Page last updated: 2024-12-08

tolterodine tartrate

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth

Description

Tolterodine Tartrate: An ANTIMUSCARINIC AGENT selective for the MUSCARINIC RECEPTORS of the BLADDER that is used in the treatment of URINARY INCONTINENCE and URINARY URGE INCONTINENCE. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID25137865
CHEBI ID32245
MeSH IDM0386986

Synonyms (5)

Synonym
2-[(1r)-3-(diisopropylamino)-1-phenylpropyl]-4-methylphenol (2r,3r)-2,3-dihydroxybutanedioic acid hydrate
(r)-2-(3-(bis(1-methylethyl)amino)-1-phenylpropyl)-4-methylphenol (r-(r*,r*))-2,3-dihydroxybutanedioate (1:1)(salt)
CHEBI:32245 ,
tolterodine tartrate
(2s,3s)-1,4-dihydroxy-1,4-dioxobutane-2,3-diolate;2-[(1r)-3-[di(propan-2-yl)amino]-1-phenylpropyl]-4-methylphenol;hydron

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" Tolterodine was safe and generally well tolerated."( Efficacy and safety of two doses of tolterodine versus placebo in patients with detrusor overactivity and symptoms of frequency, urge incontinence, and urgency: urodynamic evaluation. The International Study Group.
Höfner, K; Holmdahl, TH; Jonas, U; Madersbacher, H, 1997
)
0.3
" Safety and tolerability were assessed from adverse events and laboratory measures."( Clinical efficacy and safety of tolterodine in the treatment of overactive bladder: a pooled analysis.
Appell, RA, 1997
)
0.3
" Tolterodine at doses of 1 mg and 2 mg were tolerated significantly better than oxybutynin when adverse events, dry mouth (both frequency and intensity), dose reductions, and patient withdrawals were considered."( Clinical efficacy and safety of tolterodine in the treatment of overactive bladder: a pooled analysis.
Appell, RA, 1997
)
0.3
" Patients receiving tolterodine should not experience these limitations and instead will get safe and long-term effective treatment for their condition."( Clinical efficacy and safety of tolterodine in the treatment of overactive bladder: a pooled analysis.
Appell, RA, 1997
)
0.3
" The incidence of adverse events (mainly mild or moderate antimuscarinic effects) was comparable with placebo at tolterodine dosages of < or = 2 mg."( Efficacy and safety of tolterodine in patients with detrusor instability: a dose-ranging study.
Abrams, P; Cardozo, L; Fall, M; Nelson, E; Rentzhog, L; Stanton, SL, 1998
)
0.3
"We evaluated the efficacy, patient acceptability and side effect profile of tolterodine, a new antimuscarinic agent for treating bladder overactivity."( Clinical efficacy and safety of tolterodine compared to placebo in detrusor overactivity.
Clarke, B; Davis, BE; Dwyer, P; Millard, R; Moore, K; Susset, J; Tuttle, J, 1999
)
0.3
" There was no clinical or electrocardiographic evidence of significant cardiac adverse events."( Clinical efficacy and safety of tolterodine compared to placebo in detrusor overactivity.
Clarke, B; Davis, BE; Dwyer, P; Millard, R; Moore, K; Susset, J; Tuttle, J, 1999
)
0.3
" The incidence of adverse events (mainly mild or moderate antimuscarinic effects) was comparable between placebo and tolterodine dosages of 2 mg twice daily."( Tolterodine in the treatment of overactive bladder: analysis of the pooled phase II efficacy and safety data.
Hallén, B; Larsson, G; Nilvebrant, L, 1999
)
0.3
" Tolterodine was significantly better tolerated than oxybutynin when adverse events (particularly frequency and intensity of dry mouth), dose reduction and patient withdrawals were considered."( Clinical efficacy and safety of tolterodine compared to oxybutynin and placebo in patients with overactive bladder.
Appell, RA; Drutz, HP; Gleason, D; Klimberg, I; Radomski, S, 1999
)
0.3
"Safety and tolerability were evaluated through spontaneously reported adverse events, electrocardiogram, and blood pressure measurements."( Tolterodine: a safe and effective treatment for older patients with overactive bladder.
Malone-Lee, JG; Maugourd, MF; Walsh, JB, 2001
)
0.31
" Neither dosage of tolterodine was associated with serious drug-related adverse events during the study."( Tolterodine: a safe and effective treatment for older patients with overactive bladder.
Malone-Lee, JG; Maugourd, MF; Walsh, JB, 2001
)
0.31
"Tolterodine (taken for 4 weeks) is safe and shows efficacy, particularly at a dosage of 2 mg bid, in the treatment of older patients with urinary symptoms attributable to overactive bladder."( Tolterodine: a safe and effective treatment for older patients with overactive bladder.
Malone-Lee, JG; Maugourd, MF; Walsh, JB, 2001
)
0.31
" However such drugs are associated with a high incidence of anticholinergic adverse effects."( Safety profile of tolterodine as used in general practice in England: results of prescription-event monitoring.
Layton, D; Pearce, GL; Shakir, SA, 2001
)
0.31
"The most common adverse events reported were dry mouth, headache, malaise, constipation, dyspepsia, nausea and vomiting and pain in abdomen."( Safety profile of tolterodine as used in general practice in England: results of prescription-event monitoring.
Layton, D; Pearce, GL; Shakir, SA, 2001
)
0.31
" Dry mouth (of any severity) was the most common adverse event in both the tolterodine ER and placebo treatment arms, irrespective of age (<65: ER 22."( Efficacy, safety, and tolerability of extended-release once-daily tolterodine treatment for overactive bladder in older versus younger patients.
Mattiasson, A; Stanton, SL; Zinner, NR, 2002
)
0.31
" Tolterodine ER was safe and well tolerated."( Long-term safety, tolerability and efficacy of extended-release tolterodine in the treatment of overactive bladder.
Jonas, U; Kreder, K; Mayne, C, 2002
)
0.31
"To determine whether women with urinary incontinence (UI) can identify their allocation in a randomized controlled trial (RCT) of tolterodine (TOL), and whether correct identification is associated with outcomes and adverse effects (AEs)."( "Unblinding" in randomized controlled drug trials for urinary incontinence: Implications for assessing outcomes when adverse effects are evident.
DuBeau, CE; Khullar, V; Versi, E, 2005
)
0.33
" Tolterodine ER was well tolerated and the most common adverse event was dry mouth (33."( Long-term safety, tolerability and efficacy of extended-release tolterodine in the treatment of overactive bladder in Japanese patients.
Homma, Y; Takei, M, 2005
)
0.33
" There were no significant between-group differences in the incidence of adverse events."( Safety and tolerability of tolterodine for the treatment of overactive bladder in men with bladder outlet obstruction.
Abrams, P; De Koning Gans, HJ; Kaplan, S; Millard, R, 2006
)
0.33
" The incidence of adverse events (AEs) was similar in the three treatment groups (extended-release oxybutynin, 70%; extended-release tolterodine, 64%; and immediate-release tolterodine, 79%)."( Safety and tolerability of extended-release oxybutynin once daily in urinary incontinence: combined results from two phase 4 controlled clinical trials.
Armstrong, RB; Dmochowski, RR; Macdiarmid, S; Sand, PK, 2007
)
0.34
"The primary objectives of the treatment for the lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) are to produce rapid, sustained, and safe improvements in the symptoms that affect the quality of life in the majority of men over 50."( Efficacy and safety of combined therapy with terazosin and tolteradine for patients with lower urinary tract symptoms associated with benign prostatic hyperplasia: a prospective study.
Li, HZ; Wang, W; Xiao, H; Yang, Y; Zhang, X; Zhang, Y; Zhao, XF, 2007
)
0.34
" The incidence of adverse effects in the combination group was higher than that in the terazosin group."( Efficacy and safety of combined therapy with terazosin and tolteradine for patients with lower urinary tract symptoms associated with benign prostatic hyperplasia: a prospective study.
Li, HZ; Wang, W; Xiao, H; Yang, Y; Zhang, X; Zhang, Y; Zhao, XF, 2007
)
0.34
" This study, although short term and limited numbers of patients, provides evidence that the combined therapy with terazosin plus tolterodine is a good approach for meeting the objectives of rapid, sustained, and safe improvements in the LUTS associated with BPH."( Efficacy and safety of combined therapy with terazosin and tolteradine for patients with lower urinary tract symptoms associated with benign prostatic hyperplasia: a prospective study.
Li, HZ; Wang, W; Xiao, H; Yang, Y; Zhang, X; Zhang, Y; Zhao, XF, 2007
)
0.34
" Tamsulosin OCAS was well tolerated and the proportion of women discontinuing because of adverse events was low (4."( A randomized double-blind placebo-controlled multicentre study to explore the efficacy and safety of tamsulosin and tolterodine in women with overactive bladder syndrome.
Bolodeoku, J; Cardozo, L; Robinson, D; Terpstra, G, 2007
)
0.34
" Evaluation was by subjective assessment, visual analog scale, urodynamic assessment and adverse drug reaction monitoring."( Comparative efficacy and safety of extended-release and instant-release tolterodine in children with neural tube defects having cystometric abnormalities.
Kaur, B; Mahanta, K; Medhi, B; Narasimhan, KL, 2008
)
0.35
" No adverse effects of hyperpyrexia, flushing or intolerance to outdoor temperatures, or dryness of mouth were observed in either group."( Comparative efficacy and safety of extended-release and instant-release tolterodine in children with neural tube defects having cystometric abnormalities.
Kaur, B; Mahanta, K; Medhi, B; Narasimhan, KL, 2008
)
0.35
" Seven treatment-related adverse events were reported."( Long-term efficacy and safety of tolterodine in children with neurogenic detrusor overactivity.
Borgstein, NG; Ellsworth, PI; Nijman, RJ; Reddy, PP, 2008
)
0.35
")), adverse events, and retention."( Efficacy and safety of tolterodine extended release and dutasteride in male overactive bladder patients with prostates >30 grams.
Chung, DE; Kaplan, SA; Staskin, DR; Te, AE, 2010
)
0.36
" Treatments were generally well tolerated; discontinuation rates due to adverse events were 4%, 2%, 5%, 0%, and 1% with standard- and low-dose pregabalin/tolterodine ER, pregabalin, tolterodine ER, and placebo, respectively."( Investigation of the clinical efficacy and safety of pregabalin alone or combined with tolterodine in female subjects with idiopathic overactive bladder.
Cossons, NH; Darekar, A; Marencak, J; Mills, IW, 2011
)
0.37
" The incidence of adverse events in the tolterodine-treated group (28%) was significantly lower than that in the oxybutnin-treated group (57%) (P<0."( [Comparisons of efficacy and safety of tolterodine and oxybutynin in children with idiopathic overactive bladder].
Chen, CJ; Deng, YJ; Ge, Z; Guo, YF; Lu, RG; Ma, G; Wang, LX; Zhu, HB, 2011
)
0.37
" 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 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
"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
" The safety analysis included adverse event (AE) reporting, laboratory assessments, ECG, postvoid residual volume and vital signs (blood pressure, pulse rate)."( Mirabegron for the treatment of overactive bladder: a prespecified pooled efficacy analysis and pooled safety analysis of three randomised, double-blind, placebo-controlled, phase III studies.
Angulo, JC; Blauwet, MB; Cambronero, J; Dorrepaal, C; Herschorn, S; Khullar, V; Martin, NE; Nitti, VW; Siddiqui, E; van Kerrebroeck, P, 2013
)
0.39
" The incidence of adverse events was 54."( Phase II study on the efficacy and safety of the EP1 receptor antagonist ONO-8539 for nonneurogenic overactive bladder syndrome.
Abrams, P; Andersson, KE; Chapple, CR; Deacon, S; Kuwayama, T; Masuda, T; Radziszewski, P; Small, M, 2014
)
0.4
" The combination was well tolerated, and the adverse effects observed were consistent with the known safety profiles of tolterodine and pilocarpine."( Clinical safety, tolerability and efficacy of combination tolterodine/pilocarpine in patients with overactive bladder.
Dmochowski, RR; Duchin, K; Paborji, M; Staskin, DR; Tremblay, TM, 2014
)
0.4
"9%, 12/308) were the most frequent adverse events."( Efficacy and safety of fesoterodine 8 mg in subjects with overactive bladder after a suboptimal response to tolterodine ER.
Arumi, D; Cardozo, L; Carlsson, M; Crook, TJ; Grenabo, L; Herschorn, S; Kaplan, SA; Ntanios, F; Scholfield, D; Whelan, L, 2014
)
0.4
" 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
" Adverse events (AEs) were not increased with treatment progression."( Efficacy and Safety of Medium-to-long-term Use of Tolterodine Extended Release with or without Tamsulosin in Patients with Benign Prostate Hyperplasia and Larger Prostate Size: A Double-blind, Placebo-controlled, Randomized Clinical Trial.
Cai, JL; Jing, S; Na, YQ; Yan, YF; Yang, Y; Zhou, Z, 2016
)
0.43
" 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
" The primary outcome was safety, measured by incidence of adverse events."( Once-Daily Vibegron 75 mg for Overactive Bladder: Long-Term Safety and Efficacy from a Double-Blind Extension Study of the International Phase 3 Trial (EMPOWUR).
Frankel, J; Jankowich, R; Mudd, PN; Shortino, D; Staskin, D; Varano, S, 2021
)
0.62
"4%) discontinued owing to adverse events."( Once-Daily Vibegron 75 mg for Overactive Bladder: Long-Term Safety and Efficacy from a Double-Blind Extension Study of the International Phase 3 Trial (EMPOWUR).
Frankel, J; Jankowich, R; Mudd, PN; Shortino, D; Staskin, D; Varano, S, 2021
)
0.62
" Studies comparing one or more antimuscarinic drugs for treating OAB with reported adverse effects (AEs) were eligible."( Comparisons of the therapeutic safety of seven oral antimuscarinic drugs in patients with overactive bladder: a network meta-analysis.
Wu, Q; Xu, F; Yang, N; Zhang, X, 2021
)
0.62
"Clinical data on the use of overactive bladder (OAB) medications are limited by the physician interpretation of adverse effects rather than those that are patient reported."( Adverse Events for Overactive Bladder Medications From a Public Federal Database.
Bhojani, N; Chughtai, B; Drangsholt, S; Elterman, D; Sansone, S; Singh, Z; Stoddard, MD; Sze, C; Zorn, K, 2022
)
0.72
" Food and Drug Administration Adverse Event Report System (FAERS) database was queried from 2004 to 2019."( Adverse Events for Overactive Bladder Medications From a Public Federal Database.
Bhojani, N; Chughtai, B; Drangsholt, S; Elterman, D; Sansone, S; Singh, Z; Stoddard, MD; Sze, C; Zorn, K, 2022
)
0.72
" Aim of our study was to analyze real-life data of adverse events related to AMs and B3A reported on Eudra-Vigilance (EV) Database."( Adverse events related to antimuscarinics and beta-3-agonist: "real-life" data from the Eudra-Vigilance Database.
Cicione, A; DE Nunzio, C; DI Giacomo, F; Disabato, G; Franco, A; Gallo, G; Gravina, C; Lombardo, R; Nacchia, A; Rovesti, L; Trucchi, A; Tubaro, A; Turchi, B, 2022
)
0.72
"EV database is the system for managing and analyzing information on suspected adverse reactions to medicines which have been authorized or being studied in clinical trials in the European Economic Area (EEA)."( Adverse events related to antimuscarinics and beta-3-agonist: "real-life" data from the Eudra-Vigilance Database.
Cicione, A; DE Nunzio, C; DI Giacomo, F; Disabato, G; Franco, A; Gallo, G; Gravina, C; Lombardo, R; Nacchia, A; Rovesti, L; Trucchi, A; Tubaro, A; Turchi, B, 2022
)
0.72
" Safety was assessed through adverse events (AEs)."( Efficacy and Safety of Vibegron for the Treatment of Overactive Bladder in Women: A Subgroup Analysis From the Double-Blind, Randomized, Controlled EMPOWUR Trial.
Greene, H; Haag-Molkenteller, C; Newman, DK; Thomas, E; Varano, S, 2023
)
0.91
"In this subgroup analysis, women receiving vibegron showed significant reductions in key efficacy end points versus placebo and favorable safety profile, consistent with the overall results from EMPOWUR, suggesting that vibegron is efficacious and safe for the treatment of OAB in this patient population."( Efficacy and Safety of Vibegron for the Treatment of Overactive Bladder in Women: A Subgroup Analysis From the Double-Blind, Randomized, Controlled EMPOWUR Trial.
Greene, H; Haag-Molkenteller, C; Newman, DK; Thomas, E; Varano, S, 2023
)
0.91

Pharmacokinetics

ExcerptReferenceRelevance
"To determine whether cytochrome P450 2D6 (CYP2D6) is involved in the metabolism of tolterodine by investigating potential differences in pharmacokinetics and pharmacodynamic (heart rate, accommodation, and salivation) of tolterodine and its 5-hydroxymethyl metabolite between poor metabolizers and extensive metabolizers of debrisoquin (INN, debrisoquine)."( Influence of CYP2D6 polymorphism on the pharmacokinetics and pharmacodynamic of tolterodine.
Alván, G; Bertilsson, L; Brynne, N; Dalén, P; Gabrielsson, J, 1998
)
0.3
" The pharmacokinetics of tolterodine and 5-hydroxymethyl metabolite were determined, and the pharmacodynamic were measured."( Influence of CYP2D6 polymorphism on the pharmacokinetics and pharmacodynamic of tolterodine.
Alván, G; Bertilsson, L; Brynne, N; Dalén, P; Gabrielsson, J, 1998
)
0.3
" The elimination of tolterodine from serum was rapid, with a half-life of less than 2 h in all species."( Pharmacokinetics of tolterodine, a muscarinic receptor antagonist, in mouse, rat and dog. Interspecies relationship comparing with human pharmacokinetics.
Kankaanranta, S; Påhlman, I; Palmér, L, 2001
)
0.31
"The new ER formulation of tolterodine shows no pharmacokinetic interaction with food."( Food does not influence the pharmacokinetics of a new extended release formulation of tolterodine for once daily treatment of patients with overactive bladder.
Olsson, B; Szamosi, J, 2001
)
0.31
"The new once daily ER formulation of tolterodine 4mg shows pharmacokinetic equivalence (AUC24) to the existing IR tablet given at a dose of 2mg twice daily."( Multiple dose pharmacokinetics of a new once daily extended release tolterodine formulation versus immediate release tolterodine.
Olsson, B; Szamosi, J, 2001
)
0.31
" Pharmacokinetic assessments were performed on day 14 based on plasma levels of ethinyl estradiol and levonorgestrel up to 24 hours after dosing and serum tolterodine levels at 1 to 3 hours after dosing."( The effect of tolterodine on the pharmacokinetics and pharmacodynamics of a combination oral contraceptive containing ethinyl estradiol and levonorgestrel.
Landgren, BM; Olsson, B, 2001
)
0.31
" There was no evidence of a pharmacokinetic interaction between tolterodine and the steroid hormones in the oral contraceptive used, nor did the oral contraceptive show any relevant pharmacokinetic interaction with tolterodine."( The effect of tolterodine on the pharmacokinetics and pharmacodynamics of a combination oral contraceptive containing ethinyl estradiol and levonorgestrel.
Landgren, BM; Olsson, B, 2001
)
0.31
" These findings indicate that co-administration of tolterodine and warfarin is safe and well tolerated, with no clinically significant pharmacodynamic or kinetic interaction in healthy volunteers."( Effect of tolterodine on the anticoagulant actions and pharmacokinetics of single-dose warfarin in healthy volunteers.
Hallén, B; Narang, P; Rahimy, M, 2002
)
0.31
" The peak concentration ratios for oxybutynin and metabolite also conformed to this range; those for tolterodine did not."( Effect of the proton pump inhibitor omeprazole on the pharmacokinetics of extended-release formulations of oxybutynin and tolterodine.
Chen, A; Dmochowski, R; Gidwani, S; Gupta, S; MacDiarmid, S; Sathyan, G, 2005
)
0.33
" The objective of this study was to establish the pharmacokinetic profile of fesoterodine and to highlight ist potential pharmacokinetic advantages over tolterodine."( The pharmacokinetic profile of fesoterodine: similarities and differences to tolterodine.
Malhotra, B; Simon, HU, 2009
)
0.35
" Blood and urine samples for the analysis of 5-HMT were collected before and multiple times after drug administration for pharmacokinetic analysis."( The pharmacokinetic profile of fesoterodine: similarities and differences to tolterodine.
Malhotra, B; Simon, HU, 2009
)
0.35
"The mean peak plasma concentration (Cmax) of 5-HMT and the mean area under the time versus concentration curve (AUC) increased proportionally with the fesoterodine dose."( The pharmacokinetic profile of fesoterodine: similarities and differences to tolterodine.
Malhotra, B; Simon, HU, 2009
)
0.35
"This head-to-head study confirmed the findings of reduced pharmacokinetic variability of fesoterodine and further delineates that tolterodine, and not 5-HMT, was the principal source of variability after administration of tolterodine extended release."( Comparison of pharmacokinetic variability of fesoterodine vs. tolterodine extended release in cytochrome P450 2D6 extensive and poor metabolizers.
Crownover, P; Darsey, E; Fang, J; Glue, P; Malhotra, B, 2011
)
0.37
" Saliva and plasma samples were collected for 3-5 half-life values of sitagliptin, cinacalcet, metformin, montelukast, tolterodine, hydrochlorothiazide (HCT), lornoxicam, azithromycin, diacerhein, rosuvastatin, cloxacillin, losartan and tamsulosin after oral dosing."( Saliva versus plasma pharmacokinetics: theory and application of a salivary excretion classification system.
Arafat, T; Idkaidek, N, 2012
)
0.38
" To confirm this effect in a clinical setting, we carried out a full pharmacokinetic study of a single oral dose of CYP2D6 substrate tolterodine in 30 healthy Korean individuals (HNF4α wild type: n = 24; HNF4α G60D heterozygotes: n = 6) who were pregenotyped for CYP2D6."( Effect of HNF4α genetic polymorphism G60D on the pharmacokinetics of CYP2D6 substrate tolterodine in healthy Korean individuals.
Ghim, JL; Jiang, F; Kim, DH; Kim, EY; Kim, HS; Lee, SS; Oh, MK; Shin, JG; Shon, JH; Yeo, CW, 2013
)
0.39
" This method was successfully applied to a pharmacokinetic study in humans."( Simultaneous determination of tolterodine and its two metabolites, 5-hydroxymethyltolterodine and N-dealkyltolterodine in human plasma using LC-MS/MS and its application to a pharmacokinetic study.
Byeon, JY; Chae, WK; Jang, CG; Jung, EH; Kim, SH; Kim, YH; Lee, CM; Lee, SY; Lee, YJ, 2017
)
0.46

Compound-Compound Interactions

Tolterodine Tartrate combined with the alpha-receptor blocker Cardura was tested for the treatment of benign prostatic hyperplasia with detrusor overactivity (BPH-DO)

ExcerptReferenceRelevance
" Because older individuals typically take multiple medications, clinicians must pay special attention to potential drug-drug interactions that may cause adverse events or alter drug efficacy."( Treatment of overactive bladder: selective use of anticholinergic agents with low drug-drug interaction potential.
Chancellor, MB; de Miguel, F, 2007
)
0.34
"To compare the efficacy of antimuscarinics alone versus antimuscarinics in combination with local oestrogens for OAB; to verify whether risk factors for lower antimuscarinic efficacy can be overcome by the concomitant use of local oestrogens."( Is there a synergistic effect of topical oestrogens when administered with antimuscarinics in the treatment of symptomatic detrusor overactivity?
Bolis, P; Cardozo, L; Salvatore, S; Serati, M; Uccella, S, 2009
)
0.35
"To assess the efficacy and safety of pregabalin alone or in combination with tolterodine extended release (ER) in subjects with idiopathic OAB."( Investigation of the clinical efficacy and safety of pregabalin alone or combined with tolterodine in female subjects with idiopathic overactive bladder.
Cossons, NH; Darekar, A; Marencak, J; Mills, IW, 2011
)
0.37
"To evaluate the efficacy and safety of Tolterodine Tartrate combined with the alpha-receptor blocker in the treatment of benign prostatic hyperplasia with detrusor overactivity (BPH-DO)."( [Tolterodine tartrate combined with alpha-receptor blocker for benign prostatic hyperplasia with detrusor overactivity].
Gan, W; Jia, HT; Li, YF; Luo, MH; Xie, S; Zhang, SF, 2011
)
0.37
"A total of 113 patients with BPH-DO were randomly assigned to receive Tolterodine Tartrate combined with Cardura (Group A) and Cardura alone (Group B), both for 12 weeks."( [Tolterodine tartrate combined with alpha-receptor blocker for benign prostatic hyperplasia with detrusor overactivity].
Gan, W; Jia, HT; Li, YF; Luo, MH; Xie, S; Zhang, SF, 2011
)
0.37
"To evaluate the therapeutic effect of Parkinson's disease combined with overactive bladder syndrome (GAB) treated with combined therapy of oral administration of Tolterodine with low dose and electroacuponcture."( [Parkinson's disease combined with overactive bladder syndrome treated with acupuncture and medication].
Chen, YL; Feng, WJ; Zhang, XL, 2012
)
0.38
"Sixty cases of Parkinson's disease combined with GAB were randomly divided into a combined acupuncture and medication group (group A) and a medication group (group B), 30 cases in each group."( [Parkinson's disease combined with overactive bladder syndrome treated with acupuncture and medication].
Chen, YL; Feng, WJ; Zhang, XL, 2012
)
0.38
"The therapeutic effect of Parkinson' s disease combined with GAB treated with combined therapy of Tolterodine with low dose and electroacupuncture is superior to that of complete dose of Tolterodine with oral administration, with less adverse reactions."( [Parkinson's disease combined with overactive bladder syndrome treated with acupuncture and medication].
Chen, YL; Feng, WJ; Zhang, XL, 2012
)
0.38
" Alpha blockers in combination with muscarinic receptor antagonists may have the potential to improve symptoms."( A Randomized, Open-Label, Comparative Study of Efficacy and Safety of Tolterodine Combined with Tamsulosin or Doxazosin in Patients with Benign Prostatic Hyperplasia.
Cao, Y; Chen, T; Guo, L; Niu, H; Wang, Y; Yang, X, 2016
)
0.43

Bioavailability

ExcerptReferenceRelevance
" The absolute bioavailability was highly variable, ranging from 10 to 70%."( Pharmacokinetics and pharmacodynamics of tolterodine in man: a new drug for the treatment of urinary bladder overactivity.
Brynne, N; Edlund, PO; Gabrielsson, J; Hallén, B; Höglund, P; Palmér, L; Stahl, MM, 1997
)
0.3
" Improvements in drug delivery systems have altered drug bioavailability and pharmacokinetics."( Advancements in pharmacologic management of the overactive bladder.
Appell, RA; Dmochowski, RR, 2000
)
0.31
" Bioavailability varied between 2-20% in rodents and 58-63% in the dog."( Pharmacokinetics of tolterodine, a muscarinic receptor antagonist, in mouse, rat and dog. Interspecies relationship comparing with human pharmacokinetics.
Kankaanranta, S; Påhlman, I; Palmér, L, 2001
)
0.31
"To determine whether food intake influences the pharmacokinetics of a new, once daily, extended release (ER) capsule formulation of tolterodine in healthy volunteers, and to compare its bioavailability with that of the existing immediate release (IR) tablet."( Food does not influence the pharmacokinetics of a new extended release formulation of tolterodine for once daily treatment of patients with overactive bladder.
Olsson, B; Szamosi, J, 2001
)
0.31
"No effect of food on the bioavailability of tolterodine ER capsules was apparent and there was no sign of dose-dumping with meals."( Food does not influence the pharmacokinetics of a new extended release formulation of tolterodine for once daily treatment of patients with overactive bladder.
Olsson, B; Szamosi, J, 2001
)
0.31
"TCl, a quaternary amine, exhibits high solubility in water but low oral bioavailability (9."( Trospium chloride for the treatment of overactive bladder with urge incontinence.
Machado, C; Singh-Franco, D; Tuteja, S; Zapantis, A, 2005
)
0.33
"This study assessed the effect of the proton pump inhibitor omeprazole on the bioavailability of the extended-release formulations of oxybutynin and tolterodine."( Effect of the proton pump inhibitor omeprazole on the pharmacokinetics of extended-release formulations of oxybutynin and tolterodine.
Chen, A; Dmochowski, R; Gidwani, S; Gupta, S; MacDiarmid, S; Sathyan, G, 2005
)
0.33
" The validated LC-ESI-MS method has been used successfully to study tolterodine tartrate pharmacokinetic, bioavailability and bioequivalence in 20 healthy male volunteers."( High performance liquid chromatography-electrospray ionization mass spectrometric determination of tolterodine tartrate in human plasma.
Tian, Y; Xu, F; Zhang, B; Zhang, Z, 2005
)
0.33
" A prodrug approach was necessary for systemic bioavailability of 5-HMT after oral administration."( The design and development of fesoterodine as a prodrug of 5-hydroxymethyl tolterodine (5-HMT), the active metabolite of tolterodine.
Gandelman, K; Malhotra, B; Michel, MC; Sachse, R; Wood, N, 2009
)
0.35
" The data suggest that fesoterodine delivers 5-HMT consistently, regardless of CYP2D6 status, with up to 40% higher bioavailability compared with tolterodine."( Comparison of pharmacokinetic variability of fesoterodine vs. tolterodine extended release in cytochrome P450 2D6 extensive and poor metabolizers.
Crownover, P; Darsey, E; Fang, J; Glue, P; Malhotra, B, 2011
)
0.37
"49 mg/L, and the absolute bioavailability was 27."( Silicone adhesive, a better matrix for tolterodine patches-a research based on in vitro/in vivo studies.
Chen, Y; Fang, L; Li, C; Liu, C; Liu, J; Mu, L; Sun, L; Wang, Z; Xi, H, 2012
)
0.38
" The absolute bioavailability of tolterodine was 11."( Preparation, characterization and pharmacological evaluation of tolterodine hydrogels for the treatment of overactive bladder.
Li, Y; Liu, X; Shi, Y; Sui, C; Sun, F; Wu, Y; Zhou, Y, 2013
)
0.39
" In the pharmacokinetic studies, sustained-release over 24 h and absolute bioavailability of the hydrogels (24."( Design of transparent film-forming hydrogels of tolterodine and their effects on stratum corneum.
Dai, W; Fu, L; Li, Y; Liu, W; Liu, X; Sun, F; Teng, L; Wu, Y; Zhao, J, 2014
)
0.4
"Relative bioavailability study of tolterodine in healthy human volunteers was done using saliva and plasma matrices in order to investigate the robustness of using saliva instead of plasma as a surrogate for bioavailability and bioequivalence of class III drugs according to the salivary excretion classification system (SECS)."( Saliva versus Plasma Relative Bioavailability of Tolterodine in Humans: Validation of Class III Drugs of the Salivary Excretion Classification System.
Idkaidek, N; Najib, N; Najib, O; Salem, II, 2016
)
0.43

Dosage Studied

ExcerptRelevanceReference
" Tolterodine, in the dosage used, was both objectively and subjectively shown to exert a marked inhibitory effect on micturition in healthy subjects, and the data suggest a more pronounced effect on bladder function than on salivation."( Urodynamic and other effects of tolterodine: a novel antimuscarinic drug for the treatment of detrusor overactivity.
Andersson, KE; Ekström, B; Mattiasson, A; Sparf, B; Stahl, MM, 1995
)
0.29
" An optimal efficacy/side-effect profile is obtained with tolterodine, at a dosage of 1 or 2 mg twice daily, which seems to have less propensity to cause dry mouth than the currently available antimuscarinic drugs."( Tolterodine--a new bladder selective muscarinic receptor antagonist: preclinical pharmacological and clinical data.
Hallén, B; Larsson, G; Nilvebrant, L, 1997
)
0.3
"To investigate the efficacy and safety of tolterodine, a new antimuscarinic agent, and define the optimum dosage in patients with symptoms of detrusor instability (urgency, increased frequency of micturition and/or urge incontinence)."( Efficacy and safety of tolterodine in patients with detrusor instability: a dose-ranging study.
Abrams, P; Cardozo, L; Fall, M; Nelson, E; Rentzhog, L; Stanton, SL, 1998
)
0.3
" at a dosage of 2 mg twice daily, the frequency of micturition, episodes of incontinence and pad use were reduced by 20%, 46% and 29%, respectively, while the volume at first contraction increased by 89 mL."( Efficacy and safety of tolterodine in patients with detrusor instability: a dose-ranging study.
Abrams, P; Cardozo, L; Fall, M; Nelson, E; Rentzhog, L; Stanton, SL, 1998
)
0.3
" The optimum dosage appears to be 1-2 mg twice daily."( Efficacy and safety of tolterodine in patients with detrusor instability: a dose-ranging study.
Abrams, P; Cardozo, L; Fall, M; Nelson, E; Rentzhog, L; Stanton, SL, 1998
)
0.3
" Only minor differences in pharmacodynamic effects after tolterodine dosage were observed between the groups."( Influence of CYP2D6 polymorphism on the pharmacokinetics and pharmacodynamic of tolterodine.
Alván, G; Bertilsson, L; Brynne, N; Dalén, P; Gabrielsson, J, 1998
)
0.3
" In order to assess the optimum dosage for use in future clinical studies, a double-blind, randomized, placebo-controlled, parallel-group, multicenter study was performed in 90 patients with detrusor hyperreflexia and symptoms of urinary urgency, frequency, and/or urge incontinence."( Dose-ranging study of tolterodine in patients with detrusor hyperreflexia.
Amarenco, G; Lock, MT; Madersbacher, HG; Messelink, EJ; Soler, JM; Thüroff, JW; Van Kerrebroeck, PE, 1998
)
0.3
" Despite short terminal disposition half-lives of 2-3 and 3-4 hours for tolterodine and its active 5-hydroxy metabolite, respectively, twice/day dosing is effective due to the drug's prolonged pharmacodynamic effects."( Tolterodine, a new antimuscarinic drug for treatment of bladder overactivity.
Guay, DR, 1999
)
0.3
" A dosage of 4 mg twice daily was, however, associated with an increase in residual urinary volume."( Tolterodine in the treatment of overactive bladder: analysis of the pooled phase II efficacy and safety data.
Hallén, B; Larsson, G; Nilvebrant, L, 1999
)
0.3
" The optimal dosage is 1 to 2 mg twice daily, irrespective of metabolic phenotype."( Tolterodine in the treatment of overactive bladder: analysis of the pooled phase II efficacy and safety data.
Hallén, B; Larsson, G; Nilvebrant, L, 1999
)
0.3
" Drug dosage in the 20 patients who tolerated tolterodine was 1 mg bid in 3 and 2 mg bid in 17 (85%)."( Tolterodine for overactive bladder: time to onset of action, preferred dosage, and 9-month follow-up.
Atan, A; Chancellor, MB; Erickson, JR; Kim, DY; Konety, BR; Yokoyama, T, 1999
)
0.3
" The adverse effect profiles of tolterodine and oxybutynin are similar; however, comparative clinical trials have shown significantly fewer patients taking tolterodine require dosage reductions or discontinue therapy due to antimuscarinic adverse effects such as dry mouth."( Tolterodine use for symptoms of overactive bladder.
Morgenstern, NE; Ruscin, JM, 1999
)
0.3
" The warfarin dosage had remained constant for many weeks in both patients prior to and during the tolterodine trials."( Tolterodine-warfarin drug interaction.
Colucci, VJ; Rivey, MP, 1999
)
0.3
" Similarly, the potential improvements in tolerability associated with different dosage formulations of oxybutynin, and the clinical utility of S-oxybutynin, are yet to be conclusively demonstrated."( Muscarinic receptor antagonists in the treatment of overactive bladder.
Chapple, CR, 2000
)
0.31
" The distribution pattern after repeat oral dosing was similar to that after a single dose, although the decline in tissue concentrations was slower."( Tissue distribution of tolterodine, a muscarinic receptor antagonist, and transfer into fetus and milk in mice.
d'Argy, R; Nilvebrant, L; Påhlman, I, 2001
)
0.31
" The intestinal absorption of tolterodine after oral dosing was almost complete in all three species, with peak serum concentrations observed within 1 hour post-dose."( Pharmacokinetics of tolterodine, a muscarinic receptor antagonist, in mouse, rat and dog. Interspecies relationship comparing with human pharmacokinetics.
Kankaanranta, S; Påhlman, I; Palmér, L, 2001
)
0.31
"There were no safety concerns in terms of the change in residual urinary volume for any of the three dosage groups; values were comparable with baseline after 2 weeks of treatment for all three dosages."( The overactive bladder in children: a potential future indication for tolterodine.
Hellström, AL; Hjälmås, K; Läckgren, G; Mogren, K; Stenberg, A, 2001
)
0.31
" Dosage reduction occurred in 13% of patients."( Treatment of overactive bladder: long-term tolerability and efficacy of tolterodine.
Abrams, P; Appell, RA; Drutz, HP; Millard, R; Van Kerrebroeck, PE; Wein, A, 2001
)
0.31
" Neither dosage of tolterodine was associated with serious drug-related adverse events during the study."( Tolterodine: a safe and effective treatment for older patients with overactive bladder.
Malone-Lee, JG; Maugourd, MF; Walsh, JB, 2001
)
0.31
"Tolterodine (taken for 4 weeks) is safe and shows efficacy, particularly at a dosage of 2 mg bid, in the treatment of older patients with urinary symptoms attributable to overactive bladder."( Tolterodine: a safe and effective treatment for older patients with overactive bladder.
Malone-Lee, JG; Maugourd, MF; Walsh, JB, 2001
)
0.31
" Dosage reduction to 1 mg twice daily was required in 23% of patients."( Twelve-month treatment of overactive bladder: efficacy and tolerability of tolterodine.
Abrams, P; Jacquetin, B; Jonas, U; Malone-Lee, J; Tammela, T; Wein, A; Wyndaele, JJ, 2001
)
0.31
" Pharmacokinetic assessments were performed on day 14 based on plasma levels of ethinyl estradiol and levonorgestrel up to 24 hours after dosing and serum tolterodine levels at 1 to 3 hours after dosing."( The effect of tolterodine on the pharmacokinetics and pharmacodynamics of a combination oral contraceptive containing ethinyl estradiol and levonorgestrel.
Landgren, BM; Olsson, B, 2001
)
0.31
" The convenience of once-daily dosing of antimuscarinic agents would be expected to improve patient compliance and further relieve the symptoms of OAB."( Once-daily, extended-release formulations of antimuscarinic agents in the treatment of overactive bladder: a review.
Rovner, ES; Wein, AJ, 2002
)
0.31
" Therefore, these results suggest that the normal dosage of tolterodine (2 mg twice daily) may have less effect on visual accommodation than the equivalent dosage of oxybutynin (5 mg three times daily) in patients with an overactive bladder."( Tolterodine: selectivity for the urinary bladder over the eye (as measured by visual accommodation) in healthy volunteers.
Chapple, CR; Nilvebrant, L, 2002
)
0.31
" The dose was titrated until effective (onset of complete diurnal urinary continence), maximal recommended dosage was achieved or bothersome anticholinergic side effects developed."( Therapeutic efficacy of extended release oxybutynin chloride, and immediate release and long acting tolterodine tartrate in children with diurnal urinary incontinence.
Crocker, J; Reinberg, Y; Vandersteen, D; Wolpert, J, 2003
)
0.32
" Peak plasma concentrations of oxybutynin and the major active metabolite, N-desethyloxybutynin, are reached 24 - 48 hours after a single application and therapeutic concentrations are maintained throughout the dosage interval."( Transdermal oxybutynin: for overactive bladder.
Bang, LM; Easthope, SE; Perry, CM, 2003
)
0.32
" New antimuscarinic anticholinergic medications have improved the treatment of OAB, offering patients efficacy equal to that of immediate-release oxybutynin with fewer side effects and an improved dosing schedule."( Overactive bladder: improving the efficacy of anticholinergics by dose escalation.
MacDiarmid, SA, 2003
)
0.32
"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
)
0.32
"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
)
0.32
" The efficacy of oxybutynin chloride has been sufficiently proved; however its dosage and side effects, although scarce in children, usually cause treatment discontinuation."( [Treatment of bladder instability (non-neurogenic hyperactive bladder) in children, with tolterodine].
Caffaratti Sfulcini, J; de la Peña, E; Garat Barredo, JM, 2004
)
0.32
" These findings suggest that there should not be a need for routine adjustment of tolterodine dosage in the presence of duloxetine."( Effect of duloxetine on tolterodine pharmacokinetics in healthy volunteers.
Chan, C; Gonzales, CR; Hua, TC; Knadler, MP; Pan, A; Poo, YK; Skinner, MH; Wise, SD, 2004
)
0.32
" Clinically relevant drug interactions are limited to cytochrome P450 3A4 inhibitors, such as ketoconazole, and co-administration with such agents warrants a tolterodine dosage decrease."( Benefit-risk assessment of tolterodine in the treatment of overactive bladder in adults.
Burrows, L; Garely, AD, 2004
)
0.32
" Tolterodine at the recommended dosage of 2 mg twice daily improves incontinence and bladder volumes compared with placebo, and without significant dry mouth."( Efficacy and safety of tolterodine in people with neurogenic detrusor overactivity.
Bard, RJ; Casey, AR; Ethans, KD; Nance, PW; Schryvers, OI, 2004
)
0.32
" While trospium chloride dosage adjustments based on age or sex appear unwarranted, such adjustments may be needed in patients with severe renal impairment."( Trospium chloride in the management of overactive bladder.
Rovner, ES, 2004
)
0.32
" This finding may be explained by a high placebo response and under dosage of tolterodine among children with greater body weight."( Tolterodine treatment for children with symptoms of urinary urge incontinence suggestive of detrusor overactivity: results from 2 randomized, placebo controlled trials.
Borgstein, NG; Djurhuus, JC; Ellsworth, P; Nijman, RJ, 2005
)
0.33
" Exploratory analyses also showed that children weighing 35 kg or less with detrusor overactivity characterized by incontinence and/or frequent voiding benefited most from tolterodine treatment, suggesting that a weight adjusted dosing regimen may be required for optimal response among older and heavier children."( Tolterodine treatment for children with symptoms of urinary urge incontinence suggestive of detrusor overactivity: results from 2 randomized, placebo controlled trials.
Borgstein, NG; Djurhuus, JC; Ellsworth, P; Nijman, RJ, 2005
)
0.33
"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
)
0.33
"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
)
0.33
" We urodynamically evaluated the dose and concentration effects of tolterodine to establish safe and effective dosing regimens."( Use of tolterodine in children with neurogenic detrusor overactivity: relationship between dose and urodynamic response.
Borgstein, NG; Ellsworth, PI; Nijman, RJ; Reddy, PP, 2005
)
0.33
" PK was assessed after 8 weeks, urodynamic assessments were conducted after each 4-week dosing period and 3-day micturition diaries were completed."( Use of tolterodine in children with neurogenic detrusor overactivity: relationship between dose and urodynamic response.
Borgstein, NG; Ellsworth, PI; Nijman, RJ; Reddy, PP, 2005
)
0.33
" In study 3 (11 patients) there were no obvious dose-response relationships."( Use of tolterodine in children with neurogenic detrusor overactivity: relationship between dose and urodynamic response.
Borgstein, NG; Ellsworth, PI; Nijman, RJ; Reddy, PP, 2005
)
0.33
"These results support the safety of age and body weight adjusted dosing regimens for further clinical evaluation of tolterodine in children with neurogenic detrusor overactivity."( Use of tolterodine in children with neurogenic detrusor overactivity: relationship between dose and urodynamic response.
Borgstein, NG; Ellsworth, PI; Nijman, RJ; Reddy, PP, 2005
)
0.33
" The antagonistic effect of oral tolterodine on the dose-response curves to pilocarpine was significantly weaker than that of oxybutynin."( Characterization of muscarinic receptor binding and inhibition of salivation after oral administration of tolterodine in mice.
Maruyama, S; Oki, T; Takagi, Y; Yamada, S; Yamamura, HI, 2006
)
0.33
"To evaluate the efficacy and tolerability of nighttime tolterodine dosing on urgency-related micturitions in patients with overactive bladder (OAB) and nocturia."( Nighttime dosing with tolterodine reduces overactive bladder-related nocturnal micturitions in patients with overactive bladder and nocturia.
Guan, Z; Rackley, R; Rovner, ES; Wang, JT; Weiss, JP, 2006
)
0.33
" Adverse events associated with nighttime dosing of TER versus placebo were few."( Nighttime dosing with tolterodine reduces overactive bladder-related nocturnal micturitions in patients with overactive bladder and nocturia.
Guan, Z; Rackley, R; Rovner, ES; Wang, JT; Weiss, JP, 2006
)
0.33
" Nighttime dosing with TER was associated with few adverse events and adverse event-related withdrawals."( Nighttime dosing with tolterodine reduces overactive bladder-related nocturnal micturitions in patients with overactive bladder and nocturia.
Guan, Z; Rackley, R; Rovner, ES; Wang, JT; Weiss, JP, 2006
)
0.33
" On her next anticoagulation clinic visit, the patient's INR had increased, although the dosage of warfarin had been reduced when the tolterodine had been prescribed."( Probable interaction between tolterodine and warfarin.
Taylor, JR, 2006
)
0.33
"The dosage of the antimuscarinic drugs: Tolterodine ER or Trospium was increased to a higher-than-recommended dosage in patients where the manufacturer's recommended dosage had failed."( Neurogenic bladder treatment by doubling the recommended antimuscarinic dosage.
Aguilar, Y; Horstmann, M; Schaefer, T; Sievert, KD; Stenzl, A, 2006
)
0.33
" If neurogenic detrusor overactivity continued and the medication was well tolerated, the dosage was doubled to either 8 mg of Tolterodine ER [2 x 4 mg (n = 11)] or 90 mg of Trospium [3 x 30 mg (n = 10)]."( Neurogenic bladder treatment by doubling the recommended antimuscarinic dosage.
Aguilar, Y; Horstmann, M; Schaefer, T; Sievert, KD; Stenzl, A, 2006
)
0.33
"The increased dosage of Tolterodine or Trospium is an effective treatment in patients with neurogenic bladder."( Neurogenic bladder treatment by doubling the recommended antimuscarinic dosage.
Aguilar, Y; Horstmann, M; Schaefer, T; Sievert, KD; Stenzl, A, 2006
)
0.33
"To evaluate the efficacy and safety of nighttime dosing with tolterodine extended release (TER) in men with overactive bladder (OAB) and nocturia."( Tolterodine extended release improves overactive bladder symptoms in men with overactive bladder and nocturia.
Dmochowski, R; Guan, Z; Kaplan, SA; Roehrborn, CG; Rovner, ES; Wang, JT, 2006
)
0.33
"Nighttime TER dosing reduced urgency-related micturitions and was well tolerated in men with OAB and nocturia."( Tolterodine extended release improves overactive bladder symptoms in men with overactive bladder and nocturia.
Dmochowski, R; Guan, Z; Kaplan, SA; Roehrborn, CG; Rovner, ES; Wang, JT, 2006
)
0.33
" It is a rare complication of therapy for overactive bladder and resolved when dosage was reduced to 1 mg, although overactive bladder symptoms were still controlled."( Cognitive dysfunction with tolterodine use.
Bolis, P; Cardozo, L; Salvatore, S; Serati, M; Uccella, S, 2007
)
0.34
"To evaluate the efficacy of tamsulosin oral-controlled absorption system (OCAS) vs placebo in overactive bladder (OAB), to evaluate the safety and tolerability of once-daily dosing with tamsulosin OCAS, and to compare the efficacy and safety with tolterodine extended-release (ER)."( A randomized double-blind placebo-controlled multicentre study to explore the efficacy and safety of tamsulosin and tolterodine in women with overactive bladder syndrome.
Bolodeoku, J; Cardozo, L; Robinson, D; Terpstra, G, 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
"14]) but did not resolve urinary incontinence, with no significant dose-response association."( Systematic review: randomized, controlled trials of nonsurgical treatments for urinary incontinence in women.
Kane, RL; Shamliyan, TA; Wilt, TJ; Wyman, J, 2008
)
0.35
"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
"Only patients with primary nocturnal enuresis refractory to the maximal dosage of desmopressin were enrolled."( Combination therapy with desmopressin and an anticholinergic medication for nonresponders to desmopressin for monosymptomatic nocturnal enuresis: a randomized, double-blind, placebo-controlled trial.
Austin, PF; Campigotto, MJ; Coplen, DE; Ferguson, G; Royer, ME; Yan, Y, 2008
)
0.35
" Therefore, in contrast to tolterodine, no reduction of fesoterodine dosage is required under conditions of reduced elimination."( The pharmacokinetic profile of fesoterodine: similarities and differences to tolterodine.
Malhotra, B; Simon, HU, 2009
)
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
" Drug pharmacokinetics was studied after transdermal application to human volunteers compared to the commercial oral dosage form using a newly developed LC-MS/MS assay."( Utility of nanosized microemulsion for transdermal delivery of tolterodine tartrate: ex-vivo permeation and in-vivo pharmacokinetic studies.
Elshafeey, AH; Fathallah, MM; Kamel, AO, 2009
)
0.35
" At least partially due to the avoidance of variations in pharmacokinetic exposures observed with tolterodine, it was possible to develop fesoterodine with the flexibility of two efficacious and well-tolerated dosage regimens of 4 and 8 mg daily."( The design and development of fesoterodine as a prodrug of 5-hydroxymethyl tolterodine (5-HMT), the active metabolite of tolterodine.
Gandelman, K; Malhotra, B; Michel, MC; Sachse, R; Wood, 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
" Therefore, the developed sustained-release tablet formulation of TOL could be an alternative dosage form to the SR capsule for treatment of OAB."( Preparation and evaluation of once-daily sustained-release coated tablets of tolterodine-L-tartrate.
Chang, SW; Kim, JO; Kim, YI; Pradhan, R, 2014
)
0.4
"We aimed to clarify the impact of night-time dosing with tolterodine extended release (ER) on nocturia."( Tolterodine treatment of women with overactive bladder syndrome: Comparison of night-time and daytime dosing for nocturia.
Hsiao, SM; Lin, HH; Tsai, KH, 2017
)
0.46
" Thirty-six patients were in the daytime dosing group, and the other 36 patients were in the night-time dosing group."( Tolterodine treatment of women with overactive bladder syndrome: Comparison of night-time and daytime dosing for nocturia.
Hsiao, SM; Lin, HH; Tsai, KH, 2017
)
0.46
"Night-time dosing of tolterodine ER may benefit female patients suffering from nocturia due to a greater voided volume per micturition at midnight."( Tolterodine treatment of women with overactive bladder syndrome: Comparison of night-time and daytime dosing for nocturia.
Hsiao, SM; Lin, HH; Tsai, KH, 2017
)
0.46
" Tolterodine ER was dosed at 4 mg for 8 weeks and mirabegron was dosed at 25 mg for 4 weeks then increased to 50 mg for the next 4 weeks."( Patient-reported outcomes in patients with overactive bladder treated with mirabegron and tolterodine in a prospective, double-blind, randomized, two-period crossover, multicenter study (PREFER).
Fialkov, J; Gooch, K; Herschorn, S; Schermer, CR; Staskin, D; Tu, LM; Walsh, T, 2018
)
0.48
"To study the dosage regimen of oral M-receptor blocker following transurethral resection of the prostate (TURP) for severe benign prostate hyperplasia (BPH) with predominant urine storage period symptoms (USPSs) and its clinical effect."( [A dosage regimen of M-receptor blocker after TURP for severe BPH with predominant urine storage symptoms].
Cai, JL; Chen, D; Han, JC; Li, NC; Na, YQ; Song, YF; Xia, M; Xiao, JT, 2017
)
0.46
"Four to eight weeks of oral administration of M-receptor blocker may be an effective dosage regimen for severe BPH with predominant USPSs after TURP."( [A dosage regimen of M-receptor blocker after TURP for severe BPH with predominant urine storage symptoms].
Cai, JL; Chen, D; Han, JC; Li, NC; Na, YQ; Song, YF; Xia, M; Xiao, JT, 2017
)
0.46
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (1)

ClassDescription
tartrate saltA salt of the organic compound tartaric acid.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Research

Studies (681)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's36 (5.29)18.2507
2000's375 (55.07)29.6817
2010's229 (33.63)24.3611
2020's41 (6.02)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials258 (36.34%)5.53%
Reviews106 (14.93%)6.00%
Case Studies17 (2.39%)4.05%
Observational6 (0.85%)0.25%
Other323 (45.49%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (89)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
[NCT01291316]Phase 1/Phase 225 participants (Actual)Interventional2010-04-30Completed
Linking Altered Central Pain Processing and Genetic Polymorphism to Drug Efficacy in Chronic Low Back Pain [NCT01179828]Phase 3150 participants (Actual)Interventional2010-07-31Completed
International, Multicenter, Open-label, Randomized, Comparative Clinical Study of Efficiency and Safety of Medicinal Product Uritos® (Imidafenacin, Film-coated Tablets; 0,1 mg, Kyorin Pharmaceutical Co. Ltd, Japan) and Urotol® (Tolterodine, Film-coated Ta [NCT03575702]Phase 3300 participants (Actual)Interventional2016-07-18Completed
STUDY The Effect of HNF-4A G60D Variant on the In VIVO CYP2D6 Activity By Tolterodine Pharmacokinetic Study [NCT01181505]Phase 131 participants (Actual)Interventional2007-01-31Completed
An International Phase 3, Randomized, Double-Blind, Placebo- and Active (Tolterodine)-Controlled Multicenter Study to Evaluate the Safety and Efficacy of Vibegron in Patients With Symptoms of Overactive Bladder [NCT03492281]Phase 31,530 participants (Actual)Interventional2018-03-26Completed
Effect of Combined Use of Tolterodine and Continuous Positive Airway Pressure vs Continuous Positive Airway Pressure Only Treatment on Overactive Bladder Symptoms in Women With Moderate-to-severe Obstructive Sleep Apnea Syndrome: A Randomized Clinical Tri [NCT05250245]Phase 460 participants (Actual)Interventional2020-06-01Completed
Double Blind Exploratory Three Arm Randomized Trial to Evaluate the Safety and Efficacy of Herbal Preparation 'Herbmed Plus' in Ureteral Stent Discomfort [NCT01356355]Phase 2140 participants (Actual)Interventional2012-04-30Completed
Treatment Persistence Among Patients With Overactive Bladder: A Retrospective Secondary Data Analysis in Asia Oceania [NCT03602508]5,589 participants (Actual)Observational2018-07-20Completed
[NCT01282840]676 participants (Actual)Interventional2010-07-20Completed
Behavior Enhances Drug Reduction of Incontinence [NCT00090584]307 participants (Actual)Interventional2004-08-31Completed
An International Phase 3, Randomized, Double-Blind, Active (Tolterodine)-Controlled Multicenter Extension Study to Evaluate the Long-Term Safety and Efficacy of Vibegron in Patients With Symptoms of Overactive Bladder [NCT03583372]Phase 3506 participants (Actual)Interventional2018-06-14Completed
Comparisons of the Impact of Monotherapy With Mirabegron or Tolterodine Versus Combined Treatment With Mirabegron and Tolterodine on Autonomic Function and Bladder Blow Flow in Women With Overactive Bladder Syndrome: a Randomized Controlled Study [NCT05946902]Phase 4150 participants (Anticipated)Interventional2023-09-12Recruiting
Efficacy Comparison Between Different Management Strategies for Consistent Overactive Bladder (OAB) in Patients With Spinal Vascular Malformations After Surgery [NCT03280316]100 participants (Anticipated)Interventional2023-01-31Not yet recruiting
Effects of Amitriptyline on Central Pain Processing in Healthy Volunteers Depending on CYP Pharmacogenetics [NCT02256956]Phase 448 participants (Actual)Interventional2014-11-30Completed
A Placebo Controlled Randomized, 12-week, Dose-ranging, Double-blind Study Versus Placebo Using Tolterodine as a Study Calibrator, to Evaluate Efficacy and Safety of SSR240600C in Women With Overactive Bladder Including Urge Urinary Incontinence [NCT00564226]Phase 2345 participants (Actual)Interventional2007-11-30Completed
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 Phase IIb Randomized, Placebo- and Active Comparator (Tolterodine)-Controlled, 2-Part Clinical Study of the Efficacy and Safety of MK-4618 in Patients With Overactive Bladder A 52-week Extension to: A Phase IIb Randomized, Placebo- and Active Comparator [NCT01314872]Phase 21,395 participants (Actual)Interventional2011-03-31Completed
A Randomised, Multi-Centre, Double-Blind, Placebo and Active-Controlled, 5-Way Parallel Group Study to Investigate the Efficacy, Safety and Tolerability of ONO-8539 in Patients With Overactive Bladder [NCT00876421]Phase 2435 participants (Actual)Interventional2009-04-30Completed
Low Dose Tadalafil 5mg for Treatment of Female Overactive Bladder Syndrome :6 Months Follow up [NCT04500860]Phase 190 participants (Actual)Interventional2020-12-01Completed
A Prospective, Non-interventional, Registry Study of Patients Initiating Pharmacologic Therapy for Overactive Bladder in Taiwan, Korea and China [NCT03572231]805 participants (Actual)Observational2018-07-19Completed
Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics [NCT04090190]Phase 420 participants (Actual)Interventional2019-10-30Completed
Effects of Amitriptyline on Central Pain Processing in Healthy Volunteers Depending on CYP Pharmacogenetics [NCT02256943]Phase 448 participants (Actual)Interventional2014-11-30Completed
Exploring Predictors of Symptoms Relapse After Discontinuation of Successful Treatment With a Tolterodine Prolonged Release Capsules (4 mg, Once Daily) in Overactive Bladder Patients: A Prospective Randomized Multicenter Trial [NCT00730535]Phase 4173 participants (Actual)Interventional2006-08-31Completed
A Phase 2, 26 Week, Multicentre, Randomized Double Blind, Placebo-Controlled, Crossover Study Evaluating the Efficacy and Safety of Tolterodine, Pregabalin and a Tolterodine-Pregabalin Combination for Idiopathic Overactive Bladder [NCT00746681]Phase 2188 participants (Actual)Interventional2005-12-31Completed
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
Double-Blind Crossover Comparative Ambulatory Urodynamic Monitoring (AUM) Study of Tolterodine PR and Propiverine in Korean Patients With Overactive Bladder (OAB) [NCT00646880]Phase 341 participants (Actual)Interventional2003-03-31Completed
Assessment of Patient-reported Goal Attainment in the Treatment of Female Overactive Bladder (Phase Ⅳ) [NCT00836381]Phase 456 participants (Actual)Interventional2009-02-28Completed
Effects of THVD-201 on Pharmacokinetics and Pharmacodynamics of Tolterodine in Healthy Subjects [NCT01036035]Phase 118 participants (Actual)Interventional2009-09-30Completed
Effects of Gaba-a-Agonists on Pain Mechanisms: An Experimental Study in Healthy Volunteers [NCT01011036]Phase 317 participants (Actual)Interventional2009-12-31Completed
Randomized Controlled Trial of Tolterodine in Combination With or Without Low-Dose Intravaginal Estradiol Cream for the Treatment of Overactive Bladder in Post-Menopausal Women [NCT00465894]58 participants (Actual)Interventional2007-04-30Completed
A 3-way Cross-over, Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess Pharmacologic Effects of a 7-day Exposure to Darifenacin 15 mg o.d. and Tolterodine ER 4 mg o.d. on Cardiovascular Parameters in Healthy Subjects 50 Years of Age [NCT00703703]Phase 1117 participants (Actual)Interventional2008-05-31Completed
Symptom Specific Effectiveness of Tolterodine ER 4 mg in Patients With Symptoms of Overactive Bladder (OAB) in a Primary Care Setting. A Phase IV, Open-label, Single-arm, Non-randomized, Trial in Adult Patients With OAB. [NCT00645281]Phase 4896 participants (Actual)Interventional2004-03-31Completed
A Randomized, Double-Blind, Parallel Group, Placebo and Active Controlled, Multicenter Study to Assess the Efficacy and Safety of Mirabegron in Subjects With Symptoms of Overactive Bladder [NCT00689104]Phase 32,336 participants (Actual)Interventional2008-04-28Completed
The Clinical Efficacy of Pelvic Organ Prolapse Surgery [NCT02599311]Phase 31,000 participants (Anticipated)Interventional2015-08-31Recruiting
Special Investigation For Long Term Use Of Detrusitol (Regulatory Post Marketing Commitment Plan). [NCT00795509]374 participants (Actual)Observational2007-08-31Completed
12-Week, Randomized, Double-Blind, Double-Dummy,Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Comparison To Tolterodine ER In Patients With Overactive Bladder (OAB) [NCT00444925]Phase 31,712 participants (Actual)Interventional2007-04-30Completed
12-Week, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Comparison To Tolterodine ER In Patients With Overactive Bladder. [NCT00611026]Phase 32,417 participants (Actual)Interventional2008-02-29Completed
Efficacy Study of Tamsulosin and Tolterodine Treatment of Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome and Lower Urinary Tract Symptoms [NCT00913315]30 participants (Anticipated)Interventional2009-08-31Not yet recruiting
Is There A Synergic Effect Of Topical Oestrogens When Associated To Antimuscarinics In The Treatment Of Symptomatic Detrusor Overactivity [NCT00648310]Phase 2/Phase 30 participants Interventional2004-01-31Completed
Phase III Study of YM178 - A Placebo-controlled, Double-blind, Group Comparison Study in Patients With Overactive Bladder [NCT00966004]Phase 31,139 participants (Actual)Interventional2009-07-31Completed
A Randomized, Double-Blind, Parallel Group, Active Controlled, Multi-center Long-term Study to Assess the Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) 50 mg qd and 100 mg qd in Subjects With Symptoms of Overactive Bladder [NCT00688688]Phase 32,792 participants (Actual)Interventional2008-04-25Completed
A Randomized, Double-blind, Placebo and Active-controlled Efficacy and Safety Study of SSR240600C in Patients With Overactive Bladder (OAB) or Urge Urinary Incontinence (UUI) [NCT00174798]Phase 2118 participants (Actual)Interventional2005-05-31Completed
"Comparison of the Efficacy and Safety of Combination Treatment With Doxazosin Plus TolterodineSR 2 mg vs Doxazosin Plus TolterodineSR 4 mg in Men With an OAB/BPO: Randomized Controlled Study" [NCT00922506]Phase 483 participants (Actual)Interventional2009-05-31Completed
A Randomized, Double Blind, Placebo Controlled, Phase III Study of KUC-7483 in Patients With Overactive Bladder [NCT01004315]Phase 3750 participants (Anticipated)InterventionalCompleted
Phase III Study of YM178: A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multi-center Study in Subjects With Symptoms of Overactive Bladder [NCT01043666]Phase 31,126 participants (Actual)Interventional2009-12-31Completed
A 3-Way Cross-Over, Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Pharmacologic Effects of a 7-Day Exposure to Darifenacin 15 mg o.d. and Tolterodine ER 4 mg o.d on Cardiovascular Parameters in Healthy Subjects 50 Years of [NCT00413790]Phase 4162 participants (Actual)Interventional2006-11-30Completed
Post-Marketing Study of Mirabegron - A Pharmacokinetic Study to Assess Drug-Drug Interaction Between Mirabegron and Tolterodine - [NCT01964183]Phase 424 participants (Actual)Interventional2013-06-30Completed
Cognitive, Urinary, and Functional Trajectories of Older Women Using Pharmacologic Treatment Strategies for Urgency Incontinence [NCT05362292]Phase 4270 participants (Anticipated)Interventional2022-10-04Recruiting
A Randomized, Double-blind, Parallel Group, Proof of Concept Study of YM178 in Comparison With Placebo and Tolterodine in Patients With Symptomatic Overactive Bladder [NCT01604928]Phase 2260 participants (Actual)Interventional2004-04-30Completed
Effect of Long Acting Anticholinergic on Nocturnal Incontinence After Radical Cystectomy and Orthotopic Neobladder. A Randomized Placebo-controlled Crossover Study [NCT02877901]Phase 2/Phase 3120 participants (Actual)Interventional2016-05-31Completed
Exploratory, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single Center, Web-Based Phase IV Pilot Methodology Trial To Evaluate The Efficacy And Safety Of Tolterodine ER In Subjects With Overactive Bladder [NCT01302938]Phase 418 participants (Actual)Interventional2011-03-31Terminated(stopped due to Stop date for randomization: 31/5/2012. Recruitment terminated due to lack of recruitment. No new safety issues were identified.)
A Comparison Study on Efficacies of Electrical Pudendal Nerve Stimulation and Tolterodine Tartrate for Urgency-Frequency Syndrome in Women [NCT02723279]120 participants (Actual)Interventional2016-04-30Completed
Combined Behavioral and Drug Treatment of Overactive Bladder in Men [NCT01175382]Phase 2/Phase 3204 participants (Actual)Interventional2010-07-31Completed
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
The Applicability of the OAB Assessment Tool for Evaluation of Treatment Efficacy of Overactive Bladder. [NCT00313924]Phase 4100 participants Interventional2006-02-28Recruiting
Effects of Tolterodine, a Non-Specific Muscarinic Antagonist, on Gastrointestinal Transit in Healthy Subjects [NCT00332137]Phase 236 participants Interventional2005-09-30Completed
A Multi-centre, Randomised, Placebo Controlled, Double Blind, Parallel Group Study in Female Patients to Evaluate Whether Tolterodine ER Can Reverse the Increased Bladder Wall Thickness in Patients With Overactive Bladder. [NCT00137397]Phase 480 participants Interventional2004-11-30Completed
A Multicenter, Randomized, Double-Blind, Parallel Group, Phase II, Forced Dose Titration Study to Investigate the Efficacy and Safety of 400mg and 600mg ELB245 Given Once Daily for 12 Weeks (8 + 4 Weeks) Versus Placebo and Versus 4mg Tolterodine Given Onc [NCT00439192]Phase 2275 participants (Anticipated)Interventional2007-02-28Terminated(stopped due to side effect profile did not match expectations)
A Multi-Center, Double-Phase, Randomized, Double-Blind, Placebo Controlled (12-Week Double-Blind Followed by 12-Week Open-Label) Study Evaluating the Effect of Tolterodine ER on Urgency Urinary Incontinence (UUI), Urgency, Frequency, Sexual Quality of Lif [NCT00143481]Phase 4400 participants Interventional2005-03-31Completed
A Randomized, Double Blind, Placebo Controlled, Four Arm (Placebo, Tolterodine ER, Tamsulosin, and Tolterodine ER Plus Tamsulosin) Study To Evaluate The Clinical Efficacy And Safety Of Tolterodine ER 4 mg In Men Who Have Frequency and Urgency, With Or Wit [NCT00147654]Phase 4830 participants Interventional2004-11-30Completed
A Phase III Randomized, Double-Blind, Double Dummy, Multi-Center Study To Compare The Efficacy, Safety And Tolerability Of Tolterodine Extended Release Capsule With Tolterodine Immediate Release Tablet In Subjects With Symptoms Of Overactive Bladder [NCT00139724]Phase 3260 participants (Actual)Interventional2005-05-31Completed
A Randomized, Double-blind, Placebo-controlled, Study of Safety and Efficacy of Dutasteride in Combination With Tolterodine ER or Placebo in Men With Lower Urinary Tract Symptoms (LUTS) Including Urgency and Frequency [NCT00939120]Phase 446 participants (Actual)Interventional2009-07-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Three Arm Study To Evaluate The Effects Of Tolterodine ER 4 mg Vs. Placebo Vs. Oxybutynin ER On Memory And Other Cognitive Abilities In Elderly Subjects [NCT00411437]Phase 4220 participants Interventional2006-12-31Completed
Evaluation of Sympathetic Skin Responses and Heart Rate Variability as Objective Measures of Bladder Sensation - a Double Blind Third Party Open Placebo Controlled Randomised Study Using a Single Dose of Tolterodine in Patients With Idiopathic Overactive [NCT00481728]Phase 128 participants (Anticipated)Interventional2007-06-30Completed
Is the a Difference Between Rehabilitation Treatment, Pelvic Floor Muscle Training, Bladder Training and Anticholinergic Drug Treatment in UUI in the Long Term: A Study of Impairment, Quality of Life, and Cost Effectiveness [NCT00498888]164 participants (Actual)Interventional2007-06-30Completed
Randomized Pilot Study on the Treatment of Mixed Urinary Incontinence: Pharmacological Treatment (Tolterodine SR) vs Surgery With Tension Free Vaginal Tape [NCT00523068]Phase 440 participants (Anticipated)Interventional2007-09-30Not yet recruiting
Phase III Study of Propiverine Hydrochloride Extended-Release Capsule in the Treatment of Overactive Bladder (OAB) in Chinese Population With Urgent Micturition, Frequent Micturition and/or Urge Urinary Incontinence [NCT01512004]Phase 3324 participants (Actual)Interventional2010-01-31Completed
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
A Single-Dose Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial Extended Release Capsules [NCT01521767]Phase 116 participants (Actual)Interventional2011-10-31Completed
A Global Phase IV, Double-Blind, Placebo-Controlled, Randomized Trial To Evaluate The Effectiveness Of Detrusitol Sr 4mg On Patient's Perception Of Bladder Condition (PPBC). [NCT00143377]Phase 4600 participants Interventional2004-09-30Completed
Overactive Bladder Innovative Therapy Trial [NCT00448175]Phase 4100 participants (Actual)Interventional2006-06-30Completed
A Randomized, Placebo Controlled, Crossover Study to Evaluate the Effects of Tolterodine Tartrate on Urodynamic Parameters in Patients With Overactive Bladder [NCT00768521]Phase 120 participants (Actual)Interventional2008-09-03Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Standardization of Fluid Intake on the Variability of Measured Voiding Parameters in Female Patients With Idiopathic Overactive Bladder [NCT00553657]Phase 155 participants (Actual)Interventional2007-08-31Completed
A Multicenter, Multiphase, Single Arm, Open Label Study To Evaluate The Effects Of Tolterodine ER In Conjunction With Behavioral Intervention On Subject Satisfaction And Over- Active Bladder Symptoms (Urgency Urinary Incontinence (UUI), Urgency, Frequency [NCT00230789]Phase 4417 participants Interventional2005-10-31Completed
"A Randomized, Double Blind, Placebo Controlled Detrol LA Add-On To Alpha-Blocker Study In Men With Persistent Overactive Bladder Symptoms Of Urinary Frequency And Urgency With/Without Urgency Incontinence After Previous Monotherapy With Alpha Blocker." [NCT00282932]Phase 4600 participants Interventional2006-01-31Completed
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
Flexibly adding-on Second Antimuscarinic Agent to the First Antimuscarinics for Refractory Overactive Bladder Syndrome - A Prospective Randomized Controlled Comparative Study With Mono-antimuscarinic Therapy [NCT01824420]Phase 4129 participants (Actual)Interventional2013-03-31Completed
Combination Versus Monotherapy With Alpha Blocker and Anticholinergics to Relieve Urinary Stent Symptoms [NCT01741454]Phase 4181 participants (Actual)Interventional2012-11-30Completed
Phase One of Study on Urinary Stent Complications and Treatment [NCT01530243]Phase 2/Phase 3104 participants (Actual)Interventional2012-01-31Completed
A Parallel, Double-blind Comparison of Tolterodine vs. Placebo Treatments for Nocturia in Postmenopausal Women. [NCT00323635]Phase 419 participants (Actual)Interventional2006-04-30Terminated(stopped due to New department chairman instructed PI to discontinue study.)
[NCT02436889]Phase 423 participants (Actual)Interventional2016-02-29Completed
Multicenter, Randomized, Double-blind, Parallel, Active Control, Phase III Clinical Study to Assess the Efficacy and Safety of THVD-201 in Patients With Overactive Bladder Including an Open-label, Extension Study [NCT02485067]Phase 3384 participants (Actual)Interventional2015-01-31Completed
Postmarketing Observational Study of Tolterodine Treatment on Overactive Bladder in Real Life Setting [NCT01488578]11,157 participants (Actual)Observational2006-12-31Completed
Antimuscarinics as the First-line Treatment for Male With International Prostate Symptom Score (IPSS) Voiding-to-storage Subscore Rati (IPSS-V/S)≤1-- A Prospective Randomized Study Comparing With α-blockers [NCT01661621]Phase 4395 participants (Actual)Interventional2012-08-31Completed
Protocol for Brain-Centered Therapy Versus Medication for Urgency Urinary Incontinence An RCT: Hypnotherapy Or Pharmacotherapy [NCT01829425]165 participants (Actual)Interventional2013-04-22Completed
A Multi-centre, Double-blind, Randomised Trial Investigating the Efficacy and Safety of a Combination Therapy, Desmopressin and Tolterodine, for Treatment of Overactive Bladder With Nocturia in Women [NCT01729819]Phase 2106 participants (Actual)Interventional2013-01-31Completed
A Placebo and Active-Comparator Controlled Multiple-Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of MK-4618 in Patients With Overactive Bladder [NCT01500382]Phase 14 participants (Actual)Interventional2012-02-27Terminated(stopped due to This study was terminated early due to insufficient recruitment.)
A Prospective, Double-Blind, Randomized, Two-Period Crossover, Multi-Center Study to Evaluate the Tolerability and Patient Preference Between Myrbetriq® and Detrol® LA in Subjects With Overactive Bladder (OAB) [NCT02138747]Phase 4376 participants (Actual)Interventional2014-07-24Completed
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
NCT00090584 (9) [back to overview]Symptom Improvement
NCT00090584 (9) [back to overview]Satisfaction
NCT00090584 (9) [back to overview]Satisfaction
NCT00090584 (9) [back to overview]Change in Incontinence Episodes
NCT00090584 (9) [back to overview]Proportion of Women Who Meet Definition of Success
NCT00090584 (9) [back to overview]Symptom Distress
NCT00090584 (9) [back to overview]Change in Voids Per Day
NCT00090584 (9) [back to overview]Symptom Improvement
NCT00090584 (9) [back to overview]Symptom Bother
NCT00444925 (19) [back to overview]Percent Change From Baseline of UUI Episodes Per 24 Hours.
NCT00444925 (19) [back to overview]Percent Change From Baseline of Micturitions Per 24 Hours.
NCT00444925 (19) [back to overview]Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours.
NCT00444925 (19) [back to overview]Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours.
NCT00444925 (19) [back to overview]Percent Change From Baseline of Urgency Episodes Per 24 Hours.
NCT00444925 (19) [back to overview]Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 1 and Week 4.
NCT00444925 (19) [back to overview]Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (End of Treatment).
NCT00444925 (19) [back to overview]Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12 (End of Treatment).
NCT00444925 (19) [back to overview]Change From Baseline in Frequency-Urgency Sum (Formerly Known as Urinary Sensations Scale Sum in Protocol) Per 24 Hours.
NCT00444925 (19) [back to overview]Change From Baseline in Mean Number of Micturitions Per 24 Hours.
NCT00444925 (19) [back to overview]Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours.
NCT00444925 (19) [back to overview]Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours.
NCT00444925 (19) [back to overview]Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours.
NCT00444925 (19) [back to overview]Change From Baseline in Mean USS Rating Per Micturition Per 24 Hours.
NCT00444925 (19) [back to overview]Change From Baseline in Mean Voided Volume Per Micturition.
NCT00444925 (19) [back to overview]Change From Baseline in OAB-q: Health Related Quality of Life (HRQL) at Week 12 (End of Treatment).
NCT00444925 (19) [back to overview]Change From Baseline in Patient Perception of Bladder Condition (PPBC).
NCT00444925 (19) [back to overview]Change From Baseline in Urgency Perception Scale (UPS). UPS Equals Patient Perception of Urgency Scale (PPUS) in Protocol.
NCT00444925 (19) [back to overview]Diary Dry Rates
NCT00448175 (1) [back to overview]Frequency of Voids at 12 Weeks
NCT00465894 (13) [back to overview]Subjective Patient Change in Irritative Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I)
NCT00465894 (13) [back to overview]Subjective Patient Change in Irritative Urinary Symptoms As Measured By the 3-Day Voiding Diary
NCT00465894 (13) [back to overview]Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
NCT00465894 (13) [back to overview]Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I)
NCT00465894 (13) [back to overview]Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ)
NCT00465894 (13) [back to overview]Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ)
NCT00465894 (13) [back to overview]Evaluate Subjective Patient Change in Irritative Urinary Symptoms
NCT00465894 (13) [back to overview]Subjective Patient Change in Irritative Urinary Symptoms
NCT00465894 (13) [back to overview]Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Health Related Quality of Life (HRQL)
NCT00465894 (13) [back to overview]Subjective Patient Change in Irritative Urinary Symptoms
NCT00465894 (13) [back to overview]Subjective Patient Change in Irritative Urinary Symptoms
NCT00465894 (13) [back to overview]Subjective Patient Change in Irritative Urinary Symptoms
NCT00465894 (13) [back to overview]Subjective Patient Change in Irritative Urinary Symptoms
NCT00611026 (20) [back to overview]Percent Change From Baseline of UUI Episodes Per 24 Hours
NCT00611026 (20) [back to overview]Post-hoc Adverse Events (AEs)
NCT00611026 (20) [back to overview]Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours
NCT00611026 (20) [back to overview]Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)
NCT00611026 (20) [back to overview]Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12
NCT00611026 (20) [back to overview]Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12
NCT00611026 (20) [back to overview]Change From Baseline in Frequency-Urgency Sum (FUS) Per 24 Hours (Synonymous With USS Sum in the Study Protocol)
NCT00611026 (20) [back to overview]Change From Baseline in Mean Number of Micturitions Per 24 Hours
NCT00611026 (20) [back to overview]Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours
NCT00611026 (20) [back to overview]Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours
NCT00611026 (20) [back to overview]Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1 and Week 4
NCT00611026 (20) [back to overview]Change From Baseline in Mean Urinary Sensation Scale (USS) Rating Per Micturition Per 24 Hours.
NCT00611026 (20) [back to overview]Change From Baseline in Mean Voided Volume Per Micturition
NCT00611026 (20) [back to overview]Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Health Related Quality of Life (HRQL) at Week 12
NCT00611026 (20) [back to overview]Change From Baseline in Patient Perception of Bladder Condition (PPBC)
NCT00611026 (20) [back to overview]Change From Baseline in Urgency Perception Scale (UPS). UPS Formerly Known as Patient Perception of Urgency Scale (PPUS) in the Protocol.
NCT00611026 (20) [back to overview]Diary Dry Rate: Percentage of Participants With no Urgency Urinary Incontinence (UUI) in the 3-day Bladder Diary
NCT00611026 (20) [back to overview]Percent Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)
NCT00611026 (20) [back to overview]Percent Change From Baseline of Micturitions Per 24 Hours
NCT00611026 (20) [back to overview]Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours
NCT00688688 (28) [back to overview]Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
NCT00688688 (28) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours
NCT00688688 (28) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score
NCT00688688 (28) [back to overview]Change From Baseline to Month 12 and Final Visit in Treatment Satisfaction-visual Analog Scale (TS-VAS)
NCT00688688 (28) [back to overview]Change From Baseline to Month 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)
NCT00688688 (28) [back to overview]Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
NCT00688688 (28) [back to overview]Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score
NCT00688688 (28) [back to overview]Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
NCT00688688 (28) [back to overview]Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
NCT00688688 (28) [back to overview]Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC)
NCT00688688 (28) [back to overview]Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit
NCT00688688 (28) [back to overview]Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs)
NCT00688688 (28) [back to overview]Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed
NCT00688688 (28) [back to overview]Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment
NCT00688688 (28) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
NCT00688688 (28) [back to overview]Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working
NCT00688688 (28) [back to overview]Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit
NCT00688688 (28) [back to overview]Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment
NCT00688688 (28) [back to overview]Change From Baseline to Months 3, 6, 12 and Final Visit in Number of Non-study Related Visits to Physician
NCT00688688 (28) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours
NCT00688688 (28) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
NCT00688688 (28) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score
NCT00688688 (28) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition
NCT00688688 (28) [back to overview]Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram
NCT00688688 (28) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours
NCT00688688 (28) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency
NCT00688688 (28) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours
NCT00688688 (28) [back to overview]Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
NCT00689104 (31) [back to overview]Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit
NCT00689104 (31) [back to overview]Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
NCT00689104 (31) [back to overview]Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours
NCT00689104 (31) [back to overview]Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours
NCT00689104 (31) [back to overview]Change From Baseline to Final Visit in Mean Volume Voided Per Micturition
NCT00689104 (31) [back to overview]Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours
NCT00689104 (31) [back to overview]Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours
NCT00689104 (31) [back to overview]Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
NCT00689104 (31) [back to overview]Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
NCT00689104 (31) [back to overview]Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
NCT00689104 (31) [back to overview]Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score
NCT00689104 (31) [back to overview]Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)
NCT00689104 (31) [back to overview]Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS)
NCT00689104 (31) [back to overview]Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment
NCT00689104 (31) [back to overview]Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working
NCT00689104 (31) [back to overview]Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment
NCT00689104 (31) [back to overview]Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed
NCT00689104 (31) [back to overview]Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition
NCT00689104 (31) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score
NCT00689104 (31) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency
NCT00689104 (31) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours
NCT00689104 (31) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours
NCT00689104 (31) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours
NCT00689104 (31) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
NCT00689104 (31) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician
NCT00689104 (31) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score
NCT00689104 (31) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
NCT00689104 (31) [back to overview]Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours
NCT00689104 (31) [back to overview]Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours
NCT00689104 (31) [back to overview]Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit
NCT00689104 (31) [back to overview]Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit
NCT00768521 (2) [back to overview]Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 1 on Tolterodine 4 mg and Placebo
NCT00768521 (2) [back to overview]Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo
NCT00795509 (2) [back to overview]Adverse Drug Reaction Not Expected From the Japanese Package Insert. Number of Unlisted Treatment Related Adverse Events (TRAEs).
NCT00795509 (2) [back to overview]Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs).
NCT00939120 (9) [back to overview]Maximum Urine Flow Rate (Qmax).
NCT00939120 (9) [back to overview]Patient Perception of Bladder Condition (PPBC)
NCT00939120 (9) [back to overview]Post-void Residual (PVR) Volume
NCT00939120 (9) [back to overview]Overactive Bladder Questionnaire (OABq)
NCT00939120 (9) [back to overview]Urine Voided Volume (Voiding)
NCT00939120 (9) [back to overview]International Prostate Symptoms Score, Voiding Subscore
NCT00939120 (9) [back to overview]Acute Urinary Retention (AUR)
NCT00939120 (9) [back to overview]International Prostate Symptoms Score (IPSS), Storage Subscore
NCT00939120 (9) [back to overview]International Prostate Symptoms Score (IPSS), Total
NCT01175382 (18) [back to overview]Change in Frequency of Urination From 6 Weeks to 12 Weeks (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in Frequency of Urination After 6-week Intervention (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in Frequency of Urination From Baseline to 12 Weeks (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in Nocturia From Baseline to 6 Weeks (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in International Prostate Symptom Score (I-PSS) From Baseline to 12 Weeks (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in International Prostate Symptom Score (I-PSS) From Baseline to 6 Weeks. (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in International Prostate Symptom Score (IPSS) From 6 to 12 Weeks (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in Nocturia From 6 Weeks to 12 Weeks (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in Nocturia Measured From Baseline to 12 Weeks (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in Overactive Bladder Questionnaire (OAB-q) From 6 to 12 Weeks (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 12 Weeks (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 6 Weeks (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in Urgency From Baseline to 6 Weeks (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in Urgency Score From 6 Weeks to 12 Weeks (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in Urinary Incontinence Episodes From Baseline to 12 Weeks (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in Urinary Incontinence From 6 Weeks to 12 Weeks (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in Urinary Incontinence From Baseline to 6 Weeks (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in Urgency Score From Baseline to 12 Weeks (Last Observation Carried Forward)
NCT01302938 (20) [back to overview]Change From Baseline in Mean Voided Volume Per Micturition at Week 1, 4 and 12
NCT01302938 (20) [back to overview]Participant Perception Regarding Recommending a Friend to Enter Similar Study
NCT01302938 (20) [back to overview]Participant Perception Regarding Received Treatment in the Study
NCT01302938 (20) [back to overview]Participant Perception Regarding Cell Phone Diary
NCT01302938 (20) [back to overview]Number of Participants Who Discontinued the Study Due to Adverse Events
NCT01302938 (20) [back to overview]Number of Participants With Laboratory Abnormalities
NCT01302938 (20) [back to overview]Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12
NCT01302938 (20) [back to overview]Change From Baseline in Health Related Quality of Life (HRQL) Social Domain Score at Week 12
NCT01302938 (20) [back to overview]Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12
NCT01302938 (20) [back to overview]Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 1 and 4
NCT01302938 (20) [back to overview]Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12
NCT01302938 (20) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
NCT01302938 (20) [back to overview]Number of Participants With Response Regarding Source of First Information About Study
NCT01302938 (20) [back to overview]Participant Perception Regarding Satisfaction Related to Study
NCT01302938 (20) [back to overview]Number of Participants With Reason for Participation in the Study
NCT01302938 (20) [back to overview]Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12
NCT01302938 (20) [back to overview]Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12
NCT01302938 (20) [back to overview]Number of Participants With Adverse Events (AEs) by Relatedness and Severity
NCT01302938 (20) [back to overview]Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12
NCT01302938 (20) [back to overview]Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1, 4 and 12
NCT01314872 (12) [back to overview]Extension Study: Number of Participants Who Experienced an Adverse Event (AE)
NCT01314872 (12) [back to overview]Extension Study: Change From Baseline in Average Daily Number of Urge Incontinence Episodes at Week 52
NCT01314872 (12) [back to overview]Extension Study: Change From Baseline in Average Daily Number of Total Incontinence Episodes at Week 52
NCT01314872 (12) [back to overview]Extension Study: Change From Baseline in Average Daily Micturitions at Week 52
NCT01314872 (12) [back to overview]Extension Study: Change From Baseline in Average Daily Number of Strong Urge Episodes at Week 52
NCT01314872 (12) [back to overview]Base Study/Part 1: Change From Baseline in Average Daily Number of Strong Urge Episodes at Week 8
NCT01314872 (12) [back to overview]Base Study/Part 1 + Part 2: Number of Participants Who Experienced an Adverse Event (AE)
NCT01314872 (12) [back to overview]Base Study/Part 1 + Part 2: Number of Participants Who Had Study Medication Withdrawn Due to an AE
NCT01314872 (12) [back to overview]Base Study/Part 1: Change From Baseline in Average Daily Micturitions at Week 8
NCT01314872 (12) [back to overview]Base Study/Part 1: Change From Baseline in Average Daily Number of Total Incontinence Episodes at Week 8
NCT01314872 (12) [back to overview]Base Study/Part 1: Change From Baseline in Number of Urge Incontinence Episodes at Week 8
NCT01314872 (12) [back to overview]Extension Study: Number of Participants Who Had Study Medication Withdrawn Due to an AE
NCT01488578 (16) [back to overview]Risk Factors for the Proportion of Responders of Tolterodine-Severity of Overactive Bladder
NCT01488578 (16) [back to overview]Risk Factors for the Proportion of Responders of Tolterodine-Previous Treatment
NCT01488578 (16) [back to overview]Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinations Per Day (During Sleep)
NCT01488578 (16) [back to overview]Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies
NCT01488578 (16) [back to overview]Risk Factors for the Proportion of Responders of Tolterodine-Gender
NCT01488578 (16) [back to overview]Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs
NCT01488578 (16) [back to overview]Risk Factors for the Proportion of Responders of Tolterodine-Complications
NCT01488578 (16) [back to overview]Risk Factors for the Proportion of Responders of Tolterodine-Age
NCT01488578 (16) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Tolterodine - Comorbidity of Prostatic Hypertrophy
NCT01488578 (16) [back to overview]Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs).
NCT01488578 (16) [back to overview]Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinary Incontinence Episodes Per Day
NCT01488578 (16) [back to overview]Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants
NCT01488578 (16) [back to overview]Number of Participants With an Investigator's Assessment of Clinical Outcome at End of the Study.
NCT01488578 (16) [back to overview]Confirmation of Frequent Treatment Related Adverse Events (TRAEs) at the End of Observation Period.
NCT01488578 (16) [back to overview]"Number of Participants Which Was Evaluated as Degree of Satisfaction."
NCT01488578 (16) [back to overview]Risk Factors for the Proportion of Responders of Tolterodine-Urinary Urgency
NCT01500382 (2) [back to overview]Number of Participants Who Experienced an Adverse Event (AE)
NCT01500382 (2) [back to overview]Number of Participants Who Discontinued Use of Study Drug Due to an AE
NCT01530243 (3) [back to overview]Lower Urinary Tract Symptoms (LUTS)
NCT01530243 (3) [back to overview]Pain
NCT01530243 (3) [back to overview]Quality of Life
NCT01661621 (8) [back to overview]The Global Response Assessment (GRA) After the Treatment Day
NCT01661621 (8) [back to overview]The International Prostate Symptom Score (IPSS) Quality of Life (QoL) Score After the Treatment Day
NCT01661621 (8) [back to overview]The International Prostate Symptom Score (IPSS) Questionnaires After the Treatment Day
NCT01661621 (8) [back to overview]The IPSS Subscore (IPSS Storage) Questionnaires After the Treatment Day
NCT01661621 (8) [back to overview]The IPSS Subscore (IPSS Voiding) Questionnaires After the Treatment Day
NCT01661621 (8) [back to overview]The Voided Volume After the Treatment Day
NCT01661621 (8) [back to overview]The Maximum Flow Rate (Qmax) After the Treatment Day
NCT01661621 (8) [back to overview]The Postvoid Residual Volume (PVR) After the Treatment Day
NCT01729819 (6) [back to overview]Change in Mean Nocturnal Urine Volume From Baseline
NCT01729819 (6) [back to overview]Change in Mean Number of Nocturnal Voids From Baseline
NCT01729819 (6) [back to overview]Change in Mean Time to First Nocturnal Void From Baseline
NCT01729819 (6) [back to overview]Responder Status
NCT01729819 (6) [back to overview]Change in the Impact on Sleep as Measured by the Sleep Rating Scales From Baseline
NCT01729819 (6) [back to overview]Onset of Effect as Seen in Change in Mean Number of Nocturnal Voids From Baseline for Each Visit During Three Months of Treatment
NCT01741454 (4) [back to overview]Ureteral Stent Symptom Questionnaire Score
NCT01741454 (4) [back to overview]Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion
NCT01741454 (4) [back to overview]Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal
NCT01741454 (4) [back to overview]Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion
NCT01829425 (12) [back to overview]Percent Change in Urgency Urinary Incontinence Episodes
NCT01829425 (12) [back to overview]Percent Change in Urgency Urinary Incontinence Episodes
NCT01829425 (12) [back to overview]Voids on Bladder Diary
NCT01829425 (12) [back to overview]Voids on Bladder Diary
NCT01829425 (12) [back to overview]Overactive Bladder Questionnaire Short Form Quality of Life
NCT01829425 (12) [back to overview]Overactive Bladder Questionnaire Short Form Quality of Life
NCT01829425 (12) [back to overview]Overactive Bladder Questionnaire Short Form Quality of Life
NCT01829425 (12) [back to overview]Overactive Bladder Questionnaire Short Form Symptom Bother
NCT01829425 (12) [back to overview]Voids on Bladder Diary
NCT01829425 (12) [back to overview]Overactive Bladder Questionnaire Short Form Symptom Bother
NCT01829425 (12) [back to overview]Percent Change in Urgency Urinary Incontinence Episodes
NCT01829425 (12) [back to overview]Overactive Bladder Questionnaire Short Form Symptom Bother
NCT02138747 (13) [back to overview]Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Improvement in Day-to-Day Life Due to OAB Medication
NCT02138747 (13) [back to overview]Change From Baseline to End of Treatment (EOT) in Mean Number of Incontinence Episodes Per 24 Hours
NCT02138747 (13) [back to overview]Change From Baseline to End of Treatment (EOT) in Number of Micturitions Per 24 Hours
NCT02138747 (13) [back to overview]Participants Tolerability Assessed by the Medication Tolerability Scale of the Overactive Bladder-Satisfaction (OAB-S) Questionnaire at the End of Treatment (EOT)
NCT02138747 (13) [back to overview]Scale of the OAB-S Questionnaire at the End of Treatment Period: Impact on Daily Living With OAB.
NCT02138747 (13) [back to overview]Scale of the OAB-S Questionnaire at the End of Treatment Period: OAB Control
NCT02138747 (13) [back to overview]Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Interruption of Day-to-Day Life Due to OAB
NCT02138747 (13) [back to overview]Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Participant's Fulfillment of OAB Medication Expectations
NCT02138747 (13) [back to overview]Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Willingness to Continue OAB Medication
NCT02138747 (13) [back to overview]Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Satisfaction With OAB Medication
NCT02138747 (13) [back to overview]Scale of the OAB-S Questionnaire at the End of Treatment Period: Satisfaction With OAB Control
NCT02138747 (13) [back to overview]Number of Participants With Adverse Events
NCT02138747 (13) [back to overview]Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods.
NCT02294396 (16) [back to overview]Change From Baseline in the Mean Volume Voided Per Micturition
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 Number of Urge Incontinence Episodes 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 Micturitions Per 24 Hours
NCT02294396 (16) [back to overview]Change From Baseline in the Mean Number of Incontinence Episodes Per 24 Hours
NCT02294396 (16) [back to overview]Change From Baseline in 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 Overactive Bladder Questionnaire Short Form (OAB-q SF) Symptom Severity Score
NCT02294396 (16) [back to overview]Change From Baseline in OAB-q SF Total HRQL 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]Number of Participants Who Achieved Normalization for OABSS Total Score
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 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 Incontinence Episodes Per 24 Hours
NCT02294396 (16) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
NCT02436889 (5) [back to overview]Change From Baseline in Trail Making Test, Trail A Score at 8 Weeks
NCT02436889 (5) [back to overview]Change From Baseline in California Verbal Learning Test (CVLT) Score at 8 Weeks
NCT02436889 (5) [back to overview]Change From Baseline in Urge Incontinence Episodes Per Day on a Voiding Diary at 8 Weeks.
NCT02436889 (5) [back to overview]Change From Baseline in Total Urinary Incontinence Frequency Measured by a Voiding Diary at 8 Weeks
NCT02436889 (5) [back to overview]Change From Baseline in Short Physical Performance Battery (SPPB) Score at 8 Weeks
NCT03492281 (15) [back to overview]Percentage of OAB Wet Participants With at Least a 50% Reduction From Baseline in Total Incontinence Episodes Per 24 Hours at Week 12
NCT03492281 (15) [back to overview]Percentage of OAB Wet Participants With a 100% Reduction From Baseline in UUI Episodes Per 24 Hours at Week 12
NCT03492281 (15) [back to overview]Percentage of All OAB Participants With at Least a 50% Reduction From Baseline in Urgency Episodes Per 24 Hours at Week 12
NCT03492281 (15) [back to overview]Percentage of All OAB Participants With an Average Number of Micturitions < 8 Per 24 Hours at Week 12
NCT03492281 (15) [back to overview]CFB at Week 12 in the Symptom Bother Score From the OAB-q LF (1-week Recall) in All OAB Participants
NCT03492281 (15) [back to overview]CFB at Week 12 in the Health-related Quality of Life (HRQL) Total Score From the OAB-q LF (1-week Recall) in All OAB Participants
NCT03492281 (15) [back to overview]CFB at Week 12 in the Coping Score From the Overactive Bladder Questionnaire Long Form (OAB-q LF, 1-week Recall) in All OAB Participants
NCT03492281 (15) [back to overview]CFB at Week 12 in the Average Volume Voided Per Micturition in All OAB Participants
NCT03492281 (15) [back to overview]CFB at Week 12 in the Average Number of Urgency Episodes Over 24 Hours in All OAB Participants
NCT03492281 (15) [back to overview]CFB at Week 12 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants
NCT03492281 (15) [back to overview]CFB at Week 12 in the Average Number of Total Incontinence Episodes Over 24 Hours in OAB Wet Participants
NCT03492281 (15) [back to overview]CFB at Week 12 in Overall Control Over Bladder Symptoms Based on Patient Global Impression of Control (PGI-Control) in All OAB Participants
NCT03492281 (15) [back to overview]CFB at Week 12 in Overall Bladder Symptoms Based on Patient Global Impression of Severity (PGI-Severity) in All OAB Participants
NCT03492281 (15) [back to overview]Change From Baseline (CFB) at Week 12 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants
NCT03492281 (15) [back to overview]Percentage of OAB Wet Participants With at Least a 75% Reduction From Baseline in UUI Episodes Per 24 Hours at Week 12
NCT03575702 (15) [back to overview]Changes in the Volume of Residual Urine
NCT03575702 (15) [back to overview]Changes in the Overactive Bladder Symptom Score According to Overactive Bladder (OAB) Awareness Tool Questionnaire at 2, 4, 8 and 12 Week
NCT03575702 (15) [back to overview]Change in the Mean Weekly Number of Incontinence Episodes at Week 12
NCT03575702 (15) [back to overview]Change in the Mean Number of Incontinence Episodes at Week 2, 4 and 8
NCT03575702 (15) [back to overview]Change in the Mean Nighttime Number of Incontinence Episodes at Week 12
NCT03575702 (15) [back to overview]Change in the Mean Daytime Number of Incontinence Episodes at Week 12
NCT03575702 (15) [back to overview]Number of Patients With Adverse Events (AEs)
NCT03575702 (15) [back to overview]Number of Patients With Clinically Significant Changes in ECG Parameters
NCT03575702 (15) [back to overview]Number of Patients With Clinically Significant Vital Signs Changes
NCT03575702 (15) [back to overview]Number of Patients With Serious Adverse Events (SAEs)
NCT03575702 (15) [back to overview]Change in the EQ-5D-based Quality of Life at Week 12
NCT03575702 (15) [back to overview]Change in the Mean Daily Number of Incontinence Episodes at Week 12
NCT03575702 (15) [back to overview]Change in the Mean Daily Number of Urination Episodes at Week 12
NCT03575702 (15) [back to overview]Change in the Mean Daily Number of Urination Episodes at Week 2, 4 and 8 Visit as Compared to the Treatment Initiation Visit
NCT03575702 (15) [back to overview]Number of Patients With Clinically Significant Changes in Laboratory Parameters
NCT03583372 (5) [back to overview]CFB at Week 52 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants
NCT03583372 (5) [back to overview]CFB at Week 52 in the Average Number of Urgency Episodes (Need to Urinate Immediately) Over 24 Hours in All OAB Participants
NCT03583372 (5) [back to overview]Change From Baseline (CFB) at Week 52 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants
NCT03583372 (5) [back to overview]Number of Participants With the Indicated Type of Treatment-emergent Adverse Event
NCT03583372 (5) [back to overview]CFB at Week 52 in the Average Number of Total Urinary Incontinence Episodes Over 24 Hours in OAB Wet Participants
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.

Symptom Improvement

"Number of women who responded much better or better to question: Overall, do you feel that you are much better, better, about the same, worse or much worse?" (NCT00090584)
Timeframe: 8 months

Interventionparticipants (Number)
Combination Therapy80
Drug Therapy Alone54

[back to top]

Satisfaction

"Number of women who responded completely satisfied to question, How satisfied are you with your progress?" (NCT00090584)
Timeframe: 10 weeks

Interventionparticipants (Number)
Combination at 10 Weeks71
Drug Only at 10 Weeks55

[back to top]

Satisfaction

"Number of women who responded completely satisfied to question How satisfied are you with your progress?" (NCT00090584)
Timeframe: 8 months

Interventionparticipants (Number)
Combination Therapy38
Drug Therapy Alone25

[back to top]

Change in Incontinence Episodes

Change from baseline to 10 weeks in number of incontinence episodes per week as reported on bladder diary. (NCT00090584)
Timeframe: Baseline and 10 weeks

Interventionincontinence episodes per week (Mean)
Combination Therapy-20.4
Drug Therapy Alone-18.5

[back to top]

Proportion of Women Who Meet Definition of Success

Proportion of women who meet definition of success: not taking drug or receiving other urge UI therapy (i.e., neuromodulation, botox injections, myomectomy, electrical stimulation, or any intravesical therapy) and not taking a tricyclic antidepressant or duloxetine at 8 months; and a >70% reduction in number of incontinence episodes as compared to baseline. (NCT00090584)
Timeframe: 8 months

Interventionparticipants (Number)
Combination Therapy43
Drug Therapy Alone41

[back to top]

Symptom Distress

Urogenital distress inventory (UDI). Higher score indicates greater distress. Possible range 0 to 300. (NCT00090584)
Timeframe: baseline, 10 weeks and 8 months

Interventionunits on a scale (Mean)
Combination at Baseline121.4
Combination at 10 Weeks47.3
Combiniation at 8 Months61.9
Drug Only at Baseline118.2
Drug Only at 10 Weeks58.1
Drug Only at 8 Months83.3

[back to top]

Change in Voids Per Day

Change from baseline to 10 weeks in frequency of voids per day as reported on bladder diary (NCT00090584)
Timeframe: baseline and 10 weeks

Interventionvoids per day (Mean)
Combination Therapy-0.5
Drug Therapy Alone0.3

[back to top]

Symptom Improvement

"Number of women who responded much better or better to question: Overall, do you feel that you are much better, better, about the same, worse or much worse?" (NCT00090584)
Timeframe: 10 weeks

Interventionparticipants (Number)
Combination Therapy120
Drug Therapy Alone106

[back to top]

Symptom Bother

Disease specific overactive bladder scale (OAB-q). HIgher score indicates greater bother. Possible range 0 to 100. (NCT00090584)
Timeframe: baseline, 10 weeks and 8 months

Interventionunits on a scale (Mean)
Combination at Baseline59.9
Combination at 10 Weeks23.1
Combiniation at 8 Months29.0
Drug Only at Baseline60.0
Drug Only at 10 Weeks29.6
Drug Only at 8 Months39.6

[back to top]

Percent Change From Baseline of UUI Episodes Per 24 Hours.

UUI episodes per 24 hours calculated as total number of micturitions with USS of 5 in diary. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100. (NCT00444925)
Timeframe: Baseline, Week 1, Week 4, Week 12

,,
Interventionpercent change (Median)
Week 1 (n=302, 614, 612)Week 4 [LOCF] (n=307, 626, 618)Week 12 [LOCF] (n=307, 626, 619)
Fesoterodine-53.6-93.2-100.0
Placebo-28.6-60.0-82.1
Tolterodine ER-55.1-85.7-100.0

[back to top]

Percent Change From Baseline of Micturitions Per 24 Hours.

Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100% *(Week 12 or 4 - baseline)/baseline). (NCT00444925)
Timeframe: Baseline, Week 1, Week 4, Week 12

,,
Interventionpercent change (Median)
Week 1 (n=307, 622, 623)Week 4 [LOCF] (n=313, 634, 627)Week 12 [LOCF] (n=313, 634, 628)
Fesoterodine-7.9-14.8-18.9
Placebo-2.7-10.3-12.1
Tolterodine ER-7.7-15.0-16.2

[back to top]

Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours.

Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100% *(Week 12 or 4 - baseline)/baseline). Nocturnal (Bedtime) was defined as the time the subject went to bed until he/she arose to start the next day. (NCT00444925)
Timeframe: Baseline, Week 1, Week 4, Week 12

,,
Interventionpercent change (Median)
Week 1 (n=288, 584, 596)Week 4 [LOCF] (n=293, 596, 600)Week 12 [LOCF] (n=293, 596, 601)
Fesoterodine0.0-20.0-28.6
Placebo-10.0-22.2-25.0
Tolterodine ER-12.5-25.0-27.9

[back to top]

Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours.

Percent change calculated as change in severe urgency episodes (USS rating >= to 4 in diary ) per 24 hours at that visit divided by the baseline number of severe urgency episodes per 24 hours, multiplied by 100. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). (NCT00444925)
Timeframe: Baseline, Week 1, Week 4, Week 12

,,
Interventionpercent change (Median)
Week 1 (n=306, 618, 618)Week 4 [LOCF] (n=311, 630, 624)Week 12 [LOCF] (n=311, 630, 625)
Fesoterodine-25.0-54.5-71.4
Placebo-9.4-25.0-48.0
Tolterodine ER-25.0-45.8-63.4

[back to top]

Percent Change From Baseline of Urgency Episodes Per 24 Hours.

Percent change of urgency episodes (USS rating >= to 3 in diary) per 24 hours calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100. USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). (NCT00444925)
Timeframe: Baseline, Week 1, Week 4, Week 12

,,
Interventionpercent change (Median)
Week 1 (n=306, 619, 621)Week 4 [LOCF] (n=311,631, 627)Week 12 [LOCF] (n=311, 631, 628)
Fesoterodine-9.7-26.9-37.9
Placebo-5.6-11.4-17.6
Tolterodine ER-12.5-23.1-30.8

[back to top]

Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 1 and Week 4.

UUI episodes per 24 hours calculated as total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline. (NCT00444925)
Timeframe: Baseline, Week 1, Week 4

,,
Interventionnumber of episodes per 24 hours (Mean)
Week 1 (n=302, 614, 612)Week 4 [LOCF] (n=307, 626, 618)
Fesoterodine-0.95-1.52
Placebo-0.54-1.06
Tolterodine ER-0.92-1.40

[back to top]

Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (End of Treatment).

UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change: mean at observation minus mean at baseline. (NCT00444925)
Timeframe: Baseline, Week 12

Interventionnumber of episodes per 24 hours (Mean)
Placebo-1.46
Tolterodine ER-1.61
Fesoterodine-1.72

[back to top]

Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12 (End of Treatment).

Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/by raw score range * 100]. Higher transformed scores indicative of greater symptom bother. Negative change in Symptom Bother score indicates improvement. Change calculated as score at observation minus score at baseline. (NCT00444925)
Timeframe: Baseline, Week 12

Interventionscore on scale (Least Squares Mean)
Placebo-16.3
Tolterodine ER-22.5
Fesoterodine-27.1

[back to top]

Change From Baseline in Frequency-Urgency Sum (Formerly Known as Urinary Sensations Scale Sum in Protocol) Per 24 Hours.

Frequency-Urgency Sum rating per 24 hours calculated as mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline. (NCT00444925)
Timeframe: Baseline, Week 1, Week 4, Week 12

,,
Interventionscore on scale (Least Squares Mean)
Week 1 (n=306, 619, 621)Week 4 [LOCF] (n=311,631, 627)Week 12 [LOCF] (n=311, 631, 628)
Fesoterodine-5.5-10.5-13.2
Placebo-2.4-5.7-8.2
Tolterodine ER-5.7-9.7-12.1

[back to top]

Change From Baseline in Mean Number of Micturitions Per 24 Hours.

The mean number of micturitions was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Change calculated as mean at observation minus mean at baseline. (NCT00444925)
Timeframe: Baseline, Week 1, Week 4, Week 12

,,
Interventionnumber of micturitions per 24 hours (Least Squares Mean)
Week 1 (n=307, 622, 623)Week 4 [LOCF] (n= 313, 634, 627)Week 12 [LOCF] (n= 313, 634, 628)
Fesoterodine-1.0-1.9-2.2
Placebo-0.5-1.2-1.5
Tolterodine ER-1.0-1.8-2.1

[back to top]

Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours.

Mean number of nocturnal micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Nocturnal (Bedtime) was defined as the time the subject went to bed until he/she arose to start the next day. (NCT00444925)
Timeframe: Baseline, Week 1, Week 4, Week 12

,,
Interventionnocturnal micturitions per 24 hours (Least Squares Mean)
Week 1 (n=288, 584, 596)Week 4 [LOCF] (n=293, 596, 600)Week 12 [LOCF] (n=293, 596, 601)
Fesoterodine-0.2-0.5-0.6
Placebo-0.1-0.4-0.5
Tolterodine ER-0.3-0.5-0.6

[back to top]

Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours.

Mean number of severe urgency episodes (USS rating >= to 4 in diary ) per 24 hours: sum of all micturitions divided by total number of diary days collected at that visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline. (NCT00444925)
Timeframe: Baseline, Week 1, Week 4, Week 12

,,
Interventionsevere urgency episodes per 24 hours (Least Squares Mean)
Week 1 (n=306, 618, 618)Week 4 [LOCF] (n=311, 630, 624)Week 12 [LOCF] (n=311, 630, 625)
Fesoterodine-1.2-2.4-3.0
Placebo-0.4-1.2-1.9
Tolterodine ER-1.3-2.2-2.8

[back to top]

Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours.

Mean number urgency episodes (USS rating >= to 3 in diary) per 24 hours calculated as sum of all micturitions divided by total number of diary days collected at visit. USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline. (NCT00444925)
Timeframe: Baseline, Week 1, Week 4, Week 12

,,
Interventionurgency episodes per 24 hours (Least Squares Mean)
Week 1 (n=306, 619, 621)Week 4 [LOCF] (n=311, 631, 627)Week 12 [LOCF] (n=311, 631, 628)
Fesoterodine-1.1-2.6-3.5
Placebo-0.4-1.2-2.0
Tolterodine ER-1.3-2.4-3.1

[back to top]

Change From Baseline in Mean USS Rating Per Micturition Per 24 Hours.

Mean USS rating calculated as the sum of rating scores on USS per 24 hours divided by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline. (NCT00444925)
Timeframe: Baseline, Week 1, Week 4, Week 12

,,
Interventionscore on scale (Least Squares Mean)
Week 1 (n=306, 619, 621)Week 4 [LOCF] (n=311, 631, 627)Week 12 [LOCF] (n=311, 631, 628)
Fesoterodine-0.2-0.5-0.7
Placebo-0.1-0.2-0.4
Tolterodine ER-0.2-0.4-0.6

[back to top]

Change From Baseline in Mean Voided Volume Per Micturition.

Mean voided volume calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 in the 3-day diary at that visit. (NCT00444925)
Timeframe: Baseline, Week 1, Week 4, Week 12

,,
Interventionvoided volume per micturition (Least Squares Mean)
Week 1 (n=306, 622, 623)Week 4 [LOCF] (n=313, 633, 625)Week 12 [LOCF] (n=313, 633, 626)
Fesoterodine18.730.532.9
Placebo11.014.016.8
Tolterodine ER19.225.723.5

[back to top] [back to top]

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

Number of subjects in 4-point category: >= to 2 points improvement [major improvement]; 1 point improvement [minor improvement]; no change; deterioration, based on PPBC score (rated on 6-point scale: 1=no problems at all; 6=many severe problems). Score change: score at observation minus score at baseline; re-scaled to 4-point categorical variables. (NCT00444925)
Timeframe: Baseline, Week 1, Week, 4, Week 12

,,
Interventionparticipants (Number)
Week 1 (n=309, 625, 623), >=2 points improvementWeek 1, 1-point improvementWeek 1, no changeWeek 1, deteriorationWeek 4 (n=313, 632, 629), >=2 points improvementWeek 4, 1-point improvementWeek 4, no changeWeek 4, deteriorationWeek 12 (n=313, 632, 630), >=2 points improvementWeek 12, 1-point improvementWeek 12, no changeWeek 12, deterioration
Fesoterodine102186286491962241763325419814830
Placebo3294147365795127346710211133
Tolterodine ER79181306591692012035921018917162

[back to top]

Change From Baseline in Urgency Perception Scale (UPS). UPS Equals Patient Perception of Urgency Scale (PPUS) in Protocol.

Number of subjects in 3-point category: improvement [>=1-point improvement]; no change; deterioration [>=1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables. (NCT00444925)
Timeframe: Baseline, Week 1, Week 4, Week 12

,,
Interventionparticipants (Number)
Week 1 (n=309, 627, 624), improvementWeek 1, no changeWeek 1, deteriorationWeek 4 (n=313, 633, 629), improvementWeek 4, no changeWeek 4, deteriorationWeek 12 (n=313, 633, 630), improvementWeek 12, no changeWeek 12, deterioration
Fesoterodine171413402563482529131425
Placebo6821823981942111218120
Tolterodine ER162438272383623325434435

[back to top]

Diary Dry Rates

Diary dry rate: number of subjects with no urgency urinary incontinence episode reported in the 3 day diary at the respective time-point; based on USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). (NCT00444925)
Timeframe: Week 1, Week 4, Week 12

,,
Interventionparticipants (Number)
Week 1Week 4Week 12
Fesoterodine159306396
Placebo5497138
Tolterodine ER153290358

[back to top]

Frequency of Voids at 12 Weeks

To demonstrate that the Urgent PC system is as effective as or more effective (noninferior) than tolterodine (Detrol LA) in changing the frequency of urinary voids per day after 12 weeks of therapy. The voiding diaries completed at 12 weeks were compared to the baseline voiding diaries. (NCT00448175)
Timeframe: Baseline to 12 weeks

InterventionVoids/day (Mean)
Urgent PC Treatment Arm-2.4
4mg Daily Tolterodine-2.5

[back to top]

Subjective Patient Change in Irritative Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I)

Assessment measured using the Patient Global Impression of Improvement (PGI-I), patient perception of improvement. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 being very much better to 7 being very much worse. Each level achieved(movement towards 1), is considered an improvement. (NCT00465894)
Timeframe: Baseline through 52 weeks

Interventionpercentage of participants (Number)
Group 1: Extended Release Tolterodine + Intravaginal Estradiol85
Group 2: Intravaginal Estradiol Cream85

[back to top]

Subjective Patient Change in Irritative Urinary Symptoms As Measured By the 3-Day Voiding Diary

Number of voids and accidents/leakage per 3 day diary. A void is a voluntary and intentional event. An accident is involuntary and unintentional. (NCT00465894)
Timeframe: From baseline through 12 weeks of Intervention

,
Interventionevents (Mean)
Number of voidsNumber of voids 12 week follow-upNumber of accidents/leakageNumber of accidents/leakage at 12 weeks
Group 1: Extended Release Tolterodine30.426.310.87.2
Group 2: Intravaginal Estradiol Cream26.424.611.97.7

[back to top]

Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score

The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother. (NCT00465894)
Timeframe: From baseline through 12 Weeks of Intervention

,
Interventionunits on a scale (Mean)
Baseline12 Weeks
Group 1: Extended Release Tolterodine65.446.7
Group 2: Intravaginal Estradiol Cream61.645.4

[back to top]

Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I)

Assessment measured using the Patient Global Impression of Improvement (PGI-I), patient perception of improvement. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 being very much better to 7 being very much worse. Each level achieved(movement towards 1), is considered an improvement. (NCT00465894)
Timeframe: Baseline through 24 weeks

Interventionpercentage of participants (Number)
Group 1: Extended Release Tolterodine + Intravaginal Estradiol77
Group 2: Intravaginal Estradiol Cream + Tolterodine77

[back to top]

Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ)

"As measured by the Patient Satisfaction Questionnaire (PSQ). The PSQ consists of a single question, How satisfied are you with your progress since your treatment in which the 3 possible responses are completely satisfied, somewhat satisfied, and not satisfied. The goal of treatment was to move all participants to completely satisfied." (NCT00465894)
Timeframe: Baseline through 24 weeks

Interventionpercentage of participants (Number)
Group 1: Extended Release Tolterodine + Intravaginal Estradiol88
Group 2: Intravaginal Estradiol Cream + Tolterodine88

[back to top]

Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ)

"As measured by the Patient Satisfaction Questionnaire (PSQ).The PSQ consists of a single question, How satisfied are you with your progress since your treatment in which the 3 possible responses are completely satisfied, somewhat satisfied, and not satisfied. The goal of treatment was to move all participants to completely satisfied." (NCT00465894)
Timeframe: Baseline through 52 Weeks

Interventionpercentage of participants (Number)
Group 1: Extended Release Tolterodine + Intravaginal Estradiol84
Group 2: Intravaginal Estradiol Cream84

[back to top]

Evaluate Subjective Patient Change in Irritative Urinary Symptoms

"Assessment measured using the Patient Global Impression of Improvement (PGI-I), patient perception of improvement. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 being very much better to 7 being very much worse.~Frequencies of each response was reported. Each level achieved (movement towards 1), is considered an improvement." (NCT00465894)
Timeframe: From baseline through 12 Weeks of Intervention

,
Interventionparticipants (Number)
Very Much BetterMuch BetterA Little BetterNo ChangeA Litlle Worse
Group 1: Extended Release Tolterodine38851
Group 2: Intravaginal Estradiol Cream071250

[back to top]

Subjective Patient Change in Irritative Urinary Symptoms

"This was measured using the Patient Satisfaction Questionnaire (PSQ). The PSQ consists of a single question, How satisfied are you with your progress since your treatment in which the 3 possible responses are completely satisfied, somewhat satisfied, and not satisfied. The goal of treatment was to move all participants to completely satisfied." (NCT00465894)
Timeframe: From baseline through 12 Weeks of Intervention

,
Interventionparticipants (Number)
Completely SatisfiedSomewhat SatisfiedNot Satisfied
Extended Release Tolterodine LA5136
Intravaginal Estradiol Cream3138

[back to top] [back to top]

Subjective Patient Change in Irritative Urinary Symptoms

Assessment made using the Health Related Quality of Life (HRQL) portion of the OAB-q. The second part of the OAB-q, the HRQL consists of 25 questions that assesses HRQL which addresses coping, concern, sleep and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life. (NCT00465894)
Timeframe: Baseline through 52 weeks

Interventionunits on a scale (Mean)
Group 1: Extended Release Tolterodine + Intravaginal Estradiol26.8
Group 2: Intravaginal Estradiol Cream19.7

[back to top]

Subjective Patient Change in Irritative Urinary Symptoms

Assessment made using the Health Related Quality of Life (HRQL) portion of the OAB-q. The second part of the OAB-q, the HRQL consists of 25 questions that assesses HRQL which addresses coping, concern, sleep and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life. (NCT00465894)
Timeframe: Baseline to 24 weeks

Interventionunits on a scale (Mean)
Group 1: Extended Release Tolterodine + Intravaginal Estradiol19.3
Group 2: Intravaginal Estradiol Cream + Tolterodine20.9

[back to top]

Subjective Patient Change in Irritative Urinary Symptoms

The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother. (NCT00465894)
Timeframe: Baseline through 52 weeks

Interventionunits on a scale (Mean)
Group 1: Extended Release Tolterodine + Intravaginal Estradiol-23.4
Intravaginal Estradiol Cream + Tolterodine-31.3

[back to top]

Subjective Patient Change in Irritative Urinary Symptoms

The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother. (NCT00465894)
Timeframe: Baseline to 24 weeks

Interventionunits on a scale (Mean)
Group 1: Extended Release Tolterodine + Intravaginal Estradiol-25.4
Group 2: Intravaginal Estradiol Cream + Tolterodine-28.7

[back to top]

Percent Change From Baseline of UUI Episodes Per 24 Hours

"UUI episodes per 24 hours calculated as total number of micturitions with USS of 5 in diary. USS is 5-item scale measuring urinary urgency; range is~1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100." (NCT00611026)
Timeframe: Baseline, Week 1, Week 4, Week 12

,,
Interventionpercent change (Median)
Week 1 (n=442, 911, 899)Week 4 [LOCF] (n=448, 922, 908)Week 12 [LOCF] (n=448, 926, 908)
Fesoterodine-50.0-100.0-100.0
Placebo-40.8-75.0-100.0
Tolterodine ER-50.0-88.9-100.0

[back to top]

Post-hoc Adverse Events (AEs)

An adverse event is any untoward medical occurrence in a clinical investigation in which the participant was administered a product or medical device; the event does not necessarily need to have a causal relationship with the treatment or usage. (NCT00611026)
Timeframe: Baseline up to Week 12

,
Interventionevents (Number)
ConstipationFingers tinglingFinger numbnessHypertensionDiabetes mellitusAbdominal distension and discomfortTina pedisTingling sensation/decreased sensation of fingersDyspepsiaAbdominal bloating
Fesoterodine0112211111
Tolterodine ER1000000000

[back to top]

Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours

Percent change calculated as change in severe urgency episodes (USS rating ≥4 in diary ) per 24 hours at that visit divided by the baseline number of severe urgency episodes per 24 hours, multiplied by 100. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). (NCT00611026)
Timeframe: Baseline, Week 1, Week 4, Week 12

,,
Interventionpercent change (Median)
Week 1 (n=446, 915, 902)Week 4 [LOCF] (n=452, 926, 911)Week 12 [LOCF] (n=452, 930, 911)
Fesoterodine-25.0-61.1-79.3
Placebo-19.7-41.7-61.0
Tolterodine ER-24.1-55.6-69.2

[back to top]

Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)

Urgency Urinary episodes per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of ≥3 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). (NCT00611026)
Timeframe: Baseline, Week 1, Week 4, Week 12

,,
Interventionepisodes per 24 hours (Least Squares Mean)
Week 1 (n=447, 918, 906)Week 4 [LOCF] (n=453, 929, 915)Week 12 [LOCF] (n=453, 933, 915)
Fesoterodine-1.2-3.1-4.2
Placebo-0.8-1.9-3.2
Tolterodine ER-1.0-2.5-3.5

[back to top]

Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12

UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). (NCT00611026)
Timeframe: Baseline, Week 12

Interventionepisodes per 24 hours (Mean)
Placebo-1.62
Tolterodine ER-1.74
Fesoterodine-1.95

[back to top]

Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12

Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother. Negative change in Symptom Bother Score indicates improvement. (NCT00611026)
Timeframe: Baseline, Week 12

Interventionscores on a scale (Least Squares Mean)
Placebo-21.8
Tolterodine ER-24.3
Fesoterodine-28.9

[back to top]

Change From Baseline in Frequency-Urgency Sum (FUS) Per 24 Hours (Synonymous With USS Sum in the Study Protocol)

Frequency-Urgency Sum per 24 hours calculated as mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). (NCT00611026)
Timeframe: Baseline, Week 1, Week 4, Week 12

,,
Interventionscores on a scale (Least Squares Mean)
Week 1 (n=447, 918, 906)Week 4 [LOCF] (n=453, 929, 915)Week 12 [LOCF] (n=453, 933, 915)
Fesoterodine-5.5-12.0-15.6
Placebo-4.0-8.1-12.0
Tolterodine ER-4.8-10.1-13.2

[back to top]

Change From Baseline in Mean Number of Micturitions Per 24 Hours

The mean number of micturitions was calculated as the total number of micturitions divided by the total number of diary days collected at that visit. (NCT00611026)
Timeframe: Baseline, Week 1, Week 4, Week 12

,,
Interventionmicturitions per 24 hours (Least Squares Mean)
Week 1 (n=448, 921, 908)Week 4 [LOCF] (n=454, 931, 916)Week 12 [LOCF] (n=454, 935, 916)
Fesoterodine-1.0-2.1-2.6
Placebo-0.8-1.5-2.0
Tolterodine ER-1.0-1.8-2.3

[back to top]

Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours

Mean number of nocturnal micturitions per 24 hours was calculated as the total number of all micturitions divided by the total number of diary days collected at that visit. Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day. (NCT00611026)
Timeframe: Baseline, Week 1, Week 4, Week 12

,,
Interventionnocturnal micturitions per 24 hours (Least Squares Mean)
Week 1 (n=432, 879, 871)Week 4 [LOCF] (n=437, 888, 879)Week 12 [LOCF] (n=437, 892, 879)
Fesoterodine-0.3-0.5-0.7
Placebo-0.2-0.4-0.5
Tolterodine ER-0.3-0.5-0.6

[back to top]

Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours

Mean number of severe urgency episodes (USS rating ≥4 in diary ) per 24 hours calculated as the total number of micturitions with USS ≥4 divided by total number of diary days collected at that visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). (NCT00611026)
Timeframe: Baseline, Week 1, Week 4, Week 12

,,
Interventionsevere urgency episodes per 24 hours (Mean)
Week 1 (n=446, 915, 902)Week 4 [LOCF] (n=452, 926, 911)Week 12 [LOCF] (n=452, 930, 911)
Fesoterodine-1.58-3.21-4.08
Placebo-1.14-2.14-3.01
Tolterodine ER-1.34-2.71-3.39

[back to top]

Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1 and Week 4

UUI episodes per 24 hours calculated as total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). (NCT00611026)
Timeframe: Baseline, Week 1, Week 4

,,
Interventionepisodes per 24 hours (Mean)
Week 1 (n=442, 911, 899)Week 4 [LOCF] (n=448, 922, 908)
Fesoterodine-1.03-1.68
Placebo-0.80-1.31
Tolterodine ER-0.95-1.52

[back to top]

Change From Baseline in Mean Urinary Sensation Scale (USS) Rating Per Micturition Per 24 Hours.

Mean USS rating calculated as the sum of rating scores on USS per 24 hours divided by the total number of micturitions per 24 hours with non-missing rating at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). (NCT00611026)
Timeframe: Baseline, Week 1, Week 4, Week 12

,,
Interventionscores on a scale (Least Squares Mean)
Week 1 (n=447, 918, 906)Week 4 [LOCF] (n=453, 929, 915)Week 12 [LOCF] (n=453, 933, 915)
Fesoterodine-0.2-0.5-0.7
Placebo-0.2-0.3-0.6
Tolterodine ER-0.2-0.4-0.6

[back to top]

Change From Baseline in Mean Voided Volume Per Micturition

Mean voided volume in milliliters (mL) calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 in the 3-day diary at that visit. (NCT00611026)
Timeframe: Baseline, Week 1, Week 4, Week 12

,,
InterventionmL (Mean)
Week 1 (n=447, 917, 895)Week 4 [LOCF] (n=452, 927, 909)Week 12 [LOCF] (n=452, 930, 912)
Fesoterodine18.6332.2634.47
Placebo9.8014.2717.34
Tolterodine ER15.6526.4328.43

[back to top] [back to top]

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

Number of participants in 4-point category: ≥2 points improvement (major improvement; negative change from baseline); 1 point improvement (minor improvement); no change; deterioration (positive change from baseline), based on PPBC score (rated on 6-point scale: 1=no problems at all; 6=many severe problems). Score change: score at observation minus score at baseline; re-scaled to 4-point categorical variables. (NCT00611026)
Timeframe: Baseline, Week 1, Week, 4, Week 12

,,
Interventionparticipants (Number)
Week 1 (n=452, 931, 913) ≥2 points improvementWeek 1: 1-point improvementWeek 1: no changeWeek 1: deteriorationWeek 4 (n=455, 937, 918) ≥2 points improvementWeek 4: 1-point improvementWeek 4: no changeWeek 4: deteriorationWeek 12 (n=455, 937, 918) ≥2 points improvementWeek 12: 1-point improvementWeek 12: no changeWeek 12: deterioration
Fesoterodine144280428613342802505444023618953
Placebo43144210551111241724816610613350
Tolterodine ER138278434812902982856437925024959

[back to top]

Change From Baseline in Urgency Perception Scale (UPS). UPS Formerly Known as Patient Perception of Urgency Scale (PPUS) in the Protocol.

Number of participants in 3-point category: improvement [≥1-point improvement]; no change; deterioration [≥1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables. (NCT00611026)
Timeframe: Baseline, Week 1, Week, 4, Week 12

,,
Interventionparticipants (Number)
Week 1 (n=452, 932, 913) improvementWeek 1: no changeWeek 1: deteriorationWeek 4 (n=455, 938, 918) improvementWeek 4: no changeWeek 4: deteriorationWeek 12 (n=455, 938, 918) improvementWeek 12: no changeWeek 12: deterioration
Fesoterodine267609374214673049539330
Placebo97326291612712318323933
Tolterodine ER264619493765115144045543

[back to top]

Diary Dry Rate: Percentage of Participants With no Urgency Urinary Incontinence (UUI) in the 3-day Bladder Diary

Diary dry rate: percentage of participants with no urgency urinary incontinence episode reported in the 3 day diary at the respective time-point; based on USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). (NCT00611026)
Timeframe: Week 1, Week 4, Week 12

,,
Interventionpercentage of participants (Number)
Week 1 (n=422, 911, 899)Week 4 [LOCF] (n=448, 922, 908)Week 12 [LOCF] (n=448, 926, 908)
Fesoterodine25.151.163.2
Placebo17.639.553.8
Tolterodine ER24.546.758.1

[back to top]

Percent Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)

Percent change from baseline in mean number of Urgency Urinary episodes per 24 hours (Urinary Sensation Scale ≥3 in the diary). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100. (NCT00611026)
Timeframe: Baseline, Week 1, Week 4, Week 12

,,
Interventionpercent change (Median)
Week 1 (n=447, 918, 906)Week 4 [LOCF] (n=453, 929, 915)Week 12 [LOCF] (n=453, 933, 915)
Fesoterodine-11.8-32.1-45.5
Placebo-9.4-17.2-31.0
Tolterodine ER-12.0-26.3-37.5

[back to top]

Percent Change From Baseline of Micturitions Per 24 Hours

Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100%*(Week 1 or 4 or 12 - baseline)/baseline). (NCT00611026)
Timeframe: Baseline, Week 1, Week 4, Week 12

,,
Interventionpercent change (Median)
Week 1 (n=448, 921, 908)Week 4 [LOCF] (n=454, 931, 916)Week 12 [LOCF] (n=454, 935, 916)
Fesoterodine-9.0-18.9-23.5
Placebo-7.1-13.4-18.2
Tolterodine ER-9.4-16.7-20.8

[back to top]

Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours

Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100%*(Week 1 or 4 or 12 - baseline)/baseline). Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day. (NCT00611026)
Timeframe: Baseline, Week 1, Week 4, Week 12

,,
Interventionpercent change (Median)
Week 1 (n=432, 879, 871)Week 4 [LOCF] (n=437, 888, 879)Week 12 [LOCF] (n=437, 892, 879)
Fesoterodine-12.5-25.0-33.3
Placebo-7.7-20.0-27.3
Tolterodine ER-14.3-25.0-33.3

[back to top]

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

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

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

[back to top]

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

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

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

[back to top] [back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top] [back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top] [back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top] [back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

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

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

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

[back to top]

Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 1 on Tolterodine 4 mg and Placebo

Change from baseline in maximum cystometric capacity at 4 hours post dose 1 on tolterodine 4 mg and placebo (analysis on natural log transformed data) (NCT00768521)
Timeframe: 4 hours post dose 1

InterventionPercentage change (Least Squares Mean)
Tolterodine0.92
Placebo0.91

[back to top]

Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo

Change from baseline in maximum cystometric capacity at 4 hours post dose 7 on tolterodine 4 mg and placebo (analysis on natural log transformed data) (NCT00768521)
Timeframe: 4 hours post dose 7

InterventionPercentage change (Least Squares Mean)
Tolterodine1.15
Placebo0.94

[back to top] [back to top] [back to top]

Maximum Urine Flow Rate (Qmax).

To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: maximum urine flow rate (Qmax) measured via uroflowmetry. (NCT00939120)
Timeframe: 12 months

InterventionmL/sec (Mean)
Tolterodine ER 4mg + Dutasteride 0.5mg11.7
Placebo + Dutasteride 0.5mg12.9

[back to top]

Patient Perception of Bladder Condition (PPBC)

To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: participant reported patient perception of bladder condition (PPBC), one question scored from 1-6, higher scores indicating more severe symptoms. (NCT00939120)
Timeframe: 12 months

Interventionunits on a scale (Mean)
Tolterodine ER 4mg + Dutasteride 0.5mg3.6
Placebo + Dutasteride 0.5mg3.0

[back to top]

Post-void Residual (PVR) Volume

To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: post-voiding residual volume measured via ultrasound. (NCT00939120)
Timeframe: 12 months

InterventionmL (Mean)
Tolterodine ER 4mg + Dutasteride 0.5mg101.7
Placebo + Dutasteride 0.5mg75.8

[back to top]

Overactive Bladder Questionnaire (OABq)

To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: overactive bladder questionnaire (OABq) - 33 questions scored via 1-6 (higher scores indicate more severe symptoms), thus values ranged from 33-198. (NCT00939120)
Timeframe: 12 months

Interventionunits on a scale (Mean)
Tolterodine ER 4mg + Dutasteride 0.5mg80.2
Placebo + Dutasteride 0.5mg67.7

[back to top]

Urine Voided Volume (Voiding)

To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: urine voided volume (voiding) measured by uroflowmetry. (NCT00939120)
Timeframe: 12 months

InterventionmL (Mean)
Tolterodine ER 4mg + Dutasteride 0.5mg219.9
Placebo + Dutasteride 0.5mg232.9

[back to top]

International Prostate Symptoms Score, Voiding Subscore

To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: voiding subscore of international prostate symptoms score (IPSS) - 4 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-20. (NCT00939120)
Timeframe: 12 months

Interventionunits on a scale (Mean)
Tolterodine ER 4mg + Dutasteride 0.5mg7.5
Placebo + Dutasteride 0.5mg7.0

[back to top]

Acute Urinary Retention (AUR)

To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: acute urinary attention (AUR) - inability to urinate requiring catheterization. (NCT00939120)
Timeframe: 12 months

Interventionparticipants (Number)
Tolterodine ER 4mg + Dutasteride 0.5mg0
Placebo + Dutasteride 0.5mg0

[back to top]

International Prostate Symptoms Score (IPSS), Storage Subscore

To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: storage subscore international prostate symptoms score (IPSS) - 3 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-15. (NCT00939120)
Timeframe: 12 months

Interventionunits on a scale (Mean)
Tolterodine ER 4mg + Dutasteride 0.5mg7.9
Placebo + Dutasteride 0.5mg7.5

[back to top]

International Prostate Symptoms Score (IPSS), Total

To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: total international prostate symptoms score (IPSS) - 7 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-35. (NCT00939120)
Timeframe: 12 months

Interventionunits on a scale (Mean)
Tolterodine ER 4mg + Dutasteride 0.5mg15.4
Placebo + Dutasteride 0.5mg14.5

[back to top]

Change in Frequency of Urination From 6 Weeks to 12 Weeks (Last Observation Carried Forward)

Bladder diaries completed by subjects prior to randomization and following each phase of treatment were used to calculate changes in frequency of urination. (NCT01175382)
Timeframe: Change from 6 weeks to 12 weeks

InterventionVoids per day (Mean)
Behavioral Treatment Alone0.7
Drug Therapy (Tolterodine + Tamsulosin)1.4
Combined Behavioral + Drug Therapy0.2

[back to top]

Change in Frequency of Urination After 6-week Intervention (Last Observation Carried Forward)

Bladder diaries completed by subjects prior to randomization and following the first phase of treatment was used to calculate changes in frequency of urination. (NCT01175382)
Timeframe: From Baseline to 6 Weeks

Interventionvoids per day (Mean)
Behavioral Treatment Alone2.7
Drug Therapy (Tolterodine + Tamsulosin)1.5
Combined Behavioral + Drug Therapy3.3

[back to top]

Change in Frequency of Urination From Baseline to 12 Weeks (Last Observation Carried Forward)

Bladder diaries completed by subjects prior to randomization and following the second phase of treatment were used to calculate changes in frequency of urination (NCT01175382)
Timeframe: Baseline to 12 weeks

InterventionVoids per day (Mean)
Behavioral Treatment Alone3.3
Drug Therapy (Tolterodine + Tamsulosin)2.9
Combined Behavioral + Drug Therapy3.5

[back to top]

Change in Nocturia From Baseline to 6 Weeks (Last Observation Carried Forward)

Bladder diaries completed prior to randomization and following each phase of treatment will be used to calculate changes in frequency of nocturia. (NCT01175382)
Timeframe: From Baseline to 6 Weeks

Interventionvoids per night (Mean)
Behavioral Treatment Alone0.7
Drug Therapy (Tolterodine + Tamsulosin)0.4
Combined Behavioral + Drug Therapy0.8

[back to top]

Change in International Prostate Symptom Score (I-PSS) From Baseline to 12 Weeks (Last Observation Carried Forward)

Change from Baseline to 12 weeks on the International Prostate Symptom Score (I-PSS) to measure urinary symptoms related to BPH. The I-PSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). (NCT01175382)
Timeframe: From Baseline to 12 weeks

Interventionunits on a scale (Mean)
Behavioral Treatment Alone6.7
Drug Therapy (Tolterodine + Tamsulosin)6.7
Combined Behavioral + Drug Therapy8.8

[back to top]

Change in International Prostate Symptom Score (I-PSS) From Baseline to 6 Weeks. (Last Observation Carried Forward)

Change from baseline to 6 weeks on the International Prostate Symptom Score (IPSS) to measure urinary symptoms related to benign prostatic hypertrophy (BPH). The I-PSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). (NCT01175382)
Timeframe: From Baseline to 6 Weeks

Interventionunits on a scale (Mean)
Behavioral Treatment Alone4.0
Drug Therapy (Tolterodine + Tamsulosin)4.4
Combined Behavioral + Drug Therapy7.9

[back to top]

Change in International Prostate Symptom Score (IPSS) From 6 to 12 Weeks (Last Observation Carried Forward)

Change from 6 weeks to 12 weeks on the International Prostate Symptom Score (IPSS) to measure urinary symptoms related to BPH.The I-PSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). (NCT01175382)
Timeframe: Change from 6 weeks to 12 weeks

Interventionunits on a scale (Mean)
Behavioral Treatment Alone2.7
Drug Therapy (Tolterodine + Tamsulosin)2.2
Combined Behavioral + Drug Therapy0.8

[back to top]

Change in Nocturia From 6 Weeks to 12 Weeks (Last Observation Carried Forward)

Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in frequency of nocturia (NCT01175382)
Timeframe: Change from 6 weeks to 12 weeks

InterventionVoids per night (Mean)
Behavioral Treatment Alone0.1
Drug Therapy (Tolterodine + Tamsulosin)0.3
Combined Behavioral + Drug Therapy0.1

[back to top]

Change in Nocturia Measured From Baseline to 12 Weeks (Last Observation Carried Forward)

Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in the frequency nocturia (NCT01175382)
Timeframe: From Baseline to 12 weeks

Interventionvoids per night (Mean)
Behavioral Treatment Alone0.8
Drug Therapy (Tolterodine + Tamsulosin)0.7
Combined Behavioral + Drug Therapy0.9

[back to top]

Change in Overactive Bladder Questionnaire (OAB-q) From 6 to 12 Weeks (Last Observation Carried Forward)

Change from 6 weeks to 12 weeks on the OAB-q to measure symptom bother and condition-specific health-related quality of life. This questionnaire asks about how much you have been bothered by selected bladder symptoms during the past 4 weeks. Scale ranges from 8 to 48 with higher scores indicating a greater degree of bother. (NCT01175382)
Timeframe: Change from 6 week to 12 weeks

Interventionunits on a scale (Mean)
Behavioral Treatment Alone17.3
Drug Therapy (Tolterodine + Tamsulosin)10.8
Combined Behavioral + Drug Therapy4.6

[back to top]

Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 12 Weeks (Last Observation Carried Forward)

Change from baseline to 12 weeks on the OAB-q to measure symptom bother and condition-specific health-related quality of life. This questionnaire asks about how much you have been bothered by selected bladder symptoms during the past 4 weeks. Scale ranges from 8 to 48 with higher scores indicating a greater degree of bother. (NCT01175382)
Timeframe: From Baseline to 12 weeks

Interventionunits on a scale (Mean)
Behavioral Treatment Alone37.3
Drug Therapy (Tolterodine + Tamsulosin)31.0
Combined Behavioral + Drug Therapy42.1

[back to top]

Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 6 Weeks (Last Observation Carried Forward)

Change from baseline on the OAB-q to measure symptom bother and condition-specific health-related quality of life. This questionnaire asks about how much you have been bothered by selected bladder symptoms during the past 4 weeks. Scale ranges from 8 to 48 with higher scores indicating a greater degree of bother. (NCT01175382)
Timeframe: From Baseline to 6 Weeks

Interventionunits on a scale (Mean)
Behavioral Treatment Alone19.9
Drug Therapy (Tolterodine + Tamsulosin)20.2
Combined Behavioral + Drug Therapy37.5

[back to top]

Change in Urgency From Baseline to 6 Weeks (Last Observation Carried Forward)

Bladder diaries completed prior to randomization and following each phase of treatment will be used to calculate changes in urgency associated with each void and incontinent episode using the Indevus Urgency Severity Scale (IUSS). IUSS asks patients about the degree of urgency, as meant to describe the urge to urinate. Patients are asked to rate the degree of urgency and its impact on the completion of activity or tasks during the time that the urgency sensation is present and before reaching the toilet for a toilet void. Four distinct, subjective degrees of urgency severity were identified, including 1) no sensation of urgency, 2) awareness of urgency but easily tolerated, 3) urgency that is somewhat uncomfortable and 4) extreme urgency discomfort. (NCT01175382)
Timeframe: From Baseline to 6 Weeks

Interventionunits on a scale (Mean)
Behavioral Treatment Alone-0.1
Drug Therapy (Tolterodine + Tamsulosin)0.1
Combined Behavioral + Drug Therapy0.2

[back to top]

Change in Urgency Score From 6 Weeks to 12 Weeks (Last Observation Carried Forward)

Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in urgency associated with each void and incontinent episode using the Indevus Urgency Severity Scale (IUSS). IUSS asks patients about the degree of urgency, as meant to describe the urge to urinate. Patients are asked to rate the degree of urgency and its impact on the completion of activity or tasks during the time that the urgency sensation is present and before reaching the toilet for a toilet void. Four distinct, subjective degrees of urgency severity were identified, including 1) no sensation of urgency, 2) awareness of urgency but easily tolerated, 3) urgency that is somewhat uncomfortable and 4) extreme urgency discomfort. (NCT01175382)
Timeframe: Change from 6 weeks to 12 weeks

Interventionunits on a scale (Mean)
Behavioral Treatment Alone0.1
Drug Therapy (Tolterodine + Tamsulosin)0.1
Combined Behavioral + Drug Therapy0.1

[back to top]

Change in Urinary Incontinence Episodes From Baseline to 12 Weeks (Last Observation Carried Forward)

Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in frequency of urination (NCT01175382)
Timeframe: From Baseline to 12 weeks

Interventionvoids per day (Mean)
Behavioral Treatment Alone4.6
Drug Therapy (Tolterodine + Tamsulosin)4.6
Combined Behavioral + Drug Therapy5.2

[back to top]

Change in Urinary Incontinence From 6 Weeks to 12 Weeks (Last Observation Carried Forward)

Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in frequency of incontinence episodes. (NCT01175382)
Timeframe: Change from 6 weeks to 12 weeks

InterventionEpisodes per week (Mean)
Behavioral Treatment Alone1.3
Drug Therapy (Tolterodine + Tamsulosin)1.5
Combined Behavioral + Drug Therapy0.0

[back to top]

Change in Urinary Incontinence From Baseline to 6 Weeks (Last Observation Carried Forward)

Bladder diaries completed prior to randomization and following each phase of treatment will be used to calculate changes in frequency of incontinence episodes. (NCT01175382)
Timeframe: From Baseline to 6 Weeks

Interventionepisodes per week (Mean)
Behavioral Treatment Alone3.4
Drug Therapy (Tolterodine + Tamsulosin)3.1
Combined Behavioral + Drug Therapy5.2

[back to top]

Change in Urgency Score From Baseline to 12 Weeks (Last Observation Carried Forward)

Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in frequency of urgency associated with each void and incontinent episode using the Indevus Urgency Severity Scale (IUSS). IUSS asks patients about the degree of urgency, as meant to describe the urge to urinate. Patients are asked to rate the degree of urgency and its impact on the completion of activity or tasks during the time that the urgency sensation is present and before reaching the toilet for a toilet void. Four distinct, subjective degrees of urgency severity were identified, including 1) no sensation of urgency, 2) awareness of urgency but easily tolerated, 3) urgency that is somewhat uncomfortable and 4) extreme urgency discomfort. (NCT01175382)
Timeframe: From Baseline to 12 weeks

Interventionunits on a scale (Mean)
Behavioral Treatment Alone0.0
Drug Therapy (Tolterodine + Tamsulosin)0.1
Combined Behavioral + Drug Therapy0.2

[back to top]

Change From Baseline in Mean Voided Volume Per Micturition at Week 1, 4 and 12

Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 at that visit. Baseline values for each time point were calculated separately considering only those participants who were evaluable at the given time point. (NCT01302938)
Timeframe: Baseline, Week 1, 4, 12

,
Interventionmilliliter (mL) (Mean)
Baseline for Week 1 (n=10,5)Baseline for Week 4 (n=11,6)Baseline for Week 12 (n=11,6)Change at Week 1 (n=10,5)Change at Week 4 (n=11,6)Change at Week 12 (n=11,6)
Placebo194.2185.2185.227.919.2-10.1
Tolterodine163.7161.2161.249.845.231.9

[back to top]

Participant Perception Regarding Recommending a Friend to Enter Similar Study

"PEQ is a web-based self-administered, exploratory questionnaire that assesses the participant's perception of trial method. Number of participants who responded to question 6, How likely would you be to recommend a friend to enter a similar study? are reported." (NCT01302938)
Timeframe: Week 12

Interventionparticipants (Number)
Very likelySomewhat likelyNeither
Entire Study Population1151

[back to top]

Participant Perception Regarding Received Treatment in the Study

"PEQ is a web-based self-administered, exploratory questionnaire that assesses the participant's perception of trial method. Number of participants who responded to question 5, What treatment did you think you were on? are reported." (NCT01302938)
Timeframe: Week 12

,
Interventionparticipants (Number)
PlaceboTolterodine
Placebo42
Tolterodine38

[back to top]

Participant Perception Regarding Cell Phone Diary

"PEQ:self-administered, assesses participants perception of trial method. Question4, How satisfied were you with items? on scale 1(very easy) to 5(very difficult)- a: teaching video explaining CP use; recording urinations using CP; size of text on CP; sending your urinary information(inf) using your CP, e: overall, suitability for capturing urinations as they happened." (NCT01302938)
Timeframe: Week 12

Interventionparticipants (Number)
CP use video: neither difficult nor easyCP use video: somewhat easyCP use video: very easyRecording urinations using CP: somewhat easyRecording urinations using CP: very easyCP text size: neither difficult nor easyCP text size: somewhat easyCP text size: very easySending urinary inf using CP: somewhat easySending urinary inf using CP: very easyOverall: neither difficult nor easyOverall: somewhat easyOverall: very easy
Entire Study Population141231414124131313

[back to top]

Number of Participants Who Discontinued the Study Due to Adverse Events

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. (NCT01302938)
Timeframe: Baseline up to 28 days after last dose

Interventionparticipants (Number)
Tolterodine1
Placebo0

[back to top]

Number of Participants With Laboratory Abnormalities

Criteria for potentially clinically significant (PCS) laboratory values: Hemoglobin, hematocrit, red blood cell less than (<) 0.8 lower limit of normal(LLN); platelet <0.5 LLN, >1.75 upper LN (ULN);white blood cell <0.6 LLN, >1.5 ULN; lymphocyte, total neutrophil(absolute[AL]),Total protein, albumin, phosphate <0.8 LLN, >1.2 ULN; basophil, eosinophil, monocyte >1.2ULN; Total bilirubin >1.5ULN; aspartate, alanine aminotransferase, alkaline phosphatase >3ULN; Blood urea nitrogen, creatinine >1.3ULN; sodium <0.95LLN, >1.05ULN; potassium, chloride, bicarbonate, calcium <0.9LLN, >1.1ULN. (NCT01302938)
Timeframe: Week 12

Interventionparticipants (Number)
Tolterodine1
Placebo1

[back to top] [back to top] [back to top] [back to top]

Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 1 and 4

Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine. The mean number of micturitions per 24 hours was calculated as the total number of micturitions divided by the total number of diary days collected at that visit. Baseline values for each time point were calculated separately considering only those participants who were evaluable at the given time point. (NCT01302938)
Timeframe: Baseline, Week 1, 4

,
Interventionmicturitions per 24 hours (Mean)
Baseline for Week 1 (n=10,5)Baseline for Week 4 (n=11,6)Change at Week 1 (n=10,5)Change at Week 4 (n=11,6)
Placebo9.99.9-0.7-1.0
Tolterodine11.711.5-0.6-2.4

[back to top]

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

Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with Urinary Sensation Scale (USS) rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine. The mean number of micturitions per 24 hours was calculated as the total number of micturitions divided by the total number of diary days collected at that visit. (NCT01302938)
Timeframe: Baseline, Week 12

,
Interventionmicturitions per 24 hours (Mean)
BaselineChange at Week 12
Placebo9.9-0.3
Tolterodine11.5-2.6

[back to top]

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. (NCT01302938)
Timeframe: Baseline up to 28 days after last dose

,
Interventionparticipants (Number)
AEsSAEs
Placebo30
Tolterodine60

[back to top]

Number of Participants With Response Regarding Source of First Information About Study

"Participant experience questionnaire (PEQ) is a web-based self-administered, exploratory questionnaire that assesses the participant's perception of trial method. Number of participants who responded to question 1, Where did you hear first about the study? are reported." (NCT01302938)
Timeframe: Week 12

Interventionparticipants (Number)
FriendGoogle or related internet search engineWeb-site advertisementBlogger, on-line health group leader or activistOn-line CommunityEmailOther
Entire Study Population2331134

[back to top] [back to top]

Number of Participants With Reason for Participation in the Study

"PEQ is a web-based self-administered, exploratory questionnaire that assesses the participant's perception of trial method. Number of participants who responded to question 2, What led you to participate given the study drug is already available? are reported." (NCT01302938)
Timeframe: Week 12

Interventionparticipants (Number)
Contribute to researchExperience internet research study and try it outEase of participationFree medicationPayment for participation
Entire Study Population82331

[back to top]

Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12

PPUS: a self-administered, single-item, validated questionnaire that measures the participant's perception of urinary urgency. It is sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine [without leaking] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she is doing before going to toilet [without leaking]). Results categorized as SC from baseline on 3-point scale: improvement (positive SC), no change (SC 0), deterioration (negative SC). (NCT01302938)
Timeframe: Baseline (Bl), Week 1, 4, 12

,
Interventionparticipants (Number)
Bl,Week 1:Not able to hold urine (n=11,5)Bl,Week 1:Able to hold until reach toilet (n=11,5)Bl,Week 1:Able to finish what I am doing (n=11,5)Bl,Week 4:Not able to hold urine (n=12,6)Bl,Week 4:Able to hold until reach toilet (n=12,6)Bl,Week 4:Able to finish what I am doing (n=12,6)Bl,Week 12:Not able to hold urine (n=12,6)Bl,Week 12:Able to hold until reach toilet(n=12,6)Bl,Week 12:Able to finish what I am doing (n=12,6)Week 1:Improvement (n=11,5)Week 1:No change (n=11,5)Week 1:Deterioration (n=11,5)Week 4:Improvement (n=12,6)Week 4:No change (n=12,6)Week 4:Deterioration (n=12,6)Week 12:Improvement (n=12,6)Week 12:No change (n=12,6)Week 12:Deterioration (n=12,6)
Placebo131141141131051141
Tolterodine641651651461471660

[back to top]

Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12

PPBC: self-administered,single-item questionnaire to describe participant's perception of bladder-related problems. PPBC assessed on 6-point scale:1=no problems at all,2=some very minor problems,3=some minor problems,4=some moderate problems,5=severe problems,6=many severe problems. Results categorized as score change (SC) from baseline on 2-point scale:improvement (negative SC),no improvement (SC 0 or more) and on 4-point scale:major improvement (SC is negative in magnitude of 2 or more), minor improvement (SC is negative in magnitude of 1), no change (SC= 0),deterioration (positive SC). (NCT01302938)
Timeframe: Baseline, Week 1, 4, 12

,
Interventionparticipants (Number)
Baseline, Week 1: No Problems at all (n=11,5)Baseline, Week 1:Some Very Minor Problems(n=11,5)Baseline, Week 1: Some Minor Problems (n=11,5)Baseline, Week 1:Some Moderate Problems(n=11,5)Baseline, Week 1: Severe Problems (n=11,5)Baseline, Week 1: Many Severe Problems (n=11,5)Baseline, Week 4: No Problems at all (n=12,6)Baseline, Week 4: Some Very Minor Problems(n=12,6)Baseline, Week 4: Some Minor Problems (n=12,6)Baseline, Week 4: Some Moderate Problems (n=12,6)Baseline, Week 4: Severe Problems (n=12,6)Baseline, Week 4: Many Severe Problems (n=12,6)Baseline, Week 12: No Problems at all (n=12,6)Baseline, Week12: Some Very Minor Problems(n=12,6)Baseline, Week 12: Some Minor Problems (n=12,6)Baseline, Week 12: Some Moderate Problems (n=12,6)Baseline, Week 12: Severe Problems (n=12,6)Baseline, Week 12: Many Severe Problems (n=12,6)Week 1:Improvement (2-point scale) (n=11,5)Week 1:No improvement (2-point scale) (n=11,5)Week 1:Major improvement (4-point scale) (n=11,5)Week 1:Minor improvement (4-point scale) (n=11,5)Week 1:No Change (4-point scale) (n=11,5)Week 1:Deterioration (4-point scale) (n=11,5)Week 4:Improvement (2-point scale) (n=12,6)Week 4:No improvement (2-point scale) (n=12,6)Week 4:Major improvement (4-point scale) (n=12,6)Week 4:Minor improvement (4-point scale) (n=12,6)Week 4:No Change (4-point scale) (n=12,6)Week 4:Deterioration (4-point scale) (n=12,6)Week 12:Improvement (2-point scale) (n=12,6)Week 12:No improvement (2-point scale) (n=12,6)Week 12:Major improvement (4-point scale) (n=12,6)Week 12:Minor improvement (4-point scale) (n=12,6)Week 12:No Change (4-point scale) (n=12,6)Week 12:Deterioration (4-point scale) (n=12,6)
Placebo001211002211002211231112331221421320
Tolterodine001280001380001380742531754350937230

[back to top]

Number of Participants With Adverse Events (AEs) by Relatedness and Severity

AE:any untoward medical occurrence attributed to study medication in participant who received study drug. Relatedness to study medication was assessed by the investigator. Severity of AEs assessed as: mild (does not interfere with participant's usual function), moderate (interferes to some extent with participant's usual function) and severe (interferes significantly with participant's usual function). Mild, moderate and severe are not mutually exclusive; hence same participant may be included in more than 1 type of severity of AEs. (NCT01302938)
Timeframe: Baseline up to 28 days after last dose

,
Interventionparticipants (Number)
Treatment-related AEsMild AEsModerate AEsSevere AEs
Placebo0300
Tolterodine2431

[back to top]

Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12

OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (not at all) to 6 (a very great deal). Symptom bother score derived as sum of scores for items 1 to 8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother. (NCT01302938)
Timeframe: Baseline, Week 12

,
Interventionunits on a scale (Mean)
BaselineChange at Week 12
Placebo54.6-12.5
Tolterodine66.5-27.8

[back to top]

Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1, 4 and 12

UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Baseline values for each time point were calculated separately considering only those participants who were evaluable at the given time point. (NCT01302938)
Timeframe: Baseline, Week 1, 4, 12

,
Interventionepisodes per 24 hours (Median)
Baseline for Week 1 (n=10,5)Baseline for Week 4 (n=11,6)Baseline for Week 12 (n=11,6)Change at Week 1 (n=10,5)Change at Week 4 (n=11,6)Change at Week 12 (n=11,6)
Placebo2.32.32.3-0.7-1.9-1.2
Tolterodine3.22.72.7-1.0-1.3-1.7

[back to top]

Extension Study: Number of Participants Who Experienced an Adverse Event (AE)

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. (NCT01314872)
Timeframe: Extension: up to 54 weeks (including 2-week follow-up)

InterventionParticipants (Number)
Extension Study: Vibegron 50 mg134
Extension Study: Vibegron 100 mg157
Extension Study: Tolterodine ER 4 mg158
Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg82

[back to top]

Extension Study: Change From Baseline in Average Daily Number of Urge Incontinence Episodes at Week 52

Participants were required to keep a voiding diary, recording the occurrence of each urge incontinence episode. The average daily number of urge incontinence episodes was calculated as the total number of times a participant experienced such an episode during 52-week Extension Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study. (NCT01314872)
Timeframe: Baseline and Week 52 of Extension Study

InterventionUrge incontinence episodes (Least Squares Mean)
Extension Study: Vibegron 50 mg-2.43
Extension Study: Vibegron 100 mg-2.15
Extension Study: Tolterodine ER 4 mg-2.23
Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg-2.44

[back to top]

Extension Study: Change From Baseline in Average Daily Number of Total Incontinence Episodes at Week 52

Participants were required to keep a voiding diary, recording the occurrence of each total incontinence episode. The average daily number of total incontinence episodes was calculated as the total number of times a participant experienced such an episode during 52-week Extension Study, divided by the total divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study. (NCT01314872)
Timeframe: Baseline and Week 52 of Extension Study

InterventionIncontinence episodes (Least Squares Mean)
Extension Study: Vibegron 50 mg-2.70
Extension Study: Vibegron 100 mg-2.42
Extension Study: Tolterodine ER 4 mg-2.50
Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg-2.48

[back to top]

Extension Study: Change From Baseline in Average Daily Micturitions at Week 52

Participants were required to keep a voiding diary, recording the daily occurrence of each micturition. The average daily number of micturitions was calculated as the total number of recorded micturitions that occurred during the 52-week Extension Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study. (NCT01314872)
Timeframe: Baseline and Week 52 of Extension Study

InterventionMicturitions (Least Squares Mean)
Extension Study: Vibegron 50 mg-2.53
Extension Study: Vibegron 100 mg-2.77
Extension Study: Tolterodine ER 4 mg-2.15
Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg-3.25

[back to top]

Extension Study: Change From Baseline in Average Daily Number of Strong Urge Episodes at Week 52

Participants were required to keep a voiding diary, recording the occurrence of each strong urge episode. The average daily number of strong urge episodes was calculated as the total number of times a participant experienced such an episode during 52-week Extension Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study. (NCT01314872)
Timeframe: Baseline and Week 52 of Extension Study

InterventionStrong urge episodes (Least Squares Mean)
Extension Study: Vibegron 50 mg-3.11
Extension Study: Vibegron 100 mg-3.42
Extension Study: Tolterodine ER 4 mg-2.94
Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg-4.18

[back to top]

Base Study/Part 1: Change From Baseline in Average Daily Number of Strong Urge Episodes at Week 8

Participants were required to keep a voiding diary, recording the occurrence of each strong urge episode. The average daily number of strong urge episodes was calculated as the total number of times a participant experienced such an episode over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of strong urge episodes that occurred during the week of placebo run-in prior to Week 0 visit. (NCT01314872)
Timeframe: Baseline and Week 8

InterventionStrong urge episodes (Least Squares Mean)
Part 1: Placebo-1.59
Part 1: Vibegron 3 mg-1.77
Part 1: Vibegron 15 mg-2.27
Part 1: Vibegron 50 mg-2.36
Part 1: Vibegron 100 mg-2.83
Part 1: Tolterodine ER 4 mg-2.53
Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg-2.73

[back to top]

Base Study/Part 1 + Part 2: Number of Participants Who Experienced an Adverse Event (AE)

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. (NCT01314872)
Timeframe: Part 1: up to 8 weeks; Part 2: up to 4 weeks. The time frame was an additional 2 weeks for participants not continuing to the Extension Study.

InterventionParticipants (Number)
Part 1: Placebo66
Part 1: Vibegron 3 mg55
Part 1: Vibegron 15 mg70
Part 1: Vibegron 50 mg62
Part 1: Vibegron 100 mg70
Part 1: Tolterodine ER 4 mg68
Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg69
Part 2: Placebo22
Part 2: Vibegron 100 mg37
Part 2: Tolterodine ER 4 mg48
Part 2: Vibegron 100 mg + Tolterodine ER 4 mg40

[back to top]

Base Study/Part 1 + Part 2: Number of Participants Who Had Study Medication Withdrawn Due to an AE

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. (NCT01314872)
Timeframe: Part 1: up to 8 weeks; Part 2: up to 4 weeks

InterventionParticipants (Number)
Part 1: Placebo3
Part 1: Vibegron 3 mg3
Part 1: Vibegron 15 mg4
Part 1: Vibegron 50 mg2
Part 1: Vibegron 100 mg2
Part 1: Tolterodine ER 4 mg4
Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg3
Part 2: Placebo2
Part 2: Vibegron 100 mg4
Part 2: Tolterodine ER 4 mg0
Part 2: Vibegron 100 mg + Tolterodine ER 4 mg2

[back to top]

Base Study/Part 1: Change From Baseline in Average Daily Micturitions at Week 8

Participants were required to keep a voiding diary, recording the occurrence of each micturition. The average daily number of micturitions was calculated as the total number of micturitions that occurred over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of daily micturitions that occurred during the week of placebo run-in prior to Week 0 visit. (NCT01314872)
Timeframe: Baseline and Week 8

InterventionMicturitions (Least Squares Mean)
Part 1: Placebo-1.16
Part 1: Vibegron 3 mg-1.62
Part 1: Vibegron 15 mg-1.61
Part 1: Vibegron 50 mg-1.80
Part 1: Vibegron 100 mg-2.07
Part 1: Tolterodine ER 4 mg-1.71
Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg-2.05

[back to top]

Base Study/Part 1: Change From Baseline in Average Daily Number of Total Incontinence Episodes at Week 8

Participants were required to keep a voiding diary, recording the occurrence of each total incontinence episode. The average daily number of total incontinence episodes was calculated as the total number of times a participant experienced such an episode over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of total incontinence episodes that occurred during the week of placebo run-in prior to Week 0 visit. (NCT01314872)
Timeframe: Baseline and Week 8

InterventionIncontinence episodes (Least Squares Mean)
Part 1: Placebo-1.52
Part 1: Vibegron 3 mg-1.71
Part 1: Vibegron 15 mg-2.01
Part 1: Vibegron 50 mg-2.13
Part 1: Vibegron 100 mg-2.11
Part 1: Tolterodine ER 4 mg-1.86
Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg-2.00

[back to top]

Base Study/Part 1: Change From Baseline in Number of Urge Incontinence Episodes at Week 8

Participants were required to keep a voiding diary, recording the occurrence of each total incontinence episode. The average daily number of total incontinence episodes was calculated as the total number of times a participant experienced such an episode over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of total incontinence episodes that occurred during the week of placebo run-in prior to Week 0 visit. (NCT01314872)
Timeframe: Baseline and Week 8

InterventionUrge incontinence episodes (Least Squares Mean)
Part 1: Placebo-1.24
Part 1: Vibegron 3 mg-1.52
Part 1: Vibegron 15 mg-1.81
Part 1: Vibegron 50 mg-1.95
Part 1: Vibegron 100 mg-1.95
Part 1: Tolterodine ER 4 mg-1.69
Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg-1.71

[back to top]

Extension Study: Number of Participants Who Had Study Medication Withdrawn Due to an AE

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. (NCT01314872)
Timeframe: Extension: up to 52 weeks

InterventionParticipants (Number)
Extension Study: Vibegron 50 mg11
Extension Study: Vibegron 100 mg14
Extension Study: Tolterodine ER 4 mg24
Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg7

[back to top]

Risk Factors for the Proportion of Responders of Tolterodine-Severity of Overactive Bladder

Number of participants with responders of tolterodine to determine whether mild, moderate or severe is significant risk factor. (NCT01488578)
Timeframe: 12 week

Interventionparticipants (Number)
Mild2426
Moderate3709
Severe401

[back to top]

Risk Factors for the Proportion of Responders of Tolterodine-Previous Treatment

Number of participants with response to tolterodine to determine whether with or without previous treatment is significant risk factor. (NCT01488578)
Timeframe: 12 week

Interventionparticipants (Number)
With Previous Treatment698
Without Previous Treatment5753

[back to top]

Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinations Per Day (During Sleep)

Number of participants with responders of tolterodine to determine the Number of urinations per day (during sleep) is significant risk factor. (NCT01488578)
Timeframe: 12 week

Interventionparticipants (Number)
No Urination370
1 Urination882
2 Urinations1380
>= 3 Urinations3523

[back to top]

Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies

Number of participants with responders of tolterodine to determine whether with or without Non-drug therapies is significant risk factor. (NCT01488578)
Timeframe: 12 week

Interventionparticipants (Number)
With Non-drug Therapies317
Without Non-drug Therapies6219

[back to top]

Risk Factors for the Proportion of Responders of Tolterodine-Gender

Number of participants with responders of tolterodine to determine whether male or female is significant risk factor. (NCT01488578)
Timeframe: 12 week

Interventionparticipants (Number)
Male2745
Female3791

[back to top]

Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs

Number of participants with responders of tolterodine to determine whether with or without concomitant drugs is significant risk factor. (NCT01488578)
Timeframe: 12 week

Interventionparticipants (Number)
With Concomitant Drugs3483
Without Concomitant Drugs3053

[back to top]

Risk Factors for the Proportion of Responders of Tolterodine-Complications

Number of participants with responders of tolterodine to determine whether with or without complications is significant risk factor. (NCT01488578)
Timeframe: 12 week

Interventionparticipants (Number)
With Complications3960
Without Complications2576

[back to top]

Risk Factors for the Proportion of Responders of Tolterodine-Age

Number of participants with responders of tolterodine to determine whether <65 years or >=65 years is significant risk factor. (NCT01488578)
Timeframe: 12 week

Interventionparticipants (Number)
<65 Years2060
>=65 Years4476

[back to top] [back to top] [back to top]

Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinary Incontinence Episodes Per Day

Number of participants with responders of tolterodine to determine the Number of urinary incontinence episodes per day is significant risk factor. (NCT01488578)
Timeframe: 12 week

Interventionparticipants (Number)
1 to 2 Episodes1670
3 to 4 Episodes710
>= 5 Episodes254

[back to top] [back to top]

Number of Participants With an Investigator's Assessment of Clinical Outcome at End of the Study.

Clinical overall effectiveness was evaluated by investigators based on clinical symptoms, etc, at the end of observation period. (NCT01488578)
Timeframe: 12 week

Interventionparticipants (Number)
EffectiveNot effective
Tolterodine Tartrate65361244

[back to top] [back to top]

"Number of Participants Which Was Evaluated as Degree of Satisfaction."

Participant satisfaction was evaluated by investigators based on questioning the participants at the end of observation period using choices: Satisfied, Dissatisfied, Neither of the above. (NCT01488578)
Timeframe: 12 week

Interventionparticipants (Number)
SatisfiedDissatisfiedNeither of the aboveUnknown
Tolterodine Tartrate56091033963175

[back to top]

Risk Factors for the Proportion of Responders of Tolterodine-Urinary Urgency

Number of participants with responders of tolterodine to determine whether with or without Urinary urgency is significant risk factor. (NCT01488578)
Timeframe: 12 week

Interventionparticipants (Number)
With Urinary Urgency5529
Without Urinary Urgency829

[back to top]

Number of Participants Who Experienced an Adverse Event (AE)

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. (NCT01500382)
Timeframe: Up to 6 weeks (up to 3 weeks in Period 1 and up to 3 weeks in Period 2)

InterventionParticipants (Number)
Vibegron 100 mg0
Vibegron 100 mg + Tolterodine ER 4 mg0
Vibegron 50 mg0
Placebo0

[back to top]

Number of Participants Who Discontinued Use of Study Drug Due to an AE

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. The number of participants who discontinued study drug due to an AE were reported. (NCT01500382)
Timeframe: Up to 6 weeks (up to 3 weeks in Period 1 and up to 3 weeks in Period 2)

InterventionParticipants (Number)
Vibegron 100 mg0
Vibegron 100 mg + Tolterodine ER 4 mg0
Vibegron 50 mg0
Placebo0

[back to top]

Lower Urinary Tract Symptoms (LUTS)

LUTS was evaluated using the International Prostate Symptom Score (IPSS) questionnaire perioperatively. The IPSS constitutes of seven questions assigned score from 0 to 5 to evaluate the severity of LUTS in patients. Total scoring of IPSS ranges from 0 to 35, asymptomatic to very symptomatic. The more the score on scale is, the worse the outcome is.Therefore, the higher values represent worse outcomes. (NCT01530243)
Timeframe: Expected average of 2 weeks

Interventionunits on a scale (Mean)
Placebo11.12
Terazosin4.39
Tolterodine7.21
Tolterodine + Terazosin5.58

[back to top]

Pain

The visual analogue scale (VAS) was used to evaluate the pain at the time of voiding. This VAS scoring ranges from 0 to 10. The higher values represent worse outcomes, having more pain. (NCT01530243)
Timeframe: Expected 2 weeks later

Interventionunits on a scale (Mean)
Placebo4.16
Terazosin3.21
Tolterodine1.34
Tolterodine + Terazosin1.37

[back to top]

Quality of Life

The Quality of life of patients was evaluated using single question in IPSS questionnaire in which each of patients received scoring from 0 to 6. The higher values represent the worse quality of life. (NCT01530243)
Timeframe: Expected 2 weeks later

Interventionunits on a scale (Mean)
Placebo3.37
Terazosin2
Tolterodine2.30
Tolterodine + Terazosin0.95

[back to top]

The Global Response Assessment (GRA) After the Treatment Day

"Efficacy Using global response assessment (GRA) to compare the efficacy in Group 1 and Group 2 from baseline to 1month.~The global response assessment on a 6-point scale ranging from 1 No problems at all to 6 Many severe problems.~Changes of the global response assessment (GRA) improved or reduction by 1 points.~Change = Baseline minus Month 1 value~Safety:~Systemic adverse events such as difficult urination, dry mouth, dry eye, blurred vision, constipation, dizziness or general weakness" (NCT01661621)
Timeframe: 1 month after initial treatment

,
Interventionparticipants (Number)
GRA≥1GRA<1
Group 18927
Group 221861

[back to top]

The International Prostate Symptom Score (IPSS) Quality of Life (QoL) Score After the Treatment Day

"Efficacy:~Using the the the International Prostate Symptom Score (IPSS) quality of life (QoL) score to compare the efficacy in Group 1 and Group 2 from baseline to 1month.~The IPSS quality of life question score on a 7-point scale ranging from 0 Delighted to 6 Terrible.~IPSS-QoL ranges 0 to 6 (Delighted to Terrible)~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness" (NCT01661621)
Timeframe: Baseline and 1 month

,
Interventionunits on a scale (Mean)
Baseline1 month
Group 13.912.82
Group 23.882.82

[back to top]

The International Prostate Symptom Score (IPSS) Questionnaires After the Treatment Day

"Efficacy:~Using the total International Prostate Symptom Score (IPSS) to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.~The International Prostate Symptom Score (IPSS) is an 7 symptom questions including 4 voiding questions (IPSS-voiding), 3 storage questions (IPSS-Storage) The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always.~Total IPSS score = IPSS-voiding + IPSS-Storage Rang = 0 to 35 (asymptomatic to very symptomatic). Mild = 0 to 7; Moderate = 8 to 19; Severe = 20 to 35~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness" (NCT01661621)
Timeframe: Baseline and 1 month

,
Interventionunits on a scale (Mean)
Baseline1 month
Group 114.811.2
Group 218.010.8

[back to top]

The IPSS Subscore (IPSS Storage) Questionnaires After the Treatment Day

"Efficacy:~Using the the IPSS subscore (IPSS Storage) to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.~The IPSS subscore (IPSS Storage) is a 3 symptom questions. The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.~The total IPSS Storage score can therefore range from 0 to 15 (asymptomatic to very symptomatic).~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness" (NCT01661621)
Timeframe: Baseline and 1 month

,
Interventionunits on a scale (Mean)
Baseline1 month
Group 19.516.40
Group 25.704.31

[back to top]

The IPSS Subscore (IPSS Voiding) Questionnaires After the Treatment Day

"Efficacy:~Using the the IPSS subscore (IPSS Voiding) questionnaires to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.~The IPSS subscore (IPSS Voiding) questionnaires is a 4 symptom questions. The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.~The total IPSS Voiding score can therefore range from 0 to 20 (asymptomatic to very symptomatic).~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness" (NCT01661621)
Timeframe: Baseline and 1 month

,
Interventionunits on a scale (Mean)
Baseline1 month
Group 15.314.84
Group 212.36.49

[back to top]

The Voided Volume After the Treatment Day

"Efficacy:~Net change used the the voided volume in Group 1 and Group 2 from baseline to 1 month.~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness" (NCT01661621)
Timeframe: Baseline and 1 month

,
InterventionmL (Mean)
Baseline1 month
Group 1212.5231.6
Group 2244.0268.3

[back to top]

The Maximum Flow Rate (Qmax) After the Treatment Day

"Efficacy:~Net change used the the maximum flow rate (Qmax) in Group 1 and Group 2 from baseline to 1 month.~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness" (NCT01661621)
Timeframe: Baseline and 1 month

,
InterventionmL/s (Mean)
Baseline1 month
Group 113.113.6
Group 211.413.6

[back to top]

The Postvoid Residual Volume (PVR) After the Treatment Day

"Efficacy:~Net change used the the postvoid residual volume (PVR) in Group 1 and Group 2 from baseline to 1 month.~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness" (NCT01661621)
Timeframe: Baseline and 1 month

,
InterventionmL (Mean)
Baseline1 month
Group 150.160.4
Group 253.942.9

[back to top]

Change in Mean Nocturnal Urine Volume From Baseline

The mean nocturnal urine volume was derived from the three-day urine volume diary. The nocturnal volume was defined as the sum of the volumes for all nocturnal voids including the volume of the first morning void within 30 min of waking up in the morning. (NCT01729819)
Timeframe: Baseline to 3 months of treatment

InterventionmL (Least Squares Mean)
Combination-156.6
Tolterodine-92.46

[back to top]

Change in Mean Number of Nocturnal Voids From Baseline

A nocturnal void was defined as a void occurring at least 5 minutes after going to bed, but before getting up the next morning. The mean estimate was the average over 3 consecutive 24-hour periods prior to the respective visit as captured in the voiding and sleep diary. (NCT01729819)
Timeframe: Baseline to 3 months of treatment

InterventionVoids (Least Squares Mean)
Combination-1.63
Tolterodine-1.29

[back to top]

Change in Mean Time to First Nocturnal Void From Baseline

The time to first nocturnal void was defined as the time from going to bed with the intention of sleeping until first nocturnal void or until waking in the morning in the case there is no nocturnal void. The time to first void was calculated as the average over three consecutive 24-hour periods prior to the respective visits. (NCT01729819)
Timeframe: Baseline to 3 months of treatment

InterventionMinutes (Least Squares Mean)
Combination118.19
Tolterodine100.19

[back to top]

Responder Status

Responder status was defined as ≥33% decrease in the mean number of nocturnal void and at least one night with no voids out of the 3-day diary period. (NCT01729819)
Timeframe: Baseline to 3 months of treatment

InterventionProportion of responders (Number)
Combination0.40
Tolterodine0.29

[back to top]

Change in the Impact on Sleep as Measured by the Sleep Rating Scales From Baseline

An electronic diary was used in the trial to document the impact on sleep quality (sleep rating scales). The sleep rating scales included three questions that ranged from 0 (poor) to 10 (good). The average of each question for each visit was summarised and the change from baseline was analysed longitudinally during the three months of treatment. (NCT01729819)
Timeframe: Baseline to 3 months of treatment

,
InterventionScore on scale (Least Squares Mean)
From very tired to wide awake, how do you feel nowRate how refreshed you feel nowRate the quality of your sleep last night
Combination1.761.811.95
Tolterodine1.331.461.67

[back to top]

Onset of Effect as Seen in Change in Mean Number of Nocturnal Voids From Baseline for Each Visit During Three Months of Treatment

A nocturnal void was defined as a void occurring at least 5 minutes after going to bed, but before getting up the next morning. The mean estimate was the average over 3 consecutive 24-hour periods prior to the respective visit as captured in the voiding and sleep diary. (NCT01729819)
Timeframe: Baseline to 3 months of treatment

InterventionVoids (Least Squares Mean)
Month 1Month 2Month 3Overall (during the three months)
Treatment Difference (Combination-tolterodine)-0.19-0.44-0.43-0.35

[back to top]

Ureteral Stent Symptom Questionnaire Score

The ureteral stent symptom questionnaire contains 36 items from the 5 subscales: urinary index (11-items, total range of scores 11-54, The range of the mean score is 1-4.9), pain (8-items, total range of scores 5-27. Two items are not included in the calculation. The range of the mean score is 0.83-4.5), general health (6-items, total range of scores 4-28. The range of the mean score is 0.67-4.67), work (if stent influence patients work; 7-items, total range of scores 3-15. Four items are not included in the calculation. The range of the mean score is 1-5), and sexual matters (4-items, total range of scores 2-10. Two items are not included in the calculation. The range of the mean score is 1-5). In all cases, higher scores indicate worse outcomes. The score for each subscale is summed and divided by the number of items on the subscale. The group mean for each subscale is reported, the score is not normalized. (NCT01741454)
Timeframe: 42-48 hours post-stent insertion

,,,
Interventionscore on a scale (Mean)
Urinary indexPain scoreGeneral health scoreWorkSexual matters
Tamsulosin Plus Placebo 21-day Treatment2.982.92.642.11.83
Tamsulosin Plus Placebo 7-day Treatment2.952.662.352.042.07
Tamsulosin Plus Tolterodine ER 21-day Treatment2.832.712.781.791.75
Tamsulosin Plus Tolterodine ER 7-day Treatment2.912.892.692.922

[back to top]

Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion

The ureteral stent symptom questionnaire contains 36 items from the 5 subscales: urinary index (11-items, total range of scores 11-54, The range of the mean score is 1-4.9), pain (8-items, total range of scores 5-27. Two items are not included in the calculation. The range of the mean score is 0.83-4.5), general health (6-items, total range of scores 4-28. The range of the mean score is 0.67-4.67), work (if stent influence patients work; 7-items, total range of scores 3-15. Four items are not included in the calculation. The range of the mean score is 1-5), and sexual matters (4-items, total range of scores 2-10. Two items are not included in the calculation. The range of the mean score is 1-5). In all cases, higher scores indicate worse outcomes. The score for each subscale is summed and divided by the number of items on the subscale. The group mean for each subscale is reported, the score is not normalized. (NCT01741454)
Timeframe: 5-7 days post-stent insertion

,,,
Interventionscore on a scale (Mean)
Urinary indexPain scoreGeneral health scoreWorkSexual matters
Tamsulosin Plus Placebo 21-day Treatment2.492.582.521.941.75
Tamsulosin Plus Placebo 7-day Treatment2.462.392.342.811.5
Tamsulosin Plus Tolterodine ER 21-day Treatment2.462.42.281.472.9
Tamsulosin Plus Tolterodine ER 7-day Treatment2.552.492.332.611.59

[back to top]

Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal

The ureteral stent symptom questionnaire contains 36 items from the 5 subscales: urinary index (11-items, total range of scores 11-54, The range of the mean score is 1-4.9), pain (8-items, total range of scores 5-27. Two items are not included in the calculation. The range of the mean score is 0.83-4.5), general health (6-items, total range of scores 4-28. The range of the mean score is 0.67-4.67), work (if stent influence patients work; 7-items, total range of scores 3-15. Four items are not included in the calculation. The range of the mean score is 1-5), and sexual matters (4-items, total range of scores 2-10. Two items are not included in the calculation. The range of the mean score is 1-5). In all cases, higher scores indicate worse outcomes. The score for each subscale is summed and divided by the number of items on the subscale. The group mean for each subscale is reported, the score is not normalized. (NCT01741454)
Timeframe: Up to 24 hours after stent removal. Removal will occur 5 to 7 days after insertion.

,,,
Interventionscore on a scale (Mean)
Urinary indexPain scoreGeneral health scoreWorkSexual matters
Tamsulosin Plus Placebo 21-day Treatment1.851.971.842.131.58
Tamsulosin Plus Placebo 7-day Treatment1.721.661.731.571.42
Tamsulosin Plus Tolterodine ER 21-day Treatment2.142.081.991.562.42
Tamsulosin Plus Tolterodine ER 7-day Treatment1.911.661.671.411.3

[back to top]

Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion

The ureteral stent symptom questionnaire contains 36 items from the 5 subscales: urinary index (11-items, total range of scores 11-54, The range of the mean score is 1-4.9), pain (8-items, total range of scores 5-27. Two items are not included in the calculation. The range of the mean score is 0.83-4.5), general health (6-items, total range of scores 4-28. The range of the mean score is 0.67-4.67), work (if stent influence patients work; 7-items, total range of scores 3-15. Four items are not included in the calculation. The range of the mean score is 1-5), and sexual matters (4-items, total range of scores 2-10. Two items are not included in the calculation. The range of the mean score is 1-5). In all cases, higher scores indicate worse outcomes. The score for each subscale is summed and divided by the number of items on the subscale. The group mean for each subscale is reported, the score is not normalized. (NCT01741454)
Timeframe: Up to 24 hours prior to stent insertion

,,,
Interventionscore on a scale (Mean)
Urinary indexPain scoreGeneral health scoreWorkSexual matters
Tamsulosin Plus Placebo 21-day Treatment2.022.492.152.051.77
Tamsulosin Plus Placebo 7-day Treatment1.761.951.871.651.60
Tamsulosin Plus Tolterodine ER 21-day Treatment1.931.882.071.181.57
Tamsulosin Plus Tolterodine ER 7-day Treatment1.842.132.041.761.41

[back to top]

Percent Change in Urgency Urinary Incontinence Episodes

Percent change in median UUI episodes from baseline to 12 months with comparison made between hypnotherapy & pharmacotherapy (NCT01829425)
Timeframe: 12 months

Interventionpercentage change in median UUI episodes (Median)
Hypnotherapy85.7
Anticholinergic Medications80.0

[back to top]

Percent Change in Urgency Urinary Incontinence Episodes

Percent change in UUI episodes from baseline to 2 months with comparison made between hypnotherapy & pharmacotherapy (NCT01829425)
Timeframe: Baseline and 2 month follow-up

Interventionpercentage change in median UUI episodes (Median)
Hypnotherapy73
Anticholinergic Medications88.6

[back to top]

Voids on Bladder Diary

number of voids on 3-day bladder diary (NCT01829425)
Timeframe: 12 months

Interventioncounts (Mean)
Hypnotherapy25.74
Anticholinergic Medications25.37

[back to top]

Voids on Bladder Diary

Total Number of voids on 3-day bladder diary. (NCT01829425)
Timeframe: 2 months

Interventioncounts (Mean)
Hypnotherapy26.4
Anticholinergic Medications25.35

[back to top]

Overactive Bladder Questionnaire Short Form Quality of Life

Overactive Bladder questionnaire Short Form Quality of Life. Higher scores are better (better quality of life) and lower scores are worse (poorer quality of life). sub-scale score range 0-100. (NCT01829425)
Timeframe: 6 months

Interventionsub-scale scores (Least Squares Mean)
Hypnotherapy75.85
Anticholinergic Medications80.19

[back to top]

Overactive Bladder Questionnaire Short Form Quality of Life

Overactive Bladder questionnaire-Short Form Quality of Life. Higher scores are better (better quality of life) and lower scores are worse (poorer quality of life). sub-score range 0-100. (NCT01829425)
Timeframe: 2 months

Interventionsub-scale scores (Least Squares Mean)
Hypnotherapy73.96
Anticholinergic Medications74.86

[back to top]

Overactive Bladder Questionnaire Short Form Quality of Life

Overactive Bladder questionnaire-Short Form Quality of Life. Higher scores are better (higher quality of life) and lower scores are worse (poorer quality of life). score range 0-100. (NCT01829425)
Timeframe: 12 months

Interventionsub-scale scores (Least Squares Mean)
Hypnotherapy75.71
Anticholinergic Medications81.57

[back to top]

Overactive Bladder Questionnaire Short Form Symptom Bother

Overactive Bladder Questionnaire Short Form symptom bother Scale. Sub-Scale range 0-100. Higher numbers are worse (more bother) and lower numbers are better (less bother) (NCT01829425)
Timeframe: 2 months

Interventionscores on a sub-scale (Least Squares Mean)
Hypnotherapy38.17
Anticholinergic Medications35.33

[back to top]

Voids on Bladder Diary

number of voids on 3-day bladder diary (NCT01829425)
Timeframe: 6 months

Interventioncounts (Mean)
Hypnotherapy25.58
Anticholinergic Medications24.28

[back to top]

Overactive Bladder Questionnaire Short Form Symptom Bother

Overactive Bladder Questionnaire Short Form symptom bother. Sub-scale range 0-100. Higher numbers are worse (more bother) and lower numbers are better (less bother) (NCT01829425)
Timeframe: 6 months

Interventionsub-scale scores (Least Squares Mean)
Hypnotherapy34.61
Anticholinergic Medications27.93

[back to top]

Percent Change in Urgency Urinary Incontinence Episodes

Differences comparing hypnotherapy to pharmacotherapy percent change in median UUI episodes (NCT01829425)
Timeframe: 6 months

Interventionpercentage change in median UUI episodes (Median)
Hypnotherapy85.7
Anticholinergic Medications83.3

[back to top]

Overactive Bladder Questionnaire Short Form Symptom Bother

Overactive Bladder Questionnaire Short Form symptom bother. Sub-scale range 0-100. Higher numbers are worse (more bother) and lower numbers are better (less bother) (NCT01829425)
Timeframe: 12 months

Interventionsub-scale scores (Least Squares Mean)
Hypnotherapy32.27
Anticholinergic Medications30.74

[back to top]

Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Improvement in Day-to-Day Life Due to OAB Medication

Overall assessment of improvement in day-to-day life due to OAB medication was assessed on a scale from 1 to 5, with higher scores indicating greater improvement in day-to-day life due to current OAB medication. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)

InterventionUnits on a Scale (Mean)
Mirabegron3.43
Tolterodine ER3.46

[back to top]

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

(NCT02138747)
Timeframe: Baseline and EOT (Period 1-Week 8 and Period 2- Week 18)

InterventionIncontinence Episodes (Least Squares Mean)
Mirabegron-1.51
Tolterodine ER-1.46

[back to top]

Change From Baseline to End of Treatment (EOT) in Number of Micturitions Per 24 Hours

(NCT02138747)
Timeframe: Baseline and EOT (Period 1-Week 8 and Period 2- Week 18)

InterventionMicturitions (Least Squares Mean)
Mirabegron-2.06
Tolterodine ER-1.95

[back to top]

Participants Tolerability Assessed by the Medication Tolerability Scale of the Overactive Bladder-Satisfaction (OAB-S) Questionnaire at the End of Treatment (EOT)

The medication tolerability scale measured the level of bothersomeness related to the occurrence of a side effect that was known to be related to the approved OAB medication (i.e., constipation, dry mouth, drowsiness, headache, nausea and blurred vision). The OAB medication tolerability score was calculated as a sum of the responses and converted to a scale from 0 to 100, where higher score indicates better perceived OAB medication tolerability (less bother from side-effects). (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)

InterventionUnits on a Scale (Least Squares Mean)
Mirabegron86.29
Tolterodine ER83.40

[back to top]

Scale of the OAB-S Questionnaire at the End of Treatment Period: Impact on Daily Living With OAB.

Impact on daily living with the OAB was scored from 0 to 100, with higher scores indicating greater satisfaction with ability to perform daily activities. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)

InterventionUnits on a Scale (Mean)
Mirabegron72.98
Tolterodine ER71.92

[back to top]

Scale of the OAB-S Questionnaire at the End of Treatment Period: OAB Control

OAB control was scored from 0 to 100, with higher scores indicating better OAB control. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)

InterventionUnits on a Scale (Mean)
Mirabegron64.49
Tolterodine ER63.38

[back to top]

Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Interruption of Day-to-Day Life Due to OAB

Overall assessment of interruption of day-to-day life due to OAB was assessed on a scale from 1 to 5, with higher scores indicating less interruption of day-to-day life due to OAB symptoms. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)

InterventionUnit on a Scale (Mean)
Mirabegron3.00
Tolterodine ER3.02

[back to top]

Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Participant's Fulfillment of OAB Medication Expectations

The final item score for overall assessment of patient's fulfillment of OAB medication expectations ranged from 1 to 5, with higher scores indicating better fulfillment of OAB medication expectations. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)

InterventionUnits on a Scale (Mean)
Mirabegron3.10
Tolterodine ER3.08

[back to top]

Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Willingness to Continue OAB Medication

Overall assessment of willingness to continue OAB medication, was assessed on a scale from 1 to 5, with higher scores indicating greater desire to continue with current OAB medication. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)

InterventionUnits on a Scale (Mean)
Mirabegron3.69
Tolterodine ER3.69

[back to top]

Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Satisfaction With OAB Medication

Overall satisfaction with OAB medication was assessed on a scale of 1 to 5, with higher scores indicating greater satisfaction with current OAB medication. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)

InterventionUnits on a Scale (Mean)
Mirabegron3.70
Tolterodine ER3.66

[back to top]

Scale of the OAB-S Questionnaire at the End of Treatment Period: Satisfaction With OAB Control

Satisfaction with OAB control was scored from 0 to 100 with higher scores indicating greater satisfaction with OAB control. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)

InterventionUnits on a Scale (Mean)
Mirabegron69.17
Tolterodine ER68.31

[back to top]

Number of Participants With Adverse Events

Safety was assessed by evaluation of treatment-emergent adverse events (TEAEs; frequency, severity, seriousness and relationship to study drug), AEs of special interest, vital signs (SBP, DBP, body temperature and pulse rate) and laboratory tests (liver function tests [LFTs]). Treatment-Emergent Adverse Event (TEAEs) were defined as any adverse event starting or worsening in the period from first dose of double-blind study drug until 15 days after last dose of double-blind study drug. (NCT02138747)
Timeframe: Baseline to EOT (Week 18) and follow up (Week 20)

,
InterventionParticipants (Number)
Adverse Events (AEs)Drug-related (AEs)DeathsSerious Adverse Event (SAE)Drug-related SAEsAEs Leading to Permanent Discontinuation of DrugDrug-related AEs Leading to Permanent DiscontinuatSAEs Leading to Permanent DiscontinuationDrug-related SAEs Leading to Permanent Discontinu
Mirabegron15089032151200
Tolterodine ER168111080201250

[back to top]

Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods.

"Participants were asked to choose which treatment period they preferred and the degree of preference. Preference was assessed on a 5-point scale assessed at the end of period 2 (strong preference for period 1, mild preference for period 1, no preference, mild preference for period 2, strong preference for period 2). Participants who selected either a mild preference or strong preference were considered as having a preference for a specific study drug and participants who selected no preference were considered as having no preference for one study drug over the other study drug." (NCT02138747)
Timeframe: Week 18 (End of Period 2)

,,,
InterventionPercentage of participants (Number)
Preference for Period 1Preference for Period 2No PreferenceTotal With Preference
AA: Mirabegron/Mirabegron36.036.028.072.0
AB: Mirabegron/Tolterodine ER29.937.832.367.7
BA: Tolterodine ER /Mirabegron34.437.628.072.0
BB: Tolterodine ER /Tolterodine ER23.150.026.973.1

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

Change From Baseline in Trail Making Test, Trail A Score at 8 Weeks

Trail Making Test, Trail A Time, Range 0-150 seconds, Lower score indicates better functioning (NCT02436889)
Timeframe: Baseline and 8 weeks

Interventionseconds (Mean)
Mirabegron-11.34
Tolterodine Tartrate0.67

[back to top]

Change From Baseline in California Verbal Learning Test (CVLT) Score at 8 Weeks

Range of 0-80, with the higher the score the better. (NCT02436889)
Timeframe: Baseline to Week 8

InterventionScore on a Scale (Mean)
Mirabegron4.70
Tolterodine Tartrate1.59

[back to top]

Change From Baseline in Urge Incontinence Episodes Per Day on a Voiding Diary at 8 Weeks.

The sum of urge type incontinence episodes reported by participants on a voiding diary per day. (NCT02436889)
Timeframe: Baseline and 8 weeks

Interventionepisodes per day (Mean)
Mirabegron-1.64
Tolterodine Tartrate-3.74

[back to top]

Change From Baseline in Total Urinary Incontinence Frequency Measured by a Voiding Diary at 8 Weeks

Study participants record number of urinary incontinence episodes in a voiding diary. The total urinary incontinence frequency is the sum of urinary incontinence episodes per day. (NCT02436889)
Timeframe: Baseline to Week 8

Interventionepisodes per day (Mean)
Mirabegron-2.04
Tolterodine Tartrate-3.91

[back to top]

Change From Baseline in Short Physical Performance Battery (SPPB) Score at 8 Weeks

Physical function/mobility, Range 0-12, the higher the score the better. (NCT02436889)
Timeframe: Baseline to Week 8

Interventionscore on a scale (Mean)
Mirabegron-0.39
Tolterodine Tartrate0.24

[back to top]

Percentage of OAB Wet Participants With at Least a 50% Reduction From Baseline in Total Incontinence Episodes Per 24 Hours at Week 12

"Total incontinence is defined as having any reason for Accidental Urine Leakage and/or Accidental Urine Leakage checked, as indicated on the PVD. It is assumed that if the participant recorded a reason for leakage then the accidental urine leakage occurred. All events marked as having leakage, regardless of cause, or where Accidental Leakage was checked. were used in the analysis. Per 24 hours corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD." (NCT03492281)
Timeframe: Baseline; Week 12

,,
Interventionpercentage of participants (Number)
UnadjustedAdjusted for sex
Placebo: OAB Wet53.849.9
Tolterodine ER 4 mg: OAB Wet66.561.5
Vibegron 75 mg: OAB Wet64.061.6

[back to top]

Percentage of OAB Wet Participants With a 100% Reduction From Baseline in UUI Episodes Per 24 Hours at Week 12

"The number of UUI episodes is defined as the number of times a participant had checked urge as the main reason for the leakage in the PVD, regardless of whether more than one reason for leakage in addition to urge was checked. The average daily number of UUI episodes was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of UUI episodes that occurred on a CDD divided by the number of CCDs in the PVD. CFB was calculated as the post-BL value minus the BL value. Per 24 hours corresponds to one Diary Day (i.e., time between when participant got up for the day each morning and time participant got up for the day the next morning as recorded in the PVD)." (NCT03492281)
Timeframe: Baseline; Week 12

,,
Interventionpercentage of participants (Number)
UnadjustedAdjusted for sex
Placebo: OAB Wet22.519.0
Tolterodine ER 4 mg: OAB Wet26.620.9
Vibegron 75 mg: OAB Wet28.825.3

[back to top]

Percentage of All OAB Participants With at Least a 50% Reduction From Baseline in Urgency Episodes Per 24 Hours at Week 12

"An urgency episode is defined as the Need to Urinate Immediately as indicated on the PVD. CFB is calculated as the post-BL value minus the BL value. Per 24 hours corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD)." (NCT03492281)
Timeframe: Baseline; Week 12

,,
Interventionpercentage of participants (Number)
UnadjustedAdjusted for sex
Placebo38.332.8
Tolterodine ER 4 mg41.236.4
Vibegron 75 mg43.239.5

[back to top]

Percentage of All OAB Participants With an Average Number of Micturitions < 8 Per 24 Hours at Week 12

"A micturition/void is defined as Urinated in Toilet as indicated on the PVD. The number of micturitions is defined as the number of times a participant voided in the toilet as indicated on the PVD. A participant was defined as having an average of < 8 daily micturitions if the arithmetic mean of the number of micturitions per day in the PVD was less than 8 . Per 24 hours corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD)." (NCT03492281)
Timeframe: Week 12

,,
Interventionpercentage of participants (Number)
UnadjustedAdjusted for sex
Placebo28.724.8
Tolterodine ER 4 mg35.031.6
Vibegron 75 mg40.137.2

[back to top]

CFB at Week 12 in the Symptom Bother Score From the OAB-q LF (1-week Recall) in All OAB Participants

"The OAB-q LF is a validated patient-reported outcome. The first 8 questions of the OAB-q LF ask participants how much they were bothered by their bladder symptoms during the previous week. Each question has a response ranging from Not at all (= 1) to A very great deal (= 6). These questions make up the symptom bother scale. The raw score (sum of question scores [ranging from 8 to 48]) is transformed to a unified score, ranging from 0 to 100. Higher scores correspond to the symptoms having a larger bother, and lower scores represent a lower amount of bother due to symptoms. CFB is calculated as the post-BL value minus the BL value. Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), sex, region (U.S./non-U.S.), OAB type (wet/dry), BL score, and treatment by study visit interaction." (NCT03492281)
Timeframe: Baseline; Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-12.8
Vibegron 75 mg-19.6
Tolterodine ER 4 mg-17.4

[back to top] [back to top]

CFB at Week 12 in the Coping Score From the Overactive Bladder Questionnaire Long Form (OAB-q LF, 1-week Recall) in All OAB Participants

"The OAB-q LF is a validated patient-reported outcome. 8 questions of the OAB-q LF ask participants how well they have coped with their bladder symptoms during the previous week, as a measure of quality of life. Each question has a response ranging from not coping (= 1) to coping well (= 6). These questions make up the coping scale. The raw score (sum of question scores [ranging from 8 to 48]) is transformed to a unified score, ranging from 0 to 100. Higher scores correspond to a higher quality of life, and lower scores represent a lower quality of life. CFB is calculated as the post-BL value minus the BL value. Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), sex, region (U.S./non-U.S.), OAB type (wet/dry), BL score, and treatment by study visit interaction." (NCT03492281)
Timeframe: Baseline; Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo12.9
Vibegron 75 mg16.5
Tolterodine ER 4 mg16.0

[back to top]

CFB at Week 12 in the Average Volume Voided Per Micturition in All OAB Participants

"A micturition/void is defined as Urinated in Toilet as indicated on the PVD. The number of micturitions is defined as the number of times a participant voided in the toilet as indicated on the PVD. CFB is calculated as the post-BL value minus the BL value. Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), OAB type (wet/dry), sex, region (U.S./non-U.S.), BL volume (milliliters [mL]), and treatment by study visit interaction." (NCT03492281)
Timeframe: Baseline; Week 12

InterventionmL per micturition (Least Squares Mean)
Placebo2.2
Vibegron 75 mg23.5
Tolterodine ER 4 mg15.5

[back to top]

CFB at Week 12 in the Average Number of Urgency Episodes Over 24 Hours in All OAB Participants

"An urgency episode is defined as the Need to Urinate Immediately as indicated on the PVD. CFB is calculated as the post-BL value minus the BL value. Over 24 hours corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD). Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), OAB type (wet/dry), sex, region (U.S./non-U.S.), BL number of urgency episodes, and treatment by study visit interaction." (NCT03492281)
Timeframe: Baseline; Week 12

Interventionurgency episodes over 24 hours (Least Squares Mean)
Placebo-2.0
Vibegron 75 mg-2.7
Tolterodine ER 4 mg-2.5

[back to top]

CFB at Week 12 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants

"The number of UUI episodes is defined as the number of times a participant had checked urge as the main reason for the leakage in the PVD, regardless of whether more than one reason for leakage in addition to urge was checked. The average daily number of UUI episodes was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of UUI episodes that occurred on a CDD divided by the number of CCDs in the PVD. CFB was calculated as the post-BL value minus the BL value. Per 24 hours corresponds to one Diary Day (i.e., time between when participant got up for the day each morning and time participant got up for the day the next morning as recorded in the PVD). Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), sex, region (U.S./non-U.S.), BL number of UUI episodes and treatment by study visit interaction. FAS-I=Full Analysis Set for Incontinence." (NCT03492281)
Timeframe: Baseline; Week 12

InterventionUUI episodes per 24 hours (Least Squares Mean)
Placebo: OAB Wet-1.4
Vibegron 75 mg: OAB Wet-2.0
Tolterodine ER 4 mg: OAB Wet-1.8

[back to top]

CFB at Week 12 in the Average Number of Total Incontinence Episodes Over 24 Hours in OAB Wet Participants

"Total incontinence is defined as having any reason for Accidental Urine Leakage and/or Accidental Urine Leakage checked, as indicated on the PVD. It is assumed that if the participant recorded a reason for leakage then the accidental urine leakage occurred. CFB is calculated as the post-BL value minus the BL value. Over 24 hours corresponds to one Diary Day (i.e., time between when the par. got up for the day each morning and time the par. got up for the day the next morning as recorded in the PVD). Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), sex, region (U.S./non-U.S.), BL number of incontinence episodes, and treatment by study visit interaction. hr = hours." (NCT03492281)
Timeframe: Baseline; Week 12

Interventiontotal incontinence episodes over 24 hr (Least Squares Mean)
Placebo: OAB Wet-1.6
Vibegron 75 mg: OAB Wet-2.3
Tolterodine ER 4 mg: OAB Wet-2.0

[back to top]

CFB at Week 12 in Overall Control Over Bladder Symptoms Based on Patient Global Impression of Control (PGI-Control) in All OAB Participants

The Patient Global Impression (PGI) questions are designed to assess a participant's overall impression of OAB. For the PGI-Control score, participants were asked to rate how much control they had over their OAB symptoms over the previous week with one of the following responses: 1 = complete control, 2 = a lot of control, 3 = some control, 4 = only a little control, 5 = no control. CFB is calculated as the post-BL value minus the BL value. Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), OAB type (wet/dry), sex, region (U.S./non-U.S.), BL score, and treatment by study visit interaction. (NCT03492281)
Timeframe: Baseline; Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-0.7
Vibegron 75 mg-1.0
Tolterodine ER 4 mg-0.9

[back to top]

CFB at Week 12 in Overall Bladder Symptoms Based on Patient Global Impression of Severity (PGI-Severity) in All OAB Participants

The Patient Global Impression (PGI) questions are designed to assess a participant's overall impression of OAB. For the PGI-Severity score, participants are asked to rate their OAB symptoms over the previous week with one of the following responses: 1 = none, 2 = mild, 3 = moderate, 4 = severe. CFB is calculated as the post-BL value minus the BL value. Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), OAB type (wet/dry), sex, region (U.S./non-U.S.), BL score, and treatment by study visit interaction. (NCT03492281)
Timeframe: Baseline; Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-0.5
Vibegron 75 mg-0.8
Tolterodine ER 4 mg-0.7

[back to top]

Change From Baseline (CFB) at Week 12 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants

"A micturition/void is defined as Urinated in Toilet as indicated on the Patient Voiding Diary (PVD). The number of micturitions is defined as the number of times a participant voided in the toilet as indicated on the PVD. The average daily number of micturitions was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of micturitions that occurred on a Complete Diary Day (CDD) divided by the number of CDDs in the PVD. CFB was calculated as the post-BL value minus the BL value. Per 24 hours corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD). Covariates included in the mixed model for repeated measures are study visit (Weeks 2, 4, 8, and 12), OAB type (wet/dry), sex, region (U.S./non-U.S.), BL number of micturitions, and treatment by study visit interaction. FAS=Full Analysis Set." (NCT03492281)
Timeframe: Baseline (BL); Week 12

Interventionmicturitions per 24 hours (Least Squares Mean)
Placebo-1.3
Vibegron 75 mg-1.8
Tolterodine ER 4 mg-1.6

[back to top]

Percentage of OAB Wet Participants With at Least a 75% Reduction From Baseline in UUI Episodes Per 24 Hours at Week 12

"The number of UUI episodes is defined as the number of times a participant had checked urge as the main reason for the leakage in the PVD, regardless of whether more than one reason for leakage in addition to urge was checked. The average daily number of UUI episodes was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of UUI episodes that occurred on a CDD divided by the number of CCDs in the PVD. CFB was calculated as the post-BL value minus the BL value. Per 24 hours corresponds to one Diary Day (i.e., time between when participant got up for the day each morning and time participant got up for the day the next morning as recorded in the PVD)." (NCT03492281)
Timeframe: Baseline; Week 12

,,
Interventionpercentage of participants (Number)
UnadjustedAdjusted for sex
Placebo: OAB Wet36.832.8
Tolterodine ER 4 mg: OAB Wet47.642.2
Vibegron 75 mg: OAB Wet52.449.3

[back to top]

Changes in the Volume of Residual Urine

Measured via the urine bladder ultrasound (US) (NCT03575702)
Timeframe: Baseline and Week 4, 8 and 12

,
Interventionml (Mean)
BaselineChange week 4 of treatmentChange week 8 of treatmentChange week 12 of treatment
Uritos®10.0-0.9-1.4-1.5
Urotol®10.6-1.3-2.2-2.0

[back to top]

Changes in the Overactive Bladder Symptom Score According to Overactive Bladder (OAB) Awareness Tool Questionnaire at 2, 4, 8 and 12 Week

"Overactive bladder (OAB) Awareness Tool Questionnaire (version OAB-V8, containing 8 questions) is a validated questionnaire. Patient is asked to answer 8 questions concerning typical symptoms of OAB giving answers with a scale with minimum - 0 score defined as no bothering at all and maximmum - 5 score defined as a very big deal to assess the severity of these symptoms. All answers are simply summed to make a combined final score. Male participants should add 2 points to their final score. The final scores range from 0 to 40 (for women) and 42 (for men). The score equal to 8 and more is interpreted as high probability of OAB presence, with the higher scores indicating more bothersome symptoms of OAB." (NCT03575702)
Timeframe: Baseline and Week 2, 4, 8 and 12

,
Interventionscores on a scale (Mean)
BaselineChange (week 2)Change (week 4)Change (week 8)Change (week 12)
Uritos®24.3-8.0-10.6-12.4-14.2
Urotol®23.8-8.2-10.8-13.0-14.5

[back to top]

Change in the Mean Weekly Number of Incontinence Episodes at Week 12

The mean weekly number of incontinence episodes was calculated as the total number of episodes per day (from 7 am to 7 am the next day) for the study period (between visits) divided by the number of weeks in the period. (NCT03575702)
Timeframe: Baseline and Week 12

,
Interventionincontinence episodes per week (Mean)
BaselineWeek 12 of treatmentChange
Uritos®17.23.0-14.5
Urotol®16.93.2-13.6

[back to top]

Change in the Mean Number of Incontinence Episodes at Week 2, 4 and 8

Separately for daily, daytime and nighttime measurements. (NCT03575702)
Timeframe: Baseline and Week 2, 4 and 8

,
Interventionincontinence episodes per day (Mean)
Baseline number of daily incontinence episodesChange in daily incontinence episodes (week 2)Change in daily incontinence episodes (week 4)Change in daily incontinence episodes (week 8)Baseline number of daytime incontinence episodesChange in daytime incontinence episodes (week 2)Change in daytime incontinence episodes (week 4)Change in daytime incontinence episodes (week 8)Baseline number of nightime incontinence episodesChange in nighttime incontinence episodes (week 2)Change in nighttime incontinence episodes (week 4)Change in nighttime incontinence episodes (week 8)
Uritos®2.5-1.5-1.8-2.02.0-1.2-1.5-1.70.5-0.3-0.3-0.3
Urotol®2.4-1.3-1.7-1.81.9-1.0-1.3-1.40.5-0.3-0.4-0.4

[back to top]

Change in the Mean Nighttime Number of Incontinence Episodes at Week 12

The mean nighttime number of incontinence episodes was calculated as the total number of episodes from 11 pm to 7 am for the study period (between visits) divided by the number of days in the period. (NCT03575702)
Timeframe: Baseline and Week 12

,
Interventionnighttime incontinence episode per day (Mean)
BaselineWeek 12 of treatmentChange
Uritos®0.50.1-0.4
Urotol®0.50.1-0.4

[back to top]

Change in the Mean Daytime Number of Incontinence Episodes at Week 12

The mean daytime number of incontinence episodes was calculated as the total number of episodes from 7 am to 11 pm for the study period (between visits) divided by the number of days in the period. (NCT03575702)
Timeframe: Baseline and Week 12

,
Interventiondaytime incontinence episodes per day (Mean)
BaselineWeek 12 of treatmentChange
Uritos®2.00.4-1.7
Urotol®1.90.4-1.5

[back to top]

Number of Patients With Adverse Events (AEs)

(NCT03575702)
Timeframe: Up to 35 days after the end of treatment

InterventionParticipants (Count of Participants)
Uritos®70
Urotol®72

[back to top]

Number of Patients With Clinically Significant Changes in ECG Parameters

(NCT03575702)
Timeframe: Week 12 of treatment

InterventionParticipants (Count of Participants)
Uritos®0
Urotol®0

[back to top]

Number of Patients With Clinically Significant Vital Signs Changes

(NCT03575702)
Timeframe: Week 12 of treatment

InterventionParticipants (Count of Participants)
Uritos®0
Urotol®0

[back to top]

Number of Patients With Serious Adverse Events (SAEs)

(NCT03575702)
Timeframe: Up to 35 days after the end of treatment

InterventionParticipants (Count of Participants)
Uritos®0
Urotol®0

[back to top]

Change in the EQ-5D-based Quality of Life at Week 12

"The Euro Quality of Life five Dimensions questionnaire ( EQ-5D, version EQ-5D-5L) is a validated questionnaire for the assessment of health-related quality of life. It consists of a questionnaire and a visual analogue scale (EQ-VAS). The self-assessment questionnaire is self-reported description of the subject's current health in 5 dimensions i.e., mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The subject is asked to assess their own current level of function in each dimension by 5-level scale from no problems to significant problem grades. The EQ-VAS is a self-rated health status using a VAS in mm from 0 (the worse health status) to 100 (the best health status). The EQ-VAS records the subject's perceptions of their own current overall health quantitatively in mm and can be used to monitor changes with time. The results of patients assessment by VAS are presented." (NCT03575702)
Timeframe: Baseline and Week 12

,
Interventionscore on a scale, mm (Mean)
BaselineWeek 12 of treatmentChange (week 12)
Uritos®67.781.713.8
Urotol®66.879.512.5

[back to top]

Change in the Mean Daily Number of Incontinence Episodes at Week 12

The mean daily number of incontinence episodes was calculated as the total number of episodes (on the basis of the data that patients entered into their diaries) per day (from 7 am to 7 am the next day) for the study period (between visits) divided by the number of days in the period. (NCT03575702)
Timeframe: Baseline and Week 12

,
Interventionincontinence episodes per day (Mean)
BaselineWeek 12 of treatmentChange
Uritos®2.50.4-2.1
Urotol®2.40.5-1.9

[back to top]

Change in the Mean Daily Number of Urination Episodes at Week 12

The mean daily number of urination episodes was calculated as the total number of episodes (on the basis of the data that patients entered into their diaries) per day (from 7 am to 7 am the next day) for the study period (between visits) divided by the number of days in the period. (NCT03575702)
Timeframe: Baseline and Week 12

,
Interventionurination episodes per day (Mean)
BaselineWeek 12 of treatmentChange
Uritos®12.59.0-3.6
Urotol®11.98.6-3.4

[back to top]

Change in the Mean Daily Number of Urination Episodes at Week 2, 4 and 8 Visit as Compared to the Treatment Initiation Visit

The mean daily number of incontinence episodes was calculated as the total number of episodes (on the basis of the data that patients entered into their diaries) per day (from 7 am to 7 am the next day) for the study period (between visits) divided by the number of days in the period. (NCT03575702)
Timeframe: Baseline and Week 2, 4 and 8

,
Interventionurination episodes per day (Mean)
BaselineWeek 2 of treatmentChange (week 2)Week 4 of treatmentChange (week 4)Week 8 of treatmentChange (week 8)
Uritos®12.510.6-1.99.6-2.89.4-3.2
Urotol®11.910.3-1.69.4-2.68.9-3.1

[back to top]

Number of Patients With Clinically Significant Changes in Laboratory Parameters

Including blood chemistry, blood count and urinalysis (NCT03575702)
Timeframe: Week 8 and 12

,
InterventionParticipants (Count of Participants)
Week 8 of treatmentWeek 12 of treatment
Uritos®21
Urotol®13

[back to top]

CFB at Week 52 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants

"The number of UUI episodes is defined as the number of times a participant had checked urge as the main reason for the leakage in the PVD, regardless of whether more than one reason for leakage in addition to urge was checked. The average daily number of UUI episodes was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of UUI episodes that occurred on a CDD divided by the number of CDDs in the PVD. CFB was calculated as the post-BL value minus the BL value. Per 24 hours corresponds to one Diary Day (i.e., time between when participant got up for the day each morning and time participant got up for the day the next morning as recorded in the PVD). Covariates included in the MMRM were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: sex. Only participants with evaluable data were analyzed." (NCT03583372)
Timeframe: Baseline; Week 52

InterventionUUI episodes per 24 hours (Least Squares Mean)
52 Weeks Vibegron 75 mg-2.2
52 Weeks Tolterodine ER 4 mg-1.7

[back to top]

CFB at Week 52 in the Average Number of Urgency Episodes (Need to Urinate Immediately) Over 24 Hours in All OAB Participants

"The number of urgency episodes is defined as the number of times a participant had checked need to urinate immediately on a CDD divided by the number of CDDs in the PVD. CFB is calculated as the post-BL value minus the BL value. Over 24 hours corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD). Covariates included in the MMRM were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: OAB type (Wet versus Dry) and sex." (NCT03583372)
Timeframe: Baseline; Week 52

Interventionurgency episodes over 24 hours (Least Squares Mean)
52 Weeks Vibegron 75 mg-3.4
52 Weeks Tolterodine ER 4 mg-3.2

[back to top]

Change From Baseline (CFB) at Week 52 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants

"A micturition/void is defined as Urinated in Toilet as indicated on the Patient Voiding Diary (PVD). The number of micturitions is defined as the number of times a participant voided in the toilet as indicated in the PVD. The average daily number of micturitions was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of micturitions that occurred on a Complete Diary Day (CDD) divided by the number of CDDs in the PVD. CFB was calculated as the post-BL value minus the BL value. Per 24 hours corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD). Covariates included in the mixed model for repeated measures (MMRM) were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: OAB type (Wet versus Dry) and sex." (NCT03583372)
Timeframe: Baseline; Week 52

Interventionmicturitions per 24 hours (Least Squares Mean)
52 Weeks Vibegron 75 mg-2.4
52 Weeks Tolterodine ER 4 mg-2.0

[back to top]

Number of Participants With the Indicated Type of Treatment-emergent Adverse Event

Adverse events were collected in participants with overactive bladder (OAB) who previously completed treatment in Study RVT-901-3003. The treatment-emergent period was defined as the period of time from the first dose date of the active double-blind study treatment, whether in Study RVT-901-3003 or Study RVT-901-3004, through 28 days after the last dose of study treatment, or the date of initiation of another investigational agent or surgical intervention, whichever occurred first. (NCT03583372)
Timeframe: up to 56 weeks

,
Interventionparticipants (Number)
Any TEAEAny study drug-related TEAEAny Grade ≥ 3 TEAEAny Grade ≥ 3 study drug-related TEAEAny treatment-emergent (TE) SAEAny study drug-related TE SAEAny TEAE leading to discontinuation of study drugAny TEAE of clinical interestAny study drug-related TEAE of clinical interest
Overall Tolterodine ER 4 mg126468110283210
Overall Vibegron 75 mg171591019144114

[back to top]

CFB at Week 52 in the Average Number of Total Urinary Incontinence Episodes Over 24 Hours in OAB Wet Participants

"The number of total incontinence episodes is defined as the number of times a participant had checked the accidental urine leakage box in the PVD, including for reasons of urge, stress, or other. CFB was calculated as the post-BL value minus the BL value. Over 24 hours corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD). Covariates included in the MMRM were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: sex. hr = hour." (NCT03583372)
Timeframe: Baseline; Week 52

InterventionUrinary incontinence episodes over 24 hr (Least Squares Mean)
52 Weeks Vibegron 75 mg-2.5
52 Weeks Tolterodine ER 4 mg-1.9

[back to top]

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

[back to top]

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

[back to top]