 hours that participants had at end of treatment if their fluid intake had remained unchanged since baseline. (NCT01972841)
Timeframe: Baseline and Week 12

Interventionmicturitions (Least Squares Mean)
Placebo0.15
Mirabegron 25 mg-0.17
Mirabegron 50 mg-0.97
Solifenacin 5 mg-1.28
Solifenacin 5 mg + Mirabegron 25 mg-1.10
Solifenacin 5 mg + Mirabegron 50 mg-1.52

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Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours

A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period. (NCT01972841)
Timeframe: Baseline and EoT (up to 12 weeks)

Interventionmicturitions (Least Squares Mean)
Placebo-1.64
Mirabegron 25 mg-2.00
Mirabegron 50 mg-2.03
Solifenacin 5 mg-2.20
Solifenacin 5 mg + Mirabegron 25 mg-2.49
Solifenacin 5 mg + Mirabegron 50 mg-2.59

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Change From Baseline to EoT in Mean Volume Voided Per Micturition

The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period. (NCT01972841)
Timeframe: Baseline and EoT (up to 12 weeks)

InterventionmL (Least Squares Mean)
Placebo8.44
Mirabegron 25 mg13.32
Mirabegron 50 mg21.99
Solifenacin 5 mg30.99
Solifenacin 5 mg + Mirabegron 25 mg34.84
Solifenacin 5 mg + Mirabegron 50 mg39.73

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Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score

The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consisted of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement. (NCT01972841)
Timeframe: Baseline and EoT (up to 12 weeks)

Interventionunits on a scale (Least Squares Mean)
Placebo-19.45
Mirabegron 25 mg-23.93
Mirabegron 50 mg-26.14
Solifenacin 5 mg-26.44
Solifenacin 5 mg + Mirabegron 25 mg-31.06
Solifenacin 5 mg + Mirabegron 50 mg-32.24

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Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS)

The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement. (NCT01972841)
Timeframe: Baseline and EoT (up to 12 weeks)

Interventionunits on a scale (Least Squares Mean)
Placebo1.42
Mirabegron 25 mg2.16
Mirabegron 50 mg2.18
Solifenacin 5 mg2.28
Solifenacin 5 mg + Mirabegron 25 mg2.53
Solifenacin 5 mg + Mirabegron 50 mg2.55

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Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression

The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). (NCT01972841)
Timeframe: Baseline and EoT (up to 12 weeks)

,,,,,
Interventionparticipants (Number)
Not anxious -> not anxiousNot anxious -> slightly anxiousNot anxious -> moderately anxiousNot anxious -> severely anxiousNot anxious -> extremely anxiousNot anxious -> no dataSlightly anxious -> not anxiousSlightly anxious -> slightly anxSlightly anxious -> moderately anxiousSlightly anxious -> severely anxiousSlightly anxious -> extremely anxiousSlightly anxious -> no dataModerately anxious -> not anxiousModerately anxious -> slightly anxiousModerately anxious -> moderately anxiousModerately anxious -> severely anxiousModerately anxious -> extremely anxiousModerately anxious -> no dataSeverely anxious -> not anxiousSeverely anxious -> slightly anxiousSeverely anxious -> moderately anxiousSeverely anxious -> severely anxiousSeverely anxious -> extremely anxiousSeverely anxious -> no dataExtremely anxious -> not anxiousExtremely anxious -> slightly anxiousExtremely anxious -> moderately anxiousExtremely anxious -> severely anxiousExtremely anxious -> extremely anxiousExtremely anxious -> no dataNo data -> not anxiousNo data -> slightly anxiousNo data -> moderately anxiousNo data -> severely anxiousNo data -> extremely anxiousNo data -> no data
Mirabegron 25 mg17627620360401620313177311537101121100812000
Mirabegron 50 mg187256512544512202121911002642201011120320001
Placebo1574270024249174021219172017351010221000940001
Solifenacin 5 mg166298101594017205221410100656510021310622000
Solifenacin 5 mg + Mirabegron 25 mg36045132031227918513424318811121165002220101361011
Solifenacin 5 mg + Mirabegron 50 mg370501111613465165043541237138672301311201432100

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Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort

The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). (NCT01972841)
Timeframe: Baseline and EoT (up to 12 weeks)

,,,,,
Interventionparticipants (Number)
No pain/discomfort -> no pain/discomfortNo pain/discomfort -> slight pain/discomfortNo pain/discomfort -> moderate pain/discomfortNo pain/discomfort -> severe pain/discomfortNo pain/discomfort -> extreme pain/discomfortNo pain/discomfort -> no dataSlight pain/discomfort -> no pain/discomfortSlight pain/discomfort -> slight pain/discomfortSlight pain/discomfort -> moderate pain/discomfortSlight pain/discomfort -> severe pain/discomfortSlight pain/discomfort -> exteme pain/discomfortSlight pain/discomfort -> no dataModerate pain/discomfort -> no pain/discomfortModerate pain/discomfort -> slight pain/discomfortModerate pain/discomfort -> moderate pain/discomfModerate pain/discomfort -> severe pain/discomfortModerate pain/discomfort -> extreme pain/discomfModerate pain/discomfort -> no dataSevere pain/discomfort -> no pain/discomfortSevere pain/discomfort -> slight pain/discomfortSevere pain/discomfort -> moderate pain/discomfortSevere pain/discomfort -> severe pain/discomfortSevere pain/discomfort -> extreme pain/discomfortSevere pain/discomfort -> no dataExtreme pain/discomfort -> no pain/discomfortExtreme pain/discomfort -> slight pain/discomfortExtreme pain/discomfort -> moderate pain/discom.Extreme pain/discomfort -> severe pain/discomfortExtreme pain/discomfort -> extreme pain/discomfortExtreme pain/discomfort -> no dataNo data -> no pain/discomfortNo data -> slight pain/discomfortNo data -> moderate pain/discomfortNo data -> severe pain/discomfortNo data -> extreme pain/discomfortNo data -> no data
Mirabegron 25 mg175299003514911005141513500444310002200524000
Mirabegron 50 mg1533717304444514212242016300366111001100320001
Placebo13138100025354123222023314012384000100001120001
Solifenacin 5 mg15433133024647180022322151011411400020201622000
Solifenacin 5 mg + Mirabegron 25 mg29074193131179415602454634411811157111113101461001
Solifenacin 5 mg + Mirabegron 50 mg317512010810510119304464540601127118000110001433000

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Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care

The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). (NCT01972841)
Timeframe: Baseline and EoT (up to 12 weeks)

,,,,,
Interventionparticipants (Number)
No problems -> no problemsNo problems -> slight problemsNo problems -> moderate problemsNo problems -> severe problemsNo problems -> unable to wash/dress myselfNo problems -> no dataSlight problems -> no problemsSlight problems -> slight problemsSlight problems -> moderate problemsSlight problems -> severe problemsSlight problems -> unable to wash/dress myselfSlight problems -> no dataModerate problems -> no problemsModerate problems -> slight problemsModerate problems -> moderate problemsModerate problems -> severe problemsModerate problems -> unable to wash/dress myselfModerate problems -> no dataSevere problems -> no problemsSevere problems -> slight problemsSevere problems -> moderate problemsSevere problems -> severe problemsSevere problems -> unable to wash/dress myselfSevere problems -> no dataUnable to wash/dress myself -> no problemsUnable to wash/dress myself -> slight problemsUnable to wash/dress myself -> moderate problemsUnable to wash/dress myself -> severe problemsUnable to wash/dress myself -> unable to w/dUnable to wash/dress myself -> no dataNo data -> no problemsNo data -> slight problemsNo data -> moderate problemsNo data -> severe problemsNo data -> unable to wash/dress myselfNo data -> no data
Mirabegron 25 mg32417500813104000811000202300100000821000
Mirabegron 50 mg3369611616121000382000200001100000320001
Placebo311219014171022016390002113000010001300001
Solifenacin 5 mg31920310525122001236000130100000010811000
Solifenacin 5 mg + Mirabegron 25 mg65222121063522310117982003371000000002010001
Solifenacin 5 mg + Mirabegron 50 mg64726410123326720018791014330003000001802000

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Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities

The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). (NCT01972841)
Timeframe: Baseline and EoT (up to 12 weeks)

,,,,,
Interventionparticipants (Number)
No problems -> No problemsNo problems -> Slight problemsNo problems -> Moderate problemsNo problems -> Severe problemsNo problems -> unable to do usual activitiesNo problems -> no dataSlight problems -> no problemsSlight problems -> slight problemsSlight problems -> moderate problemsSlight problems -> severe problemsSlight problems ->unable to do usual activitiesSlight problems -> no dataModerate problems -> no problemsModerate problems -> slight problemsModerate problems -> moderate problemsModerate problems -> severe problemsModerate problems ->unable to do usual activitiesModerate problems -> no dataSevere problems -> no problemsSevere problems -> slight problemsSevere problems -> moderate problemsSevere problems -> severe problemsSevere problems -> unable to do usual activitiesSevere problems -> no dataUnable to do usual activities -> no problemsUnable to do usual activities -> slight problemsUnable to do usual activities -> moderate problemsUnable to do usual activities -> severe problemsUnable to do usual activities -> unable to do usu.Unable to do usual activities -> no dataNo data -> no problemsNo data -> slight problemsNo data -> moderate problemsNo data -> severe problemsNo data -> unable to do usual activitiesNo data -> no data
Mirabegron 25 mg2282550054129900213911301347110101000722000
Mirabegron 50 mg2192891045223320015169002765101001100230001
Placebo1963792024528152021412151017364000120001210001
Solifenacin 5 mg22325800352258003131412100626300000010712000
Solifenacin 5 mg + Mirabegron 25 mg43437131159864182024429253007892000110101812001
Solifenacin 5 mg + Mirabegron 50 mg451481111895561230426301731111879002110001532000

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Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility

The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). (NCT01972841)
Timeframe: Baseline and EoT (up to 12 weeks)

,,,,,
Interventionparticipants (Number)
No problems -> no problemsNo problems -> slight problemsNo problems -> moderate problemsNo problems -> severe problemsNo problems -> unable to walk aboutNo problems -> no dataSlight problems -> no problemsSlight problems -> slight problemsSlight problems -> moderate problemsSlight problems -> severe problemsSlight problems -> unable to walk aboutSlight problems -> no dataModerate problems -> no problemsModerate problems -> slight problemsModerate problems -> moderate problemsModerate problems -> severe problemsModerate problems -> unable to walk aboutModerate problems -> no dataSevere problems -> no problemsSevere problems -> slight problemsSevere problems -> moderate problemsSevere problems -> severe problemsSevere problems -> unable to walk aboutSevere problems -> no dataUnable to walk about -> no problemsUnable to walk about -> slight problemsUnable to walk about -> moderate problemsUnable to walk about -> severe problemsUnable to walk about -> unable to walk aboutUnable to walk about -> no dataNo data -> no problemsNo data -> slight problemsNo data -> moderate problemsNo data -> severe problemsNo data -> unable to walk aboutNo data -> no data
Mirabegron 25 mg23920123143520600371012501574500000000703100
Mirabegron 50 mg22525930535244300251010400938102000000311001
Placebo204161110233271150217182110013658000111001210001
Solifenacin 5 mg22722810430196100182213211748801200000620200
Solifenacin 5 mg + Mirabegron 25 mg449412010676401920031243381012131511012000001540201
Solifenacin 5 mg + Mirabegron 50 mg45238102196049920246253510121781513000010001622000

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Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed

The WPAI:SHP was a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes were expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement. (NCT01972841)
Timeframe: Baseline and week 12 and EoT (up to 12 weeks)

,,,,,
Interventionpercentage of work time missed (Mean)
Week 12End of treatment
Mirabegron 25 mg-0.33-0.33
Mirabegron 50 mg-1.72-1.71
Placebo-2.98-2.96
Solifenacin 5 mg-2.47-2.44
Solifenacin 5 mg + Mirabegron 25 mg-2.06-1.48
Solifenacin 5 mg + Mirabegron 50 mg-2.59-2.55

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Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping

The Coping score was calculated by adding 8 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

,,,,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12End of treatment
Mirabegron 25 mg14.8720.6422.0421.28
Mirabegron 50 mg17.6821.5224.9424.32
Placebo11.7416.1318.1717.73
Solifenacin 5 mg16.5221.6923.6723.25
Solifenacin 5 mg + Mirabegron 25 mg19.3125.4928.3227.37
Solifenacin 5 mg + Mirabegron 50 mg20.3625.8529.0328.12

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Bladder Capacity

Urodynamic bladder capacity (NCT02044510)
Timeframe: 10 weeks

InterventionmL (Least Squares Mean)
Mirabegron305
Placebo369

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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours

The mean number of pads used per 24 hours was calculated from data recorded by the participant in the micturition diary for 7 days prior to each visit. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12

,,
Interventionpads (Least Squares Mean)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg-0.67-1.12-1.30-1.38-1.35-1.23
Solifenacin 5 mg-0.96-1.30-1.24-1.31-1.37-1.38
Solifenacin 5 mg + Mirabegron 50 mg-1.25-1.49-1.59-1.65-1.67-1.66

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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours

"A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The mean number of nocturia episodes was calculated from data recorded by the participant in the micturition diary for 7 days prior to each visit." (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12

,,
Interventionnocturia episodes (Least Squares Mean)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg-0.20-0.34-0.41-0.42-0.46-0.45
Solifenacin 5 mg-0.22-0.38-0.39-0.44-0.44-0.45
Solifenacin 5 mg + Mirabegron 50 mg-0.34-0.46-0.49-0.50-0.56-0.55

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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep

The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consisted of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each time was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12

,,
Interventionunits on a scale (Least Squares Mean)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg10.9614.0914.8414.8616.5316.44
Solifenacin 5 mg14.2416.7117.7017.7318.2818.32
Solifenacin 5 mg + Mirabegron 50 mg15.8219.7520.0921.1522.1721.59

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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping

The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12

,,
Interventionunits on a scale (Least Squares Mean)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg13.0517.5719.6819.5419.4718.54
Solifenacin 5 mg15.4018.3820.5321.2121.9021.13
Solifenacin 5 mg + Mirabegron 50 mg17.5821.6422.7323.5824.8624.14

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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern

The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12

,,
Interventionunits on a scale (Least Squares Mean)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg13.2416.3717.7718.1519.1017.98
Solifenacin 5 mg15.4917.6419.0519.7419.4019.22
Solifenacin 5 mg + Mirabegron 50 mg17.6021.2321.7322.3023.3023.00

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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social

The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12

,,
Interventionunits on a scale (Least Squares Mean)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg7.9911.1411.8911.9212.2511.57
Solifenacin 5 mg9.4111.1912.5413.3313.4713.22
Solifenacin 5 mg + Mirabegron 50 mg9.8912.2213.3013.6414.5214.25

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Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT

An incontinence episode was defined as the complaint of any involuntary leakage of urine. The percentage of participants with no incontinence episodes recorded during the 7-day micturition diary is reported. (NCT02045862)
Timeframe: Months 1, 3, 6, 9, 12

,,
Interventionpercentage of participants (Number)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg17.227.032.337.141.938.9
Solifenacin 5 mg26.435.139.943.747.345.1
Solifenacin 5 mg + Mirabegron 50 mg27.940.044.746.952.549.7

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Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT

An incontinence episode was defined as the complaint of any involuntary leakage of urine. The percentage of participants with no incontinence episodes recorded during the last 3 days of the 7-day micturition diary is reported. (NCT02045862)
Timeframe: Months 1, 3, 6, 9, 12

,,
Interventionpercentage of participants (Number)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg24.440.140.647.051.647.8
Solifenacin 5 mg39.944.850.554.455.553.2
Solifenacin 5 mg + Mirabegron 50 mg38.349.654.755.861.258.8

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Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT

The percentage of participants with micturition frequency normalization was defined as participants who had ≥ 8 micturitions/24 hours at baseline and < 8 micturitions/24 hours postbaseline at months 1, 3, 6, 9, 12 and EoT. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12

,,
Interventionpercentage of participants (Number)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg34.536.742.344.546.346.0
Solifenacin 5 mg29.336.643.441.944.746.3
Solifenacin 5 mg + Mirabegron 50 mg36.846.651.452.556.455.9

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Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT

The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12

,,
Interventionpercentage of participants (Number)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg24.931.335.037.540.638.3
Solifenacin 5 mg28.233.938.240.940.439.8
Solifenacin 5 mg + Mirabegron 50 mg30.742.845.447.051.950.3

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Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT

An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12

,,
Interventionpercentage of participants (Number)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg46.758.263.267.072.969.1
Solifenacin 5 mg55.267.071.873.675.473.1
Solifenacin 5 mg + Mirabegron 50 mg62.073.376.677.881.379.5

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Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT

The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12

,,
Interventionpercentage of participants (Number)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg63.769.170.470.172.870.7
Solifenacin 5 mg67.571.374.676.174.172.4
Solifenacin 5 mg + Mirabegron 50 mg72.881.880.582.984.482.9

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Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT

The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12

,,
Interventionpercentage of participants (Number)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg46.653.656.957.158.456.2
Solifenacin 5 mg53.859.462.962.962.461.6
Solifenacin 5 mg + Mirabegron 50 mg57.064.666.167.769.068.4

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Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT

The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12

,,
Interventionpercentage of participants (Number)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg53.061.964.665.569.766.2
Solifenacin 5 mg59.265.768.868.973.771.4
Solifenacin 5 mg + Mirabegron 50 mg64.172.573.875.176.976.0

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Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT

The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The symptom bother portion of the OAB-q consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12

,,
Interventionpercentage of participants (Number)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg29.938.942.446.551.447.4
Solifenacin 5 mg35.544.846.150.853.651.4
Solifenacin 5 mg + Mirabegron 50 mg42.854.155.959.263.761.7

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Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Months 1, 3, 6, 9, 12 and EoT

An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12

,,
Interventionpercentage of participants (Number)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg36.147.850.453.159.255.7
Solifenacin 5 mg46.655.556.961.960.958.2
Solifenacin 5 mg + Mirabegron 50 mg52.665.165.869.273.270.8

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Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Months 1, 3, 6, 9, 12 and EoT

An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12

,,
Interventionpercentage of participants (Number)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg28.539.641.643.746.944.3
Solifenacin 5 mg36.643.847.951.250.449.0
Solifenacin 5 mg + Mirabegron 50 mg40.952.355.357.660.659.2

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Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT

An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12

,,
Interventionpercentage of participants (Number)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg32.143.346.849.657.652.9
Solifenacin 5 mg37.147.752.153.260.157.5
Solifenacin 5 mg + Mirabegron 50 mg46.057.660.663.067.065.1

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Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT

The PGIC is a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved). (NCT02045862)
Timeframe: Month 12

,,
Interventionpercentage of participants (Number)
Month 12: Very much improvedMonth 12: Much improvedMonth 12: Minimally improvedMonth 12: No changeMonth 12: Minimally worseMonth 12: Much worseMonth 12: Very much worseEoT: Very much improvedEoT: Much improvedEoT: Minimally improvedEoT: No changeEoT: Minimally worseEoT: Much worseEoT: Very much worse
Mirabegron 50 mg12.923.818.924.23.60.70.713.224.519.225.83.61.00.7
Solifenacin 5 mg14.726.817.124.72.700.715.127.818.125.83.00.30.7
Solifenacin 5 mg + Mirabegron 50 mg18.028.718.720.72.70.40.318.328.919.121.62.80.50.3

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Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT

The PGIC is a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved). (NCT02045862)
Timeframe: Month 12

,,
Interventionpercentage of participants (Number)
Month 12: Very much improvedMonth 12: Much improvedMonth 12: Minimally improvedMonth 12: No changeMonth 12: Minimally worseMonth 12: Much worseMonth 12: Very much worseEoT: Very much improvedEoT: Much improvedEoT: Minimally improvedEoT: No changeEoT: Minimally worseEoT: Much worseEoT: Very much worse
Mirabegron 50 mg25.530.521.95.00.71.00.325.831.522.26.30.71.30.3
Solifenacin 5 mg23.435.819.76.40.70.30.324.437.120.47.00.70.70.3
Solifenacin 5 mg + Mirabegron 50 mg33.834.016.14.50.40.10.534.134.716.65.10.40.10.5

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Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT

The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The HRQoL portion of the OAB-q consists of 25 HRQoL items comprising 4 HRQoL subscales, each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12

,,
Interventionpercentage of participants (Number)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg25.233.336.839.044.140.1
Solifenacin 5 mg29.039.141.244.047.645.2
Solifenacin 5 mg + Mirabegron 50 mg35.545.949.651.354.653.3

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Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit

An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceeded by urgency. The number of urgency incontinence episodes was the total number of urgency incontinence episodes recorded by the participant during the 7-day micturition diary period prior to each visit. (NCT02045862)
Timeframe: Months 1, 3, 6, 9, 12

,,
Interventionurgency incontinence episodes (Mean)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg13.1410.378.978.087.738.86
Solifenacin 5 mg11.218.127.316.516.067.04
Solifenacin 5 mg + Mirabegron 50 mg8.996.955.885.474.885.57

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Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

A TEAE was defined as an adverse event (AE) observed after taking the first dose of double-blind treatment until 14 days after taking the last dose of double-blind treatment for non-serious AEs and until 30 days after taking the last dose of double-blind treatment for serious adverse events (SAEs). This included abnormal laboratory tests, vital signs or electrocardiogram data that were defined as AEs if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant in the investigator's opinion. The severity of each AE was defined according to the following: Mild (No disruption of normal daily activities); Moderate (Affected normal daily activities) and Severe (Inability to perform daily activities). (NCT02045862)
Timeframe: From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 56 weeks)

,,
InterventionParticipants (Count of Participants)
Any TEAEsMild TEAEsModerate TEAEsSevere TEAEsDrug-related TEAEsSerious TEAEsDrug-related Serious TEAEsTEAEs Leading to Discontuation of Study DrugDrug-related TEAEs Leading to Discont. of DrugTEAEs Leading to Death
Mirabegron 50 mg1266152133581740
Solifenacin 5 mg134695874280540
Solifenacin 5 mg + Mirabegron 50 mg5963062385220051025171

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Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit

The number of pads used was the number of times a participant recorded a new pad used during the 7-day micturition diary period prior to each visit. (NCT02045862)
Timeframe: Months 1, 3, 6, 9, 12

,,
Interventionpads (Mean)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg12.679.617.997.657.609.09
Solifenacin 5 mg12.559.479.168.918.098.54
Solifenacin 5 mg + Mirabegron 50 mg8.757.236.516.185.706.33

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Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit

A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode during the 7-day micturition diary period prior to each visit. (NCT02045862)
Timeframe: Months 1, 3, 6, 9, 12

,,
Interventionnocturia episodes (Mean)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg8.767.937.127.406.887.13
Solifenacin 5 mg9.237.927.867.487.397.47
Solifenacin 5 mg + Mirabegron 50 mg8.007.176.966.846.336.51

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Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit

The number of incontinence-free days with < 8 micturitions per day was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded and with < 8 micturitions per day. (NCT02045862)
Timeframe: Months 1, 3, 6, 9, 12

,,
Interventiondays (Mean)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg1.031.241.561.561.871.75
Solifenacin 5 mg1.011.481.661.641.921.90
Solifenacin 5 mg + Mirabegron 50 mg1.331.912.132.202.542.43

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Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS

The TS-VAS is a visual analogue scale which asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12

,,
Interventionunits on a scale (Least Squares Mean)
Month 1Month 3Month 6Month 9Month 12
Mirabegron 50 mg1.882.102.222.242.33
Solifenacin 5 mg1.952.062.252.282.34
Solifenacin 5 mg + Mirabegron 50 mg2.272.572.722.742.89

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Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score

The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12

,,
Interventionunits on a scale (Least Squares Mean)
Month 1Month 3Month 6Month 9Month 12
Mirabegron 50 mg-16.37-19.69-20.97-21.41-23.41
Solifenacin 5 mg-20.82-23.13-24.27-25.82-25.38
Solifenacin 5 mg + Mirabegron 50 mg-22.86-26.88-27.73-28.45-30.18

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Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit

The number of incontinence-free days was the number of valid diary days during the 7-day micturition diary period prior to each visit with no incontinence episodes recorded. (NCT02045862)
Timeframe: Months 1, 3, 6, 9, 12

,,
Interventionincontinence-free days (Mean)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg2.733.303.643.974.233.98
Solifenacin 5 mg3.353.984.084.334.54.29
Solifenacin 5 mg + Mirabegron 50 mg3.464.174.444.564.814.64

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Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours

A micturition was defined as any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7-days before the baseline and prior to each visit. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12

,,
Interventionmicturitions (Least Squares Mean)
Month 1Month 3Month 6Month 9Month 12
Mirabegron 50 mg-1.09-1.63-1.85-2.03-2.20
Solifenacin 5 mg-1.36-1.87-2.04-2.03-2.13
Solifenacin 5 mg + Mirabegron 50 mg-1.642.16-2.39-2.42-2.64

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Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours

An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to the baseline and prior to each visit. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12

,,
Interventionincontinence episodes (Least Squares Mean)
Month 1Month 3Month 6Month 9Month 12
Mirabegron 50 mg-0.97-1.31-1.42-1.53-1.67
Solifenacin 5 mg-1.29-1.71-1.78-1.90-1.92
Solifenacin 5 mg + Mirabegron 50 mg-1.45-1.78-1.93-2.00-2.06

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Change From Baseline to EoT in the Patient's Assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS)

The TS-VAS is a visual analogue scale which asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement. (NCT02045862)
Timeframe: Baseline and Week 52

Interventionunits on a scale (Least Squares Mean)
Mirabegron 50 mg2.19
Solifenacin 5 mg2.15
Solifenacin 5 mg + Mirabegron 50 mg2.73

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Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score

The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement. (NCT02045862)
Timeframe: Baseline and Week 52

Interventionunits on a scale (Least Squares Mean)
Mirabegron 50 mg-21.96
Solifenacin 5 mg-24.91
Solifenacin 5 mg + Mirabegron 50 mg-29.51

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Change From Baseline to EoT in Mean Volume Voided Per Micturition

The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period. (NCT02045862)
Timeframe: Baseline and Week 52

InterventionmL (Least Squares Mean)
Mirabegron 50 mg21.83
Solifenacin 5 mg24.90
Solifenacin 5 mg + Mirabegron 50 mg37.67

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Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours

A micturition was defined as any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7-days before the baseline and week 52 clinic visits. (NCT02045862)
Timeframe: Baseline and Week 52

Interventionmicturitions (Least Squares Mean)
Mirabegron 50 mg-2.10
Solifenacin 5 mg-2.16
Solifenacin 5 mg + Mirabegron 50 mg-2.58

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Change From Baseline to EoT in Corrected Micturition Frequency

Corrected micturition frequency was defined as the mean number of micturitions per 24 hours that participants had at end of treatment if their fluid intake had remained unchanged since baseline. Corrected micturition frequency was calculated as the baseline mean volume voided per micturition multiplied by the baseline mean number of micturitions per 24 hours divided by the mean volume voided per micturition at EoT. (NCT02045862)
Timeframe: Baseline and Month 12

Interventionmicturitions (Least Squares Mean)
Mirabegron 50 mg-0.72
Solifenacin 5 mg-1.11
Solifenacin 5 mg + Mirabegron 50 mg-1.51

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Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours

An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to the baseline and week 52 clinic visits. (NCT02045862)
Timeframe: Baseline and Week 52

Interventionincontinence episodes (Least Squares Mean)
Mirabegron 50 mg-1.58
Solifenacin 5 mg-1.90
Solifenacin 5 mg + Mirabegron 50 mg-2.03

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Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit

An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes was the total number of times a participant records an incontinence episode during the 7-day micturition diary period prior to each visit. (NCT02045862)
Timeframe: Months 1, 3, 6, 9, 12

,,
Interventionincontinence episodes (Mean)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg14.8812.2310.6210.539.0910.32
Solifenacin 5 mg12.419.238.187.287.068.09
Solifenacin 5 mg + Mirabegron 50 mg10.808.337.286.746.106.85

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Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)

The number of days with < 8 micturitions was the number of valid diary days during the 7-day micturition diary period with with less than 8 micturitions per day. (NCT02045862)
Timeframe: Months 1, 3, 6, 9, 12

,,
Interventiondays (Mean)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg1.902.072.352.382.612.52
Solifenacin 5 mg1.602.142.342.332.582.58
Solifenacin 5 mg + Mirabegron 50 mg2.082.662.872.933.173.10

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Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment

The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes arre expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement. (NCT02045862)
Timeframe: Baseline and Months 6, 12

,,
Interventionpercentage of overall work impairment (Mean)
Month 6Month 12EoT
Mirabegron 50 mg-16.33-17.83-16.83
Solifenacin 5 mg-12.09-15.38-14.16
Solifenacin 5 mg + Mirabegron 50 mg-13.99-17.27-16.15

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Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment

The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement. (NCT02045862)
Timeframe: Baseline and Months 6, 12

,,
Interventionpercentage of activity Impairment (Mean)
Month 6Month 12EoT
Mirabegron 50 mg-15.04-16.85-16.02
Solifenacin 5 mg-16.25-14.12-14.02
Solifenacin 5 mg + Mirabegron 50 mg-16.94-18.91-18.75

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Change From Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working

The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement. (NCT02045862)
Timeframe: Baseline and Months 6, 12

,,
Interventionpercentage of impairment while working (Mean)
Month 6Month 12EoT
Mirabegron 50 mg-16.94-19.16-17.81
Solifenacin 5 mg-12.97-14.72-13.90
Solifenacin 5 mg + Mirabegron 50 mg-13.41-16.68-15.63

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Change From Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed

The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement. (NCT02045862)
Timeframe: Baseline and Months 6,12

,,
Interventionpercentage of work time missed (Mean)
Month 6Month 12EoT
Mirabegron 50 mg-0.490.39-0.45
Solifenacin 5 mg-0.59-1.95-1.30
Solifenacin 5 mg + Mirabegron 50 mg-3.11-3.74-3.26

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Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition

The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period prior to each visit. (NCT02045862)
Timeframe: Baseline and Months 3, 6, 12

,,
InterventionmL (Least Squares Mean)
Month 3Month 6Month 12
Mirabegron 50 mg15.3420.8721.85
Solifenacin 5 mg23.7127.0824.05
Solifenacin 5 mg + Mirabegron 50 mg34.8938.5638.72

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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume

PVR volume was assessed by ultrasonography or a bladder scanner. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12

,,
InterventionmL (Mean)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg3.1794.6861.5963.0742.0021.747
Solifenacin 5 mg4.5493.2333.4183.4364.8187.382
Solifenacin 5 mg + Mirabegron 50 mg7.8947.0336.7088.2297.9468.522

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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)

The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12

,,
Interventionunits on a scale (Least Squares Mean)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg-0.84-1.09-1.11-1.25-1.29-1.22
Solifenacin 5 mg-0.89-1.08-1.18-1.31-1.36-1.34
Solifenacin 5 mg + Mirabegron 50 mg-1.05-1.33-1.42-1.48-1.59-1.54

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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit

An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The number of urgency incontinence episodes was the total number of urgency incontinence episodes recorded by the participant during the 7-day micturition diary period prior to each visit. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12

,,
Interventionurgency incontinence episodes (Least Squares Mean)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg-6.45-9.06-10.09-11.1-11.27-10.61
Solifenacin 5 mg-8.77-11.48-11.71-12.6-12.812.66
Solifenacin 5 mg + Mirabegron 50 mg-10.1-11.99-13.0-13.44-13.8-13.59

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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit

The number of pads used was the number of times a participant recorded a new pad used during the 7-day micturition diary period prior to each visit. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12

,,
Interventionpads (Least Squares Mean)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg-4.74-7.83-9.09-9.59-9.39-8.59
Solifenacin 5 mg-6.72-9.21-8.86-9.33-9.92-9.89
Solifenacin 5 mg + Mirabegron 50 mg-8.8910.47-11.12-11.44-11.66-11.58

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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit

A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode during the 7-day micturition diary period prior to each visit (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12

,,
Interventionnocturia episodes (Least Squares Mean)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg-1.56-2.45-3.08-2.91-3.29-3.24
Solifenacin 5 mg-1.58-2.78-2.81-3.13-3.08-3.20
Solifenacin 5 mg + Mirabegron 50 mg-2.39-3.26-3.44-3.55-3.97-3.90

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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit

An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes was the total number of times a participant records an incontinence episode during the 7-day micturition diary period prior to each visit. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12

,,
Interventionincontinence episodes (Least Squares Mean)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg-6.77-9.21-10.36-10.62-11.84-11.17
Solifenacin 5 mg-9.17-12.05-12.50-13.51-13.47-13.37
Solifenacin 5 mg + Mirabegron 50 mg-10.31-12.55-13.49-14.06-14.43-14.29

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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours

An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12

,,
Interventionurgency incontinence episodes (Least Squares Mean)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg-0.93-1.30-1.40-1.60-1.60-1.51
Solifenacin 5 mg-1.25-1.64-1.67-1.78-1.82-1.81
Solifenacin 5 mg + Mirabegron 50 mg-1.43-1.71-1.86-1.92-1.98-1.94

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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours

Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. An urgency episode was defined as any micturition or incontinence episode recorded by the participant in the micturition diary for 7 days prior to each visit as 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS), where 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12

,,
Interventionurgency episodes (Least Squares Mean)
Month 1Month 3Month 6Month 9Month 12EoT
Mirabegron 50 mg-1.93-2.68-2.93-3.40-3.40-3.11
Solifenacin 5 mg-2.31-3.02-3.17-3.55-3.56-3.45
Solifenacin 5 mg + Mirabegron 50 mg-2.68-3.36-3.72-3.87-3.95-3.84

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Mean # of Incontinence Episodes/Day

"Secondary Outcome Measure based on voiding diary:~Baseline vs. Final Visit: Mean # of incontinence episodes/day" (NCT02086188)
Timeframe: 10 weeks

InterventionIncontinence Episodes/Day (Mean)
Mirabegron0.7
Placebo1.05

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Subject Global Impression (Single Question)

"Secondary Outcome Measures based on the Subject Global Impression (single question) at Final Visit compared to Baseline This is a single question: How would you rate your level of bladder control during the past week? 1-7 analog scale, 1 = terrible' 7 = delighted." (NCT02086188)
Timeframe: 10 weeks

Interventionscore on a scale (Mean)
Mirabegron5.71
Placebo4.86

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Qualiveen Questionnaire

Secondary Outcome Measures based on the Qualiveen Questionnaire at Final Visit compared to Baseline Qualiveen questionaire is used, including 8 questions about aspects of bladder problems. Each question is rated 0 (not at all)- 4 (extremely). Overall score is averaged (average score per question) (NCT02086188)
Timeframe: 10 weeks

Interventionscore on a scale (Mean)
Mirabegron0.96
Placebo0.71

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Overactive Bladder Symptom Composite Score (OAB-SCS) at Baseline vs. Titration Visit

"Secondary Outcome Measure based on voiding diary: Average daily Overactive Bladder Symptom Composite Score (OAB-SCS) Baseline compared to Titration Visit The OAB-SCS measures symptoms of overactive bladder, urgency, frequency, incontinence. This is an ordinal scale is 1-5, 1 (minimum) = no urgency, 5 (maximum) = urgency incontinence.~Higher values represent a worse outcome." (NCT02086188)
Timeframe: 5 weeks

Interventionscore on a scale (Mean)
Mirabegron2.8
Placebo2.23

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Overactive Bladder Symptom Composite Score (OAB-SCS) at Baseline vs. Final Visit

"Primary outcome: Overactive Bladder Symptom Composite Score (OAB-SCS) total score, average daily, Baseline vs. Final Visit The OAB-SCS measures symptoms of overactive bladder, urgency, frequency, incontinence. This is an ordinal scale is 1-5, 1 (minimum) = no urgency, 5 (maximum) = urgency incontinence.~Higher values represent a worse outcome." (NCT02086188)
Timeframe: 10 weeks

Interventionscore on a scale (Mean)
Mirabegron3.01
Placebo2.56

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Mean Volume Voided/Micturition

"Secondary Outcome Measure based on voiding diary:~Baseline vs. Final Visit: Mean volume voided/micturition" (NCT02086188)
Timeframe: 10 weeks

Interventionml/micturition (Mean)
Mirabegron356
Placebo282

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Mean # of Micturitions/Day Based on Voiding Diaries

"Secondary Outcome Measure based on voiding diary:~Baseline vs Final Visit: mean # of micturitions/day" (NCT02086188)
Timeframe: 10 weeks

Interventionmicturitions/day (Mean)
Mirabegron6.82
Placebo8.72

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Change in Mean Daily OAB-SCS Visit 3 vs Baseline

"The primary outcome measure will be the change in the mean daily Overactive Bladder-Symptom Composite Score (OAB-SCS) from baseline (visit 2) to visit 4.~The Over active Bladder- Symptom Composite Score requires subjects to record the severity of urgency of each micturition over a 72 hour period. Subject ratings ranges from 1 to 6 for each micturition as follows: 1. Not at all, 2.A little bit, 3.Somewhat 4.Quite a bit, 5. A great deal, 6. A very great deal. Maximum score depends on number of micturition episodes in the 72 hour period, as the rating of each episode is summed to get the total score. Higher scores indicate worse symptoms of overactive bladder." (NCT02092181)
Timeframe: baseline (7-14 days post visit 1) and visit 3 (32-40 days post visit 2)

,
Interventionunits on a scale (Mean)
visit 3 (32-40 days post visit 2baseline (7-14 days post visit 1)
Mirabegron3.53.5
Placebo3.072.6

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Change in the Mean Daily Overactive Bladder-Symptom Composite Score.

"The primary outcome measure will be the change in the mean daily Overactive Bladder-Symptom Composite Score (OAB-SCS) from baseline (visit 2) to visit 4.~The Over active Bladder- Symptom Composite Score requires subjects to record the severity of urgency of each micturition over a 72 hour period. Subject ratings ranges from 1 to 6 for each micturition as follows: 1. Not at all, 2.A little bit, 3.Somewhat 4.Quite a bit, 5. A great deal, 6. A very great deal. Maximum score depends on number of micturition episodes in the 72 hour period, as the rating of each episode is summed to get the total score. Higher scores indicate worse symptoms of overactive bladder." (NCT02092181)
Timeframe: 7-82 days. From visit 2 (baseline) to visit 4

Interventionunits on a scale (Mean)
Mirabegron-3.2
Placebo-8.9

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Change in Mean Number of Incontinence Episodes Per 24 Hours

Subjects recorded in a 72-hour micturition diary the number of episodes of urinary incontinence, and this is averaged per 24 hours. Higher scores indicate more episodes of incontinence and thus worse outcome. (NCT02092181)
Timeframe: baseline vs visit 3 (32-40 days post baseline) and baseline vs. visit 4 ((74-82 days post visit 2)

,
Interventionepisodes per 24 hrs (Mean)
V3 vs baselineV4/baseline
Mirabegron-0.060.12
Placebo-0.11-0.61

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Non- Motor Symptoms Scale (NMSS)

"Non-Motor Symptoms Scale (NMSS), which includes questions about 9 different categories of non-motor symptoms in PD, including urinary symptoms; Visit 3 and Visit 4 vs. baseline.~Symptoms assessed over the last month. The scale ranges from 0 to 360, with higher scores indicating worse symptoms." (NCT02092181)
Timeframe: baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2)

,
Interventionunits on a scale (Mean)
visit 3/baselinevisit 4/baseline
Mirabegron-7.5-10.5
Placebo-19.6-17.9

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Overactive Bladder Questionnaire Symptom Severity Scale( OAB-q)

Overactive Bladder questionnaire symptom severity scale (OAB-q), Visit 3 and Visit 4 vs. baseline Scale ranges from 8 to 48 the higher score indicating worse symptoms. (NCT02092181)
Timeframe: baseline (7-14 days post visit 1), visit 3( 32-40 days post visit 2) and visit 4(74-82 days post visit 2)

,
Interventionunits on a scale (Mean)
Week 3/baselineWeek4/baseline
Mirabegron-4.14-2.6
Placebo-3.2-8.6

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Patient Perception of Bladder Condition

Patient Perception of Bladder Condition at Visit 3 and Visit 4 vs. baseline. the scale ranges from 1 to 6 with higher score indicating worse outcome (NCT02092181)
Timeframe: baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2)

,
Interventionunits on a scale (Mean)
V3/baselineV4/baseline
Mirabegron-0.35-0.38
Placebo-0.7-1.2

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Subjects Global Impression of Change

Subject's Global Impression of Change at Visit 3 and Visit 4 vs. baseline the scale ranges from 0 to 7 with higher score indicating worse out come . (NCT02092181)
Timeframe: baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2)

,
Interventionunits on a scale (Mean)
visit 3/baselinevisit 4/baseline
Mirabegron3.53.5
Placebo3.02.6

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Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Participant's Fulfillment of OAB Medication Expectations

The final item score for overall assessment of patient's fulfillment of OAB medication expectations ranged from 1 to 5, with higher scores indicating better fulfillment of OAB medication expectations. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)

InterventionUnits on a Scale (Mean)
Mirabegron3.10
Tolterodine ER3.08

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Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Interruption of Day-to-Day Life Due to OAB

Overall assessment of interruption of day-to-day life due to OAB was assessed on a scale from 1 to 5, with higher scores indicating less interruption of day-to-day life due to OAB symptoms. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)

InterventionUnit on a Scale (Mean)
Mirabegron3.00
Tolterodine ER3.02

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Change From Baseline to End of Treatment (EOT) in Mean Number of Incontinence Episodes Per 24 Hours

(NCT02138747)
Timeframe: Baseline and EOT (Period 1-Week 8 and Period 2- Week 18)

InterventionIncontinence Episodes (Least Squares Mean)
Mirabegron-1.51
Tolterodine ER-1.46

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Change From Baseline to End of Treatment (EOT) in Number of Micturitions Per 24 Hours

(NCT02138747)
Timeframe: Baseline and EOT (Period 1-Week 8 and Period 2- Week 18)

InterventionMicturitions (Least Squares Mean)
Mirabegron-2.06
Tolterodine ER-1.95

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Participants Tolerability Assessed by the Medication Tolerability Scale of the Overactive Bladder-Satisfaction (OAB-S) Questionnaire at the End of Treatment (EOT)

The medication tolerability scale measured the level of bothersomeness related to the occurrence of a side effect that was known to be related to the approved OAB medication (i.e., constipation, dry mouth, drowsiness, headache, nausea and blurred vision). The OAB medication tolerability score was calculated as a sum of the responses and converted to a scale from 0 to 100, where higher score indicates better perceived OAB medication tolerability (less bother from side-effects). (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)

InterventionUnits on a Scale (Least Squares Mean)
Mirabegron86.29
Tolterodine ER83.40

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Scale of the OAB-S Questionnaire at the End of Treatment Period: Impact on Daily Living With OAB.

Impact on daily living with the OAB was scored from 0 to 100, with higher scores indicating greater satisfaction with ability to perform daily activities. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)

InterventionUnits on a Scale (Mean)
Mirabegron72.98
Tolterodine ER71.92

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Scale of the OAB-S Questionnaire at the End of Treatment Period: OAB Control

OAB control was scored from 0 to 100, with higher scores indicating better OAB control. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)

InterventionUnits on a Scale (Mean)
Mirabegron64.49
Tolterodine ER63.38

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Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Improvement in Day-to-Day Life Due to OAB Medication

Overall assessment of improvement in day-to-day life due to OAB medication was assessed on a scale from 1 to 5, with higher scores indicating greater improvement in day-to-day life due to current OAB medication. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)

InterventionUnits on a Scale (Mean)
Mirabegron3.43
Tolterodine ER3.46

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Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Willingness to Continue OAB Medication

Overall assessment of willingness to continue OAB medication, was assessed on a scale from 1 to 5, with higher scores indicating greater desire to continue with current OAB medication. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)

InterventionUnits on a Scale (Mean)
Mirabegron3.69
Tolterodine ER3.69

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Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Satisfaction With OAB Medication

Overall satisfaction with OAB medication was assessed on a scale of 1 to 5, with higher scores indicating greater satisfaction with current OAB medication. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)

InterventionUnits on a Scale (Mean)
Mirabegron3.70
Tolterodine ER3.66

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Scale of the OAB-S Questionnaire at the End of Treatment Period: Satisfaction With OAB Control

Satisfaction with OAB control was scored from 0 to 100 with higher scores indicating greater satisfaction with OAB control. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)

InterventionUnits on a Scale (Mean)
Mirabegron69.17
Tolterodine ER68.31

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Number of Participants With Adverse Events

Safety was assessed by evaluation of treatment-emergent adverse events (TEAEs; frequency, severity, seriousness and relationship to study drug), AEs of special interest, vital signs (SBP, DBP, body temperature and pulse rate) and laboratory tests (liver function tests [LFTs]). Treatment-Emergent Adverse Event (TEAEs) were defined as any adverse event starting or worsening in the period from first dose of double-blind study drug until 15 days after last dose of double-blind study drug. (NCT02138747)
Timeframe: Baseline to EOT (Week 18) and follow up (Week 20)

,
InterventionParticipants (Number)
Adverse Events (AEs)Drug-related (AEs)DeathsSerious Adverse Event (SAE)Drug-related SAEsAEs Leading to Permanent Discontinuation of DrugDrug-related AEs Leading to Permanent DiscontinuatSAEs Leading to Permanent DiscontinuationDrug-related SAEs Leading to Permanent Discontinu
Mirabegron15089032151200
Tolterodine ER168111080201250

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Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods.

"Participants were asked to choose which treatment period they preferred and the degree of preference. Preference was assessed on a 5-point scale assessed at the end of period 2 (strong preference for period 1, mild preference for period 1, no preference, mild preference for period 2, strong preference for period 2). Participants who selected either a mild preference or strong preference were considered as having a preference for a specific study drug and participants who selected no preference were considered as having no preference for one study drug over the other study drug." (NCT02138747)
Timeframe: Week 18 (End of Period 2)

,,,
InterventionPercentage of participants (Number)
Preference for Period 1Preference for Period 2No PreferenceTotal With Preference
AA: Mirabegron/Mirabegron36.036.028.072.0
AB: Mirabegron/Tolterodine ER29.937.832.367.7
BA: Tolterodine ER /Mirabegron34.437.628.072.0
BB: Tolterodine ER /Tolterodine ER23.150.026.973.1

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Change From Baseline in Post-void Residual Volume (PVR)

PVR was assessed by ultrasonography or bladder scan. (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)

InterventionmL (Least Squares Mean)
Placebo-3.1
Mirabegron2.6

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Change From Baseline to End of Treatment (EOT) in Mean Number of Micturitions Per 24 Hours

A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated as the average number of times a participant urinated per day during the 3-day micturition diary period. (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)

Interventionmicturitions/24 hours (Least Squares Mean)
Placebo-1.7
Mirabegron-2.3

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Change From Baseline to EOT in Barthel Index of Daily Living Score

The Barthel Index consists of 10 items that measure a person's daily functioning; specifically the activities of daily living and mobility. The total possible score ranges from 0 to 20, with lower scores indicating increased disability. (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)

Interventionunits on a scale (Least Squares Mean)
Placebo0.4
Mirabegron0.5

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Change From Baseline to EOT in Mean Number of Incontinence Episodes Per 24 Hours

An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated as the average number of times a participant recorded an incontinence episode per day during the 3-day micturition diary period. (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)

Interventionincontinence episodes/24 hours (Least Squares Mean)
Placebo-1.45
Mirabegron-2.00

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Change From Baseline to EOT in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours

Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. An urgency episode was defined as any micturition or incontinence episode with a severity of grade 3 or 4, assessed by participants based on the PPIUS, where 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The mean number of urgency episodes (grade 3 and/or 4) per 24 hours was calculated as the average number of times a participant recorded an urgency episode (grade 3 and/or 4) with or without incontinence per day during the 3-day micturition diary period. (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)

Interventionurgency episodes/24 hours (Least Squares Mean)
Placebo-2.81
Mirabegron-3.66

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Change From Baseline to EOT in OAB-q HRQL Subscale Scores

The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The Coping score has 8 items, the Concern score has 7 items, the Sleep and Social score has 5 items each. Each subscale score was calculated by adding each score's items and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)

,
Interventionunits on a scale (Least Squares Mean)
CopingConcernSleepSocial
Mirabegron18.9519.7216.8211.47
Placebo16.3616.8913.4611.15

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Change From Baseline to EOT in Mean Volume Voided Per Micturition

The mean volume voided per micturition during 3 days of the 3-day micturition diary period. (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)

InterventionmL (Least Squares Mean)
Placebo17.45
Mirabegron30.54

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Change From Baseline to EOT in Montreal Cognitive Assessment (MoCA) Score

The MoCA was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total possible score is 30 points, with lower scores indicating worse cognitive function. (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)

Interventionunits on a scale (Least Squares Mean)
Placebo-0.07
Mirabegron-0.16

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Change From Baseline to EOT in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score

The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 questions, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement. (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)

Interventionunits on a scale (Least Squares Mean)
Placebo-18.69
Mirabegron-23.39

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Change From Baseline to EOT in Patient Perception of Bladder Condition (PPBC)

The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition. (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)

Interventionunits on a scale (Least Squares Mean)
Placebo-0.7
Mirabegron-1.0

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Change From Baseline to EOT in PPIUS

The PPIUS is a 5-point categorical scale used by participants to rate the degree of associated urgency for each micturition and/or incontinence episode they experienced. categories include: 0 - No urgency, I felt no need to empty my bladder, but did so for other reasons; 1 - Mild urgency, I could postpone voiding as long as necessary, without fear of wetting myself; 2 - Moderate urgency, I could postpone voiding for a short while, without fear of wetting myself; 3 - Severe urgency, I could not postpone voiding, but had to rush to the toilet in order not to wet myself; 4 - Urge incontinence, I leaked before arriving at the toilet. Scores were recorded in the micturition diary. (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)

Interventionunits on a scale (Least Squares Mean)
Placebo-0.37
Mirabegron-0.54

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Change From Baseline to EOT in Treatment Satisfaction Visual Analog Scale (TS-VAS)

The TS-VAS is a visual analog scale that asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) to 100 (Yes, completely). (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)

Interventionunits on a scale (Least Squares Mean)
Placebo14.455
Mirabegron20.110

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Change From Baseline to EOT in University of Alabama, Birmingham - Life Space Assessment (UAB-LSA)

The UAB-LSA measures mobility in terms of the spatial extent of a person's life. Life space is defined based upon the distance a person routinely travels to perform activities over this time frame. The UAB-LSA includes determining how far and how often the person leaves his or her place of residence and the degree of independence the person has. Each level of life space represents a distance further from the room where one sleeps: 0 - Mobility limited to the room where one sleeps; 1 - Mobility limited to within one's dwelling; 2 - Mobility limited to the space just proximal to one's personal living space (for instance, a porch, patio, or yard just outside the home or hallway outside of an apartment); 3 - Mobility limited to one's neighborhood; 4 - Mobility limited to one's town; 5 - Mobility outside one's town. The total scores ranges from 0-120, where a higher score indicates greater mobility. (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)

Interventionunits on a scale (Least Squares Mean)
Placebo1.33
Mirabegron1.14

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Change From Baseline to EOT in Vulnerable Elder Survey-13 (VES-13) Score

The VES-13 is a simple function-based tool for screening community-dwelling populations to identify older persons at risk for health deterioration. The VES-13 considers age, self-related health, limitation in physical function, and functional disabilities. The total possible score ranges from 0 to 10, with higher scores indicating increased disability. (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)

Interventionunits on a scale (Least Squares Mean)
Placebo-0.1
Mirabegron-0.3

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Change From to EOT in Mean Number of Nocturia Episodes Per 24 Hours

A nocturia episode was defined as waking at night one or more time to void (i.e., any voiding associated with sleep disturbance between the date/time the participant goes to bed with the intention to sleep until the date/time the participant gets up in the morning with the intention to stay awake). A night time episode of incontinence only is not considered a nocturia episode. The mean number of nocturia episodes per 24 hours was calculated as the average number of times a participant recorded a nocturia episode per day during the 3-day micturition diary period. (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)

Interventionnocturia episodes/24 hours (Least Squares Mean)
Placebo-0.21
Mirabegron-0.29

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Percentage of Participants Major (≥ 2-Point) Improvement From Baseline in PPBC

The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition. Participants with ≥ 2-point improvement from baseline in PPBC were defined as participants with at least 1-point improvement from baseline in PPBC at each visit. (NCT02216214)
Timeframe: End of treatment (up to 12 weeks)

Interventionpercentage of participants (Number)
Placebo27.1
Mirabegron36.5

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Percentage of Participants Who Achieved Micturition Frequency Normalization

Participants who achieved micturition frequency normalization were defined as participants who had at least 8 micturitions per 24 hours at baseline and less than 8 micturitions per 24 hours post-baseline. (NCT02216214)
Timeframe: End of treatment (up to 12 weeks)

Interventionpercentage of participants (Number)
Placebo36.0
Mirabegron44.6

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Percentage of Participants With ≥ 10-Point Improvement From Baseline in OAB-q HRQL Subscales

The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The Coping score has 8 items, the Concern score has 7 items, the Sleep and Social score has 5 items each. Each subscale score was calculated by adding each score's items and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. Participants with ≥ 10-point improvement from baseline in OAB-q HRQL subscales were defined as participants with at least 10-point improvement from baseline in OAB-q Subscales at each visit. (NCT02216214)
Timeframe: End of treatment (up to 12 weeks)

,
Interventionpercentage of participants (Number)
CopingConcernSleepSocial
Mirabegron66.162.260.136.9
Placebo58.756.653.134.1

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Number of Participants With Adverse Events (AEs)

Safety was assessed by AEs, which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. AEs were considered as serious if resulted in in death, was life-threatening resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly or birth defect, required inpatient hospitalization or led to prolongation of hospitalization and other medically important events. (NCT02216214)
Timeframe: From first dose of study drug up to 30 days after last dose of study drug (up to 13 weeks)

,
InterventionParticipants (Count of Participants)
AEsRelated AEsAEs Leading to DeathsSAEsDrug-Related SAEsAEs Leading to Study Drug Discont.Drug-related AEs Leading to Study Drug Discont.
Mirabegron2098401501410
Placebo174570122147

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Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours

An incontinence episode was defined as the complaint of any involuntary leakage of urine. Participants with 50% reduction in mean number of incontinence episodes per 24 hours were defined as participants with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the treatment period at each visit. (NCT02216214)
Timeframe: End of treatment (up to 12 weeks)

Interventionpercentage of participants (Number)
Placebo60.0
Mirabegron72.4

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Percentage of Participants With ≥ 1-Point Improvement From Baseline in PPBC

The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition. Participants with ≥ 1-point improvement from baseline in PPBC were defined as participants with at least 1-point improvement from baseline in PPBC at each visit. (NCT02216214)
Timeframe: End of treatment (up to 12 weeks)

Interventionpercentage of participants (Number)
Placebo54.4
Mirabegron64.7

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Percentage of Participants With Zero Incontinence Episodes Per 24 Hours

An incontinence episode was defined as the complaint of any involuntary leakage of urine. Participants with zero incontinence episodes per 24 hours were defined as participants who had no incontinence episodes per 24 hours during the treatment period at each visit. (NCT02216214)
Timeframe: End of treatment (up to 12 weeks)

Interventionpercentage of participants (Number)
Placebo30.4
Mirabegron38.4

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Change From Baseline in Number of Incontinence Episodes Reported During 3-Day Diary Prior to Each Visit

An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes were calculated as the total number of the incontinence episodes recorded during the 3-day micturition diary period. (NCT02216214)
Timeframe: Baseline and Weeks 4, 8 and EOT (up to 12 weeks)

,
Interventionincontinence episodes (Mean)
Week 4Week 8EOT
Mirabegron-1.44-1.77-1.94
Placebo-1.03-1.36-1.40

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Change From Baseline to EOT in Mean Number of Urgency Incontinence Episodes Per 24 Hours

An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency episodes was calculated as the average number of times a participant recorded an urgency incontinence episode per day during the 3-day micturition diary period. (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)

Interventionurgency incontinence episodes/24 hours (Least Squares Mean)
Placebo-1.37
Mirabegron-1.93

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Change From Baseline in the Mean Number of Incontinence Episodes Per 24 Hours

"Participants completed the patient diary (paper document) for 3 days immediately before each visit. An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urinary incontinence' was indicated, divided by the number of days on which episodes were recorded. Only participants who had an incontinence episode at baseline was included in the analysis." (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 28, 40, 52

,,,
Interventionincontinence episodes (Mean)
Week 4Week 8Week 12Week 16Week 28Week 40Week 52End of treatment
Mirabegron + Imidafenacin-0.81-0.74-0.86-0.97-0.99-0.96-1.02-1.03
Mirabegron + Propiverine-1.06-1.21-1.34-1.32-1.28-1.28-1.29-1.18
Mirabegron + Solifenacin-1.13-1.16-1.27-1.23-1.31-1.23-1.31-1.25
Mirabegron + Tolterodine-1.09-1.21-1.23-1.33-1.28-1.07-1.18-1.15

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Change From Baseline in the Mean Number of Micturitions Per 24 Hours

"Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean number of micturitions per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urinated was indicated, divided by the number of days on which episodes were recorded." (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 28, 40, 52

,,,
Interventionmicturitions (Mean)
Week 4Week 8Week 12Week 16Week 28Week 40Week 52End of treatment
Mirabegron + Imidafenacin-1.23-1.62-1.74-1.86-1.97-1.80-1.82-1.75
Mirabegron + Propiverine-1.44-1.89-1.90-2.21-2.10-1.97-2.08-1.89
Mirabegron + Solifenacin-1.57-1.85-2.04-2.33-2.29-2.12-2.29-2.18
Mirabegron + Tolterodine-1.51-1.72-2.18-2.202.33-1.92-1.80-1.91

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Change From Baseline in the Mean Number of Nocturia Episodes Per Night

"Participants completed the patient diary (paper document) for 3 days immediately before each visit. A nocturia episode was defined as waking at night 1 or more times to void. Night time was defined as the period between bedtime and the wake-up time the following day (micturitions at the same time as the wake-up time were excluded). The mean number of nocturia episodes per night was calculated by taking the sum of nocturia episodes in the patient diary where the variable urinated was indicated during the night time, divided by the number of nights. Only participants who had a nocturia episode at baseline was included in the analysis." (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 28, 40, 52

,,,
Interventionnocturia episodes (Mean)
Week 4Week 8Week 12Week 16Week 28Week 40Week 52End of treatment
Mirabegron + Imidafenacin-0.32-0.42-0.45-0.54-0.48-0.39-0.53-0.48
Mirabegron + Propiverine-0.29-0.37-0.28-0.37-0.39-0.45-0.44-0.38
Mirabegron + Solifenacin-0.33-0.42-0.45-0.49-0.42-0.53-0.55-0.47
Mirabegron + Tolterodine-0.49-0.44-0.47-0.50-0.54-0.54-0.50-0.48

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Change From Baseline in the Mean Number of Urgency Episodes Per 24 Hours

"Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urgency episode was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urgency was indicated, divided by the number of days on which episodes were recorded. Only participants who had an urgency episode at baseline was included in the analysis." (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 28, 40, 52

,,,
Interventionurgency episodes (Mean)
Week 4Week 8Week 12Week 16Week 28Week 40Week 52End of treatment
Mirabegron + Imidafenacin-1.23-1.50-1.88-2.01-2.18-2.14-2.15-2.04
Mirabegron + Propiverine-1.63-1.90-2.18-2.36-2.26-2.27-2.33-2.24
Mirabegron + Solifenacin-1.53-1.78-2.06-2.30-2.28-2.14-2.04-2.03
Mirabegron + Tolterodine-1.49-1.89-2.10-2.26-2.28-2.19-2.26-2.07

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Change From Baseline in the Mean Volume Voided Per Micturition

"Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean volume per micturition was calculated by taking the sum of the urinary volumes where the volume voided was > 0 and where urinary incontinence was not indicated in the patient diary, divided by the number of micturitions where the volume voided was > 0 and where urinary incontinence was not indicated. Only participants who had volume voided was > 0 at baseline was included in the analysis." (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 28, 40, 52

,,,
InterventionmL (Mean)
Week 4Week 8Week 12Week 16Week 28Week 40Week 52End of treatment
Mirabegron + Imidafenacin20.06223.82027.07224.48929.87329.82636.65332.854
Mirabegron + Propiverine30.11138.61441.43340.66141.88743.10240.59938.691
Mirabegron + Solifenacin30.67738.32839.45239.95236.02543.57841.74440.004
Mirabegron + Tolterodine32.85435.35136.59837.78634.82341.37840.54840.683

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Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

TEAEs were defined as AEs observed after the first administration of the study drugs for the treatment period. The investigator assessed the severity of AEs, including abnormal clinical laboratory values, electrocardiogram (ECG), vital signs, as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator. (NCT02294396)
Timeframe: From first dose of study drug up to week 52

,,,
InterventionParticipants (Count of Participants)
Any TEAEsMildModerateSevereDrug-related TEAEsTEAEs leading to deathDrug-related TEAEs leading to deathSerious TEAEsDrug-related serious TEAEsTEAEs leading to withdrawal of treatmentDrug-related TEAEs leading to withdrawal of treat.
Mirabegron + Imidafenacin1331161527200501610
Mirabegron + Propiverine1351221308100411917
Mirabegron + Solifenacin13111315376001002312
Mirabegron + Tolterodine120104124741091188

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Change From Baseline in the Mean Number of Urge Incontinence Episodes Per 24 Hours

"Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urge incontinence episode was defined as any episode when both urgency and incontinence occurred concurrently. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urgency and urinary incontinence' were indicated, divided by the number of days on which episodes were recorded. Only participants who had an urge incontinence episode at baseline was included in the analysis." (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 28, 40, 52

,,,
Interventionurge incontinence episodes (Mean)
Week 4Week 8Week 12Week 16Week 28Week 40Week 52End of treatment
Mirabegron + Imidafenacin-0.72-0.71-0.79-0.87-0.85-0.91-0.93-0.91
Mirabegron + Propiverine-1.00-1.14-1.25-1.22-1.10-1.14-1.14-1.12
Mirabegron + Solifenacin-1.13-1.15-1.20-1.17-1.26-1.19-1.23-1.20
Mirabegron + Tolterodine-0.96-1.05-1.13-1.22-1.18-1.07-1.15-1.05

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Number for Participants Who Achieved Normalization of the Mean Number of Incontinence Episodes Per 24 Hours

Normalization for the mean number of incontinence episodes per 24 hours was defined as no incontinence episode per 24 hours. (NCT02294396)
Timeframe: Week 52 (end of treatment)

InterventionParticipants (Count of Participants)
Mirabegron + Solifenacin61
Mirabegron + Propiverine61
Mirabegron + Imidafenacin69
Mirabegron + Tolterodine71

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Number for Participants Who Achieved Normalization of the Mean Number of Micturitions Per 24 Hours

Normalization for the mean number of micturitions per 24 hours was defined as < 8 micturitions per 24 hours. (NCT02294396)
Timeframe: Week 52 (end of treatment)

InterventionParticipants (Count of Participants)
Mirabegron + Solifenacin60
Mirabegron + Propiverine47
Mirabegron + Imidafenacin47
Mirabegron + Tolterodine51

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Number for Participants Who Achieved Normalization of the Mean Number of Urgency Episodes Per 24 Hours

Normalization for the mean number of urgency episodes per 24 hours was defined as no urgency episode per 24 hours. (NCT02294396)
Timeframe: Week 52 (end of treatment)

InterventionParticipants (Count of Participants)
Mirabegron + Solifenacin70
Mirabegron + Propiverine77
Mirabegron + Imidafenacin64
Mirabegron + Tolterodine76

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Number of Participants Who Achieved Normalization for OABSS Total Score

Normalization for OABSS Total Score was defined as OABSS total score ≤ 2 or OABSS Question 3 score ≤ 1. (NCT02294396)
Timeframe: Week 52 (end of treatment)

InterventionParticipants (Count of Participants)
Mirabegron + Solifenacin98
Mirabegron + Propiverine101
Mirabegron + Imidafenacin91
Mirabegron + Tolterodine96

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Number of Participants Who Achieved Normalization of the Mean Number of Nocturia Episodes Per 24 Hours

Normalization for the mean number of nocturia episodes per 24 hours was defined as no nocturia episode per 24 hours. (NCT02294396)
Timeframe: Week 52 (end of treatment)

InterventionParticipants (Count of Participants)
Mirabegron + Solifenacin26
Mirabegron + Propiverine21
Mirabegron + Imidafenacin21
Mirabegron + Tolterodine14

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Change From Baseline in OAB-q SF Total HRQL Score

The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the HRQL. The HRQL section included 13 questions. For each participant, the total HRQL score was derived as a sum of scores for Questions 7 to 19. The total score ranges from 13 to 78 with higher total HRQL score indicating greater HRQL. OAB-q SF data obtained at week 0 visit were used as baseline. (NCT02294396)
Timeframe: Baseline and week 12, 28 and 52

,,,
Interventionunits on a scale (Mean)
Week 12Week 28Week 52End of treatment
Mirabegron + Imidafenacin11.0614.8814.6713.99
Mirabegron + Propiverine11.3513.0513.8912.46
Mirabegron + Solifenacin12.0715.1515.9914.38
Mirabegron + Tolterodine12.0512.9415.0614.36

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Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Symptom Severity Score

The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Symptom Severity and the Health-related Quality of Life (HRQL). The Symptom Severity section included 6 questions. For each participant, the symptom severity score was derived as a sum of scores for Questions 1 to 6. The total score ranges from 6 to 36 with higher symptom severity score indicating greater symptom bother. OAB-q SF data obtained at week 0 visit were used as baseline. (NCT02294396)
Timeframe: Baseline and week 12, 28 and 52

,,,
Interventionunits on a scale (Mean)
Week 12Week 28Week 52End of treatment
Mirabegron + Imidafenacin-17.15-20.40-20.51-18.89
Mirabegron + Propiverine-20.2-21.40-20.68-18.99
Mirabegron + Solifenacin-18.59-21.38-20.55-18.92
Mirabegron + Tolterodine-21.22-21.95-22.49-21.28

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Change From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score

The OABSS questionnaire was a questionnaire completed by participants with 4 questions regarding their OAB symptoms. For each participant, the OABSS total score was calculated from the sum total of the score of each question. The total score ranges from 0 to 15 with higher score indicating more symptoms. The OABSS data obtained at week 0 were used as baseline. (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 28 and 52

,,,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12Week 16Week 28Week 52End of treatment
Mirabegron + Imidafenacin-2.4-3.1-3.4-3.8-3.9-4.1-3.9
Mirabegron + Propiverine-3.1-3.7-4.2-4.4-4.4-4.1-4.1
Mirabegron + Solifenacin-2.9-3.5-4.0-4.1-4.0-4.0-3.9
Mirabegron + Tolterodine-3.0-3.5-4.0-4.4-4.3-4.3-4.2

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Change From Baseline in Postvoid Residual (PVR) Volume

Measurement of PVR volume was made using either ultrasonography or urethral catheterization, provided that the same method was used for the same participant throughout the study. (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,,
InterventionmL (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of treatment
Mirabegron + Imidafenacin6.815.777.194.042.972.795.562.192.185.193.142.222.844.52
Mirabegron + Propiverine9.993.233.671.063.534.033.871.340.663.291.030.714.586.83
Mirabegron + Solifenacin9.0710.684.727.512.324.992.950.704.116.032.172.603.568.17
Mirabegron + Tolterodine8.218.396.048.674.681.465.073.113.125.400.502.332.025.94

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Change From Baseline in Trail Making Test, Trail A Score at 8 Weeks

Trail Making Test, Trail A Time, Range 0-150 seconds, Lower score indicates better functioning (NCT02436889)
Timeframe: Baseline and 8 weeks

Interventionseconds (Mean)
Mirabegron-11.34
Tolterodine Tartrate0.67

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Change From Baseline in Urge Incontinence Episodes Per Day on a Voiding Diary at 8 Weeks.

The sum of urge type incontinence episodes reported by participants on a voiding diary per day. (NCT02436889)
Timeframe: Baseline and 8 weeks

Interventionepisodes per day (Mean)
Mirabegron-1.64
Tolterodine Tartrate-3.74

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Change From Baseline in California Verbal Learning Test (CVLT) Score at 8 Weeks

Range of 0-80, with the higher the score the better. (NCT02436889)
Timeframe: Baseline to Week 8

InterventionScore on a Scale (Mean)
Mirabegron4.70
Tolterodine Tartrate1.59

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Change From Baseline in Short Physical Performance Battery (SPPB) Score at 8 Weeks

Physical function/mobility, Range 0-12, the higher the score the better. (NCT02436889)
Timeframe: Baseline to Week 8

Interventionscore on a scale (Mean)
Mirabegron-0.39
Tolterodine Tartrate0.24

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Change From Baseline in Total Urinary Incontinence Frequency Measured by a Voiding Diary at 8 Weeks

Study participants record number of urinary incontinence episodes in a voiding diary. The total urinary incontinence frequency is the sum of urinary incontinence episodes per day. (NCT02436889)
Timeframe: Baseline to Week 8

Interventionepisodes per day (Mean)
Mirabegron-2.04
Tolterodine Tartrate-3.91

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Improvement From Baseline in the Incontinence Symptom Severity Index (ISSI) in the Myrbetriq™ Group at the 1 Week Follow-up Compared to Placebo Group.

"Only seven patients were enrolled and two of them withdrew after the first dose. Therefore, we are only left with 5 patients completing the study.~Incontinence symptom severity index is a self-assessment instrument for voiding symptom severity. It assesses 8 symptom domains: emptying, urgency, urge incontinence, nocturia, daytime frequency, stress incontinence, leakage with physical activity, and pad use. absent/mild (0-6), moderate (7-16), severe (>16).~." (NCT02462837)
Timeframe: 1 week

Interventionscore on a scale (Mean)
Treatment Arm10
Placebo Arm6.67

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Improvement From Baseline in the Incontinence Symptom Severity Index (ISSI) in the Myrbetriq™ Group at the 2 Week Follow-up Compared to Placebo Group.

Incontinence symptom severity index is a self-assessment instrument for voiding symptom severity. It assesses 8 symptom domains: emptying, urgency, urge incontinence, nocturia, daytime frequency, stress incontinence, leakage with physical activity, and pad use. absent/mild (0-6), moderate (7-16), severe (>16). (NCT02462837)
Timeframe: 2 weeks

Interventionscore on a scale (Mean)
Treatment Arm9.5
Placebo Arm8

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Improvement From Baseline on the Patient Global Impression of Severity (PGI-S) at the 2 Week Follow-up.

Only seven patients were enrolled and two of them withdrew after the fist dose. Therefore, we are only left with 5 patients completing the study. PGI-S is a four item questionnaire asking for patient enumeration of their urinary symptoms when compared to symptoms prior to surgery (1= normal, 2=mild, 3=moderate, 4=severe) (NCT02462837)
Timeframe: 2 weeks

Interventionscore on a scale (Mean)
Treatment Arm2.5
Placebo Arm2

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Reduction in Pain Medicine Intake at the 2 Week Follow-up

This outcome measure will be listed in 1) mean number of days that pain medications were taken (NCT02462837)
Timeframe: 2 weeks

Interventiondays (Mean)
Treatment Arm5
Placebo Arm7.67

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Reduction in Pain Medicine Intake at the 2 Week Follow-up

This outcome measure will be listed in mean number of times per day that pain medication was taken (NCT02462837)
Timeframe: 2 weeks

Intervention# times per day pain medication taken (Mean)
Treatment Arm2.22
Placebo Arm1.4

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Improvement in Pain and Discomfort Perception Using a 10 Point Visual Analog Scale for Pain Assessment (VAS) at the 1 and 2 Week Follow-up.

Only seven patients were enrolled and two of them withdrew after the first dose. Therefore, we are only left with 5 patients completing the study. Visual analog scale is from 1-10 (10 being the worse possible pain). (NCT02462837)
Timeframe: 1 week, 2 weeks

,
Interventionscore on a scale (Mean)
1 week follow/up2 week follow/up
Placebo Arm2.671.33
Treatment Arm44.5

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Improved Overactive Bladder Symptoms as a Measure of Efficacy of Mirabegron

Change in mean bladder capacity from baseline to final visit based on voiding diary. (NCT02468830)
Timeframe: Participants will be followed for duration of the study, up to 52 weeks

Interventionmilliliter (Median)
baselineFinal visit
Mirabegron150200

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Improved Overactive Bladder Symptoms as a Measure of Efficacy of Mirabegron

Percent change in the frequency of urinary incontinence episodes as a Measure of Efficacy. (NCT02468830)
Timeframe: Participants will be followed for the duration of the study, up to 52 weeks

InterventionParticipants (Count of Participants)
Complete elimination of urinary incontinence:100%Significant response > 90%-Partial response: 50-89%Failure < 50%
Mirabegron1314256

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Improved Quality of Life Using the Patient Perception of Bladder Condition (PPBC) Scale

"The Patient Perception of Bladder Condition (PPBC) scale on a 6-point score scale at baseline and final visit.~Explanation of possible answer:~does not cause me any problems at all,~causes me some very minor problems,~causes me some minor problems,~causes me (some) moderate problems,~causes me severe problems,~causes me many severe problems" (NCT02468830)
Timeframe: Participants will be followed for the duration of the study, up to 52 weeks

Interventionunits on a scale (Median)
baselineFinal visit
Mirabegron4.02.0

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Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Mirabegron

Cardiovascular safety: mean difference in heart rate (variation in heart rate increase of more than 20%). Heart rate was taken at initiation of study drug, at each visit and at the study end. (NCT02468830)
Timeframe: Participants will be followed for the duration of the study, up to 52 weeks

InterventionParticipants (Count of Participants)
No change in heart rate over 20%No significant change in heart rate
Mirabegron5858

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Number of Participants With Cardio Vascular Safety

"Cardiovascular safety: mean difference in blood pressure (Variation in blood pressure: systolic ±20 mmHg, diastolic ±15 mmHg).~Parameters to be measure at each visit but particularly at visit 2 (Week 0, first dose on site), to be obtained before and 1 hour after taking the medication)." (NCT02468830)
Timeframe: Participants will be followed for the duration of the study, up to 52 weeks

InterventionParticipants (Count of Participants)
No variation:systolic ±20 mmHg in blood pressureNo variation:Diastolic ±15 mmHg in blood pressure
Mirabegron5858

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Number of Participants With Grade 2 or 3 Urgency Episodes as a Measure of Efficacy

On voiding diary, participants described their urgency according to the Canadian Urological Association voiding diary, range 0 to 3 at study entry and at study end. (NCT02476175)
Timeframe: up to 52 weeks

InterventionParticipants (Count of Participants)
Participants with urgency 2-3 at entryParticipants without urgency2-3 at week 52studyend
Add-on Mirabegron3219

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Response to Urinary Incontinence as a Composite Measure of Efficacy of add-on Mirabegron

Results were based on the International Children's Continence Sociéty classification. Parents or patients supervised by their parents rated symptom relief on a questionnaire as complete cure (definied as dryness) or partial response (reduction of 50% to 99% in incontinence episodes). (NCT02476175)
Timeframe: up to 52 weeks

InterventionParticipants (Count of Participants)
Complete response:100%improvement of incontinencePartial response: 50 to 99 % reduction
Add-on Mirabegron1223

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Number of Participants Showing Improved Quality of Life Using the Patient Perception of Bladder Condition Scale and Voiding Diaries

"Effectiveness will also be assessed using the Patient Perception of Bladder Condition (PPBC) scale on a 6-point scale ranging from 1 to 6 ( 1 is the best score and 6 is the worst score), at study initiation, every visit and at the study end.~Results will be documented based on subjective relief of symptoms and objective voiding diaries.~Participants perception of bladder condition score at initiation of treatment was:4 and at last follow up score was: 2." (NCT02476175)
Timeframe: Participants will be followed for the duration of the study, up to 52 weeks

InterventionParticipants (Count of Participants)
Add-on Mirabegron35

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Number of Participants Without Variation in Heart Rate

Cardiovascular safety: mean difference in heart rate (with variation in heart rate increase of more than 20%). Heart rate was taken at initiation of study drug, at each visit and at the study end. (NCT02476175)
Timeframe: Participants will be followed for the duration of the study, up to 52 weeks

InterventionParticipants (Count of Participants)
Add-on Mirabegron35

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Number of Participants With Cardio Vascular Safety

Cardiovascular safety: mean difference in blood pressure (Variation in blood pressure: systolic ±20 mmHg, diastolic ±15 mmHg), blood pressure was taken at each visit and at the study end. (NCT02476175)
Timeframe: Participants will be followed for the duration of the study, up to 52 weeks

InterventionParticipants (Count of Participants)
No variation:systolic ±20 mmHg in blood pressureNo variation:Diastolic ±15 mmHg in blood pressure
Add-on Mirabegron3535

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Change in Urinary Distress Inventory (UDI)

The Urinary Distress Inventory is a 29-item questionnaire that asks patients to report how bothered they are by symptoms of urinary urgency on a scale from 1 (not at all) to 4 (quite a bit). The total score ranges from 0 to 300 where higher scores indicate worsening symptom severity. (NCT02495389)
Timeframe: 12 weeks

Interventionscore on a scale (Mean)
BaselineAfter 12 weeks of therapyChange Score
Mirabegron121.2569.62-51.62

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Change in Pelvic Organ Prolapse Distress Inventory (POPDI) Score

The Pelvic Organ Prolapse Distress Inventory (POPDI) is a 16-item questionnaire that asks patients to report how bothered they are by symptoms of urinary urgency on a scale from 1 (not at all) to 4 (quite a bit). The total score ranges from 0 to 300 where higher scores indicate worsening symptom severity. (NCT02495389)
Timeframe: 12 weeks

Interventionscore on a scale (Mean)
BaselineAfter 12 weeks of therapyChange Score
Mirabegron77.8548.55-29.30

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Change in Colo-Rectal-Anal Distress Inventory (CRADI)

The Colo-Rectal-Anal Distress Inventory (CRADI) is a 17-item questionnaire that asks patients to report how bothered they are by symptoms of urinary urgency on a scale from 1 (not at all) to 4 (quite a bit). The total score ranges from 0 to 400 where higher scores indicate worsening symptom severity. (NCT02495389)
Timeframe: 12 weeks

Interventionscore on a scale (Mean)
BaselineAfter 12 weeks of therapyChange Score
Mirabegron94.5062.50-32.00

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Change in Montreal Cognitive Assessment Total Score

Change in Montreal Cognitive Assessment Total Score between week 2 and week 14. The Montreal Cognitive Assessment is a screening tool for global cognitive function with a total score ranging from 0 to 30 units on a scale, with higher score indicating better cognitive global function. Normal range is 26 thru 30. (NCT02536976)
Timeframe: From Week 2 to Week 14

Interventionunits on a scale (Mean)
Active Treatment1.5
Placebo2

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Change in Unified Parkinson's Disease Rating Scale

The UPDRS assesses motor and functional abilities of the subjects as it pertains to Parkinson's disease. The total UPDRS score (range 0-199; defined for this study as the sum of Parts I, II, III, and IV (I-Mentation, behavior, and mood section (4 items; range 0-16); II-Activities of Daily Living (ADL; 13 items; range 0-52); III-motor section (27 items; range 0-108) and IV-complications section; 11 items; range 0-23) will be completed by history and examination. Higher scores indicate greater severity of Parkinson's disease symptoms. (NCT02536976)
Timeframe: From Week 2 to Week 14

Interventionunits on a scale (Mean)
Active-5.3
Placebo-9

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Change in Overactive Bladder Questionnaire Subscale Scores

The Overactive Bladder Questionnaire (OABQ) is a 33-item, self-administered instrument that contains a symptom bother scale (8 items) and a health-related quality of life (HRQL) scale (25 items), pertaining to OAB symptoms impact on HRQL. Symptom bother score ranges from 0-100 with higher scores indicating greater severity of symptoms. The HRQL score ranges from 0-100 with higher scores indicating better quality of life. (NCT02536976)
Timeframe: From Week 2 to Week 14

,
Interventionunits on a scale (Mean)
Symptom SeverityHRQL
Active-13.313.7
Placebo12.55

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Change From Baseline to EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours

An urgency incontinence episode was defined as any episode when both urgency and incontinence occurred concurrently. The mean number of urgency incontinence episodes per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit. (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)

Interventionurgency incontinence episodes (Mean)
Placebo-0.65
Mirabegron 50mg-0.75

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Change From Baseline to EoT in Total International Prostate Symptom Score (IPSS)

The IPSS included an 7-item questionnaire that assesses urinary frequency and incomplete voiding along with a QoL assessment. Total IPSS score was the sum total of the score (range: 0-35) of each item (Questions 1-7). Negative change means improvement. (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)

Interventionunits on a scale (Mean)
Placebo-3.4
Mirabegron 50mg-4.4

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Change From Baseline to EoT in Symptom Bother as Assessed by the Overactive Bladder Questionnaire (OAB-q)

"The OAB-q was a 33-item questionnaire, which consisted of an 8-item symptom bother scale and 25 health-related QoL items that form 4 subscales (coping, concern, sleep, and social interaction) and a total health-related QoL score.~Symptom Bother was derived as sum of scores for questions 1-8 (range: 0-100). Higher Symptom Bother is indicative of greater symptom bother." (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)

Interventionunits on a scale (Mean)
Placebo-11.53
Mirabegron 50mg-16.09

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Change From Baseline to EoT in Postvoid Residual (PVR) Volume

PVR was measured by ultrasonography. (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)

InterventionmL (Mean)
Placebo-0.97
Mirabegron 50mg2.72

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Change From Baseline to EoT in Mean Volume Voided Per Micturition

The mean volume voided per micturition was calculated from data recorded by participants on a 3-day micturition diary before each visit. (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)

InterventionmL (Mean)
Placebo2.632
Mirabegron 50mg14.995

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Change From Baseline to EoT in Mean Number of Urgency Episodes Per 24 Hours

An urgency episode was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit. (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)

Interventionurgency episodes (Mean)
Placebo-1.66
Mirabegron 50mg-1.89

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Change From Baseline to EoT in Mean Number of Nocturia Episodes

A nocturia episode was defined as a micturition episode initiated between night time. Night time was defined as the period between sleep onset time and the wake-up time the following day (micturitions at the same time as the wake-up time were excluded). The mean number of nocturia episodes per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit. (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)

Interventionnocturia episodes (Mean)
Placebo-0.35
Mirabegron 50mg-0.31

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Change From Baseline to EoT in Mean Number of Incontinence Episodes Per 24 Hours

An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit. (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)

Interventionincontinence episodes (Mean)
Placebo-0.72
Mirabegron 50mg-0.77

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Change From Baseline to EoT in Total Overactive Bladder Symptom Score (OABSS)

The OABSS is a 4-item questionnaire that assesses urinary frequency. Total score was the sum total of the score of each item (ranges: 0-15). Negative change means improvement. (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)

Interventionunits on a scale (Mean)
Placebo-2.2
Mirabegron 50mg-2.8

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Change From Baseline to EoT in Maximum Urine Flow Rate (Qmax)

Urine flow rate was volume voided per micturition (voided volume) divided by time for the micturition (flow time). (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)

InterventionmL (Mean)
Placebo0.20
Mirabegron 50mg-0.25

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Change From Baseline to End of Treatment (EoT) in Mean Number of Micturitions Per 24 Hours

A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit. (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)

Interventionmicturitions (Mean)
Placebo-0.90
Mirabegron 50mg-1.35

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Change From Baseline to EoT in IPSS Subscale Scores

IPSS subscale scores was calculated by following each formula. Storage subscale was derived as sum of scores for questions 2, 4, and 7 (range: 1-15). Voiding subscale-1 was derived as sum of scores for questions 3, 5, and 6 (range: 1-15). Voiding subscale-2 was derived as sum of voiding subscale-1 and the score for question 1 (range: 1-20). Individual scores and IPSS Quality of Life (QoL) score was the score of each item (range: 1-6) (Questions 1-7 and QoL item). A higher score is indicative of worse condition and a negative change from baseline indicates an improvement. (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)

,
Interventionunits on a scale (Mean)
Storage SubscaleVoiding Subscale-1Voiding Subscale-2Quality of Life Item
Mirabegron 50mg-2.4-1.4-2.0-1.2
Placebo-1.7-1.3-1.7-0.9

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Change From Baseline to EoT in OABSS Subscale Scores

"Each OABSS subscale score was based on each question in the questionnaire: Daytime Frequency (How many times do you typically urinate from waking in the morning until sleeping at night? where scores range from 0-2), Nighttime Frequency (How many times do you typically wake up to urinate from sleeping at night until waking in the morning? where scores range from 0-3), Urgency (How often do you have a sudden desire to urinate, which is difficult to defer? where scores range from 0-5), Urgency Incontinence (How often do you leak urine because you cannot defer the sudden desire to urinate? where scores range from 0-5). A higher score is indicative of worse condition and a negative change from baseline indicates an improvement." (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)

,
Interventionunits on a scale (Mean)
Daytime FrequencyNighttime FrequencyUrgencyUrgency Incontinence
Mirabegron 50mg-0.3-0.3-1.5-0.7
Placebo-0.2-0.2-1.3-0.4

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Change From Baseline to Weeks 4, 8, 12 in Mean Number of Micturitions Per 24 Hours

A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit. (NCT02656173)
Timeframe: Baseline and week 4, 8 and 12

,
Interventionmicturitions (Mean)
Week 4Week 8Week 12
Mirabegron 50mg-0.55-0.76-1.36
Placebo-0.08-0.36-0.92

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Number of Participants With Adverse Events

Treatment-emergent adverse events (TEAE) was defined as an adverse event (AE) with onset during the double-blind treatment period or an AE with onset during the screening period with worsening severity during the double-blind treatment period. The investigator assessed the severity of AEs as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator. Serious TEAE was an AE considered serious. (NCT02656173)
Timeframe: From first dose of study drug up to Week 12

,
InterventionParticipants (Count of Participants)
Any TEAEsMildModerateSevereDrug-related TEAEsTEAEs leading to deathSerious TEAEsDrug-related serious TEAEsTEAEs leading to discontinuation of study drugDrug-related TEAEs leading to disc. of study drug
Mirabegron 50mg6656821106040
Placebo6457611803143

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Spontaneous Stone Passage Using Fisher's Exact Test

The primary outcome was stone passage rate at 30-days defined by either imaging (CT or Renal Ultrasound/KUB) or identification of stone using a straining device. (NCT02744430)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Arm 1 - Active8
Arm 2 - Placebo5

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Comparison of Pain Levels Between Treatment Groups Using the Wong-Baker Pain Rating Scale

Pain measures between treatment groups will be measured daily for each patient by using the Wong-Baker Pain Rating Scale. The Questionnaire will be observed in patients who require surgical intervention, and will be observed during study visit. A general linear model will be used to compare Wong-Baker pain scores between the treated and placebo groups. The model will also be used to explore associations between pain scores and demographic or clinical characteristics adjusting for treatment group. (NCT02744430)
Timeframe: 2 months

Interventionunits on a scale (Mean)
Arm 1 - Active0.21
Arm 2 - Placebo0.19

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Number of Participants With Study Drug Acceptability for Oral Suspension at Week 24

"Participants evaluated the taste of the study medication/oral suspension by ticking 1 of the following categories:Really Bad (0), Bad (1), Not Bad, Not Good (2), Good (3) & Really Good (4). Participants evaluated the smell of the study medication/oral suspension by ticking 1 of the following categories: Really Bad (0), Bad (1),Not Bad, Not Good (2), Good (3) & Really Good (4). Participants evaluated the consumption and the preparation of the study medication/oral suspension by ticking 1 of the following categories: Really Difficult (0),Difficult (1), Not Difficult, Not Easy (2), Easy (3) & Really Easy (4)." (NCT02751931)
Timeframe: Week 24

,
InterventionParticipants (Count of Participants)
Taste - Really badTaste - BadTaste - Not bad, not goodTaste - GoodTaste - Really goodSmell - Really badSmell - BadSmell - Not bad, not goodSmell - GoodSmell - Really goodTake - Really difficultTake - DifficultTake - Not difficult, not easyTake - EasyTake - Really EasyPrepare - Really difficultPrepare - DifficultPrepare - Not difficult, not easyPrepare - EasyPrepare - Really Easy
Adolescents (12 to < 18 Years)00200002000000200020
Children (3 to < 12 Years)313106208112022613013109

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Number of Participants With Study Drug Acceptability for Oral Suspension at Week 52

"Participants evaluated the taste of the study medication/oral suspension by ticking 1 of the following categories:Really Bad (0), Bad (1), Not Bad, Not Good (2), Good (3) & Really Good (4). Participants evaluated the smell of the study medication/oral suspension by ticking 1 of the following categories: Really Bad (0), Bad (1),Not Bad, Not Good (2), Good (3) & Really Good (4). Participants evaluated the consumption and the preparation of the study medication/oral suspension by ticking 1 of the following categories: Really Difficult (0),Difficult (1), Not Difficult, Not Easy (2), Easy (3) & Really Easy (4)." (NCT02751931)
Timeframe: Week 52

,
InterventionParticipants (Count of Participants)
Taste - Really badTaste - BadTaste - Not bad, not goodTaste - GoodTaste - Really goodSmell - Really badSmell - BadSmell - Not bad, not goodSmell - GoodSmell - Really goodTake - Really difficultTake - DifficultTake - Not difficult, not easyTake - EasyTake - Really EasyPrepare - Really difficultPrepare - DifficultPrepare - Not difficult, not easyPrepare - EasyPrepare - Really Easy
Adolescents (12 to < 18 Years)00200001100000200020
Children (3 to < 12 Years)12586215122013711003910

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Number of Participants With Study Drug Acceptability for Tablets at Week 24

"Participants evaluated the taste of the study medication/tablets by ticking 1 of the following categories: Really Bad (0), Bad (1), Not Bad, Not Good (2), Good (3) & Really Good (4). Participants evaluated the swallow of the study medication/tablets by ticking one of the following categories: Really Difficult (0), Difficult (1), Not Difficult, Not Easy (2), Easy (3) and Really Easy (4)." (NCT02751931)
Timeframe: Week 24

,
InterventionParticipants (Count of Participants)
Taste - Really badTaste - BadTaste - Not bad, not goodTaste - GoodTaste - Really goodSwallow - Really difficultSwallow - DifficultSwallow - Not difficult, not easySwallow - EasySwallow - Really easy
Adolescents (12 to < 18 Years)0015620021011
Children (3 to < 12 Years)12644002312

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Number of Participants With Study Drug Acceptability for Tablets at Week 4

"Participants evaluated the taste of the study medication/tablets by ticking 1 of the following categories: Really Bad (0), Bad (1), Not Bad, Not Good (2), Good (3) & Really Good (4). Participants evaluated the swallow of the study medication/tablets by ticking one of the following categories: Really Difficult (0), Difficult (1), Not Difficult, Not Easy (2), Easy (3) and Really Easy (4)." (NCT02751931)
Timeframe: Week 4

,
InterventionParticipants (Count of Participants)
Taste - Really badTaste - BadTaste - Not bad, not goodTaste - GoodTaste - Really goodSwallow - Really difficultSwallow - DifficultSwallow - Not difficult, not easySwallow - EasySwallow - Really easy
Adolescents (12 to < 18 Years)0074100075
Children (3 to < 12 Years)0053100135

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Number of Participants With Study Drug Acceptability for Tablets at Week 52

"Participants evaluated the taste of the study medication/tablets by ticking 1 of the following categories: Really Bad (0), Bad (1), Not Bad, Not Good (2), Good (3) & Really Good (4). Participants evaluated the swallow of the study medication/tablets by ticking one of the following categories: Really Difficult (0), Difficult (1), Not Difficult, Not Easy (2), Easy (3) and Really Easy (4)." (NCT02751931)
Timeframe: Week 52

,
InterventionParticipants (Count of Participants)
Taste - Really badTaste - BadTaste - Not bad, not goodTaste - GoodTaste - Really goodSwallow - Really difficultSwallow - DifficultSwallow - Not difficult, not easySwallow - EasySwallow - Really easy
Adolescents (12 to < 18 Years)001622002711
Children (3 to < 12 Years)00863002411

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Apparent Volume of Distribution After Non-intravenous Administration (Vz/F) of Mirabegron

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. (NCT02751931)
Timeframe: A total of 4 samples were collected over 2 sampling days at 2 separate visits at any of week 4, 8, 12, 24, 36, or 52, at the following time points: Sampling day 1- Predose; Sampling day 2- Predose and 2 samples 2-5 hours postdose more than 1 hour apart.

InterventionLiter (Mean)
Children PED25 (PKAS)14450
Adolescents PED25 (PKAS)15380
Children PED50 (PKAS)12150
Adolescents PED50 (PKAS)14770

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Change From Baseline in Maximum Cystometric Capacity (MCC) at Week 24

Change from baseline in MCC was based on filling urodynamics (volume at the end of filling). During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynamic assessment was confirmed valid by the central reviewers. Missing MCC observations at week 24 were imputed using last observation carried forward (LOCF). (NCT02751931)
Timeframe: Baseline and week 24

InterventionmL (Mean)
Children (3 to < 12 Years)72.09
Adolescents (12 to < 18 Years)113.21

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Change From Baseline in Maximum Cystometric Capacity at Week 4

Change from baseline in MCC was based on filling urodynamics (volume at the end of filling). During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynamic assessment was confirmed valid by the central reviewers. (NCT02751931)
Timeframe: Baseline and week 4

InterventionmL (Mean)
Children (3 to < 12 Years)41.36
Adolescents (12 to < 18 Years)80.78

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Maximum Plasma Concentration (Cmax) of Mirabegron

Cmax was defined as the maximum plasma concentration of mirabegron. (NCT02751931)
Timeframe: A total of 4 samples were collected over 2 sampling days at 2 separate visits at any of week 4, 8, 12, 24, 36, or 52, at the following time points: Sampling day 1- Predose; Sampling day 2- Predose and 2 samples 2-5 hours postdose more than 1 hour apart.

Interventionnanogram/milliliter (ng/mL) (Mean)
Children PED25 (PKAS)9.386
Adolescents PED25 (PKAS)9.044
Children PED50 (PKAS)20.55
Adolescents PED50 (PKAS)18.40

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Plasma Concentration of Mirabegron at the End of a Dosing Interval at Steady State (Ctrough)

Ctrough was defined as the measured plasma concentration of mirabegron at the end of a dosing interval at steady state. (NCT02751931)
Timeframe: A total of 4 samples were collected over 2 sampling days at 2 separate visits at any of week 4, 8, 12, 24, 36, or 52, at the following time points: Sampling day 1- Predose; Sampling day 2- Predose and 2 samples 2-5 hours postdose more than 1 hour apart.

Interventionng/mL (Mean)
Children PED25 (PKAS)5.312
Adolescents PED25 (PKAS)4.114
Children PED50 (PKAS)9.024
Adolescents PED50 (PKAS)8.888

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Time to Reach Maximum Plasma Concentration of Mirabegron Following Drug Administration (Tmax)

Tmax was defined as the time to reach maximum plasma concentration following drug administration. (NCT02751931)
Timeframe: A total of 4 samples were collected over 2 sampling days at 2 separate visits at any of week 4, 8, 12, 24, 36, or 52, at the following time points: Sampling day 1- Predose; Sampling day 2- Predose and 2 samples 2-5 hours postdose more than 1 hour apart.

Interventionhours (Mean)
Children PED25 (PKAS)3.000
Adolescents PED25 (PKAS)3.500
Children PED50 (PKAS)3.419
Adolescents PED50 (PKAS)3.635

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Change From Baseline in Average Catheterized Volume Per Catheterization

For each participant, the average catheterized volume per catheterization was calculated as the sum of all available/non-missing catheterized volumes recorded over 2 measuring days in the weekend diary, whether or not the 2 days were consecutive divided by the number of catheterizations with non-missing volumes. If volumes were recorded on 1 single day of the weekend diary, the average catheterized volume per catheterization was calculated using all available/non-missing catheterized volumes recorded that day. If no volumes were recorded on any day of the weekend diary, the average catheterized volume per catheterization was missing. A valid bladder diary day in the weekend diary was any e-diary day for which ≥1 catheterized volume >0 mL was recorded with complete date and time. (NCT02751931)
Timeframe: Baseline and weeks 2, 4, 8, 12, 24, 36 and 52

,
InterventionmL (Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 24Change at Week 36Change at Week 52
Adolescents (12 to < 18 Years)35.9951.9645.1043.9459.3152.1442.40
Children (3 to < 12 Years)14.5830.0836.9032.2541.6353.8742.84

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Change From Baseline in Average Morning Catheterized Volume

The first morning catheterized volume was the first recorded non-zero volume within or after the hour of the wake-up time on a volume-measuring day in the e-diary. The average first morning catheterized volume was calculated as the average of the available first morning catheterized volumes recorded for the 2 measuring days in the weekend e-diary, whether or not these 2 days were consecutive. If the first morning catheterized volume was recorded on 1 single day of the weekend e-diary, the average morning catheterized is the first morning catheterized that day. If no first morning catheterized volumes are recorded on any day of the weekend e-diary, the average first morning catheterized volume was missing. A valid bladder diary day in the weekend diary was any e-diary day for which >=1 catheterized volume >0 mL was recorded with complete date and time. (NCT02751931)
Timeframe: Baseline and weeks 2, 4, 8, 12, 24, 36 and 52

,
InterventionmL (Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 24Change at Week 36Change at Week 52
Adolescents (12 to < 18 Years)39.5275.2544.4338.2386.6668.4738.14
Children (3 to < 12 Years)7.9819.8134.018.6840.7631.0831.83

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Change From Baseline in Bladder Compliance (ΔV/ΔP)

Bladder compliance was an indication of the elasticity of the bladder wall and was calculated by dividing the change in volume by the change in detrusor pressure during the filling of the bladder. Change from baseline in bladder compliance (change in volume/change in pressure) was assessed by the independent central reviewers and reported as annotations on the urodynamic trace and in an external database. During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynamic assessment was confirmed valid by the central reviewers. (NCT02751931)
Timeframe: Baseline and weeks 4 and 24

,
InterventionmL/cm H2O (Mean)
Change at Week 4Change at Week 24
Adolescents (12 to < 18 Years)15.1613.59
Children (3 to < 12 Years)-4.0914.62

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Change From Baseline in Detrusor Pressure at End of Filling

Detrusor pressure was defined as bladder pressure minus intra-abdominal pressure as assessed by urodynamics. Filling was stopped (end of filling) when the detrusor pressure exceeded 100 cm H2O or was considered dangerously high by the investigator or urodynamicist (for instance, a prolonged passive detrusor pressure > 40 cm H2O). During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynamic assessment was confirmed valid by the central reviewers. (NCT02751931)
Timeframe: Baseline and weeks 4 and 24

,
Interventioncm H2O (Mean)
Change at Week 4Change at Week 24
Adolescents (12 to < 18 Years)-6.48-13.19
Children (3 to < 12 Years)-12.38-18.11

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Change From Baseline in Filling Bladder Volume Until First Overactive Detrusor Contraction (> 15 cm H20)

Detrusor overactivity is the occurrence of involuntary detrusor contractions during filling cystometry. During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynamic assessment was confirmed valid by the central reviewers. If no detrusor contraction of > 15 cm H2O occurred, the bladder volume was imputed with maximum cystometric capacity. (NCT02751931)
Timeframe: Baseline and weeks 4 and 24

,
InterventionmL (Median)
Change at Week 4Change at Week 24
Adolescents (12 to < 18 Years)41.1562.00
Children (3 to < 12 Years)54.0068.00

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Change From Baseline in Filling Bladder Volume Until First Overactive Detrusor Contraction (> 15 cm H20): Paired T-test

Detrusor overactivity is the occurrence of involuntary detrusor contractions during filling cystometry. During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynamic assessment was confirmed valid by the central reviewers. If no detrusor contraction of > 15 cm H2O occurred, the bladder volume was imputed with maximum cystometric capacity. (NCT02751931)
Timeframe: Baseline and weeks 4 and 24

,
InterventionmL (Mean)
Change at Week 4Change at Week 24
Adolescents (12 to < 18 Years)73.80121.33
Children (3 to < 12 Years)56.0993.09

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Change From Baseline in Filling Bladder Volume Until First Overactive Detrusor Contraction (> 15 cm H20): Wilcoxon Signed-rank Test Updated Analysis

Detrusor overactivity is the occurrence of involuntary detrusor contractions during filling cystometry. During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynamic assessment was confirmed valid by the central reviewers. If no detrusor contraction of > 15 cm H2O occurred, the bladder volume was imputed with maximum cystometric capacity. This updated analysis is presented as the original analysis of bladder volume until first detrusor contraction (> 15 cm H2O) did not impute missing bladder volume data with the maximum cystometric capacity (MCC) value at that visit according to the statistical analysis plan (SAP). This analysis was updated to impute missing values for volume at first contraction with respective MCC values. (NCT02751931)
Timeframe: Baseline and weeks 4 and 24

,
InterventionmL (Median)
Change at Week 4Change at Week 24
Adolescents (12 to < 18 Years)46.3078.45
Children (3 to < 12 Years)48.0076.00

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Change From Baseline in Maximum Catheterized Daytime Volume (MCDV)

For each participant, the MCDV was calculated using all available/non-missing catheterized daytime volumes for the 2 measuring days in the weekend e-diary, whether or not the 2 days were consecutive. Maximum value was calculated separately for each measuring day and the mean of the 2 values was used. If volumes were recorded on 1 single day of the weekend e-diary, the MCDV was calculated using all available/non-zero catheterized daytime volumes recorded that day. If no volumes were recorded on any day of the weekend e-diary, the MCDV was missing. Daytime was defined as the time between wake-up time (minus 30 min) & time to sleep (plus 29 min) recorded in the e-diary. A valid bladder diary day in the weekend diary was any e-diary day for which >=1 catheterized volume >0 mL was recorded with complete date and time. (NCT02751931)
Timeframe: Baseline and weeks 2, 4, 8, 12, 24, 36 and 52

,
InterventionmL (Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 24Change at Week 36Change at Week 52
Adolescents (12 to < 18 Years)35.5870.3538.1143.0481.3750.9049.13
Children (3 to < 12 Years)18.1337.7143.9129.0544.2058.4953.76

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Change From Baseline in Maximum Catheterized Volume

For each participant, the maximum catheterized volume per day was calculated using all available/non-missing catheterized volumes recorded for the 2 measuring days in the weekend e-diary, whether or not these 2 days were consecutive. Maximum value was calculated separately for each measuring day and the mean of the two values was used. If volumes recorded on 1 single day of the weekend e-diary, the maximum catheterized volume per day was calculated using all available/non-zero catheterized volumes recorded that day. If no volumes were recorded on any day of the weekend e-diary, the maximum catheterized volume per day was missing. A valid bladder diary day in the weekend diary was any e-diary day for which >=1 catheterized volume >0 mL was recorded with complete date and time. (NCT02751931)
Timeframe: Baseline and weeks 2, 4, 8, 12, 24, 36 and 52

,
InterventionmL (Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 24Change at Week 36Change at Week 52
Adolescents (12 to < 18 Years)42.3873.2542.8647.2984.3954.7854.30
Children (3 to < 12 Years)17.5046.6945.2733.2349.8860.0953.51

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Change From Baseline in Mean Number of Leakage Episodes Per Day

For each participant, the mean number of leakage episodes per day (during day & night time) was calculated using all available/non-missing number of leakage episodes for the 2 measuring days in the weekend diary during day & night time. If the number of leakage episodes was recorded on 1 single day in the 7-day diary during day & night time, the mean number of leakage episodes per day during day & night time is equal to the total number of leakage episodes recorded that day during day & night time. If no leakage episodes were recorded on any day of the weekend diary during day & night time, the mean number of leakage episodes per day was zero. Participants who did not report any leakage episode during the visit were imputed with a '0' for that visit. A valid bladder diary day in the weekend diary was any e-diary day for which ≥1 catheterized volume >0 mL was recorded with complete date and time. (NCT02751931)
Timeframe: Baseline and weeks 2, 4, 8, 12, 24, 36 and 52

,
Interventionleakage episodes per day (Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 24Change at Week 36Change at Week 52
Adolescents (12 to < 18 Years)-0.53-0.87-0.65-0.65-0.75-0.81-1.12
Children (3 to < 12 Years)0.35-1.141.160.370.18-1.98-0.94

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Change From Baseline in Mean Number of Leakage Episodes Per Day: Updated Analysis

For each participant, the mean number(no.) of leakage episodes per day (during day & night time) was calculated using all available/non-missing no. of leakage episodes for the 2 measuring days in the weekend diary during day & night time. If the no. of leakage episodes was recorded on 1 single day in the 7-day diary during day & night time, the mean no. of leakage episodes per day during day & night time is equal to the total no. of leakage episodes recorded that day during day & night time. If no leakage episodes were recorded on any day of the weekend diary during day & night time, the mean no. of leakage episodes per day was zero. Participants who did not report leakage episode during the visit were imputed with a '0' for that visit. A valid bladder diary day in weekend diary was any e-diary day for which ≥1 catheterized volume >0 mL was recorded with complete date and time. Updated analysis is presented because one participant entered weight of leakage instead of no. of leakages. (NCT02751931)
Timeframe: Baseline and weeks 2, 4, 8, 12, 24, 36 and 52

,
Interventionleakage episodes per day (Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 24Change at Week 36Change at Week 52
Adolescents (12 to < 18 Years)-0.71-0.95-0.84-0.86-0.98-0.98-1.05
Children (3 to < 12 Years)0.78-1.321.680.49-2.34-4.10-1.99

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Change From Baseline in Number of Dry Days Per 7 Days (Day and Night Time)

Dry days were defined as leakage-free days, this included day and night time. Participants recorded dry days in the 7-day diary. Dry days were calculated as follows: Ddry was the number of valid diary days where the response to the question 'Did you leak between this catheterization and the last one' was 'No' each time a new catheterization was entered in the e-diary during the day & night time period. Dwet was the number of valid diary days where the response to the question 'Did you leak between this catheterization and the last one' was 'Yes' for at least one catheterization entered during the day and night time period. If (Ddry + Dwet) > 3, the number of dry days per 7 days was calculated as Ddry/(Ddry + Dwet) x 7, otherwise the value was missing. (NCT02751931)
Timeframe: Baseline and weeks 2, 4, 8, 12, 24, 36 and 52

,
Interventiondry days per 7 days (Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 24Change at Week 36Change at Week 52
Adolescents (12 to < 18 Years)0.821.362.261.932.171.882.14
Children (3 to < 12 Years)0.340.681.141.311.341.331.38

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Change From Baseline in Number of Overactive Detrusor Contractions (> 15 cm H20) Until End of Filling

Detrusor overactivity is the occurrence of involuntary detrusor contractions during filling cystometry. During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynamic assessment was confirmed valid by the central reviewers. (NCT02751931)
Timeframe: Baseline and weeks 4 and 24

,
Interventionoveractive detrusor contractions (Mean)
Change at Week 4Change at Week 24
Adolescents (12 to < 18 Years)-0.64-0.77
Children (3 to < 12 Years)0.44-1.86

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Change From Baseline in Patient Global Impression of Severity Scale (PGI-S)

"The PGI-S was an answer to the question: How did you feel about your bladder condition during the past 3 days? Participants evaluated their recent condition as Really Bad(0), Bad (1), Not Bad, Not Good (2), Good (3) &Really Good (4). An increase indicated improvement. The total score ranged from 0 to 4, where higher scores indicated improvement.The change from baseline to each postbaseline visit in the PGI-S score is the value at the post-baseline visit minus the value at the baseline visit. If either the baseline or the post-baseline visit value is missing, the change from baseline was missing. A positive change indicated an improvement while a negative change indicated a worsening." (NCT02751931)
Timeframe: Baseline and weeks 24 and 52

,
Interventionunits on a scale (Mean)
Change at Week 24Change at Week 52
Adolescents (12 to < 18 Years)0.640.95
Children (3 to < 12 Years)0.360.42

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Change From Baseline in Pediatric Incontinence Questionnaire (PIN-Q) Score

"PIN-Q measured quality of life via an e-diary. Total score ranged from 0 (no effect) to 80 (worst effect); decrease in score indicated improvement. Total score was 20x average of individual PinQ items, the 20 Likert scales were converted to a score: Items 6 & 17; 0: No to 4: Definitely was used; & For the other 18 items; 0: No to 4: All the time was used. Expectation that questionnaires had limited missing values; if answers >2 questions were missing, total score was not calculated & was missing. Individual item scores were directly imputed. Change from baseline to each post-baseline visit in the total score was post-baseline visit value minus baseline value. If either baseline or post-baseline visit value was missing, change from baseline was missing. If change was: <0, improvement between 2 time-points; =0, no change between 2 time points; >0, worsening between 2 time points." (NCT02751931)
Timeframe: Baseline and weeks 24 and 52

,
Interventionunits on a scale (Mean)
Change at Week 24Change at Week 52
Adolescents (12 to < 18 Years)-4.90-6.79
Children (3 to < 12 Years)2.041.30

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Apparent Total Clearance of Mirabegron From Plasma After Oral Administration (CL/F)

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. (NCT02751931)
Timeframe: A total of 4 samples were collected over 2 sampling days at 2 separate visits at any of week 4, 8, 12, 24, 36, or 52, at the following time points: Sampling day 1- Predose; Sampling day 2- Predose and 2 samples 2-5 hours postdose more than 1 hour apart.

InterventionLiter/hour (L/hr) (Mean)
Children PED25 (PKAS)192.5
Adolescents PED25 (PKAS)202.3
Children PED50 (PKAS)230.9
Adolescents PED50 (PKAS)279.6

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Number of Participants With Study Drug Acceptability for Oral Suspension at Week 4

"Participants evaluated the taste of the study medication/oral suspension by ticking 1 of the following categories:Really Bad (0), Bad (1), Not Bad, Not Good (2), Good (3) & Really Good (4). Participants evaluated the smell of the study medication/oral suspension by ticking 1 of the following categories: Really Bad (0), Bad (1),Not Bad, Not Good (2), Good (3) & Really Good (4). Participants evaluated the consumption and the preparation of the study medication/oral suspension by ticking 1 of the following categories: Really Difficult (0),Difficult (1), Not Difficult, Not Easy (2), Easy (3) & Really Easy (4)." (NCT02751931)
Timeframe: Week 4

,
InterventionParticipants (Count of Participants)
Taste - Really badTaste - BadTaste - Not bad, not goodTaste - GoodTaste - Really goodSmell - Really badSmell - BadSmell - Not bad, not goodSmell - GoodSmell - Really goodTake - Really difficultTake - DifficultTake - Not difficult, not easyTake - EasyTake - Really EasyPrepare - Really difficultPrepare - DifficultPrepare - Not difficult, not easyPrepare - EasyPrepare - Really Easy
Adolescents (12 to < 18 Years)00200001100001100002
Children (3 to < 12 Years)134113018121004711002128

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Number of Participants With Adverse Events (AEs)

An AE was defined as any untoward medical occurrence in a participant who was given the study drug or who had undergone study procedures and did not necessarily have a causal relationship with this treatment. An AE could therefore be any unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A treatment-emergent adverse event (TEAE) was defined as any AE with date of onset occurring on or after the first dose of study medication and up to the end of study. (NCT02751931)
Timeframe: From the first dose of study drug administration up to end-of-treatment (EoT) (up to week 52)

,
InterventionParticipants (Count of Participants)
TEAEDrug-related TEAESerious TEAEDrug-related Serious TEAETEAE Leading to DeathDrug-related TEAE Leading to DeathTEAE Leading to Permanent DiscontinuationDrug-related TEAE Leading to Permanent Disc.Death
Adolescents (12 to < 18 Years)1865000000
Children (3 to < 12 Years)3389000320

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Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC24) for Mirabegron

AUC (0-24) is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose. (NCT02751931)
Timeframe: A total of 4 samples were collected over 2 sampling days at 2 separate visits at any of week 4, 8, 12, 24, 36, or 52, at the following time points: Sampling day 1- Predose; Sampling day 2- Predose and 2 samples 2-5 hours postdose more than 1 hour apart.

Interventionnanogram*hour/milliliter (Mean)
Children PED25 (PKAS)166.3
Adolescents PED25 (PKAS)137.8
Children PED50 (PKAS)310.1
Adolescents PED50 (PKAS)291.6

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Number of Participants With Clinician Global Impression of Change (CGI-C)

The Clinician Global Impression of Change (CGI-C) is a 7 point scale that required the clinician to assess how much the participant's overall bladder symptoms since the start of the study on day 1 has improved or worsened and rated as: very much improved (1); much improved (2); minimally improved (3); no change (4); minimally worse (5); much worse (6); or very much worse (7). The total score range from 1-7, where lower scores indicated improvement. (NCT02751931)
Timeframe: Weeks 24 and 52

,
InterventionParticipants (Count of Participants)
Week 24 - Very much ImprovedWeek 24 - Much ImprovedWeek 24 - Minimally ImprovedWeek 24 - No ChangeWeek 24 - Minimally WorseWeek 24 - Much WorseWeek 24 - Very Much WorseWeek 52 - Very Much ImprovedWeek 52 - Much ImprovedWeek 52 - Minimally ImprovedWeek 52 - No ChangeWeek 52 - Minimally WorseWeek 52 - Much WorseWeek 52 - Very Much Worse
Adolescents (12 to < 18 Years)1075110091210010
Children (3 to < 12 Years)6246410082352000

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Change From Baseline to End of Treatment (EoT) in Mean Number of Micturitions Per Day

Participants recorded micturitions in the e-diary during three days. The mean number of micturitions was calculated as the average number of times a participant recorded a micturition per day during the 3-day period. Only voluntary micturitions were counted and the episodes of incontinence were not included. (NCT02757768)
Timeframe: Baseline and Week 12

Interventionmicturitions per day (Least Squares Mean)
Mirabegron-2.00
Placebo-1.62

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in Total Urgency and Frequency Score (TUFS)

The TUFS was calculated by adding the PPIUS scores of every void in a participant's 3-day diary, and dividing this by the number of days recorded in the diary. Due to a programming failure in the e-diary data for the number of pads used was not collected. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8 and 12

Interventionunits on a scale (Least Squares Mean)
MirabegronNA
PlaceboNA

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in Treatment Satisfaction Visual Analog Scale (TS-VAS)

The TS-VAS is a visual analog scale that asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) to 100 (Yes, completely). (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron15.618.619.118.4
Placebo12.516.116.916.9

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Change From Baseline to Week 4, Week 8, and Week 12 in Mean Number of Micturitions Per Day

Participants recorded micturitions in the e-diary during three days. The mean number of micturitions was calculated as the average number of times a participant recorded a micturition per day during the 3-day period. Only voluntary micturitions were counted and the episodes of incontinence were not included. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

,
Interventionmicturitions per day (Least Squares Mean)
Week 4Week 8Week 12
Mirabegron-1.42-1.89-1.95
Placebo-1.32-1.38-1.56

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in European Quality of Life in 5 Dimensions and 5 Levels (EQ-5D-5L Questionnaire) Utilities

The EQ-5D-5L is an international standardized non-disease specific generic instrument for describing and valuing health status. It has a multidimensional measure of health-related QoL, capable of being expressed as a single index value and specifically designed to complement other health status measures. The EQ-5D-5L has five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels (e.g., 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems/unable to perform the activity). Health-state utility (HSU) data are estimates of the preference for a given state of health on a cardinal numeric scale, where a value of 1.0 represents full health, 0.0 represents dead, and negative values represent states worse than death. Missing EoT values were imputed using LOCF method. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12EoT
Mirabegron0.0110.0190.0280.026
Placebo0.0190.0300.0320.034

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Coping Score

The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQL). The HRQL portion consists of 25 HRQL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. A higher score on OAB-q HRQL indicated a better response. The lowest and highest possible scores for the Coping subscale ranges from 8 to 48. The Coping score was calculated by adding the 8 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron10.5816.0118.9318.05
Placebo12.4715.2518.0318.02

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Sleep Score

The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQL). The HRQL portion consists of 25 HRQL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. A higher score on OAB-q HRQL indicated a better response. The lowest and highest possible scores for the Sleep subscale ranges from 5 to 30. The Sleep score was calculated by adding the 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8 and 12

,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron10.4315.3217.9416.87
Placebo10.4514.4116.4116.62

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Social Interaction Score

The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQL). The HRQL portion consists of 25 HRQL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. A higher score on OAB-q HRQL indicated a better response. The lowest and highest possible scores for the Social Interaction subscale ranges from 5 to 30. The Social Interaction score was calculated by adding the 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron5.558.039.488.96
Placebo6.658.359.579.67

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in International Prostate Symptom Score (IPSS) Total Score

The International Prostate Symptom Score (IPSS) consists of 7 questions concerning urinary symptoms and 1 question concerning quality of life (QoL) with total score and subscores (voiding, storage and QoL). The IPSS total score classification ranges from mild (0 to 7) to moderate (8 to 19) or severe (20 to 35). Higher IPSS scored indicated more severe symptoms. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron-3.9-5.0-5.9-5.7
Placebo-4.0-5.2-5.5-5.6

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in IPSS Subscale Quality of Life (QoL) Score

The International Prostate Symptom Score (IPSS) consists of 7 questions concerning urinary symptoms and 1 question concerning quality of life (QoL) with total score and subscores (voiding, storage and QoL). The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The lowest and highest possible score ranges from 0 to 6 (very pleased to terrible). A higher score is indicative of worse condition and a negative change from baseline indicates an improvement. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron-0.9-1.3-1.5-1.4
Placebo-0.7-1.1-1.3-1.3

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in IPSS Subscale Voiding Score

The International Prostate Symptom Score (IPSS) consists of 7 questions concerning urinary symptoms and 1 question concerning quality of life (QoL) with total score and subscores (voiding, storage and QoL). Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The subscale voiding score is the sum of the responses to 4 voiding symptoms questions (incomplete emptying, intermittency, weak stream, and straining). The lowest and highest possible scores range from 0 to 20 (mildly symptomatic to severely symptomatic). A higher score is indicative of worse condition and a negative change from baseline indicates an improvement. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron-1.7-2.2-2.5-2.5
Placebo-2.1-2.5-2.5-2.6

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Incontinence Episodes Per Day

An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated as the average number of times a participant recorded an incontinence episode per day during the 3-day micturition diary period. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

,
Interventionincontinence episodes per day (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron-0.97-1.29-1.48-1.45
Placebo-0.84-1.20-1.23-1.15

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours

A nocturia episode was defined as waking at night one or more time to void (i.e., any voiding associated with sleep disturbance between the date/time the participant goes to bed with the intention to sleep until the date/time the participant gets up in the morning with the intention to stay awake). A night time episode of incontinence is not considered a nocturia episode. The mean number of nocturia episodes per day (24 hours) was calculated as the average number of times a participant recorded a nocturia episode per day during the 3-day micturition diary period. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

,
Interventionnocturia episodes per 24 hours (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron-0.32-0.48-0.51-0.49
Placebo-0.45-0.55-0.52-0.52

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per Day

Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. An urgency episode was defined as any micturition or incontinence episode with a severity of grade 3 or 4, assessed by participants based on the Patient Perception of Intensity of Urgency Scale (PPIUS), where 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The mean number of urgency episodes (grade 3 and/or 4) per day was calculated as the average number of times a participant recorded an urgency episode (grade 3 and/or 4) with or without incontinence per day during the 3-day micturition diary period. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

,
Interventionurgency episodes per day (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron-1.79-2.68-2.86-2.90
Placebo-1.53-1.97-2.21-2.24

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Change From Baseline to Week 4, Week 8, Week 12, and EoT in IPSS Subscale Storage Score

The International Prostate Symptom Score (IPSS) consists of 7 questions concerning urinary symptoms and 1 question concerning quality of life (QoL) with total score and subscores (voiding, storage and QoL). Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The subscale storage score is the sum of the responses to 3 storage symptoms questions (frequency, urgency, and nocturia). The lowest and highest possible scores range from 0 to 15 (mildly symptomatic to severely symptomatic). A higher score is indicative of worse condition and a negative change from baseline indicates an improvement. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron-2.2-2.8-3.3-3.3
Placebo-1.9-2.6-3.0-3.0

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Concern Score

The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQL). The HRQL portion consists of 25 HRQL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. A higher score on OAB-q HRQL indicated a better response. The lowest and highest possible scores for the Concern subscale ranges from 7 to 42. The Concern score was calculated by adding the 7 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron9.0613.3415.6414.81
Placebo10.8712.9914.4714.67

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in Symptom Bother Score

Overactive bladder symptoms were assessed using the Symptom Bother Scale of the Overactive Bladder questionnaire (OAB-q). The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 questions, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). Lower scores on OAB-q symptom bother indicate a better response. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron-13.73-18.72-20.93-20.18
Placebo-11.98-14.88-18.03-18.07

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in Patient Perception of Bladder Condition (PPBC)

The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron-0.6-0.8-1.0-0.9
Placebo-0.5-0.7-0.9-0.9

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Volume Voided Per Micturition

The mean volume voided per micturition during 3 days of the 3-day micturition diary period. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

,
InterventionmL per micturition (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron17.7422.5626.3125.57
Placebo13.8716.2817.3216.32

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Urgency Incontinence Episodes Per Day

Urgency Incontinence was defined as the complaint of involuntary leakage accompanied by or immediately proceeded by urgency. The mean number of urgency incontinence episodes was calculated as the average number of times a participant recorded an urgency incontinence episode per day during the 3-day micturition diary period. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8 and 12

,
Interventionurgency incontinence episodes per day (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron-0.97-1.29-1.52-1.49
Placebo-0.85-1.19-1.24-1.16

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Number of Participants With Interstitial Cystitis Symptom Improvement

Evaluate urinary urgency, frequency and pain via validated O'Leary Sant questionnaire (NCT02787083)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Mirabegron1
Placebo3

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Number of Participants With Improvement in Incontinence Episodes

Evaluate incontinence episodes via bladder diary and UDI-6 questionnaire (NCT02787083)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Mirabegron1
Placebo3

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Erectile Function Assessed by IIEF Questionnaire

The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction. (NCT02916693)
Timeframe: Baseline

Interventionscore on a scale (Mean)
Mirabegron12.7

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Erectile Function Assessed by IIEF Questionnaire

The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction. (NCT02916693)
Timeframe: Week 8

Interventionscore on a scale (Mean)
Mirabegron17.8

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Erectile Function Assessed by IIEF Questionnaire

The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction. (NCT02916693)
Timeframe: Week 4

Interventionscore on a scale (Mean)
Mirabegron15.3

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Erectile Function Assessed by IIEF Questionnaire

The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction. (NCT02916693)
Timeframe: Week 2

Interventionscore on a scale (Mean)
Mirabegron13.8

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Erectile Function Assessed by IIEF Questionnaire

The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction. (NCT02916693)
Timeframe: Week 12

Interventionscore on a scale (Mean)
Mirabegron15.8

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Maximum Concentration (Cmax) For Mirabegron

Cmax for mirabegron was reported from the plasma samples collected. (NCT04501640)
Timeframe: Day 1: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 72 and 96 hour(s) postdose of each period

InterventionNanogram per milliliter (ng/mL) (Geometric Mean)
Mirabegron 25 mg Fed3.07
Mirabegron 25 mg Fasted7.88
Mirabegron 50 mg Fed15.9
Mirabegron 50 mg Fasted33.3

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Number of Participants With Adverse Events (AE)

"An AE is any untoward medical occurrence in a participant administered an study drug, and which does not necessarily have to have a causal relationship with this study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug whether or not considered related to the study drug. An AE is considered serious if, in the view of either the investigator or sponsor, the event results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions results in congenital anomaly, or birth defect, requires inpatient hospitalization, other medically important AE. An AE with onset at any time from first dosing until last scheduled procedure was classified as a TEAE." (NCT04501640)
Timeframe: From date of informed consent signed to end of study (up to 24 days)

,,,
InterventionParticipants (Number)
TEAEDrug-Related TEAESerious TEAEDrug-Related Serious TEAETEAE Leading to DeathDrug-Related TEAE Leading to DeathTEAE Leading to Withdrawal of TreatmentDrug-Related TEAE Leading to Withdrawal of TreatmentDeath
Mirabegron 25 mg Fasted220000000
Mirabegron 25 mg Fed210000000
Mirabegron 50 mg Fasted210000000
Mirabegron 50 mg Fed220000000

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Area Under The Concentration-Time Curve (AUC) From The Time of Dosing Extrapolated to Time Infinity (AUCinf) For Mirabegron

AUCinf for mirabegron was reported for the plasma samples collected. (NCT04501640)
Timeframe: Day 1: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 72 and 96 hour(s) postdose of each period

InterventionHour*nanogram per milliliter (h*ng/mL) (Geometric Mean)
Mirabegron 25 mg Fed81.8
Mirabegron 25 mg Fasted143
Mirabegron 50 mg Fed263
Mirabegron 50 mg Fasted429

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Area Under The Concentration-Time Curve (AUC) From The Time of Dosing to The Last Measurable Concentration (AUClast) For Mirabegron

AUClast for mirabegron was reported for the plasma samples collected. (NCT04501640)
Timeframe: Day 1: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 72 and 96 hour(s) postdose of each period

Interventionh*ng/mL (Geometric Mean)
Mirabegron 25 mg Fed63.3
Mirabegron 25 mg Fasted119
Mirabegron 50 mg Fed218
Mirabegron 50 mg Fasted369

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Change From Baseline (CFB) to the End of 12-Week Treatment Period in Mean Number of Micturition/24 Hours in Mirabegron 50 mg Group

A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated as the average number of times a participant urinated per day during the 3-day micturition diary period. (NCT04562090)
Timeframe: Baseline, week 12

Interventionmicturitions per 24 hours (Mean)
Mirabegron 50 mg-3.76

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Change From Baseline to Week 12 in Post Void Residual (PVR) Volume

PVR was assessed by ultrasonography. (NCT04562090)
Timeframe: Baseline, week 12

Interventionmilliliter (Mean)
Mirabegron 25 mg-2.7
Mirabegron 50 mg-1.3

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Number of Participants With Treatment Emergent Adverse Events

AE was defined as any untoward medical occurrence in a participant administered a study drug or had undergone study procedures and which did not necessarily have had a causal relationship with the treatment. An abnormality identified during a medical test (e.g., laboratory parameter, vital sign, Electrocardiography (ECG) data, and physical exam) was defined as an AE only if the abnormality induced clinical signs or symptoms or requires active intervention or requires interruption or discontinuation of study medication or the abnormality or investigational value was clinically significant in the opinion of the investigator. Treatment emergent AE was defined as an AE observed after starting administration of the IP and 30 days after the final administration of study drug. (NCT04562090)
Timeframe: From first dose up to 30 days after last dose (up to week 16)

Interventionparticipants (Number)
Mirabegron 25 mg18
Mirabegron 50 mg58

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Change From Baseline in Mean Number of Daytime Incontinence Episodes Per 24 Hours

An incontinence episode was defined as an episode with any involuntary loss of urine. Daytime was defined as time between waking up in the morning and going to sleep later the same day or next day. The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and at various specified time-intervals. (NCT04562090)
Timeframe: Baseline and weeks 4, 8, and 12

,
Interventionincontinence episodes per 24 hours (Mean)
Change at Week 4Change at Week 8Change at Week 12
Mirabegron 25 mg-0.48-1.06-1.03
Mirabegron 50 mg-0.77-0.89-0.97

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Change From Baseline in Mean Number of Grade 3 or 4 Patient Perception of Intensity of Urgency Scale (PPIUS) Urgency Episodes Per 24 Hours

Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which was difficult to defer. An urgency episode was defined as any micturition or incontinence episode with a severity of grade 3 or 4, assessed by participants based on the PPIUS, where grade 0 = No urgency; grade 1 = Mild urgency; grade 2 = Moderate urgency, could delay voiding a short while; grade 3 = Severe urgency, could not delay voiding; grade 4 = Urge incontinence, leaked before arriving to the toilet. The mean number of urgency episodes (grade 3 and/or 4) per day was calculated as the average number of times a participant recorded an urgency episode (grade 3 and/or 4) with or without incontinence per day during the 3-day micturition diary period. (NCT04562090)
Timeframe: Baseline and weeks 4, 8, and 12

,
Interventionurgency episodes per 24 hours (Mean)
Change at Week 4Change at Week 8Change at Week 12
Mirabegron 25 mg-2.09-2.66-2.57
Mirabegron 50 mg-2.53-2.98-3.55

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Change From Baseline in Mean Number of Micturition Per 24 Hours

A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated as the average number of times a participant urinated per day during the 3-day micturition diary period. (NCT04562090)
Timeframe: Baseline and weeks 4 and 8

,
Interventionmicturitions per 24 hours (Mean)
Change at Week 4Change at Week 8
Mirabegron 25 mg-2.06-2.65
Mirabegron 50 mg-2.44-3.01

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Change From Baseline in Mean Number of Nighttime Incontinence Episodes Per 24 Hours

An incontinence episode was defined as an episode with any involuntary loss of urine. Nightime was defined as time between between going to sleep on a day and waking up on the same or next day. The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and at various specified time-intervals. (NCT04562090)
Timeframe: Baseline and weeks 4, 8, and 12

,
Interventionincontinence episodes per 24 hours (Mean)
Change at Week 4Change at Week 8Change at Week 12
Mirabegron 25 mg-0.37-0.67-0.42
Mirabegron 50 mg-0.47-0.45-0.54

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Change From Baseline in Mean Number of Urge Incontinence Episodes Per 24 Hours

An incontinence episode was defined as an episode with any involuntary loss of urine. The mean number of urge incontinence episodes per 24 hours was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and at various specified time-intervals. (NCT04562090)
Timeframe: Baseline and weeks 4, 8, and 12

,
Interventionurge incontinence episodes per 24 hours (Mean)
Change at Week 4Change at Week 8Change at Week 12
Mirabegron 25 mg-0.67-1.15-0.92
Mirabegron 50 mg-1.18-1.25-1.36

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Change From Baseline in OAB Symptom Score (OABSS)

"The OABSS questionnaire was a questionnaire completed by participants with 4 questions regarding their OAB symptoms: Daytime Frequency (How many times do you typically urinate from waking in the morning until sleeping at night? where scores range from 0-2), Nighttime Frequency (How many times do you typically wake up to urinate from sleeping at night until waking in the morning? where scores range from 0-3), Urgency (How often do you have a sudden desire to urinate, which is difficult to defer? where scores range from 0-5), Urgency Incontinence (How often do you leak urine because you cannot defer the sudden desire to urinate? where scores range from 0-5). The total score ranges from 0 to 15 with higher score indicating more symptoms." (NCT04562090)
Timeframe: Baseline and weeks 4, 8, and 12

,
Interventionscores on a scale (Mean)
Change at Week 4Change at Week 8Change at Week 12
Mirabegron 25 mg-2.91-5.34-6.19
Mirabegron 50 mg-3.01-4.29-5.43

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Change From Baseline to Week 12/EoT in Mean Number of Micturitions Per 24 Hours for Age Group 5 to <12 Years

A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated as the average number of times a participant urinated per day during the 7-day micturition diary period. The analysis was performed with imputation of missing visit 7/week 12 data using the last observation carried forward (LOCF) method. (NCT04641975)
Timeframe: Baseline, week 12

Interventionmicturitions per 24 hours (Least Squares Mean)
Mirabegron (5 to < 12 Years)-1.62
Placebo (5 to < 12 Years)-3.84

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Change From Baseline in Post Void Residual (PVR) Volume

PVR was assessed by ultrasonography. (NCT04641975)
Timeframe: Baseline, weeks 4, 12, 14

InterventionmL (Mean)
Week 12Week 14
Placebo (12 to < 18 Years)0.000.00

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Change From Baseline in Post Void Residual (PVR) Volume

PVR was assessed by ultrasonography. (NCT04641975)
Timeframe: Baseline, weeks 4, 12, 14

,,
InterventionmL (Mean)
Week 4Week 12Week 14
Mirabegron (5 to < 12 Years)-0.561.632.20
Mirabegron (12 to < 18 Years)-3.005.004.50
Placebo (5 to < 12 Years)8.805.4311.0

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Change From Baseline to Week 12/EoT in Maximum Volume Voided (MVV) for Age Group 5 to <12 Years

"MVV data was derived from Pee Volume of the 2-day Weekend Episodic Diary. The MVV was the largest (non-zero) volume recorded over both of the 2 (valid) measuring days in the diary. The analysis was performed with LOCF and without LOCF method." (NCT04641975)
Timeframe: Baseline, week 12

,
InterventionmL (Mean)
Week 12 (without LOCF)Week 12 (With LOCF)
Mirabegron (5 to < 12 Years)26.0026.00
Placebo (5 to < 12 Years)26.3826.38

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Change From Baseline to Week 12/EoT in Mean Number of Daytime Incontinence Episodes Per 24 Hours for Age Group 5 to <12 Years

A daytime incontinence episode was defined as the complaint of any involuntary leakage of urine during daytime hours. Daytime was defined as time between waking up in the morning and going to sleep later the same day or next day. The mean number of daytime incontinence episodes per 24 hours was calculated by taking the sum of all daytime urinary incontinence episodes recorded in the participant diary, divided by the number of valid diary days. The analysis was performed with LOCF and without LOCF method. (NCT04641975)
Timeframe: Baseline, week 12

,
Interventionincontinence episodes per 24 hours (Mean)
Week 12 (without LOCF)Week 12 (with LOCF)
Mirabegron (5 to < 12 Years)-1.29-1.20
Placebo (5 to < 12 Years)-1.28-1.09

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Change From Baseline to Week 12/EoT in Mean Number of Daytime Micturitions Per 24 Hours for Age Group 5 to <12 Years

"For a week day the daytime micturitions was derived from Number of Times using the Toilet During the Day was entered into the 5-day Week Diary. For a weekend day the daytime micturitions was derived from the number of times a Pee in Toilet or a Pee in Toilet and Leakage was entered into the 2-day Weekend Episodic Diary between the time the participant woke-up (exclusive). The total number of micturitions per weekend day was equal to the total number of times, in the diary, an amount of pee was recorded during daytime for that day. For each participant, the mean number of daytime micturitions was calculated as:~Sum of the Number of Daytime Micturitions (per day) over the Valid Diary Days prior to Visit/Number of Valid Diary Days.~The analysis was performed with LOCF and without LOCF method." (NCT04641975)
Timeframe: Baseline, week 12

,
Interventionmicturitions per 24 hours (Mean)
Week 12 (without LOCF)Week 12 (with LOCF)
Mirabegron (5 to < 12 Years)-0.85-0.85
Placebo (5 to < 12 Years)-3.21-3.21

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Change From Baseline to Week 12/EoT in Mean Number of Nighttime Incontinence Episodes Per 24 Hours for Age Group 5 to <12 Years

A nighttime incontinence episode was defined as the complaint of any involuntary leakage of urine during nighttime hours. Nightime was defined as time between between going to sleep on a day and waking up on the same or next day. The mean number of nighttime incontinence episodes per 24 hours was calculated by taking the sum of all nighttime urinary incontinence episodes recorded in the participant diary, divided by the number of valid diary days. The analysis was performed with LOCF and without LOCF method. (NCT04641975)
Timeframe: Baseline, week 12

,
Interventionincontinence episodes per 24 hours (Mean)
Week 12 (without LOCF)Week 12 (with LOCF)
Mirabegron (5 to < 12 Years)-0.64-0.64
Placebo (5 to < 12 Years)-1.34-1.34

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Change From Baseline to Week 12/EoT in Mean Volume Voided Per 24 Hours for Age Group 5 to <12 Years

"Mean volume voided was derived from Pee Volume of the 2-day Weekend Episodic Diary. Mean volume voided per day was calculated as the sum of the volumes voided on that (valid diary) day divided by the number of times a volume was recorded on that day in the 2-day Weekend Episodic Diary. The analysis was performed with LOCF and without LOCF method." (NCT04641975)
Timeframe: Baseline, week 12

,
Interventionmilliliter (mL)/24 hours (Mean)
Week 12 (without LOCF)Week 12 (with LOCF)
Mirabegron (5 to < 12 Years)18.3818.38
Placebo (5 to < 12 Years)24.5524.55

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Change From Baseline to Week 12/EoT in Number of Dry (Incontinence-free) Days Per 7 Days for Age Group 5 to <12 Years

"A dry (incontinence free) day was defined as a day where the response is Dry to the question How was your Day and to How was your Night. For a weekend day a Dry (incontinence free) Day was defined a day where no New pee or leakage was reported. Let Ddry be the number of valid diary days where the response to both questions was Dry. Let Dwet be the number of valid diary days where the response to one of the two questions or to both questions was Wet. If (Ddry + Dwet) > 3, the number of dry days per 7 days was calculated as Ddry/(Ddry + Dwet)* 7, otherwise the value was missing.~The analysis was performed with LOCF and without LOCF method." (NCT04641975)
Timeframe: Baseline, week 12

,
Interventionincontinence-free days (Mean)
Week 12 (without LOCF)Week 12 (with LOCF)
Mirabegron (5 to < 12 Years)3.122.94
Placebo (5 to < 12 Years)1.451.46

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Number of Participants With Study Drug Acceptability and Palatability for Oral Suspension

"Participants evaluated the taste of the study drug/oral suspension by ticking 1 of the following categories: Really Bad (0), Bad (1), Not Bad, Not Good (2), Good (3) & Really Good (4). Participants evaluated the smell of the study drug/oral suspension by ticking 1 of the following categories: Really Bad (0), Bad (1),Not Bad, Not Good (2), Good (3) & Really Good (4). Participants evaluated the consumption of the study drug/oral suspension by ticking 1 of the following categories: Really Difficult (0),Difficult (1), Not Difficult, Not Easy (2), Easy (3) & Really Easy (4). Participants evaluated the preparation of the study drug/oral suspension by ticking 1 of the following categories: Really Difficult (0), Difficult (1), Not Difficult, Not Easy (2), Easy (3) & Really Easy (4)." (NCT04641975)
Timeframe: Week 12

,
InterventionParticipants (Number)
Taste: Really BadTaste: BadTaste: Not Bad, Not GoodTaste: GoodTaste: Really GoodSmell: Really BadSmell: BadSmell: Not Bad, Not GoodSmell: GoodSmell: Really GoodTaking: Really DifficultTaking: DifficultTaking: Not Difficult, Not EasyTaking: EasyTaking: Really EasyPreparing: Really DifficultPreparing: DifficultPreparing: Not Difficult, Not EasyPreparing: EasyPreparing: Really Easy
Mirabegron (5 to < 12 Years)00411003030004200042
Placebo (5 to < 12 Years)00610004210015100250

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Number of Participants With Study Drug Acceptability and Palatability for Tablets

"Participants evaluated the taste of the study drug/tablets by ticking 1 of the following categories: Really Bad (0), Bad (1), Not Bad, Not Good (2), Good (3) & Really Good (4). Participants evaluated the swallow of the study drug/tablets by ticking one of the following categories: Really Difficult (0), Difficult (1), Not Difficult, Not Easy (2), Easy (3) and Really Easy (4)." (NCT04641975)
Timeframe: Week 12

,,
InterventionParticipants (Number)
Taste: Really badTaste: BadTaste: Not Bad, Not GoodTaste: GoodTaste: Really GoodSwallow: Really DifficultSwallow: DifficultSwallow: Not Difficult, Not EasySwallow: EasySwallow: Really Easy
Mirabegron (12 to < 18 Years)0020000101
Mirabegron (5 to < 12 Years)0111000021
Placebo (5 to < 12 Years)0010000001

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Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs

An AE was any untoward medical occurrence in a participant administered a study drug and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug whether or not considered related to the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted a congenital anomaly/birth defect or other medically important event. A TEAE was defined as an AE observed after starting administration of the study drug until 30 days after last dose. (NCT04641975)
Timeframe: From first dose up to week 14

,,,
InterventionParticipants (Number)
Treatment emergent adverse eventsSerious treatment emergent adverse events
Mirabegron (12 to < 18 Years)11
Mirabegron (5 to < 12 Years)50
Placebo (12 to < 18 Years)11
Placebo (5 to < 12 Years)70

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PK of Mirabegron in Plasma: Concentration Immediately Prior to Dosing (Ctrough)

Trough level or trough concentration (Ctrough) in the concentration reached by the drug immediately before the next dose is administered. (NCT04641975)
Timeframe: Predose (1 hour prior) at weeks 4 and 12

Interventionng/mL (Mean)
Week 4
Mirabegron (12 to < 18 Years)0.00

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PK of Mirabegron in Plasma: Concentration Immediately Prior to Dosing (Ctrough)

Trough level or trough concentration (Ctrough) in the concentration reached by the drug immediately before the next dose is administered. (NCT04641975)
Timeframe: Predose (1 hour prior) at weeks 4 and 12

Interventionng/mL (Mean)
Week 4Week 12
Mirabegron (5 to < 12 Years)3.1812.68

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Change in Symptom Distress as Measured by the Urinary Distress Index (UDI-6) Questionnaire Pre- (Baseline Measure) vs. Post-treatment (Post-trial Measure)

This is a quality of life measure using a validated questionnaire called the Urinary Distress Index Scale with a range from 0-100 with higher scores meaning worse urinary distress such as urinary incontinence and leakage and bother with the life stresses related to urinary incontinence. Will include a baseline measure pre-trial and then a post-trial measure (post-trial). This includes a pre-trial measure (baseline) and a post-trial measure and then a calculation of the difference. The difference between the two measures (baseline vs. post-trial) was then compared with a sample t test. (NCT04907032)
Timeframe: 12 weeks

Interventionscore on a scale (Mean)
Posterior Tibial Nerve Stimulation With Mirabegron23.6
Posterior Tibial Nerve Stimulation Plus Placebo16.3

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Change in the Number of UUI Episodes Over a 3-day Voiding Diary Pre- vs. Post-treatment. This Includes a Baseline Measure Pre-trial and a Pos-trial Measure in 12 Weeks

change in the number of urgency urinary incontinence episodes as measures by a 3-day voiding diary pre- vs. post-treatment. This includes a baseline measure pre-trial and then a post-trial measure in 12 weeks and then you calculate the difference. The difference between the two measures (baseline vs. post-trial) was then compared with a sample t test. (NCT04907032)
Timeframe: 3 day voiding diary will be filled out prior to the 12 week PTNS trial and voiding diary will be filled out immediately after the 12 week PTNS trial

InterventionUUI episodes (Mean)
Posterior Tibial Nerve Stimulation With Mirabegron9.4
Posterior Tibial Nerve Stimulation Plus Placebo5.3

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Change in UUI (Urge Urinary Incontinence)/OAB (Overactive Bladder) Quality of Life as Measured by the Incontinence Impact Questionnaire Short Form (IIQ-7) Questionnaire Pre- (Baseline Measure) vs. Post-treatment (Post-trial Measure in 12 Weeks)

The IIQ-7 (Incontinence Impact Questionnaire) is a measure of distress caused by urge urinary incontinence and overactive bladder in the patient. This scale is a scale of 0-100 with 0 being minimal impact and 100 being worse impact and distress. This includes a baseline pre-trial measure and a post-trial measure at 12 weeks. This includes a pre-trial measure (baseline) and then a post-trial measure and then a calculation of the difference. The difference between the two measures (baseline vs. post-trial) was then compared with a sample t test. (NCT04907032)
Timeframe: pre-trial 0-100 scale measurement and then 12 weeks later post-trial measurement 0-100 with higher scores meaning worse impact.

Interventionscore on a scale (Mean)
Posterior Tibial Nerve Stimulation With Mirabegron29.7
Posterior Tibial Nerve Stimulation Plus Placebo20.2

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Change in UUI (Urge Urinary Incontinence)/OAB (Overactive Bladder) Quality of Life as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF) Questionnaire Pre- (Baseline Measure) vs. Post-treatment (Post-trial Measure)

This is the change in Quality of life measure for urge urinary incontinence for the OABq SF scale and it is a 0-100 scale where 0 equals minimum symptoms and 100 equals maximal symptoms. Lower scores indicate better quality of life and higher scores indicate worse quality of life. This includes a pre-trial measure and a post-trial measure at 12 weeks and then a calculation of the difference. The difference between the two measures (baseline vs. post-trial) was then compared with a sample t test. (NCT04907032)
Timeframe: pre trial measurements as described and then 12 weeks later post-trial measurements as described.

Interventionscore on a scale (Mean)
Posterior Tibial Nerve Stimulation With Mirabegron53.6
Posterior Tibial Nerve Stimulation Plus Placebo33.3

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