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solifenacin succinate

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Description

Solifenacin Succinate: A quinuclidine and tetrahydroisoquinoline derivative and selective M3 MUSCARINIC ANTAGONIST. It is used as a UROLOGIC AGENT in the treatment of URINARY INCONTINENCE. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID216457
CHEBI ID32151
SCHEMBL ID109333
MeSH IDM0554458

Synonyms (80)

Synonym
HY-A0002
solifenacin (succinate)
ym-53705
vesicare od
solifenacin succinate
vesikur
vesicare
solifenacin succinate (jan/usan/inn)
D01269
242478-38-2
vesicare (tn)
2(1h)-isoquinolinecarboxylic acid, 3,4-dihydro-1-phenyl-, (3r)-1-azabicyclo(2.2.2)oct-3-yl ester, (1s)-, butanedioate (1:1)
butanedioic acid, cmpd. with (1s)-(3r)-1-azabicyclo(2.2.2)oct-3-yl 3,4-dihydro-1-phenyl-2(1h)-isoquinolinecarboxylate (1:1)
solifenacin succinate [usan]
butanedioic acid, compd with (1s)-(3r)-1-azabicyclo(2.2.2)oct-3-yl 3,4-dihydro-1-phenyl-2(1h)-isoquinolinecarboxylate (1:1)
quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
ym-67905
ym67905
[(3r)-1-azabicyclo[2.2.2]octan-3-yl] (1s)-1-phenyl-3,4-dihydro-1h-isoquinoline-2-carboxylate; butanedioic acid
A819262
butanedioic acid; (1s)-1-phenyl-3,4-dihydro-1h-isoquinoline-2-carboxylic acid [(3r)-1-azabicyclo[2.2.2]octan-3-yl] ester
AKOS015994745
unii-kka5dld701
quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylatemonosuccinate
kka5dld701 ,
solifenacin succinate salt
solifenacin succinate [ep monograph]
solifenacin succinate [mart.]
solifenacin succinate [vandf]
solifenacin succinate [who-dd]
solifenacin succinate [mi]
vesicare ls
solifenacin succinate [jan]
solifenacin succinate [orange book]
solifenacin succinate [usp-rs]
AM84825
CS-0371
S3048
MLS006010416
smr004701445
SCHEMBL109333
KS-1286
(1s)-(3r)-1-azabicyclo[2.2.2]oct-3-yl-3,4-dihydro-1-phenyl-2(1h)-isoquinolinecarboxylate succinate
RXZMMZZRUPYENV-VROPFNGYSA-N
S0944
[(3r)-1-azabicyclo[2.2.2]octan-3-yl] (1s)-1-phenyl-3,4-dihydro-1h-isoquinoline-2-carboxylate;butanedioic acid
mfcd00954234
succinate, solifenacin
solifenacin succinate; (3r)-1-azabicyclo[2.2.2]octan-3-yl (1s)-1-phenyl-3,4-dihydroisoquinoline-2(1h)-carboxylate hydrogen butanedioate
CHEBI:32151
1-azabicyclo[2.2.2]octan-8-yl (1s)-1-phenyl-3,4-dihydro-1h-isoquinoline-2-carboxylate butanedioic acid
solifenacin for system suitability, europepharmacopoeia (ep) reference standard
solifenacin succinate, >=98% (hplc)
solifenacin succinate, united states pharmacopeia (usp) reference standard
solifenacin succinate, europepharmacopoeia (ep) reference standard
SW219141-1
AS-35288
(3r)-quinuclidin-3-yl (1s)-1-phenyl-3,4-dihydroisoquinoline-2(1h)-carboxylate succinate
Q374826
(s)-(r)-quinuclidin-3-yl 1-phenyl-3,4-dihydroisoquinoline-2(1h)-carboxylate succinate
HMS3887A13
CCG-269551
EX-A4170
butanedioic acid--1-azabicyclo[2.2.2]octan-3-yl 1-phenyl-3,4-dihydroisoquinoline-2(1h)-carboxylate (1/1)
DTXSID30947075
isoprenalinoe sulfate
(r)-quinuclidin-3-yl (s)-1-phenyl-3,4-dihydroisoquinoline-2(1h)-carboxylate
A881133
BS164410
solifenacin succinate- bio-x
(s)-(r)-quinuclidin-3-yl1-phenyl-3,4-dihydroisoquinoline-2(1h)-carboxylatesuccinate
solifenacin succinate5 mg
solifenacine succinate
solifenacin succinate (ep monograph)
solifenacin succinate (mart.)
solifenacin succinate10 mg
solifenacin succinate tablets
solifenacin succiate
solifenacin succinate (usp-rs)
vesicarels

Research Excerpts

Overview

Solifenacin succinate (YM905) is a new, once-daily, orally administered muscarinic receptor antagonist designed to treat overactive bladder. The drug is approved in Europe and the US for the treatment of men and women with OAB.

ExcerptReferenceRelevance
"Solifenacin succinate is a once-daily oral antimuscarinic for the treatment of OAB."( Recent developments in the management of overactive bladder: focus on the efficacy and tolerability of once daily solifenacin succinate 5 mg.
Brunton, S; Kuritzky, L, 2005
)
1.26
"Solifenacin succinate is a novel antimuscarinic agent approved in Europe and the US for the treatment of men and women with OAB."( Solifenacin in overactive bladder syndrome.
Payne, CK, 2006
)
1.06
"Solifenacin succinate (YM905) is a new, once-daily, orally administered muscarinic receptor antagonist designed to treat overactive bladder. "( Pharmacokinetic effect of ketoconazole on solifenacin in healthy volunteers.
Krauwinkel, WJ; Smith, NN; Smulders, RA; Swart, PJ, 2006
)
1.78
"Solifenacin succinate is a once daily, bladder selective antimuscarinic available in two doses (5 and 10 mg)."( Solifenacin significantly improves all symptoms of overactive bladder syndrome.
Cardozo, L; Chapple, CR; Govier, FE; Steers, WD, 2006
)
1.06
"Solifenacin succinate is a new once-daily antimuscarinic agent that is an effective and well-tolerated treatment option for patients who have overactive bladder."( Solifenacin.
Kreder, KJ, 2006
)
1.06
"Solifenacin succinate (SOL) is a competitive muscarinic-receptor antagonist approved by the US Food and Drug Administration in late 2004 for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency."( Solifenacin succinate for the treatment of symptoms of overactive bladder.
Maniscalco, M; Singh-Franco, D; Torres-Colón, R; Wolowich, WR, 2006
)
2.5
"Solifenacin succinate is a novel muscarinic receptor antagonist used for the treatment of overactive bladder (OAB). "( Effects of intravenously and orally administered solifenacin succinate (YM905) on carbachol-induced intravesical pressure elevation and salivary secretion in mice.
Noguchi, Y; Ohtake, A; Okutsu, H; Sasamata, M; Sato, S; Suzuki, M, 2007
)
2.04

Treatment

ExcerptReferenceRelevance
"Solifenacin succinate treatment was terminated in 3 patients owing to dry eye in 1 patient, increased IOP in 1 patient, and systemic side effects in 1 patient."( Changes in intraocular pressure and tear secretion in patients given 5 mg solifenacin for the treatment of overactive bladder.
Coban, S; Demirbas, M; Demirci, H; Guzelsoy, M; Turkoglu, AR; Yener, NP, 2017
)
1.18

Toxicity

ExcerptReferenceRelevance
" The most commonly reported adverse events were dry mouth, blurred vision, and headache."( Pharmacokinetics and safety of solifenacin succinate in healthy young men.
Huang, M; Krauwinkel, WJ; Smulders, RA; Swart, PJ, 2004
)
0.61
" No deaths or serious adverse events occurred during the study."( Pharmacokinetics, safety, and tolerability of solifenacin in patients with renal insufficiency.
Hoon, TJ; Krauwinkel, WJ; Smith, NN; Smulders, RA, 2007
)
0.34
"As such high-risk patients have not been well represented in most randomized trials of muscarinic receptor antagonists, we investigated whether the muscarinic receptor antagonist solifenacin alters heart rate or has other cardiovascular adverse effects during routine use in OAB patients."( Cardiovascular safety and overall tolerability of solifenacin in routine clinical use: a 12-week, open-label, post-marketing surveillance study.
de la Rosette, JJ; Michel, MC; Vogel, M; Wetterauer, U, 2008
)
0.35
" Secondary outcome measures were blood pressure and overall adverse events, which were systematically recorded before, during (after 1 week) and at study end; in many cases, an ECG was also conducted."( Cardiovascular safety and overall tolerability of solifenacin in routine clinical use: a 12-week, open-label, post-marketing surveillance study.
de la Rosette, JJ; Michel, MC; Vogel, M; Wetterauer, U, 2008
)
0.35
" Dry mouth was the most common adverse event; its incidence was the lowest in SOL5 group (7."( Efficacy and safety of solifenacin succinate in Korean patients with overactive bladder: a randomised, prospective, double-blind, multicentre study.
Choo, MS; Jung, HC; Kim, HJ; Kim, JC; Kim, YH; Lee, JB; Lee, JG; Lee, JZ; Lee, KS; Na, YG; Paick, JS; Seo, JT, 2008
)
0.66
" Safety assessment was based on adverse event reporting."( [Efficacy and safety of solifenacin in daily clinical practice--clinical study phase IV].
Fabisovský, M; Havránek, O; Krhut, J; Míka, D; Valis, P, 2008
)
0.35
" Adverse events were reported in 19 patients (5."( [Efficacy and safety of solifenacin in daily clinical practice--clinical study phase IV].
Fabisovský, M; Havránek, O; Krhut, J; Míka, D; Valis, P, 2008
)
0.35
" Adverse events were monitored throughout the study."( Safety and tolerability of solifenacin add-on therapy to alpha-blocker treated men with residual urgency and frequency.
Fakhoury, A; Fincher, R; He, W; Kaplan, SA; McCammon, K, 2009
)
0.35
"The most frequent adverse events in the solifenacin plus tamsulosin and placebo plus tamsulosin groups were dry mouth (7% and 3%, respectively) and dizziness (3% and 2%, respectively)."( Safety and tolerability of solifenacin add-on therapy to alpha-blocker treated men with residual urgency and frequency.
Fakhoury, A; Fincher, R; He, W; Kaplan, SA; McCammon, K, 2009
)
0.35
" Adverse events and changes of urodynamic values and clinical data were compared between the solifenacin and tolterodine groups."( Comparisons of urodynamic effects, therapeutic efficacy and safety of solifenacin versus tolterodine for female overactive bladder syndrome.
Chang, TC; Chen, CH; Hsiao, SM; Lin, HH; Wu, WY; Yu, HJ, 2011
)
0.37
"Both solifenacin and tolterodine had similar urodynamic effects, therapeutic efficacy and adverse events in treating women with overactive bladder syndrome; however, tolterodine had a greater effect in increasing heart rate than solifenacin."( Comparisons of urodynamic effects, therapeutic efficacy and safety of solifenacin versus tolterodine for female overactive bladder syndrome.
Chang, TC; Chen, CH; Hsiao, SM; Lin, HH; Wu, WY; Yu, HJ, 2011
)
0.37
" The most common adverse effects was dry mouths."( Efficacy and safety of solifenacin to treat overactive bladder symptoms in patients with idiopathic normal pressure hydrocephalus: an open-label, multicenter, prospective study.
Cho, KS; Chung, JH; Ha, US; Ham, WS; Han, JH; Kang, DH; Lee, JY; Lee, SH; Lee, SW; Park, J; Yoo, TK, 2012
)
0.38
" The most common adverse effects with solifenacin were dry mouth and constipation."( The efficacy and safety of solifenacin in patients with overactive bladder syndrome.
Banović, M; But, I; Goldstajn, MS; Oresković, S, 2012
)
0.38
" The AMs used to treat OAB differ in their pharmacological profiles, which may affect their potential for causing adverse effects (AEs)."( Pharmacokinetics and toxicity of antimuscarinic drugs for overactive bladder treatment in females.
Alessandri, F; Candiani, M; Ferrero, S; Leone Roberti Maggiore, U; Origoni, M; Remorgida, V; Salvatore, S; Venturini, PL, 2012
)
0.38
"5%) patients discontinued treatment due to adverse events in group I and group S, respectively."( Long-term safety and efficacy of two different antimuscarinics, imidafenacin and solifenacin, for treatment of overactive bladder: a prospective randomized controlled study.
Fukumoto, K; Hara, R; Koide, T; Miyaji, Y; Nagai, A; Yokoyama, T, 2013
)
0.39
" Adverse events were monitored throughout the study."( Safety and tolerability of solifenacin add-on therapy to α-blocker treated men with residual urgency and frequency.
Fakhoury, A; Fincher, R; He, W; Kaplan, SA; McCammon, K, 2013
)
0.39
"The most frequent adverse events in the solifenacin plus tamsulosin and placebo plus tamsulosin groups were dry mouth (7% and 3%, respectively) and dizziness (3% and 2%, respectively)."( Safety and tolerability of solifenacin add-on therapy to α-blocker treated men with residual urgency and frequency.
Fakhoury, A; Fincher, R; He, W; Kaplan, SA; McCammon, K, 2013
)
0.39
"The incidence rates of overall adverse event, dry mouth, constipation and blurred vision of the experimental group (solifenacin 5 mg once per day) was 26."( [Safety of solifenacin and tolterodine in the treatment of overactive bladder: a meta-analysis].
Jiang, XZ; Xu, C; Xu, ZS; Zhang, NZ; Zhao, HF, 2012
)
0.38
"Dry mouth is the most common adverse event of solifenacin (5 mg once per day) and tolterodine (2 mg twice per day)."( [Safety of solifenacin and tolterodine in the treatment of overactive bladder: a meta-analysis].
Jiang, XZ; Xu, C; Xu, ZS; Zhang, NZ; Zhao, HF, 2012
)
0.38
" Combination therapy was well tolerated, and adverse events were consistent with the safety profiles of both compounds."( Efficacy and safety of solifenacin plus tamsulosin OCAS in men with voiding and storage lower urinary tract symptoms: results from a phase 2, dose-finding study (SATURN).
Angulo, JC; Garcia-Hernandez, A; Haab, F; Katona, F; Klaver, M; Oelke, M; Traudtner, K; Van Kerrebroeck, P; Vik, V, 2013
)
0.39
" 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
)
0.42
" Treatment-emergent adverse events were reported in 499 (46."( Long-term safety and efficacy of single-tablet combinations of solifenacin and tamsulosin oral controlled absorption system in men with storage and voiding lower urinary tract symptoms: results from the NEPTUNE Study and NEPTUNE II open-label extension.
Chapple, C; Drake, MJ; Drogendijk, T; Klaver, M; Oelke, M; Sokol, R; Traudtner, K; Van Kerrebroeck, P, 2015
)
0.42
" We also assessed postvoid residual, maximum urinary flow rate, incidence of urinary retention (UR), adverse events."( Efficacy and safety of solifenacin plus tamsulosin oral controlled absorption system in men with lower urinary tract symptoms: a meta-analysis.
Guo, XL; Li, MC; Liu, JH; Wang, SG; Wang, T; Wang, ZY; Yang, J; Ye, ZQ,
)
0.13
" Both solifenacin and tolterodine ER have similar therapeutic efficacies and adverse events."( [Comparisons of therapeutic efficacy and safety of solifenacin versus tolterodine in patients with overactive bladder: a meta-analysis of outcomes].
Li, J; Li, P; Liu, B; Wang, Y; Wu, Y, 2014
)
0.4
" 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
)
0.42
" Quality of life (QoL) was assessed using International Prostate Symptom Score and Overactive Bladder Symptom Score questionnaires and safety according to the incidence of adverse events."( Efficacy and safety of solifenacin succinate tablets versus solifenacin succinate tablets with local estrogen for the treatment of overactive bladder in postmenopausal women--a multicenter, randomized, open-label, controlled comparison study.
Bai, WP; Cheng, XX; Gong, MY; Huang, YL; Jiang, F; Li, HF; Li, X; Tong, XW; Wang, JJ; Xu, HC; Xu, T; Xu, XX; Zhu, L, 2016
)
0.74
" The most common adverse event was dry mouth (19."( Efficacy and safety of solifenacin succinate tablets versus solifenacin succinate tablets with local estrogen for the treatment of overactive bladder in postmenopausal women--a multicenter, randomized, open-label, controlled comparison study.
Bai, WP; Cheng, XX; Gong, MY; Huang, YL; Jiang, F; Li, HF; Li, X; Tong, XW; Wang, JJ; Xu, HC; Xu, T; Xu, XX; Zhu, L, 2016
)
0.74
"Solifenacin with or without local estrogen was effective and safe for overactive bladder treatment in postmenopausal women."( Efficacy and safety of solifenacin succinate tablets versus solifenacin succinate tablets with local estrogen for the treatment of overactive bladder in postmenopausal women--a multicenter, randomized, open-label, controlled comparison study.
Bai, WP; Cheng, XX; Gong, MY; Huang, YL; Jiang, F; Li, HF; Li, X; Tong, XW; Wang, JJ; Xu, HC; Xu, T; Xu, XX; Zhu, L, 2016
)
0.74
" Adverse event were monitored and summarized."( Efficacy and Safety of Gabapentin in Comparison to Solifenacin Succinate in Adult Overactive Bladder Treatment.
Balingit, JC; Chua, ME; Esmeňa, EB; Morales, ML; See, MC, 2018
)
0.73
" End points included a change from baseline in the number of urinary incontinence episodes per day and the proportion of patients with a 100% reduction (dry) in the number of incontinence episodes per day as co-primaries, other urinary symptoms and quality of life, all at week 12, and adverse events."( The Efficacy and Safety of OnabotulinumtoxinA or Solifenacin Compared with Placebo in Solifenacin Naïve Patients with Refractory Overactive Bladder: Results from a Multicenter, Randomized, Double-Blind Phase 3b Trial.
Abrams, S; Aliotta, P; Everaert, K; Herschorn, S; Kohan, A; Lam, W; McCammon, K; Sriram, R, 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
)
0.46
" 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
)
0.46
" Outcome measures included incidence and severity of adverse events (primary end point), laboratory variables, vital signs, 12-lead electrocardiogram, post-void residual volume, and change from baseline to end of treatment in mean number of micturitions and incontinence episodes per 24 hours, number of incontinence-free days per 7 days and number of grade 3 or 4 urgency episodes per 24 hours (adolescents only)."( Long-Term Safety and Efficacy of Solifenacin in Children and Adolescents with Overactive Bladder.
Besuyen, R; Bolduc, S; Bosman, B; Dahler, E; Hollestein-Havelaar, A; Newgreen, D; Rittig, S; Sawyer, W; Snijder, R, 2017
)
0.46
" The incidence of drug related treatment emergent adverse events was 34."( Long-Term Safety and Efficacy of Solifenacin in Children and Adolescents with Overactive Bladder.
Besuyen, R; Bolduc, S; Bosman, B; Dahler, E; Hollestein-Havelaar, A; Newgreen, D; Rittig, S; Sawyer, W; Snijder, R, 2017
)
0.46
"Once daily solifenacin oral suspension was well tolerated for up to 52 weeks in children 5 to less than 12 years old and adolescents 12 to less than 18 years old diagnosed with overactive bladder, with constipation and electrocardiogram QT prolonged as the most common adverse reactions, respectively."( Long-Term Safety and Efficacy of Solifenacin in Children and Adolescents with Overactive Bladder.
Besuyen, R; Bolduc, S; Bosman, B; Dahler, E; Hollestein-Havelaar, A; Newgreen, D; Rittig, S; Sawyer, W; Snijder, R, 2017
)
0.46
"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
)
0.48
" 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
)
0.51
"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
)
0.51
" 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
)
0.51
"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
)
0.51
" 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
)
0.56
" 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
)
0.56
" However, the adverse systemic side-effects of oxybutynin, the most widely used agent, are of concern."( Long-term efficacy and safety of solifenacin in pediatric patients aged 6 months to 18 years with neurogenic detrusor overactivity: results from two phase 3 prospective open-label studies.
Baka-Ostrowska, M; Bolong, D; Bosman, B; Dahler, E; Davies, LN; Franco, I; Hoebeke, P; Newgreen, D; Snijder, R; Stroosma, O; Vande Walle, J; Verheggen, F, 2020
)
0.56
" Four and nine patients experienced constipation and thirst, respectively, and all adverse effects were graded as ≤2."( Efficacy and safety of dose escalation in male patients with overactive bladder showing poor efficacy after low-dose antimuscarinic treatment: A retrospective multicenter study.
Bang, WJ; Cho, JS; Cho, ST; Hyun, JS; Joo, KJ; Kim, BH; Kim, JK; Lee, JB; Lee, YS; Oh, CY; Seo, YJ; Shim, M, 2020
)
0.56
"Standard dose antimuscarinic treatment using solifenacin (5 mg) may be a safe and effective treatment for patients with OAB symptoms refractory to low-dose antimuscarinic treatment."( Efficacy and safety of dose escalation in male patients with overactive bladder showing poor efficacy after low-dose antimuscarinic treatment: A retrospective multicenter study.
Bang, WJ; Cho, JS; Cho, ST; Hyun, JS; Joo, KJ; Kim, BH; Kim, JK; Lee, JB; Lee, YS; Oh, CY; Seo, YJ; Shim, M, 2020
)
0.56
"The aim of this network meta-analysis was to determine the most efficacious oral antimuscarinic or β-adrenoceptor agonist accounting for adverse events for the management of IOAB."( Choosing the Most Efficacious and Safe Oral Treatment for Idiopathic Overactive Bladder: A Systematic Review and Network Meta-analysis.
Aydh, A; Carlin, GL; Grossmann, NC; Hajebrahimi, S; Jilch, S; Katayama, S; König, F; Laukhtina, E; Mori, K; Mostafaei, H; Pradere, B; Quhal, F; Rajwa, P; Roehrborn, CG; Salehi-Pourmehr, H; Sari Motlagh, R; Schuettfort, VM; Shariat, SF, 2022
)
0.72
" Gastrointestinal problems, especially due to antimuscarinic agents, were the most prevalent adverse events."( Choosing the Most Efficacious and Safe Oral Treatment for Idiopathic Overactive Bladder: A Systematic Review and Network Meta-analysis.
Aydh, A; Carlin, GL; Grossmann, NC; Hajebrahimi, S; Jilch, S; Katayama, S; König, F; Laukhtina, E; Mori, K; Mostafaei, H; Pradere, B; Quhal, F; Rajwa, P; Roehrborn, CG; Salehi-Pourmehr, H; Sari Motlagh, R; Schuettfort, VM; Shariat, SF, 2022
)
0.72
" Although finding the best medication for all is impossible, finding the best treatment for every individual patient can be done by considering the efficacy of a medicine for the most bothersome symptom(s) in balance with drug-specific adverse events."( Choosing the Most Efficacious and Safe Oral Treatment for Idiopathic Overactive Bladder: A Systematic Review and Network Meta-analysis.
Aydh, A; Carlin, GL; Grossmann, NC; Hajebrahimi, S; Jilch, S; Katayama, S; König, F; Laukhtina, E; Mori, K; Mostafaei, H; Pradere, B; Quhal, F; Rajwa, P; Roehrborn, CG; Salehi-Pourmehr, H; Sari Motlagh, R; Schuettfort, VM; Shariat, SF, 2022
)
0.72
"This study aimed to find the most efficient oral medication to treat overactive bladder, taking into consideration the adverse events."( Choosing the Most Efficacious and Safe Oral Treatment for Idiopathic Overactive Bladder: A Systematic Review and Network Meta-analysis.
Aydh, A; Carlin, GL; Grossmann, NC; Hajebrahimi, S; Jilch, S; Katayama, S; König, F; Laukhtina, E; Mori, K; Mostafaei, H; Pradere, B; Quhal, F; Rajwa, P; Roehrborn, CG; Salehi-Pourmehr, H; Sari Motlagh, R; Schuettfort, VM; Shariat, SF, 2022
)
0.72
"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
" Still, concerns have been raised over the nervous system (NS) adverse drug events (AEs) due to their dissimilarities to muscarinic receptor-subtype affinities."( Analysis of the nervous system and gastrointestinal adverse events associated with solifenacin in older adults using the US FDA adverse event reporting system.
Chyou, TY; Nicholls, C; Nishtala, PS, 2023
)
0.91
"This study aimed to identify the nervous system and gastrointestinal adverse drug events (ADEs) associated with solifenacin use in older adults (≥65 years)."( Analysis of the nervous system and gastrointestinal adverse events associated with solifenacin in older adults using the US FDA adverse event reporting system.
Chyou, TY; Nicholls, C; Nishtala, PS, 2023
)
0.91
"A case/non-case analysis was performed on the reports submitted to the FDA Adverse Event Reporting System (FAERS) between 01/01/2004 and 30/06/2020."( Analysis of the nervous system and gastrointestinal adverse events associated with solifenacin in older adults using the US FDA adverse event reporting system.
Chyou, TY; Nicholls, C; Nishtala, PS, 2023
)
0.91
" 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
)
0.72

Pharmacokinetics

Solifenacin succinate (YM905; Vesicare) is a new bladder selective muscarinic receptor antagonist for the treatment of overactive bladder.

ExcerptReferenceRelevance
"To determine the effect of food ingestion on the pharmacokinetic profile of solifenacin succinate (YM905; Vesicare, a new bladder selective muscarinic receptor antagonist for the treatment of overactive bladder, a chronic disease usually caused by involuntary detrusor muscle contractions during bladder filling."( Food does not affect the pharmacokinetics of solifenacin, a new muscarinic receptor antagonist: results of a randomized crossover trial.
Krauwinkel, WJ; Mulder, H; Smulders, RA; Uchida, T, 2004
)
0.55
" No statistically or clinically significant pharmacokinetic differences occurred between subjects in the fed and fasting states."( Food does not affect the pharmacokinetics of solifenacin, a new muscarinic receptor antagonist: results of a randomized crossover trial.
Krauwinkel, WJ; Mulder, H; Smulders, RA; Uchida, T, 2004
)
0.32
"The pharmacokinetic profile of solifenacin succinate (YM905; Vesicare), a new once-daily bladder-selective muscarinic receptor antagonist, was examined in 2 controlled trials of healthy young men."( Pharmacokinetics and safety of solifenacin succinate in healthy young men.
Huang, M; Krauwinkel, WJ; Smulders, RA; Swart, PJ, 2004
)
0.9
" Secondary parameters included terminal elimination half-life (t1/2), time to C(max) (t(max)), fraction unbound, renal clearance, amount/percent of dose excreted in urine as solifenacin and its metabolites, and trough plasma metabolite concentrations."( Effect of age on the pharmacokinetics of solifenacin in men and women.
Krauwinkel, WJ; Mulder, H; Smulders, RA; Swart, PJ; Taekema-Roelvink, ME, 2005
)
0.33
" In this study, no consistent safety/tolerability issues were associated with these pharmacokinetic differences and the administration of solifenacin 5 or 10 mg once daily was well tolerated."( Effect of age on the pharmacokinetics of solifenacin in men and women.
Krauwinkel, WJ; Mulder, H; Smulders, RA; Swart, PJ; Taekema-Roelvink, ME, 2005
)
0.33
"The aim of this study was to evaluate the effect of solifenacin on the pharmacokinetic (PK) parameters of an oral contraceptive (OC) containing ethinyl estradiol (EE) and levonorgestrel (LNG)."( Pharmacokinetic interaction of solifenacin with an oral contraceptive containing ethinyl estradiol and levonorgestrel in healthy women: a double-blind, placebo-controlled study.
Krauwinkel, WJ; Kuipers, ME; Smulders, RA; Swart, PJ; Taekema-Roelvink, ME; Visser, N, 2005
)
0.33
" The potential for pharmacokinetic and/or pharmacodynamic interactions between solifenacin and warfarin or digoxin was investigated."( Multiple doses of the antimuscarinic agent solifenacin do not affect the pharmacodynamics or pharmacokinetics of warfarin or the steady-state pharmacokinetics of digoxin in healthy subjects.
Krauwinkel, WJ; Kuipers, ME; Smulders, RA, 2006
)
0.33
" Pharmacokinetics was assessed using the standard measurements of maximum plasma concentration (Cmax), time to Cmax, area under the curve (AUC), and elimination half-life (t1/2)."( Pharmacokinetic effect of ketoconazole on solifenacin in healthy volunteers.
Krauwinkel, WJ; Smith, NN; Smulders, RA; Swart, PJ, 2006
)
0.33
" Blood and urine were collected for pharmacokinetic assessments."( Open-label study of the safety and pharmacokinetics of solifenacin in subjects with hepatic impairment.
Hoon, T; Krauwinkel, W; Kuipers, M; Smulders, R, 2006
)
0.33
" Pharmacokinetic parameters were assessed from blood samples drawn over a 360-h period."( Pharmacokinetics, safety, and tolerability of solifenacin in patients with renal insufficiency.
Hoon, TJ; Krauwinkel, WJ; Smith, NN; Smulders, RA, 2007
)
0.34
" The terminal elimination half-life ranges from 33 to 85 hours, permitting once-daily administration."( Clinical pharmacokinetics and pharmacodynamics of solifenacin.
Doroshyenko, O; Fuhr, U, 2009
)
0.35
"A pharmacokinetic bioequivalence study was conducted in Asian subjects, to compare a fixed dose combination capsule single oral dose of alpha adrenoceptor blocker-Alfuzosin hydrochloride 10mg extended release and muscarinic antagonists-Solifenacin succinate 5mg against individually administered Xatral XL 10mg tablets (Alfuzosin) of Sanofi Synthelabo Limited, United Kingdom (UK) and Vesicare 5mg tablets (Solifenacin) of Astellas Pharma Limited, UK under fed conditions."( Combining benefits of an adrenergic and a muscarinic blocker in a single formulation - a pharmacokinetic evaluation.
Arora, R; Arora, V; Dey, S; Kandhwal, K; Khuroo, AH; Madan, S; Monif, T; Nazarudheen, S; Reyar, S, 2013
)
0.57

Compound-Compound Interactions

ExcerptReferenceRelevance
"Randomized controlled trials evaluating solifenacin or its combination with tamsulosin for the treatment of SRSs were identified via a comprehensive search of Pubmed, Embase, Ovid, The Cochrane Library and relevant sources up to February 2017."( The role of solifenacin, as monotherapy or combination with tamsulosin in ureteral stent-related symptoms: a systematic review and meta-analysis.
Bai, B; Lei, Y; Mu, J; Wang, J; Zhang, T; Zhang, X, 2017
)
0.46
"The aim of this study was to compare the efficacy of the transobturator tape (TOT) procedure combined with solifenacin (TOT-S) or prasterone (TOT-P) in postmenopausal women affected by mixed urinary incontinence (MUI) with a predominant stress urinary incontinence component."( TOT in combination with solifenacin or intravaginal prasterone in postmenopausal women with mixed urinary incontinence: A retrospective analysis in 112 patients.
Cardella, G; Grossi, G; Loggia, M; Morgani, C; Palazzetti, PL; Sala, F; Schiavi, MC; Valensise, HCC; Zullo, MA, 2023
)
0.91

Bioavailability

ExcerptReferenceRelevance
" This study was designed to assess the absolute bioavailability of a single oral dose of solifenacin 10 mg, which is twice the suggested starting dose."( Solifenacin demonstrates high absolute bioavailability in healthy men.
Krauwinkel, WJ; Kuipers, ME; Mulder, H; Visser, N, 2004
)
0.32
" A single oral dose of solifenacin 10 mg had a high absolute bioavailability of 88."( Solifenacin demonstrates high absolute bioavailability in healthy men.
Krauwinkel, WJ; Kuipers, ME; Mulder, H; Visser, N, 2004
)
0.32
" This finding suggests that solifenacin may have a higher and less variable bioavailability than other antimuscarinic agents."( Solifenacin demonstrates high absolute bioavailability in healthy men.
Krauwinkel, WJ; Kuipers, ME; Mulder, H; Visser, N, 2004
)
0.32
" Solifenacin has been shown to display selectivity for bladder versus salivary tissue in vitro, and studies in healthy men have shown that absorption is slow but extensive with an absolute bioavailability of 88%."( Solifenacin in overactive bladder syndrome.
Payne, CK, 2006
)
0.33
" The validated method was successfully employed for bioavailability study after oral administration of 10 mg of alfuzosin hydrochloride and 5mg of solifenacin succinate tablet formulations in eight healthy volunteers under fed condition."( Highly sensitive and rapid LC-ESI-MS/MS method for the simultaneous quantification of uroselective alpha1-blocker, alfuzosin and an antimuscarinic agent, solifenacin in human plasma.
Jangid, AG; Mistri, HN; Pudage, A; Rathod, DM; Shrivastav, PS, 2008
)
0.55
" Studies in healthy adults have shown that the drug has high absolute bioavailability of about 90%, which does not decrease with concomitant food intake."( Clinical pharmacokinetics and pharmacodynamics of solifenacin.
Doroshyenko, O; Fuhr, U, 2009
)
0.35

Dosage Studied

To assess in a phase 3a trial the efficacy of solifenacin succinate, a once-daily oral antimuscarinic agent in development.

ExcerptRelevanceReference
"To evaluate the dose-response relationship and safety/tolerability of solifenacin succinate (YM905) in the treatment of overactive bladder (OAB), and to compare its efficacy and safety/tolerability with tolterodine 2 mg twice daily."( Solifenacin appears effective and well tolerated in patients with symptomatic idiopathic detrusor overactivity in a placebo- and tolterodine-controlled phase 2 dose-finding study.
Araño, P; Bosch, JL; Chapple, CR; De Ridder, D; Kramer, AE; Ridder, AM, 2004
)
0.56
"To assess in a phase 3a trial the efficacy of solifenacin succinate, a once-daily oral antimuscarinic agent in development at 5-mg and 10-mg dosage strengths, for the treatment of overactive bladder (OAB) (Yamanouchi Pharmaceutical Co."( Randomized, double-blind placebo- and tolterodine-controlled trial of the once-daily antimuscarinic agent solifenacin in patients with symptomatic overactive bladder.
Al-Shukri, S; Chapple, CR; Everaert, K; Huang, M; Meffan, P; Rechberger, T; Ridder, A, 2004
)
0.58
" All patients who entered the open-label extension study initially received solifenacin 5 mg daily for 4 weeks, after which a flexible dosing regimen allowed patients to individualise their treatment (5 mg or 10 mg) at each of the 3 study visits."( Long-term open-label solifenacin treatment associated with persistence with therapy in patients with overactive bladder syndrome.
Cardozo, L; Chapple, C; Haab, F; Ridder, AM, 2005
)
0.33
" Although the suppression induced by solifenacin was more persistent than that due to oxybutynin, the antagonistic effect of solifenacin on the dose-response curves to pilocarpine was significantly weaker than that of oxybutynin."( Muscarinic receptor binding, plasma concentration and inhibition of salivation after oral administration of a novel antimuscarinic agent, solifenacin succinate in mice.
Miyata, K; Oki, T; Sato, S; Yamada, S, 2005
)
0.53
"Solifenacin, with a flexible dosing regimen, showed greater efficacy to tolterodine in decreasing urgency episodes, incontinence, urge incontinence and pad usage and increasing the volume voided per micturition."( A comparison of the efficacy and tolerability of solifenacin succinate and extended release tolterodine at treating overactive bladder syndrome: results of the STAR trial.
Bolodeoku, J; Chapple, CR; Drogendijk, T; Martinez-Garcia, R; Selvaggi, L; Toozs-Hobson, P; Warnack, W; Wright, DM, 2005
)
0.58
"Solifenacin, with a flexible dosing regimen, was found to be superior to tolterodine ER with respect to the majority of the efficacy variables."( A comparison of the efficacy and tolerability of solifenacin succinate and extended release tolterodine at treating overactive bladder syndrome: results of the STAR trial.
Bolodeoku, J; Chapple, CR; Drogendijk, T; Martinez-Garcia, R; Selvaggi, L; Toozs-Hobson, P; Warnack, W; Wright, DM, 2005
)
0.58
" Subjects received warfarin on the 10th day of 16 days of dosing with either solifenacin or placebo."( Multiple doses of the antimuscarinic agent solifenacin do not affect the pharmacodynamics or pharmacokinetics of warfarin or the steady-state pharmacokinetics of digoxin in healthy subjects.
Krauwinkel, WJ; Kuipers, ME; Smulders, RA, 2006
)
0.33
"Since the pharmacokinetics and pharmacodynamics of a single dose of warfarin and the steady-state pharmacokinetics of digoxin were not affected by coadministration of solifenacin in healthy subjects, the need for dosing adjustments for digoxin and/or warfarin does not seem warranted."( Multiple doses of the antimuscarinic agent solifenacin do not affect the pharmacodynamics or pharmacokinetics of warfarin or the steady-state pharmacokinetics of digoxin in healthy subjects.
Krauwinkel, WJ; Kuipers, ME; Smulders, RA, 2006
)
0.33
" Solifenacin demonstrates a favourable tolerability profile, with mild dry mouth as the most common adverse event associated with its use, both at the 5- and 10-mg doses; this allows for flexibility in the dosing regimen, in which physicians can administer solifenacin 5 mg, with the option to safely increase the dose to 10 mg if necessary based on the severity of patient's symptoms."( Solifenacin provides effective antimuscarinic therapy for the complete management of overactive bladder.
Chapple, CR, 2006
)
0.33
"Flexibly dosed solifenacin 5 and 10 mg QD was associated with reductions in patient-reported OAB symptom bother and improvements in patients' perception of bladder condition and HRQOL."( Symptom bother and health-related quality of life outcomes following solifenacin treatment for overactive bladder: the VESIcare Open-Label Trial (VOLT).
Andoh, M; Garely, AD; Kaufman, JM; Sand, PK; Smith, N, 2006
)
0.33
" All patients were started on solifenacin 5 mg/day; at week 4, the dosage could be increased to 10 mg/day and at week 8 could be maintained or decreased back to 5 mg/day."( Solifenacin for overactive bladder with incontinence: symptom bother and health-related quality of life outcomes.
Garely, AD; Lucente, V; Smith, N; Vapnek, J, 2007
)
0.34
"Patients reporting urge incontinence as their most bothersome OAB symptom can be expected to demonstrate significant improvements in multiple patient-related outcomes following treatment with flexibly dosed solifenacin."( Solifenacin for overactive bladder with incontinence: symptom bother and health-related quality of life outcomes.
Garely, AD; Lucente, V; Smith, N; Vapnek, J, 2007
)
0.34
"In the 12 week, VESIcare Open-Label Trial (VOLT), patients received solifenacin 5 mg or 10 mg once daily according to an individualized, flexible dosing regimen."( Solifenacin treatment for overactive bladder in black patients: patient-reported symptom bother and health-related quality of life outcomes.
Burks, D; Garely, AD; Mallett, V; Smith, N, 2007
)
0.34
" This article summarizes the efficacy, contraindications, precautions, dosing and common side effects of these agents."( Pharmacologic management of overactive bladder.
Hilas, O; Lam, S, 2007
)
0.34
"A 1-year Markov model was constructed using data from a 12-week, randomised, double-blind study that compared flexible dosing with solifenacin (5 mg and 10 mg) with tolterodine (IR 2 mg bd/ER 4 mg) in adults with OAB."( A cost-utility analysis of once daily solifenacin compared to tolterodine in the treatment of overactive bladder syndrome.
Bolodeoku, J; Khullar, V; Mundy, A; Odeyemi, I; Speakman, M, 2008
)
0.35
"Flexible dosing with solifenacin is likely to be cost-effective versus tolterodine in the treatment of OAB."( A cost-utility analysis of once daily solifenacin compared to tolterodine in the treatment of overactive bladder syndrome.
Bolodeoku, J; Khullar, V; Mundy, A; Odeyemi, I; Speakman, M, 2008
)
0.35
" Once-daily, flexible dosing with this agent provides 24-hour control of OAB symptoms and significantly increases warning time (the period from onset of urgency to voiding), which may also increase a patient's chance of avoiding episodes of incontinence."( Solifenacin at 3 years: a review of efficacy and safety.
Capo, JP; Forero-Schwanhaeuser, S; Pelman, RS, 2008
)
0.35
" Patients were treated with solifenacin 5 mg or solifenacin 10 mg in the flexible dosing regimen."( [Efficacy and safety of solifenacin in daily clinical practice--clinical study phase IV].
Fabisovský, M; Havránek, O; Krhut, J; Míka, D; Valis, P, 2008
)
0.35
"The purpose of the present analysis was to analyze and compare the cost-effectiveness of solifenacin flexible dosing (5-10 mg) with tolterodine 4 mg sustained release (SR) or placebo (assumed to be comparable to no treatment) for patients with overactive bladder (OAB) symptoms."( Cost-effectiveness analysis of solifenacin flexible dosing in patients with overactive bladder symptoms in four Nordic countries.
Axelsen, S; Kulseng-Hansen, S; Mattiasson, A; Milsom, I; Nilsson, CG; Wickstrøm, J, 2009
)
0.35
"Solifenacin flexible dosing was more effective with respect to reducing OAB symptoms compared to both placebo and tolterodine 4 mg."( Cost-effectiveness analysis of solifenacin flexible dosing in patients with overactive bladder symptoms in four Nordic countries.
Axelsen, S; Kulseng-Hansen, S; Mattiasson, A; Milsom, I; Nilsson, CG; Wickstrøm, J, 2009
)
0.35
"Solifenacin flexible dosing was a cost-effective treatment alternative compared to tolterodine 4 mg SR."( Cost-effectiveness analysis of solifenacin flexible dosing in patients with overactive bladder symptoms in four Nordic countries.
Axelsen, S; Kulseng-Hansen, S; Mattiasson, A; Milsom, I; Nilsson, CG; Wickstrøm, J, 2009
)
0.35
"In this 12-week multicenter trial, 739 patients (aged >or= 18 years) were randomized to flexibly dosed solifenacin (5/10 mg) or placebo."( Solifenacin for overactive bladder: patient-reported outcomes from a large placebo-controlled trial.
Andoh, M; Forero-Schwanhaeuser, S; Karram, MM; Laramée, C; Nandy, IM; Seifeldin, R; Serels, SR; Toglia, MR, 2009
)
0.35
"In VIBRANT, a double-blind, US-based trial, patients with OAB for > or = 3 months received flexibly dosed solifenacin or placebo for 12 weeks."( Effects of solifenacin on overactive bladder symptoms, symptom bother and other patient-reported outcomes: results from VIBRANT - a double-blind, placebo-controlled trial.
Forero-Schwanhaeuser, S; He, W; Marshall, TS; Mitcheson, HD; Samuels, TA; Vardy, MD; Wegenke, JD, 2009
)
0.35
"As early as week 4 and through EOT, flexibly dosed solifenacin significantly improved OAB symptom bother and HRQL as well as the symptoms of urgency, frequency and incontinence compared with placebo."( Effects of solifenacin on overactive bladder symptoms, symptom bother and other patient-reported outcomes: results from VIBRANT - a double-blind, placebo-controlled trial.
Forero-Schwanhaeuser, S; He, W; Marshall, TS; Mitcheson, HD; Samuels, TA; Vardy, MD; Wegenke, JD, 2009
)
0.35
"Subjects with OAB for > or =3 months received flexibly dosed solifenacin for 12 weeks."( Solifenacin treatment in men with overactive bladder: effects on symptoms and patient-reported outcomes.
Andoh, M; Forero-Schwanhaeuser, S; Gittelman, M; Goldfischer, ER; Kaplan, SA; Steers, WD, 2010
)
0.36
" After a washout period of > or = 14 days, patients began treatment with solifenacin 5 mg/d with dosing adjustments allowed at week 4 (to 10 mg/d) and at week 8 (back to 5 mg/d for patients whose dose was increased to 10 mg/d at week 4)."( Impact of solifenacin on quality of life, medical care use, work productivity, and health utility in the elderly: an exploratory subgroup analysis.
Marshall, T; Noe, L; Rasouliyan, L; Runken, MC; Seifeldin, R; Zinner, N, 2009
)
0.35
"In this large group of older patients, flexibly dosed solifenacin was associated with reductions in diary-documented OAB symptoms (VERSUS)."( Efficacy and tolerability of solifenacin in patients aged ≥ 65 years with overactive bladder: post-hoc analysis of 2 open-label studies.
Capo', JP; Forero-Schwanhaeuser, S; He, W; Lucente, V, 2011
)
0.37
" Studies have found that a flexible dosing strategy can be effective in improving OAB symptoms with minimal impact on tolerability."( Severity of overactive bladder symptoms and response to dose escalation in a randomized, double-blind trial of solifenacin (SUNRISE).
Amarenco, G; Cardozo, L; Compion, G; Drogendijk, T; Mikulas, J; Pushkar, D; Wright, M, 2013
)
0.39
" Patients who requested a dose increase at week 8 generally had more severe OAB symptoms at baseline and a smaller response at week 8 to the initial solifenacin 5 mg dosage than those who did not."( Severity of overactive bladder symptoms and response to dose escalation in a randomized, double-blind trial of solifenacin (SUNRISE).
Amarenco, G; Cardozo, L; Compion, G; Drogendijk, T; Mikulas, J; Pushkar, D; Wright, M, 2013
)
0.39
"To evaluate cognitive effects during chronic stable dosing with solifenacin and oxybutynin versus placebo in older (≥75 yr) subjects with MCI."( Randomised, multicentre, placebo-controlled, double-blind crossover study investigating the effect of solifenacin and oxybutynin in elderly people with mild cognitive impairment: the SENIOR study.
Compion, G; Dale, M; Stow, B; Tretter, R; Wagg, A, 2013
)
0.39
"05 for the dose-response slope, all variables)."( Efficacy and safety of solifenacin plus tamsulosin OCAS in men with voiding and storage lower urinary tract symptoms: results from a phase 2, dose-finding study (SATURN).
Angulo, JC; Garcia-Hernandez, A; Haab, F; Katona, F; Klaver, M; Oelke, M; Traudtner, K; Van Kerrebroeck, P; Vik, V, 2013
)
0.39
" 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
)
0.42
"To evaluate long-term (up to 52 wk) safety and efficacy of flexible dosing of two fixed-dose combinations (FDC) of Soli plus TOCAS in men with moderate to severe storage symptoms and voiding symptoms."( Long-term safety and efficacy of single-tablet combinations of solifenacin and tamsulosin oral controlled absorption system in men with storage and voiding lower urinary tract symptoms: results from the NEPTUNE Study and NEPTUNE II open-label extension.
Chapple, C; Drake, MJ; Drogendijk, T; Klaver, M; Oelke, M; Sokol, R; Traudtner, K; Van Kerrebroeck, P, 2015
)
0.42
" During the treatment all patients, except for those who were assigned to the control group, received Loop Diuretic Furosemide dosed at 20-30 mg per day and Solifenacin dosed at 5 mg per day (First comparison group) and 10 mg per day (Second comparison group)."( Decrease of risk of developing symptoms of OAB in elderly men and women treated with loop diuretic for hypertensive disease using solifenacin.
Ivanovskaya, MA; Kosilov, KV; Kosilova, LV; Loparev, SA, 2014
)
0.4
"2%), group of the patients treated with Furosemide and standard- dosed (11."( Decrease of risk of developing symptoms of OAB in elderly men and women treated with loop diuretic for hypertensive disease using solifenacin.
Ivanovskaya, MA; Kosilov, KV; Kosilova, LV; Loparev, SA, 2014
)
0.4
" Administration of low dosed Solifenacin is sufficient for significant decrease in risk of developing symptoms of overactive bladder."( Decrease of risk of developing symptoms of OAB in elderly men and women treated with loop diuretic for hypertensive disease using solifenacin.
Ivanovskaya, MA; Kosilov, KV; Kosilova, LV; Loparev, SA, 2014
)
0.4
"We evaluated changes in urinary nerve growth factor (NGF) and NGF/creatinine (NGF/Cr) levels after increasing the dosage of solifenacin in overactive bladder patients."( Urinary nerve growth factor and a variable solifenacin dosage in patients with an overactive bladder.
Cekmen, MB; Ciftci, S; Ozkurkcugil, C; Ustuner, M; Yavuz, U; Yilmaz, H; Yuksekkaya, M, 2016
)
0.43
" After increasing the dosage of solifenacin to 10 mg in group 2, the NGF and NGF/Cr levels decreased to normal levels."( Urinary nerve growth factor and a variable solifenacin dosage in patients with an overactive bladder.
Cekmen, MB; Ciftci, S; Ozkurkcugil, C; Ustuner, M; Yavuz, U; Yilmaz, H; Yuksekkaya, M, 2016
)
0.43
"0% changed the dosage (84."( Profile of oab patient on treatment with flexible-dose antimuscarinic drugs in daily clinical practice.
Arumi, D; García-Mediero, JM; Lizarraga, I; Sánchez-Ballester, F; Sobrón-Bustamante, M, 2016
)
0.43
"We compared changes in nocturia and sleep-related parameters between daytime and nighttime solifenacin dosing in patents with overactive bladder (OAB) and nocturia."( Influence of Daytime or Nighttime Dosing with Solifenacin for Overactive Bladder with Nocturia: Impact on Nocturia and Sleep Quality.
Cho, WY; Choi, S; Kwon, T; Lee, JZ; Min, K; Moon, KH; Oh, TH, 2017
)
0.46
"The combination of solifenacin in a double dosage along with tamsulosin can be recommended for elderly benign prostatic hyperplasia patients with overactive bladder symptoms."( Cognitive functions and health-related quality of life in men with benign prostatic hyperplasia and symptoms of overactive bladder when treated with a combination of tamsulosin and solifenacin in a higher dosage.
Gainullina, Y; Kosilov, K; Kosilova, L; Kuzina, I; Kuznetsov, V; Loparev, S; Prokofyeva, A, 2018
)
0.48
" 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
" Thus, overall sexual function in men with BPH and severe LUTS is not impaired by prolonged intake of double dosage of solifenacin combined with dutasteride."( The Risk of Sexual Dysfunction and Effectiveness of Treatment of Benign Prostatic Hyperplasia With Severe Lower Urinary Tract Dysfunction With Combination of Dutasteride and Solifenacin.
Gainullina, Y; Karashchuk, E; Kosilov, K; Kosilova, L; Kuzina, I; Kuznetsov, V; Loparev, S; Prokofyeva, A, 2018
)
0.48
" In the case-time-control design, we made separate analyses to evaluate the dose-response risk of delirium."( Risk of delirium associated with antimuscarinics in older adults: A case-time-control study.
Chyou, TY; Nishtala, PS, 2022
)
0.72
" The dose-response risk of delirium was significant for oxybutynin (0."( Risk of delirium associated with antimuscarinics in older adults: A case-time-control study.
Chyou, TY; Nishtala, PS, 2022
)
0.72
" The work was also extended to verify content uniformity of dosage units in accordance with USP recommendations."( State-of-the-art mathematically induced filtration approaches for smart spectrophotometric assessment of silodosin and solifenacin mixture in their new challenging formulation: Multi-tool greenness and whiteness evaluation.
Abdel-Moety, EM; Marzouk, HM; Rezk, MR; Rostom, Y; Wadie, M, 2024
)
1.44
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (1)

ClassDescription
isoquinolinesA class of organic heteropolycyclic compound consisting of isoquinoline and its substitution derivatives.
[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]

Protein Targets (3)

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Muscarinic acetylcholine receptor M2Homo sapiens (human)IC50 (µMol)0.57370.00001.23267.7930AID598150
Muscarinic acetylcholine receptor M1Homo sapiens (human)IC50 (µMol)0.06350.00001.403910.0000AID598151
Muscarinic acetylcholine receptor M3Homo sapiens (human)IC50 (µMol)0.13080.00011.01049.9280AID598149
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (34)

Processvia Protein(s)Taxonomy
G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M2Homo sapiens (human)
adenylate cyclase-modulating G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M2Homo sapiens (human)
phospholipase C-activating G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M2Homo sapiens (human)
G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M2Homo sapiens (human)
nervous system developmentMuscarinic acetylcholine receptor M2Homo sapiens (human)
regulation of heart contractionMuscarinic acetylcholine receptor M2Homo sapiens (human)
response to virusMuscarinic acetylcholine receptor M2Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathwayMuscarinic acetylcholine receptor M2Homo sapiens (human)
presynaptic modulation of chemical synaptic transmissionMuscarinic acetylcholine receptor M2Homo sapiens (human)
regulation of smooth muscle contractionMuscarinic acetylcholine receptor M2Homo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M2Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerMuscarinic acetylcholine receptor M2Homo sapiens (human)
chemical synaptic transmissionMuscarinic acetylcholine receptor M2Homo sapiens (human)
positive regulation of monoatomic ion transportMuscarinic acetylcholine receptor M1Homo sapiens (human)
signal transductionMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
protein kinase C-activating G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
phospholipase C-activating G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
neuromuscular synaptic transmissionMuscarinic acetylcholine receptor M1Homo sapiens (human)
nervous system developmentMuscarinic acetylcholine receptor M1Homo sapiens (human)
regulation of locomotionMuscarinic acetylcholine receptor M1Homo sapiens (human)
saliva secretionMuscarinic acetylcholine receptor M1Homo sapiens (human)
cognitionMuscarinic acetylcholine receptor M1Homo sapiens (human)
regulation of postsynaptic membrane potentialMuscarinic acetylcholine receptor M1Homo sapiens (human)
regulation of glial cell proliferationMuscarinic acetylcholine receptor M1Homo sapiens (human)
positive regulation of intracellular protein transportMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
postsynaptic modulation of chemical synaptic transmissionMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerMuscarinic acetylcholine receptor M1Homo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
chemical synaptic transmissionMuscarinic acetylcholine receptor M1Homo sapiens (human)
calcium-mediated signalingMuscarinic acetylcholine receptor M3Homo sapiens (human)
regulation of monoatomic ion transmembrane transporter activityMuscarinic acetylcholine receptor M3Homo sapiens (human)
smooth muscle contractionMuscarinic acetylcholine receptor M3Homo sapiens (human)
signal transductionMuscarinic acetylcholine receptor M3Homo sapiens (human)
G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
phospholipase C-activating G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
synaptic transmission, cholinergicMuscarinic acetylcholine receptor M3Homo sapiens (human)
nervous system developmentMuscarinic acetylcholine receptor M3Homo sapiens (human)
positive regulation of insulin secretionMuscarinic acetylcholine receptor M3Homo sapiens (human)
protein modification processMuscarinic acetylcholine receptor M3Homo sapiens (human)
positive regulation of smooth muscle contractionMuscarinic acetylcholine receptor M3Homo sapiens (human)
saliva secretionMuscarinic acetylcholine receptor M3Homo sapiens (human)
acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
ion channel modulating, G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
ligand-gated ion channel signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
regulation of smooth muscle contractionMuscarinic acetylcholine receptor M3Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerMuscarinic acetylcholine receptor M3Homo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
chemical synaptic transmissionMuscarinic acetylcholine receptor M3Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (7)

Processvia Protein(s)Taxonomy
G protein-coupled acetylcholine receptor activityMuscarinic acetylcholine receptor M2Homo sapiens (human)
arrestin family protein bindingMuscarinic acetylcholine receptor M2Homo sapiens (human)
G protein-coupled serotonin receptor activityMuscarinic acetylcholine receptor M2Homo sapiens (human)
phosphatidylinositol phospholipase C activityMuscarinic acetylcholine receptor M1Homo sapiens (human)
protein bindingMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled acetylcholine receptor activityMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled serotonin receptor activityMuscarinic acetylcholine receptor M1Homo sapiens (human)
phosphatidylinositol phospholipase C activityMuscarinic acetylcholine receptor M3Homo sapiens (human)
protein bindingMuscarinic acetylcholine receptor M3Homo sapiens (human)
G protein-coupled acetylcholine receptor activityMuscarinic acetylcholine receptor M3Homo sapiens (human)
signaling receptor activityMuscarinic acetylcholine receptor M3Homo sapiens (human)
acetylcholine bindingMuscarinic acetylcholine receptor M3Homo sapiens (human)
G protein-coupled serotonin receptor activityMuscarinic acetylcholine receptor M3Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (18)

Processvia Protein(s)Taxonomy
plasma membraneMuscarinic acetylcholine receptor M2Homo sapiens (human)
membraneMuscarinic acetylcholine receptor M2Homo sapiens (human)
clathrin-coated endocytic vesicle membraneMuscarinic acetylcholine receptor M2Homo sapiens (human)
asymmetric synapseMuscarinic acetylcholine receptor M2Homo sapiens (human)
symmetric synapseMuscarinic acetylcholine receptor M2Homo sapiens (human)
presynaptic membraneMuscarinic acetylcholine receptor M2Homo sapiens (human)
neuronal cell bodyMuscarinic acetylcholine receptor M2Homo sapiens (human)
axon terminusMuscarinic acetylcholine receptor M2Homo sapiens (human)
postsynaptic membraneMuscarinic acetylcholine receptor M2Homo sapiens (human)
glutamatergic synapseMuscarinic acetylcholine receptor M2Homo sapiens (human)
cholinergic synapseMuscarinic acetylcholine receptor M2Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M2Homo sapiens (human)
synapseMuscarinic acetylcholine receptor M2Homo sapiens (human)
dendriteMuscarinic acetylcholine receptor M2Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M1Homo sapiens (human)
membraneMuscarinic acetylcholine receptor M1Homo sapiens (human)
presynaptic membraneMuscarinic acetylcholine receptor M1Homo sapiens (human)
axon terminusMuscarinic acetylcholine receptor M1Homo sapiens (human)
Schaffer collateral - CA1 synapseMuscarinic acetylcholine receptor M1Homo sapiens (human)
postsynaptic density membraneMuscarinic acetylcholine receptor M1Homo sapiens (human)
glutamatergic synapseMuscarinic acetylcholine receptor M1Homo sapiens (human)
cholinergic synapseMuscarinic acetylcholine receptor M1Homo sapiens (human)
synapseMuscarinic acetylcholine receptor M1Homo sapiens (human)
dendriteMuscarinic acetylcholine receptor M1Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M1Homo sapiens (human)
endoplasmic reticulum membraneMuscarinic acetylcholine receptor M3Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M3Homo sapiens (human)
basal plasma membraneMuscarinic acetylcholine receptor M3Homo sapiens (human)
basolateral plasma membraneMuscarinic acetylcholine receptor M3Homo sapiens (human)
postsynaptic membraneMuscarinic acetylcholine receptor M3Homo sapiens (human)
synapseMuscarinic acetylcholine receptor M3Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M3Homo sapiens (human)
dendriteMuscarinic acetylcholine receptor M3Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (19)

Assay IDTitleYearJournalArticle
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID598151Displacement of [3H]NMS from human muscarinic M1 receptor expressed in CHO-K1 cells after 1 hr by scintillation counting2011Bioorganic & medicinal chemistry letters, Jun-01, Volume: 21, Issue:11
Discovery of novel quaternary ammonium derivatives of (3R)-quinuclidinyl carbamates as potent and long acting muscarinic antagonists.
AID598150Displacement of [3H]NMS from human muscarinic M2 receptor expressed in CHO-K1 cells after 1 hr by scintillation counting2011Bioorganic & medicinal chemistry letters, Jun-01, Volume: 21, Issue:11
Discovery of novel quaternary ammonium derivatives of (3R)-quinuclidinyl carbamates as potent and long acting muscarinic antagonists.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID598149Displacement of [3H]NMS from human muscarinic M3 receptor expressed in CHO-K1 cells after 1 hr by scintillation counting2011Bioorganic & medicinal chemistry letters, Jun-01, Volume: 21, Issue:11
Discovery of novel quaternary ammonium derivatives of (3R)-quinuclidinyl carbamates as potent and long acting muscarinic antagonists.
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID598152Selectivity ratio of IC50 for human muscarinic M2 receptor to IC50 for human muscarinic M3 receptor2011Bioorganic & medicinal chemistry letters, Jun-01, Volume: 21, Issue:11
Discovery of novel quaternary ammonium derivatives of (3R)-quinuclidinyl carbamates as potent and long acting muscarinic antagonists.
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID598153Selectivity ratio of IC50 for human muscarinic M1 receptor to IC50 for human muscarinic M3 receptor2011Bioorganic & medicinal chemistry letters, Jun-01, Volume: 21, Issue:11
Discovery of novel quaternary ammonium derivatives of (3R)-quinuclidinyl carbamates as potent and long acting muscarinic antagonists.
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (484)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's122 (25.21)29.6817
2010's281 (58.06)24.3611
2020's81 (16.74)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 82.26

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 Index82.26 (24.57)
Research Supply Index6.58 (2.92)
Research Growth Index6.91 (4.65)
Search Engine Demand Index142.60 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (82.26)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials194 (37.16%)5.53%
Reviews80 (15.33%)6.00%
Case Studies13 (2.49%)4.05%
Observational19 (3.64%)0.25%
Other216 (41.38%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (136)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
"A Randomized, Placebo-Controlled Parallel-Design Trial of the Effect of Solifenacin Treatment for Overactive Bladder in Women With Anterior Vaginal Wall Prolapse Managed With a Pessary (the PESSARY Study)" [NCT01092624]Phase 494 participants (Anticipated)Interventional2010-03-31Terminated(stopped due to sponsor closed study due to poor enrollment)
Effect of Electroacupuncture for Women With Urgency-predominant Mixed Urinary Incontinence: a Three Armed Non-inferior Randomized Controlled Trial [NCT03787654]282 participants (Anticipated)Interventional2019-03-01Recruiting
A Therapeutic Exploratory Clinical Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder [NCT03566134]Phase 2306 participants (Actual)Interventional2018-07-10Completed
A Multicenter, Open-label, Single Ascending Dose Study to Evaluate Pharmacokinetics, Safety and Tolerability of Solifenacin Succinate Suspension in Pediatric Patients Aged 5 to 17 Years (Inclusive) With Overactive Bladder (OAB) [NCT01262391]Phase 142 participants (Actual)Interventional2010-10-20Completed
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
Comparison of Solifenacin Combined With Pelvic Floor Muscle and Whole Body Vibration Training With Solifenacin Alone in Patients With Overactive Bladder Syndrome. - A Prospective Randomized Parallel Group Trial [NCT01314781]Phase 466 participants (Actual)Interventional2012-01-31Completed
Czech Observational Study to Evaluate Quality of Life in Patients Switched to Vesicare™ (Solifenacin) From Other Antimuscarinics [NCT02087098]2,000 participants (Actual)Observational2014-06-30Completed
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
Reproducibility Study of OABSS and Its Response to Solifenacin Treatment (RESORT) and Validity in Korean Populations; Part 2: Responsiveness and Validity [NCT01318837]Phase 4100 participants (Actual)Interventional2010-04-30Completed
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
Pharmacokinetic Drug Interaction Between Solifenacin 10mg and Tamsulosin 0.4mg in Healthy Male Volunteers [NCT02180997]Phase 136 participants (Actual)Interventional2014-07-31Completed
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
Efficacy of of Pelvic Floor Muscle Training( PFMT ) With Surface Electromyographic Biofeedback and Medication in Women With Overactive Bladder [NCT04477265]140 participants (Actual)Interventional2016-06-16Completed
Peripheral Transcutaneous Neuromodulation of the Post-tibial Nerve (T-PTNS) for Solifenacin 10 mg. in the Treatment of Hyperactive Bladder Syndrome: no Inferiority Phase IV Randomized Clinical Trial [NCT03468465]Phase 4110 participants (Anticipated)Interventional2018-05-04Active, not recruiting
Predictors Affecting Long-term Use of Solifenacin or Mirabegron in Women With Overactive Bladder Syndrome [NCT05040984]500 participants (Anticipated)Observational2021-04-30Recruiting
Reproducibility Study of OABSS and Its Response to Treatment in Indonesia - Part 2: Responsiveness [NCT01122563]55 participants (Actual)Observational2009-09-30Completed
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 Double Blind, Randomized Placebo Controlled Trial of the Perioperative Use of Solifenacin in the Management of Postoperative Overactive Bladder Symptoms in Patients With Mixed Incontinence Undergoing Suburethral Sling Procedures. [NCT00852696]1 participants (Actual)Interventional2008-02-29Terminated(stopped due to Investigator left Cleveland Clinic and absolutely no data is available.)
A Study to Evaluate the Overall Effect of Solifenacin 5mg and 10mg on Bladder Wall Thickness and Urinary Nerve Growth Factor in Female Subjects With Overactive Bladder and a Diagnosis of Detrusor Overactivity - A Double-blind, Randomised, Placebo-controll [NCT01093534]Phase 4547 participants (Actual)Interventional2010-01-31Completed
Medication Effects on Periurethral Sensation, Urethral Sphincter Activity and Pressure Flow Parameters [NCT01028014]56 participants (Actual)Interventional2010-04-30Completed
URGE-PD: A Multi-site, Double-blind, Randomized, Placebo Controlled Trial of Solifenacin Succinate (VESIcare) for the Treatment of Overactive Bladder in Parkinson's Disease [NCT01018264]Phase 423 participants (Actual)Interventional2010-01-31Completed
A Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi-center Study of Fixed Dose Combinations of Solifenacin Succinate (6 mg and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg and Tamsulosin Hydrochloride OCAS 0.4 mg Monotherapy, in Male [NCT01018511]Phase 31,334 participants (Actual)Interventional2010-01-31Completed
A Randomized, Double Blind, Double Dummy, Placebo Controlled Study to Evaluate the Efficacy and Safety of Solifenacin Succinate (5 and 10mg Once Daily) Against Placebo and Oxybutynin Hydrochloride (5 mg Three Times Daily) in the Treatment of Subjects With [NCT00629642]Phase 4249 participants (Actual)Interventional2008-03-14Completed
An Open-label, Parallel Group, Randomized, Two-way Crossover, Multiple Dose Study to Compare the Pharmacokinetic Profiles of Solifenacin Succinate and Tamsulosin HCl Following Co-administration of Single Entity Tablets and Administration of Three Differen [NCT02634489]Phase 146 participants (Actual)Interventional2009-03-31Completed
Validation of a Real-time Urodynamic Measure of Urinary Urgency as a Measure of the Success of Drug Treatment [NCT00909428]Phase 451 participants (Actual)Interventional2007-01-31Completed
Efficacy and Safety of Tamsulosin/Solifenacin Combination Therapy in Patients With Voiding Symptoms and Moderate to Severe Storage Symptoms Due to Benign Prostate Hyperplasia : a Randomized, Double Blinded, Parallel Design, Active Controlled, Multi-center [NCT02827578]Phase 3588 participants (Anticipated)Interventional2016-01-31Recruiting
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
Efficacy and Safety of Mirabegron Compared With Solifenacin in Treatment of Overactive Bladder [NCT03558919]Phase 481 participants (Actual)Interventional2017-01-01Completed
The Efficacy of Solifenacin Succinate as Adjuvant Therapy for Symptomatic Non-complicated Urinary Tract Infection in Females [NCT02094703]Phase 4126 participants (Anticipated)Interventional2013-04-30Recruiting
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
Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson Disease [NCT03149809]Phase 377 participants (Actual)Interventional2018-03-01Completed
Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics [NCT04090190]Phase 420 participants (Actual)Interventional2019-10-30Completed
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
Comparison of the Effect of Flexible Dosage of Solifenacin Succinate Between Patients Who Have Frequent Micturition With and Without Urgency [NCT00979472]Phase 4291 participants (Actual)Interventional2009-04-30Completed
Solifenacin in a Flexible Dose Regimen With Tolterodine as an Active Comparator in a Double-blind, Double-dummy, Randomised Overactive Bladder Symptom Trial [NCT00802373]Phase 31,355 participants (Actual)Interventional2003-07-31Completed
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
Impact of Solifenacin Succinate for Treatment of Acute Irritative Urinary Toxicity Occurring During Radiotherapy of Prostatic Cancer [NCT02805452]Phase 34 participants (Actual)Interventional2016-07-31Terminated(stopped due to Target of recruitment not reachable)
Efficacy of Low-intensity Shock Wave Therapy on Persistent Storage Symptoms After Transurethral Surgery for Benign Prostatic Obstruction: A Randomized Controlled Trial [NCT04437108]132 participants (Actual)Interventional2020-07-04Completed
An Open-label, Randomized, Parallel Study to Evaluate the Clinical Efficacy and Safety of Tamsulosin Alone or in Combination With Solifenacin for the Treatment in Men With Lower Urinary Tract Symptoms Including Overactive Bladder Symptoms [NCT02715024]Phase 452 participants (Actual)Interventional2007-09-30Completed
A Multicenter, Double-blind, Placebo-controlled and Active-reference, Randomized, Parallel, Therapeutic Confirmatory Clinical Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder [NCT05282069]Phase 3607 participants (Actual)Interventional2022-05-12Active, not recruiting
Overactive Bladder Symptom Scores (OABSS) Responsiveness Before and After Anticholinergic Treatment in Women With Overactive Bladder (OAB) [NCT02667470]Phase 450 participants (Actual)Interventional2009-09-30Completed
Persistence of Solifenacin Treatment in Overactive Bladder Patients in Real Life Practice: A 12-month, Prospective, Multicenter, Open-label, Observational Study [NCT00985387]1,215 participants (Actual)Observational2009-08-31Completed
A Phase 1, Open-Label, Randomized, Single Dose, 3-Way Crossover Study to Address the Relative Bioavailability of Solifenacin Liquid Suspension 10mg (Fed and Fasting) Versus the VESIcare (Solifenacin Succinate) 10 mg Tablet (Fasting) in Healthy Volunteers [NCT01015040]Phase 124 participants (Actual)Interventional2009-09-30Completed
A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose Study To Investigate The Effects Of 8 Mg Fesoterodine SR Tablets And 10 Mg Solifenacin Tablet On Gastrointestinal Transit In Healthy Female Subjects. [NCT00832650]Phase 160 participants (Actual)Interventional2009-04-30Terminated(stopped due to Protocol A0221057 was terminated on December 25, 2009 for futility. There were no safety concerns related to this decision.)
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study of Solifenacin Succinate as Add-on Therapy for Overactive Bladder (OAB) Symptoms in Men Treated for Benign Prostatic Hyperplasia (BPH) With Tamsulosin Hydrochloride [NCT00771394]Phase 4638 participants (Actual)Interventional2008-10-31Completed
Recurrence of Symptoms of Overactive Bladder After Weaning Versus Sudden Stopping of Anticholinergics [NCT04064619]60 participants (Actual)Interventional2018-01-01Completed
A Prospective, Open-label, Observational, Multi-center Study for the Identification of Predictive Factors for the Solifenacin Treatment in Men With Overactive Bladder Symptoms After Tamsulosin Monotherapy for 4 Weeks and Evaluation of Efficacy and Persist [NCT00884104]Phase 4307 participants (Actual)Interventional2009-03-31Completed
Evaluation of Solifenacin in the Treatment of OAB Symptoms in Patients Who Have Successfully Undergone GreenLight Photoselective Vaporization of the Prostate (PVP)for the Treatment of Clinically Significant Benign Prostate Hyperplasia (BPH) [NCT00826527]Phase 423 participants (Anticipated)Interventional2007-01-31Recruiting
A Randomized, Double Blind, Placebo-Controlled, Parallel Group Comparison of the Efficacy and Safety of Any Alpha Blocker Monotherapy and Any Alpha Blocker Plus Solifenacin in Men With Residual Overactive Bladder Symptoms of Urinary Frequency and Urgency [NCT00699049]Phase 494 participants (Actual)Interventional2008-06-30Completed
A Phase 1, Open-Label, Randomized, Single Dose, 3-Way Crossover Study to Assess the Relative Bioavailability of Solifenacin Liquid Suspension 10 mg (Formulation B) Versus Solifenacin Liquid Suspension 10 mg (Formulation A) and to Assess the Relative Bioav [NCT01406158]Phase 124 participants (Actual)Interventional2011-05-31Completed
Randomized Double Blinded Placebo-controlled Trial of the Once Daily 5mg Dose of Solifenacin Succinate vs. Placebo in Inner City Women Ages 20-45 With Overactive Bladder [NCT00773552]Phase 40 participants (Actual)Interventional2008-11-30Withdrawn(stopped due to Investigator Left Institution)
A Randomized Clinical Trial Comparing Alpha Blacker (Tamsulosin) and Anticholinergic (Solifenacin) in Treatment of Ureteral Stent Related Symptoms [NCT01880619]Phase 4131 participants (Actual)Interventional2013-01-31Completed
Solifenacin in the Treatment of Urgency Symptoms of Overactive Bladder in a Rising Dose, Randomized, Placebo-controlled, Double-blind Trial [NCT00801944]Phase 3973 participants (Actual)Interventional2004-04-30Completed
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
A Phase 2, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multi-Center Study to Evaluate the Safety of the Co-administration of Solifenacin Succinate With 0.4 mg Tamsulosin Hydrochloride OCAS (TOCAS) Using Urodynamics in Male Subjects With [NCT00507455]Phase 2222 participants (Actual)Interventional2007-06-30Completed
Comparisons of Urodynamic Effects, Urinary Nerve Growth Factor Levels and Outcomes in Female Overactive Bladder Patients After 3-month Versus 6-month Solifenacin Treatment: a Randomized Prospective Study [NCT01876186]Phase 4200 participants (Anticipated)Interventional2013-05-31Recruiting
A Phase 1, Open-label, One-sequence Study to Assess the Effect of Verapamil on the Steady State Pharmacokinetics of Solifenacin and Tamsulosin Administered as a Combination Tablet EC905 in Healthy Male Subjects. [NCT01943487]Phase 136 participants (Actual)Interventional2009-08-31Completed
An Open-label, Randomized, Two-way Crossover, Multiple Dose Study to Evaluate the Steady State Pharmacokinetics of the Two Final Combination Tablet Formulations (EC905; Tamsulosin HCl/ Solifenacin Succinate; 0.4 mg/6 mg and 0.4 mg/9 mg) in Healthy Male Vo [NCT01953848]Phase 127 participants (Actual)Interventional2010-04-30Completed
An Open-label, Randomized, Three-period Crossover, Single Dose Study to Compare the Pharmacokinetics of the Final EC905 Formulation to Marketed Solifenacin (Vesicare®) and Tamsulosin OCAS (Omnic OCAS®) [NCT01953887]Phase 130 participants (Actual)Interventional2010-03-31Completed
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
A Randomized, Open-label, Single Dose, 2-way Crossover Study to Compare the Safety and Pharmacokinetic Characteristics After Administration of HIP1503 and HGP1103 in Healthy Male Volunteers [NCT02940314]Phase 136 participants (Actual)Interventional2016-03-31Completed
[NCT00584090]Phase 40 participants (Actual)Interventional2007-11-30Withdrawn(stopped due to Study withdrawn with intent of persuing larger, multi-site study.)
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
An Open-label, Long Term, Multi-center Study to Assess the Safety and Efficacy of Fixed Dose Combinations of Solifenacin Succinate (6 mg and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg, in Male Subjects With Lower Urinary Tract Symptoms (LUTS) Associa [NCT01021332]Phase 31,067 participants (Actual)Interventional2010-04-26Completed
Efficacy and Impact of Botulinum Toxin A Versus Anticholinergic Therapy for the Treatment of Bothersome Urge Urinary Incontinence [NCT01166438]Phase 3249 participants (Actual)Interventional2010-03-31Completed
A Study to Compare the Cognitive Effect of Solifenacin 5mg Once-daily and Oxybutynin 5mg Twice-daily After Chronic Dosing Versus Placebo in Subjects 75 Years and Over With Mild Cognitive Impairment - A Double-blind, Randomized, Multi-center Study [NCT01126424]Phase 426 participants (Actual)Interventional2010-04-30Completed
Vesicare™ (Solifenacin) in the Treatment of Urinary Incontinence After Radical Prostatectomy [NCT01215721]40 participants (Actual)Interventional2010-10-31Completed
Comparison of Oxybutynin and Solifenacin in the Treatment of Overactive Bladder: a Randomized Controlled Multicenter Trial [NCT01423838]Phase 4500 participants (Anticipated)Interventional2011-09-30Not yet recruiting
Solifenacin Succinate in a Flexible Dose Regimen With Simplified Bladder Training Versus Solifenacin Succinate in a Flexible Dose Regimen Alone in a Prospective, Randomized, Parallel Group, Overactive Bladder Symptom Study [NCT00337558]Phase 4643 participants (Actual)Interventional2006-05-31Completed
A Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi Center Dose Ranging Study of Solifenacin Succinate in Combination With Tamsulosin Hydrochloride Compared With Solifenacin Succinate Monotherapy and Tamsulosin Hydrochloride Monotherapy [NCT00510406]Phase 2919 participants (Actual)Interventional2007-01-31Completed
[NCT00189800]Phase 30 participants InterventionalCompleted
Efficacy and Safety of High Dose Vitamin D Supplementation for Overactive Bladder Dry in Children: A Randomized Clinical Trial [NCT05709990]300 participants (Anticipated)Interventional2023-01-15Recruiting
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
Efficacy and Safety of Gabapentin in Treating Overactive Bladder [NCT01486706]Phase 2/Phase 394 participants (Actual)Interventional2010-10-31Completed
Specified Drug Use Results Survey of Vesicare Tablets [NCT01489709]1,160 participants (Actual)Observational2010-06-30Completed
An Open-Label Multicenter Study to Assess the Efficacy and Safety of Daily Oral Administration of 5 and 10mg VESIcare® (Solifenacin Succinate) in Patients Who Wish to Switch From Detrol LA® (Tolterodine Tartrate Extended Release) for the Treatment of Over [NCT00454740]Phase 3441 participants (Actual)Interventional2004-06-30Completed
[NCT00441428]0 participants Observational2006-02-28Completed
An Open-label Study of the Efficacy and Safety of 5 and 10mg VESIcare® (Solifenacin Succinate) in Patients With Overactive Bladder Symptoms VOLT: VESIcare® Open-Label Trial [NCT00463541]Phase 32,225 participants (Actual)Interventional2004-06-30Completed
Solifenacin Succinate vs. Fesoterodine A Comparison Trial for the Treatment of Bothersome Urgency Symptoms [NCT01595152]60 participants (Anticipated)Interventional2012-05-31Recruiting
Multi-site, Randomized, Opened and Controlled Comparison Study on the Effectiveness and Safety of Solifenacin Succinate Tablets and Solifenacin Succinate Tablets + Estrogen for Overactive Bladder in the Post-menopausal Women [NCT01833663]Phase 4200 participants (Anticipated)Interventional2011-10-31Completed
A Randomized, Double-Blind, Paralleled, Active Controlled, Multi-Center Study of the Efficacy and Safety of 5mg Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder [NCT00368706]Phase 3246 participants (Actual)Interventional2006-09-30Completed
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 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Safety and Efficacy, Phase 4 Study of VESIcare® (Solifenacin Succinate) or Placebo in Combination With Tamsulosin HCl for the Treatment of Residual OAB Symptoms of Urgency and Fre [NCT00333112]Phase 4398 participants (Actual)Interventional2006-05-31Completed
A Prospective Randomized Trial of Behavioral Modification and Solifenacin (Vesicare)vs Solifenacin (Vesicare) Alone for the Treatment of Urge Incontinence in Patients With an Overactive Bladder [NCT00821184]Phase 312 participants (Actual)Interventional2006-09-30Terminated(stopped due to Insufficient subject availability/findings for data analysis)
A Prospective Randomized Controlled Trial: Comparison of the Transcutaneous Posterior Tibial Nerve Stimulation and Oral Solifenacin Treatments' Effects in Women Between 18-80 Years Old Who Have Overactive Bladder [NCT06024005]34 participants (Actual)Interventional2023-04-18Completed
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of Daily Oral Administration of 5mg and 10mg VESIcare® for the Treatment of Urgency Associated With Overactive Bladder [NCT00454896]Phase 3739 participants (Actual)Interventional2004-05-31Completed
A Randomized, Double-Blind, Parallel, Placebo-Controlled, Phase 4, Multicenter Study to Assess Efficacy and Safety of VESIcare® (Solifenacin Succinate) to Improve Urinary Continence of Subjects After Robotic Assisted Radical Prostatectomy [NCT01371994]Phase 4640 participants (Actual)Interventional2011-08-02Completed
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
Efficacy of Tadalafil and Solifenacin Versus Tamsulosin and Solifenacin Combination Therapy for the Treatment of Benign Prostatic Hyperplasia With Overactive Bladder: A Randomized Controlled Trial [NCT05494567]Phase 460 participants (Anticipated)Interventional2021-11-08Active, not recruiting
A Multicenter, Open-label, Single-dose Study to Evaluate Pharmacokinetics, Safety and Tolerability of Solifenacin Succinate Suspension in Pediatric Subjects From 5 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity (NDO) [NCT01539707]Phase 114 participants (Actual)Interventional2012-03-13Completed
Clinical Trial to Compare the Efficacy and Safety of Solifenacin/Tamsulosin Combination Therapy With Tamsulosin Monotherapy for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia [NCT02972268]Phase 3780 participants (Actual)Interventional2016-02-01Completed
VECTOR: A Randomized Double-blind Study to Assess the Safety and Efficacy of Solifenacin (Vesicare®) in Comparison to Oxybutynin for Overactive Bladder Patients [NCT00431041]Phase 4132 participants (Actual)Interventional2006-12-31Completed
Injections of Botulinum Toxin A or Anticholinergic Treatment as First Line Therapy to Treat Neurogenic Overactive Bladder in Patients With Multiple Sclerosis [NCT04819360]Phase 446 participants (Anticipated)Interventional2021-06-01Recruiting
Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Moderate and Severe Mixed Urinary Incontinence in Female: a Multicenter, Noninferiority, Randomized Controlled Trial [NCT02047032]500 participants (Actual)Interventional2014-04-30Completed
Urinary NGF, PGE2 and ATP: Potential Biomarkers for Diagnosis and Prediction of Treatment Efficacy in Overactive Bladder Patients [NCT01499069]191 participants (Actual)Interventional2010-02-28Completed
Studies of Psychiatric Predisposing Factors, Treatment-related Cardiovascular Effects, and Prognostic Factors Associated With Antimuscarinic Drug (Tolterodine) for Female Overactive Bladder Syndrome [NCT01503580]155 participants (Actual)Interventional2008-08-31Completed
A Prospective, Open Label, Single Arm, Multicenter Study to Estimate the Efficacy and Safety of Solifenacin in Female With Clinically Significant Stress Urinary Incontinence and Urgency Urinary Incontinence [NCT01505439]Phase 4311 participants (Actual)Interventional2011-06-30Completed
Post-treatment Normallized Urodynamic Findings as the Golden Standard of Objective Cure for Female Overactive Bladder Patients Receiving Antimuscarinic Drug and Its Correlations With Voiding Diary, King's Health Questionnaire, and Overactive Bladder Sympt [NCT01627145]300 participants (Anticipated)Interventional2012-08-31Recruiting
An Irish Observational Study to Evaluate LUTS Storage Symptom Improvement in Men Being Treated With Vesitirim™ (Solifenacin) [NCT01639794]12 participants (Actual)Observational2012-02-29Completed
"Feasibility of At-home Titration of Solifenacin 5 and 10mg and Effect on Symptoms and Quality of Life in a Typical OAB Population" [NCT00759577]Phase 436 participants (Actual)Interventional2008-09-30Terminated(stopped due to difficulty with enrollment)
Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women [NCT01737411]Phase 1/Phase 2120 participants (Anticipated)Interventional2013-01-31Recruiting
Phase 1/2 Study of the Effect of TOT or Solifenacin After Cesa or Vasa on Urge Urinary Incontinence [NCT01737918]Phase 1/Phase 2120 participants (Anticipated)Interventional2013-01-31Recruiting
A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy of Solifenacin and Percutaneous Tibial Nerve Stimulation in Patients With Refractory Overactive Bladder [NCT01764893]Phase 48 participants (Actual)Interventional2013-01-31Terminated(stopped due to Enrolling too slowly due to insurance plans no longer covering the cost of the Percutaneous Tibial Nerve Stimulation treatment.)
A Phase II Randomized Study of Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients Receiving Adjuvant Hormonal Therapy [NCT01530373]Phase 26 participants (Actual)Interventional2012-02-29Active, not recruiting
A Pilot Study to Assess the Safety and Efficacy of Solifenacin (VESIcare) for Improving Urinary and Bladder Functions in Patients Undergoing Radiation Therapy of the Prostate [NCT01777217]Phase 48 participants (Actual)Interventional2013-02-28Terminated(stopped due to Terminated)
A Phase 3, Open-Label, Baseline-controlled, Multicenter, Sequential Dose Titration Study to Assess the Long-Term Efficacy and Safety, and the Pharmacokinetics of Solifenacin Succinate Suspension in Patients From 5 to Less Than 18 Years of Age With Neuroge [NCT01565694]Phase 376 participants (Actual)Interventional2012-08-14Completed
A Prospective, Multicenter, Observation Study to Estimate the Dry Mouth in OAB Patients With Solifenacin [NCT01437670]262 participants (Actual)Observational2011-09-30Completed
Electroacupuncture Versus Solifenacin Succinate for Female Overactive Bladder: A Multicenter, Randomized, Controlled, Noninferiority Trial [NCT05798403]204 participants (Anticipated)Interventional2023-07-07Recruiting
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
Safety and Efficacy Beta 3 Agonists in Treatment of Non-neurogenic Voiding Dysfunction in Children, a Randomized Clinical Trial [NCT05240456]Phase 1/Phase 270 participants (Anticipated)Interventional2022-02-28Not yet recruiting
A Phase II, Dose Titration Study of CPC-201 in Patients With Dementia of Alzheimer's Type [NCT02549196]Phase 228 participants (Actual)Interventional2015-10-07Completed
Comparison of the Efficacy of Solifenacin With or Without Tamsulosin in Adult Women With OAB: A Prospective Randomized Multicenter Study [NCT01533597]Phase 470 participants (Actual)Interventional2010-12-31Completed
A Randomized, Double-blind, Placebo-controlled, Parallel-group, and Phase IV Study of Efficacy and Safety of Solifenacin Succinate in Patients With Overactive Bladder After TURP or PVP [NCT01747577]Phase 468 participants (Actual)Interventional2012-12-04Completed
A Phase 3, Double-Blind, Randomized, Multi-center, Placebo-Controlled Sequential Dose Titration Study to Assess Efficacy, Safety and Population Pharmacokinetics of Solifenacin Succinate Suspension in Pediatric Subjects From 5 to Less Than 18 Years of Age [NCT01565707]Phase 3189 participants (Actual)Interventional2012-06-07Completed
Therapeutic Merit of Solifenacin in the Mitigation of Ureteral Stent-induced Pain and Lower Urinary Tract Symptoms (LUTS) Post Ureteroscopy for Stone Management [NCT01381120]Phase 484 participants (Actual)Interventional2010-10-31Completed
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 Intradetrusor BOTOX Injection Combined With Percutaneous Tibial Nerve Stimulation for Managing Children With Overactive Bladder Not Responding to Monotherapy [NCT05911594]128 participants (Actual)Interventional2022-02-14Completed
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
Incontinence & Intimate Partners: Assessing the Contribution of Treatment [NCT01559389]Phase 4138 participants (Actual)Interventional2012-03-09Completed
The Effect of Solifenacin on Post Void Dribbling in Women: A Randomized Controlled Multicenter Trial [NCT01470001]118 participants (Actual)Interventional2011-11-30Completed
The Effectiveness, Superiority and Safety of EA on OAB:Multi-center Randomized Controlled Trial [NCT02452879]180 participants (Anticipated)Interventional2014-10-31Recruiting
A Phase 3, Open-Label, Baseline-controlled, Multi-center, Sequential Dose-Titration Study to Assess the Pharmacokinetics, Long-Term Efficacy and Safety of Solifenacin Succinate Suspension in Children From 6 Months to Less Than 5 Years of Age With Neurogen [NCT01981954]Phase 323 participants (Actual)Interventional2013-09-25Completed
Vesicare™ (Solifenacin) in the Treatment of Urinary Incontinence After Radical Prostatectomy [NCT00581061]13 participants (Actual)Interventional2008-06-30Terminated(stopped due to Study subjects were not compliant with study protocols.)
Urinary Nerve Growth Factor as a Biomarker for Medical Treatment of Male Lower Urinary Tract Symptoms: A Pilot Trial [NCT01457573]Phase 410 participants (Actual)Interventional2011-10-31Completed
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
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 4, Multi-center Study of VESIcare® (Solifenacin Succinate) in Overactive Bladder (OAB) Subjects to Evaluate Symptom Bother and Health Related Quality of Life VIBRANT: VESIcare® Investig [NCT00573508]Phase 4768 participants (Actual)Interventional2007-08-31Completed
Belgian Observational Study to Evaluate Storage and Voiding Symptoms Improvement in Male Subjects With Lower Urinary Tract Predominant Storage Symptoms (Overactive Bladder Syndrome) Being Treated With Solifenacin in Monotherapy or Combination [NCT01799902]86 participants (Actual)Observational2011-12-31Completed
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
[NCT01767519]Phase 3356 participants (Actual)Interventional2013-03-01Completed
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
Clinical Trial to Investigate and Compare the Pharmacokinetic Characteristics and Safety/Tolerability After Single Administration of JLP-1207 and Soifenacin/Tamsulosin in Healthy Male Volunteers. [NCT02494349]Phase 154 participants (Actual)Interventional2015-08-31Completed
An Open-Label, Long-Term Extension, Multi-center, Sequential Dose Titration Study to Assess Safety and Efficacy of Solifenacin Succinate Suspension in Pediatric Subjects With Overactive Bladder (OAB) [NCT01655069]Phase 3148 participants (Actual)Interventional2012-10-04Completed
The Effect of Short Term Solifenacin for Overactive Bladder on the Female Urinary Microbiome [NCT01642277]Phase 2134 participants (Actual)Interventional2012-07-31Completed
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
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00431041 (4) [back to overview]Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary
NCT00431041 (4) [back to overview]The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event
NCT00431041 (4) [back to overview]Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary
NCT00431041 (4) [back to overview]The Severity of Dry Mouth Reported as an Adverse Event
NCT00507455 (18) [back to overview]Change From Baseline in IPSS Storage Score
NCT00507455 (18) [back to overview]Change From Baseline in IPSS Voiding Score
NCT00507455 (18) [back to overview]Change From Baseline in Number of Incontinence Episodes Per 24 Hours
NCT00507455 (18) [back to overview]Change From Baseline in Number of Micturitions Per 24 Hours
NCT00507455 (18) [back to overview]Change From Baseline in Number of Urgency Episodes Per 24 Hours
NCT00507455 (18) [back to overview]Change From Baseline in Patient Perception of Bladder Condition (PPBC)
NCT00507455 (18) [back to overview]Change From Baseline in Post Void Residual Volume (PVR)
NCT00507455 (18) [back to overview]Change From Baseline in Volume Voided Per Micturition
NCT00507455 (18) [back to overview]Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests
NCT00507455 (18) [back to overview]Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score
NCT00507455 (18) [back to overview]Change From Baseline in ICIQ-LUTSqol Overall Symptom Interference of Life Score
NCT00507455 (18) [back to overview]Change From Baseline to End of Treatment in Percent Bladder Voiding Efficiency (BVE)
NCT00507455 (18) [back to overview]Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
NCT00507455 (18) [back to overview]Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)
NCT00507455 (18) [back to overview]Change From Baseline to End of Treatment in Bladder Contractility Index (BCI)
NCT00507455 (18) [back to overview]Change From Baseline in International Prostate Symptoms Score (IPSS)
NCT00507455 (18) [back to overview]Change From Baseline in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score
NCT00507455 (18) [back to overview]Change From Baseline in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score
NCT00573508 (13) [back to overview]Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score
NCT00573508 (13) [back to overview]Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social
NCT00573508 (13) [back to overview]Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores.
NCT00573508 (13) [back to overview]Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score
NCT00573508 (13) [back to overview]Number of Participants With Change From Baseline in the Global Assessment Score of the Patient Perception of Bladder Condition (PPBC)
NCT00573508 (13) [back to overview]Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire
NCT00573508 (13) [back to overview]Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores.
NCT00573508 (13) [back to overview]Change From Baseline in the MCUI Behavior Therapy Stratified
NCT00573508 (13) [back to overview]Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months
NCT00573508 (13) [back to overview]Change From Baseline in the Treatment Satisfaction Visual Analog Scale (TS-VAS)
NCT00573508 (13) [back to overview]Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score
NCT00573508 (13) [back to overview]Change From Baseline in Work Productivity Assessment Index (WPAI)
NCT00573508 (13) [back to overview]Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary
NCT00581061 (3) [back to overview]Compliance
NCT00581061 (3) [back to overview]Side Effects
NCT00581061 (3) [back to overview]Time to Continence
NCT00821184 (1) [back to overview]Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries.
NCT00832650 (9) [back to overview]Mean Proportion of Bowel Movements With Satisfaction Per Day
NCT00832650 (9) [back to overview]Average Score of Ease of Passage During Defecation Per Day
NCT00832650 (9) [back to overview]Colonic Filling at 6 Hours
NCT00832650 (9) [back to overview]Colonic Transit at 24 Hours
NCT00832650 (9) [back to overview]Colonic Transit at 48 Hours
NCT00832650 (9) [back to overview]Mean Number of Stools Per Day
NCT00832650 (9) [back to overview]Mean Score of Stool Consistency Per Day
NCT00832650 (9) [back to overview]Proximal Colonic Emptying Time
NCT00832650 (9) [back to overview]Time to Gastric Emptying
NCT00909428 (1) [back to overview]Change in Maximal Cystometric Capacity (mL)
NCT01018264 (5) [back to overview]Number of Urinary Incontinence Episodes Per 24 Hour Period
NCT01018264 (5) [back to overview]Number of Micturations Per 24 Hour Period
NCT01018264 (5) [back to overview]Number of Nocturia Episodes Per 24 Hour Period
NCT01018264 (5) [back to overview]Parkinson's Disease Quality of Life Scale (PDQOL)
NCT01018264 (5) [back to overview]Unified Parkinson's Disease Rating Scale (UPDRS) Total
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Total International Prostate Symptom Score
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS, Previously Known as Total Urgency Score [TUS])
NCT01018511 (44) [back to overview]Percentage of Participants Who Were OAB-q Responders at End of Treatment
NCT01018511 (44) [back to overview]Apparent Clearance (CL/F) of Tamsulosin
NCT01018511 (44) [back to overview]Area Under the Curve at Steady State (AUCss) of Tamsulosin
NCT01018511 (44) [back to overview]AUCss of Solifenacin
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in EQ-5D Mobility Score
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in EQ-5D Self-care Score
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in EQ-5D Usual Activities Score
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Individual IPSS Scores
NCT01018511 (44) [back to overview]CL/F of Solifenacin
NCT01018511 (44) [back to overview]Clinician Global Impression Scale at End of Treatment: Overall Bladder Symptoms
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score
NCT01018511 (44) [back to overview]Cminss of Solifenacin
NCT01018511 (44) [back to overview]Maximum Concentration at Steady State (Cmaxss) of Tamsulosin
NCT01018511 (44) [back to overview]Minimum Concentration at Steady State (Cminss) of Tamsulosin
NCT01018511 (44) [back to overview]Number of Participants With Adverse Events (AEs)
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours
NCT01018511 (44) [back to overview]Patient Global Impression Scale at End of Treatment: Overall Bladder Symptoms
NCT01018511 (44) [back to overview]Time of Maximum Concentration at Steady State (Tmaxss) of Tamsulosin
NCT01018511 (44) [back to overview]Tmaxss of Solifenacin
NCT01018511 (44) [back to overview]Patient Global Impression Scale at End of Treatment: General Health
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Average Flow Rate (Qmean)
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Health Related QoL (HRQoL) Subscale: Coping Score
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in HRQoL Subscale: Concern Score
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in HRQoL Subscale: Sleep Score
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Symptom Bother Score
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
NCT01018511 (44) [back to overview]Cmaxss of Solifenacin
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in IPSS Voiding Score
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in IPSS Storage Score
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in IPSS QoL Score
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in HRQoL Subscale: Total Score
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in HRQoL Subscale: Social Score
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in IPSS Quality of Life (QoL) Score
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in IPSS Storage Score
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Symptom Bother Score
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Total International Prostate Symptom Score (IPSS)
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS) (Previously Known as Total Urgency Score [TUS])
NCT01021332 (31) [back to overview]Number of OAB-q Responders Based on Health-related Quality of Life: Total Score
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in EQ-5D Mobility Score
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in EQ-5D Self-care Score
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in EQ-5D Usual Activities Score
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Individual IPSS Scores
NCT01021332 (31) [back to overview]Number of Participants With Adverse Events (AEs)
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in IPSS Voiding Score
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Average Flow Rate (Qmean)
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Concern Score
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Coping Score
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Sleep Score
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Social Score
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Total Score
NCT01028014 (3) [back to overview]Difference (Pre - Post) in Maximum Urine Flow Rate (Qmax) (Milliliters Per Second) as Measured by Pressure Flowmetry
NCT01028014 (3) [back to overview]Difference (Pre - Post) in Urethral Sensation (Milliamps) as Measured by Current Perception Threshold Testing.
NCT01028014 (3) [back to overview]Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG
NCT01093534 (25) [back to overview]Change From Baseline in Patient Assessment of Treatment Satisfaction
NCT01093534 (25) [back to overview]Change From Baseline in Patient Assessment of Urgency Bother
NCT01093534 (25) [back to overview]Change From Baseline in Patient Perception of Bladder Condition (PPBC)
NCT01093534 (25) [back to overview]Change From Baseline in Symptom Bother Score
NCT01093534 (25) [back to overview]Change From Baseline to Week 12 in Bladder Wall Thickness
NCT01093534 (25) [back to overview]Change From Baseline to Week 12 in Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr)
NCT01093534 (25) [back to overview]Change From Baseline to Week 12 in Mean Level of Urgency
NCT01093534 (25) [back to overview]Change From Baseline to Week 12 in Mean Number of Events (Micturitions Plus Incontinence Episodes) Per 24 Hours
NCT01093534 (25) [back to overview]Change From Baseline to Week 12 in Mean Number of Incontinence Episodes Per 24 Hours
NCT01093534 (25) [back to overview]Change From Baseline to Week 12 in Mean Number of Micturitions Per 24 Hours
NCT01093534 (25) [back to overview]Change From Baseline to Week 12 in Mean Number of Urgency Events Per 24 Hours
NCT01093534 (25) [back to overview]Change From Baseline to Week 12 in Mean Number of Urgency Micturitions Per 24 Hours
NCT01093534 (25) [back to overview]Change From Baseline to Week 12 in Total Urgency Score
NCT01093534 (25) [back to overview]Change From Baseline to Week 12 in Total Urinary Nerve Growth Factor Normalized by Urine Creatinine
NCT01093534 (25) [back to overview]Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12
NCT01093534 (25) [back to overview]Total Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12
NCT01093534 (25) [back to overview]Change From Baseline in Health-Related Quality of Life (HRQL)
NCT01093534 (25) [back to overview]Change From Baseline to Week 6 and Week 12 in Bladder Wall Thickness
NCT01093534 (25) [back to overview]Change From Baseline to Week 6 and Week 12 in Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine
NCT01093534 (25) [back to overview]Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr) at Week 12
NCT01093534 (25) [back to overview]Change From Baseline in EuroQoL 5-Dimension Questionnaire Visual Analog Scale
NCT01093534 (25) [back to overview]Percentage of Participants With Improvement or Deterioration in Patient Perception of Bladder Condition (PPBC)
NCT01093534 (25) [back to overview]Change From Baseline in Mean Number of Urgency Incontinence Episodes With PPIUS Grade 3 or 4 Per 24 Hours
NCT01093534 (25) [back to overview]Change From Baseline in Mean Number of Urgency Incontinence Episodes With PPIUS Grade 4 Per 24 Hours
NCT01093534 (25) [back to overview]Percentage of Participants With Improvement and Worsening on the 5 Dimensions of the EQ-5D
NCT01126424 (6) [back to overview]Change From Baseline in Cognitive Function Composite Score - Power of Attention
NCT01126424 (6) [back to overview]Change From Baseline in Cognitive Function Composite Score - Quality of Episodic Secondary Memory
NCT01126424 (6) [back to overview]Change From Baseline in Cognitive Function Composite Score - Quality of Working Memory
NCT01126424 (6) [back to overview]Change From Baseline in Cognitive Function Composite Score - Speed of Memory
NCT01126424 (6) [back to overview]Change From Baseline in Postural Stability Test
NCT01126424 (6) [back to overview]Change From Baseline in Cognitive Function Composite Score - Continuity of Attention
NCT01166438 (5) [back to overview]Change From Baseline in Score on OABq-SF
NCT01166438 (5) [back to overview]Change in PFDI-SF and PFIQ-SF Total Scores
NCT01166438 (5) [back to overview]Change in Urge Urinary Incontinence (UUI) Episodes
NCT01166438 (5) [back to overview]Efficacy
NCT01166438 (5) [back to overview]Patient Global Impression of Improvement
NCT01215721 (1) [back to overview]Time to Continence
NCT01340027 (30) [back to overview]Percentage of Participants With a Micturition Response
NCT01340027 (30) [back to overview]Percentage of Participants With Zero Incontinence Episodes Post-baseline
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]Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
NCT01340027 (30) [back to overview]Percentage of Participants With Major Improvement in PPBC
NCT01340027 (30) [back to overview]Percentage of Participants With Improvement in PPBC
NCT01340027 (30) [back to overview]Percentage of Participants With Deterioration in PPBC
NCT01340027 (30) [back to overview]Percentage of Participants With a Symptom Bother Response
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 Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)
NCT01340027 (30) [back to overview]Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC)
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
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 in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
NCT01371994 (19) [back to overview]Percentage of Participants Who Gain Continence During 12-week Treatment Period
NCT01371994 (19) [back to overview]Baseline Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment
NCT01371994 (19) [back to overview]Baseline Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed
NCT01371994 (19) [back to overview]International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score at Baseline
NCT01371994 (19) [back to overview]Time From Baseline to First Day of Returning to Work
NCT01371994 (19) [back to overview]Change From Baseline in American Urology Association Quality of Life (QOL) Score
NCT01371994 (19) [back to overview]Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment
NCT01371994 (19) [back to overview]Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment
NCT01371994 (19) [back to overview]Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score
NCT01371994 (19) [back to overview]Change From Baseline in Average Daily Pad Usage
NCT01371994 (19) [back to overview]Change From Baseline in American Urology Association Symptom Score (AUASS)
NCT01371994 (19) [back to overview]American Urology Association Symptom Score (AUASS) at Baseline
NCT01371994 (19) [back to overview]Time From First Dose to Urinary Continence
NCT01371994 (19) [back to overview]Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed
NCT01371994 (19) [back to overview]Baseline Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working
NCT01371994 (19) [back to overview]Baseline Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment
NCT01371994 (19) [back to overview]Average Daily Pad Usage at Baseline
NCT01371994 (19) [back to overview]American Urology Association Quality of Life (QOL) Score at Baseline
NCT01371994 (19) [back to overview]Change From Baseline in Work Productivity Assessment Index (WPAI): Percent Impairment While Working
NCT01381120 (2) [back to overview]Change in Post-ureteroscopy Stent-induced Pain
NCT01381120 (2) [back to overview]Change in Post-ureteroscopy Stent-induced Lower Urinary Tract Symptoms.
NCT01457573 (11) [back to overview]Change From Baseline in Urinary Growth Factor to Creatinine Ratio (GF/Cr)
NCT01457573 (11) [back to overview]Change in Post Void Residual (mL) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12
NCT01457573 (11) [back to overview]Change in PBC-Patient Perception of Bladder Condition at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12
NCT01457573 (11) [back to overview]Change in PPUS-Patient Perception of Urinary Urgency Survey Score at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12
NCT01457573 (11) [back to overview]Change in Urinary Growth Factor to Creatinine Ratio (GF/Cr) From Baseline Compared to Month 1/Week4 and Month 2/Week 8.
NCT01457573 (11) [back to overview]Change in Maximum Urinary Flow Rate (ml/s) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12
NCT01457573 (11) [back to overview]Change in IPSS-International Prostate Score Scale at Baseline Compared to Post Dose Survey at Month 1, 2, and Month 3/Week12.
NCT01457573 (11) [back to overview]Change in ICIQ-MLUTS - International Consultation on Incontinence Modular Questionnaire for Male LUTS Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12
NCT01457573 (11) [back to overview]Change in ICIQ LUTS QoL -International Consultation on Incontinence Modular Questionnaire LUTS Quality of Life for Male LUTS Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12
NCT01457573 (11) [back to overview]Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.1/Wk4 and Mo.2/Wk8
NCT01457573 (11) [back to overview]Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.3/Wk12
NCT01470001 (3) [back to overview]Change in Patients Perspective of the Impact of Their Disease, Captured Using the Pelvic Floor Distress Inventory (Urinary Questions)
NCT01470001 (3) [back to overview]the Percent of Patients With at Least 50% Reduction in Post Void Dribbling Episodes
NCT01470001 (3) [back to overview]The Percent Reduction in Post Void Dribbling Episodes (Events)
NCT01533597 (6) [back to overview]Change in Mean Number of Micturition Episodes Per 24 Hours
NCT01533597 (6) [back to overview]Change in Score of IPSS
NCT01533597 (6) [back to overview]Change of PVR
NCT01533597 (6) [back to overview]Change of Qmax
NCT01533597 (6) [back to overview]Numeric Change of Urgency Episodes Per 24 Hours
NCT01533597 (6) [back to overview]Change in Total Score of OABSS
NCT01559389 (3) [back to overview]Change in Overall Sexual Satisfaction Among Healthy Male Partners
NCT01559389 (3) [back to overview]Baseline Sexual Satisfaction Between Matched Female and Male Partners
NCT01559389 (3) [back to overview]Change in Overall Sexual Satisfaction Among Females
NCT01565694 (16) [back to overview]Change From Baseline to Last Possible Titration Step in Maximum Cystometric Capacity
NCT01565694 (16) [back to overview]Change From Baseline in Average Catheterized Volume Per Catheterization
NCT01565694 (16) [back to overview]Change From Baseline in Average First Morning Catheterized Volume
NCT01565694 (16) [back to overview]Change From Baseline in Bladder Compliance
NCT01565694 (16) [back to overview]Change From Baseline in Bladder Volume at 40 cmH2O Detrusor Pressure
NCT01565694 (16) [back to overview]Change From Baseline in Detrusor Pressure at the End of Bladder Filling
NCT01565694 (16) [back to overview]Change From Baseline in Maximum Catheterized Volume
NCT01565694 (16) [back to overview]Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours
NCT01565694 (16) [back to overview]Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days
NCT01565694 (16) [back to overview]Change From Baseline in Number of Dry (Incontinence-Free) Nights Per 7 Days
NCT01565694 (16) [back to overview]Change From Baseline in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until End of Bladder Filling
NCT01565694 (16) [back to overview]Change From Baseline in Quality of Life [QoL] (PinQ Questionnaire Score)
NCT01565694 (16) [back to overview]Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC)
NCT01565694 (16) [back to overview]Number of Participants With Adverse Events
NCT01565694 (16) [back to overview]Change From Baseline in Bladder Volume at 30 cmH2O Detrusor Pressure
NCT01565694 (16) [back to overview]Change From Baseline in Bladder Volume (mL) Until First Detrusor Contraction > 15 cmH2O as a Percentage of Expected Bladder Capacity (EBC)
NCT01565707 (20) [back to overview]Change From Baseline to End of Treatment in Mean Number of Daytime Micturitions Per 24 Hours
NCT01565707 (20) [back to overview]Area Under the Plasma Concentration - Time to Curve (AUC) for a Dose Interval (AUCtau) of Solifenacin
NCT01565707 (20) [back to overview]Change From Baseline in Post Void Residual (PVR) Volume
NCT01565707 (20) [back to overview]Change From Baseline to End of Treatment (EoT) in Mean Volume Voided (MVV) Per Micturition
NCT01565707 (20) [back to overview]Change From Baseline to End of Treatment in Daytime Maximum Volume Voided (DMaxVV) Per Micturition
NCT01565707 (20) [back to overview]Change From Baseline to End of Treatment in Mean Number of Daytime Incontinence Episodes Per 24 Hours
NCT01565707 (20) [back to overview]Number of Participants With Adverse Events (AEs)
NCT01565707 (20) [back to overview]Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Days Per 7 Days
NCT01565707 (20) [back to overview]Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Nighttimes Per 7 Days
NCT01565707 (20) [back to overview]Change From Baseline to End of Treatment in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents
NCT01565707 (20) [back to overview]Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
NCT01565707 (20) [back to overview]Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
NCT01565707 (20) [back to overview]Change From Baseline to End of Treatment in Mean Number of Nighttime Incontinence Episodes Per 24 Hours
NCT01565707 (20) [back to overview]Change From Baseline to End of Treatment in Mean Number of Nighttime Micturitions Per 24 Hours
NCT01565707 (20) [back to overview]Maximum Concentration (Cmax) of Solifenacin
NCT01565707 (20) [back to overview]Plasma Concentration Before Drug Administration (Ctrough) of Solifenacin
NCT01565707 (20) [back to overview]Time to Attain Maximum Concentration (Tmax) of Solifenacin
NCT01565707 (20) [back to overview]Apparent Terminal Elimination Half-Life (T1/2) of Solifenacin
NCT01565707 (20) [back to overview]Apparent Total Body Clearance (CL/F) of Solifenacin
NCT01565707 (20) [back to overview]Apparent Volume of Distribution (Vz/F) of Solifenacin
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 Week 12 in Anxiety/Depression 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 Usual Activities 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 4 in Pain/Discomfort 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 Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
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]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 8 in Mobility 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 Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
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 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 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 Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q
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]Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit
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 Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the 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]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 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 Improvement in PPBC: ≥1 Point Improvement at Week 12 and 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 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 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 Major Improvement in PPBC: ≥2 Point Improvement at Week 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]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]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
NCT01642277 (3) [back to overview]Bacterial Genomic Sequencing
NCT01642277 (3) [back to overview]Assessment of Pelvic Floor Disease Inventory (PFDI) Questionnaire
NCT01642277 (3) [back to overview]Assessment of Overactive Bladder Questionnaire (OABQ)
NCT01655069 (6) [back to overview]Change From Baseline to Final Visit in Postvoid Residual (PVR) Volume
NCT01655069 (6) [back to overview]Change From Baseline in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents
NCT01655069 (6) [back to overview]Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours
NCT01655069 (6) [back to overview]Change From Baseline in Mean Number of Micturitions Per 24 Hours
NCT01655069 (6) [back to overview]Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days
NCT01655069 (6) [back to overview]Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs)
NCT01745094 (15) [back to overview]Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Severity Score
NCT01745094 (15) [back to overview]Change From Baseline in Postvoid Residual (PVR) Volume
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]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 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
NCT01745094 (15) [back to overview]Number of Participants Who Achieved Normalization for OABSS Total Score
NCT01745094 (15) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
NCT01767519 (7) [back to overview]Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1
NCT01767519 (7) [back to overview]Change From Study Baseline in the Role Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1
NCT01767519 (7) [back to overview]Percentage of Patients With 100% Reduction in Incontinence Episodes in Treatment Cycle 1
NCT01767519 (7) [back to overview]Percentage of Patients With a Positive Response on the Single-Item Treatment Benefit Scale During Treatment Cycle 1
NCT01767519 (7) [back to overview]Change From Study Baseline in the Number of Micturition Episodes in Treatment Cycle 1
NCT01767519 (7) [back to overview]Change From Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1
NCT01767519 (7) [back to overview]Change From Study Baseline in the Social Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1
NCT01777217 (1) [back to overview]Change From Baseline to End of Study Measured by the American Urology Association Symptom Score Questionnaire (AUASS).
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: Pain/Discomfort
NCT01908829 (36) [back to overview]Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction
NCT01908829 (36) [back to overview]Number of Participants With Adverse Events (AEs)
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 Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression
NCT01908829 (36) [back to overview]Number of Pads Used 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 Incontinence Episodes Reported During the 3-Day Diary
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]Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score
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 in Post Void Residual (PVR) Volume
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 in OAB-q HRQL Subscale Score: Sleep
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: Concern
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 Mean Volume Voided (MVV) Per Micturition
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 Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
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 Nocturia Episodes
NCT01908829 (36) [back to overview]Change From Baseline in Mean Number of Micturitions 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 Patient Perception Bladder Control (PPBC) Score
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 10-Point Improvement From Baseline in HRQL Total 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 at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours
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 at Least a 1-Point Improvement From Baseline in PPBC
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]Number of UI Episodes Reported During the 3-Day Diary
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 Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities
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, 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, 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]Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping
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]Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT
NCT01972841 (70) [back to overview]Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT
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]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 1 Point Improvement on PPBC) 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]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]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]Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference
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 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 Activity Impairment
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 EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility
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 EQ-5D Questionnaire Subscale Score: Self-Care
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: Anxiety/Depression
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 Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
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]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 EoT in Mean Number of Micturitions 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 Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes
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 Mean Volume Voided Per Micturition
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]Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT
NCT01981954 (42) [back to overview]Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6
NCT01981954 (42) [back to overview]Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9
NCT01981954 (42) [back to overview]Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3
NCT01981954 (42) [back to overview]Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 20 cmH20 Detrusor Pressure
NCT01981954 (42) [back to overview]Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC)
NCT01981954 (42) [back to overview]Change From Baseline to Week 24 and 52 in Infant and Toddler Quality of Life Short Form-47 Questionnaire (ITQoL SF-47) - Overall Health Score
NCT01981954 (42) [back to overview]Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Behaviour Score
NCT01981954 (42) [back to overview]Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Change in Health Score
NCT01981954 (42) [back to overview]Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Family Cohesion Impact Score
NCT01981954 (42) [back to overview]Change From Baseline to Week 24 and 52 in ITQoL SF-47 - General Health Score
NCT01981954 (42) [back to overview]Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Growth and Development Score
NCT01981954 (42) [back to overview]Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Pain Score
NCT01981954 (42) [back to overview]Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Parent-Emotional Impact Score
NCT01981954 (42) [back to overview]Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Parent-Time Impact Score
NCT01981954 (42) [back to overview]Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Physical Abilities Score
NCT01981954 (42) [back to overview]Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Temperament and Moods Score
NCT01981954 (42) [back to overview]Change From Baseline to Weeks 3, 6, 9, 12 and 52 in MCC
NCT01981954 (42) [back to overview]Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Compliance
NCT01981954 (42) [back to overview]Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 10 cmH20 Detrusor Pressure
NCT01981954 (42) [back to overview]Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 30 cmH20 Detrusor Pressure
NCT01981954 (42) [back to overview]Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume Until First Detrusor Contraction (> 15 cmH2O)
NCT01981954 (42) [back to overview]Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Catheterized Volume 5 Minutes After End of Bladder-Filling
NCT01981954 (42) [back to overview]Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure 5 Minutes After End of Bladder-Filling
NCT01981954 (42) [back to overview]Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure at End of Bladder-Filling
NCT01981954 (42) [back to overview]Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until Leakage or End of Bladder-Filling
NCT01981954 (42) [back to overview]Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average Catheterized Volume Per Catheterization
NCT01981954 (42) [back to overview]Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average First Morning Catheterized Volume
NCT01981954 (42) [back to overview]Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Maximum Catheterized Volume (MCV)
NCT01981954 (42) [back to overview]Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Mean Number of Periods Between the Clean Intermittent Catheterizations (CICs) With Incontinence Per 24 Hours
NCT01981954 (42) [back to overview]Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline
NCT01981954 (42) [back to overview]Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12
NCT01981954 (42) [back to overview]Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24
NCT01981954 (42) [back to overview]Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3
NCT01981954 (42) [back to overview]Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36
NCT01981954 (42) [back to overview]Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52
NCT01981954 (42) [back to overview]Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6
NCT01981954 (42) [back to overview]Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9
NCT01981954 (42) [back to overview]Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline
NCT01981954 (42) [back to overview]Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12
NCT01981954 (42) [back to overview]Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24
NCT01981954 (42) [back to overview]Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36
NCT01981954 (42) [back to overview]Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52
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 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]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 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working
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 in WPAI:SHP Score: Percent Overall Work Impairment
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]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 HRQoL Subscale Score: Coping
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]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]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]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]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 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]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 HRQoL Subscale Score: Sleep
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 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 Urgency Episodes (Grade 3 or 4) 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 Incontinence Episodes Per 24 Hours
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 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 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 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 Patient Perception of Bladder Condition (PPBC)
NCT02045862 (53) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume
NCT02047032 (12) [back to overview]Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12
NCT02047032 (12) [back to overview]Change of Episodes From Baseline in Mean 72-h Incontinence Episodes
NCT02047032 (12) [back to overview]Patient's Treatment Satisfaction Degree
NCT02047032 (12) [back to overview]Patient Global Impression Improvement
NCT02047032 (12) [back to overview]Weekly Median Number of Urine Pads Used During Weeks 1-12, 13-24, and 25-36
NCT02047032 (12) [back to overview]The Number of Participants Using Urine Pads
NCT02047032 (12) [back to overview]the Amount of Urine Leakage (Grams) Measured by the 1-hour Pad Test at Weeks 4 and 12
NCT02047032 (12) [back to overview]Percentage of Participants With ≥50% Decrease in Average 72-h Incontinence Episode Frequency
NCT02047032 (12) [back to overview]Percentage of Change From Baseline in Mean 72-hour IEF During Weeks 13-24 and Weeks 25-36
NCT02047032 (12) [back to overview]Electroacupuncture Acceptance Assessment
NCT02047032 (12) [back to overview]Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes
NCT02047032 (12) [back to overview]Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score
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
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 Urge Incontinence Episodes Per 24 Hours
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)
NCT02549196 (2) [back to overview]Number of Participants Who Reached the Maximum Allowed Dose (MAD) in Their Respective Cohort
NCT02549196 (2) [back to overview]Number of Participants With TEAEs Leading to Study Drug Discontinuation
NCT04090190 (2) [back to overview]The Effectiveness of Anticholinergic Treatment in Relation to the Urinary Microbiome. Culture to Standard Culture Media Will Pickup Aerobic Bacteria and Yeasts After DNA Extraction and End Point PCR for 16S rDNA Genes.
NCT04090190 (2) [back to overview]Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu.

Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary

"Subjects were instructed to complete the diary in the 3 day period immediately preceding the visit. Subjects recorded each urgency episode or instance of strong desire to pass urine.~The mean was calculated for each time point as the average of the day 1-3 measurements from the associated 3 day diary. Change from Baseline was calculated as Week 8- Baseline." (NCT00431041)
Timeframe: Baseline and 8 weeks

,
Interventionurgency episodes per day (Mean)
Change in urgency episodes at 8 weeks (N=52; 40)Urgency episodes at Baseline (N= 68; 64)Urgency episodes at 8 weeks (N=52; 40)
Oxybutynin IR-3.706.62.1
Solifenacin-2.656.33.8

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The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event

The number of subjects reporting incidence of dry mouth as an adverse event (AE) following direct questioning at each patient follow-up visit (NCT00431041)
Timeframe: 8 weeks

Interventionparticipants (Number)
Solifenacin24
Oxybutynin IR53

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Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary

"Subjects were instructed to complete the diary in the 3 day period immediately proceding the visit. Subjects recorded each micturition or instance of passing urine in the toliet.~The mean was calculated for each time point as the average of the day 1-3 measurements from the associated 3 day diary. Change from baseline was calculated as Week 8- Baseline." (NCT00431041)
Timeframe: Baseline and 8 Weeks

,
InterventionMicturitions per day (Mean)
Change in micturition frequency at 8 wks(N=52; 40)Micturition frequency at Baseline (N=68; 64)Micturition frequency at 8 weeks (N=52; 40)
Oxybutynin IR-3.112.59.0
Solifenacin-2.312.49.9

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The Severity of Dry Mouth Reported as an Adverse Event

"The number of subjects reporting dry mouth at each severity level when dry mouth was reported as an Adverse Event (AE).~Dry mouth severity was categorized as mild (relieved with fluid/hard candy), moderate (dry mouth and throat with no difficulty swallowing solid food/water) & severe (very dry mouth & throat, difficulty swallowing solid food without water)" (NCT00431041)
Timeframe: 8 weeks

,
Interventionparticipants (Number)
MildModerateSevere
Oxybutynin IR162215
Solifenacin1833

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Change From Baseline in IPSS Storage 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 (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 2, 4, 8 and 12

,,
Interventionunits on a scale (Least Squares Mean)
Week 2 (N=62, 67, 58)Week 4 (N=60, 66, 58)Week 8 (N=58, 67, 58)Week 12 (N=58, 63, 57)End of Treatment (N=62, 67, 59)
6 mg Solifenacin + 0.4 mg Tamsulosin-1.6-2.6-2.8-3.3-3.4
9 mg Solifenacin + 0.4 mg Tamsulosin-2.1-2.5-3.1-3.1-3.0
Placebo-1.5-2.1-2.7-2.8-2.7

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Change From Baseline in 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 (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 2, 4, 8 and 12

,,
Interventionunits on a scale (Least Squares Mean)
Week 2 (N=61, 67, 58)Week 4 (N=60, 65, 57)Week 8 (N=58, 67, 57)Week 12 (N=58, 64, 57)End of Treatment (N=62, 67, 59)
6 mg Solifenacin + 0.4 mg Tamsulosin-2.9-3.8-4.3-4.7-4.6
9 mg Solifenacin + 0.4 mg Tamsulosin-2.6-3.6-3.8-4.1-3.9
Placebo-2.2-3.2-4.1-4.0-3.9

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Change From Baseline in 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 (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 2, 4, 8 and 12

,,
Interventionincontinence episodes (Least Squares Mean)
Week 2 (N=13, 10, 13)Week 4 (N=13, 10, 13)Week 8 (N=12, 10, 12)Week 12 (N=12, 9, 12)End of Treatment (N=13, 10, 13)
6 mg Solifenacin + 0.4 mg Tamsulosin-1.45-1.45-1.55-1.48-1.66
9 mg Solifenacin + 0.4 mg Tamsulosin-1.01-0.81-0.78-0.85-1.02
Placebo-0.81-1.00-1.86-1.99-1.54

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Change From Baseline in 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 (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 2, 4, 8 and 12

,,
Interventionmicturitions (Least Squares Mean)
Week 2 (N=60, 67, 59)Week 4 (N=60, 65, 58)Week 8 (N=58, 67, 58)Week 12 (N=58, 65, 58)End of Treatment (N=60, 67, 59)
6 mg Solifenacin + 0.4 mg Tamsulosin-1.25-1.32-1.31-1.91-1.91
9 mg Solifenacin + 0.4 mg Tamsulosin-1.19-1.72-2.00-1.89-1.87
Placebo-0.44-1.03-1.33-1.07-0.95

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Change From Baseline in Number of Urgency Episodes Per 24 Hours

"For each micturition and/or incontinence episode 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. An urgency episode is defined as an episode with urgency severity of three or higher.~The mean number of urgency episodes 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 (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 2, 4, 8 and 12

,,
Interventionurgency episodes (Least Squares Mean)
Week 2 (N=60, 67, 59)Week 4 (N=60, 65, 58)Week 8 (N=58, 67, 58)Week 12 (N=58, 65, 58)End of Treatment (N=60, 67, 59)
6 mg Solifenacin + 0.4 mg Tamsulosin-0.89-1.39-1.34-1.54-1.45
9 mg Solifenacin + 0.4 mg Tamsulosin-0.95-1.34-1.08-1.18-1.23
Placebo-0.59-1.18-1.45-1.47-1.41

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

"The patient perception of bladder condition (PPBC) questionnaire 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 (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 2, 4, 8 and 12

,,
Interventionunits on a scale (Least Squares Mean)
Week 2 (N=61, 66, 58)Week 4 (N=60, 66, 58)Week 8 (N=58, 67, 58)Week 12 (N=58, 64, 57)End of Treatment (N=62, 67, 59)
6 mg Solifenacin + 0.4 mg Tamsulosin-0.3-0.5-0.8-1.0-0.9
9 mg Solifenacin + 0.4 mg Tamsulosin-0.5-0.9-1.1-1.1-1.1
Placebo-0.5-0.7-1.0-1.1-1.1

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Change From Baseline in Post Void Residual Volume (PVR)

"Healthy micturitions result in complete emptying of the bladder. Post Void Residual (PVR) is the volume of urine retained after voiding (post-void residual urine). Post void residual volume was assessed by abdominal ultrasound. An increasing PVR over time is an indicator of abnormal bladder function or detrusor decompensation.~End-of-treatment is the last post-baseline assessment during the treatment period.~Least squares (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 2, 4, 8 and 12

,,
InterventionmL (Least Squares Mean)
Week 2 (N=61, 67, 58)Week 4 (N=60, 67, 59)Week 8 (N=58, 66, 58)Week 12 (N=57, 63, 57)End of Treatment (N=62, 67, 59)
6 mg Solifenacin + 0.4 mg Tamsulosin16.7814.929.6426.8125.63
9 mg Solifenacin + 0.4 mg Tamsulosin8.979.656.6418.7219.07
Placebo-10.21-7.86-12.441.160.14

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Change From Baseline in Volume Voided 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 (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 2, 4, 8 and 12

,,
InterventionmL (Least Squares Mean)
Week 2 (N=60, 67, 59)Week 4 (N=60, 65, 58)Week 8 (N=58, 67, 58)Week 12 (N=58, 65, 58)End of Treatment (N=60, 67, 59)
6 mg Solifenacin + 0.4 mg Tamsulosin31.4635.2733.7235.0236.26
9 mg Solifenacin + 0.4 mg Tamsulosin18.2530.3435.5331.1830.33
Placebo9.3610.4010.509.037.56

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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 (no disruption of normal daily activities), moderate (affected normal daily activities) or severe (inability to perform daily activities) and for causal relationship to study drug. (NCT00507455)
Timeframe: From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).

,,
Interventionparticipants (Number)
Any adverse eventMild adverse eventModerate adverse eventSevere adverse eventSerious adverse eventAE leading to study drug discontinuationDrug-related adverse eventsDeaths
6 mg Solifenacin + 0.4 mg Tamsulosin382113423240
9 mg Solifenacin + 0.4 mg Tamsulosin372012526260
Placebo29216213150

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Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score

"The degree to which urinary symptoms bothered participants was assessed by the ICIQ MLUTS questionnaire which consists of 13 symptom bother questions. Each question is answered by the participant on a scale from 0 (not at all) to 10 (a great deal). The total bother score ranges from 0 to 130, where larger scores correspond to worse outcomes.~Least squares (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
Interventionunits on a scale (Least Squares Mean)
Week 4 (N=52, 57, 48)Week 8 (N=51, 55, 47)Week 12 (N=51, 51, 47)End of Treatment (N=58, 60, 53)
6 mg Solifenacin + 0.4 mg Tamsulosin-11.0-19.4-23.9-21.1
9 mg Solifenacin + 0.4 mg Tamsulosin-17.0-20.7-23.9-22.4
Placebo-14.6-20.7-22.6-21.7

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Change From Baseline in 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 (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
Interventionunits on a scale (Least Squares Mean)
Week 4 (N=57, 66, 56)Week 8 (N=56, 65, 55)Week 12 (N=56, 63, 55)End of Treatment (N=60, 66, 57)
6 mg Solifenacin + 0.4 mg Tamsulosin-1.2-1.7-2.0-1.9
9 mg Solifenacin + 0.4 mg Tamsulosin-1.3-1.8-2.2-2.1
Placebo-1.2-1.7-2.1-2.0

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

"Percent 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.~LS means were adjusted for pooled center and Baseline value." (NCT00507455)
Timeframe: Baseline and Week 12

InterventionPercent voiding efficiency (Least Squares Mean)
Placebo-0.67
6 mg Solifenacin + 0.4 mg Tamsulosin-1.38
9 mg Solifenacin + 0.4 mg Tamsulosin-3.79

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

The maximum flow rate (Qmax) during a micturition (urination) was recorded using uroflowmetry. A reduction in maximum flow rate may be due to an obstruction of the bladder outlet or a failure of the detrusor muscle to aid in expelling urine. (NCT00507455)
Timeframe: Baseline and Week 12

InterventionmL/sec (Least Squares Mean)
Placebo0.17
6 mg Solifenacin + 0.4 mg Tamsulosin1.85
9 mg Solifenacin + 0.4 mg Tamsulosin2.35

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

Detrusor pressure (Pdet) measures the force the detrusor muscle is exerting. This pressure is required to expel urine from the bladder during normal voiding. A high detrusor pressure may be observed in the presence of outflow tract obstruction. Detrusor pressure at maximum urinary flow rate (PdetQmax) was evaluated using simultaneous recording of urinary voiding by an uroflowmeter during detrusor pressure evaluation by cystometry. (NCT00507455)
Timeframe: Baseline and Week 12

InterventioncmH2O (Least Squares Mean)
Placebo-1.69
6 mg Solifenacin + 0.4 mg Tamsulosin-7.84
9 mg Solifenacin + 0.4 mg Tamsulosin-6.69

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

"The Bladder Contractility 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.~LS means were adjusted for pooled center and Baseline value." (NCT00507455)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-1.63
6 mg Solifenacin + 0.4 mg Tamsulosin1.84
9 mg Solifenacin + 0.4 mg Tamsulosin3.86

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Change From Baseline in International Prostate Symptoms Score (IPSS)

"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:~Sensation of incomplete emptying~Repeat urinating after 2 hours (frequency)~Start and stop several times (intermittency)~Urgency~Weak stream~Straining~Nocturia~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 (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 2, 4, 8 and 12

,,
Interventionunits on a scale (Least Squares Mean)
Week 2 (N=61, 67, 58)Week 4 (N=60, 65, 57)Week 8 (N=58, 67, 57)Week 12 (N=58, 63, 57)End of Treatment (N=62, 67, 59)
6 mg Solifenacin + 0.4 mg Tamsulosin-4.5-6.4-7.1-7.9-8.0
9 mg Solifenacin + 0.4 mg Tamsulosin-4.7-6.2-6.9-7.2-6.9
Placebo-3.8-5.3-6.8-6.9-6.6

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Change From Baseline 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 MLUTS questionnaire which consists of 13 questions regarding urinary symptoms. Each question is answered by the participant on a scale from 0 (never) to 4 (all the time). The total symptom score ranges from 0 to 52, where larger scores correspond to worse conditions.~Least squares (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
Interventionunits on a scale (Least Squares Mean)
Week 4 (N=58, 66, 52)Week 8 (N=55, 63, 53)Week 12 (N=55, 61, 53)End of Treatment (N=60, 66, 57)
6 mg Solifenacin + 0.4 mg Tamsulosin-4.5-5.6-6.5-6.0
9 mg Solifenacin + 0.4 mg Tamsulosin-4.6-5.8-5.9-5.8
Placebo-3.9-5.5-5.5-5.2

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Change From Baseline 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 regarding daily activities affected by urinary problems. Participants responded to each question on a scale from 1 (not at all) to 4 (a lot). The total symptom score ranges from 19 to 76, where larger scores correspond to a lesser quality of life).~Least squares (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
Interventionunits on a scale (Least Squares Mean)
Week 4 (N=33, 36, 36)Week 8 (N=33, 32, 31)Week 12 (N=35, 33, 28)End of Treatment (N=39, 39, 38)
6 mg Solifenacin + 0.4 mg Tamsulosin-2.4-4.3-6.5-5.3
9 mg Solifenacin + 0.4 mg Tamsulosin-5.1-6.7-8.4-7.3
Placebo-2.7-3.6-4.8-4.7

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Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score

"The OAB-q is used to assess how much a patient is bothered by OAB symptoms and the impact of these symptoms on the patient's HRQL. It is a validated patient administered tool comprised of 33 items, where the first 8 items define symptom bother with raw score being converted to a scale of 0 to 100.~Higher score values are indicative of greater symptom severity or bother, and a lower score in change from baseline indicates improvement.~Change is calculated as Actual Data for each timepoint - Baseline." (NCT00573508)
Timeframe: Baseline, Week 4, Week 8 and Week 12

,
InterventionOAB-q Score (Mean)
Baseline ( N= 374 ; 377)Week 4 (N=371; 370)Change at Week 4 (N=371; 370)Week 8 (N=342; 356)Change at Week 8 (N=342; 356)Week 12 (N=318; 339)Change at Week 12 (N=318; 339)
Placebo57.941.6-16.437.0-21.036.0-21.7
Solifenacin Succinate58.235.5-22.629.8-28.927.6-30.9

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Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social

"The OAB-q is used to assess how much a patient is bothered by OAB symptoms & the impact on the patient's HRQL. It is comprised of 33 items, with raw scores for each sub-domain being converted to a scale of 0 to 100.~Higher score values are indicative of better HRQL, and a positive score in change from baseline indicates improvement.~Change is calculated End of Treatment (EOT) for each sub-domain - Baseline." (NCT00573508)
Timeframe: Baseline, Week 4, Week 8 and Week 12

,
InterventionOAB-q HRQL Sub Domain Score (Mean)
Coping- Baseline (N= 374 ; 377)Coping- Change at Week 4 (N=371; 370)Coping- Change at Week 8 (N=342; 356)Coping- Change at Week 12 (N=318; 339)Concern- Baseline (N= 374 ; 377)Concern- Change at Week 4 (N=371; 370)Concern- Change at Week 8 (N=342; 356)Concern- Change at Week 12 (N=318; 339)Sleep- Baseline (N= 374 ; 377)Sleep- Change at Week 4 (N=371; 370)Sleep- Change at Week 8 (N=342; 356)Sleep- Change at Week 12 (N=318; 339)Social- Baseline (N= 374 ; 377)Social- Change at Week 4 (N=371; 370)Social- Change at Week 8 (N=340; 356)Social- Change at Week 12 (N=318; 339)
Placebo53.714.918.919.952.015.819.820.951.313.918.719.078.97.89.410.0
Solifenacin Succinate52.222.227.028.851.922.428.429.947.319.326.227.578.710.313.113.7

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Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores.

"ICIQ-MLUTSsex is a patient reported outcome instrument to further evaluate the effect of solifenacin succinate on patients' overall satisfaction & quality of life. The questionnaire contains 5 questions for detailed evaluation of sexual matters associated with lower urinary track symptoms & impact on sexual quality of life, with a scale of 0 to 12.~Change from baseline with a negative score indicates improvement. End of Treatment results include patients who had early discontinuation. Change is calculated as End of Treatment(EOT)-Baseline." (NCT00573508)
Timeframe: Baseline and 12 Weeks

,
InterventionICIQ-MLUTSsex (Mean)
Symptom- Baseline (N=59; 71)Symptom- EOT (N=55; 68)Symptom- Change at EOT (N=54; 68)Bother- Baseline (N=59; 71)Bother- EOT (N=51; 67)Bother- Change at EOT (N=50; 67)
Placebo3.63.2-0.112.110.3-1.6
Solifenacin Succinate3.53.70.111.811.4-0.6

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Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score

"The OAB-q is used to assess how much a patient is bothered by OAB symptoms & the impact of these symptoms on the patient's Health Related Quality of Life(HRQL). It is a patient administered tool comprised of 33 items, where the first 8 define symptom bother with raw score being converted to a scale of 0 to 100.~Higher score values are indicative of greater symptom severity or bother, and a lower score in change from baseline indicates improvement.~End of Treatment results include patients who had early discontinuation from the study.~Change is calculated as End of Treatment - Baseline." (NCT00573508)
Timeframe: Baseline and 12 Weeks

,
InterventionOAB-q Score (Mean)
BaselineEnd of TreatmentChange at End of Treatment
Placebo57.937.5-20.4
Solifenacin Succinate58.228.3-29.9

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Number of Participants With Change From Baseline in the Global Assessment Score of the Patient Perception of Bladder Condition (PPBC)

"The PPBC is a validated, global assessment tool using a 6-point Likert scale which requires patients to assess their bladder condition by selecting one of the following responses: 1=Does not cause me any problem at all; 2=Cause 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~Improvement is defined by any reduction in PPBC score.~End of Treatment results include patients who had early discontinuation from the study.~Change is calculated as End of Treatment (EOT) - Baseline" (NCT00573508)
Timeframe: Baseline and 12 Weeks

,
InterventionParticipants (Number)
Improvement from Baseline to End of TreatmentNo Improvement from Baseline to End of Treatment
Placebo231131
Solifenacin Succinate27890

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Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire

The BSW questionnaire is a validated instrument that can be used to assess patient satisfaction with antimuscarinic agents for OAB. It is designed to capture the patient's perception of the effect of treatment in terms of relative benefit, patient satisfaction, and patient intention or willingness to continue on therapy. (NCT00573508)
Timeframe: Baseline and 12 Weeks

,
InterventionParticipants (Number)
Benefit from Treatment - NoBenefit from Treatment - LittleBenefit from Treatment - MuchBenifit from Treatment - N/ASatisfied with Treatment - NoSatisfied with Treatment - YesWillingness to Continue - NoWillingness to Continue - Yes
Placebo115901092129187128188
Solifenacin Succinate538019666626971264

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Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores.

"ICIQ-FLUTSsex is a patient reported outcome instrument to further evaluate the effect of solifenacin succinate on patients' overall satisfaction & quality of life.The questionnaire contains 5 questions for detailed evaluation of sexual matters associated with lower urinary track symptoms & impact on sexual quality of life, with a scale of 0 to 14.~Change from baseline with a negative score indicates improvement. End of Treatment results include patients who had early discontinuation. Change is calculated as End of Treatment(EOT)-Baseline." (NCT00573508)
Timeframe: Baseline and 12 Weeks

,
InterventionICIQ-FLUTSsex (Mean)
Symptom- Baseline (N=302; 300)Symptom- EOT (N=297; 291)Symptom- Change at EOT (N=288; 288)Bother- Baseline (N=281; 282)Bother- EOT (N=263; 262)Bother- Change at EOT (N=245; 249)
Placebo4.93.9-0.99.06.1-3.1
Solifenacin Succinate5.23.8-1.310.06.6-3.6

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Change From Baseline in the MCUI Behavior Therapy Stratified

"MCUI is a Patient Reported Outcome instrument utilized to further evaluate the effect of solifenacin succinate on patient's overall satisfaction and quality of life. The tool included questions concerning the effect of the patients bladder condition on access to medical care.~A negative score in Change from Baseline indicates improvement.~End of Treatment results include patients who had early discontinuation from the study.~Change is calculated as End of Treatment (EOT) - Baseline" (NCT00573508)
Timeframe: Baseline and 12 Weeks

,
InterventionNumber of Days (Mean)
days with timed voiding- Baseline (N=364; 365)days with timed voiding- EOT (N=356; 360)days with timed voiding-Change at EOT(N=347; 350)days with fluid management-Baseline(N=368; 369)days with fluid management- EOT (N=355; 366)days with fluid management-Change at EOT(349; 360)days w/ pelvic floor exercises-Baseline(364; 366)days w/ pelvic floor exercises- EOT (N=352; 358)days w/pelvic flr exercises-Change atEOT(344; 349)days with biofeedback- Baseline (N=359; 360)days with biofeedback- EOT (N=352; 358)days with biofeedback- Change at EOT (N=338; 343)days w/ electrical stimulation-Baseline (358; 362)days w/ electrical stimulation- EOT (N=352; 358)days w/ elec stimulation-Change at EOT(N=337; 345)
Placebo14.810.3-4.021.315.1-6.38.512.13.40.40.0-0.40.00.00.0
Solifenacin Succinate12.17.4-5.322.111.5-11.09.25.5-3.20.10.00.00.10.10.0

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Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months

"MCUI is a Patient Reported Outcome instrument utilized to further evaluate the effect of solifenacin succinate on patient's overall satisfaction and quality of life.The tool included questions concerning the effect of the patients bladder condition on access to medical care.~A negative score in Change from Baseline indicates improvement.~End of Treatment results include patients who had early discontinuation from the study.~Change is calculated as End of Treatment (EOT) - Baseline" (NCT00573508)
Timeframe: Baseline and 12 Weeks

,
InterventionNumber of categorical items (Mean)
physician office visits- Baseline (N=371; 375)physician office visits- EOT (N=362; 366)physician office visits- Change at EOT(359; 365)urinary tract infections-Baseline (N=371; 370)urinary tract infections- EOT (N=358; 362)urinary tract infections-Change at EOT (355; 356)skin rashes- Baseline (N=367; 368)skin rashes- EOT (N=354; 357)skin rashes- Change at EOT (N=347; 351)falls- Baseline (N=365; 364)falls- EOT (N=356; 358)falls- Change at EOT (N=347; 349)pad/diapers used/ week- Baseline (N=371; 375)pad/diapers used/ week- EOT (N=360; 364)pad/diapers used/ week- Change at EOT(N=357; 362)
Placebo0.50.2-0.40.10.1-0.11.51.00.00.20.1-0.110.09.8-0.2
Solifenacin Succinate0.50.2-0.30.10.10.00.30.2-0.10.20.50.210.48.3-2.1

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Change From Baseline in the Treatment Satisfaction Visual Analog Scale (TS-VAS)

"The TS-VAS is a instrument utilized to further evaluate the effect of solifenacin succinate on patients' overall satisfaction & quality of life. Each patient completed a TS-VAS to rate satisfaction with treatment. They were to answer the following question: Are you satisfied with your treatment? by placing a mark on a line that ran from 0 (no, not at all) to 100 (yes, completely).~Change from baseline with a positive score indicates an improvement. The End of Treatment (EOT) results include patients who had early discontinuation from the study.~Change is calculated as EOT - Baseline" (NCT00573508)
Timeframe: Baseline and 12 Weeks

,
InterventionTS-VAS (Mean)
Baseline (N=363; 367)End of Treatment (N=363; 367)Change at EOT (N=352; 357)
Placebo32.751.218.4
Solifenacin Succinate29.067.438.2

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Change From Baseline in Work Productivity Assessment Index (WPAI)

"The WPAI is a tool used to evaluate the effect of solifenacin succinate on a patient's overall satisfaction & quality of life, and included 6 questions regarding the effect that bladder condition had on ability to perform work-related functions & carry out daily activities over the past 4 weeks. The scores were converted to percentages for reporting.~A negative score in Change from Baseline indicates improvement. End of Treatment results include patients who had early discontinuation from the study.~Change from baseline is based on the ANCOVA model after adjusting baseline value & center." (NCT00573508)
Timeframe: Baseline and 12 Weeks

,
InterventionPercentage of indicated parameter (Mean)
% work time missed- Baseline (N=175;175)% work time missed- EOT (N=161;157)% work time missed- Change at EOT (N=145;142)% impairment while working- Baseline(N=203;194)% impairment while working- EOT (N=193;197)% impairment working-Change at EOT(N=172;175)% overall work impairment- Baseline (N=174;175)% overall work impairment- EOT (N=161;157)%overall work impairment-Change at EOT(N=145;142)%activity impairment- Baseline (N=368;375)% activity impairment- EOT (N=357;362)% activity impairment- Change at EOT(N=351;360)
Placebo1.40.80.127.518.4-8.728.520.8-8.238.623.4-14.7
Solifenacin Succinate1.10.5-0.527.613.2-14.628.214.1-12.937.319.2-18.1

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Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary

"The mean parameters recorded for previous 24 hours in the 3-day diary were: number of micturitions, number of incontinence episodes, number of urgency episodes, number of nocturia episodes and number of nocturnal voids.~Change from baseline with a lower score indicates an improvement.~End of Treatment (EOT) results include patients who had early discontinuation from the study; only patients who had the symptom at baseline and data at the EOT in the 3-day diary are included in the data table.~Change is calculated as EOT - Baseline" (NCT00573508)
Timeframe: Baseline and 12 Weeks

,
InterventionNumber of Category Events / 24 Hours (Mean)
Micturitions- Baseline (N=363;369)Micturitions- End of Treatment (N=363;369)Micturitions- Change at EOT (N=363;369)Incontinence Episodes- Baseline (N=267;268)Incontinence Episodes-End of Treatment (N=267;268)Incontinence Episodes-Change at EOT (N=267;268)Urgency Episodes- Baseline (N=364;369)Urgency Episodes- End of Treatment (N=364;369)Urgency Episodes- Change at EOT (N=364;369)Nocturia Episodes- Baseline (N=309;313)Nocturia Episodes- End of Treatment (N=309;313)Nocturia Episodes- Change at EOT (N=309;313)Nocturnal Voids- Baseline (N=329;326)Nocturnal Voids- End of Treatment (N=329;326)Nocturnal Voids- Change at EOT (N=329;326)
Placebo11.8510.49-1.362.801.56-1.245.703.86-1.841.571.09-0.481.891.41-0.48
Solifenacin Succinate11.739.50-2.232.921.07-1.855.722.66-3.051.741.11-0.631.991.29-0.70

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Compliance

Number of subjects that were in compliance with the study protocol and took medication for at least one month. (NCT00581061)
Timeframe: 3 months

Interventionparticipants (Number)
Vesicare10

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Side Effects

Number of people who experienced side effects while taking Vesicare, per study protocol. (NCT00581061)
Timeframe: 3 months

Interventionparticipants (Number)
ConstipationFatigueHeartburnDry HandsDry Mouth
Vesicare21112

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Time to Continence

Time in days to achieve pad free urinary continence (NCT00581061)
Timeframe: 12 months

Interventiondays (Mean)
Vesicare50

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Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries.

(NCT00821184)
Timeframe: 0 week - 12 weeks

Interventionincontinence episodes per 24 hours (Mean)
Vesicare Alone1
Vesicare Plus Behavioral Modification10

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Mean Proportion of Bowel Movements With Satisfaction Per Day

"The number of stools with satisfaction of Yes divided by the total number of stools passed on each notional day. Mean of 3 days." (NCT00832650)
Timeframe: Day 11 to 13

Interventionmean proportion (Mean)
Fesoterodine0.88
Placebo0.81
Solifenacin0.93

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Average Score of Ease of Passage During Defecation Per Day

Calculated by averaging the values given for the ease of passage at each visit to the toilet on each notional day. Mean of 3 days. Range of possible scores: 1 (Manual disimpaction) to 7 (Incontinent). (NCT00832650)
Timeframe: Day 11 to 13

Interventionscore on a scale (Mean)
Fesoterodine3.90
Placebo3.97
Solifenacin3.83

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Colonic Filling at 6 Hours

A surrogate marker of small bowel transit time. (NCT00832650)
Timeframe: Day 12

Interventionpercentage (Mean)
Fesoterodine7.84
Placebo69.58
Solifenacin24.06

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Colonic Transit at 24 Hours

Colonic transit: Geometric centre at 24 hours (GC24) was estimated using geometric mean of counts in ascending (AC), transverse (TC), descending (DC) and rectosigmoid (RS) colon and stool (weighted by factors of 1 to 5 respectively). To calculate the geometric centre, the proportion of colonic counts in each colonic region was multiplied by its weighing factor: (% AC *1 + % TC *2 + % DC *3 + % RS *4 + % stool * 5 ) divided by 100. (NCT00832650)
Timeframe: Day 13 (Day 12 24 hours post-meal)

Interventioncounts (Mean)
Fesoterodine1.98
Placebo2.51
Solifenacin1.91

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Colonic Transit at 48 Hours

Colonic transit: Geometric centre at 48 hours (GC48) was estimated using geometric mean of counts in ascending (AC), transverse (TC), descending (DC) and rectosigmoid (RS) colon and stool (weighted by factors of 1 to 5 respectively). To calculate the geometric centre, the proportion of colonic counts in each colonic region was multiplied by its weighing factor: (% AC *1 + % TC *2 + % DC *3 + % RS *4 + % stool * 5 ) divided by 100. (NCT00832650)
Timeframe: Day 14 (Day 12 48 hours post-meal)

Interventioncounts (Mean)
Fesoterodine3.55
Placebo3.67
Solifenacin3.14

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Mean Number of Stools Per Day

Number of stools passed on each notional day where each visit to the toilet counts as one stool (only) unless nothing is passed. Mean of 3 days. (NCT00832650)
Timeframe: Day 11 to 13

Interventionstools (Mean)
Fesoterodine0.93
Placebo1.06
Solifenacin1.11

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Mean Score of Stool Consistency Per Day

Calculated by averaging the values of the stool form given at each visit to the toilet on each notional day. Mean of 3 days. Range of possible scores: 1 (hard lumps) to 7 (watery). (NCT00832650)
Timeframe: Day 11 to 13

Interventionscore on a scale (Mean)
Fesoterodine3.66
Placebo3.29
Solifenacin3.02

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Proximal Colonic Emptying Time

Estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. (NCT00832650)
Timeframe: Day 12 to 14

Interventionhours (Mean)
Fesoterodine21.06
Placebo14.79
Solifenacin19.23

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Time to Gastric Emptying

Ascending colon emptying t½ was estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. (NCT00832650)
Timeframe: Day 12: 2 hours, 4 hours

Interventionminutes (Mean)
Fesoterodine145.00
Placebo112.92
Solifenacin127.47

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Change in Maximal Cystometric Capacity (mL)

At baseline, a small catheter is placed inside the participant's bladder. The bladder is filled with sterile water through the catheter and participants' maximal tolerated cystometric capacity (MCC) is measured in milliliters. Following completion of the bladder test, participants take 10mg solifenacin succinate (VesicareR) daily for 30 days. After 30 days of treatment, participants repeat the bladder test. Change in the MCC is used to evaluate the effectiveness of the drug. (NCT00909428)
Timeframe: 30 Days

Interventionmilliliters (mL) (Median)
Baseline Maximal Cystometric Capacity95
One Month Maximal Cystometric Capacity473.50

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Number of Urinary Incontinence Episodes Per 24 Hour Period

This scale it the mean number of urinary incontinence episodes per 24 hour period, as assessed by a 3-day bladder diary. The goal is to examine the effect of solifenacin succinate (VESIcare) on urinary incontinence severity. (NCT01018264)
Timeframe: 12 weeks

,
InterventionNumber of incontinence episodes/24 hours (Mean)
BaselineEndpoint (12 weeks)
Placebo1.781.61
Solifenacin Succinate (VESIcare)1.480.30

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Number of Micturations Per 24 Hour Period

The primary objective of this study is to measure the efficacy of solifenacin succinate (VESIcare) in reducing the mean number of micturitions per 24 hour period in Parkinson's disease (PD) patients as measured by voiding diaries. (NCT01018264)
Timeframe: 12 weeks

,
InterventionNumber of micturations per 24 hours (Mean)
BaselineEndpoint (12 weeks)
Placebo9.198.94
Solifenacin Succinate (VESIcare)8.788.00

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Number of Nocturia Episodes Per 24 Hour Period

To examine the effect of solifenacin succinate (VESIcare) on urinary incontinence severity (NCT01018264)
Timeframe: 12 weeks

,
InterventionNumber of nocturia episodes per 24 hours (Mean)
BaselineEndpoint (12 weeks)
Placebo1.921.78
Solifenacin Succinate (VESIcare)2.482.04

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Parkinson's Disease Quality of Life Scale (PDQOL)

This scale is used to assess quality of life in Parkinson's Disease patients. Parkinson's disease quality of life scale has a possible point range from 37 (worst outcome) to 185 (best outcome). The goal of this outcome measure is to examine the effect of solifenacin succinate (VESIcare) on quality of life. (NCT01018264)
Timeframe: 12 weeks

,
Interventionunits on a scale (Mean)
BaselineEndpoint (12 weeks)
Placebo114.50112.92
Solifenacin Succinate (VESIcare)125.00116.00

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Unified Parkinson's Disease Rating Scale (UPDRS) Total

To examine the effect of solifenacin succinate (VESIcare) on Parkinson's disease severity. The UPDRS total score ranges from 0 (no disability) to 199 (total disability). (NCT01018264)
Timeframe: 12 weeks

,
Interventionunits on a scale (Mean)
BaselineEndpoint (12 weeks)
Placebo25.6725.75
Solifenacin Succinate (VESIcare)25.0021.67

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Change From Baseline to End of Treatment in Total International Prostate Symptom Score

"The International Prostate Symptom Score (IPSS) is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms:~Incomplete emptying of the bladder~Intermittency~Weak stream~Hesitancy~Frequency~Urgency~Nocturia~Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic)." (NCT01018511)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-5.4
TOCAS 0.4 mg-6.2
FDC 0.4 mg/6 mg-7.0
FDC 0.4 mg/9 mg-6.5

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Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS, Previously Known as Total Urgency Score [TUS])

"The Patient Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale:~0. No urgency;~1. Mild urgency;~2. Moderate urgency;~3. Severe urgency;~4. Urgency incontinence~TUFS was calculated as the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded. Higher scores indicate more severe urgency." (NCT01018511)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-4.4
TOCAS 0.4 mg-6.7
FDC 0.4 mg/6 mg-8.1
FDC 0.4 mg/9 mg-7.6

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Percentage of Participants Who Were OAB-q Responders at End of Treatment

A OAB-q responder was defined as a participant with an improvement from baseline in HRQoL subscale total score ≥ 10. (NCT01018511)
Timeframe: Week 12 (end of treatment)

Interventionpercentage of participants (Number)
Placebo40.8
TOCAS 0.4 mg42.9
FDC 0.4 mg/6 mg45.5
FDC 0.4 mg/9 mg47.5

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Apparent Clearance (CL/F) of Tamsulosin

(NCT01018511)
Timeframe: Week 4, Week 8 and Week 12

,,
InterventionL/h (Geometric Mean)
Week 4 [N=263; 281; 274]Week 8 [N=255; 259; 248]Week 12 [N=163; 167; 166]
FDC 0.4 mg/6 mg2.612.412.40
FDC 0.4 mg/9 mg2.532.362.46
TOCAS 0.4 mg2.782.622.52

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Area Under the Curve at Steady State (AUCss) of Tamsulosin

(NCT01018511)
Timeframe: Week 4, Week 8 and Week 12 (collection time points: trough, 1-3 hours post dose, 4-5 hours post-dose and 7-10 hours post-dose)

,,
Interventionng.h/mL (Geometric Mean)
Week 4 [N= 263; 281; 274]Week 8 [N= 255; 259; 248]Week 12 [N= 163; 167; 166]
FDC 0.4 mg/6 mg153166167
FDC 0.4 mg/9 mg158169162
TOCAS 0.4 mg144153159

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AUCss of Solifenacin

(NCT01018511)
Timeframe: Week 4, Week 8 and Week 12 (collection time points: trough, 1-3 hours post dose, 4-5 hours post-dose and 7-10 hours post-dose)

,
Interventionng.h/mL (Geometric Mean)
Week 4 [N= 281; 273]Week 8 [N= 258; 248]Week 12 [N= 166; 167]
FDC 0.4 mg/6 mg657673652
FDC 0.4 mg/9 mg9701020988

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Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score

"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= not anxious, 2= moderately anxious, 3 = extremely anxious)." (NCT01018511)
Timeframe: Baseline and Week 12

,,,
Interventionparticipants (Number)
Not anxious -> Not anxiousNot anxious -> Moderately anxiousNot anxious -> Extremely anxiousNot anxious -> No dataModerately anxious -> Not anxiousModerately anxious -> Moderately anxiousModerately anxious -> Extremely anxiousModerately anxious -> No dataExtremely anxious -> Not anxiousExtremely anxious -> Moderately anxiousExtremely anxious -> Extremely anxiousExtremely anxious -> No dataNo data -> Not anxiousNo data -> Moderately anxiousNo data -> Extremely anxiousNo data -> No data
FDC 0.4 mg/6 mg233160127391011301000
FDC 0.4 mg/9 mg214180325341103200000
Placebo219160334421020100000
TOCAS 0.4 mg213110025432100201000

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Change From Baseline to End of Treatment in EQ-5D Mobility Score

"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = confined to bed)." (NCT01018511)
Timeframe: Baseline and Week 12

,,,
Interventionparticipants (Number)
No problem -> No problemNo problem -> Some problemNo problem -> Confined to bedNo problem -> No dataSome problem -> No problemSome problem -> Some problemSome problem -> Confined to bedSome problem -> No dataConfined to bed -> No problemConfined to bed -> Some problemConfined to bed -> Confined to bedConfined to bed -> No dataNo data -> No problemNo data -> Some problemNo data -> Confined to bedNo data -> No data
FDC 0.4 mg/6 mg255100112350000000000
FDC 0.4 mg/9 mg233130319310100001000
Placebo240160319400000000000
TOCAS 0.4 mg230131121310000001000

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Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score

"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no pain, 2= moderate pain, 3 = extreme pain)." (NCT01018511)
Timeframe: Baseline and Week 12

,,,
Interventionparticipants (Number)
No pain -> No painNo pain -> Moderate painNo pain -> Extreme painNo pain -> No dataModerate pain-> No painModerate pain-> Moderate painModerate pain-> Extreme painModerate pain-> No dataExtreme pain -> No painExtreme pain -> Moderate painExtreme pain -> Extreme painExtreme pain -> No dataNo data -> No painNo data -> Moderate painNo data -> Extreme painNo data -> No data
FDC 0.4 mg/6 mg153191161721012200000
FDC 0.4 mg/9 mg152240241701234200000
Placebo162142355732004100200
TOCAS 0.4 mg159141041722212202000

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Change From Baseline to End of Treatment in EQ-5D Self-care Score

"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to wash/dress)." (NCT01018511)
Timeframe: Baseline and Week 12

,,,
Interventionparticipants (Number)
No problem -> No problemNo problem -> Some problemNo problem -> Unable to wash/ dressNo problem -> No DataSome problem -> No problemSome problem -> Some problemSome problem -> Unable to wash/ dressSome problem -> No dataUnable to wash/ dress -> No problemUnable to wash/ dress -> Some problemUnable to wash/ dress -> Unable to wash/ dressUnable to wash/ dress -> No dataNo data -> No problemNo data -> Some problemNo data -> Unable to wash/ dressNo data -> No data
FDC 0.4 mg/6 mg293301860010001000
FDC 0.4 mg/9 mg286404330000001000
Placebo295803830000001000
TOCAS 0.4 mg273801680000101000

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Change From Baseline to End of Treatment in EQ-5D Usual Activities Score

"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to perform usual activities)." (NCT01018511)
Timeframe: Baseline and Week 12

,,,
Interventionparticipants (Number)
No problem -> No problemNo problem -> Some problemNo problem -> Unable to perform usual activitiesNo problem -> No dataSome problem -> No problemSome problem -> Some problemSome problem -> Unable to perform usual activitiesSome problem -> No dataUnable to perform usual activities -> No problemUnable to perform usual activities -> Some problemUnable to perform usual activities -> same statusUnable to perform usual activities -> No dataNo data -> No problemNo data -> Some problemNo data -> Unable to perform usual activitiesNo data -> No data
FDC 0.4 mg/6 mg248140126220020000000
FDC 0.4 mg/9 mg235180327170100000000
Placebo254180321220000000000
TOCAS 0.4 mg228131122280011102000

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Change From Baseline to End of Treatment in Individual IPSS Scores

"The IPSS is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms:~Incomplete emptying of the bladder~Intermittency~Weak stream~Hesitancy~Frequency~Urgency~Nocturia~Each question is assigned points from 0 to 5 indicating increasing severity of the symptom." (NCT01018511)
Timeframe: Baseline and Week 12

,,,
Interventionunits on a scale (Least Squares Mean)
Incomplete emptying of the bladderFrequencyIntermittencyUrgencyWeak streamHesitancyNocturia
FDC 0.4 mg/6 mg-1.0-1.3-1.0-1.4-1.3-0.8-0.8
FDC 0.4 mg/9 mg-1.0-1.4-0.7-1.6-1.3-0.7-0.6
Placebo-0.9-1.0-0.9-1.2-1.1-0.5-0.5
TOCAS 0.4 mg-0.9-1.2-0.8-1.3-1.3-0.7-0.7

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CL/F of Solifenacin

(NCT01018511)
Timeframe: Week 4, Week 8 and Week 12

,
InterventionL/h (Geometric Mean)
Week 4 [N= 281;273]Week 8 [N= 258; 248]Week 12 [N= 166; 167]
FDC 0.4 mg/6 mg6.886.726.94
FDC 0.4 mg/9 mg7.006.676.87

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Clinician Global Impression Scale at End of Treatment: Overall Bladder Symptoms

The Clinician Global Impression (CGI) is a questionnaire completed by the physician to assess change in the participants bladder symptoms since the start of the study. The questionnaire consists of 1 question with 7 response levels ranging from 1 to 7 (very much improved to very much worse). (NCT01018511)
Timeframe: Baseline and Week 12

,,,
Interventionparticipants (Number)
Very Much ImprovedMuch ImprovedMinimally ImprovedNo ChangeMinimally WorseMuch WorseVery Much Worse
FDC 0.4 mg/6 mg221179748210
FDC 0.4 mg/9 mg201249237340
Placebo99511172910
TOCAS 0.4 mg151069854510

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Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score

Visual Analogue Scale (VAS) is part of the EQ-5D questionnaire. The VAS is self-rated by the participant ranging from 0 to 100 (worst imaginable health state to best imaginable health state). (NCT01018511)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Placebo4.0
TOCAS 0.4 mg3.7
FDC 0.4 mg/6 mg5.5
FDC 0.4 mg/9 mg6.2

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Cminss of Solifenacin

(NCT01018511)
Timeframe: Week 4, Week 8 and Week 12

,
Interventionng/mL (Geometric Mean)
Week 4 [N= 281; 273]Week 8 [N= 258; 248]Week 12 [N= 166; 167]
FDC 0.4 mg/6 mg24.525.224.4
FDC 0.4 mg/9 mg36.138.237.0

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Maximum Concentration at Steady State (Cmaxss) of Tamsulosin

(NCT01018511)
Timeframe: Week 4, Week 8 and Week 12

,,
Interventionng/mL (Geometric Mean)
Week 4 [N= 263; 281; 274]Week 8 [N= 255; 259; 248]Week 12 [N= 163; 167; 166]
FDC 0.4 mg/6 mg7.808.328.38
FDC 0.4 mg/9 mg8.008.468.16
TOCAS 0.4 mg7.387.697.97

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Minimum Concentration at Steady State (Cminss) of Tamsulosin

(NCT01018511)
Timeframe: Week 4, Week 8 and Week 12

,,
Interventionng/mL (Geometric Mean)
Week 4 [N= 263; 281; 274]Week 8 [N= 255; 259; 248]Week 12 [N= 163; 167; 166]
FDC 0.4 mg/6 mg4.555.085.05
FDC 0.4 mg/9 mg4.755.194.94
TOCAS 0.4 mg4.194.634.84

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Number of Participants With Adverse Events (AEs)

Safety is monitored by collecting AEs, which include abnormal laboratory parameters, vital signs or ECG data if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE (SAE) 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 (no disruption of normal daily activities), moderate (affected normal daily activities) or severe (inability to perform daily activities) and for causal relationship to study drug. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred after administration of the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug. (NCT01018511)
Timeframe: From first dose of double-blind study drug up to 14 days of last dose of double-blind study drug (up to 14 weeks)

,,,
Interventionparticipants (Number)
Total TEAEsMild TEAEsModerate TEAEsSevere TEAEsDrug-related TEAEsSAEsDeathsAEs Leading to DiscontinDrug-related AEs Leading to Discontin
FDC 0.4 mg/6 mg99682745751139
FDC 0.4 mg/9 mg100682756590108
Placebo8759253303053
TOCAS 0.4 mg74422932710195

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

The mean number of pads per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01018511)
Timeframe: Baseline and Week 12

Interventionpads (Least Squares Mean)
Placebo-0.7
TOCAS 0.4 mg-0.8
FDC 0.4 mg/6 mg-1.2
FDC 0.4 mg/9 mg-1.2

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Patient Global Impression Scale at End of Treatment: Overall Bladder Symptoms

The Patient Global Impression (PGI) is a global questionnaire completed by the participant to assess both the change in the participants overall condition and the change in bladder symptoms since the start of the study. The questionnaire consists of 2 questions with 7 response levels ranging from 1 to 7 (very much improved to very much worse). (NCT01018511)
Timeframe: Baseline and Week 12

,,,
Interventionparticipants (Number)
Very Much ImprovedMuch ImprovedMinimally ImprovedNo ChangeMinimally WorseMuch WorseVery Much Worse
FDC 0.4 mg/6 mg209512446200
FDC 0.4 mg/9 mg2310510538910
Placebo775113861250
TOCAS 0.4 mg148599681330

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Time of Maximum Concentration at Steady State (Tmaxss) of Tamsulosin

(NCT01018511)
Timeframe: Week 4, Week 8 and Week 12

,,
Interventionh (Geometric Mean)
Week 4 [N= 263; 281; 274]Week 8 [N= 255; 259; 248]Week 12 [N= 163; 167; 166]
FDC 0.4 mg/6 mg5.065.105.09
FDC 0.4 mg/9 mg5.085.115.09
TOCAS 0.4 mg5.045.095.10

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Tmaxss of Solifenacin

(NCT01018511)
Timeframe: Week 4, Week 8 and Week 12

,
Interventionh (Geometric Mean)
Week 4 [N= 281; 273]Week 8 [N= 258; 248]Week 12 [N= 166; 167]
FDC 0.4 mg/6 mg5.475.485.48
FDC 0.4 mg/9 mg5.475.485.48

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Patient Global Impression Scale at End of Treatment: General Health

The Patient Global Impression (PGI) is a global questionnaire completed by the participant to assess both the change in the participants overall condition and the change in bladder symptoms since the start of the study. The questionnaire consists of 2 questions with 7 response levels ranging from 1 to 7 (very much improved to very much worse). (NCT01018511)
Timeframe: Baseline and Week 12

,,,
Interventionparticipants (Number)
Very Much ImprovedMuch ImprovedMinimally ImprovedNo ChangeMinimally WorseMuch Worse• Very Much Worse
FDC 0.4 mg/6 mg107287110800
FDC 0.4 mg/9 mg77594941010
Placebo543791521520
TOCAS 0.4 mg95877126930

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

A nocturia episode is defined as waking up at night 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 patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01018511)
Timeframe: Baseline and Week 12

Interventionnocturia episodes (Least Squares Mean)
Placebo-0.3
TOCAS 0.4 mg-0.4
FDC 0.4 mg/6 mg-0.5
FDC 0.4 mg/9 mg-0.4

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Change From Baseline to 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. (NCT01018511)
Timeframe: Baseline and Week 12

Interventionmicturitions (Least Squares Mean)
Placebo-1.1
TOCAS 0.4 mg-1.7
FDC 0.4 mg/6 mg-2.3
FDC 0.4 mg/9 mg-1.9

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Change From Baseline to End of Treatment in Average Flow Rate (Qmean)

Qmean during a micturition (urination) was recorded using uroflowmetry. (NCT01018511)
Timeframe: Baseline and Week 12

InterventionmL/s (Mean)
Placebo1.5
TOCAS 0.4 mg1.3
FDC 0.4 mg/6 mg1.9
FDC 0.4 mg/9 mg1.7

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Change From Baseline to End of Treatment in HRQoL Subscale: Concern Score

"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 HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Concern score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement." (NCT01018511)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo7.5
TOCAS 0.4 mg9.3
FDC 0.4 mg/6 mg12.0
FDC 0.4 mg/9 mg11.5

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Change From Baseline to End of Treatment in HRQoL Subscale: Sleep Score

"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 HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Sleep score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement." (NCT01018511)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo8.3
TOCAS 0.4 mg8.8
FDC 0.4 mg/6 mg11.9
FDC 0.4 mg/9 mg10.0

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

An urgency incontinence episode is defined as an episode with any involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes with PPIUS grade 3 (Severe incontinence) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01018511)
Timeframe: Baseline and Week 12

Interventionurgency incontinence episodes (Least Squares Mean)
Placebo-1.0
TOCAS 0.4 mg-1.4
FDC 0.4 mg/6 mg-1.3
FDC 0.4 mg/9 mg-1.1

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

An urgency episode is defined as an episode of strong desire to void accompanied by fear of leakage or pain. The mean number of urgency episodes with PPIUS grade 3 (Severe urgency) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01018511)
Timeframe: Baseline and Week 12

Interventionurgency episodes (Least Squares Mean)
Placebo-1.6
TOCAS 0.4 mg-2.5
FDC 0.4 mg/6 mg-2.6
FDC 0.4 mg 9 mg-2.8

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

A micturition is any voluntary urination, excluding episodes of incontinence only. 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. (NCT01018511)
Timeframe: Baseline and Week 12

InterventionmL (Least Squares Mean)
Placebo11.1
TOCAS 0.4 mg15.5
FDC 0.4 mg/6 mg38.6
FDC 0.4 mg/9 mg38.7

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Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume

PVR volume is the volume of urine retained after voiding. PVR volume was assessed by ultrasonography or bladder scan. (NCT01018511)
Timeframe: Baseline and Week 12

InterventionmL (Mean)
Placebo-6.1
TOCAS 0.4 mg-5.0
FDC 0.4 mg/6 mg3.8
FDC 0.4 mg/9 mg12.3

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Change From Baseline to End of Treatment in Symptom Bother Score

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 an 8-item scale scored from 1 to 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 indicates an improvement. (NCT01018511)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-11.8
TOCAS 0.4 mg-14.4
FDC 0.4 mg/6 mg-16.5
FDC 0.4 mg/9 mg-17.1

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

An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01018511)
Timeframe: Baseline and Week 12

Interventionincontinence episodes (Least Squares Mean)
Placebo0.1
TOCAS 0.4 mg-0.2
FDC 0.4 mg/6 mg0.0
FDC 0.4 mg/9 mg0.1

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Cmaxss of Solifenacin

(NCT01018511)
Timeframe: Week 4, Week 8 and Week 12

,
Interventionng/mL (Geometric Mean)
Week 4 [N= 281; 273]Week 8 [N= 258; 248]Week 12 [N= 166; 167]
FDC 0.4 mg/6 mg29.430.029.1
FDC 0.4 mg/9 mg43.445.344.1

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

Qmax during a micturition (urination) was recorded using uroflowmetry. (NCT01018511)
Timeframe: Baseline and Week 12

InterventionmL/s (Mean)
Placebo3.3
TOCAS 0.4 mg3.2
FDC 0.4 mg/6 mg3.8
FDC 0.4 mg/9 mg3.5

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Change From Baseline to End of Treatment in IPSS Voiding Score

The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions. 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 voiding questions (incomplete emptying of the bladder, intermittency, weak stream, hesitancy) and ranges from 0 to 20 (mildly symptomatic to severely symptomatic). (NCT01018511)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-3.0
TOCAS 0.4 mg-3.3
FDC 0.4 mg/6 mg-3.7
FDC 0.4 mg/9 mg-3.2

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Change From Baseline to End of Treatment in IPSS Storage Score

The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on 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 storage questions (frequency, urgency and nocturia) and ranges from 0 to 15 (mildly symptomatic to severely symptomatic). (NCT01018511)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-2.4
TOCAS 0.4 mg-2.9
FDC 0.4 mg/6 mg-3.5
FDC 0.4 mg/9 mg-3.3

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Change From Baseline to End of Treatment in IPSS QoL Score

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 answers ranged from 0 to 6 (delighted to terrible). (NCT01018511)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-0.9
TOCAS 0.4 mg-1.0
FDC 0.4 mg/6 mg-1.3
FDC 0.4 mg/9 mg-1.3

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Change From Baseline to End of Treatment in HRQoL Subscale: Total Score

"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 HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Total score is 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 indicates an improvement." (NCT01018511)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo7.4
TOCAS 0.4 mg8.8
FDC 0.4 mg/6 mg11.4
FDC 0.4 mg/9 mg10.7

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Change From Baseline to End of Treatment in HRQoL Subscale: Social Score

"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 HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Social score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement." (NCT01018511)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo3.8
TOCAS 0.4 mg4.5
FDC 0.4 mg/6 mg6.2
FDC 0.4 mg/9 mg5.8

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Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition

A micturition is any voluntary urination, excluding episodes of incontinence only. The maximum volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01018511)
Timeframe: Baseline and Week 12

InterventionmL (Least Squares Mean)
Placebo-5.9
TOCAS 0.4 mg-1.8
FDC 0.4 mg/6 mg12.7
FDC 0.4 mg/9 mg12.9

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Change From Baseline to End of Treatment in IPSS Quality of Life (QoL) Score

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 answers ranged from 0 to 6 (delighted to terrible). (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionunits on a scale (Mean)
Total Group-1.9

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Change From Baseline to End of Treatment in IPSS Storage Score

The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on 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 storage questions (frequency,urgency and nocturia) and ranges from 0 to 15 (mildly symptomatic to severely symptomatic). (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionunits on a scale (Mean)
Total Group-4.3

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

Qmax during a micturition (urination) was recorded using uroflowmetry. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionml/s (Mean)
Total Group4.54

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Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition

A micturition is any voluntary urination, excluding episodes of incontinence only. The maximum volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionml (Mean)
Total Group16.6

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

An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionincontinence episodes (Mean)
Total Group-1.4

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Change From Baseline to 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. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionmicturitions (Mean)
Total Group-2.5

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

The mean number of pads per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionpads (Mean)
Total Group-0.9

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

An urgency episode is defined as an episode of strong desire to void accompanied by fear of leakage or pain. The mean number of urgency episodes with PPIUS grade 3 (Severe urgency) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionurgency episodes (Mean)
Total Group-3.1

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

An urgency incontinence episode is defined as an episode with any involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes with PPIUS grade 3 (Severe incontinence) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionurgency incontinence episodes (Mean)
Total Group-1.5

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

A micturition is any voluntary urination, excluding episodes of incontinence only. 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. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionml (Mean)
Total Group39.0

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Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume

PVR volume is the volume of urine retained after voiding. PVR volume was assessed by ultrasonography or bladder scan. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionml (Mean)
Total Group10.7

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Change From Baseline to End of Treatment in Symptom Bother Score

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 an 8-item scale scored from 1 to 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 indicates an improvement. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionunits on a scale (Mean)
Total Group-20.6

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Change From Baseline to End of Treatment in Total International Prostate Symptom Score (IPSS)

"The International Prostate Symptom Score (IPSS) is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms:~Incomplete emptying of the bladder~Intermittency~Weak stream~Hesitancy~Frequency~Urgency~Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic)." (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionunits on a scale (Mean)
Total Group-9.0

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Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS) (Previously Known as Total Urgency Score [TUS])

"The Patient Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale:~0. No urgency;~1. Mild urgency;~2. Moderate urgency;~3. Severe urgency;~4. Urgency incontinence TUS/TUFS was calculated as the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded. Higher scores indicate more severe urgency." (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionunits on a scale (Mean)
Total Group-10.1

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Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score

"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= not anxious, 2= moderately anxious, 3 = extremely anxious)." (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionparticipants (Number)
Not anxious -> Not anxiousNot anxious -> moderately anxiousNot anxious -> extremely anxiousNot anxious -> no dataModerately anxious -> not anxiousModerately anxious -> moderately anxiousModerately anxious -> extremely anxiousModerately anxious -> no dataExtremely anxious -> not anxiousExtremely anxious -> moderately anxiousExtremely anxious -> extremely anxiousExtremely anxious -> no dataNo data -> not anxiousNo data -> moderately anxiousNo data -> extremely anxiousNo data -> no data
Total Group73737101031093044501000

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Change From Baseline to End of Treatment in EQ-5D Mobility Score

"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = confined to bed)." (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionparticipants (Number)
No problem -> No problemNo problem -> Some problemNo problem -> confined to bedNo problem -> no dataSome problem -> No problemSome problem -> Some problemSome problem -> confined to bedSome problem -> No dataConfined to bed -> no problemConfined to bed -> some problemConfined to bed -> confined to bedConfined to bed -> no dataNo data -> no problemNo data -> some problemNo data -> confined to bedNo data -> no data
Total Group7755810671020000001000

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Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score

"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no pain, 2= moderate pain, 3 = extreme pain)." (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionparticipants (Number)
No pain -> no painNo pain -> moderate painNo pain -> extreme painNo pain -> no dataModerate pain -> no painModerate pain -> moderate painModerate pain -> extreme painModerate pain -> no dataExtreme pain -> no painExtreme pain -> moderate painExtreme pain -> extreme painExtreme pain -> no dataNo data -> no painNo data -> moderate painNo data -> extreme painNo data -> no data
Total Group499712020220050107602000

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Change From Baseline to End of Treatment in EQ-5D Self-care Score

"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to wash/dress)." (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionparticipants (Number)
No problem -> No problemNo problem -> Some problemNo problem -> Unable to wash/dressNo problem -> No dataSome problem -> no problemSome problem -> some problemSome problem -> unable to wash/dressSome problem -> no dataUnable to wash/dress -> no problemUnable to wash/dress -> some problemUnable to wash/dress -> unable to wash/dressUnable to wash/dress -> no dataNo data -> no problemNo data -> some problemNo data -> unable to wash/dressNo data -> no data
Total Group934271018190020003000

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Change From Baseline to End of Treatment in EQ-5D Usual Activities Score

"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to perform usual activities)." (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionparticipants (Number)
No problem -> No problemNo problem -> Some problemNo problem -> unable to perform usual activitiesNo problem -> no dataSome problem -> no problemSome problem -> some problemSome problem -> unable to perform usual activitiesSome problem -> no dataUnable to perform usual activities -> no problemUnable to perform usual activities -> some problemUnable to perform usual activities -> same statusUnable to perform usual activities -> no dataNo data -> no problemNo data -> some problemNo data -> unable to perform usual activitiesNo data -> no data
Total Group805541080600012001000

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Change From Baseline to End of Treatment in Individual IPSS Scores

"The IPSS is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms:~Incomplete emptying of the bladder~Intermittency~Weak stream~Hesitancy~Frequency~Urgency~Nocturia~Each question is assigned points from 0 to 5 indicating increasing severity of the symptom." (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionunits on a scale (Mean)
Incomplete emptying of the bladderFrequencyIntermittencyUrgencyWeak streamHesitancyNocturia
Total Group-1.3-1.7-1.0-1.8-1.6-0.8-0.9

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Number of Participants With Adverse Events (AEs)

Safety is monitored by collecting AEs, which include abnormal lab parameters, vital signs or ECG data if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A serious AE (SAE) was an AE resulting in death, persistent or significant disability/incapacity or congenital anomaly/birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity (mild-no disruption of normal daily activities, moderate-affected normal daily activities or severe-inability to perform daily activities) and for causal relationship to study drug. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred after the intake of first dose of double-blind study drug (if on FDC in 905-CL-055) or after first open-label dose until 30 days after the last dose of open-label study drug (in 905-CL-057). (NCT01021332)
Timeframe: From first dose of double-blind study drug (if on FDC in 905-CL-055) or first open-label dose up to 30 days after last dose of open-label study drug (in 905-CL-057) (up to 56 weeks)

Interventionparticipants (Number)
Participants With Treatment-Emergent Adverse EventDrug-related AEsDrug-related SAEsAny TEAE causing discontinuation of study drug.
Total Group4992551269

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Change From Baseline to End of Treatment in IPSS Voiding Score

The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions. 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 voiding questions (incomplete emptying of the bladder, intermittency, weak stream, hesitancy) and ranges from 0 to 20 (mildly symptomatic to severely symptomatic). (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionunits on a scale (Mean)
Total Group-4.7

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

A nocturia episode is defined as waking up at night 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 patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionnocturia episodes (Mean)
Total Group-0.7

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Change From Baseline to End of Treatment in Average Flow Rate (Qmean)

Qmean during a micturition (urination) was recorded using uroflowmetry. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionml/s (Mean)
Total Group2.05

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Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score

Visual Analogue Scale (VAS) is part of the EQ-5D questionnaire. The VAS is self-rated by the participant ranging from 0 to 100 (worst imaginable health state to best imaginable health state). (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionunits on a scale (Mean)
Total Group6.4

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Difference (Pre - Post) in Maximum Urine Flow Rate (Qmax) (Milliliters Per Second) as Measured by Pressure Flowmetry

Pressure Flowmetry was used to measure maximum urine flow rate (Qmax)before and after 2 weeks of therapy with one of 6 randomly assigned medications. A 300 cc bladder fill was performed through the catheter, the catheter was removed, and transurethral and transrectal pressure transducers were placed for the pressure flow study. Voiding was performed in the seated position. Information obtained for the database included Qmax, average flow rate, time to Qmax, detrusor pressure at maximum flow rate, voided volume, and a calculated post-void residual. (NCT01028014)
Timeframe: 2 weeks

Interventionmilliliters per second (Median)
Pseudoephedrine 120mg ER Daily-7.3
Solifenacin 5mg Daily5.0
Tamsulosin 0.4mg Daily-5.6
Imipramine 25mg Daily-6.6
Cyclobenzaprine 10mg Daily10.3
Lactose Capsules, One Daily10.4

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Difference (Pre - Post) in Urethral Sensation (Milliamps) as Measured by Current Perception Threshold Testing.

Current Perception Threshold testing was used to measure urethral sensation before and after 2 weeks of therapy with one of 6 randomly assigned medications. We performed CPT testing in the urethra using a Neurometer®, which is a constant current stimulator capable of delivering sine wave electrical stimuli at 3 frequencies (2000 Hz, 250 Hz and 5 Hz). At all 3 frequencies, the stimulus intensity was gradually increased until first perceived, and then decreased until no longer perceptible. CPT values were obtained using a semi-automated forced choice paradigm. (NCT01028014)
Timeframe: 2 weeks

InterventionMilliamps (Median)
Pseudoephedrine 120mg ER Daily0.06
Solifenacin 5mg Daily0.06
Tamsulosin 0.4mg Daily-0.8
Imipramine 25mg Daily-0.12
Cyclobenzaprine 10mg Daily0.0
Lactose Capsules, One Daily0.03

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Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG

Concentric needle EMG was used to measure urethral sphincter activity at 2-3 sites around the urethral meatus before and after 2 weeks of therapy with one of 6 randomly assigned medications. Two methods of quantitative electromyography were performed on all subjects. (1) Multi-Motor Unit Action Potential (MUP) analysis, which has been shown to be the most sensitive technique in distinguishing neuropathic from control muscles; and (2) interference pattern analysis (IPA) which reflects changes in MUP recruitment from weak effort to maximal contraction. (NCT01028014)
Timeframe: 2 weeks

Interventionmicrovolts (Median)
Pseudoephedrine 120mg ER Daily-18
Solifenacin 5mg Daily10
Tamsulosin 0.4mg Daily11
Imipramine 25mg Daily-15
Cyclobenzaprine 10mg Daily12
Lactose Capsules, One Daily36

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Change From Baseline in Patient Assessment of Treatment Satisfaction

The treatment satisfaction visual analog scale (TS_VAS) asks patients to rate their satisfaction with treatment by placing a vertical mark on a 100 mm line where the endpoints are labeled 'No, not at all' on the left (score = 0) to 'Yes, completely satisfied' on the right (score = 100). A positive change from Baseline indicates improvement. (NCT01093534)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Placebo18.90
Solifenacin 5 mg24.90
Solifenacin 10 mg31.90
Pooled Solifenacin28.20

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Change From Baseline in Patient Assessment of Urgency Bother

"The participants' perception and impression of bother associated with their condition were assessed using the Urgency Bother-Visual Analog Scale (UB-VAS). The participant was asked to place a vertical mark on a 100 mm line to indicate how much bother has urgency been for them in the past week, whereby 'no bother at all' is represented on the left end (score = 0) and 'worst possible bother' (score = 100) at the right end of the line.~A negative change from Baseline indicates improvement." (NCT01093534)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Placebo-12.60
Solifenacin 5 mg-27.70
Solifenacin 10 mg-28.90
Pooled Solifenacin-28.20

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Change From Baseline 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. (NCT01093534)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Placebo-0.7
Solifenacin 5 mg-1.3
Solifenacin 10 mg-1.3
Pooled Solifenacin-1.3

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Change From Baseline in Symptom Bother Score

"Overactive bladder symptoms were assessed using the symptom bother scale of the Overactive Bladder Symptom and Health-Related Quality of Life Questionnaire (OAB-q). The OAB-q is a patient-administered instrument comprising an 8-item symptom bother scale and 25 health-related quality of life items (see next outcome measure). In the symptom bother scale participants were asked how much they had been bothered by selected bladder symptoms during the past 4 weeks. Each question has a 6-point Likert scale response ranging from 'not at all' (1) to 'a very great deal' (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 improvement." (NCT01093534)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Placebo-14.90
Solifenacin 5 mg-22.32
Solifenacin 10 mg-22.91
Pooled Solifenacin-22.60

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Change From Baseline to Week 12 in Bladder Wall Thickness

Bladder wall thickness (BWT) measurements were obtained using transvaginal ultrasound. The BWT was derived as one mean value per image pooled over measurements of 3 locations (anterior wall, dome and trigone), and performed by 2 central readers and 1 adjudicator. (NCT01093534)
Timeframe: Baseline and Week 12

Interventionmm (Mean)
Placebo0.00
Solifenacin 5 mg-0.29
Solifenacin 10 mg-0.18
Pooled Solifenacin-0.24

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Change From Baseline to Week 12 in Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr)

Brain derived neurotrophic factor (uBDNF) and creatinine (Cr) were measured from urine samples by the central laboratories. uBDNF/Cr was derived by dividing uBDNF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant. (NCT01093534)
Timeframe: Baseline and Week 12

Interventionpg/µmol (Mean)
Placebo-27.4
Solifenacin 5 mg31.1
Solifenacin 10 mg-88.1
Pooled Solifenacin-27.8

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Change From Baseline to Week 12 in Mean Level of Urgency

"The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 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.~The mean level of urgency was calculated by adding the PPIUS grade for all events (micturition or incontinence) and dividing by the number of episodes recorded in the diary over 3 days prior to the Baseline and Week 12 visits." (NCT01093534)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Placebo-0.15
Solifenacin 5 mg-0.23
Solifenacin 10 mg-0.24
Pooled Solifenacin-0.23

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Change From Baseline to Week 12 in Mean Number of Events (Micturitions Plus Incontinence Episodes) Per 24 Hours

The average number of micturitions (urinations) and incontinence episodes (any involuntary leakage of urine) per day was derived from the number of events recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits. (NCT01093534)
Timeframe: Baseline and Week 12

Interventionevents (Mean)
Placebo-1.40
Solifenacin 5 mg-2.44
Solifenacin 10 mg-1.80
Pooled Solifenacin-2.13

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Change From Baseline to 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 calculated from the number of incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits. (NCT01093534)
Timeframe: Baseline and Week 12

Interventionincontinence episodes (Mean)
Placebo-0.60
Solifenacin 5 mg-1.49
Solifenacin 10 mg-1.04
Pooled Solifenacin-1.24

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

The average number of micturitions (urinations) per 24 hours was derived from the number of micturitions recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits. (NCT01093534)
Timeframe: Baseline and Week 12

Interventionmicturitions (Mean)
Placebo-1.18
Solifenacin 5 mg-1.80
Solifenacin 10 mg-1.28
Pooled Solifenacin-1.55

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Change From Baseline to Week 12 in Mean Number of Urgency Events Per 24 Hours

"The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 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.~An urgency event is defined as any micturition or incontinence episode classified by the participant as a grade 3 or 4 on the PPIUS scale. The average number of urgency events per day is derived from the diary data completed by participants on the 3 days prior to the Baseline and Week 12 visits." (NCT01093534)
Timeframe: 12 weeks

Interventionurgency events (Mean)
Placebo-1.58
Solifenacin 5 mg-2.22
Solifenacin 10 mg-1.88
Pooled Solifenacin-2.06

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

"An urgency micturition is defined as any micturition classified by the participant as a grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 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.~The average number of urgency micturitions per 24 hours was derived from the number of urgency micturitions recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits." (NCT01093534)
Timeframe: Baseline and Week 12

Interventionurgency micturitions (Mean)
Placebo-1.35
Solifenacin 5 mg-1.77
Solifenacin 10 mg-1.60
Pooled Solifenacin-1.69

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Change From Baseline to Week 12 in Total Urgency Score

"The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 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.~The total urgency score was calculated by adding all PPIUS scores over a 3-day period prior to the Baseline and Week 12 visits for each participant." (NCT01093534)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Placebo-13.61
Solifenacin 5 mg-22.39
Solifenacin 10 mg-16.91
Pooled Solifenacin-19.81

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Change From Baseline to Week 12 in Total Urinary Nerve Growth Factor Normalized by Urine Creatinine

Total (acidified) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Total uNGF/Cr was derived by dividing total uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant. (NCT01093534)
Timeframe: Baseline and Week 12

Interventionpg/µmol (Mean)
Placebo-0.962
Solifenacin 5 mg2.758
Solifenacin 10 mg3.858
Pooled Solifenacin3.302

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Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12

Free (neutralized) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Free (neutralized) uNGF/Cr was derived by dividing free (neutralized) uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant. (NCT01093534)
Timeframe: Week 12

Interventionpg/µmol (Mean)
Placebo30.359
Solifenacin 5 mg31.855
Solifenacin 10 mg38.917
Pooled Solifenacin35.325

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Total Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12

Total (acidified) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Total uNGF/Cr was derived by dividing total uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant. (NCT01093534)
Timeframe: Week 12

Interventionpg/µmol (Mean)
Placebo26.564
Solifenacin 5 mg30.135
Solifenacin 10 mg34.199
Pooled Solifenacin32.143

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Change From Baseline to Week 6 and Week 12 in Bladder Wall Thickness

Bladder wall thickness (BWT) measurements were obtained using transvaginal ultrasound. The BWT was derived as one mean value per image pooled over measurements of 3 locations (anterior wall, dome and trigone), and performed by 2 central readers and 1 adjudicator. (NCT01093534)
Timeframe: Baseline, Week 6 and Week 12

,,,
Interventionmm (Mean)
Week 6 (n=157, 145, 141, 286)Week 12 (n=160, 143, 135, 278)
Placebo-0.010.02
Pooled Solifenacin-0.09-0.24
Solifenacin 10 mg-0.14-0.22
Solifenacin 5 mg-0.04-0.26

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Change From Baseline to Week 6 and Week 12 in Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine

Free (neutralized) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Free (neutralized) uNGF/Cr was derived by dividing free (neutralized) uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant. (NCT01093534)
Timeframe: Baseline, Week 6 and Week 12

,,,
Interventionpg/µmol (Mean)
Week 6 (n=168, 163, 160, 323)Week 12 (n=173, 171, 166, 337)
Placebo-4.638-1.318
Pooled Solifenacin4.4811.699
Solifenacin 10 mg4.3092.625
Solifenacin 5 mg4.6500.801

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Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr) at Week 12

Brain derived neurotrophic factor (uBDNF) and creatinine (Cr) were measured from urine samples by the central laboratories. uBDNF/Cr was derived by dividing uBDNF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant. (NCT01093534)
Timeframe: Week 12

Interventionpg/µmol (Mean)
Placebo116.9
Solifenacin 5 mg158.1
Solifenacin 10 mg160.4
Pooled Solifenacin159.2

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Change From Baseline in EuroQoL 5-Dimension Questionnaire Visual Analog Scale

"The participants' quality of life was assessed using the EuroQoL 5 Dimension Questionnaire (EQ-5D) visual analog scale (VAS).~Health status is completed by the participant indicating their own health state today by drawing a line on a vertical 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." (NCT01093534)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Placebo3.60
Solifenacin 5 mg4.80
Solifenacin 10 mg5.10
Pooled Solifenacin4.90

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Percentage of Participants With Improvement or Deterioration 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: ≥ 1 point improvement compared to Baseline; Major Improvement: ≥ 2 point improvement compared to Baseline; Deterioration: ≥ 1 point deterioration compared to Baseline." (NCT01093534)
Timeframe: Baseline and Week 12

,,,
Interventionpercentage of participants (Number)
DeteriorationNo changeImprovementMajor Improvement
Placebo15.434.949.727.4
Pooled Solifenacin5.921.073.142.0
Solifenacin 10 mg5.220.374.544.4
Solifenacin 5 mg6.421.671.939.8

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Change From Baseline in Mean Number of Urgency Incontinence Episodes With PPIUS Grade 3 or 4 Per 24 Hours

"An urgency incontinence episode is defined as any incontinence episode classified by the participant as a grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 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.~The average number of grade 3 or 4 urgency incontinence episodes per 24 hours was calculated from the number of urgency incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits." (NCT01093534)
Timeframe: Baseline and Week 12

Interventionurgency incontinence episodes (Mean)
Placebo-0.71
Solifenacin 5 mg-1.32
Solifenacin 10 mg-0.90
Pooled Solifenacin-1.09

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Change From Baseline in Mean Number of Urgency Incontinence Episodes With PPIUS Grade 4 Per 24 Hours

"An urgency incontinence episode is defined as any incontinence episode classified by the participant as a grade 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 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.~The average number of grade 4 urgency incontinence episodes per 24 hours was calculated from the number of urgency incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits." (NCT01093534)
Timeframe: Baseline and Week 12

Interventionurgency incontinence episodes (Mean)
Placebo-0.70
Solifenacin 5 mg-0.96
Solifenacin 10 mg-0.70
Pooled Solifenacin-0.82

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Percentage of Participants With Improvement and Worsening on the 5 Dimensions of the EQ-5D

"The participants' quality of life was assessed using the EuroQoL 5 Dimension Questionnaire (EQ-5D). The EQ-5D is a standardized instrument for use as a measure of health outcome and is based on the following 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension participants were asked to select the statement which best described their health that day, from level 1 (indicating no problems) to 3 (indicating extreme problems/unable to perform).~Improvement was defined as a change from a state of being unable to perform or extreme problems at Baseline to no problems or to some or moderate problems at Week 12, and from some or moderate problems to no problems.~Worsening was defined as a change from no problems at Baseline to some or moderate problems or to a state of being unable to perform or extreme problems at Week 12, and from some or moderate problems to a state of being unable to perform or extreme problems." (NCT01093534)
Timeframe: Baseline and Week 12

,,,
Interventionpercentage of participants (Number)
Mobility: ImprovementMobility: WorseningSelf-care: ImprovementSelf-care: WorseningUsual Activities: ImprovementUsual Activities: WorseningPain/Discomfort: ImprovementPain/Discomfort: WorseningAnxiety/Depression: ImprovementAnxiety/Depression: Worsening
Placebo6.710.32.42.47.97.915.210.317.010.3
Pooled Solifenacin10.05.33.73.79.38.018.98.018.612.3
Solifenacin 10 mg9.63.43.44.111.04.818.54.819.913.7
Solifenacin 5 mg10.37.13.93.27.711.019.411.017.411.0

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Change From Baseline in Cognitive Function Composite Score - Power of Attention

Cognitive effects were assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time to attain maximum plasma concentration (Tmax) for solifenacin (6 hours) and oxybutynin (2 hours). Power of attention is calculated from the sum of three cognitive function speed tests: Simple Reaction Time, Choice Reaction Time and the Speed of Detections in Digit Vigilance task. A low score reflects a fast reaction time and a high intensity of concentration. A positive change from baseline reflects impairment compared to the baseline assessment. (NCT01126424)
Timeframe: Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.

,,
Interventionmsec (Mean)
Baseline at 2 hours [Oxybutynin Tmax]Change from Baseline at 2 hoursBaseline at 6 hours [Solifenacin Tmax]Change from Baseline at 6 hours
Oxybutynin1423.3817.811405.41-0.74
Placebo1401.211.991393.9811.77
Solifenacin1413.67-5.861421.80-14.80

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Change From Baseline in Cognitive Function Composite Score - Quality of Episodic Secondary Memory

Cognitive effects were assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time of maximum plasma concentration for solifenacin and oxybutynin. Quality of episodic secondary memory is calculated from the sum of 4 tests: Immediate and delayed word recall, and word and picture recognition, and ranges from -200 to 400. A high score reflects a good ability to store, hold and retrieve information of an episodic nature (i.e. an event or a name) and a negative change from baseline reflects impairment compared to baseline. (NCT01126424)
Timeframe: Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.

,,
InterventionScores on a scale (Mean)
Baseline at 2 hours [Oxybutynin Tmax]Change from Baseline at 2 hoursBaseline at 6 hours [Solifenacin Tmax]Change from Baseline at 6 hours
Oxybutynin107.666333-0.917833104.917167-3.502000
Placebo110.0001520.531515106.5150001.589394
Solifenacin111.893636-3.788636101.3634857.728182

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Change From Baseline in Cognitive Function Composite Score - Quality of Working Memory

Cognitive effects were assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time to attain maximum plasma concentration (Tmax) for solifenacin (6 hours) and oxybutynin (2 hours). Quality of working memory is calculated from the sum of two cognitive function sensitivity tests: Numeric Working Memory Sensitivity and Spatial Working Memory Sensitivity, and ranges from -2 to 2. A higher score reflects a good working memory and a negative change from baseline reflects impairment compared to the baseline assessment. (NCT01126424)
Timeframe: Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.

,,
InterventionScores on a scale (Mean)
Baseline at 2 hours [Oxybutynin Tmax]Change from Baseline at 2 hoursBaseline at 6 hours [Solifenacin Tmax]Change from Baseline at 6 hours
Oxybutynin1.7251-0.00431.64410.0633
Placebo1.70870.04921.75480.0047
Solifenacin1.7921-0.08671.66660.0580

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Change From Baseline in Cognitive Function Composite Score - Speed of Memory

Cognitive effects were assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time to attain maximum plasma concentration for solifenacin and oxybutynin. Speed of Memory was calculated from the sum of 4 cognitive function speed tests: numeric and spatial working memory and word and picture recognition. A low score reflects that a person is able to recall a name, a face or any other item fast from the episodic secondary memory; a positive change from baseline reflects impairment compared to baseline. (NCT01126424)
Timeframe: Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.

,,
Interventionmsec (Mean)
Baseline at 2 hours [Oxybutynin Tmax]Change from Baseline at 2 hoursBaseline at 6 hours [Solifenacin Tmax]Change from Baseline at 6 hours
Oxybutynin4545.75-11.564606.51-118.14
Placebo4741.30-240.624655.29-126.04
Solifenacin4505.9624.094496.65-149.79

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Change From Baseline in Postural Stability Test

"The postural stability test measures the ability to stand upright without moving, and was assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time to attain maximum plasma concentration for solifenacin and oxybutynin. Using apparatus modeled on the Wright Ataxia-meter, a cord from the meter is attached to the patient who is required to stand as still as possible with feet apart and eyes closed for 1 minute.~The amount of sway is expressed as the total angular movement, summed regardless of sign, in the antero-posterior plane and calibrated in units of one-third degree of angle of sway. Wright (1971) described a range of 20-30 units as a normal range for adults with eyes wide open, increasing by 50 to 100% with eyes shut." (NCT01126424)
Timeframe: Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.

,,
Intervention1/3 degree of angle of sway (Mean)
Baseline at 2 hours [Oxybutynin Tmax]Change from Baseline at 2 hoursBaseline at 6 hours [Solifenacin Tmax]Change from Baseline at 6 hours
Oxybutynin36.22.738.90.7
Placebo37.50.440.0-0.1
Solifenacin37.75.237.79.9

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Change From Baseline in Cognitive Function Composite Score - Continuity of Attention

Cognitive effects were assessed using a computerized assessment system at time points close to the predicted time of maximum plasma concentration for solifenacin and oxybutynin. For continuity of attention, the number of correct responses (out of 50) for choice reaction time was added to the total number of targets correctly identified (out of 45) digit vigilance minus the number of false alarms (total score of -45 to 95). A high score reflects someone able to keep his/her mind on a single task for a prolonged period. A negative change from baseline reflects impairment compared to baseline. (NCT01126424)
Timeframe: Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.

,,
InterventionScores on a scale (Mean)
Baseline at 2 hours [Oxybutynin Tmax]Change from Baseline at 2 hoursBaseline at 6 hours [Solifenacin Tmax]Change from Baseline at 6 hours
Oxybutynin91.3000.15091.9010.100
Placebo91.3640.90991.728-0.045
Solifenacin91.5910.54591.228-0.318

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Change From Baseline in Score on OABq-SF

Values for the Overactive Bladder Questionnaire Short Form (OABq-SF) are changes from baseline in the adjusted mean scores for months 1 to 6. Scores on the OABq-SF range from 0 to 100, with higher scores on the symptom-severity scale indicating greater severity of symptoms and higher scores on the quality-of-life scale indicating better quality of life. Data were available for 123 participants in the Standardized Anticholinergic Regimen group and 119 in the Botox A A group. (NCT01166438)
Timeframe: Baseline through 6 months

,
InterventionChange from baseline in score on OABq-SF (Mean)
OABq-SF Symptom Severity ScoreOABq-SF Quality of Life Score
Botox A-44.0837.13
Standardized Anticholinergic Regimen-44.5537.05

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Change in PFDI-SF and PFIQ-SF Total Scores

Values for Pelvic Floor Distress Inventory Short Form (PFDI-SF) are changes from baseline in the adjusted mean scores for months 3 to 6. Scores on the PFDI-SF range from 0 to 300, with higher scores indicating more symptoms and more bothersome symptoms. Values for the Pelvic Floor Impact Questionnaire Short Form (PFIQ-SF) are changes from baseline in the adjusted mean scores for months 3 to 6. Scores on the PFIQ-SF range from 0 to 300, with higher scores indicating a more negative effect on activities, relationships, and feelings. (NCT01166438)
Timeframe: Baseline through 6 months

,
InterventionChanges in adjusted mean scores (Mean)
Change from baseline in PFDI-SF total scoreChange from baseline in PFIQ-SF total score
Botox A-48.20-33.85
Standardized Anticholinergic Regimen-43.69-32.82

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Change in Urge Urinary Incontinence (UUI) Episodes

Change from baseline in mean number of UUI episodes over 6 month double-blind period. (NCT01166438)
Timeframe: Baseline through 6 months

,
InterventionMean change in UUI episodes from baselin (Mean)
1 Month2 Months3 Months4 Months5 Months6 Months
Botox A-3.13-3.32-3.22-3.36-3.42-3.27
Standardized Anticholinergic Regimen-3.15-3.25-3.55-3.40-3.49-3.33

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Efficacy

Efficacy outcomes assessed reduction and resolution of incontinence, including urgency urinary incontinence (UUI). (NCT01166438)
Timeframe: 6 months

,
InterventionParticipants (Count of Participants)
Complete resolution of UUIComplete resolution of all incontinence>75% reduction in UUI episodes
Botox A302661
Standardized Anticholinergic Regimen161348

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Patient Global Impression of Improvement

The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had adequate improvement, defined as a rating of 1 or 2 (much better). (NCT01166438)
Timeframe: 3 and 6 months

,
InterventionParticipants (Count of Participants)
Month 3Month 6
Botox A6160
Standardized Anticholinergic Regimen5967

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Time to Continence

Days to zero pad continence were assessed by patient self-reported Pad free continence declaration card. (NCT01215721)
Timeframe: 12 months

InterventionDays to Continence (Median)
Vesicare, 5mg Treatment Group95

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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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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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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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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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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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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 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 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 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 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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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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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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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 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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Percentage of Participants Who Gain Continence During 12-week Treatment Period

"Urinary continence is defined as three consecutive 24-hour days in which a participant uses no pads or a pad for security which remains completely dry. Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period.~End of treatment is the last on-treatment assessment during the treatment period." (NCT01371994)
Timeframe: Weeks 4, 8, and 12

,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12End of Treatment
Placebo10.418.819.121.4
Solifenacin Succinate11.821.126.529.1

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Baseline Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment

Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent overall work impairment takes into account both hours missed due to urinary leakage and the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity. (NCT01371994)
Timeframe: Baseline

Interventionpercent overall work impairment (Mean)
Placebo42.5
Solifenacin Succinate44.8

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Baseline Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed

Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent work time missed is derived from the number of hours of work missed due to urinary leakage as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. (NCT01371994)
Timeframe: Baseline

Interventionpercent work time missed (Mean)
Placebo43.6
Solifenacin Succinate37.9

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International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score at Baseline

The ICIQ-SF is a validated self-administered questionnaire designed for patients with urinary incontinence. The ICIQ-SF assessed urinary incontinence using 3 scored questions which ask patients about their frequency of urine leakage, how much urine leakage, and perceived impact of leakage on daily lives over the past 4 weeks. The ICIQ-SF is a sum of the 3 scores and ranges from 0 (low bother) to 21 (maximum bother). (NCT01371994)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Placebo14.1
Solifenacin Succinate13.8

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Time From Baseline to First Day of Returning to Work

The time from Baseline to first day of returning to work was estimated using the Kaplan-Meier method. (NCT01371994)
Timeframe: From Baseline to Week 12

Interventiondays (Median)
Placebo5.0
Solifenacin Succinate5.0

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Change From Baseline in American Urology Association Quality of Life (QOL) Score

"The American Urology Association (AUA) includes a single bother question which asked participants how they would feel if they had to live with their urinary condition the way it is now for the rest of their life. The bother question score ranges from 0 (delighted) to 6 (terrible).~End of treatment is the last on-treatment assessment during the treatment period." (NCT01371994)
Timeframe: Baseline and Week 12

,
Interventionunits on a scale (Least Squares Mean)
Week 12 (n=261, 276)End of treatment (n=292, 306)
Placebo-1.9-1.8
Solifenacin Succinate-2.1-2.0

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Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment

Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent overall work impairment takes into account both hours missed due to urinary leakage and the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement. (NCT01371994)
Timeframe: Baseline and Week 12

,
Interventionpercent overall work impairment (Least Squares Mean)
Week 12 (n= 59, 69)End of treatment (n=65, 79)
Placebo-30.4-30.0
Solifenacin Succinate-33.7-31.1

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Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment

Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent activity impairment is derived from the participant's assessment of the degree to which their urinary leakage affected their regular daily activities. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement. (NCT01371994)
Timeframe: Baseline and Week 12

,
InterventionPercent activity impairment (Least Squares Mean)
Week 12 (n=115, 129)End of treatment (n=124, 145)
Placebo-28.2-28.4
Solifenacin Succinate-30.2-28.8

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Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score

The ICIQ-SF is a validated self-administered questionnaire designed for patients with urinary incontinence. The ICIQ-SF assessed urinary incontinence using 3 scored questions which ask patients about their frequency of urine leakage, how much urine leakage, and perceived impact of leakage on daily lives over the past 4 weeks. The ICIQ-SF is a sum of the 3 scores and ranges from 0 (low bother) to 21 (maximum bother). (NCT01371994)
Timeframe: Baseline and Week 12

,
Interventionunits on a scale (Least Squares Mean)
Week 12 (n=262, 277)End of treatment (n=292, 307)
Placebo-5.7-5.5
Solifenacin Succinate-6.2-6.0

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Change From Baseline in Average Daily Pad Usage

"Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period. A 7-day window was used to calculate the average daily pad usage.~End of treatment is the last on-treatment assessment during the treatment period." (NCT01371994)
Timeframe: Baseline and Weeks 4, 8 and 12

,
Interventionpads (Least Squares Mean)
Week 4 (n=297, 302)Week 8 (n=280, 292)Week 12 (n=226, 226)End of treatment (n=298, 302)
Placebo-1.9-2.5-3.1-2.9
Solifenacin Succinate-2.0-2.8-3.4-3.2

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Change From Baseline in American Urology Association Symptom Score (AUASS)

"Quality of life was measured by the American Urology Association Symptom Score (AUASS). The AUASS includes 7 questions addressing symptoms of frequency, urgency, nocturia (waking during the night to urinate), hesitancy, weak urinary, incomplete emptying, and intermittence. The questionnaire asked participants to consider how these symptoms affected them over the past month on a scale from 0 (not at all) to 5 (almost always).~The AUASS Symptom Score is a sum of the 7 symptom scores and ranges from 0 (best) to 35 (worst).~End of treatment is the last on-treatment assessment during the treatment period." (NCT01371994)
Timeframe: Baseline and Week 12

,
Interventionunits on a scale (Least Squares Mean)
Week 12 (n=262, 277)End of treatment (n=293, 307)
Placebo-7.7-7.4
Solifenacin Succinate-8.0-7.7

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American Urology Association Symptom Score (AUASS) at Baseline

"Quality of life was measured by the American Urology Association Symptom Score (AUASS). The AUASS includes 7 questions addressing symptoms of frequency, urgency, nocturia (waking during the night to urinate), hesitancy, weak urinary, incomplete emptying, and intermittence. The questionnaire asked participants to consider how these symptoms affected them over the past month on a scale from 0 (not at all) to 5 (almost always).~The AUASS is a sum of the 7 symptom scores and ranges from 0 (best) to 35 (worst)." (NCT01371994)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Placebo16.7
Solifenacin Succinate16.2

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Time From First Dose to Urinary Continence

Urinary continence is defined as the first of three consecutive 24-hour days in which a participant uses no pads, or a pad for security which remains completely dry, during the 12-week treatment period. Participants recorded their daily pad usage in an electronic diary. Kaplan-Meier curves were used to estimate the distribution of cumulative incidence of urinary continence over the 12-week study treatment period. Participants who did not experience the event during the 12-week treatment period were considered as censored at the End of Treatment (EOT) visit or Week 12, whichever occurs first. (NCT01371994)
Timeframe: 12 weeks

Interventiondays (Median)
PlaceboNA
Solifenacin SuccinateNA

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Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed

Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent work time missed is derived from the number of hours of work missed due to urinary leakage 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. (NCT01371994)
Timeframe: Baseline and Week 12

,
InterventionPercent work time missed (Least Squares Mean)
Week 12 (n= 81, 88)End of treatment (n=88, 102)
Placebo-37.9-36.8
Solifenacin Succinate-37.6-34.4

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Baseline Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working

Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent impairment while working was derived from the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity. (NCT01371994)
Timeframe: Baseline

Interventionpercent impairment while working (Mean)
Placebo35.5
Solifenacin Succinate34.1

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Baseline Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment

Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent activity impairment is derived from the participant's assessment of the degree to which their urinary leakage affected their regular daily activities. A higher percentage indicates greater impairment and less productivity. (NCT01371994)
Timeframe: Baseline

Interventionpercent activity impairment (Mean)
Placebo41.6
Solifenacin Succinate41.4

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Average Daily Pad Usage at Baseline

Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period. A 7-day window was used to calculate the average daily pad usage. (NCT01371994)
Timeframe: Baseline (7 days prior to Day 1)

Interventionpads (Mean)
Placebo5.0
Solifenacin Succinate4.7

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American Urology Association Quality of Life (QOL) Score at Baseline

The American Urology Association (AUA) includes a single bother question which asked participants how they would feel if they had to live with their urinary condition the way it is now for the rest of their life. The bother question score ranges from 0 (delighted) to 6 (terrible). (NCT01371994)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Placebo4.8
Solifenacin Succinate4.7

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Change From Baseline in Work Productivity Assessment Index (WPAI): Percent Impairment While Working

Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent impairment while working was derived from the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement. (NCT01371994)
Timeframe: Baseline and Week 12

,
Interventionpercent impairment while working (Least Squares Mean)
Week 12 (n=66, 80)End of treatment (n=72, 91)
Placebo-21.8-20.8
Solifenacin Succinate-23.8-21.8

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Change in Post-ureteroscopy Stent-induced Pain

Measured through the use of the ureteral stent symptom questionnaire. Patients reported pain on a scale of 0 to 10 (0 being the absence of pain and 10 being the most excruciating pain of their life). The questionnaire was administered a couple days post-op and once again several weeks later. The mean difference (baseline minus 3 months) on this continuous scale was used for this outcome measure. (NCT01381120)
Timeframe: Baseline and 3 months.

Interventionunits on a scale (Mean)
VESIcare + Narcotic Painkiller4.61
Narcotic Painkiller3.11

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Change in Post-ureteroscopy Stent-induced Lower Urinary Tract Symptoms.

Measured through the use of the ureteral stent symptom questionnaire. Patients reported symptoms on a scale of 1 to 5 (1 being the absence of symptoms and 5 being very debilitating symptoms). The questionnaire was administered a couple days post-op and once again several weeks later. The mean difference (baseline minus 3 months) on this continuous scale was used for this outcome measure. (NCT01381120)
Timeframe: Baseline and three months.

Interventionunits on a scale (Mean)
VESIcare + Narcotic Painkiller1.90
Narcotic Painkiller1.13

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Change From Baseline in Urinary Growth Factor to Creatinine Ratio (GF/Cr)

The urinary growth factor (GF) to creatinine ratio may be potential biomarker for overactive bladder, based on published articles. Measuring the ratio at baseline and Month 3, comparing the difference after treatment with tamsulosin and solifenacin which may provide insight into how lower urinary tract symptoms in men progresses. (NCT01457573)
Timeframe: change from baseline score to Month 3

Interventionratio (Mean)
Baseline Characteristics-19.61

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Change in Post Void Residual (mL) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12

Urine sample tested for urinary post void residual (measured in mL) at baseline (pre-dose), Month 1 and Month 2and week 12/Month 3 post-dose, post dose w/tamsulosin and solifenacin. (NCT01457573)
Timeframe: Change from baseline to months 1, 2 and 3

Interventionml (Mean)
Change at Month 1Change at Month 2Change at Month 3
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg-6.90-10.00-3.60

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Change in PBC-Patient Perception of Bladder Condition at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12

Change in the Perception of Bladder through a self administered survey at baseline compared to Month 1, Month 2, and Month 3, following exposure to tamsulosin and solifenacin. The survey score measures from zero to 6, with 6 being the most bothersome bladder symptoms and 0 to 1 being the least bothersome. (NCT01457573)
Timeframe: Change from baseline to months 1, 2 and 3

Interventionunits on a scale (Mean)
Change at Month 1Change at Month 2Change at Month 3
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg1.290.290.00

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Change in PPUS-Patient Perception of Urinary Urgency Survey Score at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12

The Patient Perception of Urinary Urgency self administered survey score has a maximum score 4, zero to four, for how severe a patient describes their urinary voiding frequency. Four is the most bothersome score, 0 or 1 is the least bothersome. Pre-dose / baseline score is compared at Month 1, Month 2, and Month 3, after dosing with tamsulosin and solifenacin. (NCT01457573)
Timeframe: Change from baseline to months 1, 2 and 3

Interventionunits on a scale (Mean)
Change at Month 1Change at Month 2Change at Month 3
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg0.000.300

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Change in Urinary Growth Factor to Creatinine Ratio (GF/Cr) From Baseline Compared to Month 1/Week4 and Month 2/Week 8.

Assessing the change from baseline to Month 1/Week 4 and Month 2/Week 8, of the urinary growth factor (GF) to creatinine ratio in men, which may be potential biomarker for overactive bladder, based on published articles. Measuring the ratio at baseline compared to Month 1 and Month 2 may provide insight into how lower urinary tract symptoms in men progresses. (NCT01457573)
Timeframe: change from baseline score to Mo.1/Wk4 and Mo.2/Wk8 scores

Interventionratio (Mean)
Change at Month 1Change at Month 2
Baseline Characteristics-21.85-20.56

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Change in Maximum Urinary Flow Rate (ml/s) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12

Urination flow rate (measured in milliliters per second) at baseline (pre-dose), and Month 1, Month 2, and Month 3/Week 12 pose-dosing with tamsulosin and solifenacin. An average maximum urinary flow rate in males is 21 ml/sec aged 14-45 years-old and 12 ml/sec in males aged 46-65 years-old. (NCT01457573)
Timeframe: Change from baseline to months 1, 2 and 3

Interventionml/s (Mean)
Change at Month 1Change at Month 2Change at Month 3
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg-3.20-3.90-4.70

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Change in IPSS-International Prostate Score Scale at Baseline Compared to Post Dose Survey at Month 1, 2, and Month 3/Week12.

The survey, IPSS-International Prostate Score Scale, survey responses measured 0-35, is collected at baseline compared to post dose survey response at Month 1, Month 2, and Month 3/Week12 post-dose. The lower the score is indicative of less or fewer urinary symptoms while 35 is consistent with more bothersome symptoms. (NCT01457573)
Timeframe: Change from baseline to months 1, 2 and 3

Interventionunits on a scale (Mean)
Change at Month 1Change at Month 2Change at Month 3
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg-2.00-5.30-7.33

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Change in ICIQ-MLUTS - International Consultation on Incontinence Modular Questionnaire for Male LUTS Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12

Measuring change in the International Consultation on Incontinence Modular Questionnaire for male lower urinary tract symptoms through a self administered survey at baseline compared to Month 1, Month 2, and Month 3, after exposure to tamsulosin and solifenacin. The survey score is a zero to 182 range with 182 being the most bothersome and zero to one being the least bothersome. (NCT01457573)
Timeframe: Change from baseline to months 1, 2 and 3

Interventionunits on a scale (Mean)
Change at Month 1Change at Month 2Change at Month 3
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg-22.40-22.20-29.8

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Change in ICIQ LUTS QoL -International Consultation on Incontinence Modular Questionnaire LUTS Quality of Life for Male LUTS Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12

Change in the International Consultation on Incontinence Modular Questionnaire on lower urinary tract symptoms quality of life survey for men, self administered, compared to Month 1, Month 2, and Month 3, after exposure to tamsulosin and solifenacin. The survey scoring is zero to 182, with 182 being the most bothersome and 0 to 1 being the least bothersome. (NCT01457573)
Timeframe: Change from baseline to months 1, 2 and 3

Interventionunits on a scale (Mean)
Change at Month 1Change at Month 2Change at Month 3
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg34.6038.30-9.00

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Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.1/Wk4 and Mo.2/Wk8

Urine sample tested for urinary Nerve Growth Factor (uNGF as measured in pg/mL), a small secreted protein in the bladder that supports bladder function regulation, at baseline (pre-dose) compared to Month 1/Week 4 and Month 2/Week 8, post dosing with tamsulosin and solifenacin. (NCT01457573)
Timeframe: Change from baseline to Mo.1/Wk4 and Mo.2/Wk8

Interventionpg/ml (Mean)
Change at Month 1Change at Month 2
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg11.1715.64

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Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.3/Wk12

Urine sample tested for urinary Nerve Growth Factor (uNGF as measured in pg/mL), a small secreted protein in the bladder that supports bladder function regulation, at baseline (pre-dose) and week 12/Month 3 post-dose, after using daily tamsulosin and solifenacin. (NCT01457573)
Timeframe: Change from baseline to week 12 (3 months)

Interventionpg/ml (Mean)
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg-10.9

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Change in Patients Perspective of the Impact of Their Disease, Captured Using the Pelvic Floor Distress Inventory (Urinary Questions)

"The difference between baseline and follow up (last 20 days on drug) scores was the recorded measure. The larger the negative # the greater the effect.~The survey was divided into 3 sections, each section worth 100 points. Total scores could range from 0 to 300 (0 no disease, 300 severe disease)." (NCT01470001)
Timeframe: outcome measures will be assessed at week 0 (baseline), and compared to an average measure of the last 20 days on placebo or treatment

Interventionchange in score (Mean)
Solifenacin-35.12
Placebo-28.84

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the Percent of Patients With at Least 50% Reduction in Post Void Dribbling Episodes

(NCT01470001)
Timeframe: outcome measures will be assessed at week 0 (baseline), and compared to an average measure of weeks 10 through 12

Interventionpercent (Number)
Solifenacin69.8
Placebo55.5

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The Percent Reduction in Post Void Dribbling Episodes (Events)

(NCT01470001)
Timeframe: outcome measures will be assessed at week 0 (baseline), and compared to an average measure of weeks 10 through 12

Interventionpercent reduction (Mean)
Solifenacin59.8
Placebo42.1

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Change in Mean Number of Micturition Episodes Per 24 Hours

(NCT01533597)
Timeframe: at week 24 relative to baseline

Interventionepisodes (Mean)
Solifenacin-1.9
Solifenacin Plus Tamsulosin-2.2

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Change in Score of IPSS

Total Score of IPSS(International Prostate Symptom Score) is the sum of 7 questions, ranging from 0 (best possible outcome) to 35 (worst possible outcome). The 7 symptom questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 for a total of maximum 35 points. (NCT01533597)
Timeframe: at week 24 relative to baseline

Interventionunits on a scale (Mean)
Solifenacin-7.7
Solifenacin Plus Tamsulosin-8.3

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Change of PVR

Change from baseline in Post-Void Residual (PVR) volume (NCT01533597)
Timeframe: at week 24 relative to baseline

InterventionmL (Mean)
Solifenacin13.2
Solifenacin Plus Tamsulosin10.8

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Change of Qmax

maximal urinary flow rate (Qmax) assessed by uroflowmetry (NCT01533597)
Timeframe: at week 24 relative to baseline

InterventionmL/sec (Mean)
Solifenacin1.1
Solifenacin Plus Tamsulosin2.1

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Numeric Change of Urgency Episodes Per 24 Hours

(NCT01533597)
Timeframe: at week 24 relative to baseline

Interventionepisodes (Mean)
Solifenacin-2.4
Solifenacin Plus Tamsulosin-2.1

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Change in Total Score of OABSS

Total Score of OABSS(Overactive Bladder Symptom Score) is the sum of 4 questions, ranging from 0 (best possible outcome) to 15 (worst possible outcome) (NCT01533597)
Timeframe: at week 24 relative to baseline

Interventionunits on a scale (Mean)
Solifenacin-3.1
Solifenacin Plus Tamsulosin-3.5

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Change in Overall Sexual Satisfaction Among Healthy Male Partners

Healthy male partners of female participants complete the Golombok Rust Inventory of Sexual Satisfaction (GRISS) survey. For this outcome, their baseline score is subtracted from their follow-up score which is collected after their female partner completes approximately 12-16 weeks of solifenacin treatment for UUI symptoms. This change score is compared between male partners of female participants who respond to solifenacin versus male partners of female participants who do not respond to solifenacin. The GRISS is a 28-item self-administered questionnaire that assess the quality of the sexual relationship of a heterosexual couple. Scores range from 0 to 10 with higher scores indicating greater sexual dysfunction. (NCT01559389)
Timeframe: Baseline and 12-16 weeks

Interventionscore on a scale (Median)
Male Partners of Female Responders0
Male Partners of Female Non-Responders0

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Baseline Sexual Satisfaction Between Matched Female and Male Partners

Prior to beginning treatment with solifenacin, females presenting with UUI complete the Golombok Rust Inventory of Sexual Satisfaction (GRISS). Their male partners also complete the GRISS at the baseline visit. The GRISS is a 28-item self-administered questionnaire that assess the quality of the sexual relationship of a heterosexual couple. Scores range from 0 to 10 with higher scores indicating greater sexual dysfunction. (NCT01559389)
Timeframe: 0 Weeks

Interventionscore on a scale (Mean)
Females With UUI4.2
Male Partners4.8

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Change in Overall Sexual Satisfaction Among Females

Females presenting with UUI complete the Golombok Rust Inventory of Sexual Satisfaction (GRISS) at baseline (0 weeks) and after 12-16 weeks of treatment with solifenacin. For this outcome, the baseline score is subtracted from the follow-up score and this change score is compared between those who respond and do not respond to treatment with solifenacin. The GRISS is a 28-item self-administered questionnaire that assess the quality of the sexual relationship of a heterosexual couple. Scores range from 0 to 10 with higher scores indicating greater sexual dysfunction. (NCT01559389)
Timeframe: Baseline and 12-16 weeks

Interventionscore on a scale (Median)
Responder-0.5
Non-Responder0

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Change From Baseline to Last Possible Titration Step in Maximum Cystometric Capacity

During urodynamic assessments, the bladder was filled until voiding/leakage begins, or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. MCC is the maximum bladder capacity reached during filling cystometry before either leakage or pain/discomfort was observed. Based on study requirements, the last possible titration step was Week 9 for participants enrolled under versions 1.0 and 1.1 and Week 12 under later versions. (NCT01565694)
Timeframe: Baseline, Week 9 or Week 12

InterventionmL (Mean)
Solifenacin Succinate57.4

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Change From Baseline in Average Catheterized Volume Per Catheterization

The average catheterized volume per catheterization was calculated using all available (non-zero) catheterized volumes recorded over both of the 2 measuring days in the diary, whether or not these 2 days are concurrent. (NCT01565694)
Timeframe: Baseline to Week 24

InterventionmL (Mean)
Change from Baseline Week 24Change from Baseline Week 24 (LOCF)
Solifenacin Succinate46.2348.86

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Change From Baseline in Average First Morning Catheterized Volume

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 diary, whether or not these 2 days are concurrent. (NCT01565694)
Timeframe: Baseline to Week 24

InterventionmL (Mean)
Change from Baseline Week 24Change from Baseline Week 24 (LOCF)
Solifenacin Succinate43.2444.21

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Change From Baseline in Bladder Compliance

Bladder compliance gives 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. (NCT01565694)
Timeframe: Baseline and Week 24

InterventionmL/cmH2O (Mean)
Change from Baseline Week 24Change from Baseline Week 24 (LOCF)
Solifenacin Succinate9.18.8

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Change From Baseline in Bladder Volume at 40 cmH2O Detrusor Pressure

Bladder volumes at 40 cm H2O detrusor pressure were calculated using urodynamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the subject experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. (NCT01565694)
Timeframe: Baseline and Week 24

InterventionmL (Mean)
Change from Baseline Week 24Change from Baseline Week 24 (LOCF)
Solifenacin Succinate67.054.4

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Change From Baseline in Detrusor Pressure at the End of Bladder Filling

The bladder was filled until voiding/leakage began or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. Pressure was recorded for an extra 5 minutes after leakage began or the end of bladder-filling, whichever is sooner. (NCT01565694)
Timeframe: Baseline to Week 24

InterventioncmH2O (Mean)
Change from Baseline Week 24Change from Baseline Week 24 (LOCF)
Solifenacin Succinate-9.2-8.2

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Change From Baseline in Maximum Catheterized Volume

The maximum catheterized volume per day was calculated using all available (non-zero) catheterized volumes recorded for the 2 measuring days in the diary, whether or not these 2 days were concurrent. The maximum value was calculated separately for each measuring day and the mean of these two values was used. (NCT01565694)
Timeframe: Baseline to Week 24

InterventionmL (Mean)
Change from Baseline Week 24Change from Baseline Week 24 (LOCF)
Solifenacin Succinate67.4569.63

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

The mean of the number of incontinence episodes per 24h was calculated as the mean over the valid diary days in the 7-day diary. (NCT01565694)
Timeframe: Baseline to Week 24

InterventionIncontinence Episodes (Mean)
Change from Baseline Week 24Change from Baseline Week 24 (LOCF)
Solifenacin Succinate-1.60-1.62

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Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days

The number of incontinence-free days was calculated from the 7-day micturition diary. (NCT01565694)
Timeframe: Baseline to Week 24

InterventionDays (Mean)
Change from Baseline Week 24Change from Baseline Week 24 (LOCF)
Solifenacin Succinate1.061.19

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Change From Baseline in Number of Dry (Incontinence-Free) Nights Per 7 Days

The number of incontinence-free nights was calculated from the 7-day micturition diary. (NCT01565694)
Timeframe: Baseline to Week 24

InterventionNights (Mean)
Change from Baseline Week 24Change from Baseline Week 24 (LOCF)
Solifenacin Succinate1.601.64

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Change From Baseline in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until End of Bladder Filling

"Change from baseline in number of overactive detrusor contractions until end of bladder filling was measured by urodynamic testing. If leakage occurred, the Detrusor pressure at leakage was recorded otherwise the volume of fluid instilled into the bladder was recorded." (NCT01565694)
Timeframe: Baseline to Week 24

InterventionDetrusor Contractions (Mean)
Change from Baseline Week 24Change from Baseline Week 24 (LOCF)
Solifenacin Succinate-2.3-1.8

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Change From Baseline in Quality of Life [QoL] (PinQ Questionnaire Score)

Pediatric Incontinence Questionnaire (PinQ) is a 20-item questionnaire addressing quality of life for participants with bladder disorders. Each question was answered on a scale from 0 (no, never) to 4 (all the time). The total score ranged from 0 to 80, with higher scores indicated more impact on the quality of life. (NCT01565694)
Timeframe: Baseline to Week 24

InterventionUnits on a Scale (Mean)
Change from Baseline Week 24Change from Baseline Week 24 (LOCF)
Solifenacin Succinate-0.7-0.7

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Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC)

During urodynamic assessments, the bladder was filled until voiding/leakage begins, or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. MCC is the maximum bladder capacity reached during filling cystometry before either leakage or pain/discomfort was observed. (NCT01565694)
Timeframe: Baseline and Week 24

InterventionmL (Mean)
Change from Baseline Week 24Change from Baseline Week 24 (LOCF)
Solifenacin Succinate57.259.3

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Number of Participants With Adverse Events

A treatment-emergent adverse event (TEAE) was defined as an adverse event observed after starting administration of the first dose of study medication on Day 1. All adverse events collected within 7 days after taking the last dose of study drug were counted as a TEAE. (NCT01565694)
Timeframe: Baseline to End of Study Visit (Week 52)

InterventionParticipants (Count of Participants)
TEAEsDrug related TEAEDeathsSerious TEAEsDrug related Serious TEAEsTEAEs Leading to DiscontinuationDrug related TEAEs Leading to Discontinuation
Solifenacin Succinate511507043

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Change From Baseline in Bladder Volume at 30 cmH2O Detrusor Pressure

Bladder volumes at 30 cm H2O detrusor pressure was calculated using the urodynamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the participants experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. (NCT01565694)
Timeframe: Baseline and Week 24

InterventionmL (Mean)
Change from Baseline Week 24Change from Baseline Week 24 (LOCF)
Solifenacin Succinate61.871.9

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Change From Baseline in Bladder Volume (mL) Until First Detrusor Contraction > 15 cmH2O as a Percentage of Expected Bladder Capacity (EBC)

Change from baseline in the bladder volume was calculated using urodyanamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the subject experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. If no detrusor contraction of at least 15 cmH2O occurs, the bladder volume was imputed with MCC. (NCT01565694)
Timeframe: Baseline and Week 24

InterventionPercentage of EBC (Median)
Solifenacin Succinate23.10

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

The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence. Daytime is defined as the time between waking up in the morning and going to bed later the same day. (NCT01565707)
Timeframe: Baseline and week 12

Interventiondaytime micturitions (Least Squares Mean)
Placebo Children-1.1
Solifenacin Succinate Suspension Children-1.2
Placebo Adolescents-0.5
Solifenacin Succinate Suspension Adolescents-0.3

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Area Under the Plasma Concentration - Time to Curve (AUC) for a Dose Interval (AUCtau) of Solifenacin

Pharmacokinetic sampling was performed at steady state at the end of treatment. (NCT01565707)
Timeframe: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).

Interventionng*h/mL (Mean)
Children PED 5298.7
Children PED 7.5452.8
Adolescents PED 7.5269.2
Children PED 10560
Adolescents PED 10745.7

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Change From Baseline in Post Void Residual (PVR) Volume

Post Void Residual (PVR) Volume was assessed by ultrasonography or bladder scan. (NCT01565707)
Timeframe: Baseline and Week 12

InterventionmL (Least Squares Mean)
Placebo Children0.07
Solifenacin Succinate Suspension Children-0.99
Placebo Adolescents-3.58
Solifenacin Succinate Suspension Adolescents0.95

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

The mean voided volume was calculated from the participant diary data recorded during two measuring days (i.e., those days when the participant recorded the volume of each micturition) in the 7 days prior to the baseline and end of treatment visits. The MVV is equal to the mean of the non-zero volumes recorded over the 2 measuring days. A micturition is any voluntary urination, excluding episodes of incontinence. (NCT01565707)
Timeframe: Baseline and Week 12

InterventionmL (Least Squares Mean)
Placebo Children13.4
Solifenacin Succinate Suspension Children25.5
Placebo Adolescents6.9
Solifenacin Succinate Suspension Adolescents2.3

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Change From Baseline to End of Treatment in Daytime Maximum Volume Voided (DMaxVV) Per Micturition

The mean daytime maximum volume voided (DMaxVV) was determined using the participant diary data recorded during two measuring days (i.e., those days when the participant recorded the volume of each micturition) in the 7 days prior to the Baseline and end of treatment visits. The daytime maximum volume voided (DMaxVV) is the largest (non-zero) volume recorded over both of the 2 measuring days in the diary. The first morning void is excluded from the calculation. Daytime is defined as the time between waking up in the morning and going to bed later the same day. A micturition is any voluntary urination, excluding episodes of incontinence. (NCT01565707)
Timeframe: Baseline and Week 12

InterventionmL (Least Squares Mean)
Placebo Children11.3
Solifenacin Succinate Suspension Children43.2
Placebo Adolescents-8.4
Solifenacin Succinate Suspension Adolescents-25.7

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

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 end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine. Daytime is defined as the time between waking up in the morning and going to bed later the same day. (NCT01565707)
Timeframe: Baseline and Week 12

Interventiondaytime incontinence episodes (Least Squares Mean)
Placebo Children-1.1
Solifenacin Succinate Suspension Children-1.2
Placebo Adolescents-0.2
Solifenacin Succinate Suspension Adolescents-0.8

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Number of Participants With Adverse Events (AEs)

A treatment emergent adverse event (TEAE) was defined as an AE that occurred after the first dose of study drug and within 7 days after last dose of study medication. (NCT01565707)
Timeframe: From the first dose of study drug until 7 days after last dose of study medication (13 weeks).

,,,
Interventionparticipants (Number)
Any TEAEDrug Related TEAEsDeathsSerious TEAEsDrug-related Serious TEAEsTEAEs Leading to DiscontinuationDrug-related TEAEs Leading to Permanent Discont.
Placebo Adolescents12201021
Placebo Children45902111
Solifenacin Succinate Suspension Adolescents9301021
Solifenacin Succinate Suspension Children441402063

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Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Days Per 7 Days

The mean number of dry days was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine. (NCT01565707)
Timeframe: Baseline and Week 12

InterventionDry Days (Least Squares Mean)
Placebo Children1.7
Solifenacin Succinate Suspension Children1.3
Placebo Adolescents1.5
Solifenacin Succinate Suspension Adolescents1.6

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Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Nighttimes Per 7 Days

The mean number of dry nights was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine. (NCT01565707)
Timeframe: Baseline and Week 12

InterventionDry Nights (Least Squares Mean)
Placebo Children0.7
Solifenacin Succinate Suspension Children0.4
Placebo Adolescents-0.1
Solifenacin Succinate Suspension Adolescents0.4

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Change From Baseline to End of Treatment in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents

Adolescent participants were asked to record the degree of urgency associated with each micturition and incontinence episode according to the Patient Perception of Intensity of Urgency Scale (PPIUS) scale (0 - no urgency, 1 - mild urgency, 2 - moderate urgency, 3 - severe urgency, 4 - urge incontinence). The mean number of grade 3 or 4 urgency episodes was determined using using diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. (NCT01565707)
Timeframe: Baseline and Week 12

Interventionurgency episodes (Least Squares Mean)
Placebo Adolescents-0.7
Solifenacin Succinate Suspension Adolescents-1.0

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

An incontinence episode is defined as an episode with any involuntary loss of urine. 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 end of treatment visit. (NCT01565707)
Timeframe: Baseline and Week 12

Interventionincontinence episodes (Least Squares Mean)
Placebo Children-1.2
Solifenacin Succinate Suspension Children-1.1
Placebo Adolescents-0.7
Solifenacin Succinate Suspension Adolescents-0.6

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

The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence. (NCT01565707)
Timeframe: Baseline and Week 12

Interventionmicturitions (Least Squares Mean)
Placebo Children-0.8
Solifenacin Succinate Suspension Children-1.1
Placebo Adolescents-0.6
Solifenacin Succinate Suspension Adolescents-0.4

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

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 end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine. Nighttime is defined as the time between going to bed and waking up the following morning. (NCT01565707)
Timeframe: Baseline and Week 12

Interventionnighttime incontinence episodes (Least Squares Mean)
Placebo Children-0.2
Solifenacin Succinate Suspension Children-0.1
Placebo Adolescents-0.2
Solifenacin Succinate Suspension Adolescents-0.2

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

The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence. Nighttime is defined as the time between going to bed and waking up the following morning. (NCT01565707)
Timeframe: Baseline and Week 12

Interventionnighttime micturitions (Least Squares Mean)
Placebo Children0.0
Solifenacin Succinate Suspension Children-0.1
Placebo Adolescents0.4
Solifenacin Succinate Suspension Adolescents0.1

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Maximum Concentration (Cmax) of Solifenacin

Pharmacokinetic sampling was performed at steady state at the end of treatment. Cmax could not be calculated for 2 children and 1 adolescent in the Pharmacokinetic Analysis Set (PKAS). (NCT01565707)
Timeframe: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).

Interventionng/mL (Mean)
Children PED 516.67
Children PED 7.526.24
Adolescents PED 7.517.08
Children PED 1033.48
Adolescents PED 1042.85

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Plasma Concentration Before Drug Administration (Ctrough) of Solifenacin

Pharmacokinetic sampling was performed at steady state at the end of treatment. Ctrough could not be calculated for 2 children and 1 adolescent in the PKAS. (NCT01565707)
Timeframe: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).

Interventionng/mL (Mean)
Children PED 59.534
Children PED 7.516.1
Adolescents PED 7.58.828
Children PED 1019.05
Adolescents PED 1027.94

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Time to Attain Maximum Concentration (Tmax) of Solifenacin

Pharmacokinetic sampling was performed at steady state at the end of treatment. Tmax could not be calculated for 2 children and 1 adolescent in the PKAS. (NCT01565707)
Timeframe: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).

Interventionhours (Mean)
Children PED 52.933
Children PED 7.53.175
Adolescents PED 7.52.8
Children PED 102.874
Adolescents PED 102.85

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Apparent Terminal Elimination Half-Life (T1/2) of Solifenacin

Pharmacokinetic sampling was performed at steady state at the end of treatment. (NCT01565707)
Timeframe: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).

Interventionhours (Mean)
Children PED 527.3
Children PED 7.530.98
Adolescents PED 7.524.84
Children PED 1026.85
Adolescents PED 1041.27

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Apparent Total Body Clearance (CL/F) of Solifenacin

Pharmacokinetic sampling was performed at steady state at the end of treatment. (NCT01565707)
Timeframe: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).

InterventionL/h (Mean)
Children PED 56.968
Children PED 7.57.608
Adolescents PED 7.514.56
Children PED 108.773
Adolescents PED 1011.3

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Apparent Volume of Distribution (Vz/F) of Solifenacin

Pharmacokinetic sampling was performed at steady state at the end of treatment. (NCT01565707)
Timeframe: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).

InterventionL (Mean)
Children PED 5272.4
Children PED 7.5329.5
Adolescents PED 7.5521.9
Children PED 10315.7
Adolescents PED 10561.7

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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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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 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 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 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 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 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 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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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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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 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 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 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 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 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 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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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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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 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 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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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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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 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 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 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 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 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 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 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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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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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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Bacterial Genomic Sequencing

Participants were classified into Low Biomass, Lactobacillus, Gardnerella, Diverse, and Other urotypes based on the bacterial DNA at baseline. (NCT01642277)
Timeframe: 12 weeks

Interventionparticipants (Number)
Low biomassLactobacillus urotypeDiverse urotypeGardnerella urotypeOther urotypes
Urinary Urge Incontinence2511363

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Assessment of Pelvic Floor Disease Inventory (PFDI) Questionnaire

"The PFDI comprises 46 items on a 4-point symptom severity scale ranging from 1 = Not at all to 4 = Quite a bit. From these items, 13 separate sub-scales are reported: (1) Obstructive discomfort, (2) Irritation, (3) Stress resulting from urinal distress, (4) A general sub-scale for pelvic organ prolapse distress, (5) An anterior sub-scale for pelvic organ prolapse distress, (6) A posterior sub-scale for pelvic organ prolapse distress, (7) An obstructive sub-scale for colorectal anal distress, (8) Incontinence, (9) Pain, and (10) A rectal prolapse sub-scale for colorectal anal distress. For each of these sub-scales, scores from from 0 to 100 (where higher scores indicate greater symptom severity). There are three additional sub-scales: (11) The urinary distress inventory, (12) The pelvic organ distress inventory, and (13) The colorectal distress inventory. Each of these ranges from 0 to 400 (with higher scores indicating greater symptom severity)." (NCT01642277)
Timeframe: 12 weeks

,
Interventionunits on a scale (Median)
Obstructive Discomfort ScoreIrritative ScoreStress ScoreUrinary Distress Inventory ScoreGeneral ScoreAnterior ScorePosterior ScorePelvic Organ Prolapse Distress Inventory ScoreObstructive ScorePain Irritation ScoreRectal ProlapseColo-Rectal-Anal Distress Inventory ScoreIncontinence Score
Solifenacin Non-Responder7.6932.5016.6760.2614.298.3316.6747.6216.6710.71042.8610.00
Solifenacin Responder5.7712.508.3340.197.148.33020.83010.71017.860

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Assessment of Overactive Bladder Questionnaire (OABQ)

The Overactive Bladder Questionnaire (OAB-q) was developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related quality of life (HRQL). The instrument comprises 33 items. Response options for the symptom frequency and HRQL items are presented as 6-point Likert scales ranging from 'none of the time' to 'all of the time' for symptom frequency (and 'not at all' to 'a very great deal' for symptom bother). From these 33 items, six sub-scales are assessed separately: (1) OAB symptom severity, (2) Coping with OAB symptoms, (3) Concern for OAB symptoms, (4) Sleep as a function of OAB symptoms, (5) Social functioning as a consequence of OAB symptoms, and (6) Health related quality of life (HRQL) as a function of OAB symptoms. Each sub-scale score ranges from 0 to 100 (where higher scores indicate more severe OAB symptoms and lower scores indicate minimal symptom severity). (NCT01642277)
Timeframe: End of study (Week 12)

,
Interventionunits on a scale (Median)
Symptom Severity ScoreCoping ScoreConcern ScoreSleep ScoreSocial ScoreHealth Related Quality of Life (HRQL)
Solifenacin Non-Responder37.5080.0082.8684.0096.0076.00
Solifenacin Responder17.5092.5097.1492.00100.0092.80

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Change From Baseline to Final Visit in Postvoid Residual (PVR) Volume

PVR volume was assessed by ultrasonography or bladder scan during 905-CL-076 and 905-CL-077. The value reported is the last PVR volume value after first dose of solifenacin up to 52 weeks. (NCT01655069)
Timeframe: Baseline (of 905-CL-076 study) to final Visit (the most recent value after first dose of solifenacin up to 40 weeks for participants who received placebo in 076 and 52 weeks for those who received solifenacin in 076.)

InterventionmL (Mean)
Children (Aged 5 to Less Than 12 Years)1.3
Adolescents (Aged 12 to Less Than 18 Years)0.7

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Change From Baseline in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents

Adolescent participants were also asked to record urgencies for at least 2 of the 7 diary days using the Perception of Intensity of Urgency Scale (PPIUS): (0 - no urgency, 1 - mild urgency, 2 - moderate urgency, 3 - severe urgency, 4 - urge incontinence). This data is based on 7-day diary data completed by participants prior to each visit from the start of 905-CL-076 to the end of 905-CL-077. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group. (NCT01655069)
Timeframe: Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment

Interventionurgency episodes (Mean)
3 weeks solifenacin treatment6 weeks solifenacin treatment9 weeks solifenacin treatment12 weeks solifenacin treatment24weeks solifenacin treatment40 weeks solifenacin treatment52 weeks solifenacin treatment
Adolescents (Aged 12 to Less Than 18 Years)-0.79-1.36-1.15-1.31-1.11-2.18-1.87

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

The mean number of incontinence episodes was based on 7-day diary data completed by participants prior to each visit from the start of 905-CL-076 to the end of 905-CL-077. An Incontinence episode is defined as an episode with any involuntary loss of urine. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group. (NCT01655069)
Timeframe: Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment

,
Interventionincontinence episodes (Mean)
3 weeks solifenacin treatment6 weeks solifenacin treatment9 weeks solifenacin treatment12 weeks solifenacin treatment24 weeks solifenacin treatment40 weeks solifenacin treatment52 weeks solifenacin treatment
Adolescents (Aged 12 to Less Than 18 Years)-1.05-1.40-1.48-1.66-1.73-1.49-1.34
Children (Aged 5 to Less Than 12 Years)-0.92-1.11-1.28-1.39-1.61-1.66-1.56

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Change From Baseline in Mean Number of Micturitions Per 24 Hours

The mean number of micturitions (urinations) was based on 7-day diary data completed by participants prior to each visit from start of 905-CL-076 to end of 905-CL-077. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group. (NCT01655069)
Timeframe: Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment

,
Interventionmicturitions (Mean)
3 weeks solifenacin treatment6 weeks solifenacin treatment9 weeks solifenacin treatment12 weeks solifenacin treatment24 weeks solifenacin treatment40 weeks solifenacin treatment52 weeks solifenacin treatment
Adolescents (Aged 12 to Less Than 18 Years)-1.29-1.38-1.15-1.24-1.01-1.39-0.81
Children (Aged 5 to Less Than 12 Years)-0.78-0.96-1.15-1.09-1.42-1.43-1.80

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Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days

The number of dry (incontinence-free) days was based on 7-day diary data completed by participants prior to each visit from start of 905-C L-076 to end of 905-C L-077. An incontinence-free day is a day without any incontinence episodes. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group. (NCT01655069)
Timeframe: Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment

,
Interventiondays (Mean)
3 weeks solifenacin treatment6 weeks solifenacin treatment9 weeks solifenacin treatment12 weeks solifenacin treatment24 weeks solifenacin treatment40 weeks solifenacin treatment52 weeks solifenacin treatment
Adolescents (Aged 12 to Less Than 18 Years)1.692.211.942.893.192.713.27
Children (Aged 5 to Less Than 12 Years)1.171.281.591.602.092.152.57

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

"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: Affect normal daily activities; Severe: Inability to perform daily activities. In participants treated with placebo in Study 905-CL-076, a TEAE was defined as an AE that started/worsened after the first dose of open-label solifenacin in Study 905-CL-077 up to 7 days after the last dose of solifenacin. In participants treated with solifenacin in Study 905-CL-076, a TEAE was defined as an AE that started/worsened after the first dose of double-blind solifenacin in Study 905-CL-076 up to 7 days after last dose of open-label solifenacin in Study 905-CL-077." (NCT01655069)
Timeframe: From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076).

,
InterventionParticipants (Count of Participants)
TEAE - MildTEAE - ModerateTEAE - SevereAny TEAEDrug-related TEAEsDeathsSerious TEAEsDrug-related serious TEAEsTEAEs leading to discontinuationDrug related TEAEs leading to permanent discont.
Adolescents (Aged 12 to Less Than 18 Years)1082201101054
Children (Aged 5 to Less Than 12 Years)7220193410101212

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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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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 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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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 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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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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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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Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1

Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. (NCT01767519)
Timeframe: Study Baseline, Week 12

,,
InterventionIncontinence Episodes (Mean)
Study BaselineChange from Study Baseline at Week 12
BOTOX®4.86-3.10
Placebo4.38-0.98
Solifenacin5.23-2.66

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Change From Study Baseline in the Role Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1

The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the role limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. (NCT01767519)
Timeframe: Study Baseline, Week 12

,,
InterventionScores on a Scale (Mean)
Study BaselineChange from Study Baseline at Wk 12 (N=135,145,57)
BOTOX®76.09-30.0
Placebo81.36-17.25
Solifenacin72.11-23.79

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Percentage of Patients With 100% Reduction in Incontinence Episodes in Treatment Cycle 1

Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period and compared to baseline to determine 100% reduction in episodes. (NCT01767519)
Timeframe: Study Baseline, Week 12

InterventionPercentage of Patients (Number)
BOTOX®33.8
Solifenacin24.5
Placebo11.7

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Percentage of Patients With a Positive Response on the Single-Item Treatment Benefit Scale During Treatment Cycle 1

A positive treatment response on the Treatment Benefit Scale is a score of either 1 or 2, representing 'greatly improved' or 'improved.' (NCT01767519)
Timeframe: Week 12

InterventionPercentage of Patients (Number)
BOTOX®71.3
Solifenacin74.0
Placebo44.8

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Change From Study Baseline in the Number of Micturition Episodes in Treatment Cycle 1

The number of micturition episodes (the number of times a patient urinates into the toilet) in Treatment Cycle 1 was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. (NCT01767519)
Timeframe: Study Baseline, Week 12

,,
InterventionMicturition Episodes (Mean)
Study BaselineChange from Study Baseline at Wk 12 (N=135,144,57)
BOTOX®10.74-2.40
Placebo10.18-0.87
Solifenacin10.40-2.03

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Change From Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1

Nocturia episodes are measured over a 3 day diary prior to each visit in Treatment Cycle 1. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. (NCT01767519)
Timeframe: Study Baseline, Week 12

,,
InterventionNocturia Episodes (Mean)
Study BaselineChange from Study Baseline at Wk 12 (N=135,144,57)
BOTOX®2.03-0.54
Placebo1.98-0.23
Solifenacin2.04-0.49

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Change From Study Baseline in the Social Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1

The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the social limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. (NCT01767519)
Timeframe: Study Baseline, Week 12

,,
InterventionScores on a Scale (Mean)
Study BaselineChange from Study Baseline at Wk 12 (N=135,145,57)
BOTOX®59.66-13.46
Placebo62.57-7.60
Solifenacin56.22-12.70

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Change From Baseline to End of Study Measured by the American Urology Association Symptom Score Questionnaire (AUASS).

The AUASS score range is 1-7 (mild), 8-19 (moderate) and 20-35 (severe). The AUASS asks 7 questions scored 0-5, the scores are summed for the total score. (NCT01777217)
Timeframe: baseline and 16 weeks

InterventionScores on a scale (Median)
Solifenacin Succinate9.4
Placebo6.7

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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: 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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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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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 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 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 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 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 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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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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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 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 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 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 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: 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: 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 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 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 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 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 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 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 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 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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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 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 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 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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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 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 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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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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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 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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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, 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, 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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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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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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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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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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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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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 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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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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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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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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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 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 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 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 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 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 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 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: 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: 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 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 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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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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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 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 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 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 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 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 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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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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Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6

Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Week 6 visit

Interventionpercentage of days with incontinence (Number)
06:00-07:0007:00-08:0008:00-09:0009:00-10:0010:00-11:0011:00-12:0012:00-13:0013:00-14:0014:00-15:0015:00-16:0016:00-17:0017:00-18:0018:00-19:0019:00-20:0020:00-21:0021:00-22:0022:00-23:0023:00-00:0000:00-01:0001:00-02:0002:00-03:0003:00-04:0004:00-05:0005:00-06:00
Solifenacin Succinate25.018.311.711.720.020.013.36.711.726.721.723.315.025.010.023.35.05.0003.31.73.35.0

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Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9

Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Week 9 visit

Interventionpercentage of days with incontinence (Number)
06:00-07:0007:00-08:0008:00-09:0009:00-10:0010:00-11:0011:00-12:0012:00-13:0013:00-14:0014:00-15:0015:00-16:0016:00-17:0017:00-18:0018:00-19:0019:00-20:0020:00-21:0021:00-22:0022:00-23:0023:00-00:0000:00-01:0001:00-02:0002:00-03:0003:00-04:0004:00-05:0005:00-06:00
Solifenacin Succinate14.320.69.59.525.422.211.111.112.722.220.620.611.115.914.311.16.34.81.63.21.63.21.69.5

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Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3

Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Week 3 visit

Interventionpercentage of days with incontinence (Number)
06:00-07:0007:00-08:0008:00-09:0009:00-10:0010:00-11:0011:00-12:0012:00-13:0013:00-14:0014:00-15:0015:00-16:0016:00-17:0017:00-18:0018:00-19:0019:00-20:0020:00-21:0021:00-22:0022:00-23:0023:00-00:0000:00-01:0001:00-02:0002:00-03:0003:00-04:0004:00-05:0005:00-06:00
Solifenacin Succinate17.525.411.122.222.214.315.915.920.620.615.920.614.327.019.019.03.27.94.83.21.61.609.5

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Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 20 cmH20 Detrusor Pressure

Bladder volume as assessed by urodynamics. (NCT01981954)
Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 52

InterventionmL (Mean)
Week 3Week 6Week 9Week 12Week 24Week 52
Solifenacin Succinate52.465.552.053.940.175.4

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Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC)

MCC was the volume instilled into the bladder prior to leakage or end of bladder-filling (whichever was reached first), as assessed by urodynamics (procedure: the bladder was to be filled until voiding/leakage began, or until it was stopped because either the participant experienced pain or discomfort or 135% of expected bladder capacity [EBC] was reached for participants ≥ 2 years or of maximum catheterized volume [MCV] for participants aged 6 months to < 2 years; the participants' bladder was emptied via catheterization). (NCT01981954)
Timeframe: Baseline and Week 24

InterventionmL (Mean)
Solifenacin Succinate37.0

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Change From Baseline to Week 24 and 52 in Infant and Toddler Quality of Life Short Form-47 Questionnaire (ITQoL SF-47) - Overall Health Score

The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). (NCT01981954)
Timeframe: Baseline and Weeks 24, 52

Interventionunits on a scale (Mean)
Week 24Week 52
Solifenacin Succinate-1.89.0

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Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Behaviour Score

The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). (NCT01981954)
Timeframe: Baseline and Weeks 24, 52

Interventionunits on a scale (Mean)
Week 24Week 52
Solifenacin Succinate-1.69-0.06

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Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Change in Health Score

The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). (NCT01981954)
Timeframe: Baseline and Weeks 24, 52

Interventionunits on a scale (Mean)
Week 24Week 52
Solifenacin Succinate0.005.77

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Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Family Cohesion Impact Score

The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). (NCT01981954)
Timeframe: Baseline and Weeks 24, 52

Interventionunits on a scale (Mean)
Week 24Week 52
Solifenacin Succinate1.5-4.2

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Change From Baseline to Week 24 and 52 in ITQoL SF-47 - General Health Score

The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). (NCT01981954)
Timeframe: Baseline and Weeks 24, 52

Interventionunits on a scale (Mean)
Week 24Week 52
Solifenacin Succinate0.394.29

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Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Growth and Development Score

The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). (NCT01981954)
Timeframe: Baseline and Weeks 24, 52

Interventionunits on a scale (Mean)
Week 24Week 52
Solifenacin Succinate-1.502.33

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Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Pain Score

The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). (NCT01981954)
Timeframe: Baseline and Weeks 24, 52

Interventionunits on a scale (Mean)
Week 24Week 52
Solifenacin Succinate-3.47-0.83

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Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Parent-Emotional Impact Score

The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). (NCT01981954)
Timeframe: Baseline and Weeks 24, 52

Interventionunits on a scale (Mean)
Week 24Week 52
Solifenacin Succinate-3.314.81

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Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Parent-Time Impact Score

The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). (NCT01981954)
Timeframe: Baseline and Weeks 24, 52

Interventionunits on a scale (Mean)
Week 24Week 52
Solifenacin Succinate15.27.1

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Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Physical Abilities Score

The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). (NCT01981954)
Timeframe: Baseline and Weeks 24, 52

Interventionunits on a scale (Mean)
Week 24Week 52
Solifenacin Succinate2.173.93

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Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Temperament and Moods Score

The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). (NCT01981954)
Timeframe: Baseline and Weeks 24, 52

Interventionunits on a scale (Mean)
Week 24Week 52
Solifenacin Succinate-1.85-1.11

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Change From Baseline to Weeks 3, 6, 9, 12 and 52 in MCC

MCC was the volume instilled into the bladder prior to leakage or end of bladder-filling (whichever was reached first) as assessed by urodynamics (procedure: the bladder was to be filled until voiding/leakage began, or until it was stopped because either the participant experienced pain or discomfort or 135% of EBC was reached for participants ≥ 2 years or of MCV for participants aged 6 months to < 2 years. The participants' bladder was emptied via catheterization). (NCT01981954)
Timeframe: Baseline and Weeks 3, 6, 9, 12, 52

InterventionmL (Mean)
Week 3Week 6Week 9Week 12Week 52
Solifenacin Succinate45.236.523.940.258.6

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Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Compliance

Bladder compliance gives an indication of the elasticity of the bladder wall. Bladder compliance was calculated by dividing the change in volume during the filling of the bladder by the change in detrusor pressure during that change in bladder volume using urodynamic assessments. The values for bladder volume and detrusor pressure at the beginning and end of filling were taken and used. (NCT01981954)
Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 52

InterventionmL/cmH2O (Mean)
Week 3Week 6Week 9Week 12Week 24Week 52
Solifenacin Succinate4.555.4510.004.145.105.94

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Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 10 cmH20 Detrusor Pressure

Bladder volume as assessed by urodynamics. (NCT01981954)
Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 52

InterventionmL (Mean)
Week 3Week 6Week 9Week 12Week 24Week 52
Solifenacin Succinate31.947.831.530.128.749.4

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Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 30 cmH20 Detrusor Pressure

Bladder volume as assessed by urodynamics. (NCT01981954)
Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 52

InterventionmL (Mean)
Week 3Week 6Week 9Week 12Week 24Week 52
Solifenacin Succinate101.9-2.376.074.767.593.6

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Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume Until First Detrusor Contraction (> 15 cmH2O)

Bladder volume as assessed by urodynamics. (NCT01981954)
Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 52

InterventionmL (Mean)
Week 3Week 6Week 9Week 12Week 24Week 52
Solifenacin Succinate47.087.477.018.722.989.2

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Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Catheterized Volume 5 Minutes After End of Bladder-Filling

Catheterized volume was measured when the bladder was emptied via catheterization 5 minutes after the end of bladder-filling. (NCT01981954)
Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 52

InterventionmL (Mean)
Week 3Week 6Week 9Week 12Week 24Week 52
Solifenacin Succinate38.641.850.550.544.059.8

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Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure 5 Minutes After End of Bladder-Filling

Detrusor pressure was expressed as bladder pressure minus intra-abdominal pressure as assessed by urodynamics. (NCT01981954)
Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 52

InterventioncmH2O (Mean)
Week 3Week 6Week 9Week 12Week 24Week 52
Solifenacin Succinate0.91.31.2-4.1-2.0-2.3

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Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure at End of Bladder-Filling

Detrusor pressure was expressed as bladder pressure minus intra-abdominal pressure as assessed by urodynamics. (NCT01981954)
Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 52

InterventioncmH2O (Mean)
Week 3Week 6Week 9Week 12Week 24Week 52
Solifenacin Succinate-5.2-8.3-10.3-0.6-1.0-9.8

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Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until Leakage or End of Bladder-Filling

(NCT01981954)
Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 52

Interventioncontractions (Mean)
Week 3Week 6Week 9Week 12Week 24Week 52
Solifenacin Succinate-3.4-4.2-6.3-6.8-7.0-7.2

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Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average Catheterized Volume Per Catheterization

The average catheterized volume per catheterization was calculated using all available (non-zero) catheterized volumes recorded over both of the 2 measuring days in the diary, whether or not these 2 days were concurrent. Catheterized volumes were recorded for 2 days in a participant diary prior to each visit. Four to six catheterizations were performed every day. (NCT01981954)
Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 36, 52

InterventionmL (Mean)
Week 3Week 6Week 9Week 12Week 24Week 36Week 52
Solifenacin Succinate21.5623.9325.1337.6434.3843.7940.42

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Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average First Morning Catheterized Volume

The first morning catheterized volume was the volume associated with the first morning catheterization. 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 diary, whether or not these 2 days are concurrent. (NCT01981954)
Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 36, 52

InterventionmL (Mean)
Week 3Week 6Week 9Week 12Week 24Week 36Week 52
Solifenacin Succinate19.4724.2623.0632.5640.5840.6239.88

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Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Maximum Catheterized Volume (MCV)

The maximum catheterized volume per day was calculated using all available (non-zero) catheterized volumes recorded for the 2 measuring days in the diary, whether or not these 2 days were concurrent. The maximum value was calculated separately for each measuring day and the mean of these two values was used. (NCT01981954)
Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 36, 52

InterventionmL (Mean)
Week 3Week 6Week 9Week 12Week 24Week 36Week 52
Solifenacin Succinate30.0031.0627.3140.5640.5657.9141.69

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Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Mean Number of Periods Between the Clean Intermittent Catheterizations (CICs) With Incontinence Per 24 Hours

Participants were required to have 4-6 CICs per day on a schedule fixed for the duration of the study. To calculate the number of periods between CICs with incontinence in a diary day, the diary day was divided into periods between CICs (i.e. inter-CIC periods). The hour period, rather than the exact time, of each CIC and incontinence episode was recorded in the diary. When an incontinence episode and a CIC were marked in the same hour period, the incontinence episode was counted as occurring prior to the CIC (when the bladder had not yet emptied), rather than after it (when the bladder had recently been emptied), i.e. the inter-CIC period ended with the hour in which the CIC was recorded. The mean number of periods between CICs with incontinence per 24 hours was the number of periods between CICs when incontinence occurred, divided by the total number of valid diary days. (NCT01981954)
Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 36, 52

Interventionperiods (Mean)
Week 3Week 6Week 9Week 12Week 24Week 36Week 52
Solifenacin Succinate-1.18-1.38-1.47-1.25-1.31-1.06-1.29

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Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline

For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Baseline visit

Interventionpercentage of days with catheterization (Number)
06:00-07:0007:00-08:0008:00-09:0009:00-10:0010:00-11:0011:00-12:0012:00-13:0013:00-14:0014:00-15:0015:00-16:0016:00-17:0017:00-18:0018:00-19:0019:00-20:0020:00-21:0021:00-22:0022:00-23:0023:00-00:0000:00-01:0001:00-02:0002:00-03:0003:00-04:0004:00-05:0005:00-06:00
Solifenacin Succinate46.329.618.527.816.722.244.420.420.424.127.814.840.731.513.038.914.813.024.19.31.93.7013.0

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Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12

For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Week 12 visit

Interventionpercentage of days with catheterization (Number)
06:00-07:0007:00-08:0008:00-09:0009:00-10:0010:00-11:0011:00-12:0012:00-13:0013:00-14:0014:00-15:0015:00-16:0016:00-17:0017:00-18:0018:00-19:0019:00-20:0020:00-21:0021:00-22:0022:00-23:0023:00-00:0000:00-01:0001:00-02:0002:00-03:0003:00-04:0004:00-05:0005:00-06:00
Solifenacin Succinate39.731.720.627.019.015.958.719.012.722.231.715.941.322.227.038.111.114.330.21.63.23.206.3

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Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24

For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Week 24 visit

Interventionpercentage of days with catheterization (Number)
06:00-07:0007:00-08:0008:00-09:0009:00-10:0010:00-11:0011:00-12:0012:00-13:0013:00-14:0014:00-15:0015:00-16:0016:00-17:0017:00-18:0018:00-19:0019:00-20:0020:00-21:0021:00-22:0022:00-23:0023:00-00:0000:00-01:0001:00-02:0002:00-03:0003:00-04:0004:00-05:0005:00-06:00
Solifenacin Succinate33.333.322.215.923.819.044.433.39.523.827.027.034.930.220.638.16.317.525.43.23.2006.3

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Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3

For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Week 3 visit

Interventionpercentage of days with catheterization (Number)
06:00-07:0007:00-08:0008:00-09:0009:00-10:0010:00-11:0011:00-12:0012:00-13:0013:00-14:0014:00-15:0015:00-16:0016:00-17:0017:00-18:0018:00-19:0019:00-20:0020:00-21:0021:00-22:0022:00-23:0023:00-00:0000:00-01:0001:00-02:0002:00-03:0003:00-04:0004:00-05:0005:00-06:00
Solifenacin Succinate36.530.220.627.020.619.036.534.915.923.820.628.636.525.420.636.517.59.525.412.73.20011.1

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Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36

For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Week 36 visit

Interventionpercentage of days with catheterization (Number)
06:00-07:0007:00-08:0008:00-09:0009:00-10:0010:00-11:0011:00-12:0012:00-13:0013:00-14:0014:00-15:0015:00-16:0016:00-17:0017:00-18:0018:00-19:0019:00-20:0020:00-21:0021:00-22:0022:00-23:0023:00-00:0000:00-01:0001:00-02:0002:00-03:0003:00-04:0004:00-05:0005:00-06:00
Solifenacin Succinate36.735.026.720.016.716.753.330.08.325.026.723.343.321.723.338.35.015.025.05.01.701.71.7

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Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52

For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all subjects. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Week 52 visit

Interventionpercentage of days with catheterization (Number)
06:00-07:0007:00-08:0008:00-09:0009:00-10:0010:00-11:0011:00-12:0012:00-13:0013:00-14:0014:00-15:0015:00-16:0016:00-17:0017:00-18:0018:00-19:0019:00-20:0020:00-21:0021:00-22:0022:00-23:0023:00-00:0000:00-01:0001:00-02:0002:00-03:0003:00-04:0004:00-05:0005:00-06:00
Solifenacin Succinate35.133.328.122.815.817.550.926.310.528.119.324.645.624.621.136.815.819.314.000003.5

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Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6

For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Week 6 visit

Interventionpercentage of days with catheterization (Number)
06:00-07:0007:00-08:0008:00-09:0009:00-10:0010:00-11:0011:00-12:0012:00-13:0013:00-14:0014:00-15:0015:00-16:0016:00-17:0017:00-18:0018:00-19:0019:00-20:0020:00-21:0021:00-22:0022:00-23:0023:00-00:0000:00-01:0001:00-02:0002:00-03:0003:00-04:0004:00-05:0005:00-06:00
Solifenacin Succinate35.030.020.036.715.011.743.333.315.030.025.020.035.028.311.740.018.316.718.305.03.306.7

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Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9

For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Week 9 visit

Interventionpercentage of days with catheterization (Number)
06:00-07:0007:00-08:0008:00-09:0009:00-10:0010:00-11:0011:00-12:0012:00-13:0013:00-14:0014:00-15:0015:00-16:0016:00-17:0017:00-18:0018:00-19:0019:00-20:0020:00-21:0021:00-22:0022:00-23:0023:00-00:0000:00-01:0001:00-02:0002:00-03:0003:00-04:0004:00-05:0005:00-06:00
Solifenacin Succinate34.936.519.023.817.519.042.927.017.531.715.923.838.127.017.538.112.719.019.04.81.61.61.69.5

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Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline

Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Baseline visit

Interventionpercentage of days with incontinence (Number)
06:00-07:0007:00-08:0008:00-09:0009:00-10:0010:00-11:0011:00-12:0012:00-13:0013:00-14:0014:00-15:0015:00-16:0016:00-17:0017:00-18:0018:00-19:0019:00-20:0020:00-21:0021:00-22:0022:00-23:0023:00-00:0000:00-01:0001:00-02:0002:00-03:0003:00-04:0004:00-05:0005:00-06:00
Solifenacin Succinate27.827.816.737.025.922.235.233.325.931.537.024.124.131.514.835.214.89.313.05.61.91.91.97.4

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Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12

Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Week 12 visit

Interventionpercentage of days with incontinence (Number)
06:00-07:0007:00-08:0008:00-09:0009:00-10:0010:00-11:0011:00-12:0012:00-13:0013:00-14:0014:00-15:0015:00-16:0016:00-17:0017:00-18:0018:00-19:0019:00-20:0020:00-21:0021:00-22:0022:00-23:0023:00-00:0000:00-01:0001:00-02:0002:00-03:0003:00-04:0004:00-05:0005:00-06:00
Solifenacin Succinate17.511.19.528.622.223.825.44.89.528.612.717.517.517.512.711.19.56.34.81.61.61.607.9

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Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24

Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Week 24 visit

Interventionpercentage of days with incontinence (Number)
06:00-07:0007:00-08:0008:00-09:0009:00-10:0010:00-11:0011:00-12:0012:00-13:0013:00-14:0014:00-15:0015:00-16:0016:00-17:0017:00-18:0018:00-19:0019:00-20:0020:00-21:0021:00-22:0022:00-23:0023:00-00:0000:00-01:0001:00-02:0002:00-03:0003:00-04:0004:00-05:0005:00-06:00
Solifenacin Succinate25.414.37.915.931.723.811.111.19.525.414.330.217.519.015.97.97.96.33.23.21.6004.8

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Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36

Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Week 36 visit

Interventionpercentage of days with incontinence (Number)
06:00-07:0007:00-08:0008:00-09:0009:00-10:0010:00-11:0011:00-12:0012:00-13:0013:00-14:0014:00-15:0015:00-16:0016:00-17:0017:00-18:0018:00-19:0019:00-20:0020:00-21:0021:00-22:0022:00-23:0023:00-00:0000:00-01:0001:00-02:0002:00-03:0003:00-04:0004:00-05:0005:00-06:00
Solifenacin Succinate25.013.311.718.320.020.021.713.311.731.711.716.711.730.021.718.35.011.76.73.301.71.75.0

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Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52

Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Week 52 visit

Interventionpercentage of days with incontinence (Number)
06:00-07:0007:00-08:0008:00-09:0009:00-10:0010:00-11:0011:00-12:0012:00-13:0013:00-14:0014:00-15:0015:00-16:0016:00-17:0017:00-18:0018:00-19:0019:00-20:0020:00-21:0021:00-22:0022:00-23:0023:00-00:0000:00-01:0001:00-02:0002:00-03:0003:00-04:0004:00-05:0005:00-06:00
Solifenacin Succinate19.319.317.514.024.633.317.58.812.329.817.522.819.321.117.521.11.83.55.33.53.51.85.33.5

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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 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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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 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 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 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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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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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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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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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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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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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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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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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 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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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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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 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 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 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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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 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 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 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 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 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 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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Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12

The average 72-h IEF is calculated based on a 72-h bladder diary. All relevant time points used in the calculation in the Time Frame (baseline, weeks 1-12) (NCT02047032)
Timeframe: baseline, weeks 1-12

Interventionpercent change (Least Squares Mean)
Solifenacin Plus PFMT-36.49
Electroacupuncture-37.83

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Change of Episodes From Baseline in Mean 72-h Incontinence Episodes

(NCT02047032)
Timeframe: Weeks 1-12, 13-24, 25-36

,
Interventionepisodes (Least Squares Mean)
Weeks 1-12Weeks 13-24Weeks 25-36
Electroacupuncture-4.56-7.27-8.31
Solifenacin Plus PFMT-4.37-6.95-8.22

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Patient's Treatment Satisfaction Degree

The self-assessing satisfaction degree on a 5-point Likert scale (range, 1 [unsatisfied strongly] to 5 [satisfied strongly]) will be finished by participants to evaluate their satisfaction for the treatment. (NCT02047032)
Timeframe: Weeks 12, 36

InterventionParticipants (Count of Participants)
Week 1272253229Week 1272253230Week 3672253229Week 3672253230
SatisfactionDissatisfactionMarked satisfactionNo changeMarked dissatisfaction
Electroacupuncture62
Solifenacin Plus PFMT84
Electroacupuncture112
Solifenacin Plus PFMT80
Electroacupuncture56
Solifenacin Plus PFMT12
Electroacupuncture12
Solifenacin Plus PFMT0
Electroacupuncture1
Solifenacin Plus PFMT77
Electroacupuncture85
Solifenacin Plus PFMT90
Electroacupuncture101
Solifenacin Plus PFMT58
Electroacupuncture47
Solifenacin Plus PFMT9
Electroacupuncture11
Electroacupuncture0

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Patient Global Impression Improvement

Participants will be asked to finish one item evaluating their present condition. (NCT02047032)
Timeframe: Weeks 12, 36

InterventionParticipants (Count of Participants)
Week 1272253232Week 1272253231Week 3672253232Week 3672253231
Marked improvementModerate improvementNo changeModerate worseningSlight improvementSlight worseningMarked worening
Electroacupuncture69
Solifenacin Plus PFMT52
Electroacupuncture85
Solifenacin Plus PFMT75
Electroacupuncture82
Solifenacin Plus PFMT96
Electroacupuncture8
Solifenacin Plus PFMT8
Solifenacin Plus PFMT3
Electroacupuncture0
Electroacupuncture87
Solifenacin Plus PFMT74
Electroacupuncture93
Solifenacin Plus PFMT92
Electroacupuncture55
Solifenacin Plus PFMT59
Electroacupuncture9
Solifenacin Plus PFMT9
Electroacupuncture1
Solifenacin Plus PFMT1
Solifenacin Plus PFMT0

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Weekly Median Number of Urine Pads Used During Weeks 1-12, 13-24, and 25-36

(NCT02047032)
Timeframe: Baseline, weeks 1-12, 13-24, 25-36

,
Interventionurine pads (Median)
Weeks 1-12Weeks 13-24Weeks 25-36
Electroacupuncture8.07.08.0
Solifenacin Plus PFMT9.08.08.0

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The Number of Participants Using Urine Pads

(NCT02047032)
Timeframe: Weeks 1-12, 13-24, 25-36

,
InterventionParticipants (Count of Participants)
Weeks 1-12Weeks 13-24Weeks 25-36
Electroacupuncture866859
Solifenacin Plus PFMT1058072

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the Amount of Urine Leakage (Grams) Measured by the 1-hour Pad Test at Weeks 4 and 12

"The performance of 1-hour pad test according to the International Incontinence Society:~Participants were instructed to void 2 hours before the pad test. On arrival, they received a pre-weighed pad and were asked to sit and drink 500 ml sodium-free water in 15 minutes. Next, they were instructed to walk for 30 minutes, including going up and down 24 stairs. On returning to the clinic, the participants were instructed to perform several activities, including standing and sitting 10 times, coughing vigorously 10 times, running for 1 minute, picking up a coin from the floor 5 times, and putting their hands under water for 1 minute. After the activities were completed, the pad was reweighed to measure the amount of urinary leakage using a gram sensitive weight scale (Xiangshan, EK3820)." (NCT02047032)
Timeframe: Weeks 4 and 12

,
Interventionamount of leakage (grams) (Least Squares Mean)
Week 4Week 12
Electroacupuncture-6.74-12.16
Solifenacin Plus PFMT-6.96-11.49

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Percentage of Participants With ≥50% Decrease in Average 72-h Incontinence Episode Frequency

Count the number of cases with the reduction of average 72-h incontinence episode frequency ≥50% and divide it by the number of participants at baseline. (NCT02047032)
Timeframe: Weeks 1-12, 13-24, 25-36

,
InterventionParticipants (Count of Participants)
Weeks 1-12Weeks 13-24Weeks 25-36
Electroacupuncture109174190
Solifenacin Plus PFMT112164188

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Percentage of Change From Baseline in Mean 72-hour IEF During Weeks 13-24 and Weeks 25-36

Calculated as the same way as the primary outcome. But this outcome will be assessed at different time point. (NCT02047032)
Timeframe: baseline, weeks 13-24, week 25-36

,
Interventionpercent change (Least Squares Mean)
Weeks 13-24Weeks 25-36
Electroacupuncture-58.20-64.20
Solifenacin Plus PFMT-56.69-65.48

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Electroacupuncture Acceptance Assessment

The acceptance of electroacupuncture will be tested within 5 minute with a 5-point scale ('0' means very difficult to accept and '4' means accept easily). Median of scores of the three times will be calculated. (NCT02047032)
Timeframe: Weeks 2, 6 and 12

Interventionunits on a scale (Median)
Week 2Week 6Week 12
Electroacupuncture3.03.03.0

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Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes

The average 72-h IEF (urinary incontinence, stress urinary incontinence and urgency urinary incontinence respectively) is calculated based on a 72-h bladder diary. For example, the average 72-h incontinence episodes from the 13th to 36th week equal to the sum of 72-h incontinence episodes of the 16th, 20th, 24th, 28th, 32nd, 36th weeks divided by 6. (NCT02047032)
Timeframe: Baseline, weeks 1-12, 13-24, 25-36

,
Interventionpercent change (Least Squares Mean)
Change in the 72-h urgence, Weeks 1-12Change in the 72-h urgence, Weeks 13-24Change in the 72-h urgence, Weeks 25-36Change in the 72-h urination, Weeks 1-12Change in the 72-h urination, Weeks 13-24Change in the 72-h urination, Weeks 25-36Change in the 72-h nocturia, Weeks 1-12Change in the 72-h nocturia, Weeks 13-24Change in the 72-h nocturia, Weeks 25-36
Electroacupuncture-2.62-4.75-5.55-3.23-5.96-7.02-0.79-1.38-1.58
Solifenacin Plus PFMT-2.99-4.77-5.55-3.62-5.26-6.11-0.87-1.33-1.58

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Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score

The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF (range, 0 [best]-21 [worst] outcomes, and 2.52 as minimal clinically important differences (MCID)) scores. (NCT02047032)
Timeframe: baseline, weeks 12, 24 and 36

,
Interventionunits on a scale (Least Squares Mean)
Week 12Week 24Week 36
Electroacupuncture-3.96-6.44-7.06
Solifenacin Plus PFMT-3.73-5.97-6.80

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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 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 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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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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Number of Participants Who Reached the Maximum Allowed Dose (MAD) in Their Respective Cohort

Of the four cohorts with different dosing schedules for CPC-201, the cohort with the greatest proportion of participants to reach the donepezil MAD was determined to be the optimal administration regimen. (NCT02549196)
Timeframe: 1-7 weeks

InterventionParticipants (Count of Participants)
Cohort 12
Cohort 20
Cohort 1b1
Cohort 3c6

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Number of Participants With TEAEs Leading to Study Drug Discontinuation

Number of subjects who experienced any treatment-emergent adverse events (TEAEs) leading to study drug discontinuation (NCT02549196)
Timeframe: 1-7 weeks

InterventionParticipants (Count of Participants)
Cohort 12
Cohort 20
Cohort 1b1
Cohort 3c4

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The Effectiveness of Anticholinergic Treatment in Relation to the Urinary Microbiome. Culture to Standard Culture Media Will Pickup Aerobic Bacteria and Yeasts After DNA Extraction and End Point PCR for 16S rDNA Genes.

The change in g_lactobacillus from Baseline to Follow-up (6 weeks), which corresponds to before and after anticholinergic treatment. (NCT04090190)
Timeframe: At the 6 week mark

Interventionpg/mL (Median)
Standard of Care Anticholinergic Treatment0.001131599

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Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu.

Statistical testing was used to determine if there was a difference in inflammatory markers in the urine of patients between baseline visit and 6 week visit. 7 markers were chosen and compared, all inflammatory markers present in urine. (NCT04090190)
Timeframe: Baseline and 6 weeks

Interventionpg/mL (Median)
Baseline CRPFollow-up CRPBaseline IL-12/IL-23p40Follow-up IL-12/IL-23p40Baseline MCP-1Follow-up MCP-1Baseline GM-CSFFollow-up GM CSFBaseline IL-1BFollow-up IL-1BBaseline IL-6Follow-up IL-6Baseline IL-8Follow-up IL-8
Standard of Care Anticholinergic Treatment2.1922.5652.1922.56575.4965.020.1020.2030.2030.4150.6670.9677.2116.116

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