Trial | Phase | Enrollment | Study Type | Start Date | Status |
"A Randomized, Placebo-Controlled Parallel-Design Trial of the Effect of Solifenacin Treatment for Overactive Bladder in Women With Anterior Vaginal Wall Prolapse Managed With a Pessary (the PESSARY Study)" [NCT01092624] | Phase 4 | 94 participants (Anticipated) | Interventional | 2010-03-31 | Terminated(stopped due to sponsor closed study due to poor enrollment) |
Effect of Electroacupuncture for Women With Urgency-predominant Mixed Urinary Incontinence: a Three Armed Non-inferior Randomized Controlled Trial [NCT03787654] | | 282 participants (Anticipated) | Interventional | 2019-03-01 | Recruiting |
A Therapeutic Exploratory Clinical Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder [NCT03566134] | Phase 2 | 306 participants (Actual) | Interventional | 2018-07-10 | Completed |
A Multicenter, Open-label, Single Ascending Dose Study to Evaluate Pharmacokinetics, Safety and Tolerability of Solifenacin Succinate Suspension in Pediatric Patients Aged 5 to 17 Years (Inclusive) With Overactive Bladder (OAB) [NCT01262391] | Phase 1 | 42 participants (Actual) | Interventional | 2010-10-20 | Completed |
Comparative Study of Solifenacin and Mirabegron in Treatment of Overactive Bladder Symptoms in Men After Transurethral Resection of the Prostate - A Randomized Prospective Study [NCT03632772] | Phase 2 | 130 participants (Anticipated) | Interventional | 2018-08-01 | Recruiting |
Comparison of Solifenacin Combined With Pelvic Floor Muscle and Whole Body Vibration Training With Solifenacin Alone in Patients With Overactive Bladder Syndrome. - A Prospective Randomized Parallel Group Trial [NCT01314781] | Phase 4 | 66 participants (Actual) | Interventional | 2012-01-31 | Completed |
Czech Observational Study to Evaluate Quality of Life in Patients Switched to Vesicare™ (Solifenacin) From Other Antimuscarinics [NCT02087098] | | 2,000 participants (Actual) | Observational | 2014-06-30 | Completed |
A Phase 1 Study to Evaluate the Effect of Steady State Solifenacin and Mirabegron on the Steady State Pharmacokinetics of Digoxin in Healthy Subjects [NCT02127034] | Phase 1 | 26 participants (Actual) | Interventional | 2014-03-31 | Completed |
Reproducibility Study of OABSS and Its Response to Solifenacin Treatment (RESORT) and Validity in Korean Populations; Part 2: Responsiveness and Validity [NCT01318837] | Phase 4 | 100 participants (Actual) | Interventional | 2010-04-30 | Completed |
Treatment Persistence Among Patients With Overactive Bladder: A Retrospective Secondary Data Analysis in Asia Oceania [NCT03602508] | | 5,589 participants (Actual) | Observational | 2018-07-20 | Completed |
An Open-label, One-sequence, Two-arm Study to Evaluate the Effect of Steady State Concentrations of Mirabegron on the Pharmacokinetics of Solifenacin and to Evaluate the Effect of Steady State Concentrations of Solifenacin on the Pharmacokinetics of Mirab [NCT01297192] | Phase 1 | 41 participants (Actual) | Interventional | 2009-03-31 | Completed |
Pharmacokinetic Drug Interaction Between Solifenacin 10mg and Tamsulosin 0.4mg in Healthy Male Volunteers [NCT02180997] | Phase 1 | 36 participants (Actual) | Interventional | 2014-07-31 | Completed |
Mirabegron, Propevirine, Solifenacin for Treatment of Lower Urinary Tract Symptoms During Intravesical BCG Instillation: Prospective Randomized Controlled Trial [NCT05490082] | Phase 3 | 100 participants (Anticipated) | Interventional | 2022-03-01 | Recruiting |
Efficacy of of Pelvic Floor Muscle Training( PFMT ) With Surface Electromyographic Biofeedback and Medication in Women With Overactive Bladder [NCT04477265] | | 140 participants (Actual) | Interventional | 2016-06-16 | Completed |
Peripheral Transcutaneous Neuromodulation of the Post-tibial Nerve (T-PTNS) for Solifenacin 10 mg. in the Treatment of Hyperactive Bladder Syndrome: no Inferiority Phase IV Randomized Clinical Trial [NCT03468465] | Phase 4 | 110 participants (Anticipated) | Interventional | 2018-05-04 | Active, not recruiting |
Predictors Affecting Long-term Use of Solifenacin or Mirabegron in Women With Overactive Bladder Syndrome [NCT05040984] | | 500 participants (Anticipated) | Observational | 2021-04-30 | Recruiting |
Reproducibility Study of OABSS and Its Response to Treatment in Indonesia - Part 2: Responsiveness [NCT01122563] | | 55 participants (Actual) | Observational | 2009-09-30 | Completed |
Higher Neural and Cognitive Changes Following Anticholinergic Versus Beta 3 Agonist Versus Placebo Treatments in Female Patients With Overactive Bladder: a Multicenter Randomized Controlled Pilot Trial [NCT03817931] | Phase 4 | 30 participants (Anticipated) | Interventional | 2019-08-05 | Recruiting |
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) | Interventional | 2008-02-29 | Terminated(stopped due to Investigator left Cleveland Clinic and absolutely no data is available.) |
A Study to Evaluate the Overall Effect of Solifenacin 5mg and 10mg on Bladder Wall Thickness and Urinary Nerve Growth Factor in Female Subjects With Overactive Bladder and a Diagnosis of Detrusor Overactivity - A Double-blind, Randomised, Placebo-controll [NCT01093534] | Phase 4 | 547 participants (Actual) | Interventional | 2010-01-31 | Completed |
Medication Effects on Periurethral Sensation, Urethral Sphincter Activity and Pressure Flow Parameters [NCT01028014] | | 56 participants (Actual) | Interventional | 2010-04-30 | Completed |
URGE-PD: A Multi-site, Double-blind, Randomized, Placebo Controlled Trial of Solifenacin Succinate (VESIcare) for the Treatment of Overactive Bladder in Parkinson's Disease [NCT01018264] | Phase 4 | 23 participants (Actual) | Interventional | 2010-01-31 | Completed |
A Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi-center Study of Fixed Dose Combinations of Solifenacin Succinate (6 mg and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg and Tamsulosin Hydrochloride OCAS 0.4 mg Monotherapy, in Male [NCT01018511] | Phase 3 | 1,334 participants (Actual) | Interventional | 2010-01-31 | Completed |
A Randomized, Double Blind, Double Dummy, Placebo Controlled Study to Evaluate the Efficacy and Safety of Solifenacin Succinate (5 and 10mg Once Daily) Against Placebo and Oxybutynin Hydrochloride (5 mg Three Times Daily) in the Treatment of Subjects With [NCT00629642] | Phase 4 | 249 participants (Actual) | Interventional | 2008-03-14 | Completed |
An Open-label, Parallel Group, Randomized, Two-way Crossover, Multiple Dose Study to Compare the Pharmacokinetic Profiles of Solifenacin Succinate and Tamsulosin HCl Following Co-administration of Single Entity Tablets and Administration of Three Differen [NCT02634489] | Phase 1 | 46 participants (Actual) | Interventional | 2009-03-31 | Completed |
Validation of a Real-time Urodynamic Measure of Urinary Urgency as a Measure of the Success of Drug Treatment [NCT00909428] | Phase 4 | 51 participants (Actual) | Interventional | 2007-01-31 | Completed |
Efficacy and Safety of Tamsulosin/Solifenacin Combination Therapy in Patients With Voiding Symptoms and Moderate to Severe Storage Symptoms Due to Benign Prostate Hyperplasia : a Randomized, Double Blinded, Parallel Design, Active Controlled, Multi-center [NCT02827578] | Phase 3 | 588 participants (Anticipated) | Interventional | 2016-01-31 | Recruiting |
A Phase 1 Study to Evaluate the Effect of Steady State Solifenacin and Mirabegron on the Steady State Pharmacokinetics of Tamsulosin HCl in Healthy Male Subjects [NCT02169713] | Phase 1 | 20 participants (Actual) | Interventional | 2014-05-31 | Completed |
Efficacy and Safety of Mirabegron Compared With Solifenacin in Treatment of Overactive Bladder [NCT03558919] | Phase 4 | 81 participants (Actual) | Interventional | 2017-01-01 | Completed |
The Efficacy of Solifenacin Succinate as Adjuvant Therapy for Symptomatic Non-complicated Urinary Tract Infection in Females [NCT02094703] | Phase 4 | 126 participants (Anticipated) | Interventional | 2013-04-30 | Recruiting |
A Prospective, Non-interventional, Registry Study of Patients Initiating Pharmacologic Therapy for Overactive Bladder in Taiwan, Korea and China [NCT03572231] | | 805 participants (Actual) | Observational | 2018-07-19 | Completed |
Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson Disease [NCT03149809] | Phase 3 | 77 participants (Actual) | Interventional | 2018-03-01 | Completed |
Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics [NCT04090190] | Phase 4 | 20 participants (Actual) | Interventional | 2019-10-30 | Completed |
Phase 2a Exploratory, Randomized, Double-blind, Parallel-group Study of ONO-8577 Compared to Combination of Solifenacin Succinate/ Mirabegron for Overactive Bladder [NCT03106623] | Phase 2 | 207 participants (Actual) | Interventional | 2017-04-07 | Completed |
Comparison of the Effect of Flexible Dosage of Solifenacin Succinate Between Patients Who Have Frequent Micturition With and Without Urgency [NCT00979472] | Phase 4 | 291 participants (Actual) | Interventional | 2009-04-30 | Completed |
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 3 | 1,355 participants (Actual) | Interventional | 2003-07-31 | Completed |
Comparisons of the Effects of Solifenacin Versus Mirabegron on Autonomic System, Arterial Stiffness and Psychosomatic Distress and Clinical Outcomes: A Prospective Randomized Controlled Trial [NCT02540707] | Phase 4 | 113 participants (Actual) | Interventional | 2015-09-08 | Completed |
Impact of Solifenacin Succinate for Treatment of Acute Irritative Urinary Toxicity Occurring During Radiotherapy of Prostatic Cancer [NCT02805452] | Phase 3 | 4 participants (Actual) | Interventional | 2016-07-31 | Terminated(stopped due to Target of recruitment not reachable) |
Efficacy of Low-intensity Shock Wave Therapy on Persistent Storage Symptoms After Transurethral Surgery for Benign Prostatic Obstruction: A Randomized Controlled Trial [NCT04437108] | | 132 participants (Actual) | Interventional | 2020-07-04 | Completed |
An Open-label, Randomized, Parallel Study to Evaluate the Clinical Efficacy and Safety of Tamsulosin Alone or in Combination With Solifenacin for the Treatment in Men With Lower Urinary Tract Symptoms Including Overactive Bladder Symptoms [NCT02715024] | Phase 4 | 52 participants (Actual) | Interventional | 2007-09-30 | Completed |
A Multicenter, Double-blind, Placebo-controlled and Active-reference, Randomized, Parallel, Therapeutic Confirmatory Clinical Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder [NCT05282069] | Phase 3 | 607 participants (Actual) | Interventional | 2022-05-12 | Active, not recruiting |
Overactive Bladder Symptom Scores (OABSS) Responsiveness Before and After Anticholinergic Treatment in Women With Overactive Bladder (OAB) [NCT02667470] | Phase 4 | 50 participants (Actual) | Interventional | 2009-09-30 | Completed |
Persistence of Solifenacin Treatment in Overactive Bladder Patients in Real Life Practice: A 12-month, Prospective, Multicenter, Open-label, Observational Study [NCT00985387] | | 1,215 participants (Actual) | Observational | 2009-08-31 | Completed |
A Phase 1, Open-Label, Randomized, Single Dose, 3-Way Crossover Study to Address the Relative Bioavailability of Solifenacin Liquid Suspension 10mg (Fed and Fasting) Versus the VESIcare (Solifenacin Succinate) 10 mg Tablet (Fasting) in Healthy Volunteers [NCT01015040] | Phase 1 | 24 participants (Actual) | Interventional | 2009-09-30 | Completed |
A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose Study To Investigate The Effects Of 8 Mg Fesoterodine SR Tablets And 10 Mg Solifenacin Tablet On Gastrointestinal Transit In Healthy Female Subjects. [NCT00832650] | Phase 1 | 60 participants (Actual) | Interventional | 2009-04-30 | Terminated(stopped due to Protocol A0221057 was terminated on December 25, 2009 for futility. There were no safety concerns related to this decision.) |
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study of Solifenacin Succinate as Add-on Therapy for Overactive Bladder (OAB) Symptoms in Men Treated for Benign Prostatic Hyperplasia (BPH) With Tamsulosin Hydrochloride [NCT00771394] | Phase 4 | 638 participants (Actual) | Interventional | 2008-10-31 | Completed |
Recurrence of Symptoms of Overactive Bladder After Weaning Versus Sudden Stopping of Anticholinergics [NCT04064619] | | 60 participants (Actual) | Interventional | 2018-01-01 | Completed |
A Prospective, Open-label, Observational, Multi-center Study for the Identification of Predictive Factors for the Solifenacin Treatment in Men With Overactive Bladder Symptoms After Tamsulosin Monotherapy for 4 Weeks and Evaluation of Efficacy and Persist [NCT00884104] | Phase 4 | 307 participants (Actual) | Interventional | 2009-03-31 | Completed |
Evaluation of Solifenacin in the Treatment of OAB Symptoms in Patients Who Have Successfully Undergone GreenLight Photoselective Vaporization of the Prostate (PVP)for the Treatment of Clinically Significant Benign Prostate Hyperplasia (BPH) [NCT00826527] | Phase 4 | 23 participants (Anticipated) | Interventional | 2007-01-31 | Recruiting |
A Randomized, Double Blind, Placebo-Controlled, Parallel Group Comparison of the Efficacy and Safety of Any Alpha Blocker Monotherapy and Any Alpha Blocker Plus Solifenacin in Men With Residual Overactive Bladder Symptoms of Urinary Frequency and Urgency [NCT00699049] | Phase 4 | 94 participants (Actual) | Interventional | 2008-06-30 | Completed |
A Phase 1, Open-Label, Randomized, Single Dose, 3-Way Crossover Study to Assess the Relative Bioavailability of Solifenacin Liquid Suspension 10 mg (Formulation B) Versus Solifenacin Liquid Suspension 10 mg (Formulation A) and to Assess the Relative Bioav [NCT01406158] | Phase 1 | 24 participants (Actual) | Interventional | 2011-05-31 | Completed |
Randomized Double Blinded Placebo-controlled Trial of the Once Daily 5mg Dose of Solifenacin Succinate vs. Placebo in Inner City Women Ages 20-45 With Overactive Bladder [NCT00773552] | Phase 4 | 0 participants (Actual) | Interventional | 2008-11-30 | Withdrawn(stopped due to Investigator Left Institution) |
A Randomized Clinical Trial Comparing Alpha Blacker (Tamsulosin) and Anticholinergic (Solifenacin) in Treatment of Ureteral Stent Related Symptoms [NCT01880619] | Phase 4 | 131 participants (Actual) | Interventional | 2013-01-31 | Completed |
Solifenacin in the Treatment of Urgency Symptoms of Overactive Bladder in a Rising Dose, Randomized, Placebo-controlled, Double-blind Trial [NCT00801944] | Phase 3 | 973 participants (Actual) | Interventional | 2004-04-30 | Completed |
To Explore the Effect of beta3-adrenoceptor Agonist on Patients With Overactive Bladder and Develop Its Urinary Biomarker [NCT04693897] | | 400 participants (Anticipated) | Observational [Patient Registry] | 2021-03-01 | Not yet recruiting |
A Phase 2, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multi-Center Study to Evaluate the Safety of the Co-administration of Solifenacin Succinate With 0.4 mg Tamsulosin Hydrochloride OCAS (TOCAS) Using Urodynamics in Male Subjects With [NCT00507455] | Phase 2 | 222 participants (Actual) | Interventional | 2007-06-30 | Completed |
Comparisons of Urodynamic Effects, Urinary Nerve Growth Factor Levels and Outcomes in Female Overactive Bladder Patients After 3-month Versus 6-month Solifenacin Treatment: a Randomized Prospective Study [NCT01876186] | Phase 4 | 200 participants (Anticipated) | Interventional | 2013-05-31 | Recruiting |
A Phase 1, Open-label, One-sequence Study to Assess the Effect of Verapamil on the Steady State Pharmacokinetics of Solifenacin and Tamsulosin Administered as a Combination Tablet EC905 in Healthy Male Subjects. [NCT01943487] | Phase 1 | 36 participants (Actual) | Interventional | 2009-08-31 | Completed |
An Open-label, Randomized, Two-way Crossover, Multiple Dose Study to Evaluate the Steady State Pharmacokinetics of the Two Final Combination Tablet Formulations (EC905; Tamsulosin HCl/ Solifenacin Succinate; 0.4 mg/6 mg and 0.4 mg/9 mg) in Healthy Male Vo [NCT01953848] | Phase 1 | 27 participants (Actual) | Interventional | 2010-04-30 | Completed |
An Open-label, Randomized, Three-period Crossover, Single Dose Study to Compare the Pharmacokinetics of the Final EC905 Formulation to Marketed Solifenacin (Vesicare®) and Tamsulosin OCAS (Omnic OCAS®) [NCT01953887] | Phase 1 | 30 participants (Actual) | Interventional | 2010-03-31 | Completed |
Evaluation of the Efficacy and Urodynamic Outcomes Between Intradetrusor onabotulinumtoxinA Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity [NCT05968885] | Phase 4 | 300 participants (Anticipated) | Interventional | 2021-10-01 | Recruiting |
An Open-label, Parallel Group, Randomized, Two-sequence, Three-way Crossover Study to Assess the Relative Bioavailability of Solifenacin Succinate and Mirabegron Fixed-dose Combination Tablets Compared to Co-administration of Single Entity Tablets at Thre [NCT02010944] | Phase 1 | 72 participants (Actual) | Interventional | 2012-09-30 | Completed |
A Randomized, Open-label, Single Dose, 2-way Crossover Study to Compare the Safety and Pharmacokinetic Characteristics After Administration of HIP1503 and HGP1103 in Healthy Male Volunteers [NCT02940314] | Phase 1 | 36 participants (Actual) | Interventional | 2016-03-31 | Completed |
[NCT00584090] | Phase 4 | 0 participants (Actual) | Interventional | 2007-11-30 | Withdrawn(stopped due to Study withdrawn with intent of persuing larger, multi-site study.) |
A Randomized, Double-Blind, Factorial, Parallel-Group, Active and Placebo-Controlled, Multicenter Dose-Ranging Study to Evaluate the Efficacy, Safety and Tolerability of Six Dose Combinations of Solifenacin Succinate and Mirabegron Compared to Mirabegron [NCT01340027] | Phase 2 | 1,307 participants (Actual) | Interventional | 2011-03-29 | Completed |
An Open-label, Long Term, Multi-center Study to Assess the Safety and Efficacy of Fixed Dose Combinations of Solifenacin Succinate (6 mg and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg, in Male Subjects With Lower Urinary Tract Symptoms (LUTS) Associa [NCT01021332] | Phase 3 | 1,067 participants (Actual) | Interventional | 2010-04-26 | Completed |
Efficacy and Impact of Botulinum Toxin A Versus Anticholinergic Therapy for the Treatment of Bothersome Urge Urinary Incontinence [NCT01166438] | Phase 3 | 249 participants (Actual) | Interventional | 2010-03-31 | Completed |
A Study to Compare the Cognitive Effect of Solifenacin 5mg Once-daily and Oxybutynin 5mg Twice-daily After Chronic Dosing Versus Placebo in Subjects 75 Years and Over With Mild Cognitive Impairment - A Double-blind, Randomized, Multi-center Study [NCT01126424] | Phase 4 | 26 participants (Actual) | Interventional | 2010-04-30 | Completed |
Vesicare™ (Solifenacin) in the Treatment of Urinary Incontinence After Radical Prostatectomy [NCT01215721] | | 40 participants (Actual) | Interventional | 2010-10-31 | Completed |
Comparison of Oxybutynin and Solifenacin in the Treatment of Overactive Bladder: a Randomized Controlled Multicenter Trial [NCT01423838] | Phase 4 | 500 participants (Anticipated) | Interventional | 2011-09-30 | Not yet recruiting |
Solifenacin Succinate in a Flexible Dose Regimen With Simplified Bladder Training Versus Solifenacin Succinate in a Flexible Dose Regimen Alone in a Prospective, Randomized, Parallel Group, Overactive Bladder Symptom Study [NCT00337558] | Phase 4 | 643 participants (Actual) | Interventional | 2006-05-31 | Completed |
A Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi Center Dose Ranging Study of Solifenacin Succinate in Combination With Tamsulosin Hydrochloride Compared With Solifenacin Succinate Monotherapy and Tamsulosin Hydrochloride Monotherapy [NCT00510406] | Phase 2 | 919 participants (Actual) | Interventional | 2007-01-31 | Completed |
[NCT00189800] | Phase 3 | 0 participants | Interventional | | Completed |
Efficacy and Safety of High Dose Vitamin D Supplementation for Overactive Bladder Dry in Children: A Randomized Clinical Trial [NCT05709990] | | 300 participants (Anticipated) | Interventional | 2023-01-15 | Recruiting |
Efficacy of Mirabegron Versus Tamsulosin Versus Solifenacin for Treatment of Ureteral Stents-Related Symptoms: a Randomized Controlled Trial [NCT04325880] | Phase 3 | 240 participants (Anticipated) | Interventional | 2021-12-01 | Recruiting |
Efficacy and Safety of Gabapentin in Treating Overactive Bladder [NCT01486706] | Phase 2/Phase 3 | 94 participants (Actual) | Interventional | 2010-10-31 | Completed |
Specified Drug Use Results Survey of Vesicare Tablets [NCT01489709] | | 1,160 participants (Actual) | Observational | 2010-06-30 | Completed |
An Open-Label Multicenter Study to Assess the Efficacy and Safety of Daily Oral Administration of 5 and 10mg VESIcare® (Solifenacin Succinate) in Patients Who Wish to Switch From Detrol LA® (Tolterodine Tartrate Extended Release) for the Treatment of Over [NCT00454740] | Phase 3 | 441 participants (Actual) | Interventional | 2004-06-30 | Completed |
[NCT00441428] | | 0 participants | Observational | 2006-02-28 | Completed |
An Open-label Study of the Efficacy and Safety of 5 and 10mg VESIcare® (Solifenacin Succinate) in Patients With Overactive Bladder Symptoms VOLT: VESIcare® Open-Label Trial [NCT00463541] | Phase 3 | 2,225 participants (Actual) | Interventional | 2004-06-30 | Completed |
Solifenacin Succinate vs. Fesoterodine A Comparison Trial for the Treatment of Bothersome Urgency Symptoms [NCT01595152] | | 60 participants (Anticipated) | Interventional | 2012-05-31 | Recruiting |
Multi-site, Randomized, Opened and Controlled Comparison Study on the Effectiveness and Safety of Solifenacin Succinate Tablets and Solifenacin Succinate Tablets + Estrogen for Overactive Bladder in the Post-menopausal Women [NCT01833663] | Phase 4 | 200 participants (Anticipated) | Interventional | 2011-10-31 | Completed |
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 3 | 246 participants (Actual) | Interventional | 2006-09-30 | Completed |
An Open Label Randomized, Single Dose, Three-way, Partial Replicate Bioequivalence Study to Determine the Bioequivalence of Solifenacin Succinate & Mirabegron From Mirfenacin MR 5/50 mg Extended Release Tablets (Hikma Pharma, Egypt) Versus Vesicare 5 mg F [NCT05767632] | Phase 1 | 30 participants (Actual) | Interventional | 2022-05-30 | Completed |
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Safety and Efficacy, Phase 4 Study of VESIcare® (Solifenacin Succinate) or Placebo in Combination With Tamsulosin HCl for the Treatment of Residual OAB Symptoms of Urgency and Fre [NCT00333112] | Phase 4 | 398 participants (Actual) | Interventional | 2006-05-31 | Completed |
A Prospective Randomized Trial of Behavioral Modification and Solifenacin (Vesicare)vs Solifenacin (Vesicare) Alone for the Treatment of Urge Incontinence in Patients With an Overactive Bladder [NCT00821184] | Phase 3 | 12 participants (Actual) | Interventional | 2006-09-30 | Terminated(stopped due to Insufficient subject availability/findings for data analysis) |
A Prospective Randomized Controlled Trial: Comparison of the Transcutaneous Posterior Tibial Nerve Stimulation and Oral Solifenacin Treatments' Effects in Women Between 18-80 Years Old Who Have Overactive Bladder [NCT06024005] | | 34 participants (Actual) | Interventional | 2023-04-18 | Completed |
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of Daily Oral Administration of 5mg and 10mg VESIcare® for the Treatment of Urgency Associated With Overactive Bladder [NCT00454896] | Phase 3 | 739 participants (Actual) | Interventional | 2004-05-31 | Completed |
A Randomized, Double-Blind, Parallel, Placebo-Controlled, Phase 4, Multicenter Study to Assess Efficacy and Safety of VESIcare® (Solifenacin Succinate) to Improve Urinary Continence of Subjects After Robotic Assisted Radical Prostatectomy [NCT01371994] | Phase 4 | 640 participants (Actual) | Interventional | 2011-08-02 | Completed |
The Therapeutic Effect of Beta-3 Agonist and Anti-muscarinic Agent on Overactive Bladder Among Sjogren's Syndrome Patient [NCT04909255] | Phase 4 | 50 participants (Anticipated) | Interventional | 2021-03-23 | Recruiting |
Efficacy of Tadalafil and Solifenacin Versus Tamsulosin and Solifenacin Combination Therapy for the Treatment of Benign Prostatic Hyperplasia With Overactive Bladder: A Randomized Controlled Trial [NCT05494567] | Phase 4 | 60 participants (Anticipated) | Interventional | 2021-11-08 | Active, not recruiting |
A Multicenter, Open-label, Single-dose Study to Evaluate Pharmacokinetics, Safety and Tolerability of Solifenacin Succinate Suspension in Pediatric Subjects From 5 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity (NDO) [NCT01539707] | Phase 1 | 14 participants (Actual) | Interventional | 2012-03-13 | Completed |
Clinical Trial to Compare the Efficacy and Safety of Solifenacin/Tamsulosin Combination Therapy With Tamsulosin Monotherapy for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia [NCT02972268] | Phase 3 | 780 participants (Actual) | Interventional | 2016-02-01 | Completed |
VECTOR: A Randomized Double-blind Study to Assess the Safety and Efficacy of Solifenacin (Vesicare®) in Comparison to Oxybutynin for Overactive Bladder Patients [NCT00431041] | Phase 4 | 132 participants (Actual) | Interventional | 2006-12-31 | Completed |
Injections of Botulinum Toxin A or Anticholinergic Treatment as First Line Therapy to Treat Neurogenic Overactive Bladder in Patients With Multiple Sclerosis [NCT04819360] | Phase 4 | 46 participants (Anticipated) | Interventional | 2021-06-01 | Recruiting |
Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Moderate and Severe Mixed Urinary Incontinence in Female: a Multicenter, Noninferiority, Randomized Controlled Trial [NCT02047032] | | 500 participants (Actual) | Interventional | 2014-04-30 | Completed |
Urinary NGF, PGE2 and ATP: Potential Biomarkers for Diagnosis and Prediction of Treatment Efficacy in Overactive Bladder Patients [NCT01499069] | | 191 participants (Actual) | Interventional | 2010-02-28 | Completed |
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) | Interventional | 2008-08-31 | Completed |
A Prospective, Open Label, Single Arm, Multicenter Study to Estimate the Efficacy and Safety of Solifenacin in Female With Clinically Significant Stress Urinary Incontinence and Urgency Urinary Incontinence [NCT01505439] | Phase 4 | 311 participants (Actual) | Interventional | 2011-06-30 | Completed |
Post-treatment Normallized Urodynamic Findings as the Golden Standard of Objective Cure for Female Overactive Bladder Patients Receiving Antimuscarinic Drug and Its Correlations With Voiding Diary, King's Health Questionnaire, and Overactive Bladder Sympt [NCT01627145] | | 300 participants (Anticipated) | Interventional | 2012-08-31 | Recruiting |
An Irish Observational Study to Evaluate LUTS Storage Symptom Improvement in Men Being Treated With Vesitirim™ (Solifenacin) [NCT01639794] | | 12 participants (Actual) | Observational | 2012-02-29 | Completed |
"Feasibility of At-home Titration of Solifenacin 5 and 10mg and Effect on Symptoms and Quality of Life in a Typical OAB Population" [NCT00759577] | Phase 4 | 36 participants (Actual) | Interventional | 2008-09-30 | Terminated(stopped due to difficulty with enrollment) |
Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women [NCT01737411] | Phase 1/Phase 2 | 120 participants (Anticipated) | Interventional | 2013-01-31 | Recruiting |
Phase 1/2 Study of the Effect of TOT or Solifenacin After Cesa or Vasa on Urge Urinary Incontinence [NCT01737918] | Phase 1/Phase 2 | 120 participants (Anticipated) | Interventional | 2013-01-31 | Recruiting |
A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy of Solifenacin and Percutaneous Tibial Nerve Stimulation in Patients With Refractory Overactive Bladder [NCT01764893] | Phase 4 | 8 participants (Actual) | Interventional | 2013-01-31 | Terminated(stopped due to Enrolling too slowly due to insurance plans no longer covering the cost of the Percutaneous Tibial Nerve Stimulation treatment.) |
A Phase II Randomized Study of Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients Receiving Adjuvant Hormonal Therapy [NCT01530373] | Phase 2 | 6 participants (Actual) | Interventional | 2012-02-29 | Active, not recruiting |
A Pilot Study to Assess the Safety and Efficacy of Solifenacin (VESIcare) for Improving Urinary and Bladder Functions in Patients Undergoing Radiation Therapy of the Prostate [NCT01777217] | Phase 4 | 8 participants (Actual) | Interventional | 2013-02-28 | Terminated(stopped due to Terminated) |
A Phase 3, Open-Label, Baseline-controlled, Multicenter, Sequential Dose Titration Study to Assess the Long-Term Efficacy and Safety, and the Pharmacokinetics of Solifenacin Succinate Suspension in Patients From 5 to Less Than 18 Years of Age With Neuroge [NCT01565694] | Phase 3 | 76 participants (Actual) | Interventional | 2012-08-14 | Completed |
A Prospective, Multicenter, Observation Study to Estimate the Dry Mouth in OAB Patients With Solifenacin [NCT01437670] | | 262 participants (Actual) | Observational | 2011-09-30 | Completed |
Electroacupuncture Versus Solifenacin Succinate for Female Overactive Bladder: A Multicenter, Randomized, Controlled, Noninferiority Trial [NCT05798403] | | 204 participants (Anticipated) | Interventional | 2023-07-07 | Recruiting |
Comparisons of the Impact of Beta-3 Agonist Versus Antimuscarinics on Psychological Distress, Sexual Function, Bladder Wall Thickness and Blood Flow in Women With Overactive Bladder Syndrome: a Randomized Controlled Study. [NCT04023253] | Phase 3 | 120 participants (Anticipated) | Interventional | 2019-08-01 | Recruiting |
Safety and Efficacy Beta 3 Agonists in Treatment of Non-neurogenic Voiding Dysfunction in Children, a Randomized Clinical Trial [NCT05240456] | Phase 1/Phase 2 | 70 participants (Anticipated) | Interventional | 2022-02-28 | Not yet recruiting |
A Phase II, Dose Titration Study of CPC-201 in Patients With Dementia of Alzheimer's Type [NCT02549196] | Phase 2 | 28 participants (Actual) | Interventional | 2015-10-07 | Completed |
Comparison of the Efficacy of Solifenacin With or Without Tamsulosin in Adult Women With OAB: A Prospective Randomized Multicenter Study [NCT01533597] | Phase 4 | 70 participants (Actual) | Interventional | 2010-12-31 | Completed |
A Randomized, Double-blind, Placebo-controlled, Parallel-group, and Phase IV Study of Efficacy and Safety of Solifenacin Succinate in Patients With Overactive Bladder After TURP or PVP [NCT01747577] | Phase 4 | 68 participants (Actual) | Interventional | 2012-12-04 | Completed |
A Phase 3, Double-Blind, Randomized, Multi-center, Placebo-Controlled Sequential Dose Titration Study to Assess Efficacy, Safety and Population Pharmacokinetics of Solifenacin Succinate Suspension in Pediatric Subjects From 5 to Less Than 18 Years of Age [NCT01565707] | Phase 3 | 189 participants (Actual) | Interventional | 2012-06-07 | Completed |
Therapeutic Merit of Solifenacin in the Mitigation of Ureteral Stent-induced Pain and Lower Urinary Tract Symptoms (LUTS) Post Ureteroscopy for Stone Management [NCT01381120] | Phase 4 | 84 participants (Actual) | Interventional | 2010-10-31 | Completed |
A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Multi-center Study to Evaluate the Long-Term Safety and Efficacy of Combination of Solifenacin Succinate With Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in Subject [NCT02045862] | Phase 3 | 1,829 participants (Actual) | Interventional | 2014-03-17 | Completed |
Efficacy and Safety of Intradetrusor BOTOX Injection Combined With Percutaneous Tibial Nerve Stimulation for Managing Children With Overactive Bladder Not Responding to Monotherapy [NCT05911594] | | 128 participants (Actual) | Interventional | 2022-02-14 | Completed |
A Double-Blind, Randomized, Parallel Group, Multi-Centre Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Subjects With Overactive Bladder (OAB) Treated With Antimuscarinics and Dissatisfied Due to Lack of Efficacy [NCT01638000] | Phase 3 | 1,887 participants (Actual) | Interventional | 2012-06-12 | Completed |
Incontinence & Intimate Partners: Assessing the Contribution of Treatment [NCT01559389] | Phase 4 | 138 participants (Actual) | Interventional | 2012-03-09 | Completed |
The Effect of Solifenacin on Post Void Dribbling in Women: A Randomized Controlled Multicenter Trial [NCT01470001] | | 118 participants (Actual) | Interventional | 2011-11-30 | Completed |
The Effectiveness, Superiority and Safety of EA on OAB:Multi-center Randomized Controlled Trial [NCT02452879] | | 180 participants (Anticipated) | Interventional | 2014-10-31 | Recruiting |
A Phase 3, Open-Label, Baseline-controlled, Multi-center, Sequential Dose-Titration Study to Assess the Pharmacokinetics, Long-Term Efficacy and Safety of Solifenacin Succinate Suspension in Children From 6 Months to Less Than 5 Years of Age With Neurogen [NCT01981954] | Phase 3 | 23 participants (Actual) | Interventional | 2013-09-25 | Completed |
Vesicare™ (Solifenacin) in the Treatment of Urinary Incontinence After Radical Prostatectomy [NCT00581061] | | 13 participants (Actual) | Interventional | 2008-06-30 | Terminated(stopped due to Study subjects were not compliant with study protocols.) |
Urinary Nerve Growth Factor as a Biomarker for Medical Treatment of Male Lower Urinary Tract Symptoms: A Pilot Trial [NCT01457573] | Phase 4 | 10 participants (Actual) | Interventional | 2011-10-31 | Completed |
A Randomized, Double-Blind, Multi-Centre Study to Evaluate the Efficacy and Safety of Adding Mirabegron to Solifenacin in Incontinent OAB Subjects Who Have Received Solifenacin for 4 Weeks and Warrant Additional Relief for Their OAB Symptoms [NCT01908829] | Phase 3 | 2,174 participants (Actual) | Interventional | 2013-07-10 | Completed |
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 4, Multi-center Study of VESIcare® (Solifenacin Succinate) in Overactive Bladder (OAB) Subjects to Evaluate Symptom Bother and Health Related Quality of Life VIBRANT: VESIcare® Investig [NCT00573508] | Phase 4 | 768 participants (Actual) | Interventional | 2007-08-31 | Completed |
Belgian Observational Study to Evaluate Storage and Voiding Symptoms Improvement in Male Subjects With Lower Urinary Tract Predominant Storage Symptoms (Overactive Bladder Syndrome) Being Treated With Solifenacin in Monotherapy or Combination [NCT01799902] | | 86 participants (Actual) | Observational | 2011-12-31 | Completed |
A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multi-center Study to Evaluate the Efficacy, Safety and Tolerability of Combinations of Solifenacin Succinate and Mirabegron Compared to Solifenacin Succinate and Mirabegron Monot [NCT01972841] | Phase 3 | 3,527 participants (Actual) | Interventional | 2013-11-05 | Completed |
[NCT01767519] | Phase 3 | 356 participants (Actual) | Interventional | 2013-03-01 | Completed |
Safety and Efficacy of Mirabegron as Add-on Therapy in Patients With Overactive Bladder Treated With Solifenacin: A Postmarketing Open-label Study in Japan [NCT01745094] | Phase 4 | 223 participants (Actual) | Interventional | 2012-10-01 | Completed |
Clinical Trial to Investigate and Compare the Pharmacokinetic Characteristics and Safety/Tolerability After Single Administration of JLP-1207 and Soifenacin/Tamsulosin in Healthy Male Volunteers. [NCT02494349] | Phase 1 | 54 participants (Actual) | Interventional | 2015-08-31 | Completed |
An Open-Label, Long-Term Extension, Multi-center, Sequential Dose Titration Study to Assess Safety and Efficacy of Solifenacin Succinate Suspension in Pediatric Subjects With Overactive Bladder (OAB) [NCT01655069] | Phase 3 | 148 participants (Actual) | Interventional | 2012-10-04 | Completed |
The Effect of Short Term Solifenacin for Overactive Bladder on the Female Urinary Microbiome [NCT01642277] | Phase 2 | 134 participants (Actual) | Interventional | 2012-07-31 | Completed |
Postmarketing Study of Mirabegron in Japan: Long-term Add-on Therapy With Antimuscarinics in Patients With Overactive Bladder Treated With Mirabegron [NCT02294396] | Phase 4 | 649 participants (Actual) | Interventional | 2014-10-28 | Completed |
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Trial | Outcome |
NCT00431041 (4) [back to overview] | Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary |
NCT00431041 (4) [back to overview] | The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event |
NCT00431041 (4) [back to overview] | Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary |
NCT00431041 (4) [back to overview] | The Severity of Dry Mouth Reported as an Adverse Event |
NCT00507455 (18) [back to overview] | Change From Baseline in IPSS Storage Score |
NCT00507455 (18) [back to overview] | Change From Baseline in IPSS Voiding Score |
NCT00507455 (18) [back to overview] | Change From Baseline in Number of Incontinence Episodes Per 24 Hours |
NCT00507455 (18) [back to overview] | Change From Baseline in Number of Micturitions Per 24 Hours |
NCT00507455 (18) [back to overview] | Change From Baseline in Number of Urgency Episodes Per 24 Hours |
NCT00507455 (18) [back to overview] | Change From Baseline in Patient Perception of Bladder Condition (PPBC) |
NCT00507455 (18) [back to overview] | Change From Baseline in Post Void Residual Volume (PVR) |
NCT00507455 (18) [back to overview] | Change From Baseline in Volume Voided Per Micturition |
NCT00507455 (18) [back to overview] | Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests |
NCT00507455 (18) [back to overview] | Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score |
NCT00507455 (18) [back to overview] | Change From Baseline in ICIQ-LUTSqol Overall Symptom Interference of Life Score |
NCT00507455 (18) [back to overview] | Change From Baseline to End of Treatment in Percent Bladder Voiding Efficiency (BVE) |
NCT00507455 (18) [back to overview] | Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax) |
NCT00507455 (18) [back to overview] | Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax) |
NCT00507455 (18) [back to overview] | Change From Baseline to End of Treatment in Bladder Contractility Index (BCI) |
NCT00507455 (18) [back to overview] | Change From Baseline in International Prostate Symptoms Score (IPSS) |
NCT00507455 (18) [back to overview] | Change From Baseline in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score |
NCT00507455 (18) [back to overview] | Change From Baseline in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score |
NCT00573508 (13) [back to overview] | Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score |
NCT00573508 (13) [back to overview] | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social |
NCT00573508 (13) [back to overview] | Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores. |
NCT00573508 (13) [back to overview] | Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score |
NCT00573508 (13) [back to overview] | Number of Participants With Change From Baseline in the Global Assessment Score of the Patient Perception of Bladder Condition (PPBC) |
NCT00573508 (13) [back to overview] | Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire |
NCT00573508 (13) [back to overview] | Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores. |
NCT00573508 (13) [back to overview] | Change From Baseline in the MCUI Behavior Therapy Stratified |
NCT00573508 (13) [back to overview] | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months |
NCT00573508 (13) [back to overview] | Change From Baseline in the Treatment Satisfaction Visual Analog Scale (TS-VAS) |
NCT00573508 (13) [back to overview] | Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score |
NCT00573508 (13) [back to overview] | Change From Baseline in Work Productivity Assessment Index (WPAI) |
NCT00573508 (13) [back to overview] | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary |
NCT00581061 (3) [back to overview] | Compliance |
NCT00581061 (3) [back to overview] | Side Effects |
NCT00581061 (3) [back to overview] | Time to Continence |
NCT00821184 (1) [back to overview] | Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries. |
NCT00832650 (9) [back to overview] | Mean Proportion of Bowel Movements With Satisfaction Per Day |
NCT00832650 (9) [back to overview] | Average Score of Ease of Passage During Defecation Per Day |
NCT00832650 (9) [back to overview] | Colonic Filling at 6 Hours |
NCT00832650 (9) [back to overview] | Colonic Transit at 24 Hours |
NCT00832650 (9) [back to overview] | Colonic Transit at 48 Hours |
NCT00832650 (9) [back to overview] | Mean Number of Stools Per Day |
NCT00832650 (9) [back to overview] | Mean Score of Stool Consistency Per Day |
NCT00832650 (9) [back to overview] | Proximal Colonic Emptying Time |
NCT00832650 (9) [back to overview] | Time to Gastric Emptying |
NCT00909428 (1) [back to overview] | Change in Maximal Cystometric Capacity (mL) |
NCT01018264 (5) [back to overview] | Number of Urinary Incontinence Episodes Per 24 Hour Period |
NCT01018264 (5) [back to overview] | Number of Micturations Per 24 Hour Period |
NCT01018264 (5) [back to overview] | Number of Nocturia Episodes Per 24 Hour Period |
NCT01018264 (5) [back to overview] | Parkinson's Disease Quality of Life Scale (PDQOL) |
NCT01018264 (5) [back to overview] | Unified Parkinson's Disease Rating Scale (UPDRS) Total |
NCT01018511 (44) [back to overview] | Change From Baseline to End of Treatment in Total International Prostate Symptom Score |
NCT01018511 (44) [back to overview] | Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS, Previously Known as Total Urgency Score [TUS]) |
NCT01018511 (44) [back to overview] | Percentage of Participants Who Were OAB-q Responders at End of Treatment |
NCT01018511 (44) [back to overview] | Apparent Clearance (CL/F) of Tamsulosin |
NCT01018511 (44) [back to overview] | Area Under the Curve at Steady State (AUCss) of Tamsulosin |
NCT01018511 (44) [back to overview] | AUCss of Solifenacin |
NCT01018511 (44) [back to overview] | Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score |
NCT01018511 (44) [back to overview] | Change From Baseline to End of Treatment in EQ-5D Mobility Score |
NCT01018511 (44) [back to overview] | Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score |
NCT01018511 (44) [back to overview] | Change From Baseline to End of Treatment in EQ-5D Self-care Score |
NCT01018511 (44) [back to overview] | Change From Baseline to End of Treatment in EQ-5D Usual Activities Score |
NCT01018511 (44) [back to overview] | Change From Baseline to End of Treatment in Individual IPSS Scores |
NCT01018511 (44) [back to overview] | CL/F of Solifenacin |
NCT01018511 (44) [back to overview] | Clinician Global Impression Scale at End of Treatment: Overall Bladder Symptoms |
NCT01018511 (44) [back to overview] | Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score |
NCT01018511 (44) [back to overview] | Cminss of Solifenacin |
NCT01018511 (44) [back to overview] | Maximum Concentration at Steady State (Cmaxss) of Tamsulosin |
NCT01018511 (44) [back to overview] | Minimum Concentration at Steady State (Cminss) of Tamsulosin |
NCT01018511 (44) [back to overview] | Number of Participants With Adverse Events (AEs) |
NCT01018511 (44) [back to overview] | Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours |
NCT01018511 (44) [back to overview] | Patient Global Impression Scale at End of Treatment: Overall Bladder Symptoms |
NCT01018511 (44) [back to overview] | Time of Maximum Concentration at Steady State (Tmaxss) of Tamsulosin |
NCT01018511 (44) [back to overview] | Tmaxss of Solifenacin |
NCT01018511 (44) [back to overview] | Patient Global Impression Scale at End of Treatment: General Health |
NCT01018511 (44) [back to overview] | Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours |
NCT01018511 (44) [back to overview] | Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours |
NCT01018511 (44) [back to overview] | Change From Baseline to End of Treatment in Average Flow Rate (Qmean) |
NCT01018511 (44) [back to overview] | Change From Baseline to End of Treatment in Health Related QoL (HRQoL) Subscale: Coping Score |
NCT01018511 (44) [back to overview] | Change From Baseline to End of Treatment in HRQoL Subscale: Concern Score |
NCT01018511 (44) [back to overview] | Change From Baseline to End of Treatment in HRQoL Subscale: Sleep Score |
NCT01018511 (44) [back to overview] | Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours |
NCT01018511 (44) [back to overview] | Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours |
NCT01018511 (44) [back to overview] | Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition |
NCT01018511 (44) [back to overview] | Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume |
NCT01018511 (44) [back to overview] | Change From Baseline to End of Treatment in Symptom Bother Score |
NCT01018511 (44) [back to overview] | Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours |
NCT01018511 (44) [back to overview] | Cmaxss of Solifenacin |
NCT01018511 (44) [back to overview] | Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax) |
NCT01018511 (44) [back to overview] | Change From Baseline to End of Treatment in IPSS Voiding Score |
NCT01018511 (44) [back to overview] | Change From Baseline to End of Treatment in IPSS Storage Score |
NCT01018511 (44) [back to overview] | Change From Baseline to End of Treatment in IPSS QoL Score |
NCT01018511 (44) [back to overview] | Change From Baseline to End of Treatment in HRQoL Subscale: Total Score |
NCT01018511 (44) [back to overview] | Change From Baseline to End of Treatment in HRQoL Subscale: Social Score |
NCT01018511 (44) [back to overview] | Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition |
NCT01021332 (31) [back to overview] | Change From Baseline to End of Treatment in IPSS Quality of Life (QoL) Score |
NCT01021332 (31) [back to overview] | Change From Baseline to End of Treatment in IPSS Storage Score |
NCT01021332 (31) [back to overview] | Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax) |
NCT01021332 (31) [back to overview] | Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition |
NCT01021332 (31) [back to overview] | Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours |
NCT01021332 (31) [back to overview] | Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours |
NCT01021332 (31) [back to overview] | Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours |
NCT01021332 (31) [back to overview] | Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours |
NCT01021332 (31) [back to overview] | Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours |
NCT01021332 (31) [back to overview] | Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition |
NCT01021332 (31) [back to overview] | Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume |
NCT01021332 (31) [back to overview] | Change From Baseline to End of Treatment in Symptom Bother Score |
NCT01021332 (31) [back to overview] | Change From Baseline to End of Treatment in Total International Prostate Symptom Score (IPSS) |
NCT01021332 (31) [back to overview] | Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS) (Previously Known as Total Urgency Score [TUS]) |
NCT01021332 (31) [back to overview] | Number of OAB-q Responders Based on Health-related Quality of Life: Total Score |
NCT01021332 (31) [back to overview] | Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score |
NCT01021332 (31) [back to overview] | Change From Baseline to End of Treatment in EQ-5D Mobility Score |
NCT01021332 (31) [back to overview] | Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score |
NCT01021332 (31) [back to overview] | Change From Baseline to End of Treatment in EQ-5D Self-care Score |
NCT01021332 (31) [back to overview] | Change From Baseline to End of Treatment in EQ-5D Usual Activities Score |
NCT01021332 (31) [back to overview] | Change From Baseline to End of Treatment in Individual IPSS Scores |
NCT01021332 (31) [back to overview] | Number of Participants With Adverse Events (AEs) |
NCT01021332 (31) [back to overview] | Change From Baseline to End of Treatment in IPSS Voiding Score |
NCT01021332 (31) [back to overview] | Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours |
NCT01021332 (31) [back to overview] | Change From Baseline to End of Treatment in Average Flow Rate (Qmean) |
NCT01021332 (31) [back to overview] | Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score |
NCT01021332 (31) [back to overview] | Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Concern Score |
NCT01021332 (31) [back to overview] | Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Coping Score |
NCT01021332 (31) [back to overview] | Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Sleep Score |
NCT01021332 (31) [back to overview] | Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Social Score |
NCT01021332 (31) [back to overview] | Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Total Score |
NCT01028014 (3) [back to overview] | Difference (Pre - Post) in Maximum Urine Flow Rate (Qmax) (Milliliters Per Second) as Measured by Pressure Flowmetry |
NCT01028014 (3) [back to overview] | Difference (Pre - Post) in Urethral Sensation (Milliamps) as Measured by Current Perception Threshold Testing. |
NCT01028014 (3) [back to overview] | Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG |
NCT01093534 (25) [back to overview] | Change From Baseline in Patient Assessment of Treatment Satisfaction |
NCT01093534 (25) [back to overview] | Change From Baseline in Patient Assessment of Urgency Bother |
NCT01093534 (25) [back to overview] | Change From Baseline in Patient Perception of Bladder Condition (PPBC) |
NCT01093534 (25) [back to overview] | Change From Baseline in Symptom Bother Score |
NCT01093534 (25) [back to overview] | Change From Baseline to Week 12 in Bladder Wall Thickness |
NCT01093534 (25) [back to overview] | Change From Baseline to Week 12 in Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr) |
NCT01093534 (25) [back to overview] | Change From Baseline to Week 12 in Mean Level of Urgency |
NCT01093534 (25) [back to overview] | Change From Baseline to Week 12 in Mean Number of Events (Micturitions Plus Incontinence Episodes) Per 24 Hours |
NCT01093534 (25) [back to overview] | Change From Baseline to Week 12 in Mean Number of Incontinence Episodes Per 24 Hours |
NCT01093534 (25) [back to overview] | Change From Baseline to Week 12 in Mean Number of Micturitions Per 24 Hours |
NCT01093534 (25) [back to overview] | Change From Baseline to Week 12 in Mean Number of Urgency Events Per 24 Hours |
NCT01093534 (25) [back to overview] | Change From Baseline to Week 12 in Mean Number of Urgency Micturitions Per 24 Hours |
NCT01093534 (25) [back to overview] | Change From Baseline to Week 12 in Total Urgency Score |
NCT01093534 (25) [back to overview] | Change From Baseline to Week 12 in Total Urinary Nerve Growth Factor Normalized by Urine Creatinine |
NCT01093534 (25) [back to overview] | Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12 |
NCT01093534 (25) [back to overview] | Total Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12 |
NCT01093534 (25) [back to overview] | Change From Baseline in Health-Related Quality of Life (HRQL) |
NCT01093534 (25) [back to overview] | Change From Baseline to Week 6 and Week 12 in Bladder Wall Thickness |
NCT01093534 (25) [back to overview] | Change From Baseline to Week 6 and Week 12 in Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine |
NCT01093534 (25) [back to overview] | Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr) at Week 12 |
NCT01093534 (25) [back to overview] | Change From Baseline in EuroQoL 5-Dimension Questionnaire Visual Analog Scale |
NCT01093534 (25) [back to overview] | Percentage of Participants With Improvement or Deterioration in Patient Perception of Bladder Condition (PPBC) |
NCT01093534 (25) [back to overview] | Change From Baseline in Mean Number of Urgency Incontinence Episodes With PPIUS Grade 3 or 4 Per 24 Hours |
NCT01093534 (25) [back to overview] | Change From Baseline in Mean Number of Urgency Incontinence Episodes With PPIUS Grade 4 Per 24 Hours |
NCT01093534 (25) [back to overview] | Percentage of Participants With Improvement and Worsening on the 5 Dimensions of the EQ-5D |
NCT01126424 (6) [back to overview] | Change From Baseline in Cognitive Function Composite Score - Power of Attention |
NCT01126424 (6) [back to overview] | Change From Baseline in Cognitive Function Composite Score - Quality of Episodic Secondary Memory |
NCT01126424 (6) [back to overview] | Change From Baseline in Cognitive Function Composite Score - Quality of Working Memory |
NCT01126424 (6) [back to overview] | Change From Baseline in Cognitive Function Composite Score - Speed of Memory |
NCT01126424 (6) [back to overview] | Change From Baseline in Postural Stability Test |
NCT01126424 (6) [back to overview] | Change From Baseline in Cognitive Function Composite Score - Continuity of Attention |
NCT01166438 (5) [back to overview] | Change From Baseline in Score on OABq-SF |
NCT01166438 (5) [back to overview] | Change in PFDI-SF and PFIQ-SF Total Scores |
NCT01166438 (5) [back to overview] | Change in Urge Urinary Incontinence (UUI) Episodes |
NCT01166438 (5) [back to overview] | Efficacy |
NCT01166438 (5) [back to overview] | Patient Global Impression of Improvement |
NCT01215721 (1) [back to overview] | Time to Continence |
NCT01340027 (30) [back to overview] | Percentage of Participants With a Micturition Response |
NCT01340027 (30) [back to overview] | Percentage of Participants With Zero Incontinence Episodes Post-baseline |
NCT01340027 (30) [back to overview] | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score |
NCT01340027 (30) [back to overview] | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score |
NCT01340027 (30) [back to overview] | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score |
NCT01340027 (30) [back to overview] | Change From Baseline to Each Visit in Mean Level of Urgency |
NCT01340027 (30) [back to overview] | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours |
NCT01340027 (30) [back to overview] | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours |
NCT01340027 (30) [back to overview] | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours |
NCT01340027 (30) [back to overview] | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours |
NCT01340027 (30) [back to overview] | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours |
NCT01340027 (30) [back to overview] | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours |
NCT01340027 (30) [back to overview] | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition |
NCT01340027 (30) [back to overview] | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) |
NCT01340027 (30) [back to overview] | Percentage of Participants With 50% Reduction in Incontinence Episodes |
NCT01340027 (30) [back to overview] | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score |
NCT01340027 (30) [back to overview] | Percentage of Participants With Major Improvement in PPBC |
NCT01340027 (30) [back to overview] | Percentage of Participants With Improvement in PPBC |
NCT01340027 (30) [back to overview] | Percentage of Participants With Deterioration in PPBC |
NCT01340027 (30) [back to overview] | Percentage of Participants With a Symptom Bother Response |
NCT01340027 (30) [back to overview] | Percentage of Participants With a Health-related Quality of Life Total Score Response |
NCT01340027 (30) [back to overview] | Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS) |
NCT01340027 (30) [back to overview] | Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) |
NCT01340027 (30) [back to overview] | Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC) |
NCT01340027 (30) [back to overview] | Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours |
NCT01340027 (30) [back to overview] | Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours |
NCT01340027 (30) [back to overview] | Change From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score |
NCT01340027 (30) [back to overview] | Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) |
NCT01340027 (30) [back to overview] | Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition |
NCT01340027 (30) [back to overview] | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score |
NCT01371994 (19) [back to overview] | Percentage of Participants Who Gain Continence During 12-week Treatment Period |
NCT01371994 (19) [back to overview] | Baseline Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment |
NCT01371994 (19) [back to overview] | Baseline Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed |
NCT01371994 (19) [back to overview] | International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score at Baseline |
NCT01371994 (19) [back to overview] | Time From Baseline to First Day of Returning to Work |
NCT01371994 (19) [back to overview] | Change From Baseline in American Urology Association Quality of Life (QOL) Score |
NCT01371994 (19) [back to overview] | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment |
NCT01371994 (19) [back to overview] | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment |
NCT01371994 (19) [back to overview] | Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score |
NCT01371994 (19) [back to overview] | Change From Baseline in Average Daily Pad Usage |
NCT01371994 (19) [back to overview] | Change From Baseline in American Urology Association Symptom Score (AUASS) |
NCT01371994 (19) [back to overview] | American Urology Association Symptom Score (AUASS) at Baseline |
NCT01371994 (19) [back to overview] | Time From First Dose to Urinary Continence |
NCT01371994 (19) [back to overview] | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed |
NCT01371994 (19) [back to overview] | Baseline Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working |
NCT01371994 (19) [back to overview] | Baseline Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment |
NCT01371994 (19) [back to overview] | Average Daily Pad Usage at Baseline |
NCT01371994 (19) [back to overview] | American Urology Association Quality of Life (QOL) Score at Baseline |
NCT01371994 (19) [back to overview] | Change From Baseline in Work Productivity Assessment Index (WPAI): Percent Impairment While Working |
NCT01381120 (2) [back to overview] | Change in Post-ureteroscopy Stent-induced Pain |
NCT01381120 (2) [back to overview] | Change in Post-ureteroscopy Stent-induced Lower Urinary Tract Symptoms. |
NCT01457573 (11) [back to overview] | Change From Baseline in Urinary Growth Factor to Creatinine Ratio (GF/Cr) |
NCT01457573 (11) [back to overview] | Change in Post Void Residual (mL) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12 |
NCT01457573 (11) [back to overview] | Change in PBC-Patient Perception of Bladder Condition at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12 |
NCT01457573 (11) [back to overview] | Change in PPUS-Patient Perception of Urinary Urgency Survey Score at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12 |
NCT01457573 (11) [back to overview] | Change in Urinary Growth Factor to Creatinine Ratio (GF/Cr) From Baseline Compared to Month 1/Week4 and Month 2/Week 8. |
NCT01457573 (11) [back to overview] | Change in Maximum Urinary Flow Rate (ml/s) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12 |
NCT01457573 (11) [back to overview] | Change in IPSS-International Prostate Score Scale at Baseline Compared to Post Dose Survey at Month 1, 2, and Month 3/Week12. |
NCT01457573 (11) [back to overview] | Change in ICIQ-MLUTS - International Consultation on Incontinence Modular Questionnaire for Male LUTS Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12 |
NCT01457573 (11) [back to overview] | Change in ICIQ LUTS QoL -International Consultation on Incontinence Modular Questionnaire LUTS Quality of Life for Male LUTS Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12 |
NCT01457573 (11) [back to overview] | Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.1/Wk4 and Mo.2/Wk8 |
NCT01457573 (11) [back to overview] | Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.3/Wk12 |
NCT01470001 (3) [back to overview] | Change in Patients Perspective of the Impact of Their Disease, Captured Using the Pelvic Floor Distress Inventory (Urinary Questions) |
NCT01470001 (3) [back to overview] | the Percent of Patients With at Least 50% Reduction in Post Void Dribbling Episodes |
NCT01470001 (3) [back to overview] | The Percent Reduction in Post Void Dribbling Episodes (Events) |
NCT01533597 (6) [back to overview] | Change in Mean Number of Micturition Episodes Per 24 Hours |
NCT01533597 (6) [back to overview] | Change in Score of IPSS |
NCT01533597 (6) [back to overview] | Change of PVR |
NCT01533597 (6) [back to overview] | Change of Qmax |
NCT01533597 (6) [back to overview] | Numeric Change of Urgency Episodes Per 24 Hours |
NCT01533597 (6) [back to overview] | Change in Total Score of OABSS |
NCT01559389 (3) [back to overview] | Change in Overall Sexual Satisfaction Among Healthy Male Partners |
NCT01559389 (3) [back to overview] | Baseline Sexual Satisfaction Between Matched Female and Male Partners |
NCT01559389 (3) [back to overview] | Change in Overall Sexual Satisfaction Among Females |
NCT01565694 (16) [back to overview] | Change From Baseline to Last Possible Titration Step in Maximum Cystometric Capacity |
NCT01565694 (16) [back to overview] | Change From Baseline in Average Catheterized Volume Per Catheterization |
NCT01565694 (16) [back to overview] | Change From Baseline in Average First Morning Catheterized Volume |
NCT01565694 (16) [back to overview] | Change From Baseline in Bladder Compliance |
NCT01565694 (16) [back to overview] | Change From Baseline in Bladder Volume at 40 cmH2O Detrusor Pressure |
NCT01565694 (16) [back to overview] | Change From Baseline in Detrusor Pressure at the End of Bladder Filling |
NCT01565694 (16) [back to overview] | Change From Baseline in Maximum Catheterized Volume |
NCT01565694 (16) [back to overview] | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours |
NCT01565694 (16) [back to overview] | Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days |
NCT01565694 (16) [back to overview] | Change From Baseline in Number of Dry (Incontinence-Free) Nights Per 7 Days |
NCT01565694 (16) [back to overview] | Change From Baseline in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until End of Bladder Filling |
NCT01565694 (16) [back to overview] | Change From Baseline in Quality of Life [QoL] (PinQ Questionnaire Score) |
NCT01565694 (16) [back to overview] | Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC) |
NCT01565694 (16) [back to overview] | Number of Participants With Adverse Events |
NCT01565694 (16) [back to overview] | Change From Baseline in Bladder Volume at 30 cmH2O Detrusor Pressure |
NCT01565694 (16) [back to overview] | Change From Baseline in Bladder Volume (mL) Until First Detrusor Contraction > 15 cmH2O as a Percentage of Expected Bladder Capacity (EBC) |
NCT01565707 (20) [back to overview] | Change From Baseline to End of Treatment in Mean Number of Daytime Micturitions Per 24 Hours |
NCT01565707 (20) [back to overview] | Area Under the Plasma Concentration - Time to Curve (AUC) for a Dose Interval (AUCtau) of Solifenacin |
NCT01565707 (20) [back to overview] | Change From Baseline in Post Void Residual (PVR) Volume |
NCT01565707 (20) [back to overview] | Change From Baseline to End of Treatment (EoT) in Mean Volume Voided (MVV) Per Micturition |
NCT01565707 (20) [back to overview] | Change From Baseline to End of Treatment in Daytime Maximum Volume Voided (DMaxVV) Per Micturition |
NCT01565707 (20) [back to overview] | Change From Baseline to End of Treatment in Mean Number of Daytime Incontinence Episodes Per 24 Hours |
NCT01565707 (20) [back to overview] | Number of Participants With Adverse Events (AEs) |
NCT01565707 (20) [back to overview] | Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Days Per 7 Days |
NCT01565707 (20) [back to overview] | Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Nighttimes Per 7 Days |
NCT01565707 (20) [back to overview] | Change From Baseline to End of Treatment in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents |
NCT01565707 (20) [back to overview] | Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours |
NCT01565707 (20) [back to overview] | Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours |
NCT01565707 (20) [back to overview] | Change From Baseline to End of Treatment in Mean Number of Nighttime Incontinence Episodes Per 24 Hours |
NCT01565707 (20) [back to overview] | Change From Baseline to End of Treatment in Mean Number of Nighttime Micturitions Per 24 Hours |
NCT01565707 (20) [back to overview] | Maximum Concentration (Cmax) of Solifenacin |
NCT01565707 (20) [back to overview] | Plasma Concentration Before Drug Administration (Ctrough) of Solifenacin |
NCT01565707 (20) [back to overview] | Time to Attain Maximum Concentration (Tmax) of Solifenacin |
NCT01565707 (20) [back to overview] | Apparent Terminal Elimination Half-Life (T1/2) of Solifenacin |
NCT01565707 (20) [back to overview] | Apparent Total Body Clearance (CL/F) of Solifenacin |
NCT01565707 (20) [back to overview] | Apparent Volume of Distribution (Vz/F) of Solifenacin |
NCT01638000 (47) [back to overview] | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS) |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert Scale |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC) |
NCT01638000 (47) [back to overview] | Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) |
NCT01638000 (47) [back to overview] | Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q |
NCT01638000 (47) [back to overview] | Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit |
NCT01638000 (47) [back to overview] | Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit |
NCT01638000 (47) [back to overview] | Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit |
NCT01638000 (47) [back to overview] | Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit |
NCT01638000 (47) [back to overview] | Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period |
NCT01638000 (47) [back to overview] | Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit |
NCT01638000 (47) [back to overview] | Percentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final Visit |
NCT01638000 (47) [back to overview] | Percentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final Visit |
NCT01638000 (47) [back to overview] | Percentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final Visit |
NCT01638000 (47) [back to overview] | Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit |
NCT01638000 (47) [back to overview] | Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12 |
NCT01638000 (47) [back to overview] | Percentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final Visit |
NCT01638000 (47) [back to overview] | Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit |
NCT01638000 (47) [back to overview] | Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours |
NCT01638000 (47) [back to overview] | Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment |
NCT01638000 (47) [back to overview] | Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment |
NCT01638000 (47) [back to overview] | Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency |
NCT01638000 (47) [back to overview] | Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours |
NCT01638000 (47) [back to overview] | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours |
NCT01638000 (47) [back to overview] | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours |
NCT01638000 (47) [back to overview] | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours |
NCT01638000 (47) [back to overview] | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01642277 (3) [back to overview] | Bacterial Genomic Sequencing |
NCT01642277 (3) [back to overview] | Assessment of Pelvic Floor Disease Inventory (PFDI) Questionnaire |
NCT01642277 (3) [back to overview] | Assessment of Overactive Bladder Questionnaire (OABQ) |
NCT01655069 (6) [back to overview] | Change From Baseline to Final Visit in Postvoid Residual (PVR) Volume |
NCT01655069 (6) [back to overview] | Change From Baseline in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents |
NCT01655069 (6) [back to overview] | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours |
NCT01655069 (6) [back to overview] | Change From Baseline in Mean Number of Micturitions Per 24 Hours |
NCT01655069 (6) [back to overview] | Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days |
NCT01655069 (6) [back to overview] | Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) |
NCT01745094 (15) [back to overview] | Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Severity Score |
NCT01745094 (15) [back to overview] | Change From Baseline in Postvoid Residual (PVR) Volume |
NCT01745094 (15) [back to overview] | Number for Participants Who Achieved Normalization of the Number of Incontinence Episodes Per 24 Hours |
NCT01745094 (15) [back to overview] | Number for Participants Who Achieved Normalization of the Number of Micturitions Per 24 Hours |
NCT01745094 (15) [back to overview] | Number for Participants Who Achieved Normalization of the Number of Urgency Episodes Per 24 Hours |
NCT01745094 (15) [back to overview] | Change From Baseline in OAB-q SF Total HRQL Score |
NCT01745094 (15) [back to overview] | Change From Baseline in OABSS Total Score |
NCT01745094 (15) [back to overview] | Change From Baseline in the Number of Incontinence Episodes Per 24 Hours |
NCT01745094 (15) [back to overview] | Change From Baseline in the Number of Micturitions Per 24 Hours |
NCT01745094 (15) [back to overview] | Change From Baseline in the Number of Nocturia Episodes Per Night |
NCT01745094 (15) [back to overview] | Change From Baseline in the Number of Urge Incontinence Episodes Per 24 Hours |
NCT01745094 (15) [back to overview] | Change From Baseline in the Number of Urgency Episodes Per 24 Hours |
NCT01745094 (15) [back to overview] | Change From Baseline in the Volume Voided Per Micturition |
NCT01745094 (15) [back to overview] | Number of Participants Who Achieved Normalization for OABSS Total Score |
NCT01745094 (15) [back to overview] | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
NCT01767519 (7) [back to overview] | Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1 |
NCT01767519 (7) [back to overview] | Change From Study Baseline in the Role Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1 |
NCT01767519 (7) [back to overview] | Percentage of Patients With 100% Reduction in Incontinence Episodes in Treatment Cycle 1 |
NCT01767519 (7) [back to overview] | Percentage of Patients With a Positive Response on the Single-Item Treatment Benefit Scale During Treatment Cycle 1 |
NCT01767519 (7) [back to overview] | Change From Study Baseline in the Number of Micturition Episodes in Treatment Cycle 1 |
NCT01767519 (7) [back to overview] | Change From Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1 |
NCT01767519 (7) [back to overview] | Change From Study Baseline in the Social Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1 |
NCT01777217 (1) [back to overview] | Change From Baseline to End of Study Measured by the American Urology Association Symptom Score Questionnaire (AUASS). |
NCT01908829 (36) [back to overview] | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care |
NCT01908829 (36) [back to overview] | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort |
NCT01908829 (36) [back to overview] | Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction |
NCT01908829 (36) [back to overview] | Number of Participants With Adverse Events (AEs) |
NCT01908829 (36) [back to overview] | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) |
NCT01908829 (36) [back to overview] | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression |
NCT01908829 (36) [back to overview] | Number of Pads Used During the 3-Day Diary |
NCT01908829 (36) [back to overview] | Number of Nocturia Episodes Reported Over 3-Day Diary |
NCT01908829 (36) [back to overview] | Number of Incontinence Episodes Reported During the 3-Day Diary |
NCT01908829 (36) [back to overview] | Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours |
NCT01908829 (36) [back to overview] | Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score |
NCT01908829 (36) [back to overview] | Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score |
NCT01908829 (36) [back to overview] | Change From Baseline in Post Void Residual (PVR) Volume |
NCT01908829 (36) [back to overview] | Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours |
NCT01908829 (36) [back to overview] | Change From Baseline in OAB-q HRQL Subscale Score: Sleep |
NCT01908829 (36) [back to overview] | Change From Baseline in OAB-q HRQL Subscale Score: Coping |
NCT01908829 (36) [back to overview] | Change From Baseline in OAB-q HRQL Subscale Score: Concern |
NCT01908829 (36) [back to overview] | Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score |
NCT01908829 (36) [back to overview] | Change From Baseline in Mean Volume Voided (MVV) Per Micturition |
NCT01908829 (36) [back to overview] | Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours |
NCT01908829 (36) [back to overview] | Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours |
NCT01908829 (36) [back to overview] | Change From Baseline in Mean Number of Pads Per 24 Hours |
NCT01908829 (36) [back to overview] | Change From Baseline in Mean Number of Nocturia Episodes |
NCT01908829 (36) [back to overview] | Change From Baseline in Mean Number of Micturitions Per 24 Hours |
NCT01908829 (36) [back to overview] | Change From Baseline to EoT in Corrected Micturition Frequency (CMF) |
NCT01908829 (36) [back to overview] | Change From Baseline in Patient Perception Bladder Control (PPBC) Score |
NCT01908829 (36) [back to overview] | Percentage of Participants With Zero Incontinence Episodes Postbaseline |
NCT01908829 (36) [back to overview] | Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score |
NCT01908829 (36) [back to overview] | Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC |
NCT01908829 (36) [back to overview] | Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours |
NCT01908829 (36) [back to overview] | Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score |
NCT01908829 (36) [back to overview] | Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC |
NCT01908829 (36) [back to overview] | Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline |
NCT01908829 (36) [back to overview] | Number of UI Episodes Reported During the 3-Day Diary |
NCT01908829 (36) [back to overview] | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility |
NCT01908829 (36) [back to overview] | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP) |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC) |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume |
NCT01972841 (70) [back to overview] | Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT |
NCT01972841 (70) [back to overview] | Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT |
NCT01972841 (70) [back to overview] | Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT |
NCT01972841 (70) [back to overview] | Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR) |
NCT01972841 (70) [back to overview] | Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Number of Pads Used at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
NCT01972841 (70) [back to overview] | Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT |
NCT01972841 (70) [back to overview] | Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP) |
NCT01972841 (70) [back to overview] | Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | PGIC Scale: Impression in General Health at Week 12 and EoT |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference |
NCT01972841 (70) [back to overview] | Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment |
NCT01972841 (70) [back to overview] | Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working |
NCT01972841 (70) [back to overview] | Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment |
NCT01972841 (70) [back to overview] | Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed |
NCT01972841 (70) [back to overview] | Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility |
NCT01972841 (70) [back to overview] | Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities |
NCT01972841 (70) [back to overview] | Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care |
NCT01972841 (70) [back to overview] | Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort |
NCT01972841 (70) [back to overview] | Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression |
NCT01972841 (70) [back to overview] | Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS) |
NCT01972841 (70) [back to overview] | Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score |
NCT01972841 (70) [back to overview] | Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window |
NCT01972841 (70) [back to overview] | Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours |
NCT01972841 (70) [back to overview] | Change From Baseline to EoT in Corrected Micturition Frequency |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes |
NCT01972841 (70) [back to overview] | Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours |
NCT01972841 (70) [back to overview] | Change From Baseline to EoT in Mean Volume Voided Per Micturition |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8 and 12 in TS-VAS |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours |
NCT01972841 (70) [back to overview] | Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT |
NCT01981954 (42) [back to overview] | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 |
NCT01981954 (42) [back to overview] | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 |
NCT01981954 (42) [back to overview] | Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 |
NCT01981954 (42) [back to overview] | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 20 cmH20 Detrusor Pressure |
NCT01981954 (42) [back to overview] | Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC) |
NCT01981954 (42) [back to overview] | Change From Baseline to Week 24 and 52 in Infant and Toddler Quality of Life Short Form-47 Questionnaire (ITQoL SF-47) - Overall Health Score |
NCT01981954 (42) [back to overview] | Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Behaviour Score |
NCT01981954 (42) [back to overview] | Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Change in Health Score |
NCT01981954 (42) [back to overview] | Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Family Cohesion Impact Score |
NCT01981954 (42) [back to overview] | Change From Baseline to Week 24 and 52 in ITQoL SF-47 - General Health Score |
NCT01981954 (42) [back to overview] | Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Growth and Development Score |
NCT01981954 (42) [back to overview] | Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Pain Score |
NCT01981954 (42) [back to overview] | Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Parent-Emotional Impact Score |
NCT01981954 (42) [back to overview] | Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Parent-Time Impact Score |
NCT01981954 (42) [back to overview] | Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Physical Abilities Score |
NCT01981954 (42) [back to overview] | Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Temperament and Moods Score |
NCT01981954 (42) [back to overview] | Change From Baseline to Weeks 3, 6, 9, 12 and 52 in MCC |
NCT01981954 (42) [back to overview] | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Compliance |
NCT01981954 (42) [back to overview] | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 10 cmH20 Detrusor Pressure |
NCT01981954 (42) [back to overview] | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 30 cmH20 Detrusor Pressure |
NCT01981954 (42) [back to overview] | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume Until First Detrusor Contraction (> 15 cmH2O) |
NCT01981954 (42) [back to overview] | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Catheterized Volume 5 Minutes After End of Bladder-Filling |
NCT01981954 (42) [back to overview] | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure 5 Minutes After End of Bladder-Filling |
NCT01981954 (42) [back to overview] | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure at End of Bladder-Filling |
NCT01981954 (42) [back to overview] | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until Leakage or End of Bladder-Filling |
NCT01981954 (42) [back to overview] | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average Catheterized Volume Per Catheterization |
NCT01981954 (42) [back to overview] | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average First Morning Catheterized Volume |
NCT01981954 (42) [back to overview] | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Maximum Catheterized Volume (MCV) |
NCT01981954 (42) [back to overview] | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Mean Number of Periods Between the Clean Intermittent Catheterizations (CICs) With Incontinence Per 24 Hours |
NCT01981954 (42) [back to overview] | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline |
NCT01981954 (42) [back to overview] | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 |
NCT01981954 (42) [back to overview] | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 |
NCT01981954 (42) [back to overview] | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 |
NCT01981954 (42) [back to overview] | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 |
NCT01981954 (42) [back to overview] | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 |
NCT01981954 (42) [back to overview] | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 |
NCT01981954 (42) [back to overview] | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 |
NCT01981954 (42) [back to overview] | Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline |
NCT01981954 (42) [back to overview] | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 |
NCT01981954 (42) [back to overview] | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 |
NCT01981954 (42) [back to overview] | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 |
NCT01981954 (42) [back to overview] | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed |
NCT02045862 (53) [back to overview] | Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment |
NCT02045862 (53) [back to overview] | Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT) |
NCT02045862 (53) [back to overview] | Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping |
NCT02045862 (53) [back to overview] | Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT |
NCT02045862 (53) [back to overview] | Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT |
NCT02045862 (53) [back to overview] | Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT |
NCT02045862 (53) [back to overview] | Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT |
NCT02045862 (53) [back to overview] | Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT |
NCT02045862 (53) [back to overview] | Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT |
NCT02045862 (53) [back to overview] | Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT |
NCT02045862 (53) [back to overview] | Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT |
NCT02045862 (53) [back to overview] | Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT |
NCT02045862 (53) [back to overview] | Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Months 1, 3, 6, 9, 12 and EoT |
NCT02045862 (53) [back to overview] | Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Months 1, 3, 6, 9, 12 and EoT |
NCT02045862 (53) [back to overview] | Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT |
NCT02045862 (53) [back to overview] | Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT |
NCT02045862 (53) [back to overview] | Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours |
NCT02045862 (53) [back to overview] | Change From Baseline to EoT in the Patient's Assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS) |
NCT02045862 (53) [back to overview] | Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score |
NCT02045862 (53) [back to overview] | Change From Baseline to EoT in Mean Volume Voided Per Micturition |
NCT02045862 (53) [back to overview] | Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours |
NCT02045862 (53) [back to overview] | Change From Baseline to EoT in Corrected Micturition Frequency |
NCT02045862 (53) [back to overview] | Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours |
NCT02045862 (53) [back to overview] | Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT |
NCT02045862 (53) [back to overview] | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
NCT02045862 (53) [back to overview] | Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit |
NCT02045862 (53) [back to overview] | Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit |
NCT02045862 (53) [back to overview] | Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit |
NCT02045862 (53) [back to overview] | Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC) |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume |
NCT02047032 (12) [back to overview] | Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12 |
NCT02047032 (12) [back to overview] | Change of Episodes From Baseline in Mean 72-h Incontinence Episodes |
NCT02047032 (12) [back to overview] | Patient's Treatment Satisfaction Degree |
NCT02047032 (12) [back to overview] | Patient Global Impression Improvement |
NCT02047032 (12) [back to overview] | Weekly Median Number of Urine Pads Used During Weeks 1-12, 13-24, and 25-36 |
NCT02047032 (12) [back to overview] | The Number of Participants Using Urine Pads |
NCT02047032 (12) [back to overview] | the Amount of Urine Leakage (Grams) Measured by the 1-hour Pad Test at Weeks 4 and 12 |
NCT02047032 (12) [back to overview] | Percentage of Participants With ≥50% Decrease in Average 72-h Incontinence Episode Frequency |
NCT02047032 (12) [back to overview] | Percentage of Change From Baseline in Mean 72-hour IEF During Weeks 13-24 and Weeks 25-36 |
NCT02047032 (12) [back to overview] | Electroacupuncture Acceptance Assessment |
NCT02047032 (12) [back to overview] | Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes |
NCT02047032 (12) [back to overview] | Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score |
NCT02294396 (16) [back to overview] | Number for Participants Who Achieved Normalization of the Mean Number of Incontinence Episodes Per 24 Hours |
NCT02294396 (16) [back to overview] | Number for Participants Who Achieved Normalization of the Mean Number of Micturitions Per 24 Hours |
NCT02294396 (16) [back to overview] | Number for Participants Who Achieved Normalization of the Mean Number of Urgency Episodes Per 24 Hours |
NCT02294396 (16) [back to overview] | Number of Participants Who Achieved Normalization for OABSS Total Score |
NCT02294396 (16) [back to overview] | Number of Participants Who Achieved Normalization of the Mean Number of Nocturia Episodes Per 24 Hours |
NCT02294396 (16) [back to overview] | Change From Baseline in OAB-q SF Total HRQL Score |
NCT02294396 (16) [back to overview] | Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Symptom Severity Score |
NCT02294396 (16) [back to overview] | Change From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score |
NCT02294396 (16) [back to overview] | Change From Baseline in Postvoid Residual (PVR) Volume |
NCT02294396 (16) [back to overview] | Change From Baseline in the Mean Number of Incontinence Episodes Per 24 Hours |
NCT02294396 (16) [back to overview] | Change From Baseline in the Mean Number of Micturitions Per 24 Hours |
NCT02294396 (16) [back to overview] | Change From Baseline in the Mean Number of Nocturia Episodes Per Night |
NCT02294396 (16) [back to overview] | Change From Baseline in the Mean Number of Urge Incontinence Episodes Per 24 Hours |
NCT02294396 (16) [back to overview] | Change From Baseline in the Mean Number of Urgency Episodes Per 24 Hours |
NCT02294396 (16) [back to overview] | Change From Baseline in the Mean Volume Voided Per Micturition |
NCT02294396 (16) [back to overview] | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
NCT02549196 (2) [back to overview] | Number of Participants Who Reached the Maximum Allowed Dose (MAD) in Their Respective Cohort |
NCT02549196 (2) [back to overview] | Number of Participants With TEAEs Leading to Study Drug Discontinuation |
NCT04090190 (2) [back to overview] | The Effectiveness of Anticholinergic Treatment in Relation to the Urinary Microbiome. Culture to Standard Culture Media Will Pickup Aerobic Bacteria and Yeasts After DNA Extraction and End Point PCR for 16S rDNA Genes. |
NCT04090190 (2) [back to overview] | Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu. |
Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary
"Subjects were instructed to complete the diary in the 3 day period immediately preceding the visit. Subjects recorded each urgency episode or instance of strong desire to pass urine.~The mean was calculated for each time point as the average of the day 1-3 measurements from the associated 3 day diary. Change from Baseline was calculated as Week 8- Baseline." (NCT00431041)
Timeframe: Baseline and 8 weeks
Intervention | urgency episodes per day (Mean) |
---|
| Change in urgency episodes at 8 weeks (N=52; 40) | Urgency episodes at Baseline (N= 68; 64) | Urgency episodes at 8 weeks (N=52; 40) |
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Oxybutynin IR | -3.70 | 6.6 | 2.1 |
,Solifenacin | -2.65 | 6.3 | 3.8 |
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The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event
The number of subjects reporting incidence of dry mouth as an adverse event (AE) following direct questioning at each patient follow-up visit (NCT00431041)
Timeframe: 8 weeks
Intervention | participants (Number) |
---|
Solifenacin | 24 |
Oxybutynin IR | 53 |
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Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary
"Subjects were instructed to complete the diary in the 3 day period immediately proceding the visit. Subjects recorded each micturition or instance of passing urine in the toliet.~The mean was calculated for each time point as the average of the day 1-3 measurements from the associated 3 day diary. Change from baseline was calculated as Week 8- Baseline." (NCT00431041)
Timeframe: Baseline and 8 Weeks
Intervention | Micturitions per day (Mean) |
---|
| Change in micturition frequency at 8 wks(N=52; 40) | Micturition frequency at Baseline (N=68; 64) | Micturition frequency at 8 weeks (N=52; 40) |
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Oxybutynin IR | -3.1 | 12.5 | 9.0 |
,Solifenacin | -2.3 | 12.4 | 9.9 |
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The Severity of Dry Mouth Reported as an Adverse Event
"The number of subjects reporting dry mouth at each severity level when dry mouth was reported as an Adverse Event (AE).~Dry mouth severity was categorized as mild (relieved with fluid/hard candy), moderate (dry mouth and throat with no difficulty swallowing solid food/water) & severe (very dry mouth & throat, difficulty swallowing solid food without water)" (NCT00431041)
Timeframe: 8 weeks
Intervention | participants (Number) |
---|
| Mild | Moderate | Severe |
---|
Oxybutynin IR | 16 | 22 | 15 |
,Solifenacin | 18 | 3 | 3 |
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Change From Baseline in IPSS Storage Score
"The IPSS is a validated global questionnaire used to assess the degree of bother from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 questions relating to storage symptoms (frequency, urgency and nocturia) and ranges from 0 to 15 (asymptomatic to very symptomatic).~Least squares (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 2, 4, 8 and 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 2 (N=62, 67, 58) | Week 4 (N=60, 66, 58) | Week 8 (N=58, 67, 58) | Week 12 (N=58, 63, 57) | End of Treatment (N=62, 67, 59) |
---|
6 mg Solifenacin + 0.4 mg Tamsulosin | -1.6 | -2.6 | -2.8 | -3.3 | -3.4 |
,9 mg Solifenacin + 0.4 mg Tamsulosin | -2.1 | -2.5 | -3.1 | -3.1 | -3.0 |
,Placebo | -1.5 | -2.1 | -2.7 | -2.8 | -2.7 |
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Change From Baseline in IPSS Voiding Score
"The IPSS is a validated global questionnaire used to assess the degree of bother from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 questions relating to urination (incomplete emptying, intermittency, weak stream and straining) and ranges from 0 to 20 (asymptomatic to very symptomatic).~Least squares (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 2, 4, 8 and 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 2 (N=61, 67, 58) | Week 4 (N=60, 65, 57) | Week 8 (N=58, 67, 57) | Week 12 (N=58, 64, 57) | End of Treatment (N=62, 67, 59) |
---|
6 mg Solifenacin + 0.4 mg Tamsulosin | -2.9 | -3.8 | -4.3 | -4.7 | -4.6 |
,9 mg Solifenacin + 0.4 mg Tamsulosin | -2.6 | -3.6 | -3.8 | -4.1 | -3.9 |
,Placebo | -2.2 | -3.2 | -4.1 | -4.0 | -3.9 |
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Change From Baseline in Number of Incontinence Episodes Per 24 Hours
"The mean number of incontinence episodes (the involuntary leakage of urine) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 2, 4, 8 and 12
Intervention | incontinence episodes (Least Squares Mean) |
---|
| Week 2 (N=13, 10, 13) | Week 4 (N=13, 10, 13) | Week 8 (N=12, 10, 12) | Week 12 (N=12, 9, 12) | End of Treatment (N=13, 10, 13) |
---|
6 mg Solifenacin + 0.4 mg Tamsulosin | -1.45 | -1.45 | -1.55 | -1.48 | -1.66 |
,9 mg Solifenacin + 0.4 mg Tamsulosin | -1.01 | -0.81 | -0.78 | -0.85 | -1.02 |
,Placebo | -0.81 | -1.00 | -1.86 | -1.99 | -1.54 |
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Change From Baseline in Number of Micturitions Per 24 Hours
"A micturition is any voluntary urination, excluding episodes of incontinence only. The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 2, 4, 8 and 12
Intervention | micturitions (Least Squares Mean) |
---|
| Week 2 (N=60, 67, 59) | Week 4 (N=60, 65, 58) | Week 8 (N=58, 67, 58) | Week 12 (N=58, 65, 58) | End of Treatment (N=60, 67, 59) |
---|
6 mg Solifenacin + 0.4 mg Tamsulosin | -1.25 | -1.32 | -1.31 | -1.91 | -1.91 |
,9 mg Solifenacin + 0.4 mg Tamsulosin | -1.19 | -1.72 | -2.00 | -1.89 | -1.87 |
,Placebo | -0.44 | -1.03 | -1.33 | -1.07 | -0.95 |
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Change From Baseline in Number of Urgency Episodes Per 24 Hours
"For each micturition and/or incontinence episode participants rated the degree of associated urgency (the sudden compelling desire to pass urine, which is difficult to defer) according to the following scale: 0: No Urgency, felt no need to empty my bladder but did so for another reason; 1: Mild urgency, could postpone passing water for as long as necessary; 2: Moderate urgency, could postpone passing water for a short while; 3: Severe urgency, could not postpone passing water; 4: Urge incontinence, leaked before reaching the toilet. An urgency episode is defined as an episode with urgency severity of three or higher.~The mean number of urgency episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 2, 4, 8 and 12
Intervention | urgency episodes (Least Squares Mean) |
---|
| Week 2 (N=60, 67, 59) | Week 4 (N=60, 65, 58) | Week 8 (N=58, 67, 58) | Week 12 (N=58, 65, 58) | End of Treatment (N=60, 67, 59) |
---|
6 mg Solifenacin + 0.4 mg Tamsulosin | -0.89 | -1.39 | -1.34 | -1.54 | -1.45 |
,9 mg Solifenacin + 0.4 mg Tamsulosin | -0.95 | -1.34 | -1.08 | -1.18 | -1.23 |
,Placebo | -0.59 | -1.18 | -1.45 | -1.47 | -1.41 |
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Change From Baseline in Patient Perception of Bladder Condition (PPBC)
"The patient perception of bladder condition (PPBC) questionnaire asks participants to assess their bladder condition using a 6-point validated Likert scale which ranges from 1 (does not cause me any problems at all) to 6 (causes me many severe problems).~Least squares (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 2, 4, 8 and 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 2 (N=61, 66, 58) | Week 4 (N=60, 66, 58) | Week 8 (N=58, 67, 58) | Week 12 (N=58, 64, 57) | End of Treatment (N=62, 67, 59) |
---|
6 mg Solifenacin + 0.4 mg Tamsulosin | -0.3 | -0.5 | -0.8 | -1.0 | -0.9 |
,9 mg Solifenacin + 0.4 mg Tamsulosin | -0.5 | -0.9 | -1.1 | -1.1 | -1.1 |
,Placebo | -0.5 | -0.7 | -1.0 | -1.1 | -1.1 |
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Change From Baseline in Post Void Residual Volume (PVR)
"Healthy micturitions result in complete emptying of the bladder. Post Void Residual (PVR) is the volume of urine retained after voiding (post-void residual urine). Post void residual volume was assessed by abdominal ultrasound. An increasing PVR over time is an indicator of abnormal bladder function or detrusor decompensation.~End-of-treatment is the last post-baseline assessment during the treatment period.~Least squares (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 2, 4, 8 and 12
Intervention | mL (Least Squares Mean) |
---|
| Week 2 (N=61, 67, 58) | Week 4 (N=60, 67, 59) | Week 8 (N=58, 66, 58) | Week 12 (N=57, 63, 57) | End of Treatment (N=62, 67, 59) |
---|
6 mg Solifenacin + 0.4 mg Tamsulosin | 16.78 | 14.92 | 9.64 | 26.81 | 25.63 |
,9 mg Solifenacin + 0.4 mg Tamsulosin | 8.97 | 9.65 | 6.64 | 18.72 | 19.07 |
,Placebo | -10.21 | -7.86 | -12.44 | 1.16 | 0.14 |
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Change From Baseline in Volume Voided Per Micturition
"The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 2, 4, 8 and 12
Intervention | mL (Least Squares Mean) |
---|
| Week 2 (N=60, 67, 59) | Week 4 (N=60, 65, 58) | Week 8 (N=58, 67, 58) | Week 12 (N=58, 65, 58) | End of Treatment (N=60, 67, 59) |
---|
6 mg Solifenacin + 0.4 mg Tamsulosin | 31.46 | 35.27 | 33.72 | 35.02 | 36.26 |
,9 mg Solifenacin + 0.4 mg Tamsulosin | 18.25 | 30.34 | 35.53 | 31.18 | 30.33 |
,Placebo | 9.36 | 10.40 | 10.50 | 9.03 | 7.56 |
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Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests
Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild (no disruption of normal daily activities), moderate (affected normal daily activities) or severe (inability to perform daily activities) and for causal relationship to study drug. (NCT00507455)
Timeframe: From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
Intervention | participants (Number) |
---|
| Any adverse event | Mild adverse event | Moderate adverse event | Severe adverse event | Serious adverse event | AE leading to study drug discontinuation | Drug-related adverse events | Deaths |
---|
6 mg Solifenacin + 0.4 mg Tamsulosin | 38 | 21 | 13 | 4 | 2 | 3 | 24 | 0 |
,9 mg Solifenacin + 0.4 mg Tamsulosin | 37 | 20 | 12 | 5 | 2 | 6 | 26 | 0 |
,Placebo | 29 | 21 | 6 | 2 | 1 | 3 | 15 | 0 |
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Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score
"The degree to which urinary symptoms bothered participants was assessed by the ICIQ MLUTS questionnaire which consists of 13 symptom bother questions. Each question is answered by the participant on a scale from 0 (not at all) to 10 (a great deal). The total bother score ranges from 0 to 130, where larger scores correspond to worse outcomes.~Least squares (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 (N=52, 57, 48) | Week 8 (N=51, 55, 47) | Week 12 (N=51, 51, 47) | End of Treatment (N=58, 60, 53) |
---|
6 mg Solifenacin + 0.4 mg Tamsulosin | -11.0 | -19.4 | -23.9 | -21.1 |
,9 mg Solifenacin + 0.4 mg Tamsulosin | -17.0 | -20.7 | -23.9 | -22.4 |
,Placebo | -14.6 | -20.7 | -22.6 | -21.7 |
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Change From Baseline in ICIQ-LUTSqol Overall Symptom Interference of Life Score
"Participants were asked to rate how much their urinary symptoms interfered overall with their everyday life on a scale from 0 (not at all) to 10 (a great deal).~Least squares (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 (N=57, 66, 56) | Week 8 (N=56, 65, 55) | Week 12 (N=56, 63, 55) | End of Treatment (N=60, 66, 57) |
---|
6 mg Solifenacin + 0.4 mg Tamsulosin | -1.2 | -1.7 | -2.0 | -1.9 |
,9 mg Solifenacin + 0.4 mg Tamsulosin | -1.3 | -1.8 | -2.2 | -2.1 |
,Placebo | -1.2 | -1.7 | -2.1 | -2.0 |
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Change From Baseline to End of Treatment in Percent Bladder Voiding Efficiency (BVE)
"Percent Bladder Voiding Efficiency (BVE) is a product of bladder contractility against the urethral resistance and is measured according to the degree of bladder emptying. BVE is expressed as a percentage and is calculated using the formula:~Bladder Voiding efficiency = (Voided volume x 100)/maximum cystometric capacity.~A higher number indicates a higher voiding efficiency.~LS means were adjusted for pooled center and Baseline value." (NCT00507455)
Timeframe: Baseline and Week 12
Intervention | Percent voiding efficiency (Least Squares Mean) |
---|
Placebo | -0.67 |
6 mg Solifenacin + 0.4 mg Tamsulosin | -1.38 |
9 mg Solifenacin + 0.4 mg Tamsulosin | -3.79 |
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Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
The maximum flow rate (Qmax) during a micturition (urination) was recorded using uroflowmetry. A reduction in maximum flow rate may be due to an obstruction of the bladder outlet or a failure of the detrusor muscle to aid in expelling urine. (NCT00507455)
Timeframe: Baseline and Week 12
Intervention | mL/sec (Least Squares Mean) |
---|
Placebo | 0.17 |
6 mg Solifenacin + 0.4 mg Tamsulosin | 1.85 |
9 mg Solifenacin + 0.4 mg Tamsulosin | 2.35 |
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Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)
Detrusor pressure (Pdet) measures the force the detrusor muscle is exerting. This pressure is required to expel urine from the bladder during normal voiding. A high detrusor pressure may be observed in the presence of outflow tract obstruction. Detrusor pressure at maximum urinary flow rate (PdetQmax) was evaluated using simultaneous recording of urinary voiding by an uroflowmeter during detrusor pressure evaluation by cystometry. (NCT00507455)
Timeframe: Baseline and Week 12
Intervention | cmH2O (Least Squares Mean) |
---|
Placebo | -1.69 |
6 mg Solifenacin + 0.4 mg Tamsulosin | -7.84 |
9 mg Solifenacin + 0.4 mg Tamsulosin | -6.69 |
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Change From Baseline to End of Treatment in Bladder Contractility Index (BCI)
"The Bladder Contractility Index (BCI) is a value used to measure the degree of contractility. BCI was calculated using the following formula:~BCI = pdetQmax + 5Qmax.~Strong contractility is a BCI > 150, normal contractility is a BCI of 100-150 and weak contractility is a BCI of < 100.~LS means were adjusted for pooled center and Baseline value." (NCT00507455)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | -1.63 |
6 mg Solifenacin + 0.4 mg Tamsulosin | 1.84 |
9 mg Solifenacin + 0.4 mg Tamsulosin | 3.86 |
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Change From Baseline in International Prostate Symptoms Score (IPSS)
"The IPSS is a validated global questionnaire used to assess the degree of bother from benign prostatic hyperplasia symptoms and is based on the answers to 7 questions concerning urinary symptoms:~Sensation of incomplete emptying~Repeat urinating after 2 hours (frequency)~Start and stop several times (intermittency)~Urgency~Weak stream~Straining~Nocturia~Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).~Least squares (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 2, 4, 8 and 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 2 (N=61, 67, 58) | Week 4 (N=60, 65, 57) | Week 8 (N=58, 67, 57) | Week 12 (N=58, 63, 57) | End of Treatment (N=62, 67, 59) |
---|
6 mg Solifenacin + 0.4 mg Tamsulosin | -4.5 | -6.4 | -7.1 | -7.9 | -8.0 |
,9 mg Solifenacin + 0.4 mg Tamsulosin | -4.7 | -6.2 | -6.9 | -7.2 | -6.9 |
,Placebo | -3.8 | -5.3 | -6.8 | -6.9 | -6.6 |
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Change From Baseline in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score
"Male lower urinary tract symptoms were assessed by the ICIQ MLUTS questionnaire which consists of 13 questions regarding urinary symptoms. Each question is answered by the participant on a scale from 0 (never) to 4 (all the time). The total symptom score ranges from 0 to 52, where larger scores correspond to worse conditions.~Least squares (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 (N=58, 66, 52) | Week 8 (N=55, 63, 53) | Week 12 (N=55, 61, 53) | End of Treatment (N=60, 66, 57) |
---|
6 mg Solifenacin + 0.4 mg Tamsulosin | -4.5 | -5.6 | -6.5 | -6.0 |
,9 mg Solifenacin + 0.4 mg Tamsulosin | -4.6 | -5.8 | -5.9 | -5.8 |
,Placebo | -3.9 | -5.5 | -5.5 | -5.2 |
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Change From Baseline in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score
"Quality of life was assessed by the ICIQ-LUTSqol questionnaire which consists of 19 questions regarding daily activities affected by urinary problems. Participants responded to each question on a scale from 1 (not at all) to 4 (a lot). The total symptom score ranges from 19 to 76, where larger scores correspond to a lesser quality of life).~Least squares (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 (N=33, 36, 36) | Week 8 (N=33, 32, 31) | Week 12 (N=35, 33, 28) | End of Treatment (N=39, 39, 38) |
---|
6 mg Solifenacin + 0.4 mg Tamsulosin | -2.4 | -4.3 | -6.5 | -5.3 |
,9 mg Solifenacin + 0.4 mg Tamsulosin | -5.1 | -6.7 | -8.4 | -7.3 |
,Placebo | -2.7 | -3.6 | -4.8 | -4.7 |
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Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score
"The OAB-q is used to assess how much a patient is bothered by OAB symptoms and the impact of these symptoms on the patient's HRQL. It is a validated patient administered tool comprised of 33 items, where the first 8 items define symptom bother with raw score being converted to a scale of 0 to 100.~Higher score values are indicative of greater symptom severity or bother, and a lower score in change from baseline indicates improvement.~Change is calculated as Actual Data for each timepoint - Baseline." (NCT00573508)
Timeframe: Baseline, Week 4, Week 8 and Week 12
Intervention | OAB-q Score (Mean) |
---|
| Baseline ( N= 374 ; 377) | Week 4 (N=371; 370) | Change at Week 4 (N=371; 370) | Week 8 (N=342; 356) | Change at Week 8 (N=342; 356) | Week 12 (N=318; 339) | Change at Week 12 (N=318; 339) |
---|
Placebo | 57.9 | 41.6 | -16.4 | 37.0 | -21.0 | 36.0 | -21.7 |
,Solifenacin Succinate | 58.2 | 35.5 | -22.6 | 29.8 | -28.9 | 27.6 | -30.9 |
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Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social
"The OAB-q is used to assess how much a patient is bothered by OAB symptoms & the impact on the patient's HRQL. It is comprised of 33 items, with raw scores for each sub-domain being converted to a scale of 0 to 100.~Higher score values are indicative of better HRQL, and a positive score in change from baseline indicates improvement.~Change is calculated End of Treatment (EOT) for each sub-domain - Baseline." (NCT00573508)
Timeframe: Baseline, Week 4, Week 8 and Week 12
Intervention | OAB-q HRQL Sub Domain Score (Mean) |
---|
| Coping- Baseline (N= 374 ; 377) | Coping- Change at Week 4 (N=371; 370) | Coping- Change at Week 8 (N=342; 356) | Coping- Change at Week 12 (N=318; 339) | Concern- Baseline (N= 374 ; 377) | Concern- Change at Week 4 (N=371; 370) | Concern- Change at Week 8 (N=342; 356) | Concern- Change at Week 12 (N=318; 339) | Sleep- Baseline (N= 374 ; 377) | Sleep- Change at Week 4 (N=371; 370) | Sleep- Change at Week 8 (N=342; 356) | Sleep- Change at Week 12 (N=318; 339) | Social- Baseline (N= 374 ; 377) | Social- Change at Week 4 (N=371; 370) | Social- Change at Week 8 (N=340; 356) | Social- Change at Week 12 (N=318; 339) |
---|
Placebo | 53.7 | 14.9 | 18.9 | 19.9 | 52.0 | 15.8 | 19.8 | 20.9 | 51.3 | 13.9 | 18.7 | 19.0 | 78.9 | 7.8 | 9.4 | 10.0 |
,Solifenacin Succinate | 52.2 | 22.2 | 27.0 | 28.8 | 51.9 | 22.4 | 28.4 | 29.9 | 47.3 | 19.3 | 26.2 | 27.5 | 78.7 | 10.3 | 13.1 | 13.7 |
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Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores.
"ICIQ-MLUTSsex is a patient reported outcome instrument to further evaluate the effect of solifenacin succinate on patients' overall satisfaction & quality of life. The questionnaire contains 5 questions for detailed evaluation of sexual matters associated with lower urinary track symptoms & impact on sexual quality of life, with a scale of 0 to 12.~Change from baseline with a negative score indicates improvement. End of Treatment results include patients who had early discontinuation. Change is calculated as End of Treatment(EOT)-Baseline." (NCT00573508)
Timeframe: Baseline and 12 Weeks
Intervention | ICIQ-MLUTSsex (Mean) |
---|
| Symptom- Baseline (N=59; 71) | Symptom- EOT (N=55; 68) | Symptom- Change at EOT (N=54; 68) | Bother- Baseline (N=59; 71) | Bother- EOT (N=51; 67) | Bother- Change at EOT (N=50; 67) |
---|
Placebo | 3.6 | 3.2 | -0.1 | 12.1 | 10.3 | -1.6 |
,Solifenacin Succinate | 3.5 | 3.7 | 0.1 | 11.8 | 11.4 | -0.6 |
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Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score
"The OAB-q is used to assess how much a patient is bothered by OAB symptoms & the impact of these symptoms on the patient's Health Related Quality of Life(HRQL). It is a patient administered tool comprised of 33 items, where the first 8 define symptom bother with raw score being converted to a scale of 0 to 100.~Higher score values are indicative of greater symptom severity or bother, and a lower score in change from baseline indicates improvement.~End of Treatment results include patients who had early discontinuation from the study.~Change is calculated as End of Treatment - Baseline." (NCT00573508)
Timeframe: Baseline and 12 Weeks
Intervention | OAB-q Score (Mean) |
---|
| Baseline | End of Treatment | Change at End of Treatment |
---|
Placebo | 57.9 | 37.5 | -20.4 |
,Solifenacin Succinate | 58.2 | 28.3 | -29.9 |
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Number of Participants With Change From Baseline in the Global Assessment Score of the Patient Perception of Bladder Condition (PPBC)
"The PPBC is a validated, global assessment tool using a 6-point Likert scale which requires patients to assess their bladder condition by selecting one of the following responses: 1=Does not cause me any problem at all; 2=Cause me some very minor problems; 3=Causes me some minor problems; 4=Causes me (some) moderate problems; 5=Causes me severe problems; 6=Causes me many severe problems~Improvement is defined by any reduction in PPBC score.~End of Treatment results include patients who had early discontinuation from the study.~Change is calculated as End of Treatment (EOT) - Baseline" (NCT00573508)
Timeframe: Baseline and 12 Weeks
Intervention | Participants (Number) |
---|
| Improvement from Baseline to End of Treatment | No Improvement from Baseline to End of Treatment |
---|
Placebo | 231 | 131 |
,Solifenacin Succinate | 278 | 90 |
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Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire
The BSW questionnaire is a validated instrument that can be used to assess patient satisfaction with antimuscarinic agents for OAB. It is designed to capture the patient's perception of the effect of treatment in terms of relative benefit, patient satisfaction, and patient intention or willingness to continue on therapy. (NCT00573508)
Timeframe: Baseline and 12 Weeks
Intervention | Participants (Number) |
---|
| Benefit from Treatment - No | Benefit from Treatment - Little | Benefit from Treatment - Much | Benifit from Treatment - N/A | Satisfied with Treatment - No | Satisfied with Treatment - Yes | Willingness to Continue - No | Willingness to Continue - Yes |
---|
Placebo | 115 | 90 | 109 | 2 | 129 | 187 | 128 | 188 |
,Solifenacin Succinate | 53 | 80 | 196 | 6 | 66 | 269 | 71 | 264 |
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Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores.
"ICIQ-FLUTSsex is a patient reported outcome instrument to further evaluate the effect of solifenacin succinate on patients' overall satisfaction & quality of life.The questionnaire contains 5 questions for detailed evaluation of sexual matters associated with lower urinary track symptoms & impact on sexual quality of life, with a scale of 0 to 14.~Change from baseline with a negative score indicates improvement. End of Treatment results include patients who had early discontinuation. Change is calculated as End of Treatment(EOT)-Baseline." (NCT00573508)
Timeframe: Baseline and 12 Weeks
Intervention | ICIQ-FLUTSsex (Mean) |
---|
| Symptom- Baseline (N=302; 300) | Symptom- EOT (N=297; 291) | Symptom- Change at EOT (N=288; 288) | Bother- Baseline (N=281; 282) | Bother- EOT (N=263; 262) | Bother- Change at EOT (N=245; 249) |
---|
Placebo | 4.9 | 3.9 | -0.9 | 9.0 | 6.1 | -3.1 |
,Solifenacin Succinate | 5.2 | 3.8 | -1.3 | 10.0 | 6.6 | -3.6 |
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Change From Baseline in the MCUI Behavior Therapy Stratified
"MCUI is a Patient Reported Outcome instrument utilized to further evaluate the effect of solifenacin succinate on patient's overall satisfaction and quality of life. The tool included questions concerning the effect of the patients bladder condition on access to medical care.~A negative score in Change from Baseline indicates improvement.~End of Treatment results include patients who had early discontinuation from the study.~Change is calculated as End of Treatment (EOT) - Baseline" (NCT00573508)
Timeframe: Baseline and 12 Weeks
Intervention | Number of Days (Mean) |
---|
| days with timed voiding- Baseline (N=364; 365) | days with timed voiding- EOT (N=356; 360) | days with timed voiding-Change at EOT(N=347; 350) | days with fluid management-Baseline(N=368; 369) | days with fluid management- EOT (N=355; 366) | days with fluid management-Change at EOT(349; 360) | days w/ pelvic floor exercises-Baseline(364; 366) | days w/ pelvic floor exercises- EOT (N=352; 358) | days w/pelvic flr exercises-Change atEOT(344; 349) | days with biofeedback- Baseline (N=359; 360) | days with biofeedback- EOT (N=352; 358) | days with biofeedback- Change at EOT (N=338; 343) | days w/ electrical stimulation-Baseline (358; 362) | days w/ electrical stimulation- EOT (N=352; 358) | days w/ elec stimulation-Change at EOT(N=337; 345) |
---|
Placebo | 14.8 | 10.3 | -4.0 | 21.3 | 15.1 | -6.3 | 8.5 | 12.1 | 3.4 | 0.4 | 0.0 | -0.4 | 0.0 | 0.0 | 0.0 |
,Solifenacin Succinate | 12.1 | 7.4 | -5.3 | 22.1 | 11.5 | -11.0 | 9.2 | 5.5 | -3.2 | 0.1 | 0.0 | 0.0 | 0.1 | 0.1 | 0.0 |
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Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months
"MCUI is a Patient Reported Outcome instrument utilized to further evaluate the effect of solifenacin succinate on patient's overall satisfaction and quality of life.The tool included questions concerning the effect of the patients bladder condition on access to medical care.~A negative score in Change from Baseline indicates improvement.~End of Treatment results include patients who had early discontinuation from the study.~Change is calculated as End of Treatment (EOT) - Baseline" (NCT00573508)
Timeframe: Baseline and 12 Weeks
Intervention | Number of categorical items (Mean) |
---|
| physician office visits- Baseline (N=371; 375) | physician office visits- EOT (N=362; 366) | physician office visits- Change at EOT(359; 365) | urinary tract infections-Baseline (N=371; 370) | urinary tract infections- EOT (N=358; 362) | urinary tract infections-Change at EOT (355; 356) | skin rashes- Baseline (N=367; 368) | skin rashes- EOT (N=354; 357) | skin rashes- Change at EOT (N=347; 351) | falls- Baseline (N=365; 364) | falls- EOT (N=356; 358) | falls- Change at EOT (N=347; 349) | pad/diapers used/ week- Baseline (N=371; 375) | pad/diapers used/ week- EOT (N=360; 364) | pad/diapers used/ week- Change at EOT(N=357; 362) |
---|
Placebo | 0.5 | 0.2 | -0.4 | 0.1 | 0.1 | -0.1 | 1.5 | 1.0 | 0.0 | 0.2 | 0.1 | -0.1 | 10.0 | 9.8 | -0.2 |
,Solifenacin Succinate | 0.5 | 0.2 | -0.3 | 0.1 | 0.1 | 0.0 | 0.3 | 0.2 | -0.1 | 0.2 | 0.5 | 0.2 | 10.4 | 8.3 | -2.1 |
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Change From Baseline in the Treatment Satisfaction Visual Analog Scale (TS-VAS)
"The TS-VAS is a instrument utilized to further evaluate the effect of solifenacin succinate on patients' overall satisfaction & quality of life. Each patient completed a TS-VAS to rate satisfaction with treatment. They were to answer the following question: Are you satisfied with your treatment? by placing a mark on a line that ran from 0 (no, not at all) to 100 (yes, completely).~Change from baseline with a positive score indicates an improvement. The End of Treatment (EOT) results include patients who had early discontinuation from the study.~Change is calculated as EOT - Baseline" (NCT00573508)
Timeframe: Baseline and 12 Weeks
Intervention | TS-VAS (Mean) |
---|
| Baseline (N=363; 367) | End of Treatment (N=363; 367) | Change at EOT (N=352; 357) |
---|
Placebo | 32.7 | 51.2 | 18.4 |
,Solifenacin Succinate | 29.0 | 67.4 | 38.2 |
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Change From Baseline in Work Productivity Assessment Index (WPAI)
"The WPAI is a tool used to evaluate the effect of solifenacin succinate on a patient's overall satisfaction & quality of life, and included 6 questions regarding the effect that bladder condition had on ability to perform work-related functions & carry out daily activities over the past 4 weeks. The scores were converted to percentages for reporting.~A negative score in Change from Baseline indicates improvement. End of Treatment results include patients who had early discontinuation from the study.~Change from baseline is based on the ANCOVA model after adjusting baseline value & center." (NCT00573508)
Timeframe: Baseline and 12 Weeks
Intervention | Percentage of indicated parameter (Mean) |
---|
| % work time missed- Baseline (N=175;175) | % work time missed- EOT (N=161;157) | % work time missed- Change at EOT (N=145;142) | % impairment while working- Baseline(N=203;194) | % impairment while working- EOT (N=193;197) | % impairment working-Change at EOT(N=172;175) | % overall work impairment- Baseline (N=174;175) | % overall work impairment- EOT (N=161;157) | %overall work impairment-Change at EOT(N=145;142) | %activity impairment- Baseline (N=368;375) | % activity impairment- EOT (N=357;362) | % activity impairment- Change at EOT(N=351;360) |
---|
Placebo | 1.4 | 0.8 | 0.1 | 27.5 | 18.4 | -8.7 | 28.5 | 20.8 | -8.2 | 38.6 | 23.4 | -14.7 |
,Solifenacin Succinate | 1.1 | 0.5 | -0.5 | 27.6 | 13.2 | -14.6 | 28.2 | 14.1 | -12.9 | 37.3 | 19.2 | -18.1 |
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Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary
"The mean parameters recorded for previous 24 hours in the 3-day diary were: number of micturitions, number of incontinence episodes, number of urgency episodes, number of nocturia episodes and number of nocturnal voids.~Change from baseline with a lower score indicates an improvement.~End of Treatment (EOT) results include patients who had early discontinuation from the study; only patients who had the symptom at baseline and data at the EOT in the 3-day diary are included in the data table.~Change is calculated as EOT - Baseline" (NCT00573508)
Timeframe: Baseline and 12 Weeks
Intervention | Number of Category Events / 24 Hours (Mean) |
---|
| Micturitions- Baseline (N=363;369) | Micturitions- End of Treatment (N=363;369) | Micturitions- Change at EOT (N=363;369) | Incontinence Episodes- Baseline (N=267;268) | Incontinence Episodes-End of Treatment (N=267;268) | Incontinence Episodes-Change at EOT (N=267;268) | Urgency Episodes- Baseline (N=364;369) | Urgency Episodes- End of Treatment (N=364;369) | Urgency Episodes- Change at EOT (N=364;369) | Nocturia Episodes- Baseline (N=309;313) | Nocturia Episodes- End of Treatment (N=309;313) | Nocturia Episodes- Change at EOT (N=309;313) | Nocturnal Voids- Baseline (N=329;326) | Nocturnal Voids- End of Treatment (N=329;326) | Nocturnal Voids- Change at EOT (N=329;326) |
---|
Placebo | 11.85 | 10.49 | -1.36 | 2.80 | 1.56 | -1.24 | 5.70 | 3.86 | -1.84 | 1.57 | 1.09 | -0.48 | 1.89 | 1.41 | -0.48 |
,Solifenacin Succinate | 11.73 | 9.50 | -2.23 | 2.92 | 1.07 | -1.85 | 5.72 | 2.66 | -3.05 | 1.74 | 1.11 | -0.63 | 1.99 | 1.29 | -0.70 |
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Compliance
Number of subjects that were in compliance with the study protocol and took medication for at least one month. (NCT00581061)
Timeframe: 3 months
Intervention | participants (Number) |
---|
Vesicare | 10 |
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Side Effects
Number of people who experienced side effects while taking Vesicare, per study protocol. (NCT00581061)
Timeframe: 3 months
Intervention | participants (Number) |
---|
| Constipation | Fatigue | Heartburn | Dry Hands | Dry Mouth |
---|
Vesicare | 2 | 1 | 1 | 1 | 2 |
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Time to Continence
Time in days to achieve pad free urinary continence (NCT00581061)
Timeframe: 12 months
Intervention | days (Mean) |
---|
Vesicare | 50 |
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Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries.
(NCT00821184)
Timeframe: 0 week - 12 weeks
Intervention | incontinence episodes per 24 hours (Mean) |
---|
Vesicare Alone | 1 |
Vesicare Plus Behavioral Modification | 10 |
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Mean Proportion of Bowel Movements With Satisfaction Per Day
"The number of stools with satisfaction of Yes divided by the total number of stools passed on each notional day. Mean of 3 days." (NCT00832650)
Timeframe: Day 11 to 13
Intervention | mean proportion (Mean) |
---|
Fesoterodine | 0.88 |
Placebo | 0.81 |
Solifenacin | 0.93 |
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Average Score of Ease of Passage During Defecation Per Day
Calculated by averaging the values given for the ease of passage at each visit to the toilet on each notional day. Mean of 3 days. Range of possible scores: 1 (Manual disimpaction) to 7 (Incontinent). (NCT00832650)
Timeframe: Day 11 to 13
Intervention | score on a scale (Mean) |
---|
Fesoterodine | 3.90 |
Placebo | 3.97 |
Solifenacin | 3.83 |
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Colonic Filling at 6 Hours
A surrogate marker of small bowel transit time. (NCT00832650)
Timeframe: Day 12
Intervention | percentage (Mean) |
---|
Fesoterodine | 7.84 |
Placebo | 69.58 |
Solifenacin | 24.06 |
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Colonic Transit at 24 Hours
Colonic transit: Geometric centre at 24 hours (GC24) was estimated using geometric mean of counts in ascending (AC), transverse (TC), descending (DC) and rectosigmoid (RS) colon and stool (weighted by factors of 1 to 5 respectively). To calculate the geometric centre, the proportion of colonic counts in each colonic region was multiplied by its weighing factor: (% AC *1 + % TC *2 + % DC *3 + % RS *4 + % stool * 5 ) divided by 100. (NCT00832650)
Timeframe: Day 13 (Day 12 24 hours post-meal)
Intervention | counts (Mean) |
---|
Fesoterodine | 1.98 |
Placebo | 2.51 |
Solifenacin | 1.91 |
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Colonic Transit at 48 Hours
Colonic transit: Geometric centre at 48 hours (GC48) was estimated using geometric mean of counts in ascending (AC), transverse (TC), descending (DC) and rectosigmoid (RS) colon and stool (weighted by factors of 1 to 5 respectively). To calculate the geometric centre, the proportion of colonic counts in each colonic region was multiplied by its weighing factor: (% AC *1 + % TC *2 + % DC *3 + % RS *4 + % stool * 5 ) divided by 100. (NCT00832650)
Timeframe: Day 14 (Day 12 48 hours post-meal)
Intervention | counts (Mean) |
---|
Fesoterodine | 3.55 |
Placebo | 3.67 |
Solifenacin | 3.14 |
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Proximal Colonic Emptying Time
Estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. (NCT00832650)
Timeframe: Day 12 to 14
Intervention | hours (Mean) |
---|
Fesoterodine | 21.06 |
Placebo | 14.79 |
Solifenacin | 19.23 |
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Time to Gastric Emptying
Ascending colon emptying t½ was estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. (NCT00832650)
Timeframe: Day 12: 2 hours, 4 hours
Intervention | minutes (Mean) |
---|
Fesoterodine | 145.00 |
Placebo | 112.92 |
Solifenacin | 127.47 |
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Change in Maximal Cystometric Capacity (mL)
At baseline, a small catheter is placed inside the participant's bladder. The bladder is filled with sterile water through the catheter and participants' maximal tolerated cystometric capacity (MCC) is measured in milliliters. Following completion of the bladder test, participants take 10mg solifenacin succinate (VesicareR) daily for 30 days. After 30 days of treatment, participants repeat the bladder test. Change in the MCC is used to evaluate the effectiveness of the drug. (NCT00909428)
Timeframe: 30 Days
Intervention | milliliters (mL) (Median) |
---|
Baseline Maximal Cystometric Capacity | 95 |
One Month Maximal Cystometric Capacity | 473.50 |
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Number of Urinary Incontinence Episodes Per 24 Hour Period
This scale it the mean number of urinary incontinence episodes per 24 hour period, as assessed by a 3-day bladder diary. The goal is to examine the effect of solifenacin succinate (VESIcare) on urinary incontinence severity. (NCT01018264)
Timeframe: 12 weeks
Intervention | Number of incontinence episodes/24 hours (Mean) |
---|
| Baseline | Endpoint (12 weeks) |
---|
Placebo | 1.78 | 1.61 |
,Solifenacin Succinate (VESIcare) | 1.48 | 0.30 |
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Number of Micturations Per 24 Hour Period
The primary objective of this study is to measure the efficacy of solifenacin succinate (VESIcare) in reducing the mean number of micturitions per 24 hour period in Parkinson's disease (PD) patients as measured by voiding diaries. (NCT01018264)
Timeframe: 12 weeks
Intervention | Number of micturations per 24 hours (Mean) |
---|
| Baseline | Endpoint (12 weeks) |
---|
Placebo | 9.19 | 8.94 |
,Solifenacin Succinate (VESIcare) | 8.78 | 8.00 |
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Number of Nocturia Episodes Per 24 Hour Period
To examine the effect of solifenacin succinate (VESIcare) on urinary incontinence severity (NCT01018264)
Timeframe: 12 weeks
Intervention | Number of nocturia episodes per 24 hours (Mean) |
---|
| Baseline | Endpoint (12 weeks) |
---|
Placebo | 1.92 | 1.78 |
,Solifenacin Succinate (VESIcare) | 2.48 | 2.04 |
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Parkinson's Disease Quality of Life Scale (PDQOL)
This scale is used to assess quality of life in Parkinson's Disease patients. Parkinson's disease quality of life scale has a possible point range from 37 (worst outcome) to 185 (best outcome). The goal of this outcome measure is to examine the effect of solifenacin succinate (VESIcare) on quality of life. (NCT01018264)
Timeframe: 12 weeks
Intervention | units on a scale (Mean) |
---|
| Baseline | Endpoint (12 weeks) |
---|
Placebo | 114.50 | 112.92 |
,Solifenacin Succinate (VESIcare) | 125.00 | 116.00 |
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Unified Parkinson's Disease Rating Scale (UPDRS) Total
To examine the effect of solifenacin succinate (VESIcare) on Parkinson's disease severity. The UPDRS total score ranges from 0 (no disability) to 199 (total disability). (NCT01018264)
Timeframe: 12 weeks
Intervention | units on a scale (Mean) |
---|
| Baseline | Endpoint (12 weeks) |
---|
Placebo | 25.67 | 25.75 |
,Solifenacin Succinate (VESIcare) | 25.00 | 21.67 |
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Change From Baseline to End of Treatment in Total International Prostate Symptom Score
"The International Prostate Symptom Score (IPSS) is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms:~Incomplete emptying of the bladder~Intermittency~Weak stream~Hesitancy~Frequency~Urgency~Nocturia~Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic)." (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | -5.4 |
TOCAS 0.4 mg | -6.2 |
FDC 0.4 mg/6 mg | -7.0 |
FDC 0.4 mg/9 mg | -6.5 |
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Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS, Previously Known as Total Urgency Score [TUS])
"The Patient Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale:~0. No urgency;~1. Mild urgency;~2. Moderate urgency;~3. Severe urgency;~4. Urgency incontinence~TUFS was calculated as the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded. Higher scores indicate more severe urgency." (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | -4.4 |
TOCAS 0.4 mg | -6.7 |
FDC 0.4 mg/6 mg | -8.1 |
FDC 0.4 mg/9 mg | -7.6 |
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Percentage of Participants Who Were OAB-q Responders at End of Treatment
A OAB-q responder was defined as a participant with an improvement from baseline in HRQoL subscale total score ≥ 10. (NCT01018511)
Timeframe: Week 12 (end of treatment)
Intervention | percentage of participants (Number) |
---|
Placebo | 40.8 |
TOCAS 0.4 mg | 42.9 |
FDC 0.4 mg/6 mg | 45.5 |
FDC 0.4 mg/9 mg | 47.5 |
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Apparent Clearance (CL/F) of Tamsulosin
(NCT01018511)
Timeframe: Week 4, Week 8 and Week 12
Intervention | L/h (Geometric Mean) |
---|
| Week 4 [N=263; 281; 274] | Week 8 [N=255; 259; 248] | Week 12 [N=163; 167; 166] |
---|
FDC 0.4 mg/6 mg | 2.61 | 2.41 | 2.40 |
,FDC 0.4 mg/9 mg | 2.53 | 2.36 | 2.46 |
,TOCAS 0.4 mg | 2.78 | 2.62 | 2.52 |
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Area Under the Curve at Steady State (AUCss) of Tamsulosin
(NCT01018511)
Timeframe: Week 4, Week 8 and Week 12 (collection time points: trough, 1-3 hours post dose, 4-5 hours post-dose and 7-10 hours post-dose)
Intervention | ng.h/mL (Geometric Mean) |
---|
| Week 4 [N= 263; 281; 274] | Week 8 [N= 255; 259; 248] | Week 12 [N= 163; 167; 166] |
---|
FDC 0.4 mg/6 mg | 153 | 166 | 167 |
,FDC 0.4 mg/9 mg | 158 | 169 | 162 |
,TOCAS 0.4 mg | 144 | 153 | 159 |
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AUCss of Solifenacin
(NCT01018511)
Timeframe: Week 4, Week 8 and Week 12 (collection time points: trough, 1-3 hours post dose, 4-5 hours post-dose and 7-10 hours post-dose)
Intervention | ng.h/mL (Geometric Mean) |
---|
| Week 4 [N= 281; 273] | Week 8 [N= 258; 248] | Week 12 [N= 166; 167] |
---|
FDC 0.4 mg/6 mg | 657 | 673 | 652 |
,FDC 0.4 mg/9 mg | 970 | 1020 | 988 |
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Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score
"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= not anxious, 2= moderately anxious, 3 = extremely anxious)." (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| Not anxious -> Not anxious | Not anxious -> Moderately anxious | Not anxious -> Extremely anxious | Not anxious -> No data | Moderately anxious -> Not anxious | Moderately anxious -> Moderately anxious | Moderately anxious -> Extremely anxious | Moderately anxious -> No data | Extremely anxious -> Not anxious | Extremely anxious -> Moderately anxious | Extremely anxious -> Extremely anxious | Extremely anxious -> No data | No data -> Not anxious | No data -> Moderately anxious | No data -> Extremely anxious | No data -> No data |
---|
FDC 0.4 mg/6 mg | 233 | 16 | 0 | 1 | 27 | 39 | 1 | 0 | 1 | 1 | 3 | 0 | 1 | 0 | 0 | 0 |
,FDC 0.4 mg/9 mg | 214 | 18 | 0 | 3 | 25 | 34 | 1 | 1 | 0 | 3 | 2 | 0 | 0 | 0 | 0 | 0 |
,Placebo | 219 | 16 | 0 | 3 | 34 | 42 | 1 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
,TOCAS 0.4 mg | 213 | 11 | 0 | 0 | 25 | 43 | 2 | 1 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 0 |
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Change From Baseline to End of Treatment in EQ-5D Mobility Score
"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = confined to bed)." (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No problem -> No problem | No problem -> Some problem | No problem -> Confined to bed | No problem -> No data | Some problem -> No problem | Some problem -> Some problem | Some problem -> Confined to bed | Some problem -> No data | Confined to bed -> No problem | Confined to bed -> Some problem | Confined to bed -> Confined to bed | Confined to bed -> No data | No data -> No problem | No data -> Some problem | No data -> Confined to bed | No data -> No data |
---|
FDC 0.4 mg/6 mg | 255 | 10 | 0 | 1 | 12 | 35 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,FDC 0.4 mg/9 mg | 233 | 13 | 0 | 3 | 19 | 31 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
,Placebo | 240 | 16 | 0 | 3 | 19 | 40 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,TOCAS 0.4 mg | 230 | 13 | 1 | 1 | 21 | 31 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
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Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score
"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no pain, 2= moderate pain, 3 = extreme pain)." (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No pain -> No pain | No pain -> Moderate pain | No pain -> Extreme pain | No pain -> No data | Moderate pain-> No pain | Moderate pain-> Moderate pain | Moderate pain-> Extreme pain | Moderate pain-> No data | Extreme pain -> No pain | Extreme pain -> Moderate pain | Extreme pain -> Extreme pain | Extreme pain -> No data | No data -> No pain | No data -> Moderate pain | No data -> Extreme pain | No data -> No data |
---|
FDC 0.4 mg/6 mg | 153 | 19 | 1 | 1 | 61 | 72 | 1 | 0 | 1 | 2 | 2 | 0 | 0 | 0 | 0 | 0 |
,FDC 0.4 mg/9 mg | 152 | 24 | 0 | 2 | 41 | 70 | 1 | 2 | 3 | 4 | 2 | 0 | 0 | 0 | 0 | 0 |
,Placebo | 162 | 14 | 2 | 3 | 55 | 73 | 2 | 0 | 0 | 4 | 1 | 0 | 0 | 2 | 0 | 0 |
,TOCAS 0.4 mg | 159 | 14 | 1 | 0 | 41 | 72 | 2 | 2 | 1 | 2 | 2 | 0 | 2 | 0 | 0 | 0 |
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Change From Baseline to End of Treatment in EQ-5D Self-care Score
"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to wash/dress)." (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No problem -> No problem | No problem -> Some problem | No problem -> Unable to wash/ dress | No problem -> No Data | Some problem -> No problem | Some problem -> Some problem | Some problem -> Unable to wash/ dress | Some problem -> No data | Unable to wash/ dress -> No problem | Unable to wash/ dress -> Some problem | Unable to wash/ dress -> Unable to wash/ dress | Unable to wash/ dress -> No data | No data -> No problem | No data -> Some problem | No data -> Unable to wash/ dress | No data -> No data |
---|
FDC 0.4 mg/6 mg | 293 | 3 | 0 | 1 | 8 | 6 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
,FDC 0.4 mg/9 mg | 286 | 4 | 0 | 4 | 3 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
,Placebo | 295 | 8 | 0 | 3 | 8 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
,TOCAS 0.4 mg | 273 | 8 | 0 | 1 | 6 | 8 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
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Change From Baseline to End of Treatment in EQ-5D Usual Activities Score
"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to perform usual activities)." (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No problem -> No problem | No problem -> Some problem | No problem -> Unable to perform usual activities | No problem -> No data | Some problem -> No problem | Some problem -> Some problem | Some problem -> Unable to perform usual activities | Some problem -> No data | Unable to perform usual activities -> No problem | Unable to perform usual activities -> Some problem | Unable to perform usual activities -> same status | Unable to perform usual activities -> No data | No data -> No problem | No data -> Some problem | No data -> Unable to perform usual activities | No data -> No data |
---|
FDC 0.4 mg/6 mg | 248 | 14 | 0 | 1 | 26 | 22 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,FDC 0.4 mg/9 mg | 235 | 18 | 0 | 3 | 27 | 17 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Placebo | 254 | 18 | 0 | 3 | 21 | 22 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,TOCAS 0.4 mg | 228 | 13 | 1 | 1 | 22 | 28 | 0 | 0 | 1 | 1 | 1 | 0 | 2 | 0 | 0 | 0 |
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Change From Baseline to End of Treatment in Individual IPSS Scores
"The IPSS is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms:~Incomplete emptying of the bladder~Intermittency~Weak stream~Hesitancy~Frequency~Urgency~Nocturia~Each question is assigned points from 0 to 5 indicating increasing severity of the symptom." (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Incomplete emptying of the bladder | Frequency | Intermittency | Urgency | Weak stream | Hesitancy | Nocturia |
---|
FDC 0.4 mg/6 mg | -1.0 | -1.3 | -1.0 | -1.4 | -1.3 | -0.8 | -0.8 |
,FDC 0.4 mg/9 mg | -1.0 | -1.4 | -0.7 | -1.6 | -1.3 | -0.7 | -0.6 |
,Placebo | -0.9 | -1.0 | -0.9 | -1.2 | -1.1 | -0.5 | -0.5 |
,TOCAS 0.4 mg | -0.9 | -1.2 | -0.8 | -1.3 | -1.3 | -0.7 | -0.7 |
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CL/F of Solifenacin
(NCT01018511)
Timeframe: Week 4, Week 8 and Week 12
Intervention | L/h (Geometric Mean) |
---|
| Week 4 [N= 281;273] | Week 8 [N= 258; 248] | Week 12 [N= 166; 167] |
---|
FDC 0.4 mg/6 mg | 6.88 | 6.72 | 6.94 |
,FDC 0.4 mg/9 mg | 7.00 | 6.67 | 6.87 |
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Clinician Global Impression Scale at End of Treatment: Overall Bladder Symptoms
The Clinician Global Impression (CGI) is a questionnaire completed by the physician to assess change in the participants bladder symptoms since the start of the study. The questionnaire consists of 1 question with 7 response levels ranging from 1 to 7 (very much improved to very much worse). (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| Very Much Improved | Much Improved | Minimally Improved | No Change | Minimally Worse | Much Worse | Very Much Worse |
---|
FDC 0.4 mg/6 mg | 22 | 117 | 97 | 48 | 2 | 1 | 0 |
,FDC 0.4 mg/9 mg | 20 | 124 | 92 | 37 | 3 | 4 | 0 |
,Placebo | 9 | 95 | 111 | 72 | 9 | 1 | 0 |
,TOCAS 0.4 mg | 15 | 106 | 98 | 54 | 5 | 1 | 0 |
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Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score
Visual Analogue Scale (VAS) is part of the EQ-5D questionnaire. The VAS is self-rated by the participant ranging from 0 to 100 (worst imaginable health state to best imaginable health state). (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Mean) |
---|
Placebo | 4.0 |
TOCAS 0.4 mg | 3.7 |
FDC 0.4 mg/6 mg | 5.5 |
FDC 0.4 mg/9 mg | 6.2 |
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Cminss of Solifenacin
(NCT01018511)
Timeframe: Week 4, Week 8 and Week 12
Intervention | ng/mL (Geometric Mean) |
---|
| Week 4 [N= 281; 273] | Week 8 [N= 258; 248] | Week 12 [N= 166; 167] |
---|
FDC 0.4 mg/6 mg | 24.5 | 25.2 | 24.4 |
,FDC 0.4 mg/9 mg | 36.1 | 38.2 | 37.0 |
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Maximum Concentration at Steady State (Cmaxss) of Tamsulosin
(NCT01018511)
Timeframe: Week 4, Week 8 and Week 12
Intervention | ng/mL (Geometric Mean) |
---|
| Week 4 [N= 263; 281; 274] | Week 8 [N= 255; 259; 248] | Week 12 [N= 163; 167; 166] |
---|
FDC 0.4 mg/6 mg | 7.80 | 8.32 | 8.38 |
,FDC 0.4 mg/9 mg | 8.00 | 8.46 | 8.16 |
,TOCAS 0.4 mg | 7.38 | 7.69 | 7.97 |
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Minimum Concentration at Steady State (Cminss) of Tamsulosin
(NCT01018511)
Timeframe: Week 4, Week 8 and Week 12
Intervention | ng/mL (Geometric Mean) |
---|
| Week 4 [N= 263; 281; 274] | Week 8 [N= 255; 259; 248] | Week 12 [N= 163; 167; 166] |
---|
FDC 0.4 mg/6 mg | 4.55 | 5.08 | 5.05 |
,FDC 0.4 mg/9 mg | 4.75 | 5.19 | 4.94 |
,TOCAS 0.4 mg | 4.19 | 4.63 | 4.84 |
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Number of Participants With Adverse Events (AEs)
Safety is monitored by collecting AEs, which include abnormal laboratory parameters, vital signs or ECG data if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE (SAE) was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild (no disruption of normal daily activities), moderate (affected normal daily activities) or severe (inability to perform daily activities) and for causal relationship to study drug. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred after administration of the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug. (NCT01018511)
Timeframe: From first dose of double-blind study drug up to 14 days of last dose of double-blind study drug (up to 14 weeks)
Intervention | participants (Number) |
---|
| Total TEAEs | Mild TEAEs | Moderate TEAEs | Severe TEAEs | Drug-related TEAEs | SAEs | Deaths | AEs Leading to Discontin | Drug-related AEs Leading to Discontin |
---|
FDC 0.4 mg/6 mg | 99 | 68 | 27 | 4 | 57 | 5 | 1 | 13 | 9 |
,FDC 0.4 mg/9 mg | 100 | 68 | 27 | 5 | 65 | 9 | 0 | 10 | 8 |
,Placebo | 87 | 59 | 25 | 3 | 30 | 3 | 0 | 5 | 3 |
,TOCAS 0.4 mg | 74 | 42 | 29 | 3 | 27 | 10 | 1 | 9 | 5 |
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Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours
The mean number of pads per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | pads (Least Squares Mean) |
---|
Placebo | -0.7 |
TOCAS 0.4 mg | -0.8 |
FDC 0.4 mg/6 mg | -1.2 |
FDC 0.4 mg/9 mg | -1.2 |
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Patient Global Impression Scale at End of Treatment: Overall Bladder Symptoms
The Patient Global Impression (PGI) is a global questionnaire completed by the participant to assess both the change in the participants overall condition and the change in bladder symptoms since the start of the study. The questionnaire consists of 2 questions with 7 response levels ranging from 1 to 7 (very much improved to very much worse). (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| Very Much Improved | Much Improved | Minimally Improved | No Change | Minimally Worse | Much Worse | Very Much Worse |
---|
FDC 0.4 mg/6 mg | 20 | 95 | 124 | 46 | 2 | 0 | 0 |
,FDC 0.4 mg/9 mg | 23 | 105 | 105 | 38 | 9 | 1 | 0 |
,Placebo | 7 | 75 | 113 | 86 | 12 | 5 | 0 |
,TOCAS 0.4 mg | 14 | 85 | 99 | 68 | 13 | 3 | 0 |
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Time of Maximum Concentration at Steady State (Tmaxss) of Tamsulosin
(NCT01018511)
Timeframe: Week 4, Week 8 and Week 12
Intervention | h (Geometric Mean) |
---|
| Week 4 [N= 263; 281; 274] | Week 8 [N= 255; 259; 248] | Week 12 [N= 163; 167; 166] |
---|
FDC 0.4 mg/6 mg | 5.06 | 5.10 | 5.09 |
,FDC 0.4 mg/9 mg | 5.08 | 5.11 | 5.09 |
,TOCAS 0.4 mg | 5.04 | 5.09 | 5.10 |
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Tmaxss of Solifenacin
(NCT01018511)
Timeframe: Week 4, Week 8 and Week 12
Intervention | h (Geometric Mean) |
---|
| Week 4 [N= 281; 273] | Week 8 [N= 258; 248] | Week 12 [N= 166; 167] |
---|
FDC 0.4 mg/6 mg | 5.47 | 5.48 | 5.48 |
,FDC 0.4 mg/9 mg | 5.47 | 5.48 | 5.48 |
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Patient Global Impression Scale at End of Treatment: General Health
The Patient Global Impression (PGI) is a global questionnaire completed by the participant to assess both the change in the participants overall condition and the change in bladder symptoms since the start of the study. The questionnaire consists of 2 questions with 7 response levels ranging from 1 to 7 (very much improved to very much worse). (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| Very Much Improved | Much Improved | Minimally Improved | No Change | Minimally Worse | Much Worse | • Very Much Worse |
---|
FDC 0.4 mg/6 mg | 10 | 72 | 87 | 110 | 8 | 0 | 0 |
,FDC 0.4 mg/9 mg | 7 | 75 | 94 | 94 | 10 | 1 | 0 |
,Placebo | 5 | 43 | 79 | 152 | 15 | 2 | 0 |
,TOCAS 0.4 mg | 9 | 58 | 77 | 126 | 9 | 3 | 0 |
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Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours
A nocturia episode is defined as waking up at night to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | nocturia episodes (Least Squares Mean) |
---|
Placebo | -0.3 |
TOCAS 0.4 mg | -0.4 |
FDC 0.4 mg/6 mg | -0.5 |
FDC 0.4 mg/9 mg | -0.4 |
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Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
A micturition is any voluntary urination, excluding episodes of incontinence only.The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | micturitions (Least Squares Mean) |
---|
Placebo | -1.1 |
TOCAS 0.4 mg | -1.7 |
FDC 0.4 mg/6 mg | -2.3 |
FDC 0.4 mg/9 mg | -1.9 |
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Change From Baseline to End of Treatment in Average Flow Rate (Qmean)
Qmean during a micturition (urination) was recorded using uroflowmetry. (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | mL/s (Mean) |
---|
Placebo | 1.5 |
TOCAS 0.4 mg | 1.3 |
FDC 0.4 mg/6 mg | 1.9 |
FDC 0.4 mg/9 mg | 1.7 |
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Change From Baseline to End of Treatment in HRQoL Subscale: Concern Score
"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Concern score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement." (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | 7.5 |
TOCAS 0.4 mg | 9.3 |
FDC 0.4 mg/6 mg | 12.0 |
FDC 0.4 mg/9 mg | 11.5 |
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Change From Baseline to End of Treatment in HRQoL Subscale: Sleep Score
"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Sleep score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement." (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | 8.3 |
TOCAS 0.4 mg | 8.8 |
FDC 0.4 mg/6 mg | 11.9 |
FDC 0.4 mg/9 mg | 10.0 |
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Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours
An urgency incontinence episode is defined as an episode with any involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes with PPIUS grade 3 (Severe incontinence) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | urgency incontinence episodes (Least Squares Mean) |
---|
Placebo | -1.0 |
TOCAS 0.4 mg | -1.4 |
FDC 0.4 mg/6 mg | -1.3 |
FDC 0.4 mg/9 mg | -1.1 |
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Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours
An urgency episode is defined as an episode of strong desire to void accompanied by fear of leakage or pain. The mean number of urgency episodes with PPIUS grade 3 (Severe urgency) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | urgency episodes (Least Squares Mean) |
---|
Placebo | -1.6 |
TOCAS 0.4 mg | -2.5 |
FDC 0.4 mg/6 mg | -2.6 |
FDC 0.4 mg 9 mg | -2.8 |
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Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition
A micturition is any voluntary urination, excluding episodes of incontinence only. The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | mL (Least Squares Mean) |
---|
Placebo | 11.1 |
TOCAS 0.4 mg | 15.5 |
FDC 0.4 mg/6 mg | 38.6 |
FDC 0.4 mg/9 mg | 38.7 |
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Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume
PVR volume is the volume of urine retained after voiding. PVR volume was assessed by ultrasonography or bladder scan. (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | mL (Mean) |
---|
Placebo | -6.1 |
TOCAS 0.4 mg | -5.0 |
FDC 0.4 mg/6 mg | 3.8 |
FDC 0.4 mg/9 mg | 12.3 |
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Change From Baseline to End of Treatment in Symptom Bother Score
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The Symptom Bother portion consists of an 8-item scale scored from 1 to 6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from baseline indicates an improvement. (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | -11.8 |
TOCAS 0.4 mg | -14.4 |
FDC 0.4 mg/6 mg | -16.5 |
FDC 0.4 mg/9 mg | -17.1 |
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Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | incontinence episodes (Least Squares Mean) |
---|
Placebo | 0.1 |
TOCAS 0.4 mg | -0.2 |
FDC 0.4 mg/6 mg | 0.0 |
FDC 0.4 mg/9 mg | 0.1 |
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Cmaxss of Solifenacin
(NCT01018511)
Timeframe: Week 4, Week 8 and Week 12
Intervention | ng/mL (Geometric Mean) |
---|
| Week 4 [N= 281; 273] | Week 8 [N= 258; 248] | Week 12 [N= 166; 167] |
---|
FDC 0.4 mg/6 mg | 29.4 | 30.0 | 29.1 |
,FDC 0.4 mg/9 mg | 43.4 | 45.3 | 44.1 |
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Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
Qmax during a micturition (urination) was recorded using uroflowmetry. (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | mL/s (Mean) |
---|
Placebo | 3.3 |
TOCAS 0.4 mg | 3.2 |
FDC 0.4 mg/6 mg | 3.8 |
FDC 0.4 mg/9 mg | 3.5 |
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Change From Baseline to End of Treatment in IPSS Voiding Score
The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 voiding questions (incomplete emptying of the bladder, intermittency, weak stream, hesitancy) and ranges from 0 to 20 (mildly symptomatic to severely symptomatic). (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | -3.0 |
TOCAS 0.4 mg | -3.3 |
FDC 0.4 mg/6 mg | -3.7 |
FDC 0.4 mg/9 mg | -3.2 |
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Change From Baseline to End of Treatment in IPSS Storage Score
The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 storage questions (frequency, urgency and nocturia) and ranges from 0 to 15 (mildly symptomatic to severely symptomatic). (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | -2.4 |
TOCAS 0.4 mg | -2.9 |
FDC 0.4 mg/6 mg | -3.5 |
FDC 0.4 mg/9 mg | -3.3 |
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Change From Baseline to End of Treatment in IPSS QoL Score
The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The answers ranged from 0 to 6 (delighted to terrible). (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | -0.9 |
TOCAS 0.4 mg | -1.0 |
FDC 0.4 mg/6 mg | -1.3 |
FDC 0.4 mg/9 mg | -1.3 |
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Change From Baseline to End of Treatment in HRQoL Subscale: Total Score
"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement." (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | 7.4 |
TOCAS 0.4 mg | 8.8 |
FDC 0.4 mg/6 mg | 11.4 |
FDC 0.4 mg/9 mg | 10.7 |
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Change From Baseline to End of Treatment in HRQoL Subscale: Social Score
"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Social score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement." (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | 3.8 |
TOCAS 0.4 mg | 4.5 |
FDC 0.4 mg/6 mg | 6.2 |
FDC 0.4 mg/9 mg | 5.8 |
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Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition
A micturition is any voluntary urination, excluding episodes of incontinence only. The maximum volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01018511)
Timeframe: Baseline and Week 12
Intervention | mL (Least Squares Mean) |
---|
Placebo | -5.9 |
TOCAS 0.4 mg | -1.8 |
FDC 0.4 mg/6 mg | 12.7 |
FDC 0.4 mg/9 mg | 12.9 |
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Change From Baseline to End of Treatment in IPSS Quality of Life (QoL) Score
The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The answers ranged from 0 to 6 (delighted to terrible). (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment
Intervention | units on a scale (Mean) |
---|
Total Group | -1.9 |
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Change From Baseline to End of Treatment in IPSS Storage Score
The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 storage questions (frequency,urgency and nocturia) and ranges from 0 to 15 (mildly symptomatic to severely symptomatic). (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment
Intervention | units on a scale (Mean) |
---|
Total Group | -4.3 |
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Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
Qmax during a micturition (urination) was recorded using uroflowmetry. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment
Intervention | ml/s (Mean) |
---|
Total Group | 4.54 |
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Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition
A micturition is any voluntary urination, excluding episodes of incontinence only. The maximum volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment
Intervention | ml (Mean) |
---|
Total Group | 16.6 |
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Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment
Intervention | incontinence episodes (Mean) |
---|
Total Group | -1.4 |
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Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
A micturition is any voluntary urination, excluding episodes of incontinence only.The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment
Intervention | micturitions (Mean) |
---|
Total Group | -2.5 |
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Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours
The mean number of pads per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment
Intervention | pads (Mean) |
---|
Total Group | -0.9 |
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Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours
An urgency episode is defined as an episode of strong desire to void accompanied by fear of leakage or pain. The mean number of urgency episodes with PPIUS grade 3 (Severe urgency) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment
Intervention | urgency episodes (Mean) |
---|
Total Group | -3.1 |
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Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours
An urgency incontinence episode is defined as an episode with any involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes with PPIUS grade 3 (Severe incontinence) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment
Intervention | urgency incontinence episodes (Mean) |
---|
Total Group | -1.5 |
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Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition
A micturition is any voluntary urination, excluding episodes of incontinence only. The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment
Intervention | ml (Mean) |
---|
Total Group | 39.0 |
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Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume
PVR volume is the volume of urine retained after voiding. PVR volume was assessed by ultrasonography or bladder scan. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment
Intervention | ml (Mean) |
---|
Total Group | 10.7 |
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Change From Baseline to End of Treatment in Symptom Bother Score
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The Symptom Bother portion consists of an 8-item scale scored from 1 to 6.The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from baseline indicates an improvement. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment
Intervention | units on a scale (Mean) |
---|
Total Group | -20.6 |
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Change From Baseline to End of Treatment in Total International Prostate Symptom Score (IPSS)
"The International Prostate Symptom Score (IPSS) is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms:~Incomplete emptying of the bladder~Intermittency~Weak stream~Hesitancy~Frequency~Urgency~Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic)." (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment
Intervention | units on a scale (Mean) |
---|
Total Group | -9.0 |
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Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS) (Previously Known as Total Urgency Score [TUS])
"The Patient Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale:~0. No urgency;~1. Mild urgency;~2. Moderate urgency;~3. Severe urgency;~4. Urgency incontinence TUS/TUFS was calculated as the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded. Higher scores indicate more severe urgency." (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment
Intervention | units on a scale (Mean) |
---|
Total Group | -10.1 |
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Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score
"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= not anxious, 2= moderately anxious, 3 = extremely anxious)." (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment
Intervention | participants (Number) |
---|
| Not anxious -> Not anxious | Not anxious -> moderately anxious | Not anxious -> extremely anxious | Not anxious -> no data | Moderately anxious -> not anxious | Moderately anxious -> moderately anxious | Moderately anxious -> extremely anxious | Moderately anxious -> no data | Extremely anxious -> not anxious | Extremely anxious -> moderately anxious | Extremely anxious -> extremely anxious | Extremely anxious -> no data | No data -> not anxious | No data -> moderately anxious | No data -> extremely anxious | No data -> no data |
---|
Total Group | 737 | 37 | 1 | 0 | 103 | 109 | 3 | 0 | 4 | 4 | 5 | 0 | 1 | 0 | 0 | 0 |
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Change From Baseline to End of Treatment in EQ-5D Mobility Score
"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = confined to bed)." (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment
Intervention | participants (Number) |
---|
| No problem -> No problem | No problem -> Some problem | No problem -> confined to bed | No problem -> no data | Some problem -> No problem | Some problem -> Some problem | Some problem -> confined to bed | Some problem -> No data | Confined to bed -> no problem | Confined to bed -> some problem | Confined to bed -> confined to bed | Confined to bed -> no data | No data -> no problem | No data -> some problem | No data -> confined to bed | No data -> no data |
---|
Total Group | 775 | 58 | 1 | 0 | 67 | 102 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
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Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score
"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no pain, 2= moderate pain, 3 = extreme pain)." (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment
Intervention | participants (Number) |
---|
| No pain -> no pain | No pain -> moderate pain | No pain -> extreme pain | No pain -> no data | Moderate pain -> no pain | Moderate pain -> moderate pain | Moderate pain -> extreme pain | Moderate pain -> no data | Extreme pain -> no pain | Extreme pain -> moderate pain | Extreme pain -> extreme pain | Extreme pain -> no data | No data -> no pain | No data -> moderate pain | No data -> extreme pain | No data -> no data |
---|
Total Group | 499 | 71 | 2 | 0 | 202 | 200 | 5 | 0 | 10 | 7 | 6 | 0 | 2 | 0 | 0 | 0 |
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Change From Baseline to End of Treatment in EQ-5D Self-care Score
"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to wash/dress)." (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment
Intervention | participants (Number) |
---|
| No problem -> No problem | No problem -> Some problem | No problem -> Unable to wash/dress | No problem -> No data | Some problem -> no problem | Some problem -> some problem | Some problem -> unable to wash/dress | Some problem -> no data | Unable to wash/dress -> no problem | Unable to wash/dress -> some problem | Unable to wash/dress -> unable to wash/dress | Unable to wash/dress -> no data | No data -> no problem | No data -> some problem | No data -> unable to wash/dress | No data -> no data |
---|
Total Group | 934 | 27 | 1 | 0 | 18 | 19 | 0 | 0 | 2 | 0 | 0 | 0 | 3 | 0 | 0 | 0 |
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Change From Baseline to End of Treatment in EQ-5D Usual Activities Score
"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to perform usual activities)." (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment
Intervention | participants (Number) |
---|
| No problem -> No problem | No problem -> Some problem | No problem -> unable to perform usual activities | No problem -> no data | Some problem -> no problem | Some problem -> some problem | Some problem -> unable to perform usual activities | Some problem -> no data | Unable to perform usual activities -> no problem | Unable to perform usual activities -> some problem | Unable to perform usual activities -> same status | Unable to perform usual activities -> no data | No data -> no problem | No data -> some problem | No data -> unable to perform usual activities | No data -> no data |
---|
Total Group | 805 | 54 | 1 | 0 | 80 | 60 | 0 | 0 | 1 | 2 | 0 | 0 | 1 | 0 | 0 | 0 |
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Change From Baseline to End of Treatment in Individual IPSS Scores
"The IPSS is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms:~Incomplete emptying of the bladder~Intermittency~Weak stream~Hesitancy~Frequency~Urgency~Nocturia~Each question is assigned points from 0 to 5 indicating increasing severity of the symptom." (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment
Intervention | units on a scale (Mean) |
---|
| Incomplete emptying of the bladder | Frequency | Intermittency | Urgency | Weak stream | Hesitancy | Nocturia |
---|
Total Group | -1.3 | -1.7 | -1.0 | -1.8 | -1.6 | -0.8 | -0.9 |
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Number of Participants With Adverse Events (AEs)
Safety is monitored by collecting AEs, which include abnormal lab parameters, vital signs or ECG data if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A serious AE (SAE) was an AE resulting in death, persistent or significant disability/incapacity or congenital anomaly/birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity (mild-no disruption of normal daily activities, moderate-affected normal daily activities or severe-inability to perform daily activities) and for causal relationship to study drug. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred after the intake of first dose of double-blind study drug (if on FDC in 905-CL-055) or after first open-label dose until 30 days after the last dose of open-label study drug (in 905-CL-057). (NCT01021332)
Timeframe: From first dose of double-blind study drug (if on FDC in 905-CL-055) or first open-label dose up to 30 days after last dose of open-label study drug (in 905-CL-057) (up to 56 weeks)
Intervention | participants (Number) |
---|
| Participants With Treatment-Emergent Adverse Event | Drug-related AEs | Drug-related SAEs | Any TEAE causing discontinuation of study drug. |
---|
Total Group | 499 | 255 | 12 | 69 |
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Change From Baseline to End of Treatment in IPSS Voiding Score
The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 voiding questions (incomplete emptying of the bladder, intermittency, weak stream, hesitancy) and ranges from 0 to 20 (mildly symptomatic to severely symptomatic). (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment
Intervention | units on a scale (Mean) |
---|
Total Group | -4.7 |
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Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours
A nocturia episode is defined as waking up at night to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment
Intervention | nocturia episodes (Mean) |
---|
Total Group | -0.7 |
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Change From Baseline to End of Treatment in Average Flow Rate (Qmean)
Qmean during a micturition (urination) was recorded using uroflowmetry. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment
Intervention | ml/s (Mean) |
---|
Total Group | 2.05 |
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Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score
Visual Analogue Scale (VAS) is part of the EQ-5D questionnaire. The VAS is self-rated by the participant ranging from 0 to 100 (worst imaginable health state to best imaginable health state). (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment
Intervention | units on a scale (Mean) |
---|
Total Group | 6.4 |
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Difference (Pre - Post) in Maximum Urine Flow Rate (Qmax) (Milliliters Per Second) as Measured by Pressure Flowmetry
Pressure Flowmetry was used to measure maximum urine flow rate (Qmax)before and after 2 weeks of therapy with one of 6 randomly assigned medications. A 300 cc bladder fill was performed through the catheter, the catheter was removed, and transurethral and transrectal pressure transducers were placed for the pressure flow study. Voiding was performed in the seated position. Information obtained for the database included Qmax, average flow rate, time to Qmax, detrusor pressure at maximum flow rate, voided volume, and a calculated post-void residual. (NCT01028014)
Timeframe: 2 weeks
Intervention | milliliters per second (Median) |
---|
Pseudoephedrine 120mg ER Daily | -7.3 |
Solifenacin 5mg Daily | 5.0 |
Tamsulosin 0.4mg Daily | -5.6 |
Imipramine 25mg Daily | -6.6 |
Cyclobenzaprine 10mg Daily | 10.3 |
Lactose Capsules, One Daily | 10.4 |
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Difference (Pre - Post) in Urethral Sensation (Milliamps) as Measured by Current Perception Threshold Testing.
Current Perception Threshold testing was used to measure urethral sensation before and after 2 weeks of therapy with one of 6 randomly assigned medications. We performed CPT testing in the urethra using a Neurometer®, which is a constant current stimulator capable of delivering sine wave electrical stimuli at 3 frequencies (2000 Hz, 250 Hz and 5 Hz). At all 3 frequencies, the stimulus intensity was gradually increased until first perceived, and then decreased until no longer perceptible. CPT values were obtained using a semi-automated forced choice paradigm. (NCT01028014)
Timeframe: 2 weeks
Intervention | Milliamps (Median) |
---|
Pseudoephedrine 120mg ER Daily | 0.06 |
Solifenacin 5mg Daily | 0.06 |
Tamsulosin 0.4mg Daily | -0.8 |
Imipramine 25mg Daily | -0.12 |
Cyclobenzaprine 10mg Daily | 0.0 |
Lactose Capsules, One Daily | 0.03 |
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Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG
Concentric needle EMG was used to measure urethral sphincter activity at 2-3 sites around the urethral meatus before and after 2 weeks of therapy with one of 6 randomly assigned medications. Two methods of quantitative electromyography were performed on all subjects. (1) Multi-Motor Unit Action Potential (MUP) analysis, which has been shown to be the most sensitive technique in distinguishing neuropathic from control muscles; and (2) interference pattern analysis (IPA) which reflects changes in MUP recruitment from weak effort to maximal contraction. (NCT01028014)
Timeframe: 2 weeks
Intervention | microvolts (Median) |
---|
Pseudoephedrine 120mg ER Daily | -18 |
Solifenacin 5mg Daily | 10 |
Tamsulosin 0.4mg Daily | 11 |
Imipramine 25mg Daily | -15 |
Cyclobenzaprine 10mg Daily | 12 |
Lactose Capsules, One Daily | 36 |
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Change From Baseline in Patient Assessment of Treatment Satisfaction
The treatment satisfaction visual analog scale (TS_VAS) asks patients to rate their satisfaction with treatment by placing a vertical mark on a 100 mm line where the endpoints are labeled 'No, not at all' on the left (score = 0) to 'Yes, completely satisfied' on the right (score = 100). A positive change from Baseline indicates improvement. (NCT01093534)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Mean) |
---|
Placebo | 18.90 |
Solifenacin 5 mg | 24.90 |
Solifenacin 10 mg | 31.90 |
Pooled Solifenacin | 28.20 |
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Change From Baseline in Patient Assessment of Urgency Bother
"The participants' perception and impression of bother associated with their condition were assessed using the Urgency Bother-Visual Analog Scale (UB-VAS). The participant was asked to place a vertical mark on a 100 mm line to indicate how much bother has urgency been for them in the past week, whereby 'no bother at all' is represented on the left end (score = 0) and 'worst possible bother' (score = 100) at the right end of the line.~A negative change from Baseline indicates improvement." (NCT01093534)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Mean) |
---|
Placebo | -12.60 |
Solifenacin 5 mg | -27.70 |
Solifenacin 10 mg | -28.90 |
Pooled Solifenacin | -28.20 |
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Change From Baseline in Patient Perception of Bladder Condition (PPBC)
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement. (NCT01093534)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Mean) |
---|
Placebo | -0.7 |
Solifenacin 5 mg | -1.3 |
Solifenacin 10 mg | -1.3 |
Pooled Solifenacin | -1.3 |
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Change From Baseline in Symptom Bother Score
"Overactive bladder symptoms were assessed using the symptom bother scale of the Overactive Bladder Symptom and Health-Related Quality of Life Questionnaire (OAB-q). The OAB-q is a patient-administered instrument comprising an 8-item symptom bother scale and 25 health-related quality of life items (see next outcome measure). In the symptom bother scale participants were asked how much they had been bothered by selected bladder symptoms during the past 4 weeks. Each question has a 6-point Likert scale response ranging from 'not at all' (1) to 'a very great deal' (6).~The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvement." (NCT01093534)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Mean) |
---|
Placebo | -14.90 |
Solifenacin 5 mg | -22.32 |
Solifenacin 10 mg | -22.91 |
Pooled Solifenacin | -22.60 |
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Change From Baseline to Week 12 in Bladder Wall Thickness
Bladder wall thickness (BWT) measurements were obtained using transvaginal ultrasound. The BWT was derived as one mean value per image pooled over measurements of 3 locations (anterior wall, dome and trigone), and performed by 2 central readers and 1 adjudicator. (NCT01093534)
Timeframe: Baseline and Week 12
Intervention | mm (Mean) |
---|
Placebo | 0.00 |
Solifenacin 5 mg | -0.29 |
Solifenacin 10 mg | -0.18 |
Pooled Solifenacin | -0.24 |
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Change From Baseline to Week 12 in Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr)
Brain derived neurotrophic factor (uBDNF) and creatinine (Cr) were measured from urine samples by the central laboratories. uBDNF/Cr was derived by dividing uBDNF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant. (NCT01093534)
Timeframe: Baseline and Week 12
Intervention | pg/µmol (Mean) |
---|
Placebo | -27.4 |
Solifenacin 5 mg | 31.1 |
Solifenacin 10 mg | -88.1 |
Pooled Solifenacin | -27.8 |
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Change From Baseline to Week 12 in Mean Level of Urgency
"The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.~The mean level of urgency was calculated by adding the PPIUS grade for all events (micturition or incontinence) and dividing by the number of episodes recorded in the diary over 3 days prior to the Baseline and Week 12 visits." (NCT01093534)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Mean) |
---|
Placebo | -0.15 |
Solifenacin 5 mg | -0.23 |
Solifenacin 10 mg | -0.24 |
Pooled Solifenacin | -0.23 |
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Change From Baseline to Week 12 in Mean Number of Events (Micturitions Plus Incontinence Episodes) Per 24 Hours
The average number of micturitions (urinations) and incontinence episodes (any involuntary leakage of urine) per day was derived from the number of events recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits. (NCT01093534)
Timeframe: Baseline and Week 12
Intervention | events (Mean) |
---|
Placebo | -1.40 |
Solifenacin 5 mg | -2.44 |
Solifenacin 10 mg | -1.80 |
Pooled Solifenacin | -2.13 |
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Change From Baseline to Week 12 in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was calculated from the number of incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits. (NCT01093534)
Timeframe: Baseline and Week 12
Intervention | incontinence episodes (Mean) |
---|
Placebo | -0.60 |
Solifenacin 5 mg | -1.49 |
Solifenacin 10 mg | -1.04 |
Pooled Solifenacin | -1.24 |
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Change From Baseline to Week 12 in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was derived from the number of micturitions recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits. (NCT01093534)
Timeframe: Baseline and Week 12
Intervention | micturitions (Mean) |
---|
Placebo | -1.18 |
Solifenacin 5 mg | -1.80 |
Solifenacin 10 mg | -1.28 |
Pooled Solifenacin | -1.55 |
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Change From Baseline to Week 12 in Mean Number of Urgency Events Per 24 Hours
"The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.~An urgency event is defined as any micturition or incontinence episode classified by the participant as a grade 3 or 4 on the PPIUS scale. The average number of urgency events per day is derived from the diary data completed by participants on the 3 days prior to the Baseline and Week 12 visits." (NCT01093534)
Timeframe: 12 weeks
Intervention | urgency events (Mean) |
---|
Placebo | -1.58 |
Solifenacin 5 mg | -2.22 |
Solifenacin 10 mg | -1.88 |
Pooled Solifenacin | -2.06 |
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Change From Baseline to Week 12 in Mean Number of Urgency Micturitions Per 24 Hours
"An urgency micturition is defined as any micturition classified by the participant as a grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.~The average number of urgency micturitions per 24 hours was derived from the number of urgency micturitions recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits." (NCT01093534)
Timeframe: Baseline and Week 12
Intervention | urgency micturitions (Mean) |
---|
Placebo | -1.35 |
Solifenacin 5 mg | -1.77 |
Solifenacin 10 mg | -1.60 |
Pooled Solifenacin | -1.69 |
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Change From Baseline to Week 12 in Total Urgency Score
"The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.~The total urgency score was calculated by adding all PPIUS scores over a 3-day period prior to the Baseline and Week 12 visits for each participant." (NCT01093534)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Mean) |
---|
Placebo | -13.61 |
Solifenacin 5 mg | -22.39 |
Solifenacin 10 mg | -16.91 |
Pooled Solifenacin | -19.81 |
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Change From Baseline to Week 12 in Total Urinary Nerve Growth Factor Normalized by Urine Creatinine
Total (acidified) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Total uNGF/Cr was derived by dividing total uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant. (NCT01093534)
Timeframe: Baseline and Week 12
Intervention | pg/µmol (Mean) |
---|
Placebo | -0.962 |
Solifenacin 5 mg | 2.758 |
Solifenacin 10 mg | 3.858 |
Pooled Solifenacin | 3.302 |
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Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12
Free (neutralized) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Free (neutralized) uNGF/Cr was derived by dividing free (neutralized) uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant. (NCT01093534)
Timeframe: Week 12
Intervention | pg/µmol (Mean) |
---|
Placebo | 30.359 |
Solifenacin 5 mg | 31.855 |
Solifenacin 10 mg | 38.917 |
Pooled Solifenacin | 35.325 |
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Total Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12
Total (acidified) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Total uNGF/Cr was derived by dividing total uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant. (NCT01093534)
Timeframe: Week 12
Intervention | pg/µmol (Mean) |
---|
Placebo | 26.564 |
Solifenacin 5 mg | 30.135 |
Solifenacin 10 mg | 34.199 |
Pooled Solifenacin | 32.143 |
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Change From Baseline to Week 6 and Week 12 in Bladder Wall Thickness
Bladder wall thickness (BWT) measurements were obtained using transvaginal ultrasound. The BWT was derived as one mean value per image pooled over measurements of 3 locations (anterior wall, dome and trigone), and performed by 2 central readers and 1 adjudicator. (NCT01093534)
Timeframe: Baseline, Week 6 and Week 12
Intervention | mm (Mean) |
---|
| Week 6 (n=157, 145, 141, 286) | Week 12 (n=160, 143, 135, 278) |
---|
Placebo | -0.01 | 0.02 |
,Pooled Solifenacin | -0.09 | -0.24 |
,Solifenacin 10 mg | -0.14 | -0.22 |
,Solifenacin 5 mg | -0.04 | -0.26 |
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Change From Baseline to Week 6 and Week 12 in Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine
Free (neutralized) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Free (neutralized) uNGF/Cr was derived by dividing free (neutralized) uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant. (NCT01093534)
Timeframe: Baseline, Week 6 and Week 12
Intervention | pg/µmol (Mean) |
---|
| Week 6 (n=168, 163, 160, 323) | Week 12 (n=173, 171, 166, 337) |
---|
Placebo | -4.638 | -1.318 |
,Pooled Solifenacin | 4.481 | 1.699 |
,Solifenacin 10 mg | 4.309 | 2.625 |
,Solifenacin 5 mg | 4.650 | 0.801 |
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Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr) at Week 12
Brain derived neurotrophic factor (uBDNF) and creatinine (Cr) were measured from urine samples by the central laboratories. uBDNF/Cr was derived by dividing uBDNF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant. (NCT01093534)
Timeframe: Week 12
Intervention | pg/µmol (Mean) |
---|
Placebo | 116.9 |
Solifenacin 5 mg | 158.1 |
Solifenacin 10 mg | 160.4 |
Pooled Solifenacin | 159.2 |
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Change From Baseline in EuroQoL 5-Dimension Questionnaire Visual Analog Scale
"The participants' quality of life was assessed using the EuroQoL 5 Dimension Questionnaire (EQ-5D) visual analog scale (VAS).~Health status is completed by the participant indicating their own health state today by drawing a line on a vertical scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from Baseline indicates improvement." (NCT01093534)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Mean) |
---|
Placebo | 3.60 |
Solifenacin 5 mg | 4.80 |
Solifenacin 10 mg | 5.10 |
Pooled Solifenacin | 4.90 |
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Percentage of Participants With Improvement or Deterioration in Patient Perception of Bladder Condition (PPBC)
"The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'.~Improvement: ≥ 1 point improvement compared to Baseline; Major Improvement: ≥ 2 point improvement compared to Baseline; Deterioration: ≥ 1 point deterioration compared to Baseline." (NCT01093534)
Timeframe: Baseline and Week 12
Intervention | percentage of participants (Number) |
---|
| Deterioration | No change | Improvement | Major Improvement |
---|
Placebo | 15.4 | 34.9 | 49.7 | 27.4 |
,Pooled Solifenacin | 5.9 | 21.0 | 73.1 | 42.0 |
,Solifenacin 10 mg | 5.2 | 20.3 | 74.5 | 44.4 |
,Solifenacin 5 mg | 6.4 | 21.6 | 71.9 | 39.8 |
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Change From Baseline in Mean Number of Urgency Incontinence Episodes With PPIUS Grade 3 or 4 Per 24 Hours
"An urgency incontinence episode is defined as any incontinence episode classified by the participant as a grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.~The average number of grade 3 or 4 urgency incontinence episodes per 24 hours was calculated from the number of urgency incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits." (NCT01093534)
Timeframe: Baseline and Week 12
Intervention | urgency incontinence episodes (Mean) |
---|
Placebo | -0.71 |
Solifenacin 5 mg | -1.32 |
Solifenacin 10 mg | -0.90 |
Pooled Solifenacin | -1.09 |
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Change From Baseline in Mean Number of Urgency Incontinence Episodes With PPIUS Grade 4 Per 24 Hours
"An urgency incontinence episode is defined as any incontinence episode classified by the participant as a grade 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.~The average number of grade 4 urgency incontinence episodes per 24 hours was calculated from the number of urgency incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits." (NCT01093534)
Timeframe: Baseline and Week 12
Intervention | urgency incontinence episodes (Mean) |
---|
Placebo | -0.70 |
Solifenacin 5 mg | -0.96 |
Solifenacin 10 mg | -0.70 |
Pooled Solifenacin | -0.82 |
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Percentage of Participants With Improvement and Worsening on the 5 Dimensions of the EQ-5D
"The participants' quality of life was assessed using the EuroQoL 5 Dimension Questionnaire (EQ-5D). The EQ-5D is a standardized instrument for use as a measure of health outcome and is based on the following 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension participants were asked to select the statement which best described their health that day, from level 1 (indicating no problems) to 3 (indicating extreme problems/unable to perform).~Improvement was defined as a change from a state of being unable to perform or extreme problems at Baseline to no problems or to some or moderate problems at Week 12, and from some or moderate problems to no problems.~Worsening was defined as a change from no problems at Baseline to some or moderate problems or to a state of being unable to perform or extreme problems at Week 12, and from some or moderate problems to a state of being unable to perform or extreme problems." (NCT01093534)
Timeframe: Baseline and Week 12
Intervention | percentage of participants (Number) |
---|
| Mobility: Improvement | Mobility: Worsening | Self-care: Improvement | Self-care: Worsening | Usual Activities: Improvement | Usual Activities: Worsening | Pain/Discomfort: Improvement | Pain/Discomfort: Worsening | Anxiety/Depression: Improvement | Anxiety/Depression: Worsening |
---|
Placebo | 6.7 | 10.3 | 2.4 | 2.4 | 7.9 | 7.9 | 15.2 | 10.3 | 17.0 | 10.3 |
,Pooled Solifenacin | 10.0 | 5.3 | 3.7 | 3.7 | 9.3 | 8.0 | 18.9 | 8.0 | 18.6 | 12.3 |
,Solifenacin 10 mg | 9.6 | 3.4 | 3.4 | 4.1 | 11.0 | 4.8 | 18.5 | 4.8 | 19.9 | 13.7 |
,Solifenacin 5 mg | 10.3 | 7.1 | 3.9 | 3.2 | 7.7 | 11.0 | 19.4 | 11.0 | 17.4 | 11.0 |
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Change From Baseline in Cognitive Function Composite Score - Power of Attention
Cognitive effects were assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time to attain maximum plasma concentration (Tmax) for solifenacin (6 hours) and oxybutynin (2 hours). Power of attention is calculated from the sum of three cognitive function speed tests: Simple Reaction Time, Choice Reaction Time and the Speed of Detections in Digit Vigilance task. A low score reflects a fast reaction time and a high intensity of concentration. A positive change from baseline reflects impairment compared to the baseline assessment. (NCT01126424)
Timeframe: Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.
Intervention | msec (Mean) |
---|
| Baseline at 2 hours [Oxybutynin Tmax] | Change from Baseline at 2 hours | Baseline at 6 hours [Solifenacin Tmax] | Change from Baseline at 6 hours |
---|
Oxybutynin | 1423.38 | 17.81 | 1405.41 | -0.74 |
,Placebo | 1401.21 | 1.99 | 1393.98 | 11.77 |
,Solifenacin | 1413.67 | -5.86 | 1421.80 | -14.80 |
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Change From Baseline in Cognitive Function Composite Score - Quality of Episodic Secondary Memory
Cognitive effects were assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time of maximum plasma concentration for solifenacin and oxybutynin. Quality of episodic secondary memory is calculated from the sum of 4 tests: Immediate and delayed word recall, and word and picture recognition, and ranges from -200 to 400. A high score reflects a good ability to store, hold and retrieve information of an episodic nature (i.e. an event or a name) and a negative change from baseline reflects impairment compared to baseline. (NCT01126424)
Timeframe: Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.
Intervention | Scores on a scale (Mean) |
---|
| Baseline at 2 hours [Oxybutynin Tmax] | Change from Baseline at 2 hours | Baseline at 6 hours [Solifenacin Tmax] | Change from Baseline at 6 hours |
---|
Oxybutynin | 107.666333 | -0.917833 | 104.917167 | -3.502000 |
,Placebo | 110.000152 | 0.531515 | 106.515000 | 1.589394 |
,Solifenacin | 111.893636 | -3.788636 | 101.363485 | 7.728182 |
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Change From Baseline in Cognitive Function Composite Score - Quality of Working Memory
Cognitive effects were assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time to attain maximum plasma concentration (Tmax) for solifenacin (6 hours) and oxybutynin (2 hours). Quality of working memory is calculated from the sum of two cognitive function sensitivity tests: Numeric Working Memory Sensitivity and Spatial Working Memory Sensitivity, and ranges from -2 to 2. A higher score reflects a good working memory and a negative change from baseline reflects impairment compared to the baseline assessment. (NCT01126424)
Timeframe: Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.
Intervention | Scores on a scale (Mean) |
---|
| Baseline at 2 hours [Oxybutynin Tmax] | Change from Baseline at 2 hours | Baseline at 6 hours [Solifenacin Tmax] | Change from Baseline at 6 hours |
---|
Oxybutynin | 1.7251 | -0.0043 | 1.6441 | 0.0633 |
,Placebo | 1.7087 | 0.0492 | 1.7548 | 0.0047 |
,Solifenacin | 1.7921 | -0.0867 | 1.6666 | 0.0580 |
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Change From Baseline in Cognitive Function Composite Score - Speed of Memory
Cognitive effects were assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time to attain maximum plasma concentration for solifenacin and oxybutynin. Speed of Memory was calculated from the sum of 4 cognitive function speed tests: numeric and spatial working memory and word and picture recognition. A low score reflects that a person is able to recall a name, a face or any other item fast from the episodic secondary memory; a positive change from baseline reflects impairment compared to baseline. (NCT01126424)
Timeframe: Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.
Intervention | msec (Mean) |
---|
| Baseline at 2 hours [Oxybutynin Tmax] | Change from Baseline at 2 hours | Baseline at 6 hours [Solifenacin Tmax] | Change from Baseline at 6 hours |
---|
Oxybutynin | 4545.75 | -11.56 | 4606.51 | -118.14 |
,Placebo | 4741.30 | -240.62 | 4655.29 | -126.04 |
,Solifenacin | 4505.96 | 24.09 | 4496.65 | -149.79 |
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Change From Baseline in Postural Stability Test
"The postural stability test measures the ability to stand upright without moving, and was assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time to attain maximum plasma concentration for solifenacin and oxybutynin. Using apparatus modeled on the Wright Ataxia-meter, a cord from the meter is attached to the patient who is required to stand as still as possible with feet apart and eyes closed for 1 minute.~The amount of sway is expressed as the total angular movement, summed regardless of sign, in the antero-posterior plane and calibrated in units of one-third degree of angle of sway. Wright (1971) described a range of 20-30 units as a normal range for adults with eyes wide open, increasing by 50 to 100% with eyes shut." (NCT01126424)
Timeframe: Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.
Intervention | 1/3 degree of angle of sway (Mean) |
---|
| Baseline at 2 hours [Oxybutynin Tmax] | Change from Baseline at 2 hours | Baseline at 6 hours [Solifenacin Tmax] | Change from Baseline at 6 hours |
---|
Oxybutynin | 36.2 | 2.7 | 38.9 | 0.7 |
,Placebo | 37.5 | 0.4 | 40.0 | -0.1 |
,Solifenacin | 37.7 | 5.2 | 37.7 | 9.9 |
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Change From Baseline in Cognitive Function Composite Score - Continuity of Attention
Cognitive effects were assessed using a computerized assessment system at time points close to the predicted time of maximum plasma concentration for solifenacin and oxybutynin. For continuity of attention, the number of correct responses (out of 50) for choice reaction time was added to the total number of targets correctly identified (out of 45) digit vigilance minus the number of false alarms (total score of -45 to 95). A high score reflects someone able to keep his/her mind on a single task for a prolonged period. A negative change from baseline reflects impairment compared to baseline. (NCT01126424)
Timeframe: Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.
Intervention | Scores on a scale (Mean) |
---|
| Baseline at 2 hours [Oxybutynin Tmax] | Change from Baseline at 2 hours | Baseline at 6 hours [Solifenacin Tmax] | Change from Baseline at 6 hours |
---|
Oxybutynin | 91.300 | 0.150 | 91.901 | 0.100 |
,Placebo | 91.364 | 0.909 | 91.728 | -0.045 |
,Solifenacin | 91.591 | 0.545 | 91.228 | -0.318 |
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Change From Baseline in Score on OABq-SF
Values for the Overactive Bladder Questionnaire Short Form (OABq-SF) are changes from baseline in the adjusted mean scores for months 1 to 6. Scores on the OABq-SF range from 0 to 100, with higher scores on the symptom-severity scale indicating greater severity of symptoms and higher scores on the quality-of-life scale indicating better quality of life. Data were available for 123 participants in the Standardized Anticholinergic Regimen group and 119 in the Botox A A group. (NCT01166438)
Timeframe: Baseline through 6 months
Intervention | Change from baseline in score on OABq-SF (Mean) |
---|
| OABq-SF Symptom Severity Score | OABq-SF Quality of Life Score |
---|
Botox A | -44.08 | 37.13 |
,Standardized Anticholinergic Regimen | -44.55 | 37.05 |
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Change in PFDI-SF and PFIQ-SF Total Scores
Values for Pelvic Floor Distress Inventory Short Form (PFDI-SF) are changes from baseline in the adjusted mean scores for months 3 to 6. Scores on the PFDI-SF range from 0 to 300, with higher scores indicating more symptoms and more bothersome symptoms. Values for the Pelvic Floor Impact Questionnaire Short Form (PFIQ-SF) are changes from baseline in the adjusted mean scores for months 3 to 6. Scores on the PFIQ-SF range from 0 to 300, with higher scores indicating a more negative effect on activities, relationships, and feelings. (NCT01166438)
Timeframe: Baseline through 6 months
Intervention | Changes in adjusted mean scores (Mean) |
---|
| Change from baseline in PFDI-SF total score | Change from baseline in PFIQ-SF total score |
---|
Botox A | -48.20 | -33.85 |
,Standardized Anticholinergic Regimen | -43.69 | -32.82 |
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Change in Urge Urinary Incontinence (UUI) Episodes
Change from baseline in mean number of UUI episodes over 6 month double-blind period. (NCT01166438)
Timeframe: Baseline through 6 months
Intervention | Mean change in UUI episodes from baselin (Mean) |
---|
| 1 Month | 2 Months | 3 Months | 4 Months | 5 Months | 6 Months |
---|
Botox A | -3.13 | -3.32 | -3.22 | -3.36 | -3.42 | -3.27 |
,Standardized Anticholinergic Regimen | -3.15 | -3.25 | -3.55 | -3.40 | -3.49 | -3.33 |
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Efficacy
Efficacy outcomes assessed reduction and resolution of incontinence, including urgency urinary incontinence (UUI). (NCT01166438)
Timeframe: 6 months
Intervention | Participants (Count of Participants) |
---|
| Complete resolution of UUI | Complete resolution of all incontinence | >75% reduction in UUI episodes |
---|
Botox A | 30 | 26 | 61 |
,Standardized Anticholinergic Regimen | 16 | 13 | 48 |
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Patient Global Impression of Improvement
The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had adequate improvement, defined as a rating of 1 or 2 (much better). (NCT01166438)
Timeframe: 3 and 6 months
Intervention | Participants (Count of Participants) |
---|
| Month 3 | Month 6 |
---|
Botox A | 61 | 60 |
,Standardized Anticholinergic Regimen | 59 | 67 |
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Time to Continence
Days to zero pad continence were assessed by patient self-reported Pad free continence declaration card. (NCT01215721)
Timeframe: 12 months
Intervention | Days to Continence (Median) |
---|
Vesicare, 5mg Treatment Group | 95 |
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Percentage of Participants With a Micturition Response
A responder is defined as a participant with at most 8 micturitions per 24 hours post-baseline and a negative change (i.e. an improvement) from Baseline. (NCT01340027)
Timeframe: Baseline and Weeks 2, 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 2; n=79,70,75,71,144,72,143,143,135,137,77,76 | Week 4; n=78,72,73,73,144,72,139,140,137,140,77,74 | Week 8; n=76,70,73,72,145,73,141,140,133,142,77,73 | Week 12;n=74,69,72,69,142,72,136,136,132,142,75,72 | EOT; n=79,75,76,73,146,75,144,145,140,146,78,79 |
---|
Mirabegron 25 mg | 25.7 | 27.8 | 35.7 | 46.4 | 42.7 |
,Mirabegron 50 mg | 37.3 | 43.8 | 50.7 | 47.2 | 47.4 |
,Placebo | 27.8 | 42.3 | 53.9 | 55.4 | 53.2 |
,Solifenacin 10 mg | 34.7 | 44.4 | 56.2 | 55.6 | 54.7 |
,Solifenacin 10 mg + Mirabegron 25 mg | 36.4 | 48.1 | 57.1 | 65.3 | 65.4 |
,Solifenacin 10 mg + Mirabegron 50 mg | 46.1 | 41.9 | 64.4 | 61.1 | 58.2 |
,Solifenacin 2.5 mg | 29.6 | 35.6 | 43.1 | 53.6 | 54.8 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | 36.4 | 45.3 | 46.8 | 55.1 | 54.2 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | 38.5 | 42.1 | 54.3 | 55.1 | 53.1 |
,Solifenacin 5 mg | 26.4 | 34.0 | 40.0 | 47.9 | 47.9 |
,Solifenacin 5 mg + Mirabegron 25 mg | 34.1 | 48.2 | 49.6 | 53.8 | 52.1 |
,Solifenacin 5 mg + Mirabegron 50 mg | 36.5 | 56.4 | 56.3 | 62.0 | 61.6 |
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Percentage of Participants With Zero Incontinence Episodes Post-baseline
The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the participant. (NCT01340027)
Timeframe: Weeks 2, 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | EOT; n=17,13,18,15,35,15,35,33,32,24,24,20 |
---|
Mirabegron 25 mg | 23.1 | 20.0 | 50.0 | 50.0 | 46.2 |
,Mirabegron 50 mg | 44.4 | 55.6 | 61.1 | 61.1 | 61.1 |
,Placebo | 47.1 | 64.7 | 58.8 | 82.4 | 82.4 |
,Solifenacin 10 mg | 50.0 | 71.4 | 73.3 | 57.1 | 53.3 |
,Solifenacin 10 mg + Mirabegron 25 mg | 70.8 | 79.2 | 79.2 | 79.2 | 79.2 |
,Solifenacin 10 mg + Mirabegron 50 mg | 52.6 | 52.6 | 65.0 | 75.0 | 75.0 |
,Solifenacin 2.5 mg | 40.0 | 73.3 | 71.4 | 69.2 | 66.7 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | 40.0 | 55.9 | 54.3 | 51.5 | 54.3 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | 51.5 | 46.7 | 50.0 | 63.3 | 60.6 |
,Solifenacin 5 mg | 45.5 | 64.7 | 50.0 | 58.8 | 60.0 |
,Solifenacin 5 mg + Mirabegron 25 mg | 65.6 | 62.5 | 71.9 | 86.7 | 87.5 |
,Solifenacin 5 mg + Mirabegron 50 mg | 52.4 | 52.2 | 77.3 | 87.0 | 87.5 |
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Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of participants in that category." (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No pain → No pain | No pain → Moderate pain | No pain → Extreme pain | No pain → Missing data | Moderate pain → No pain | Moderate pain → Moderate pain | Moderate pain → Extreme pain | Moderate pain → Missing data | Extreme pain → No pain | Extreme pain → Moderate pain | Extreme pain → Extreme pain | Extreme pain → Missing data | Missing data → No pain | Missing data → Moderate pain | Missing data → Extreme pain | Missing data → Missing data |
---|
Mirabegron 25 mg | 33 | 12 | 0 | 0 | 14 | 15 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
,Mirabegron 50 mg | 40 | 6 | 0 | 0 | 10 | 19 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
,Placebo | 38 | 9 | 0 | 0 | 12 | 16 | 1 | 1 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 10 mg | 35 | 3 | 1 | 1 | 13 | 18 | 0 | 0 | 2 | 0 | 3 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 10 mg + Mirabegron 25 mg | 39 | 8 | 0 | 0 | 14 | 12 | 1 | 0 | 0 | 3 | 1 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 10 mg + Mirabegron 50 mg | 32 | 6 | 0 | 2 | 20 | 18 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 2.5 mg | 38 | 4 | 0 | 0 | 12 | 19 | 1 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | 67 | 6 | 1 | 1 | 24 | 37 | 4 | 0 | 3 | 2 | 0 | 0 | 0 | 1 | 0 | 0 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | 61 | 11 | 0 | 1 | 34 | 33 | 1 | 0 | 1 | 2 | 2 | 0 | 0 | 1 | 0 | 0 |
,Solifenacin 5 mg | 70 | 15 | 0 | 0 | 24 | 37 | 0 | 0 | 1 | 1 | 2 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 25 mg | 66 | 14 | 0 | 0 | 28 | 27 | 0 | 2 | 1 | 2 | 1 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 50 mg | 73 | 7 | 0 | 1 | 36 | 25 | 0 | 1 | 1 | 4 | 0 | 0 | 2 | 0 | 0 | 0 |
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Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself.~In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category." (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No problem → No problem | No problem → Some problems | No problem → Unable | No problem → Missing data | Some problems → No problems | Some problems → Some problems | Some problems → Unable | Some problems → Missing data | Unable → No problems | Unable → Some problems | Unable → Unable | Unable → Missing data | Missing data → No problem | Missing data → Some problems | Missing data → Unable | Missing data → Missing data |
---|
Mirabegron 25 mg | 69 | 1 | 0 | 0 | 4 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Mirabegron 50 mg | 73 | 3 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Placebo | 76 | 0 | 0 | 1 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 10 mg | 68 | 2 | 1 | 1 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 10 mg + Mirabegron 25 mg | 74 | 1 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 10 mg + Mirabegron 50 mg | 72 | 0 | 0 | 2 | 2 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 2.5 mg | 72 | 2 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | 128 | 5 | 0 | 1 | 8 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | 138 | 2 | 0 | 1 | 3 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
,Solifenacin 5 mg | 138 | 2 | 1 | 0 | 6 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 25 mg | 130 | 1 | 0 | 2 | 3 | 4 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 50 mg | 141 | 1 | 0 | 2 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
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Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
"The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities.~In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category." (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No problem → No problem | No problem → Some problems | No problem → Unable | No problem → Missing data | Some problems → No problems | Some problems → Some problems | Some problems → Unable | Some problems → Missing data | Unable → No problems | Unable → Some problems | Unable → Unable | Unable → Missing data | Missing data → No problem | Missing data → Some problems | Missing data → Unable | Missing data → Missing data |
---|
Mirabegron 25 mg | 52 | 2 | 0 | 0 | 11 | 10 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Mirabegron 50 mg | 58 | 3 | 0 | 1 | 8 | 6 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
,Placebo | 62 | 2 | 0 | 0 | 11 | 4 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 10 mg | 57 | 4 | 1 | 1 | 7 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 10 mg + Mirabegron 25 mg | 57 | 1 | 0 | 0 | 14 | 4 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 10 mg + Mirabegron 50 mg | 48 | 5 | 1 | 2 | 14 | 8 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 2.5 mg | 60 | 2 | 0 | 0 | 11 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | 89 | 8 | 0 | 1 | 29 | 18 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | 110 | 3 | 0 | 1 | 24 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
,Solifenacin 5 mg | 115 | 3 | 0 | 0 | 16 | 13 | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 25 mg | 106 | 9 | 0 | 1 | 12 | 11 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 50 mg | 109 | 4 | 0 | 2 | 21 | 12 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
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Change From Baseline to Each Visit in Mean Level of Urgency
Average of participants' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in the 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. (NCT01340027)
Timeframe: Baseline and Weeks 2, 4, 8 and 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | EOT; n=80,76,77,77,150,76,146,147,141,150,78,80 |
---|
Mirabegron 25 mg | -0.19 | -0.28 | -0.30 | -0.35 | -0.33 |
,Mirabegron 50 mg | -0.15 | -0.26 | -0.36 | -0.44 | -0.41 |
,Placebo | -0.24 | -0.32 | -0.42 | -0.48 | -0.46 |
,Solifenacin 10 mg | -0.21 | -0.35 | -0.44 | -0.49 | -0.47 |
,Solifenacin 10 mg + Mirabegron 25 mg | -0.31 | -0.41 | -0.53 | -0.61 | -0.59 |
,Solifenacin 10 mg + Mirabegron 50 mg | -0.20 | -0.31 | -0.43 | -0.49 | -0.47 |
,Solifenacin 2.5 mg | -0.25 | -0.33 | -0.45 | -0.42 | -0.45 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | -0.19 | -0.32 | -0.39 | -0.43 | -0.42 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | -0.26 | -0.35 | -0.41 | -0.54 | -0.50 |
,Solifenacin 5 mg | -0.14 | -0.23 | -0.30 | -0.33 | -0.33 |
,Solifenacin 5 mg + Mirabegron 25 mg | -0.26 | -0.35 | -0.45 | -0.50 | -0.48 |
,Solifenacin 5 mg + Mirabegron 50 mg | -0.28 | -0.37 | -0.46 | -0.54 | -0.55 |
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Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit. (NCT01340027)
Timeframe: Baseline and Weeks 2, 4, 8 and 12
Intervention | incontinence episodes (Least Squares Mean) |
---|
| Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 |
---|
Mirabegron 25 mg | -0.43 | -0.48 | -0.65 | -0.59 |
,Mirabegron 50 mg | -0.85 | -0.89 | -0.92 | -0.89 |
,Placebo | -0.83 | -0.87 | -0.82 | -0.93 |
,Solifenacin 10 mg | -0.71 | -0.84 | -1.04 | -0.95 |
,Solifenacin 10 mg + Mirabegron 25 mg | -1.14 | -1.18 | -0.93 | -0.27 |
,Solifenacin 10 mg + Mirabegron 50 mg | -0.77 | -0.71 | -0.91 | -0.96 |
,Solifenacin 2.5 mg | -0.98 | -1.20 | -1.12 | -1.21 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | -0.49 | -0.73 | -0.78 | -0.74 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | -0.64 | -0.67 | -0.82 | -0.88 |
,Solifenacin 5 mg | -0.67 | -0.80 | -0.72 | -0.84 |
,Solifenacin 5 mg + Mirabegron 25 mg | -0.70 | -0.81 | -1.01 | -1.20 |
,Solifenacin 5 mg + Mirabegron 50 mg | -0.65 | -0.88 | -0.95 | -1.11 |
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Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit. (NCT01340027)
Timeframe: Baseline and Weeks 2, 4, 8 and 12
Intervention | micturitions (Least Squares Mean) |
---|
| Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 |
---|
Mirabegron 25 mg | -1.69 | -2.02 | -2.27 | -2.51 |
,Mirabegron 50 mg | -1.60 | -1.99 | -2.42 | -2.67 |
,Placebo | -1.18 | -1.68 | -2.27 | -2.59 |
,Solifenacin 10 mg | -1.32 | -2.25 | -2.97 | -3.31 |
,Solifenacin 10 mg + Mirabegron 25 mg | -1.74 | -2.55 | -3.04 | -3.47 |
,Solifenacin 10 mg + Mirabegron 50 mg | -2.35 | -2.69 | -3.49 | -3.63 |
,Solifenacin 2.5 mg | -1.49 | -2.10 | -2.46 | -2.38 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | -1.52 | -2.03 | -2.58 | -2.64 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | -1.95 | -2.11 | -2.66 | -3.02 |
,Solifenacin 5 mg | -1.16 | -1.80 | -2.22 | -2.58 |
,Solifenacin 5 mg + Mirabegron 25 mg | -1.68 | -2.29 | -2.43 | -2.64 |
,Solifenacin 5 mg + Mirabegron 50 mg | -2.21 | -2.77 | -3.20 | -3.35 |
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Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours
Nocturia is defined as waking at night one or more times to void. The average number of times a participant urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day micturition diary. (NCT01340027)
Timeframe: Baseline and Weeks 2, 4, 8 and 12
Intervention | nocturia episodes (Least Squares Mean) |
---|
| Week 2; n=78,69,75,72,144,71,142,138,133,138,74,73 | Week 4; n=77,69,74,74,143,71,138,135,134,141,74,71 | Week 8; n=75,67,73,73,143,72,140,135,130,142,74,70 | Week 12;n=73,66,73,71,140,71,135,131,130,141,72,69 | EOT; n=78,73,76,75,146,74,143,140,137,147,75,76 |
---|
Mirabegron 25 mg | -0.37 | -0.60 | -0.65 | -0.69 | -0.69 |
,Mirabegron 50 mg | -0.60 | -0.71 | -0.68 | -0.84 | -0.82 |
,Placebo | -0.33 | -0.50 | -0.64 | -0.79 | -0.74 |
,Solifenacin 10 mg | -0.45 | -0.74 | -1.01 | -0.99 | -0.95 |
,Solifenacin 10 mg + Mirabegron 25 mg | -0.43 | -0.67 | -0.81 | -0.98 | -0.94 |
,Solifenacin 10 mg + Mirabegron 50 mg | -0.53 | -0.75 | -0.91 | -1.03 | -0.96 |
,Solifenacin 2.5 mg | -0.38 | -0.55 | -0.80 | -0.59 | -0.68 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | -0.43 | -0.59 | -0.76 | -0.75 | -0.73 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | -0.51 | -0.54 | -0.79 | -0.81 | -0.77 |
,Solifenacin 5 mg | -0.30 | -0.47 | -0.65 | -0.70 | -0.69 |
,Solifenacin 5 mg + Mirabegron 25 mg | -0.49 | -0.69 | -0.76 | -0.80 | -0.77 |
,Solifenacin 5 mg + Mirabegron 50 mg | -0.61 | -0.80 | -0.98 | -1.05 | -1.04 |
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Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours
The average number of times a participant recorded a new pad used per day during the 3-day micturition diary period. (NCT01340027)
Timeframe: Baseline and Weeks 2, 4, 8 and 12
Intervention | pads (Least Squares Mean) |
---|
| Week 2; n=33,33,34,31,74,23,62,55,62,62,45,30 | Week 4; n=32,31,35,31,75,23,61,52,64,62,45,30 | Week 8; n=30,31,34,31,74,24,63,52,64,61,45,30 | Week 12; n=30,31,34,29,72,23,60,52,63,62,45,31 | EOT; n=33,34,35,32,76,24,63,56,64,65,46,32 |
---|
Mirabegron 25 mg | -0.87 | -0.93 | -0.90 | -0.97 | -1.04 |
,Mirabegron 50 mg | -0.88 | -0.70 | -1.11 | -0.93 | -0.95 |
,Placebo | -0.81 | -0.76 | -0.97 | -0.92 | -0.63 |
,Solifenacin 10 mg | -0.91 | -1.23 | -1.53 | -1.75 | -1.73 |
,Solifenacin 10 mg + Mirabegron 25 mg | -1.13 | -1.35 | -1.37 | -1.60 | -1.59 |
,Solifenacin 10 mg + Mirabegron 50 mg | -1.31 | -1.36 | -1.56 | -1.60 | -1.63 |
,Solifenacin 2.5 mg | -1.31 | -1.62 | -1.47 | -1.35 | -1.44 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | -0.86 | -0.94 | -1.10 | -1.02 | -1.04 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | -0.96 | -1.09 | -1.39 | -1.44 | -1.38 |
,Solifenacin 5 mg | -0.92 | -1.26 | -1.25 | -1.39 | -1.38 |
,Solifenacin 5 mg + Mirabegron 25 mg | -0.89 | -1.24 | -1.29 | -1.45 | -1.46 |
,Solifenacin 5 mg + Mirabegron 50 mg | -1.02 | -1.30 | -1.51 | -1.63 | -1.63 |
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Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the participant in the 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. (NCT01340027)
Timeframe: Baseline and Weeks 2, 4, 8 and 12
Intervention | urgency episodes (Least Squares Mean) |
---|
| Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | EOT; n=80,76,77,77,150,76,146,147,141,150,78,80 |
---|
Mirabegron 25 mg | -2.06 | -2.70 | -2.86 | -3.31 | -3.23 |
,Mirabegron 50 mg | -1.91 | -2.70 | -3.27 | -3.65 | -3.44 |
,Placebo | -2.07 | -2.55 | -3.42 | -3.69 | -3.53 |
,Solifenacin 10 mg | -1.97 | -3.02 | -3.63 | -4.15 | -3.98 |
,Solifenacin 10 mg + Mirabegron 25 mg | -2.35 | -3.04 | -3.53 | -3.76 | -3.71 |
,Solifenacin 10 mg + Mirabegron 50 mg | -2.23 | -2.81 | -3.63 | -3.93 | -3.91 |
,Solifenacin 2.5 mg | -2.49 | -3.16 | -3.61 | -3.54 | -3.62 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | -1.84 | -2.64 | -3.34 | -3.26 | -3.21 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | -2.59 | -3.14 | -3.60 | -4.24 | -3.97 |
,Solifenacin 5 mg | -1.63 | -2.24 | -2.67 | -2.71 | -2.73 |
,Solifenacin 5 mg + Mirabegron 25 mg | -2.30 | -3.08 | -3.60 | -3.98 | -3.86 |
,Solifenacin 5 mg + Mirabegron 50 mg | -2.57 | -3.17 | -3.85 | -4.09 | -4.10 |
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Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Urgency incontinence is the involuntary leakage of urine accompanied by or immediately preceded by urgency, and was derived from the number of incontinence episodes classified by the participant in a 3-day micturition diary as Grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. (NCT01340027)
Timeframe: Baseline and Weeks 2, 4, 8 and 12
Intervention | urgency incontinence episodes (Least Squares Mean) |
---|
| Week 2; n=14,13,17,15,33,12,29,33,31,21,24,18 | Week 4; n=14,10,17,15,34,12,28,30,31,22,24,18 | Week 8; n=14,10,17,14,34,13,29,30,31,21,24,19 | Week 12; n=14,10,17,13,34,12,28,30,29,22,24,19 | EOT; n=14,13,17,15,35,13,29,33,31,23,24,19 |
---|
Mirabegron 25 mg | -0.59 | -0.48 | -0.65 | -0.54 | -0.80 |
,Mirabegron 50 mg | -0.83 | -0.93 | -1.00 | -0.87 | -0.88 |
,Placebo | -0.80 | -0.83 | -0.86 | -0.84 | -0.86 |
,Solifenacin 10 mg | -0.77 | -1.00 | -1.16 | -1.13 | -1.13 |
,Solifenacin 10 mg + Mirabegron 25 mg | -1.12 | -1.20 | -0.91 | -0.28 | -0.28 |
,Solifenacin 10 mg + Mirabegron 50 mg | -0.76 | -0.68 | -0.88 | -0.93 | -0.94 |
,Solifenacin 2.5 mg | -0.96 | -1.13 | -1.04 | -1.13 | -1.17 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | -0.52 | -0.73 | -0.86 | -0.81 | -0.81 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | -0.68 | -0.70 | -0.84 | -0.91 | -0.87 |
,Solifenacin 5 mg | -0.66 | -0.77 | -0.76 | -0.83 | -0.86 |
,Solifenacin 5 mg + Mirabegron 25 mg | -0.68 | -0.81 | -0.99 | -1.19 | -1.20 |
,Solifenacin 5 mg + Mirabegron 50 mg | -0.64 | -0.86 | -0.89 | -1.06 | -1.08 |
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Change From Baseline to Each Visit in Mean Volume Voided Per Micturition
The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and each post-baseline clinic visit. (NCT01340027)
Timeframe: Baseline and Weeks 2, 4, 8 and 12
Intervention | mL (Least Squares Mean) |
---|
| Week 2; n=80,71,76,74,148,73,145,145,136,141,76,77 | Week 4; n=79,72,74,76,146,72,141,142,138,144,77,75 | Week 8; n=77,70,73,75,147,73,143,142,134,143,76,74 | Week 12;n=75,68,73,73,144,72,138,138,133,140,72,73 |
---|
Mirabegron 25 mg | 14.3 | 16.8 | 24.6 | 23.0 |
,Mirabegron 50 mg | 26.0 | 29.4 | 35.4 | 35.5 |
,Placebo | 8.7 | 10.2 | 13.5 | 14.7 |
,Solifenacin 10 mg | 16.1 | 28.3 | 37.7 | 35.8 |
,Solifenacin 10 mg + Mirabegron 25 mg | 29.5 | 45.7 | 55.8 | 59.8 |
,Solifenacin 10 mg + Mirabegron 50 mg | 42.1 | 54.5 | 68.5 | 66.2 |
,Solifenacin 2.5 mg | 22.7 | 24.8 | 28.3 | 36.9 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | 22.5 | 29.2 | 35.6 | 38.6 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | 29.2 | 36.5 | 42.3 | 43.7 |
,Solifenacin 5 mg | 23.1 | 29.6 | 30.1 | 34.6 |
,Solifenacin 5 mg + Mirabegron 25 mg | 29.9 | 42.7 | 49.7 | 54.7 |
,Solifenacin 5 mg + Mirabegron 50 mg | 32.3 | 44.5 | 52.2 | 56.6 |
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Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI)
This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant's assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant's assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicates improvement. (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Mean) |
---|
| Percent work time missed | Percent impairment while working | Percent overall work impairment | Percent activity impairment |
---|
Mirabegron 25 mg | 0.53 | -16.13 | -16.32 | -14.52 |
,Mirabegron 50 mg | -0.24 | -10.00 | -9.91 | -13.95 |
,Placebo | -2.44 | -7.50 | -9.50 | -9.62 |
,Solifenacin 10 mg | -0.28 | -10.00 | -9.95 | -17.12 |
,Solifenacin 10 mg + Mirabegron 25 mg | 0.79 | -18.00 | -17.69 | -19.34 |
,Solifenacin 10 mg + Mirabegron 50 mg | -1.12 | -9.29 | -10.32 | -19.74 |
,Solifenacin 2.5 mg | -2.85 | -16.67 | -17.88 | -13.73 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | -0.55 | -8.43 | -8.59 | -14.11 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | -0.83 | -17.72 | -17.16 | -25.31 |
,Solifenacin 5 mg | -1.29 | -17.33 | -17.26 | -14.38 |
,Solifenacin 5 mg + Mirabegron 25 mg | -0.84 | -13.85 | -14.00 | -17.43 |
,Solifenacin 5 mg + Mirabegron 50 mg | -1.65 | -13.39 | -14.18 | -20.42 |
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Percentage of Participants With 50% Reduction in Incontinence Episodes
The percentage of participants with at least a 50% decrease from Baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the participant's micturition diary. (NCT01340027)
Timeframe: Baseline and Weeks 2, 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | EOT; n=17,13,18,15,35,15,35,33,32,24,24,20 |
---|
Mirabegron 25 mg | 30.8 | 40.0 | 60.0 | 70.0 | 61.5 |
,Mirabegron 50 mg | 66.7 | 72.2 | 77.8 | 77.8 | 77.8 |
,Placebo | 64.7 | 82.4 | 76.5 | 94.1 | 94.1 |
,Solifenacin 10 mg | 57.1 | 78.6 | 86.7 | 64.3 | 66.7 |
,Solifenacin 10 mg + Mirabegron 25 mg | 91.7 | 95.8 | 91.7 | 95.8 | 95.8 |
,Solifenacin 10 mg + Mirabegron 50 mg | 68.4 | 68.4 | 75.0 | 90.0 | 90.0 |
,Solifenacin 2.5 mg | 73.3 | 86.7 | 85.7 | 84.6 | 86.7 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | 51.4 | 64.7 | 82.9 | 66.7 | 68.6 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | 66.7 | 63.3 | 73.3 | 80.0 | 75.8 |
,Solifenacin 5 mg | 57.6 | 76.5 | 58.8 | 73.5 | 74.3 |
,Solifenacin 5 mg + Mirabegron 25 mg | 71.9 | 75.0 | 90.6 | 96.7 | 96.9 |
,Solifenacin 5 mg + Mirabegron 50 mg | 66.7 | 78.3 | 81.8 | 95.7 | 95.8 |
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Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category." (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No anxiety → No anxiety | No anxiety → Moderate anxiety | No anxiety → Extreme anxiety | No anxiety → Missing data | Moderate anxiety → No anxiety | Moderate anxiety → Moderate anxiety | Moderate anxiety → Extreme anxiety | Moderate anxiety → Missing data | Extreme anxiety → No anxiety | Extreme anxiety → Moderate anxiety | Extreme anxiety → Extreme anxiety | Extreme anxiety → Missing data | Missing data → No anxiety | Missing data → Moderate anxiety | Missing data → Extreme anxiety | Missing data → Missing data |
---|
Mirabegron 25 mg | 38 | 8 | 0 | 0 | 9 | 18 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
,Mirabegron 50 mg | 39 | 7 | 0 | 0 | 15 | 14 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Placebo | 41 | 5 | 1 | 0 | 17 | 13 | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 0 |
,Solifenacin 10 mg | 36 | 6 | 0 | 0 | 19 | 12 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 10 mg + Mirabegron 25 mg | 44 | 5 | 0 | 0 | 15 | 8 | 0 | 0 | 3 | 1 | 2 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 10 mg + Mirabegron 50 mg | 36 | 6 | 0 | 2 | 14 | 19 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 2.5 mg | 42 | 4 | 0 | 0 | 21 | 9 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | 81 | 7 | 0 | 1 | 25 | 21 | 1 | 0 | 1 | 7 | 1 | 0 | 1 | 0 | 0 | 0 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | 78 | 5 | 1 | 1 | 35 | 22 | 0 | 0 | 2 | 1 | 1 | 0 | 0 | 0 | 1 | 0 |
,Solifenacin 5 mg | 76 | 11 | 1 | 0 | 24 | 33 | 2 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 25 mg | 76 | 9 | 0 | 1 | 28 | 19 | 1 | 1 | 2 | 4 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 50 mg | 80 | 3 | 0 | 1 | 33 | 26 | 1 | 1 | 2 | 1 | 0 | 0 | 2 | 0 | 0 | 0 |
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Percentage of Participants With Major Improvement in PPBC
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Major improvement was defined as at least a 2-point improvement (decrease) from Baseline in PPBC score. (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | percentage of participants (Number) |
---|
Placebo | 39.7 |
Mirabegron 25 mg | 42.5 |
Mirabegron 50 mg | 38.2 |
Solifenacin 2.5 mg | 44.0 |
Solifenacin 5 mg | 42.2 |
Solifenacin 10 mg | 46.6 |
Solifenacin 2.5 mg + Mirabegron 25 mg | 48.2 |
Solifenacin 2.5 mg + Mirabegron 50 mg | 52.4 |
Solifenacin 5 mg + Mirabegron 25 mg | 54.4 |
Solifenacin 5 mg + Mirabegron 50 mg | 54.9 |
Solifenacin 10 mg + Mirabegron 25 mg | 57.9 |
Solifenacin 10 mg + Mirabegron 50 mg | 50.0 |
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Percentage of Participants With Improvement in PPBC
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1-point improvement (decrease) from Baseline in PPBC score. (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | percentage of participants (Number) |
---|
Placebo | 69.2 |
Mirabegron 25 mg | 76.7 |
Mirabegron 50 mg | 78.9 |
Solifenacin 2.5 mg | 68.0 |
Solifenacin 5 mg | 72.8 |
Solifenacin 10 mg | 84.9 |
Solifenacin 2.5 mg + Mirabegron 25 mg | 74.5 |
Solifenacin 2.5 mg + Mirabegron 50 mg | 83.2 |
Solifenacin 5 mg + Mirabegron 25 mg | 77.9 |
Solifenacin 5 mg + Mirabegron 50 mg | 82.6 |
Solifenacin 10 mg + Mirabegron 25 mg | 82.9 |
Solifenacin 10 mg + Mirabegron 50 mg | 75.6 |
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Percentage of Participants With Deterioration in PPBC
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Deterioration was defined as at least a 1 point increase from Baseline in PPBC score. (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | percentage of participants (Number) |
---|
Placebo | 6.4 |
Mirabegron 25 mg | 4.1 |
Mirabegron 50 mg | 5.3 |
Solifenacin 2.5 mg | 4.0 |
Solifenacin 5 mg | 4.8 |
Solifenacin 10 mg | 2.7 |
Solifenacin 2.5 mg + Mirabegron 25 mg | 4.3 |
Solifenacin 2.5 mg + Mirabegron 50 mg | 2.8 |
Solifenacin 5 mg + Mirabegron 25 mg | 2.9 |
Solifenacin 5 mg + Mirabegron 50 mg | 1.4 |
Solifenacin 10 mg + Mirabegron 25 mg | 1.3 |
Solifenacin 10 mg + Mirabegron 50 mg | 6.4 |
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Percentage of Participants With a Symptom Bother Response
Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. Symptom bother response is defined as improvement (decrease) of at least 10 points from Baseline. (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | percentage of participants (Number) |
---|
Placebo | 73.4 |
Mirabegron 25 mg | 84.0 |
Mirabegron 50 mg | 78.9 |
Solifenacin 2.5 mg | 85.7 |
Solifenacin 5 mg | 81.3 |
Solifenacin 10 mg | 85.3 |
Solifenacin 2.5 mg + Mirabegron 25 mg | 82.6 |
Solifenacin 2.5 mg + Mirabegron 50 mg | 85.5 |
Solifenacin 5 mg + Mirabegron 25 mg | 85.6 |
Solifenacin 5 mg + Mirabegron 50 mg | 88.4 |
Solifenacin 10 mg + Mirabegron 25 mg | 88.5 |
Solifenacin 10 mg + Mirabegron 50 mg | 83.3 |
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Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS)
The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). A positive change from Baseline indicates improvement. (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | 2.44 |
Mirabegron 25 mg | 2.61 |
Mirabegron 50 mg | 3.17 |
Solifenacin 2.5 mg | 3.10 |
Solifenacin 5 mg | 2.78 |
Solifenacin 10 mg | 2.96 |
Solifenacin 2.5 mg + Mirabegron 25 mg | 2.96 |
Solifenacin 2.5 mg + Mirabegron 50 mg | 3.24 |
Solifenacin 5 mg + Mirabegron 25 mg | 3.47 |
Solifenacin 5 mg + Mirabegron 50 mg | 3.24 |
Solifenacin 10 mg + Mirabegron 25 mg | 3.51 |
Solifenacin 10 mg + Mirabegron 50 mg | 3.72 |
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Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)
Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements. (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | -25.5 |
Mirabegron 25 mg | -27.1 |
Mirabegron 50 mg | -27.5 |
Solifenacin 2.5 mg | -29.8 |
Solifenacin 5 mg | -26.8 |
Solifenacin 10 mg | -29.9 |
Solifenacin 2.5 mg + Mirabegron 25 mg | -28.0 |
Solifenacin 2.5 mg + Mirabegron 50 mg | -31.7 |
Solifenacin 5 mg + Mirabegron 25 mg | -32.0 |
Solifenacin 5 mg + Mirabegron 50 mg | -33.5 |
Solifenacin 10 mg + Mirabegron 25 mg | -33.6 |
Solifenacin 10 mg + Mirabegron 50 mg | -31.4 |
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Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC)
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement. (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | -1.4 |
Mirabegron 25 mg | -1.4 |
Mirabegron 50 mg | -1.5 |
Solifenacin 2.5 mg | -1.5 |
Solifenacin 5 mg | -1.3 |
Solifenacin 10 mg | -1.5 |
Solifenacin 2.5 mg + Mirabegron 25 mg | -1.4 |
Solifenacin 2.5 mg + Mirabegron 50 mg | -1.7 |
Solifenacin 5 mg + Mirabegron 25 mg | -1.7 |
Solifenacin 5 mg + Mirabegron 50 mg | -1.8 |
Solifenacin 10 mg + Mirabegron 25 mg | -1.8 |
Solifenacin 10 mg + Mirabegron 50 mg | -1.6 |
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Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits. (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | micturitions (Least Squares Mean) |
---|
Placebo | -2.43 |
Mirabegron 25 mg | -2.48 |
Mirabegron 50 mg | -2.56 |
Solifenacin 2.5 mg | -2.44 |
Solifenacin 5 mg | -2.54 |
Solifenacin 10 mg | -3.22 |
Solifenacin 2.5 mg + Mirabegron 25 mg | -2.58 |
Solifenacin 2.5 mg + Mirabegron 50 mg | -2.93 |
Solifenacin 5 mg + Mirabegron 25 mg | -2.56 |
Solifenacin 5 mg + Mirabegron 50 mg | -3.34 |
Solifenacin 10 mg + Mirabegron 25 mg | -3.42 |
Solifenacin 10 mg + Mirabegron 50 mg | -3.52 |
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Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits. (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | incontinence episodes (Least Squares Mean) |
---|
Placebo | -0.95 |
Mirabegron 25 mg | -0.74 |
Mirabegron 50 mg | -0.90 |
Solifenacin 2.5 mg | -1.26 |
Solifenacin 5 mg | -0.88 |
Solifenacin 10 mg | -0.97 |
Solifenacin 2.5 mg + Mirabegron 25 mg | -0.75 |
Solifenacin 2.5 mg + Mirabegron 50 mg | -0.85 |
Solifenacin 5 mg + Mirabegron 25 mg | -1.22 |
Solifenacin 5 mg + Mirabegron 50 mg | -1.14 |
Solifenacin 10 mg + Mirabegron 25 mg | -0.27 |
Solifenacin 10 mg + Mirabegron 50 mg | -0.97 |
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Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement. (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Mean) |
---|
Placebo | 13.1 |
Mirabegron 25 mg | 5.8 |
Mirabegron 50 mg | 14.3 |
Solifenacin 2.5 mg | 11.1 |
Solifenacin 5 mg | 11.9 |
Solifenacin 10 mg | 13.3 |
Solifenacin 2.5 mg + Mirabegron 25 mg | 11.6 |
Solifenacin 2.5 mg + Mirabegron 50 mg | 12.5 |
Solifenacin 5 mg + Mirabegron 25 mg | 11.8 |
Solifenacin 5 mg + Mirabegron 50 mg | 15.9 |
Solifenacin 10 mg + Mirabegron 25 mg | 15.3 |
Solifenacin 10 mg + Mirabegron 50 mg | 11.1 |
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Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition
The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | mL (Least Squares Mean) |
---|
Placebo | 14.0 |
Mirabegron 25 mg | 24.9 |
Mirabegron 50 mg | 34.5 |
Solifenacin 2.5 mg | 36.4 |
Solifenacin 5 mg | 36.0 |
Solifenacin 10 mg | 36.2 |
Solifenacin 2.5 mg + Mirabegron 25 mg | 39.4 |
Solifenacin 2.5 mg + Mirabegron 50 mg | 41.9 |
Solifenacin 5 mg + Mirabegron 25 mg | 53.6 |
Solifenacin 5 mg + Mirabegron 50 mg | 54.2 |
Solifenacin 10 mg + Mirabegron 25 mg | 57.6 |
Solifenacin 10 mg + Mirabegron 50 mg | 62.3 |
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Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems in walking about; I have some problems in walking about; I am confined to bed.~In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category." (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No problem → No problem | No problem → Some problems | No problem → Confined to bed | No problem → Missing data | Some problems → No problems | Some problems → Some problems | Some problems → Confined to bed | Some problems → Missing data | Confined → No problems | Confined → Some problems | Confined → Confined to bed | Confined → Missing data | Missing data → No problem | Missing data → Some problems | Missing data → Confined to bed | Missing data → Missing data |
---|
Mirabegron 25 mg | 58 | 1 | 0 | 1 | 6 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Mirabegron 50 mg | 63 | 4 | 0 | 1 | 6 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Placebo | 60 | 6 | 0 | 1 | 5 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 10 mg | 54 | 4 | 0 | 1 | 8 | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 10 mg + Mirabegron 25 mg | 59 | 0 | 0 | 0 | 11 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 10 mg + Mirabegron 50 mg | 56 | 5 | 0 | 2 | 8 | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 2.5 mg | 59 | 4 | 0 | 0 | 4 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | 94 | 9 | 0 | 1 | 21 | 20 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | 113 | 5 | 0 | 1 | 15 | 12 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
,Solifenacin 5 mg | 118 | 6 | 0 | 0 | 11 | 15 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 25 mg | 102 | 9 | 0 | 1 | 13 | 15 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 50 mg | 120 | 1 | 0 | 1 | 14 | 11 | 0 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
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Percentage of Participants Who Gain Continence During 12-week Treatment Period
"Urinary continence is defined as three consecutive 24-hour days in which a participant uses no pads or a pad for security which remains completely dry. Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period.~End of treatment is the last on-treatment assessment during the treatment period." (NCT01371994)
Timeframe: Weeks 4, 8, and 12
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | End of Treatment |
---|
Placebo | 10.4 | 18.8 | 19.1 | 21.4 |
,Solifenacin Succinate | 11.8 | 21.1 | 26.5 | 29.1 |
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Baseline Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment
Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent overall work impairment takes into account both hours missed due to urinary leakage and the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity. (NCT01371994)
Timeframe: Baseline
Intervention | percent overall work impairment (Mean) |
---|
Placebo | 42.5 |
Solifenacin Succinate | 44.8 |
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Baseline Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed
Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent work time missed is derived from the number of hours of work missed due to urinary leakage as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. (NCT01371994)
Timeframe: Baseline
Intervention | percent work time missed (Mean) |
---|
Placebo | 43.6 |
Solifenacin Succinate | 37.9 |
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Time From Baseline to First Day of Returning to Work
The time from Baseline to first day of returning to work was estimated using the Kaplan-Meier method. (NCT01371994)
Timeframe: From Baseline to Week 12
Intervention | days (Median) |
---|
Placebo | 5.0 |
Solifenacin Succinate | 5.0 |
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Change From Baseline in American Urology Association Quality of Life (QOL) Score
"The American Urology Association (AUA) includes a single bother question which asked participants how they would feel if they had to live with their urinary condition the way it is now for the rest of their life. The bother question score ranges from 0 (delighted) to 6 (terrible).~End of treatment is the last on-treatment assessment during the treatment period." (NCT01371994)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 12 (n=261, 276) | End of treatment (n=292, 306) |
---|
Placebo | -1.9 | -1.8 |
,Solifenacin Succinate | -2.1 | -2.0 |
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Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment
Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent overall work impairment takes into account both hours missed due to urinary leakage and the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement. (NCT01371994)
Timeframe: Baseline and Week 12
Intervention | percent overall work impairment (Least Squares Mean) |
---|
| Week 12 (n= 59, 69) | End of treatment (n=65, 79) |
---|
Placebo | -30.4 | -30.0 |
,Solifenacin Succinate | -33.7 | -31.1 |
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Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment
Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent activity impairment is derived from the participant's assessment of the degree to which their urinary leakage affected their regular daily activities. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement. (NCT01371994)
Timeframe: Baseline and Week 12
Intervention | Percent activity impairment (Least Squares Mean) |
---|
| Week 12 (n=115, 129) | End of treatment (n=124, 145) |
---|
Placebo | -28.2 | -28.4 |
,Solifenacin Succinate | -30.2 | -28.8 |
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Change From Baseline in Average Daily Pad Usage
"Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period. A 7-day window was used to calculate the average daily pad usage.~End of treatment is the last on-treatment assessment during the treatment period." (NCT01371994)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | pads (Least Squares Mean) |
---|
| Week 4 (n=297, 302) | Week 8 (n=280, 292) | Week 12 (n=226, 226) | End of treatment (n=298, 302) |
---|
Placebo | -1.9 | -2.5 | -3.1 | -2.9 |
,Solifenacin Succinate | -2.0 | -2.8 | -3.4 | -3.2 |
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Change From Baseline in American Urology Association Symptom Score (AUASS)
"Quality of life was measured by the American Urology Association Symptom Score (AUASS). The AUASS includes 7 questions addressing symptoms of frequency, urgency, nocturia (waking during the night to urinate), hesitancy, weak urinary, incomplete emptying, and intermittence. The questionnaire asked participants to consider how these symptoms affected them over the past month on a scale from 0 (not at all) to 5 (almost always).~The AUASS Symptom Score is a sum of the 7 symptom scores and ranges from 0 (best) to 35 (worst).~End of treatment is the last on-treatment assessment during the treatment period." (NCT01371994)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 12 (n=262, 277) | End of treatment (n=293, 307) |
---|
Placebo | -7.7 | -7.4 |
,Solifenacin Succinate | -8.0 | -7.7 |
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American Urology Association Symptom Score (AUASS) at Baseline
"Quality of life was measured by the American Urology Association Symptom Score (AUASS). The AUASS includes 7 questions addressing symptoms of frequency, urgency, nocturia (waking during the night to urinate), hesitancy, weak urinary, incomplete emptying, and intermittence. The questionnaire asked participants to consider how these symptoms affected them over the past month on a scale from 0 (not at all) to 5 (almost always).~The AUASS is a sum of the 7 symptom scores and ranges from 0 (best) to 35 (worst)." (NCT01371994)
Timeframe: Baseline
Intervention | units on a scale (Mean) |
---|
Placebo | 16.7 |
Solifenacin Succinate | 16.2 |
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Time From First Dose to Urinary Continence
Urinary continence is defined as the first of three consecutive 24-hour days in which a participant uses no pads, or a pad for security which remains completely dry, during the 12-week treatment period. Participants recorded their daily pad usage in an electronic diary. Kaplan-Meier curves were used to estimate the distribution of cumulative incidence of urinary continence over the 12-week study treatment period. Participants who did not experience the event during the 12-week treatment period were considered as censored at the End of Treatment (EOT) visit or Week 12, whichever occurs first. (NCT01371994)
Timeframe: 12 weeks
Intervention | days (Median) |
---|
Placebo | NA |
Solifenacin Succinate | NA |
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Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed
Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent work time missed is derived from the number of hours of work missed due to urinary leakage as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from Baseline indicates improvement. (NCT01371994)
Timeframe: Baseline and Week 12
Intervention | Percent work time missed (Least Squares Mean) |
---|
| Week 12 (n= 81, 88) | End of treatment (n=88, 102) |
---|
Placebo | -37.9 | -36.8 |
,Solifenacin Succinate | -37.6 | -34.4 |
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Baseline Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working
Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent impairment while working was derived from the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity. (NCT01371994)
Timeframe: Baseline
Intervention | percent impairment while working (Mean) |
---|
Placebo | 35.5 |
Solifenacin Succinate | 34.1 |
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Baseline Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment
Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent activity impairment is derived from the participant's assessment of the degree to which their urinary leakage affected their regular daily activities. A higher percentage indicates greater impairment and less productivity. (NCT01371994)
Timeframe: Baseline
Intervention | percent activity impairment (Mean) |
---|
Placebo | 41.6 |
Solifenacin Succinate | 41.4 |
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Average Daily Pad Usage at Baseline
Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period. A 7-day window was used to calculate the average daily pad usage. (NCT01371994)
Timeframe: Baseline (7 days prior to Day 1)
Intervention | pads (Mean) |
---|
Placebo | 5.0 |
Solifenacin Succinate | 4.7 |
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American Urology Association Quality of Life (QOL) Score at Baseline
The American Urology Association (AUA) includes a single bother question which asked participants how they would feel if they had to live with their urinary condition the way it is now for the rest of their life. The bother question score ranges from 0 (delighted) to 6 (terrible). (NCT01371994)
Timeframe: Baseline
Intervention | units on a scale (Mean) |
---|
Placebo | 4.8 |
Solifenacin Succinate | 4.7 |
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Change From Baseline in Work Productivity Assessment Index (WPAI): Percent Impairment While Working
Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent impairment while working was derived from the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement. (NCT01371994)
Timeframe: Baseline and Week 12
Intervention | percent impairment while working (Least Squares Mean) |
---|
| Week 12 (n=66, 80) | End of treatment (n=72, 91) |
---|
Placebo | -21.8 | -20.8 |
,Solifenacin Succinate | -23.8 | -21.8 |
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Change in Post-ureteroscopy Stent-induced Pain
Measured through the use of the ureteral stent symptom questionnaire. Patients reported pain on a scale of 0 to 10 (0 being the absence of pain and 10 being the most excruciating pain of their life). The questionnaire was administered a couple days post-op and once again several weeks later. The mean difference (baseline minus 3 months) on this continuous scale was used for this outcome measure. (NCT01381120)
Timeframe: Baseline and 3 months.
Intervention | units on a scale (Mean) |
---|
VESIcare + Narcotic Painkiller | 4.61 |
Narcotic Painkiller | 3.11 |
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Change in Post-ureteroscopy Stent-induced Lower Urinary Tract Symptoms.
Measured through the use of the ureteral stent symptom questionnaire. Patients reported symptoms on a scale of 1 to 5 (1 being the absence of symptoms and 5 being very debilitating symptoms). The questionnaire was administered a couple days post-op and once again several weeks later. The mean difference (baseline minus 3 months) on this continuous scale was used for this outcome measure. (NCT01381120)
Timeframe: Baseline and three months.
Intervention | units on a scale (Mean) |
---|
VESIcare + Narcotic Painkiller | 1.90 |
Narcotic Painkiller | 1.13 |
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Change From Baseline in Urinary Growth Factor to Creatinine Ratio (GF/Cr)
The urinary growth factor (GF) to creatinine ratio may be potential biomarker for overactive bladder, based on published articles. Measuring the ratio at baseline and Month 3, comparing the difference after treatment with tamsulosin and solifenacin which may provide insight into how lower urinary tract symptoms in men progresses. (NCT01457573)
Timeframe: change from baseline score to Month 3
Intervention | ratio (Mean) |
---|
Baseline Characteristics | -19.61 |
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Change in Post Void Residual (mL) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12
Urine sample tested for urinary post void residual (measured in mL) at baseline (pre-dose), Month 1 and Month 2and week 12/Month 3 post-dose, post dose w/tamsulosin and solifenacin. (NCT01457573)
Timeframe: Change from baseline to months 1, 2 and 3
Intervention | ml (Mean) |
---|
| Change at Month 1 | Change at Month 2 | Change at Month 3 |
---|
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg | -6.90 | -10.00 | -3.60 |
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Change in PBC-Patient Perception of Bladder Condition at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12
Change in the Perception of Bladder through a self administered survey at baseline compared to Month 1, Month 2, and Month 3, following exposure to tamsulosin and solifenacin. The survey score measures from zero to 6, with 6 being the most bothersome bladder symptoms and 0 to 1 being the least bothersome. (NCT01457573)
Timeframe: Change from baseline to months 1, 2 and 3
Intervention | units on a scale (Mean) |
---|
| Change at Month 1 | Change at Month 2 | Change at Month 3 |
---|
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg | 1.29 | 0.29 | 0.00 |
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Change in PPUS-Patient Perception of Urinary Urgency Survey Score at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12
The Patient Perception of Urinary Urgency self administered survey score has a maximum score 4, zero to four, for how severe a patient describes their urinary voiding frequency. Four is the most bothersome score, 0 or 1 is the least bothersome. Pre-dose / baseline score is compared at Month 1, Month 2, and Month 3, after dosing with tamsulosin and solifenacin. (NCT01457573)
Timeframe: Change from baseline to months 1, 2 and 3
Intervention | units on a scale (Mean) |
---|
| Change at Month 1 | Change at Month 2 | Change at Month 3 |
---|
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg | 0.00 | 0.30 | 0 |
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Change in Urinary Growth Factor to Creatinine Ratio (GF/Cr) From Baseline Compared to Month 1/Week4 and Month 2/Week 8.
Assessing the change from baseline to Month 1/Week 4 and Month 2/Week 8, of the urinary growth factor (GF) to creatinine ratio in men, which may be potential biomarker for overactive bladder, based on published articles. Measuring the ratio at baseline compared to Month 1 and Month 2 may provide insight into how lower urinary tract symptoms in men progresses. (NCT01457573)
Timeframe: change from baseline score to Mo.1/Wk4 and Mo.2/Wk8 scores
Intervention | ratio (Mean) |
---|
| Change at Month 1 | Change at Month 2 |
---|
Baseline Characteristics | -21.85 | -20.56 |
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Change in Maximum Urinary Flow Rate (ml/s) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12
Urination flow rate (measured in milliliters per second) at baseline (pre-dose), and Month 1, Month 2, and Month 3/Week 12 pose-dosing with tamsulosin and solifenacin. An average maximum urinary flow rate in males is 21 ml/sec aged 14-45 years-old and 12 ml/sec in males aged 46-65 years-old. (NCT01457573)
Timeframe: Change from baseline to months 1, 2 and 3
Intervention | ml/s (Mean) |
---|
| Change at Month 1 | Change at Month 2 | Change at Month 3 |
---|
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg | -3.20 | -3.90 | -4.70 |
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Change in IPSS-International Prostate Score Scale at Baseline Compared to Post Dose Survey at Month 1, 2, and Month 3/Week12.
The survey, IPSS-International Prostate Score Scale, survey responses measured 0-35, is collected at baseline compared to post dose survey response at Month 1, Month 2, and Month 3/Week12 post-dose. The lower the score is indicative of less or fewer urinary symptoms while 35 is consistent with more bothersome symptoms. (NCT01457573)
Timeframe: Change from baseline to months 1, 2 and 3
Intervention | units on a scale (Mean) |
---|
| Change at Month 1 | Change at Month 2 | Change at Month 3 |
---|
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg | -2.00 | -5.30 | -7.33 |
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Change in ICIQ-MLUTS - International Consultation on Incontinence Modular Questionnaire for Male LUTS Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12
Measuring change in the International Consultation on Incontinence Modular Questionnaire for male lower urinary tract symptoms through a self administered survey at baseline compared to Month 1, Month 2, and Month 3, after exposure to tamsulosin and solifenacin. The survey score is a zero to 182 range with 182 being the most bothersome and zero to one being the least bothersome. (NCT01457573)
Timeframe: Change from baseline to months 1, 2 and 3
Intervention | units on a scale (Mean) |
---|
| Change at Month 1 | Change at Month 2 | Change at Month 3 |
---|
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg | -22.40 | -22.20 | -29.8 |
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Change in ICIQ LUTS QoL -International Consultation on Incontinence Modular Questionnaire LUTS Quality of Life for Male LUTS Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12
Change in the International Consultation on Incontinence Modular Questionnaire on lower urinary tract symptoms quality of life survey for men, self administered, compared to Month 1, Month 2, and Month 3, after exposure to tamsulosin and solifenacin. The survey scoring is zero to 182, with 182 being the most bothersome and 0 to 1 being the least bothersome. (NCT01457573)
Timeframe: Change from baseline to months 1, 2 and 3
Intervention | units on a scale (Mean) |
---|
| Change at Month 1 | Change at Month 2 | Change at Month 3 |
---|
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg | 34.60 | 38.30 | -9.00 |
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Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.1/Wk4 and Mo.2/Wk8
Urine sample tested for urinary Nerve Growth Factor (uNGF as measured in pg/mL), a small secreted protein in the bladder that supports bladder function regulation, at baseline (pre-dose) compared to Month 1/Week 4 and Month 2/Week 8, post dosing with tamsulosin and solifenacin. (NCT01457573)
Timeframe: Change from baseline to Mo.1/Wk4 and Mo.2/Wk8
Intervention | pg/ml (Mean) |
---|
| Change at Month 1 | Change at Month 2 |
---|
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg | 11.17 | 15.64 |
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Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.3/Wk12
Urine sample tested for urinary Nerve Growth Factor (uNGF as measured in pg/mL), a small secreted protein in the bladder that supports bladder function regulation, at baseline (pre-dose) and week 12/Month 3 post-dose, after using daily tamsulosin and solifenacin. (NCT01457573)
Timeframe: Change from baseline to week 12 (3 months)
Intervention | pg/ml (Mean) |
---|
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg | -10.9 |
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Change in Patients Perspective of the Impact of Their Disease, Captured Using the Pelvic Floor Distress Inventory (Urinary Questions)
"The difference between baseline and follow up (last 20 days on drug) scores was the recorded measure. The larger the negative # the greater the effect.~The survey was divided into 3 sections, each section worth 100 points. Total scores could range from 0 to 300 (0 no disease, 300 severe disease)." (NCT01470001)
Timeframe: outcome measures will be assessed at week 0 (baseline), and compared to an average measure of the last 20 days on placebo or treatment
Intervention | change in score (Mean) |
---|
Solifenacin | -35.12 |
Placebo | -28.84 |
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the Percent of Patients With at Least 50% Reduction in Post Void Dribbling Episodes
(NCT01470001)
Timeframe: outcome measures will be assessed at week 0 (baseline), and compared to an average measure of weeks 10 through 12
Intervention | percent (Number) |
---|
Solifenacin | 69.8 |
Placebo | 55.5 |
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The Percent Reduction in Post Void Dribbling Episodes (Events)
(NCT01470001)
Timeframe: outcome measures will be assessed at week 0 (baseline), and compared to an average measure of weeks 10 through 12
Intervention | percent reduction (Mean) |
---|
Solifenacin | 59.8 |
Placebo | 42.1 |
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Change in Mean Number of Micturition Episodes Per 24 Hours
(NCT01533597)
Timeframe: at week 24 relative to baseline
Intervention | episodes (Mean) |
---|
Solifenacin | -1.9 |
Solifenacin Plus Tamsulosin | -2.2 |
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Change in Score of IPSS
Total Score of IPSS(International Prostate Symptom Score) is the sum of 7 questions, ranging from 0 (best possible outcome) to 35 (worst possible outcome). The 7 symptom questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 for a total of maximum 35 points. (NCT01533597)
Timeframe: at week 24 relative to baseline
Intervention | units on a scale (Mean) |
---|
Solifenacin | -7.7 |
Solifenacin Plus Tamsulosin | -8.3 |
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Change of PVR
Change from baseline in Post-Void Residual (PVR) volume (NCT01533597)
Timeframe: at week 24 relative to baseline
Intervention | mL (Mean) |
---|
Solifenacin | 13.2 |
Solifenacin Plus Tamsulosin | 10.8 |
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Change of Qmax
maximal urinary flow rate (Qmax) assessed by uroflowmetry (NCT01533597)
Timeframe: at week 24 relative to baseline
Intervention | mL/sec (Mean) |
---|
Solifenacin | 1.1 |
Solifenacin Plus Tamsulosin | 2.1 |
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Numeric Change of Urgency Episodes Per 24 Hours
(NCT01533597)
Timeframe: at week 24 relative to baseline
Intervention | episodes (Mean) |
---|
Solifenacin | -2.4 |
Solifenacin Plus Tamsulosin | -2.1 |
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Change in Total Score of OABSS
Total Score of OABSS(Overactive Bladder Symptom Score) is the sum of 4 questions, ranging from 0 (best possible outcome) to 15 (worst possible outcome) (NCT01533597)
Timeframe: at week 24 relative to baseline
Intervention | units on a scale (Mean) |
---|
Solifenacin | -3.1 |
Solifenacin Plus Tamsulosin | -3.5 |
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Change in Overall Sexual Satisfaction Among Healthy Male Partners
Healthy male partners of female participants complete the Golombok Rust Inventory of Sexual Satisfaction (GRISS) survey. For this outcome, their baseline score is subtracted from their follow-up score which is collected after their female partner completes approximately 12-16 weeks of solifenacin treatment for UUI symptoms. This change score is compared between male partners of female participants who respond to solifenacin versus male partners of female participants who do not respond to solifenacin. The GRISS is a 28-item self-administered questionnaire that assess the quality of the sexual relationship of a heterosexual couple. Scores range from 0 to 10 with higher scores indicating greater sexual dysfunction. (NCT01559389)
Timeframe: Baseline and 12-16 weeks
Intervention | score on a scale (Median) |
---|
Male Partners of Female Responders | 0 |
Male Partners of Female Non-Responders | 0 |
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Baseline Sexual Satisfaction Between Matched Female and Male Partners
Prior to beginning treatment with solifenacin, females presenting with UUI complete the Golombok Rust Inventory of Sexual Satisfaction (GRISS). Their male partners also complete the GRISS at the baseline visit. The GRISS is a 28-item self-administered questionnaire that assess the quality of the sexual relationship of a heterosexual couple. Scores range from 0 to 10 with higher scores indicating greater sexual dysfunction. (NCT01559389)
Timeframe: 0 Weeks
Intervention | score on a scale (Mean) |
---|
Females With UUI | 4.2 |
Male Partners | 4.8 |
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Change in Overall Sexual Satisfaction Among Females
Females presenting with UUI complete the Golombok Rust Inventory of Sexual Satisfaction (GRISS) at baseline (0 weeks) and after 12-16 weeks of treatment with solifenacin. For this outcome, the baseline score is subtracted from the follow-up score and this change score is compared between those who respond and do not respond to treatment with solifenacin. The GRISS is a 28-item self-administered questionnaire that assess the quality of the sexual relationship of a heterosexual couple. Scores range from 0 to 10 with higher scores indicating greater sexual dysfunction. (NCT01559389)
Timeframe: Baseline and 12-16 weeks
Intervention | score on a scale (Median) |
---|
Responder | -0.5 |
Non-Responder | 0 |
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Change From Baseline to Last Possible Titration Step in Maximum Cystometric Capacity
During urodynamic assessments, the bladder was filled until voiding/leakage begins, or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. MCC is the maximum bladder capacity reached during filling cystometry before either leakage or pain/discomfort was observed. Based on study requirements, the last possible titration step was Week 9 for participants enrolled under versions 1.0 and 1.1 and Week 12 under later versions. (NCT01565694)
Timeframe: Baseline, Week 9 or Week 12
Intervention | mL (Mean) |
---|
Solifenacin Succinate | 57.4 |
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Change From Baseline in Average Catheterized Volume Per Catheterization
The average catheterized volume per catheterization was calculated using all available (non-zero) catheterized volumes recorded over both of the 2 measuring days in the diary, whether or not these 2 days are concurrent. (NCT01565694)
Timeframe: Baseline to Week 24
Intervention | mL (Mean) |
---|
| Change from Baseline Week 24 | Change from Baseline Week 24 (LOCF) |
---|
Solifenacin Succinate | 46.23 | 48.86 |
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Change From Baseline in Average First Morning Catheterized Volume
The average first morning catheterized volume was calculated as the average of the available first morning catheterized volumes recorded for the 2 measuring days in the diary, whether or not these 2 days are concurrent. (NCT01565694)
Timeframe: Baseline to Week 24
Intervention | mL (Mean) |
---|
| Change from Baseline Week 24 | Change from Baseline Week 24 (LOCF) |
---|
Solifenacin Succinate | 43.24 | 44.21 |
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Change From Baseline in Bladder Compliance
Bladder compliance gives an indication of the elasticity of the bladder wall and was calculated by dividing the change in volume by the change in detrusor pressure during the filling of the bladder. (NCT01565694)
Timeframe: Baseline and Week 24
Intervention | mL/cmH2O (Mean) |
---|
| Change from Baseline Week 24 | Change from Baseline Week 24 (LOCF) |
---|
Solifenacin Succinate | 9.1 | 8.8 |
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Change From Baseline in Bladder Volume at 40 cmH2O Detrusor Pressure
Bladder volumes at 40 cm H2O detrusor pressure were calculated using urodynamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the subject experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. (NCT01565694)
Timeframe: Baseline and Week 24
Intervention | mL (Mean) |
---|
| Change from Baseline Week 24 | Change from Baseline Week 24 (LOCF) |
---|
Solifenacin Succinate | 67.0 | 54.4 |
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Change From Baseline in Detrusor Pressure at the End of Bladder Filling
The bladder was filled until voiding/leakage began or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. Pressure was recorded for an extra 5 minutes after leakage began or the end of bladder-filling, whichever is sooner. (NCT01565694)
Timeframe: Baseline to Week 24
Intervention | cmH2O (Mean) |
---|
| Change from Baseline Week 24 | Change from Baseline Week 24 (LOCF) |
---|
Solifenacin Succinate | -9.2 | -8.2 |
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Change From Baseline in Maximum Catheterized Volume
The maximum catheterized volume per day was calculated using all available (non-zero) catheterized volumes recorded for the 2 measuring days in the diary, whether or not these 2 days were concurrent. The maximum value was calculated separately for each measuring day and the mean of these two values was used. (NCT01565694)
Timeframe: Baseline to Week 24
Intervention | mL (Mean) |
---|
| Change from Baseline Week 24 | Change from Baseline Week 24 (LOCF) |
---|
Solifenacin Succinate | 67.45 | 69.63 |
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Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours
The mean of the number of incontinence episodes per 24h was calculated as the mean over the valid diary days in the 7-day diary. (NCT01565694)
Timeframe: Baseline to Week 24
Intervention | Incontinence Episodes (Mean) |
---|
| Change from Baseline Week 24 | Change from Baseline Week 24 (LOCF) |
---|
Solifenacin Succinate | -1.60 | -1.62 |
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Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days
The number of incontinence-free days was calculated from the 7-day micturition diary. (NCT01565694)
Timeframe: Baseline to Week 24
Intervention | Days (Mean) |
---|
| Change from Baseline Week 24 | Change from Baseline Week 24 (LOCF) |
---|
Solifenacin Succinate | 1.06 | 1.19 |
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Change From Baseline in Number of Dry (Incontinence-Free) Nights Per 7 Days
The number of incontinence-free nights was calculated from the 7-day micturition diary. (NCT01565694)
Timeframe: Baseline to Week 24
Intervention | Nights (Mean) |
---|
| Change from Baseline Week 24 | Change from Baseline Week 24 (LOCF) |
---|
Solifenacin Succinate | 1.60 | 1.64 |
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Change From Baseline in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until End of Bladder Filling
"Change from baseline in number of overactive detrusor contractions until end of bladder filling was measured by urodynamic testing. If leakage occurred, the Detrusor pressure at leakage was recorded otherwise the volume of fluid instilled into the bladder was recorded." (NCT01565694)
Timeframe: Baseline to Week 24
Intervention | Detrusor Contractions (Mean) |
---|
| Change from Baseline Week 24 | Change from Baseline Week 24 (LOCF) |
---|
Solifenacin Succinate | -2.3 | -1.8 |
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Change From Baseline in Quality of Life [QoL] (PinQ Questionnaire Score)
Pediatric Incontinence Questionnaire (PinQ) is a 20-item questionnaire addressing quality of life for participants with bladder disorders. Each question was answered on a scale from 0 (no, never) to 4 (all the time). The total score ranged from 0 to 80, with higher scores indicated more impact on the quality of life. (NCT01565694)
Timeframe: Baseline to Week 24
Intervention | Units on a Scale (Mean) |
---|
| Change from Baseline Week 24 | Change from Baseline Week 24 (LOCF) |
---|
Solifenacin Succinate | -0.7 | -0.7 |
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Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC)
During urodynamic assessments, the bladder was filled until voiding/leakage begins, or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. MCC is the maximum bladder capacity reached during filling cystometry before either leakage or pain/discomfort was observed. (NCT01565694)
Timeframe: Baseline and Week 24
Intervention | mL (Mean) |
---|
| Change from Baseline Week 24 | Change from Baseline Week 24 (LOCF) |
---|
Solifenacin Succinate | 57.2 | 59.3 |
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Number of Participants With Adverse Events
A treatment-emergent adverse event (TEAE) was defined as an adverse event observed after starting administration of the first dose of study medication on Day 1. All adverse events collected within 7 days after taking the last dose of study drug were counted as a TEAE. (NCT01565694)
Timeframe: Baseline to End of Study Visit (Week 52)
Intervention | Participants (Count of Participants) |
---|
| TEAEs | Drug related TEAE | Deaths | Serious TEAEs | Drug related Serious TEAEs | TEAEs Leading to Discontinuation | Drug related TEAEs Leading to Discontinuation |
---|
Solifenacin Succinate | 51 | 15 | 0 | 7 | 0 | 4 | 3 |
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Change From Baseline in Bladder Volume at 30 cmH2O Detrusor Pressure
Bladder volumes at 30 cm H2O detrusor pressure was calculated using the urodynamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the participants experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. (NCT01565694)
Timeframe: Baseline and Week 24
Intervention | mL (Mean) |
---|
| Change from Baseline Week 24 | Change from Baseline Week 24 (LOCF) |
---|
Solifenacin Succinate | 61.8 | 71.9 |
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Change From Baseline in Bladder Volume (mL) Until First Detrusor Contraction > 15 cmH2O as a Percentage of Expected Bladder Capacity (EBC)
Change from baseline in the bladder volume was calculated using urodyanamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the subject experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. If no detrusor contraction of at least 15 cmH2O occurs, the bladder volume was imputed with MCC. (NCT01565694)
Timeframe: Baseline and Week 24
Intervention | Percentage of EBC (Median) |
---|
Solifenacin Succinate | 23.10 |
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Change From Baseline to End of Treatment in Mean Number of Daytime Micturitions Per 24 Hours
The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence. Daytime is defined as the time between waking up in the morning and going to bed later the same day. (NCT01565707)
Timeframe: Baseline and week 12
Intervention | daytime micturitions (Least Squares Mean) |
---|
Placebo Children | -1.1 |
Solifenacin Succinate Suspension Children | -1.2 |
Placebo Adolescents | -0.5 |
Solifenacin Succinate Suspension Adolescents | -0.3 |
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Area Under the Plasma Concentration - Time to Curve (AUC) for a Dose Interval (AUCtau) of Solifenacin
Pharmacokinetic sampling was performed at steady state at the end of treatment. (NCT01565707)
Timeframe: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).
Intervention | ng*h/mL (Mean) |
---|
Children PED 5 | 298.7 |
Children PED 7.5 | 452.8 |
Adolescents PED 7.5 | 269.2 |
Children PED 10 | 560 |
Adolescents PED 10 | 745.7 |
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Change From Baseline in Post Void Residual (PVR) Volume
Post Void Residual (PVR) Volume was assessed by ultrasonography or bladder scan. (NCT01565707)
Timeframe: Baseline and Week 12
Intervention | mL (Least Squares Mean) |
---|
Placebo Children | 0.07 |
Solifenacin Succinate Suspension Children | -0.99 |
Placebo Adolescents | -3.58 |
Solifenacin Succinate Suspension Adolescents | 0.95 |
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Change From Baseline to End of Treatment (EoT) in Mean Volume Voided (MVV) Per Micturition
The mean voided volume was calculated from the participant diary data recorded during two measuring days (i.e., those days when the participant recorded the volume of each micturition) in the 7 days prior to the baseline and end of treatment visits. The MVV is equal to the mean of the non-zero volumes recorded over the 2 measuring days. A micturition is any voluntary urination, excluding episodes of incontinence. (NCT01565707)
Timeframe: Baseline and Week 12
Intervention | mL (Least Squares Mean) |
---|
Placebo Children | 13.4 |
Solifenacin Succinate Suspension Children | 25.5 |
Placebo Adolescents | 6.9 |
Solifenacin Succinate Suspension Adolescents | 2.3 |
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Change From Baseline to End of Treatment in Daytime Maximum Volume Voided (DMaxVV) Per Micturition
The mean daytime maximum volume voided (DMaxVV) was determined using the participant diary data recorded during two measuring days (i.e., those days when the participant recorded the volume of each micturition) in the 7 days prior to the Baseline and end of treatment visits. The daytime maximum volume voided (DMaxVV) is the largest (non-zero) volume recorded over both of the 2 measuring days in the diary. The first morning void is excluded from the calculation. Daytime is defined as the time between waking up in the morning and going to bed later the same day. A micturition is any voluntary urination, excluding episodes of incontinence. (NCT01565707)
Timeframe: Baseline and Week 12
Intervention | mL (Least Squares Mean) |
---|
Placebo Children | 11.3 |
Solifenacin Succinate Suspension Children | 43.2 |
Placebo Adolescents | -8.4 |
Solifenacin Succinate Suspension Adolescents | -25.7 |
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Change From Baseline to End of Treatment in Mean Number of Daytime Incontinence Episodes Per 24 Hours
The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine. Daytime is defined as the time between waking up in the morning and going to bed later the same day. (NCT01565707)
Timeframe: Baseline and Week 12
Intervention | daytime incontinence episodes (Least Squares Mean) |
---|
Placebo Children | -1.1 |
Solifenacin Succinate Suspension Children | -1.2 |
Placebo Adolescents | -0.2 |
Solifenacin Succinate Suspension Adolescents | -0.8 |
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Number of Participants With Adverse Events (AEs)
A treatment emergent adverse event (TEAE) was defined as an AE that occurred after the first dose of study drug and within 7 days after last dose of study medication. (NCT01565707)
Timeframe: From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Intervention | participants (Number) |
---|
| Any TEAE | Drug Related TEAEs | Deaths | Serious TEAEs | Drug-related Serious TEAEs | TEAEs Leading to Discontinuation | Drug-related TEAEs Leading to Permanent Discont. |
---|
Placebo Adolescents | 12 | 2 | 0 | 1 | 0 | 2 | 1 |
,Placebo Children | 45 | 9 | 0 | 2 | 1 | 1 | 1 |
,Solifenacin Succinate Suspension Adolescents | 9 | 3 | 0 | 1 | 0 | 2 | 1 |
,Solifenacin Succinate Suspension Children | 44 | 14 | 0 | 2 | 0 | 6 | 3 |
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Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Days Per 7 Days
The mean number of dry days was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine. (NCT01565707)
Timeframe: Baseline and Week 12
Intervention | Dry Days (Least Squares Mean) |
---|
Placebo Children | 1.7 |
Solifenacin Succinate Suspension Children | 1.3 |
Placebo Adolescents | 1.5 |
Solifenacin Succinate Suspension Adolescents | 1.6 |
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Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Nighttimes Per 7 Days
The mean number of dry nights was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine. (NCT01565707)
Timeframe: Baseline and Week 12
Intervention | Dry Nights (Least Squares Mean) |
---|
Placebo Children | 0.7 |
Solifenacin Succinate Suspension Children | 0.4 |
Placebo Adolescents | -0.1 |
Solifenacin Succinate Suspension Adolescents | 0.4 |
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Change From Baseline to End of Treatment in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents
Adolescent participants were asked to record the degree of urgency associated with each micturition and incontinence episode according to the Patient Perception of Intensity of Urgency Scale (PPIUS) scale (0 - no urgency, 1 - mild urgency, 2 - moderate urgency, 3 - severe urgency, 4 - urge incontinence). The mean number of grade 3 or 4 urgency episodes was determined using using diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. (NCT01565707)
Timeframe: Baseline and Week 12
Intervention | urgency episodes (Least Squares Mean) |
---|
Placebo Adolescents | -0.7 |
Solifenacin Succinate Suspension Adolescents | -1.0 |
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Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. (NCT01565707)
Timeframe: Baseline and Week 12
Intervention | incontinence episodes (Least Squares Mean) |
---|
Placebo Children | -1.2 |
Solifenacin Succinate Suspension Children | -1.1 |
Placebo Adolescents | -0.7 |
Solifenacin Succinate Suspension Adolescents | -0.6 |
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Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence. (NCT01565707)
Timeframe: Baseline and Week 12
Intervention | micturitions (Least Squares Mean) |
---|
Placebo Children | -0.8 |
Solifenacin Succinate Suspension Children | -1.1 |
Placebo Adolescents | -0.6 |
Solifenacin Succinate Suspension Adolescents | -0.4 |
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Change From Baseline to End of Treatment in Mean Number of Nighttime Incontinence Episodes Per 24 Hours
The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine. Nighttime is defined as the time between going to bed and waking up the following morning. (NCT01565707)
Timeframe: Baseline and Week 12
Intervention | nighttime incontinence episodes (Least Squares Mean) |
---|
Placebo Children | -0.2 |
Solifenacin Succinate Suspension Children | -0.1 |
Placebo Adolescents | -0.2 |
Solifenacin Succinate Suspension Adolescents | -0.2 |
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Change From Baseline to End of Treatment in Mean Number of Nighttime Micturitions Per 24 Hours
The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence. Nighttime is defined as the time between going to bed and waking up the following morning. (NCT01565707)
Timeframe: Baseline and Week 12
Intervention | nighttime micturitions (Least Squares Mean) |
---|
Placebo Children | 0.0 |
Solifenacin Succinate Suspension Children | -0.1 |
Placebo Adolescents | 0.4 |
Solifenacin Succinate Suspension Adolescents | 0.1 |
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Maximum Concentration (Cmax) of Solifenacin
Pharmacokinetic sampling was performed at steady state at the end of treatment. Cmax could not be calculated for 2 children and 1 adolescent in the Pharmacokinetic Analysis Set (PKAS). (NCT01565707)
Timeframe: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).
Intervention | ng/mL (Mean) |
---|
Children PED 5 | 16.67 |
Children PED 7.5 | 26.24 |
Adolescents PED 7.5 | 17.08 |
Children PED 10 | 33.48 |
Adolescents PED 10 | 42.85 |
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Plasma Concentration Before Drug Administration (Ctrough) of Solifenacin
Pharmacokinetic sampling was performed at steady state at the end of treatment. Ctrough could not be calculated for 2 children and 1 adolescent in the PKAS. (NCT01565707)
Timeframe: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).
Intervention | ng/mL (Mean) |
---|
Children PED 5 | 9.534 |
Children PED 7.5 | 16.1 |
Adolescents PED 7.5 | 8.828 |
Children PED 10 | 19.05 |
Adolescents PED 10 | 27.94 |
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Time to Attain Maximum Concentration (Tmax) of Solifenacin
Pharmacokinetic sampling was performed at steady state at the end of treatment. Tmax could not be calculated for 2 children and 1 adolescent in the PKAS. (NCT01565707)
Timeframe: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).
Intervention | hours (Mean) |
---|
Children PED 5 | 2.933 |
Children PED 7.5 | 3.175 |
Adolescents PED 7.5 | 2.8 |
Children PED 10 | 2.874 |
Adolescents PED 10 | 2.85 |
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Apparent Terminal Elimination Half-Life (T1/2) of Solifenacin
Pharmacokinetic sampling was performed at steady state at the end of treatment. (NCT01565707)
Timeframe: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).
Intervention | hours (Mean) |
---|
Children PED 5 | 27.3 |
Children PED 7.5 | 30.98 |
Adolescents PED 7.5 | 24.84 |
Children PED 10 | 26.85 |
Adolescents PED 10 | 41.27 |
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Apparent Total Body Clearance (CL/F) of Solifenacin
Pharmacokinetic sampling was performed at steady state at the end of treatment. (NCT01565707)
Timeframe: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).
Intervention | L/h (Mean) |
---|
Children PED 5 | 6.968 |
Children PED 7.5 | 7.608 |
Adolescents PED 7.5 | 14.56 |
Children PED 10 | 8.773 |
Adolescents PED 10 | 11.3 |
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Apparent Volume of Distribution (Vz/F) of Solifenacin
Pharmacokinetic sampling was performed at steady state at the end of treatment. (NCT01565707)
Timeframe: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).
Intervention | L (Mean) |
---|
Children PED 5 | 272.4 |
Children PED 7.5 | 329.5 |
Adolescents PED 7.5 | 521.9 |
Children PED 10 | 315.7 |
Adolescents PED 10 | 561.7 |
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Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and final visit (up to Week 12)
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 297 | 55 | 15 | 2 | 0 | 2 | 116 | 103 | 30 | 2 | 0 | 1 | 80 | 51 | 48 | 10 | 0 | 1 | 39 | 16 | 16 | 15 | 2 | 0 | 4 | 2 | 1 | 1 | 1 | 0 | 7 | 2 | 1 | 0 | 0 | 1 |
,Solifenacin 5 mg | 306 | 52 | 13 | 4 | 0 | 3 | 118 | 93 | 20 | 4 | 0 | 0 | 83 | 72 | 44 | 7 | 2 | 1 | 34 | 14 | 15 | 3 | 1 | 1 | 5 | 2 | 3 | 1 | 1 | 1 | 5 | 4 | 0 | 0 | 0 | 0 |
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Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and final visit (up to Week 12)
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme data | No data -> no data |
---|
Mirabegron 50 mg | 697 | 27 | 5 | 1 | 2 | 4 | 43 | 15 | 15 | 1 | 0 | 0 | 45 | 8 | 6 | 1 | 0 | 0 | 25 | 4 | 0 | 4 | 0 | 0 | 5 | 1 | 0 | 0 | 1 | 0 | 8 | 2 | 0 | 0 | 0 | 1 |
,Solifenacin 5 mg | 699 | 26 | 6 | 1 | 0 | 4 | 43 | 14 | 6 | 1 | 0 | 0 | 46 | 6 | 8 | 0 | 0 | 0 | 25 | 7 | 4 | 1 | 0 | 1 | 4 | 0 | 0 | 0 | 0 | 1 | 9 | 0 | 0 | 0 | 0 | 0 |
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Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and final visit (up to Week 12)
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problem | Extreme problems -> moderate problem | Extreme problems -> severe problem | Extreme problems -> extreme problem | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 444 | 46 | 15 | 2 | 0 | 4 | 106 | 45 | 15 | 3 | 0 | 0 | 83 | 42 | 29 | 7 | 0 | 0 | 31 | 9 | 6 | 10 | 1 | 0 | 7 | 1 | 2 | 1 | 1 | 0 | 7 | 3 | 0 | 0 | 0 | 1 |
,Solifenacin 5 mg | 440 | 49 | 8 | 2 | 0 | 3 | 113 | 54 | 9 | 1 | 0 | 0 | 79 | 34 | 20 | 6 | 0 | 0 | 41 | 14 | 8 | 5 | 0 | 3 | 7 | 2 | 3 | 1 | 1 | 0 | 8 | 1 | 0 | 0 | 0 | 0 |
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Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS)
"The Treatment Satisfaction (TS)-Visual Analogue Scale (VAS) was a self-rated scale with the participant answering the question Are you satisfied with your treatment? and placing a vertical mark on a line from 0 (No, not at all) to 10 (Yes, completely)." (NCT01638000)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 12 [N=865,857] | Final visit [N=891,876] |
---|
Mirabegron 50 mg | 3.51 | 3.44 |
,Solifenacin 5 mg | 3.93 | 3.86 |
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Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert Scale
"The Treatment Satisfaction (TS)-Likert Scale was a self-rated scale with the participant answering the question How satisfied were you with your treatment? with on a scale from 1 (extremely dissatisfied) to 7 (extremely satisfied)." (NCT01638000)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 12 [N=876,871] | Final visit [N=897,889] |
---|
Mirabegron 50 mg | 2.92 | 2.88 |
,Solifenacin 5 mg | 3.07 | 3.03 |
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Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 323 | 53 | 10 | 1 | 1 | 16 | 132 | 84 | 26 | 3 | 0 | 10 | 52 | 51 | 18 | 8 | 2 | 10 | 38 | 25 | 7 | 9 | 1 | 5 | 10 | 5 | 3 | 2 | 1 | 4 | 9 | 1 | 0 | 0 | 0 | 1 |
,Solifenacin 5 mg | 341 | 48 | 10 | 2 | 0 | 20 | 118 | 80 | 15 | 2 | 0 | 9 | 67 | 44 | 28 | 5 | 1 | 6 | 35 | 17 | 14 | 2 | 0 | 9 | 15 | 2 | 7 | 2 | 2 | 2 | 7 | 2 | 0 | 0 | 0 | 0 |
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Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 442 | 36 | 10 | 6 | 1 | 26 | 77 | 43 | 15 | 2 | 0 | 7 | 57 | 31 | 35 | 7 | 0 | 6 | 53 | 15 | 15 | 18 | 0 | 5 | 2 | 0 | 0 | 0 | 0 | 1 | 2 | 5 | 3 | 0 | 0 | 1 |
,Solifenacin 5 mg | 459 | 25 | 10 | 5 | 0 | 16 | 82 | 32 | 16 | 2 | 0 | 11 | 63 | 43 | 30 | 4 | 0 | 9 | 51 | 17 | 7 | 8 | 0 | 10 | 1 | 1 | 0 | 0 | 1 | 0 | 9 | 0 | 0 | 0 | 0 | 0 |
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Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 287 | 50 | 15 | 2 | 0 | 17 | 112 | 97 | 29 | 2 | 0 | 12 | 79 | 49 | 42 | 10 | 0 | 10 | 39 | 14 | 16 | 12 | 2 | 5 | 4 | 2 | 1 | 1 | 0 | 1 | 7 | 2 | 1 | 0 | 0 | 1 |
,Solifenacin 5 mg | 299 | 49 | 11 | 4 | 0 | 15 | 116 | 87 | 18 | 4 | 0 | 10 | 80 | 71 | 38 | 6 | 1 | 13 | 34 | 13 | 12 | 1 | 1 | 7 | 5 | 2 | 3 | 1 | 1 | 1 | 5 | 4 | 0 | 0 | 0 | 0 |
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Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 667 | 26 | 5 | 1 | 1 | 36 | 43 | 13 | 14 | 1 | 0 | 3 | 44 | 8 | 5 | 1 | 0 | 2 | 25 | 4 | 0 | 3 | 0 | 1 | 4 | 0 | 0 | 0 | 0 | 3 | 8 | 2 | 0 | 0 | 0 | 1 |
,Solifenacin 5 mg | 670 | 23 | 6 | 1 | 0 | 36 | 42 | 12 | 5 | 1 | 0 | 4 | 46 | 6 | 6 | 0 | 0 | 2 | 25 | 7 | 2 | 1 | 0 | 3 | 4 | 0 | 0 | 0 | 0 | 1 | 9 | 0 | 0 | 0 | 0 | 0 |
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Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 425 | 43 | 14 | 2 | 0 | 27 | 103 | 45 | 12 | 3 | 0 | 6 | 81 | 41 | 25 | 6 | 0 | 8 | 31 | 7 | 6 | 9 | 1 | 3 | 7 | 1 | 2 | 1 | 0 | 1 | 7 | 3 | 0 | 0 | 0 | 1 |
,Solifenacin 5 mg | 426 | 45 | 7 | 2 | 0 | 22 | 107 | 53 | 9 | 1 | 0 | 7 | 79 | 31 | 15 | 5 | 0 | 9 | 40 | 13 | 6 | 5 | 0 | 7 | 7 | 2 | 3 | 1 | 0 | 1 | 8 | 1 | 0 | 0 | 0 | 0 |
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Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 4
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 328 | 59 | 11 | 2 | 0 | 4 | 98 | 122 | 29 | 5 | 1 | 0 | 25 | 64 | 37 | 12 | 3 | 0 | 12 | 32 | 26 | 12 | 2 | 1 | 7 | 8 | 3 | 4 | 3 | 0 | 1 | 2 | 0 | 0 | 0 | 8 |
,Solifenacin 5 mg | 339 | 65 | 11 | 2 | 2 | 2 | 102 | 94 | 25 | 3 | 0 | 0 | 33 | 65 | 40 | 10 | 1 | 2 | 17 | 29 | 19 | 9 | 0 | 3 | 12 | 4 | 5 | 4 | 5 | 0 | 1 | 1 | 0 | 0 | 0 | 7 |
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Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire
The European Quality of Life 5-Dimensions Questionnaire (EQ-5D-5L) is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 4
Intervention | participants (Number) |
---|
| No problems -> No problems | No problems -> Slight problems | No problems -> Moderate problems | No problems -> Severe problems | No problems -> Extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 447 | 45 | 23 | 2 | 0 | 4 | 66 | 47 | 24 | 6 | 0 | 1 | 39 | 39 | 50 | 7 | 1 | 0 | 20 | 24 | 45 | 16 | 1 | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 8 |
,Solifenacin 5 mg | 443 | 43 | 19 | 6 | 1 | 3 | 80 | 47 | 11 | 3 | 1 | 1 | 51 | 45 | 46 | 6 | 0 | 1 | 16 | 34 | 29 | 12 | 0 | 2 | 1 | 1 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 7 |
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Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 4
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extrme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 299 | 57 | 11 | 1 | 1 | 2 | 101 | 116 | 32 | 2 | 0 | 1 | 51 | 60 | 66 | 10 | 1 | 2 | 21 | 22 | 19 | 20 | 6 | 0 | 1 | 2 | 3 | 1 | 2 | 0 | 1 | 0 | 2 | 0 | 0 | 8 |
,Solifenacin 5 mg | 285 | 67 | 17 | 5 | 0 | 4 | 97 | 109 | 25 | 4 | 0 | 0 | 44 | 86 | 65 | 12 | 1 | 1 | 19 | 25 | 17 | 6 | 0 | 1 | 1 | 6 | 3 | 2 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 7 |
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Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 4
Intervention | participants (Number) |
---|
| No problems -> No problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> No problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 693 | 26 | 12 | 0 | 0 | 5 | 37 | 28 | 8 | 1 | 0 | 0 | 24 | 18 | 17 | 1 | 0 | 0 | 9 | 13 | 7 | 4 | 0 | 0 | 4 | 1 | 1 | 0 | 1 | 0 | 1 | 1 | 1 | 0 | 0 | 8 |
,Solifenacin 5 mg | 703 | 23 | 4 | 0 | 1 | 5 | 41 | 16 | 5 | 2 | 0 | 0 | 17 | 28 | 15 | 0 | 0 | 0 | 15 | 15 | 6 | 0 | 1 | 1 | 1 | 1 | 0 | 2 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 7 |
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Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 4
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 421 | 61 | 20 | 4 | 1 | 4 | 102 | 49 | 14 | 2 | 1 | 1 | 47 | 59 | 45 | 9 | 1 | 0 | 17 | 21 | 11 | 7 | 1 | 0 | 0 | 3 | 5 | 3 | 1 | 0 | 0 | 2 | 1 | 0 | 0 | 8 |
,Solifenacin 5 mg | 422 | 63 | 10 | 3 | 0 | 4 | 101 | 58 | 16 | 1 | 1 | 0 | 34 | 59 | 39 | 7 | 0 | 0 | 28 | 19 | 13 | 7 | 1 | 3 | 4 | 5 | 3 | 1 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 7 |
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Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit
A responder is defined as a participant who reported incontinence episodes at baseline and reported no incontinence episodes during the treatment period at specified visit. (NCT01638000)
Timeframe: Week 4, Week 8, Week 12
Intervention | percentage of participants (Number) |
---|
| Week 4 [N=404,410] | Week 8 [N=387,397] | Week 12 [N=381,387] | Final visit [N=404,413] |
---|
Mirabegron 50 mg | 47.3 | 64.3 | 69.0 | 67.3 |
,Solifenacin 5 mg | 52.0 | 63.2 | 69.5 | 68.5 |
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Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 8
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 325 | 52 | 15 | 2 | 0 | 10 | 122 | 94 | 26 | 4 | 3 | 6 | 42 | 50 | 31 | 11 | 0 | 7 | 23 | 39 | 11 | 7 | 1 | 4 | 9 | 7 | 2 | 3 | 3 | 1 | 5 | 3 | 0 | 0 | 0 | 3 |
,Solifenacin 5 mg | 334 | 65 | 8 | 1 | 0 | 13 | 116 | 79 | 20 | 3 | 2 | 4 | 49 | 59 | 34 | 4 | 0 | 5 | 13 | 37 | 12 | 6 | 3 | 6 | 11 | 10 | 4 | 1 | 4 | 0 | 2 | 2 | 1 | 0 | 0 | 4 |
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Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 8
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> modrate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 445 | 38 | 20 | 3 | 1 | 14 | 70 | 46 | 19 | 3 | 0 | 6 | 51 | 41 | 31 | 8 | 1 | 4 | 30 | 30 | 21 | 20 | 1 | 4 | 1 | 1 | 1 | 0 | 0 | 0 | 4 | 3 | 1 | 0 | 0 | 3 |
,Solifenacin 5 mg | 446 | 31 | 23 | 3 | 1 | 11 | 78 | 44 | 12 | 3 | 0 | 6 | 47 | 52 | 40 | 6 | 0 | 4 | 22 | 41 | 15 | 8 | 0 | 7 | 0 | 1 | 0 | 1 | 1 | 0 | 4 | 1 | 0 | 0 | 0 | 4 |
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Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 8
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 291 | 52 | 13 | 4 | 1 | 10 | 103 | 111 | 25 | 6 | 0 | 7 | 59 | 66 | 46 | 10 | 1 | 8 | 17 | 37 | 12 | 18 | 2 | 2 | 1 | 4 | 2 | 0 | 1 | 1 | 4 | 4 | 0 | 0 | 0 | 3 |
,Solifenacin 5 mg | 286 | 66 | 16 | 0 | 0 | 10 | 96 | 103 | 30 | 1 | 0 | 5 | 61 | 78 | 57 | 4 | 1 | 8 | 16 | 25 | 15 | 7 | 1 | 4 | 3 | 4 | 4 | 1 | 0 | 1 | 2 | 3 | 0 | 0 | 0 | 4 |
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Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 8
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> exteme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 672 | 35 | 7 | 1 | 1 | 20 | 42 | 19 | 9 | 1 | 0 | 3 | 34 | 17 | 5 | 2 | 0 | 2 | 17 | 9 | 4 | 2 | 0 | 1 | 1 | 4 | 0 | 0 | 0 | 2 | 6 | 2 | 0 | 0 | 0 | 3 |
,Solifenacin 5 mg | 673 | 38 | 2 | 1 | 1 | 21 | 33 | 20 | 9 | 0 | 0 | 2 | 34 | 16 | 6 | 2 | 0 | 2 | 13 | 15 | 8 | 0 | 0 | 2 | 2 | 2 | 0 | 0 | 0 | 1 | 5 | 0 | 0 | 0 | 0 | 4 |
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Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 8
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 430 | 48 | 15 | 2 | 0 | 16 | 101 | 45 | 16 | 3 | 1 | 3 | 61 | 57 | 26 | 10 | 1 | 6 | 13 | 23 | 12 | 7 | 0 | 2 | 5 | 2 | 2 | 2 | 0 | 1 | 3 | 5 | 0 | 0 | 0 | 3 |
,Solifenacin 5 mg | 426 | 49 | 11 | 3 | 0 | 13 | 109 | 50 | 12 | 2 | 0 | 4 | 53 | 53 | 20 | 6 | 1 | 6 | 16 | 32 | 15 | 3 | 0 | 5 | 4 | 5 | 3 | 0 | 2 | 0 | 4 | 1 | 0 | 0 | 0 | 4 |
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Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC)
The Patient Perception of Bladder Condition (PPBC) questionnaire is a single-item questionnare used to assess participants' perceptions and impressions of their bladder condition. Participants assessed their bladder condition using a 6-point categorical scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. (NCT01638000)
Timeframe: Baseline and Week 4, Week 8, Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 [N=905,896] | Week 8 [N=882,875] | Week 12 [N=865,858] | Final visit [N=906,897] |
---|
Mirabegron 50 mg | -0.91 | -1.30 | -1.58 | -1.53 |
,Solifenacin 5 mg | -1.00 | -1.46 | -1.73 | -1.67 |
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Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, scored from 1 to 6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement. (NCT01638000)
Timeframe: Baseline and Week 4, Week 8, Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 [N=905,896] | Week 8 [N=882,875] | Week 12 [N=865,859] | Final visit [N=906,897] |
---|
Mirabegron 50 mg | -20.51 | -25.96 | -29.74 | -28.89 |
,Solifenacin 5 mg | -22.20 | -27.76 | -31.84 | -30.76 |
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Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit
An incontinence episode is any involuntary leakage of urine. The total number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit. (NCT01638000)
Timeframe: Week 4, Week 8, Week 12
Intervention | incontinence episodes (Mean) |
---|
| Week 4 [N=404,410] | Week 8 [N=387,397] | Week 12 [N=381,387] | Final visit [N=404,413] |
---|
Mirabegron 50 mg | 2.64 | 2.19 | 2.07 | 2.13 |
,Solifenacin 5 mg | 2.25 | 1.28 | 1.08 | 1.29 |
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Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit
A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The total number of nocturia episodes were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit. (NCT01638000)
Timeframe: Week 4, Week 8, Week 12
Intervention | nocturia episodes (Mean) |
---|
| Week 4 [N=877,871] | Week 8 [N=850, 844] | Week 12 [N=831,828] | Final Visit [N=879,875] |
---|
Mirabegron 50 mg | 4.78 | 4.26 | 3.94 | 4.05 |
,Solifenacin 5 mg | 5.12 | 4.41 | 4.06 | 4.13 |
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Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit
The total number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit. (NCT01638000)
Timeframe: Week 4, Week 8, Week 12
Intervention | pads (Mean) |
---|
| Week 4 [N=574,563] | Week 8 [N=551,543] | Week 12 [N=543,532] | Final visit [N=576,565] |
---|
Mirabegron 50 mg | 4.25 | 3.33 | 3.19 | 3.32 |
,Solifenacin 5 mg | 4.26 | 3.27 | 3.04 | 3.19 |
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Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit
An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The total number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit. (NCT01638000)
Timeframe: Week 4, Week 8, Week 12
Intervention | urgency incontinence episodes (Mean) |
---|
| Week 4 [N=395,399] | Week 8 [N=379,386] | Week 12 [N=373,377] | Final visit [N=395,402] |
---|
Mirabegron 50 mg | 2.27 | 1.74 | 1.44 | 1.51 |
,Solifenacin 5 mg | 2.16 | 1.13 | 1.03 | 1.23 |
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Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE; defined as any untoward medical occurrence in a patient administered a study drug) that started or worsened in the period from the first double-blind medication intake until 30 days after the last double-blind medication intake. The following TEAEs were selected for inclusion in the analysis: Dry mouth (aptyalism, dry mouth, dry throat), constipation (constipation), blurred vision (vision blurred, myopia, refraction disorder, accommodation disorder). (NCT01638000)
Timeframe: From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks)
Intervention | percentage of participants (Number) |
---|
| Overall | Dry mouth | Dry throat | Blurred vision | Constipation |
---|
Mirabegron 50 mg | 5 | 3.1 | 0.1 | 0.6 | 2.2 |
,Solifenacin 5 mg | 7.4 | 5.8 | 0.1 | 0.4 | 2.5 |
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Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit
A responder is defined as a participant with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the treatment period at specified visit. (NCT01638000)
Timeframe: Week 4, Week 8, Week 12
Intervention | percentage of participants (Number) |
---|
| Week 4 [N=404,410] | Week 8 [N=387,397] | Week 12 [N=381,387] | Final visit [N=404,413] |
---|
Mirabegron 50 mg | 75.5 | 85.5 | 86.1 | 85.1 |
,Solifenacin 5 mg | 77.3 | 86.9 | 89.1 | 88.1 |
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Percentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final Visit
A responder is defined as a participant with >=10 points improvement in the total HRQL score from baseline. (NCT01638000)
Timeframe: Baseline to Week 12
Intervention | percentage of participants (Number) |
---|
| Week 12 [N=865,859] | Final visit [N=906,897] |
---|
Mirabegron 50 mg | 69.2 | 67.5 |
,Solifenacin 5 mg | 72.6 | 71.0 |
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Percentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final Visit
A responder is defined as a participant with ≥1 point improvement in PPBC from baseline. (NCT01638000)
Timeframe: Baseline to Week 12
Intervention | percentage of participants (Number) |
---|
| Week 12 [N=865,858] | Final visit [N=906,897] |
---|
Mirabegron 50 mg | 73.1 | 71.9 |
,Solifenacin 5 mg | 76.7 | 74.9 |
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Percentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final Visit
A responder is defined as a participant with ≥10 points improvement in symptom bother from baseline. (NCT01638000)
Timeframe: Baseline to Week 12
Intervention | percentage of participants (Number) |
---|
| Week 12 [N=865,859] | Final visit [N=906,897] |
---|
Mirabegron 50 mg | 77.5 | 76.2 |
,Solifenacin 5 mg | 82.4 | 81.2 |
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Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit
A responder is defined as a participant with >=1 or >=2 or >=3 or >=4 or >=5 or 6-point improvement from baseline in TS-Likert scale. (NCT01638000)
Timeframe: Baseline to final visit (up to Week 12)
Intervention | percentage of participants (Number) |
---|
| ≥1 point improvement | ≥2 point improvement | ≥3 point improvement | ≥4 point improvement | ≥5 point improvement | 6 point improvement |
---|
Mirabegron 50 mg | 85.6 | 79.0 | 66.7 | 43.8 | 15.4 | 2.5 |
,Solifenacin 5 mg | 89.4 | 82.6 | 70.8 | 46.6 | 15.1 | 2.8 |
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Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12
A responder is defined as a participant with ≥1, ≥2, ≥3, ≥4, ≥5 or 6-point improvement from baseline in TS-Likert scale. (NCT01638000)
Timeframe: Baseline to Week 12
Intervention | percentage of participants (Number) |
---|
| ≥1 point improvement | ≥2 point improvement | ≥3 point improvement | ≥4 point improvement | ≥5 point improvement | 6 point improvement |
---|
Mirabegron 50 mg | 86.4 | 80.3 | 67.7 | 44.4 | 15.6 | 2.5 |
,Solifenacin 5 mg | 90.4 | 83.6 | 71.9 | 47.5 | 15.4 | 2.9 |
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Percentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final Visit
A responder is defined as a participant with ≥2 point improvement in PPBC from baseline. (NCT01638000)
Timeframe: Baseline to Week 12
Intervention | percentage of participants (Number) |
---|
| Week 12 [N=865,858] | Final visit [N=906,897] |
---|
Mirabegron 50 mg | 47.6 | 46.2 |
,Solifenacin 5 mg | 52.6 | 51.1 |
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Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit
A responder is defined as a participant who has ≥8 micturitions at baseline and has <8 micturitions per 24 hours during the treatment period at each specified visit, where change from baseline is <0. (NCT01638000)
Timeframe: Week 4, Week 8, Week 12
Intervention | percentage of participants (Number) |
---|
| Week 4 [N=916,906] | Week 8 [N=888,876] | Week 12 [N=870,856] | Final visit [N=920,910] |
---|
Mirabegron 50 mg | 32.3 | 41.2 | 44.8 | 44.2 |
,Solifenacin 5 mg | 33.9 | 46.9 | 49.3 | 48.8 |
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Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours
A micturition is any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. (NCT01638000)
Timeframe: Baseline and final visit (up to Week 12)
Intervention | micturitions (Least Squares Mean) |
---|
Mirabegron 50 mg | -2.95 |
Solifenacin 5 mg | -3.13 |
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Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment
A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. (NCT01638000)
Timeframe: Baseline and Week 4, Week 8, Week 12
Intervention | nocturia episodes (Least Squares Mean) |
---|
| Week 4 [N=877,871] | Week 8 [N=850,844] | Week 12 [N=831,828] |
---|
Mirabegron 50 mg | -0.72 | -0.90 | -0.98 |
,Solifenacin 5 mg | -0.63 | -0.87 | -0.97 |
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Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment
The mean number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. (NCT01638000)
Timeframe: Baseline and Week 4, Week 8 , Week 12
Intervention | pads (Least Squares Mean) |
---|
| Week 4 [M=574,563] | Week 8 [N=551,543] | Week 12 [N=543,532] |
---|
Mirabegron 50 mg | -1.80 | -2.10 | -2.14 |
,Solifenacin 5 mg | -1.82 | -2.14 | -2.20 |
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Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency
Urgency level was rated by the participant during the 3-day micturition diary period using the PPIUS 5-point categorical scale: 0. No urgency; 1. Mild urgency; 2. Moderate urgency; 3. Severe urgency; 4. Urgency incontinence. (NCT01638000)
Timeframe: Baseline and Week 4, Week 8, Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 [N=916,906] | Week 8 [N=888,876] | Week 12 [N=870,856] | Final visit [N=920,910] |
---|
Mirabegron 50 mg | -0.36 | -0.50 | -0.60 | -0.58 |
,Solifenacin 5 mg | -0.36 | -0.52 | -0.60 | -0.57 |
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Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours
An urgency episode is a sudden compelling desire to pass urine immediately followed by an incontinent event or the patient having to rush to the toilet and make it in time; severity recorded as 3 (severe urgency) or 4 (urgency incontinence) on the Patient Perception of the Intensity of Urgency Scale (PPIUS) validated scale. The mean number of urgency episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. (NCT01638000)
Timeframe: Baseline and Week 4, Week 8, Week 12
Intervention | urgency episodes (Least Squares Mean) |
---|
| Week 4 [N=915,905] | Week 8 [N=887,875] | Week 12 [N=869,855] | Final Visit [N=919,909] |
---|
Mirabegron 50 mg | -3.75 | -4.44 | -4.67 | -4.61 |
,Solifenacin 5 mg | -3.88 | -4.79 | -4.99 | -4.84 |
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Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
An incontinence episode is any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. (NCT01638000)
Timeframe: Baseline and Week 4, Week 8, Week 12
Intervention | incontinence episodes (Least Squares Mean) |
---|
| Week 4 [N=404,410] | Week 8 [N=387,397] | Week 12 [N=381,387] |
---|
Mirabegron 50 mg | -1.22 | -1.37 | -1.41 |
,Solifenacin 5 mg | -1.30 | -1.59 | -1.66 |
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Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours
(NCT01638000)
Timeframe: Baseline and Week 4, Week 8, Week 12
Intervention | micturitions (Least Squares Mean) |
---|
| Week 4 [N=916,906] | Week 8 [N=888,876] | Week 12 [N=870,856] |
---|
Mirabegron 50 mg | -2.37 | -2.77 | -3.02 |
,Solifenacin 5 mg | -2.33 | -3.00 | -3.21 |
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Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours
An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The mean number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. (NCT01638000)
Timeframe: Baseline and Week 4, Week 8, Week 12
Intervention | urgency incontinence episodes (Least Squares Mean) |
---|
| Week 4 [N=395,399] | Week 8 [N=379,386] | Week 12 [N=373,377] |
---|
Mirabegron 50 mg | -1.22 | -1.39 | -1.49 |
,Solifenacin 5 mg | -1.24 | -1.56 | -1.59 |
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Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and final visit (up to Week 12)
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 332 | 55 | 11 | 2 | 1 | 3 | 133 | 92 | 26 | 4 | 0 | 0 | 55 | 52 | 22 | 10 | 2 | 0 | 38 | 25 | 8 | 12 | 1 | 1 | 10 | 6 | 3 | 3 | 3 | 0 | 9 | 1 | 0 | 0 | 0 | 1 |
,Solifenacin 5 mg | 356 | 52 | 10 | 2 | 0 | 1 | 121 | 83 | 17 | 2 | 1 | 0 | 68 | 45 | 29 | 6 | 1 | 2 | 35 | 18 | 15 | 6 | 0 | 3 | 15 | 2 | 7 | 3 | 3 | 0 | 7 | 2 | 0 | 0 | 0 | 0 |
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Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and final visit (up to Week 12)
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 460 | 37 | 14 | 6 | 1 | 3 | 80 | 45 | 16 | 2 | 0 | 1 | 60 | 33 | 36 | 7 | 0 | 0 | 53 | 15 | 17 | 20 | 1 | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 2 | 5 | 3 | 0 | 0 | 1 |
,Solifenacin 5 mg | 471 | 25 | 12 | 5 | 0 | 2 | 88 | 34 | 18 | 2 | 0 | 1 | 67 | 46 | 31 | 4 | 0 | 1 | 52 | 17 | 11 | 11 | 0 | 2 | 1 | 1 | 0 | 0 | 1 | 0 | 9 | 0 | 0 | 0 | 0 | 0 |
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Bacterial Genomic Sequencing
Participants were classified into Low Biomass, Lactobacillus, Gardnerella, Diverse, and Other urotypes based on the bacterial DNA at baseline. (NCT01642277)
Timeframe: 12 weeks
Intervention | participants (Number) |
---|
| Low biomass | Lactobacillus urotype | Diverse urotype | Gardnerella urotype | Other urotypes |
---|
Urinary Urge Incontinence | 25 | 11 | 3 | 6 | 3 |
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Assessment of Pelvic Floor Disease Inventory (PFDI) Questionnaire
"The PFDI comprises 46 items on a 4-point symptom severity scale ranging from 1 = Not at all to 4 = Quite a bit. From these items, 13 separate sub-scales are reported: (1) Obstructive discomfort, (2) Irritation, (3) Stress resulting from urinal distress, (4) A general sub-scale for pelvic organ prolapse distress, (5) An anterior sub-scale for pelvic organ prolapse distress, (6) A posterior sub-scale for pelvic organ prolapse distress, (7) An obstructive sub-scale for colorectal anal distress, (8) Incontinence, (9) Pain, and (10) A rectal prolapse sub-scale for colorectal anal distress. For each of these sub-scales, scores from from 0 to 100 (where higher scores indicate greater symptom severity). There are three additional sub-scales: (11) The urinary distress inventory, (12) The pelvic organ distress inventory, and (13) The colorectal distress inventory. Each of these ranges from 0 to 400 (with higher scores indicating greater symptom severity)." (NCT01642277)
Timeframe: 12 weeks
Intervention | units on a scale (Median) |
---|
| Obstructive Discomfort Score | Irritative Score | Stress Score | Urinary Distress Inventory Score | General Score | Anterior Score | Posterior Score | Pelvic Organ Prolapse Distress Inventory Score | Obstructive Score | Pain Irritation Score | Rectal Prolapse | Colo-Rectal-Anal Distress Inventory Score | Incontinence Score |
---|
Solifenacin Non-Responder | 7.69 | 32.50 | 16.67 | 60.26 | 14.29 | 8.33 | 16.67 | 47.62 | 16.67 | 10.71 | 0 | 42.86 | 10.00 |
,Solifenacin Responder | 5.77 | 12.50 | 8.33 | 40.19 | 7.14 | 8.33 | 0 | 20.83 | 0 | 10.71 | 0 | 17.86 | 0 |
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Assessment of Overactive Bladder Questionnaire (OABQ)
The Overactive Bladder Questionnaire (OAB-q) was developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related quality of life (HRQL). The instrument comprises 33 items. Response options for the symptom frequency and HRQL items are presented as 6-point Likert scales ranging from 'none of the time' to 'all of the time' for symptom frequency (and 'not at all' to 'a very great deal' for symptom bother). From these 33 items, six sub-scales are assessed separately: (1) OAB symptom severity, (2) Coping with OAB symptoms, (3) Concern for OAB symptoms, (4) Sleep as a function of OAB symptoms, (5) Social functioning as a consequence of OAB symptoms, and (6) Health related quality of life (HRQL) as a function of OAB symptoms. Each sub-scale score ranges from 0 to 100 (where higher scores indicate more severe OAB symptoms and lower scores indicate minimal symptom severity). (NCT01642277)
Timeframe: End of study (Week 12)
Intervention | units on a scale (Median) |
---|
| Symptom Severity Score | Coping Score | Concern Score | Sleep Score | Social Score | Health Related Quality of Life (HRQL) |
---|
Solifenacin Non-Responder | 37.50 | 80.00 | 82.86 | 84.00 | 96.00 | 76.00 |
,Solifenacin Responder | 17.50 | 92.50 | 97.14 | 92.00 | 100.00 | 92.80 |
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Change From Baseline to Final Visit in Postvoid Residual (PVR) Volume
PVR volume was assessed by ultrasonography or bladder scan during 905-CL-076 and 905-CL-077. The value reported is the last PVR volume value after first dose of solifenacin up to 52 weeks. (NCT01655069)
Timeframe: Baseline (of 905-CL-076 study) to final Visit (the most recent value after first dose of solifenacin up to 40 weeks for participants who received placebo in 076 and 52 weeks for those who received solifenacin in 076.)
Intervention | mL (Mean) |
---|
Children (Aged 5 to Less Than 12 Years) | 1.3 |
Adolescents (Aged 12 to Less Than 18 Years) | 0.7 |
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Change From Baseline in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents
Adolescent participants were also asked to record urgencies for at least 2 of the 7 diary days using the Perception of Intensity of Urgency Scale (PPIUS): (0 - no urgency, 1 - mild urgency, 2 - moderate urgency, 3 - severe urgency, 4 - urge incontinence). This data is based on 7-day diary data completed by participants prior to each visit from the start of 905-CL-076 to the end of 905-CL-077. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group. (NCT01655069)
Timeframe: Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment
Intervention | urgency episodes (Mean) |
---|
| 3 weeks solifenacin treatment | 6 weeks solifenacin treatment | 9 weeks solifenacin treatment | 12 weeks solifenacin treatment | 24weeks solifenacin treatment | 40 weeks solifenacin treatment | 52 weeks solifenacin treatment |
---|
Adolescents (Aged 12 to Less Than 18 Years) | -0.79 | -1.36 | -1.15 | -1.31 | -1.11 | -2.18 | -1.87 |
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Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours
The mean number of incontinence episodes was based on 7-day diary data completed by participants prior to each visit from the start of 905-CL-076 to the end of 905-CL-077. An Incontinence episode is defined as an episode with any involuntary loss of urine. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group. (NCT01655069)
Timeframe: Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment
Intervention | incontinence episodes (Mean) |
---|
| 3 weeks solifenacin treatment | 6 weeks solifenacin treatment | 9 weeks solifenacin treatment | 12 weeks solifenacin treatment | 24 weeks solifenacin treatment | 40 weeks solifenacin treatment | 52 weeks solifenacin treatment |
---|
Adolescents (Aged 12 to Less Than 18 Years) | -1.05 | -1.40 | -1.48 | -1.66 | -1.73 | -1.49 | -1.34 |
,Children (Aged 5 to Less Than 12 Years) | -0.92 | -1.11 | -1.28 | -1.39 | -1.61 | -1.66 | -1.56 |
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Change From Baseline in Mean Number of Micturitions Per 24 Hours
The mean number of micturitions (urinations) was based on 7-day diary data completed by participants prior to each visit from start of 905-CL-076 to end of 905-CL-077. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group. (NCT01655069)
Timeframe: Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment
Intervention | micturitions (Mean) |
---|
| 3 weeks solifenacin treatment | 6 weeks solifenacin treatment | 9 weeks solifenacin treatment | 12 weeks solifenacin treatment | 24 weeks solifenacin treatment | 40 weeks solifenacin treatment | 52 weeks solifenacin treatment |
---|
Adolescents (Aged 12 to Less Than 18 Years) | -1.29 | -1.38 | -1.15 | -1.24 | -1.01 | -1.39 | -0.81 |
,Children (Aged 5 to Less Than 12 Years) | -0.78 | -0.96 | -1.15 | -1.09 | -1.42 | -1.43 | -1.80 |
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Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days
The number of dry (incontinence-free) days was based on 7-day diary data completed by participants prior to each visit from start of 905-C L-076 to end of 905-C L-077. An incontinence-free day is a day without any incontinence episodes. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group. (NCT01655069)
Timeframe: Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment
Intervention | days (Mean) |
---|
| 3 weeks solifenacin treatment | 6 weeks solifenacin treatment | 9 weeks solifenacin treatment | 12 weeks solifenacin treatment | 24 weeks solifenacin treatment | 40 weeks solifenacin treatment | 52 weeks solifenacin treatment |
---|
Adolescents (Aged 12 to Less Than 18 Years) | 1.69 | 2.21 | 1.94 | 2.89 | 3.19 | 2.71 | 3.27 |
,Children (Aged 5 to Less Than 12 Years) | 1.17 | 1.28 | 1.59 | 1.60 | 2.09 | 2.15 | 2.57 |
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Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs)
"The investigator assessed the severity of AEs, including abnormal clinical laboratory values, electrocardiogram (ECG), vital signs, as follows:~Mild: No disruption of normal daily activities; Moderate: Affect normal daily activities; Severe: Inability to perform daily activities. In participants treated with placebo in Study 905-CL-076, a TEAE was defined as an AE that started/worsened after the first dose of open-label solifenacin in Study 905-CL-077 up to 7 days after the last dose of solifenacin. In participants treated with solifenacin in Study 905-CL-076, a TEAE was defined as an AE that started/worsened after the first dose of double-blind solifenacin in Study 905-CL-076 up to 7 days after last dose of open-label solifenacin in Study 905-CL-077." (NCT01655069)
Timeframe: From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076).
Intervention | Participants (Count of Participants) |
---|
| TEAE - Mild | TEAE - Moderate | TEAE - Severe | Any TEAE | Drug-related TEAEs | Deaths | Serious TEAEs | Drug-related serious TEAEs | TEAEs leading to discontinuation | Drug related TEAEs leading to permanent discont. |
---|
Adolescents (Aged 12 to Less Than 18 Years) | 10 | 8 | 2 | 20 | 11 | 0 | 1 | 0 | 5 | 4 |
,Children (Aged 5 to Less Than 12 Years) | 72 | 20 | 1 | 93 | 41 | 0 | 1 | 0 | 12 | 12 |
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Change From Baseline in Postvoid Residual (PVR) Volume
Measurement of PVR volume was made using either ultrasonography or urethral catheterization, provided that the same method was used for the same participant throughout the study. (NCT01745094)
Timeframe: Baseline and week 4, 8, 12, 16
Intervention | mL (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 16 (LOCF) |
---|
Solifenacin 2.5 mg + Mirabegron 25 mg | -4.95 | -2.83 | -2.53 | 0.63 | -0.42 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | 5.88 | 5.07 | 5.29 | 3.96 | 3.96 |
,Solifenacin 5 mg + Mirabegron 25 mg | 13.78 | 11.05 | 6.51 | 7.31 | 8.00 |
,Solifenacin 5 mg + Mirabegron 50 mg | 4.36 | 1.87 | 1.17 | 3.60 | 3.17 |
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Number for Participants Who Achieved Normalization of the Number of Incontinence Episodes Per 24 Hours
Normalization for the mean number of incontinence episodes per 24 hours was defined as no incontinence episode per 24 hours. (NCT01745094)
Timeframe: Week 16
Intervention | Participants (Count of Participants) |
---|
Solifenacin 2.5 mg + Mirabegron 25 mg | 10 |
Solifenacin 2.5 mg + Mirabegron 50 mg | 21 |
Solifenacin 5 mg + Mirabegron 25 mg | 19 |
Solifenacin 5 mg + Mirabegron 50 mg | 46 |
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Number for Participants Who Achieved Normalization of the Number of Micturitions Per 24 Hours
Normalization for the mean number of micturitions per 24 hours was defined as < 8 micturitions per 24 hours. (NCT01745094)
Timeframe: Week 16
Intervention | Participants (Count of Participants) |
---|
Solifenacin 2.5 mg + Mirabegron 25 mg | 10 |
Solifenacin 2.5 mg + Mirabegron 50 mg | 17 |
Solifenacin 5 mg + Mirabegron 25 mg | 23 |
Solifenacin 5 mg + Mirabegron 50 mg | 40 |
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Number for Participants Who Achieved Normalization of the Number of Urgency Episodes Per 24 Hours
Normalization for the mean number of urgency episodes per 24 hours was defined as no urgency episode per 24 hours. (NCT01745094)
Timeframe: Week 16
Intervention | Participants (Count of Participants) |
---|
Solifenacin 2.5 mg + Mirabegron 25 mg | 16 |
Solifenacin 2.5 mg + Mirabegron 50 mg | 13 |
Solifenacin 5 mg + Mirabegron 25 mg | 31 |
Solifenacin 5 mg + Mirabegron 50 mg | 38 |
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Change From Baseline in OAB-q SF Total HRQL Score
The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the HRQL. The HRQL section included 13 questions. For each participant, the total HRQL score was derived as a sum of scores for Questions 7 to 19. The total score ranges from 13 to 78 with higher total HRQL score indicating greater HRQL. OAB-q SF data obtained at week 0 visit were used as baseline. (NCT01745094)
Timeframe: Baseline and week 8, 16
Intervention | units on a scale (Mean) |
---|
| Week 8 | Week 16 | Week 16 (LOCF) |
---|
Solifenacin 2.5 mg + Mirabegron 25 mg | 15.14 | 17.54 | 17.34 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | 9.31 | 16.72 | 16.72 |
,Solifenacin 5 mg + Mirabegron 25 mg | 12.43 | 14.72 | 13.88 |
,Solifenacin 5 mg + Mirabegron 50 mg | 6.14 | 12.72 | 12.56 |
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Change From Baseline in OABSS Total Score
The OABSS questionnaire was a questionnaire completed by participants with 4 questions regarding their OAB symptoms. For each participant, the OABSS total score was calculated from the sum total of the score of each question. The total score ranges from 0 to 15 with higher score indicating more symptoms. The OABSS data obtained at week 0 were used as baseline. (NCT01745094)
Timeframe: Baseline and week 8, 16
Intervention | units on a scale (Mean) |
---|
| Week 8 | Week 16 | Week 16 (LOCF) |
---|
Solifenacin 2.5 mg + Mirabegron 25 mg | -3.5 | -3.5 | -3.4 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | -2.1 | -3.9 | -3.9 |
,Solifenacin 5 mg + Mirabegron 25 mg | -3.5 | -3.6 | -3.6 |
,Solifenacin 5 mg + Mirabegron 50 mg | -2.5 | -4.0 | -4.0 |
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Change From Baseline in the Number of Incontinence Episodes Per 24 Hours
"Participants completed the patient diary (paper document) for 3 days immediately before each visit. An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urinary incontinence' was indicated, divided by the number of days on which episodes were recorded. Only participants who had an incontinence episode at baseline was included in the analysis." (NCT01745094)
Timeframe: Baseline and week 4, 8, 12, 16
Intervention | incontinence episodes (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 16 (LOCF) |
---|
Solifenacin 2.5 mg + Mirabegron 25 mg | -0.85 | -1.06 | -1.31 | -1.22 | -1.07 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | -0.55 | -0.73 | -1.04 | -1.08 | -1.08 |
,Solifenacin 5 mg + Mirabegron 25 mg | -1.12 | -1.26 | -1.03 | -1.32 | -1.32 |
,Solifenacin 5 mg + Mirabegron 50 mg | -0.64 | -0.76 | -0.93 | -1.08 | -1.06 |
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Change From Baseline in the Number of Micturitions Per 24 Hours
"Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean number of micturitions per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urinated was indicated, divided by the number of days on which episodes were recorded." (NCT01745094)
Timeframe: Baseline and week 4, 8, 12, 16
Intervention | micturitions (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 16 (LOCF) |
---|
Solifenacin 2.5 mg + Mirabegron 25 mg | -0.34 | -1.69 | -1.98 | -2.06 | -1.89 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | -0.98 | -1.31 | -2.40 | -2.36 | -2.36 |
,Solifenacin 5 mg + Mirabegron 25 mg | -1.33 | -1.74 | -1.50 | -1.90 | -1.94 |
,Solifenacin 5 mg + Mirabegron 50 mg | -1.02 | -1.32 | -1.75 | -2.13 | -2.12 |
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Change From Baseline in the Number of Nocturia Episodes Per Night
"Participants completed the patient diary (paper document) for 3 days immediately before each visit. A nocturia episode was defined as waking at night 1 or more times to void. Night time was defined as the period between bedtime and the wake-up time the following day (micturitions at the same time as the wake-up time were excluded). The mean number of nocturia episodes per night was calculated by taking the sum of nocturia episodes in the patient diary where the variable urinated was indicated during the night time, divided by the number of nights. Only participants who had a nocturia episode at baseline was included in the analysis." (NCT01745094)
Timeframe: Baseline and week 4, 8, 12, 16
Intervention | nocturia episodes (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 16 (LOCF) |
---|
Solifenacin 2.5 mg + Mirabegron 25 mg | 0.17 | -0.38 | -0.35 | -0.38 | -0.43 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | -0.07 | -0.21 | -0.48 | -0.31 | -0.31 |
,Solifenacin 5 mg + Mirabegron 25 mg | -0.45 | -0.37 | -0.29 | -0.44 | -0.44 |
,Solifenacin 5 mg + Mirabegron 50 mg | -0.27 | -0.44 | -0.58 | -0.61 | -0.60 |
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Change From Baseline in the Number of Urge Incontinence Episodes Per 24 Hours
"Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urge incontinence episode was defined as any episode when both urgency and incontinence occurred concurrently. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urgency and urinary incontinence' were indicated, divided by the number of days on which episodes were recorded. Only participants who had an urge incontinence episode at baseline was included in the analysis." (NCT01745094)
Timeframe: Baseline and week 4, 8, 12, 16
Intervention | urge incontinence episodes (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 16 (LOCF) |
---|
Solifenacin 2.5 mg + Mirabegron 25 mg | -0.87 | -1.17 | -1.30 | -1.07 | -0.97 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | -0.50 | -0.65 | -0.94 | -1.00 | -1.00 |
,Solifenacin 5 mg + Mirabegron 25 mg | -0.77 | -1.07 | -0.84 | -1.11 | -1.04 |
,Solifenacin 5 mg + Mirabegron 50 mg | -0.82 | -0.72 | -0.91 | -0.96 | -0.94 |
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Change From Baseline in the Number of Urgency Episodes Per 24 Hours
"Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urgency episode was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urgency was indicated, divided by the number of days on which episodes were recorded. Only participants who had an urgency episode at baseline was included in the analysis." (NCT01745094)
Timeframe: Baseline and week 4, 8, 12, 16
Intervention | urgency episodes (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 16 (LOCF) |
---|
Solifenacin 2.5 mg + Mirabegron 25 mg | -1.15 | -1.77 | -1.95 | -1.77 | -1.57 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | -1.26 | -1.49 | -2.55 | -2.59 | -2.59 |
,Solifenacin 5 mg + Mirabegron 25 mg | -1.45 | -1.76 | -1.89 | -1.93 | -1.93 |
,Solifenacin 5 mg + Mirabegron 50 mg | -1.43 | -1.37 | -1.88 | -2.06 | -2.02 |
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Change From Baseline in the Volume Voided Per Micturition
"Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean volume per micturition was calculated by taking the sum of the urinary volumes where the volume voided was > 0 and where urinary incontinence was not indicated in the patient diary, divided by the number of micturitions where the volume voided was > 0 and where urinary incontinence was not indicated. Only participants who had volume voided was > 0 at baseline was included in the analysis." (NCT01745094)
Timeframe: Baseline and week 8, 16
Intervention | mL (Mean) |
---|
| Week 8 | Week16 | Week 16 (LOCF) |
---|
Solifenacin 2.5 mg + Mirabegron 25 mg | 22.120 | 28.532 | 29.865 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | 19.380 | 33.031 | 33.031 |
,Solifenacin 5 mg + Mirabegron 25 mg | 33.781 | 35.780 | 34.118 |
,Solifenacin 5 mg + Mirabegron 50 mg | 24.821 | 36.921 | 36.957 |
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Number of Participants Who Achieved Normalization for OABSS Total Score
Normalization for OABSS Total Score was defined as OABSS total score ≤ 2 or OABSS Question 3 score ≤ 1. (NCT01745094)
Timeframe: Week 8 and 16
Intervention | Participants (Count of Participants) |
---|
| Week 8 | Week 16 | Week 16 (LOCF) |
---|
Solifenacin 2.5 mg + Mirabegron 25 mg | 19 | 18 | 19 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | 8 | 16 | 16 |
,Solifenacin 5 mg + Mirabegron 25 mg | 28 | 27 | 29 |
,Solifenacin 5 mg + Mirabegron 50 mg | 26 | 48 | 49 |
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAEs were defined as AEs observed after the first administration of the study drugs for the treatment period. The investigator assessed the severity of AEs, including abnormal clinical laboratory values, Electrocardiogram (ECG), vital signs, as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator. (NCT01745094)
Timeframe: From first dose of study drug up to weeks 16
Intervention | Participants (Count of Participants) |
---|
| Any TEAEs | Mild | Moderate | Severe | Drug-related TEAEs | Deaths | Serious TEAEs | Drug-related Serious TEAEs | TEAEs leading to permanent discontinuation (PD) | Drug-related TEAEs leading to PD |
---|
Solifenacin 2.5 mg + Mirabegron 25 mg | 23 | 22 | 1 | 0 | 6 | 0 | 1 | 0 | 0 | 0 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | 21 | 20 | 1 | 0 | 6 | 0 | 1 | 0 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 25 mg | 42 | 40 | 1 | 1 | 12 | 0 | 5 | 1 | 3 | 2 |
,Solifenacin 5 mg + Mirabegron 50 mg | 69 | 67 | 2 | 0 | 28 | 0 | 4 | 0 | 1 | 1 |
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Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. (NCT01767519)
Timeframe: Study Baseline, Week 12
Intervention | Incontinence Episodes (Mean) |
---|
| Study Baseline | Change from Study Baseline at Week 12 |
---|
BOTOX® | 4.86 | -3.10 |
,Placebo | 4.38 | -0.98 |
,Solifenacin | 5.23 | -2.66 |
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Change From Study Baseline in the Role Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1
The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the role limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. (NCT01767519)
Timeframe: Study Baseline, Week 12
Intervention | Scores on a Scale (Mean) |
---|
| Study Baseline | Change from Study Baseline at Wk 12 (N=135,145,57) |
---|
BOTOX® | 76.09 | -30.0 |
,Placebo | 81.36 | -17.25 |
,Solifenacin | 72.11 | -23.79 |
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Percentage of Patients With 100% Reduction in Incontinence Episodes in Treatment Cycle 1
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period and compared to baseline to determine 100% reduction in episodes. (NCT01767519)
Timeframe: Study Baseline, Week 12
Intervention | Percentage of Patients (Number) |
---|
BOTOX® | 33.8 |
Solifenacin | 24.5 |
Placebo | 11.7 |
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Percentage of Patients With a Positive Response on the Single-Item Treatment Benefit Scale During Treatment Cycle 1
A positive treatment response on the Treatment Benefit Scale is a score of either 1 or 2, representing 'greatly improved' or 'improved.' (NCT01767519)
Timeframe: Week 12
Intervention | Percentage of Patients (Number) |
---|
BOTOX® | 71.3 |
Solifenacin | 74.0 |
Placebo | 44.8 |
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Change From Study Baseline in the Number of Micturition Episodes in Treatment Cycle 1
The number of micturition episodes (the number of times a patient urinates into the toilet) in Treatment Cycle 1 was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. (NCT01767519)
Timeframe: Study Baseline, Week 12
Intervention | Micturition Episodes (Mean) |
---|
| Study Baseline | Change from Study Baseline at Wk 12 (N=135,144,57) |
---|
BOTOX® | 10.74 | -2.40 |
,Placebo | 10.18 | -0.87 |
,Solifenacin | 10.40 | -2.03 |
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Change From Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1
Nocturia episodes are measured over a 3 day diary prior to each visit in Treatment Cycle 1. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. (NCT01767519)
Timeframe: Study Baseline, Week 12
Intervention | Nocturia Episodes (Mean) |
---|
| Study Baseline | Change from Study Baseline at Wk 12 (N=135,144,57) |
---|
BOTOX® | 2.03 | -0.54 |
,Placebo | 1.98 | -0.23 |
,Solifenacin | 2.04 | -0.49 |
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Change From Study Baseline in the Social Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1
The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the social limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. (NCT01767519)
Timeframe: Study Baseline, Week 12
Intervention | Scores on a Scale (Mean) |
---|
| Study Baseline | Change from Study Baseline at Wk 12 (N=135,145,57) |
---|
BOTOX® | 59.66 | -13.46 |
,Placebo | 62.57 | -7.60 |
,Solifenacin | 56.22 | -12.70 |
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Change From Baseline to End of Study Measured by the American Urology Association Symptom Score Questionnaire (AUASS).
The AUASS score range is 1-7 (mild), 8-19 (moderate) and 20-35 (severe). The AUASS asks 7 questions scored 0-5, the scores are summed for the total score. (NCT01777217)
Timeframe: baseline and 16 weeks
Intervention | Scores on a scale (Median) |
---|
Solifenacin Succinate | 9.4 |
Placebo | 6.7 |
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Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care
The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity. (NCT01908829)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Combination (Solifenacin + Mirabegron) | 548 | 28 | 0 | 3 | 0 | 6 | 37 | 23 | 9 | 1 | 0 | 0 | 12 | 9 | 11 | 0 | 0 | 0 | 7 | 2 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 6 | 0 | 0 | 0 | 0 | 1 |
,Solifenacin 10 mg | 548 | 25 | 7 | 2 | 0 | 4 | 32 | 22 | 9 | 0 | 0 | 1 | 7 | 5 | 12 | 2 | 0 | 0 | 0 | 2 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 17 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 5 mg | 541 | 26 | 14 | 0 | 0 | 5 | 25 | 24 | 7 | 0 | 0 | 0 | 16 | 9 | 7 | 2 | 0 | 0 | 5 | 2 | 1 | 4 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 14 | 2 | 0 | 0 | 0 | 0 |
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Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort
The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity. (NCT01908829)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | participants (Number) |
---|
| No pain -> no pain | No pain -> slight pain | No pain -> moderate pain | No pain -> severe pain | No pain -> extreme pain | No pain -> no data | Slight pain -> no pain | Slight pain -> slight pain | Slight pain -> moderate pain | Slight pain -> severe pain | Slight pain -> extreme pain | Slight pain -> no data | Moderate pain -> no pain | Moderate pain -> slight pain | Moderate pain -> moderate pain | Moderate pain -> severe pain | Moderate pain -> extreme pain | Moderate pain -> no data | Severe pain -> no pain | Severe pain -> slight pain | Severe pain -> moderate pain | Severe pain -> severe pain | Severe pain -> extreme pain | Severe pain -> no data | Extreme pain -> no pain | Extreme pain -> slight pain | Extreme pain -> moderate pain | Extreme pain -> severe pain | Extreme pain -> extreme pain | Extreme pain -> no data | No data -> no pain | No data -> slight pain | No data -> moderate pain | No data -> severe pain | No data -> extreme pain | No data -> no data |
---|
Combination (Solifenacin + Mirabegron) | 299 | 45 | 12 | 3 | 0 | 4 | 79 | 58 | 28 | 0 | 1 | 0 | 39 | 37 | 34 | 7 | 0 | 2 | 7 | 12 | 11 | 10 | 0 | 0 | 4 | 0 | 1 | 6 | 1 | 0 | 4 | 1 | 1 | 0 | 0 | 1 |
,Solifenacin 10 mg | 283 | 51 | 17 | 2 | 1 | 3 | 81 | 55 | 31 | 5 | 0 | 2 | 21 | 39 | 39 | 8 | 0 | 0 | 10 | 4 | 16 | 9 | 1 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 11 | 4 | 2 | 0 | 0 | 0 |
,Solifenacin 5 mg | 290 | 62 | 14 | 9 | 0 | 4 | 82 | 64 | 17 | 2 | 2 | 0 | 36 | 36 | 30 | 4 | 1 | 1 | 4 | 7 | 16 | 4 | 1 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 8 | 3 | 5 | 0 | 0 | 0 |
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Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction
The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life). (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 9.58 | 11.93 | 14.70 | 14.39 |
,Solifenacin 10 mg | 8.95 | 10.16 | 11.98 | 11.72 |
,Solifenacin 5 mg | 7.85 | 10.84 | 12.08 | 11.91 |
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Number of Participants With Adverse Events (AEs)
AE was defined as any untoward medical occurrence in a participant administered a study drug or has undergone study procedures & which does not necessarily have a causal relationship with this treatment. Treatment-Emergent Adverse Event (TEAE) referred to an adverse event which started or worsened in the period from first double-blind medication intake until 30 days after the last double-blind medication intake. (NCT01908829)
Timeframe: From first dose of double blind treatment until 30 days after last dose (up to 16 weeks)
Intervention | Participants (Count of Participants) |
---|
| AEs | Drug-related AEs | Serious Adverse Events (SAEs) | Drug-related SAEs | AEs Leading to Perm. Disc. of Study Drug | Drug-related AEs Leading to Perm. Disc. of Drug | Deaths |
---|
Combination (Solifenacin + Mirabegron) | 260 | 141 | 13 | 1 | 11 | 9 | 0 |
,Solifenacin 10 mg | 283 | 161 | 15 | 3 | 11 | 9 | 0 |
,Solifenacin 5 mg | 241 | 125 | 10 | 0 | 11 | 10 | 0 |
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Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC)
The PGIC was a 2-part questionnaire, assessing both the change in the participant's overall condition (Patient Impression in General Health (PIBS)) and change in bladder condition since the start of the study (Patient Impression in General Health (PIGH)) (from very much worse to very much improved). The CGIC was a single questionnaire assessing the participant's change in bladder condition since the beginning of the study (Clinician Impression in Bladder Symptoms (CIBS)). (NCT01908829)
Timeframe: End of treatment (up to 12 weeks)
Intervention | participants (Number) |
---|
| PIBS Very Much Improved | PIBS Much Improved | PIBS Minimally Improved | PIBS No Change | PIBS Minimally Worse | PIBS Much Worse | PIBS Very Much Worse | PIGH Very Much Improved | PIGH Much Improved | PIGH Minimally Improved | PIGH No Change | PIGH Minimally Worse | PIGH Much Worse | PIGH Very Much Worse | CIBS Very Much Improved | CIBS Much Improved | CIBS Minimally Improved | CIBS No Change | CIBS Minimally Worse | CIBS Much Worse | CIBS Very Much Worse |
---|
Combination (Solifenacin + Mirabegron) | 227 | 257 | 135 | 25 | 7 | 4 | 0 | 144 | 239 | 143 | 113 | 14 | 1 | 1 | 184 | 311 | 141 | 23 | 4 | 4 | 3 |
,Solifenacin 10 mg | 171 | 284 | 152 | 56 | 4 | 6 | 1 | 108 | 244 | 146 | 160 | 10 | 4 | 2 | 141 | 329 | 155 | 40 | 5 | 5 | 4 |
,Solifenacin 5 mg | 152 | 264 | 170 | 55 | 11 | 4 | 1 | 104 | 236 | 147 | 142 | 23 | 4 | 1 | 118 | 316 | 164 | 56 | 8 | 3 | 3 |
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Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression
The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity. (NCT01908829)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | participants (Number) |
---|
| Not anxious -> not anxious | Not anxious -> slightly anxious | Not anxious -> moderately anxious | Not anxious -> severely anxious | Not anxious-> extremely anxious | Not anxious -> no data | Slightly anxious -> not anxious | Slightly anxious -> slightly anxious | Slightly anxious -> moderately anxious | Slightly anxious -> severely anxious | Slightly anxious -> extremely anxious | Slightly anxious -> no data | Moderately anxious -> not anxious | Moderately anxious -> slightly anxious | Moderately anxious -> moderately anxious | Moderately anxious -> severely anxious | Moderately anxious -> extremely anxious | Moderately anxious -> no data | Severely anxious -> not anxious | Severely anxious -> slightly anxious | Severely anxious -> moderately anxious | Severely anxious -> severely anxious | Severely anxious -> extremely anxious | Severely anxious -> no data | Extremely anxious -> not anxious | Extremely anxious -> slightly anxious | Extremely anxious -> moderately anxious | Extremely anxious -> severely anxious | Extremely anxious -> extremely anxious | Extremely anxious -> no data | No data -> not anxious | No data -> slightly anxious | No data -> moderately anxious | No data -> severely anxious | No data -> extremely anxious | No data -> no data |
---|
Combination (Solifenacin + Mirabegron) | 322 | 43 | 11 | 2 | 0 | 4 | 107 | 56 | 13 | 1 | 0 | 1 | 36 | 36 | 22 | 3 | 0 | 0 | 10 | 9 | 6 | 5 | 0 | 0 | 1 | 2 | 4 | 4 | 1 | 1 | 5 | 0 | 1 | 0 | 0 | 1 |
,Solifenacin 10 mg | 307 | 43 | 15 | 3 | 0 | 3 | 90 | 69 | 23 | 2 | 0 | 2 | 34 | 33 | 17 | 1 | 1 | 0 | 8 | 5 | 11 | 7 | 0 | 0 | 1 | 1 | 3 | 1 | 1 | 0 | 11 | 5 | 1 | 0 | 0 | 0 |
,Solifenacin 5 mg | 300 | 39 | 17 | 2 | 0 | 3 | 99 | 60 | 11 | 2 | 0 | 2 | 38 | 40 | 26 | 7 | 3 | 0 | 8 | 5 | 6 | 8 | 3 | 0 | 4 | 1 | 2 | 1 | 2 | 0 | 13 | 2 | 1 | 0 | 0 | 0 |
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Number of Pads Used During the 3-Day Diary
The number of pads used was defined as the number of times a participant recorded a new pad used during the 3-day micturition diary period. This was calculated using the sum of each record with new pad checked. Only records with new pad checked on a valid diary day were counted. (NCT01908829)
Timeframe: Weeks 4, 8 and 12
Intervention | pads (Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 4.80 | 3.64 | 3.23 | 3.29 |
,Solifenacin 10 mg | 5.41 | 4.50 | 4.07 | 4.17 |
,Solifenacin 5 mg | 5.69 | 4.71 | 4.13 | 4.27 |
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Number of Nocturia Episodes Reported Over 3-Day Diary
The number of nocturia episodes was defined as the number of times a participant urinated (excluding incontinence only episodes) during sleeping time during the 3-day micturition diary period. This was calculated using the sum of each nocturia episode recorded on valid diary days during the 3-day micturition diary period. (NCT01908829)
Timeframe: Weeks 4, 8 and 12
Intervention | nocturia episodes (Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 3.63 | 3.33 | 3.12 | 3.16 |
,Solifenacin 10 mg | 3.58 | 3.32 | 3.23 | 3.19 |
,Solifenacin 5 mg | 3.59 | 3.35 | 3.26 | 3.28 |
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Number of Incontinence Episodes Reported During the 3-Day Diary
The number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from total number of incontinence episodes on valid diary days recorded during the 3-day micturition diary period. (NCT01908829)
Timeframe: Weeks 4, 8 and 12
Intervention | incontinence episodes (Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 5.81 | 4.55 | 4.03 | 4.25 |
,Solifenacin 10 mg | 6.41 | 5.28 | 4.62 | 4.72 |
,Solifenacin 5 mg | 6.68 | 5.43 | 4.56 | 4.87 |
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Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours
The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12
Intervention | incontinence episodes (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 |
---|
Combination (Solifenacin + Mirabegron) | -1.24 | -1.68 | -1.81 |
,Solifenacin 10 mg | -1.12 | -1.49 | -1.67 |
,Solifenacin 5 mg | -0.91 | -1.29 | -1.57 |
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Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score
The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). Symptom Bother score ranges from 0 (least severity) to 100 (worst severity). (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | -16.68 | -22.86 | -27.90 | -26.89 |
,Solifenacin 10 mg | -15.82 | -19.34 | -24.09 | -23.59 |
,Solifenacin 5 mg | -13.79 | -18.36 | -22.31 | -21.93 |
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Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score
The TS-VAS rated participant satisfaction with treatment on a scale from 0 (No, not at all) to 10 (Yes, completely). (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 1.2 | 1.5 | 1.9 | 1.8 |
,Solifenacin 10 mg | 1.1 | 1.3 | 1.6 | 1.6 |
,Solifenacin 5 mg | 0.8 | 1.2 | 1.4 | 1.4 |
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Change From Baseline in Post Void Residual (PVR) Volume
PVR Volume was assessed by bladder scan. (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12
Intervention | mL (Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 1.545 | 2.245 | 6.356 | 5.478 |
,Solifenacin 10 mg | 7.308 | 7.232 | 6.552 | 7.354 |
,Solifenacin 5 mg | 2.821 | 1.117 | 2.337 | 3.046 |
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Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours
The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. The analysis population consisted of the Full Analysis Set (FAS) which comprised of all the Randomized Analysis Set's (RAS) participants who met the following criteria: took at least 1 dose of double-blind study drug after randomization, reported at least 1 micturition in the baseline diary & at least 1 micturition postbaseline & reported at least 1 incontinence episode in the baseline diary. For participants who withdrew before EoT (week 12) and have no measurement available for that diary period, the Last Observation Carried Forward (LOCF) value during the double-blind study period was used as EoT value to derive the primary variable. (NCT01908829)
Timeframe: Baseline and end of treatment (up to 12 weeks)
Intervention | incontinence episodes (Least Squares Mean) |
---|
Combination (Solifenacin + Mirabegron) | -1.8 |
Solifenacin 5 mg | -1.53 |
Solifenacin 10 mg | -1.67 |
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Change From Baseline in OAB-q HRQL Subscale Score: Sleep
The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life). (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week EoT |
---|
Combination (Solifenacin + Mirabegron) | 11.58 | 16.18 | 20.00 | 19.16 |
,Solifenacin 10 mg | 11.16 | 13.72 | 16.84 | 16.55 |
,Solifenacin 5 mg | 11.04 | 14.57 | 17.74 | 17.30 |
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Change From Baseline in OAB-q HRQL Subscale Score: Coping
The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life). (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 15.17 | 20.82 | 25.16 | 24.48 |
,Solifenacin 10 mg | 14.25 | 16.87 | 20.20 | 19.90 |
,Solifenacin 5 mg | 12.27 | 17.47 | 20.45 | 20.19 |
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Change From Baseline in OAB-q HRQL Subscale Score: Concern
The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life). (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week EoT |
---|
Combination (Solifenacin + Mirabegron) | 13.79 | 18.87 | 22.85 | 22.28 |
,Solifenacin 10 mg | 13.82 | 15.88 | 19.67 | 19.28 |
,Solifenacin 5 mg | 11.85 | 16.36 | 19.24 | 19.00 |
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Change From Baseline in Mean Volume Voided (MVV) Per Micturition
MVV per micturition was defined as MVV (mL) per micturition during last 3 days of the 3-day micturition diary period. MVV per micturition was calculated as the sum of each volume voided for each record with volume voided > 0 on valid diary days divided by the total number of records with a volume voided > 0 on valid diary days during the 3-day micturition diary period. (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12
Intervention | mL (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 15.06 | 25.21 | 29.54 | 28.05 |
,Solifenacin 10 mg | 14.99 | 21.08 | 20.99 | 20.30 |
,Solifenacin 5 mg | 11.20 | 14.02 | 17.16 | 16.52 |
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Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours
UI was defined as the complaint of involuntary urine leakage accompanied by or immediately preceded by urgency. UI was measured using the Patient Perception of Intensity of Urgency Scale (PPIUS), a patient reported outcome validated 5-point categorical scale rating the degree of associated urinary urgency severity (0=No urgency, I felt no need to empty my bladder, but did so for other reasons. 1=Mild, I could postpone voiding as long as necessary, without fear of wetting myself. 2= Moderate, I could postpone voiding for a short while, without fear of wetting myself. 3=Severe, I could not postpone voiding, but had to rush to the toilet in order not to wet myself. 4=Urgency incontinence, I leaked before arriving to the toilet). One urgency incontinence episode was counted for each record of the diary in which the following occurred: incontinence episode or 'both' was recorded & severity of urinary urgency recorded was 3 or 4. (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12
Intervention | UI episodes (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | -1.26 | -1.70 | -1.84 | -1.82 |
,Solifenacin 10 mg | -1.14 | -1.45 | -1.62 | -1.63 |
,Solifenacin 5 mg | -0.91 | -1.25 | -1.58 | -1.54 |
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Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
An urgency episode was defined as the complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes (severity of 3 or 4) per 24 hours was defined as the average number of times a participant recorded an urgency episode (severity of 3 or 4) with or without incontinence per day during the 3-day micturition diary period. Measured using the PPIUS scale. This was calculated using the sum of each record with an urgency episode (severity of 3 or 4) recorded on a valid diary day divided by the number of valid diary days during the 3-day micturition diary period. (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12
Intervention | urgency episodes (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | -1.84 | -2.64 | -2.97 | -2.95 |
,Solifenacin 10 mg | -1.74 | -2.29 | -2.55 | -2.54 |
,Solifenacin 5 mg | -1.39 | -2.00 | -2.44 | -2.41 |
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Change From Baseline in Mean Number of Pads Per 24 Hours
The mean number of pads per 24 hours was defined as the average number of times a participant recorded a new pad used per day during the 3-day micturition diary period. This was calculated using the number of new pads used during valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12
Intervention | pads (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | -1.12 | -1.50 | -1.65 | -1.66 |
,Solifenacin 10 mg | -1.04 | -1.36 | -1.43 | -1.43 |
,Solifenacin 5 mg | -0.86 | -1.17 | -1.38 | -1.35 |
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Change From Baseline in Mean Number of Nocturia Episodes
Mean number of nocturia episodes was defined as the number of times a participant urinated (excluding incontinence only episodes) while sleeping during the 3-day diary period, divided by the number of valid diary days during the diary period. Night time episode of incontinence only was not considered a nocturia episode. Nocturia episodes were counted for each micturition record which occurred between the date/time of going to bed with intention to sleep and the date/time of getting up with intention to stay awake on a valid diary day & which was accompanied by a sleep interruption. Nocturia only determined for those who were not night-shift workers. (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12
Intervention | nocturia episodes (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | -0.28 | -0.37 | -0.46 | -0.43 |
,Solifenacin 10 mg | -0.29 | -0.37 | -0.41 | -0.41 |
,Solifenacin 5 mg | -0.27 | -0.35 | -0.38 | -0.37 |
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Change From Baseline in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (voluntary urinations (excluding incontinence only episodes)) per 24 hours was derived from number of micturitions recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period (excluding incontinence only episodes). (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12
Intervention | micturitions (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | -0.95 | -1.36 | -1.63 | -1.59 |
,Solifenacin 10 mg | -0.79 | -1.00 | -1.11 | -1.12 |
,Solifenacin 5 mg | -0.69 | -0.94 | -1.16 | -1.14 |
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Change From Baseline to EoT in Corrected Micturition Frequency (CMF)
CMF was defined as the mean number of micturitions per 24 hours that participants would have at EoT if their fluid intake had remained unchanged since baseline. This was calculated by the MVV per Micturition at baseline multiplied by the mean number of micturitions per 24 hours at baseline divided by the MVV per micturition at EoT. (NCT01908829)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | micturitions (Least Squares Mean) |
---|
Combination (Solifenacin + Mirabegron) | -0.96 |
Solifenacin 5 mg | -0.52 |
Solifenacin 10 mg | -0.71 |
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Change From Baseline in Patient Perception Bladder Control (PPBC) Score
The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. PPBC score: 1-no problem, 2- some very minor problems, 3-some minor problems, 4-moderate problems, 5-severe problems, 6-many severe problems. (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | -0.9 | -1.2 | -1.5 | -1.5 |
,Solifenacin 10 mg | -0.7 | -1.0 | -1.3 | -1.3 |
,Solifenacin 5 mg | -0.6 | -1.0 | -1.2 | -1.2 |
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Percentage of Participants With Zero Incontinence Episodes Postbaseline
Incontinence was defined as any involuntary leakage of urine. (NCT01908829)
Timeframe: Weeks 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 23.5 | 40.4 | 47.3 | 46.0 |
,Solifenacin 10 mg | 22.1 | 34.3 | 40.7 | 40.2 |
,Solifenacin 5 mg | 20.0 | 31.6 | 39.5 | 37.9 |
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Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score
HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life). (NCT01908829)
Timeframe: Weeks 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 52.6 | 63.6 | 70.5 | 68.6 |
,Solifenacin 10 mg | 48.1 | 53.8 | 60.4 | 60.1 |
,Solifenacin 5 mg | 44.5 | 54.8 | 60.8 | 60.6 |
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Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC
The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. (NCT01908829)
Timeframe: Weeks 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 26.6 | 39.5 | 51.8 | 49.8 |
,Solifenacin 10 mg | 21.6 | 31.8 | 43.8 | 43.2 |
,Solifenacin 5 mg | 21.6 | 31.5 | 39.8 | 39.1 |
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Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours
Incontinence was defined as any involuntary leakage of urine. (NCT01908829)
Timeframe: Weeks 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 52.5 | 66.9 | 72.4 | 71.2 |
,Solifenacin 10 mg | 49.0 | 61.8 | 66.9 | 66.6 |
,Solifenacin 5 mg | 43.3 | 57.6 | 64.0 | 63.1 |
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Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score
The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). Symptom Bother score ranges from 0 (least severity) to 100 (worst severity). (NCT01908829)
Timeframe: Weeks 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 67.9 | 77.2 | 83.5 | 81.7 |
,Solifenacin 10 mg | 61.9 | 69.1 | 75.4 | 74.6 |
,Solifenacin 5 mg | 58.2 | 66.4 | 72.1 | 71.7 |
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Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC
The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. (NCT01908829)
Timeframe: Weeks 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 61.1 | 70.1 | 77.9 | 76.5 |
,Solifenacin 10 mg | 56.3 | 64.6 | 72.7 | 71.9 |
,Solifenacin 5 mg | 52.1 | 62.1 | 70.4 | 69.5 |
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Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline
Micturitions were defined as voluntary urinations (excluding incontinence only episodes). (NCT01908829)
Timeframe: Weeks 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 21.0 | 28.1 | 31.4 | 30.2 |
,Solifenacin 10 mg | 20.2 | 26.3 | 28.0 | 27.7 |
,Solifenacin 5 mg | 18.7 | 22.4 | 24.8 | 25.0 |
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Number of UI Episodes Reported During the 3-Day Diary
Number of UI episodes was calculated using the number of UI episodes recorded on valid diary days during the 3-day micturition diary period. NOTE: Only urgency incontinence episodes recorded on a valid diary day were counted. (NCT01908829)
Timeframe: Weeks 4, 8 and 12
Intervention | UI episodes (Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 4.96 | 3.55 | 3.10 | 3.33 |
,Solifenacin 10 mg | 5.50 | 4.50 | 3.91 | 3.96 |
,Solifenacin 5 mg | 5.86 | 4.76 | 3.78 | 4.00 |
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Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility
The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity. (NCT01908829)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Combination (Solifenacin + Mirabegron) | 409 | 33 | 14 | 0 | 0 | 2 | 52 | 43 | 15 | 1 | 0 | 2 | 24 | 25 | 28 | 2 | 0 | 1 | 7 | 6 | 17 | 12 | 0 | 1 | 3 | 1 | 1 | 1 | 0 | 0 | 4 | 2 | 0 | 0 | 0 | 1 |
,Solifenacin 10 mg | 374 | 36 | 11 | 4 | 0 | 5 | 60 | 40 | 16 | 3 | 0 | 0 | 25 | 23 | 40 | 7 | 0 | 0 | 2 | 7 | 11 | 14 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 13 | 1 | 3 | 0 | 0 | 0 |
,Solifenacin 5 mg | 370 | 35 | 11 | 7 | 1 | 4 | 58 | 46 | 28 | 3 | 0 | 0 | 36 | 18 | 28 | 3 | 1 | 0 | 8 | 7 | 11 | 10 | 0 | 1 | 2 | 0 | 1 | 0 | 0 | 0 | 9 | 4 | 3 | 0 | 0 | 0 |
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Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities
The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity. (NCT01908829)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Combination (Solifenacin + Mirabegron) | 397 | 38 | 12 | 1 | 0 | 4 | 75 | 46 | 12 | 1 | 0 | 0 | 29 | 22 | 22 | 3 | 1 | 2 | 9 | 7 | 7 | 5 | 0 | 0 | 2 | 1 | 3 | 1 | 0 | 0 | 5 | 1 | 0 | 0 | 0 | 1 |
,Solifenacin 10 mg | 379 | 42 | 11 | 1 | 1 | 3 | 78 | 37 | 15 | 3 | 0 | 2 | 25 | 28 | 21 | 4 | 0 | 0 | 12 | 1 | 9 | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 15 | 1 | 1 | 0 | 0 | 0 |
,Solifenacin 5 mg | 384 | 30 | 19 | 4 | 0 | 3 | 81 | 45 | 16 | 1 | 1 | 1 | 35 | 20 | 18 | 3 | 0 | 1 | 8 | 5 | 6 | 7 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 11 | 4 | 1 | 0 | 0 | 0 |
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Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours
The mean number of pads used per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit. (NCT01972841)
Timeframe: Baseline and weeks 4, 8 and 12 (up to 12 weeks)
Intervention | pads (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | -0.81 | -1.20 | -1.30 | -1.26 |
,Mirabegron 50 mg | -1.12 | -1.24 | -1.37 | -1.41 |
,Placebo | -0.52 | -0.82 | -0.92 | -0.94 |
,Solifenacin 5 mg | -1.19 | -1.53 | -1.56 | -1.53 |
,Solifenacin 5 mg + Mirabegron 25 mg | -1.09 | -1.36 | -1.54 | -1.53 |
,Solifenacin 5 mg + Mirabegron 50 mg | -1.23 | -1.51 | -1.59 | -1.58 |
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Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours
An urgency episode was a complaint of a sudden, compelling desire to pass urine, which was difficult to defer; it was recorded when a micturition or incontinence episode was recorded and the severity of urinary urgency recorded was 3 (severe urgency) or 4 (urgency incontinence) according to the Patient Perception of Intensity of Urgency Scale (PPIUS). The mean number of urgency episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit. (NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | urgency episodes (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | -1.95 | -2.54 | -2.85 | -2.74 |
,Mirabegron 50 mg | -1.91 | -2.43 | -2.70 | -2.63 |
,Placebo | -1.34 | -1.85 | -2.05 | -2.06 |
,Solifenacin 5 mg | -2.14 | -2.90 | -3.11 | -3.05 |
,Solifenacin 5 mg + Mirabegron 25 mg | -2.42 | -3.13 | -3.45 | -3.38 |
,Solifenacin 5 mg + Mirabegron 50 mg | -2.66 | -3.28 | -3.50 | -3.51 |
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Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours
The mean number of urgency incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit. (NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | urgency incontinence episodes (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | -1.00 | -1.43 | -1.63 | -1.58 |
,Mirabegron 50 mg | -1.15 | -1.44 | -1.67 | -1.62 |
,Placebo | -0.78 | -1.15 | -1.29 | -1.33 |
,Solifenacin 5 mg | -1.19 | -1.56 | -1.72 | -1.71 |
,Solifenacin 5 mg + Mirabegron 25 mg | -1.35 | -1.74 | -1.99 | -1.95 |
,Solifenacin 5 mg + Mirabegron 50 mg | -1.47 | -1.79 | -1.93 | -1.94 |
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Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes
(NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | incontinence episodes (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | -7.59 | -10.57 | -12.33 | -11.93 |
,Mirabegron 50 mg | -8.99 | -10.97 | -12.58 | -12.39 |
,Placebo | -5.23 | -8.79 | -9.05 | -9.42 |
,Solifenacin 5 mg | -8.92 | -11.89 | -12.75 | -12.65 |
,Solifenacin 5 mg + Mirabegron 25 mg | -9.62 | -12.53 | -14.50 | -14.29 |
,Solifenacin 5 mg + Mirabegron 50 mg | -10.51 | -12.78 | -13.94 | -13.98 |
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Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)
Vital signs (blood pressure and pulse rate) were monitored using an ambulatory blood pressure monitoring (ABPM) device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Intervention | mmHg (Least Squares Mean) |
---|
| Week 4: 24-hour mean | Week 4: mean daytime | Week 4: mean nighttime | Week 12: 24-hour mean | Week 12: mean daytime | Week 12: mean nighttime | End of treatment: 24-hour mean | End of treatment: mean daytime | End of treatment: mean nighttime |
---|
Mirabegron 25 mg | -2.04 | -1.19 | -1.14 | -2.70 | -2.53 | -2.81 | -3.44 | -3.29 | -3.48 |
,Mirabegron 50 mg | 0.96 | -0.67 | 1.42 | -1.75 | -2.14 | -0.77 | -1.14 | -1.92 | -0.60 |
,Placebo | -1.00 | -1.55 | -0.51 | -1.97 | -2.22 | -1.03 | -1.73 | -2.01 | -1.00 |
,Solifenacin 5 mg | 1.03 | -1.13 | 0.41 | 0.40 | -2.09 | 1.31 | 0.37 | -2.17 | 1.42 |
,Solifenacin 5 mg + Mirabegron 25 mg | -0.85 | -1.63 | 1.14 | -0.71 | -0.39 | 0.11 | -0.52 | -0.68 | 0.41 |
,Solifenacin 5 mg + Mirabegron 50 mg | 0.31 | -0.53 | 0.54 | 0.40 | -0.71 | 0.79 | -0.08 | -1.28 | 0.91 |
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Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used
(NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12 and EOT (up to 12 weeks)
Intervention | pads (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | -5.68 | -8.44 | -9.06 | -8.76 |
,Mirabegron 50 mg | -7.83 | -8.43 | -9.41 | -9.80 |
,Placebo | -3.69 | -6.24 | -6.29 | -6.60 |
,Solifenacin 5 mg | -8.23 | -10.67 | -10.80 | -10.63 |
,Solifenacin 5 mg + Mirabegron 25 mg | -7.61 | -9.49 | -10.66 | -10.67 |
,Solifenacin 5 mg + Mirabegron 50 mg | -8.58 | -10.59 | -11.23 | -11.21 |
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Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes
(NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | urgency incontinence episodes (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | -7.07 | -9.93 | -11.39 | -11.03 |
,Mirabegron 50 mg | -8.39 | -10.07 | -11.66 | -11.44 |
,Placebo | -5.49 | -8.30 | -8.96 | -9.26 |
,Solifenacin 5 mg | -8.53 | -11.10 | -12.10 | -12.03 |
,Solifenacin 5 mg + Mirabegron 25 mg | -9.44 | -12.18 | -13.87 | -13.64 |
,Solifenacin 5 mg + Mirabegron 50 mg | -10.23 | -12.18 | -13.53 | -13.64 |
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Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern
The Concern score was calculated by adding 7 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 15.89 | 20.63 | 22.37 | 21.55 |
,Mirabegron 50 mg | 17.39 | 20.55 | 23.62 | 23.07 |
,Placebo | 11.24 | 16.10 | 17.53 | 16.98 |
,Solifenacin 5 mg | 17.18 | 20.96 | 23.19 | 22.65 |
,Solifenacin 5 mg + Mirabegron 25 mg | 20.48 | 25.26 | 27.53 | 26.89 |
,Solifenacin 5 mg + Mirabegron 50 mg | 21.09 | 25.65 | 28.24 | 27.47 |
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Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping
The Coping score was calculated by adding 8 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 14.87 | 20.64 | 22.04 | 21.28 |
,Mirabegron 50 mg | 17.68 | 21.52 | 24.94 | 24.32 |
,Placebo | 11.74 | 16.13 | 18.17 | 17.73 |
,Solifenacin 5 mg | 16.52 | 21.69 | 23.67 | 23.25 |
,Solifenacin 5 mg + Mirabegron 25 mg | 19.31 | 25.49 | 28.32 | 27.37 |
,Solifenacin 5 mg + Mirabegron 50 mg | 20.36 | 25.85 | 29.03 | 28.12 |
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Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep
The Sleep score was calculated by adding 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 12.70 | 16.39 | 18.04 | 17.51 |
,Mirabegron 50 mg | 13.80 | 17.33 | 19.16 | 19.11 |
,Placebo | 9.28 | 13.58 | 14.40 | 14.17 |
,Solifenacin 5 mg | 13.08 | 16.43 | 18.35 | 17.97 |
,Solifenacin 5 mg + Mirabegron 25 mg | 15.97 | 20.29 | 22.97 | 22.39 |
,Solifenacin 5 mg + Mirabegron 50 mg | 16.66 | 20.49 | 22.76 | 22.39 |
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Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social
The Social score was calculated by adding 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 9.04 | 11.50 | 13.43 | 13.04 |
,Mirabegron 50 mg | 10.19 | 12.34 | 15.35 | 14.87 |
,Placebo | 7.07 | 10.65 | 10.84 | 10.56 |
,Solifenacin 5 mg | 9.89 | 12.02 | 13.74 | 13.57 |
,Solifenacin 5 mg + Mirabegron 25 mg | 11.55 | 14.89 | 16.16 | 15.84 |
,Solifenacin 5 mg + Mirabegron 50 mg | 11.25 | 14.73 | 16.08 | 15.82 |
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Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)
The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. (NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12, EoT (up to 12 weeks)
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | -0.72 | -1.07 | -1.23 | -1.18 |
,Mirabegron 50 mg | -0.83 | -1.12 | -1.34 | -1.31 |
,Placebo | -0.54 | -0.80 | -0.95 | -0.91 |
,Solifenacin 5 mg | -0.81 | -1.18 | -1.32 | -1.27 |
,Solifenacin 5 mg + Mirabegron 25 mg | -0.99 | -1.32 | -1.57 | -1.53 |
,Solifenacin 5 mg + Mirabegron 50 mg | -1.07 | -1.48 | -1.72 | -1.66 |
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Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume
PVR volume was assessed by ultrasonography or a bladder scanner. (NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | mL (Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 1.6 | -0.4 | 1.0 | 0.7 |
,Mirabegron 50 mg | -2.1 | -0.6 | 0.0 | -0.8 |
,Placebo | -0.8 | -1.9 | -1.0 | -1.0 |
,Solifenacin 5 mg | 5.8 | 5.4 | 4.7 | 4.8 |
,Solifenacin 5 mg + Mirabegron 25 mg | 7.2 | 7.0 | 7.9 | 9.0 |
,Solifenacin 5 mg + Mirabegron 50 mg | 10.6 | 9.9 | 9.6 | 11.0 |
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Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Intervention | mmHg (Least Squares Mean) |
---|
| Week 4 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 19.15 | 19.52 | 19.29 |
,Mirabegron 50 mg | 20.41 | 20.41 | 20.71 |
,Placebo | 18.78 | 19.68 | 20.29 |
,Solifenacin 5 mg | 20.02 | 21.18 | 20.47 |
,Solifenacin 5 mg + Mirabegron 25 mg | 20.74 | 19.26 | 20.29 |
,Solifenacin 5 mg + Mirabegron 50 mg | 20.27 | 20.01 | 20.36 |
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Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Intervention | bpm (Least Squares Mean) |
---|
| Week 4 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 23.86 | 23.54 | 24.12 |
,Mirabegron 50 mg | 25.12 | 26.03 | 26.23 |
,Placebo | 22.34 | 22.63 | 23.01 |
,Solifenacin 5 mg | 24.28 | 23.52 | 23.33 |
,Solifenacin 5 mg + Mirabegron 25 mg | 21.48 | 22.60 | 22.66 |
,Solifenacin 5 mg + Mirabegron 50 mg | 21.80 | 24.08 | 24.14 |
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Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Intervention | mmHg (Least Squares Mean) |
---|
| Week 4 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 31.14 | 30.68 | 30.65 |
,Mirabegron 50 mg | 38.20 | 32.88 | 33.53 |
,Placebo | 34.05 | 33.21 | 34.98 |
,Solifenacin 5 mg | 35.16 | 35.11 | 34.95 |
,Solifenacin 5 mg + Mirabegron 25 mg | 32.88 | 33.53 | 34.70 |
,Solifenacin 5 mg + Mirabegron 50 mg | 32.80 | 32.82 | 32.55 |
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Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT
The number of days with < 8 micturitions was the number of valid diary days during the 7-day micturition diary period with less than 8 micturitions per day. (NCT01972841)
Timeframe: Weeks 4, 8,12 and EoT (up to 12 weeks)
Intervention | days (Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 1.74 | 2.08 | 2.31 | 2.28 |
,Mirabegron 50 mg | 1.55 | 1.99 | 2.25 | 2.22 |
,Placebo | 1.49 | 1.69 | 1.76 | 1.80 |
,Solifenacin 5 mg | 1.86 | 2.22 | 2.49 | 2.49 |
,Solifenacin 5 mg + Mirabegron 25 mg | 2.07 | 2.59 | 2.87 | 2.84 |
,Solifenacin 5 mg + Mirabegron 50 mg | 2.11 | 2.70 | 2.95 | 2.92 |
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Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT
The number of incontinence episodes was calculated as the total number of incontinence episodes on valid diary days recorded during the 7-day micturition diary period. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | incontinence episodes (Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 15.65 | 12.84 | 10.60 | 11.19 |
,Mirabegron 50 mg | 12.90 | 11.31 | 9.50 | 9.79 |
,Placebo | 18.09 | 14.45 | 14.06 | 13.70 |
,Solifenacin 5 mg | 15.31 | 12.19 | 11.25 | 11.21 |
,Solifenacin 5 mg + Mirabegron 25 mg | 12.51 | 9.70 | 7.62 | 8.02 |
,Solifenacin 5 mg + Mirabegron 50 mg | 11.44 | 9.33 | 8.21 | 8.18 |
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Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Intervention | beats per minute (bpm) (Least Squares Mean) |
---|
| Week 4: 24-hour mean | Week 4: mean daytime | Week 4: mean nighttime | Week 12: 24-hour mean | Week 12: mean daytime | Week 12: mean nighttime | End of treatment: 24-hour mean | End of treatment: mean daytime | End of treatment: mean nighttime |
---|
Mirabegron 25 mg | 1.14 | 1.19 | 0.98 | 0.38 | 0.25 | 0.21 | 0.63 | 0.37 | 0.82 |
,Mirabegron 50 mg | 2.32 | 3.52 | 1.77 | 1.19 | 2.12 | 0.19 | 1.67 | 2.64 | 0.75 |
,Placebo | -0.83 | -0.70 | -0.72 | 0.70 | 0.89 | 0.34 | 0.41 | 0.45 | 0.39 |
,Solifenacin 5 mg | 0.36 | 0.37 | 1.09 | 0.12 | -0.13 | 0.06 | 0.02 | -0.07 | 0.45 |
,Solifenacin 5 mg + Mirabegron 25 mg | 0.40 | -0.05 | 0.86 | 0.94 | 0.84 | 0.76 | 0.85 | 0.32 | 1.21 |
,Solifenacin 5 mg + Mirabegron 50 mg | 0.69 | 0.61 | 0.86 | 1.44 | 1.36 | 1.52 | 1.52 | 1.24 | 1.64 |
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Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT
The number of incontinence-free days with < 8 micturitions per day was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded and with < 8 micturitions per day. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | days (Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 0.84 | 1.20 | 1.47 | 1.40 |
,Mirabegron 50 mg | 0.87 | 1.23 | 1.50 | 1.47 |
,Placebo | 0.64 | 0.85 | 0.98 | 1.01 |
,Solifenacin 5 mg | 0.91 | 1.31 | 1.60 | 1.59 |
,Solifenacin 5 mg + Mirabegron 25 mg | 1.21 | 1.75 | 2.12 | 2.04 |
,Solifenacin 5 mg + Mirabegron 50 mg | 1.32 | 1.89 | 2.15 | 2.12 |
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Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT
A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant went to bed with the intention to sleep until the time the patients got up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode on valid diary days during the 7-day micturition diary period prior to each visit. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | nocturia episodes (Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 8.46 | 8.07 | 7.99 | 7.79 |
,Mirabegron 50 mg | 9.11 | 8.61 | 8.34 | 8.14 |
,Placebo | 9.62 | 8.99 | 8.91 | 8.83 |
,Solifenacin 5 mg | 9.22 | 8.37 | 8.17 | 8.12 |
,Solifenacin 5 mg + Mirabegron 25 mg | 8.40 | 7.63 | 7.26 | 7.33 |
,Solifenacin 5 mg + Mirabegron 50 mg | 8.09 | 7.11 | 6.67 | 6.67 |
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Number of Pads Used at Weeks 4, 8, 12 and EoT
The number of pads used was the number of times a participant recorded a new pad used on valid diary days during the 7-day micturition diary period prior to each visit. (NCT01972841)
Timeframe: Weeks 4, 8 and 12 (up to 12 weeks)
Intervention | pads (Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 13.46 | 10.79 | 9.65 | 10.15 |
,Mirabegron 50 mg | 10.05 | 9.53 | 8.44 | 8.16 |
,Placebo | 15.62 | 12.75 | 12.62 | 12.29 |
,Solifenacin 5 mg | 11.41 | 8.45 | 8.21 | 8.53 |
,Solifenacin 5 mg + Mirabegron 25 mg | 9.71 | 8.07 | 6.60 | 7.04 |
,Solifenacin 5 mg + Mirabegron 50 mg | 9.34 | 7.58 | 6.64 | 6.80 |
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
A TEAE refered to an adverse event (AE; defined as any untoward medical occurrence in a participant administered a study drug or who had undergone study procedures and did not necessarily have a causal relationship with this treatment) which started or worsened in the period from first double-blind medication intake until 14 days after the last double-blind medication intake. Serious TEAEs with a start date reported until 30 days after the last double-blind medication intake were also summarized as TEAEs, and also included serious TEAEs upgraded by the sponsor based on review of the sponsor's list of Always Serious terms if any upgrade was done. Drug-related TEAEs may be possible or probable, as assessed by the investigator, or records where relationship is missing. (NCT01972841)
Timeframe: From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 16 weeks)
Intervention | Participants (Count of Participants) |
---|
| Any TEAE | Drug-related TEAEs | Deaths | Serious TEAEs | Drug-related serious TEAEs | TEAEs leading to discontinuation | Drug-related TEAEs leading to discontinuation |
---|
Mirabegron 25 mg | 135 | 37 | 0 | 6 | 1 | 7 | 4 |
,Mirabegron 50 mg | 147 | 52 | 0 | 5 | 1 | 10 | 6 |
,Placebo | 145 | 45 | 0 | 8 | 0 | 9 | 7 |
,Solifenacin 5 mg | 149 | 63 | 0 | 3 | 0 | 7 | 5 |
,Solifenacin 5 mg + Mirabegron 25 mg | 345 | 157 | 0 | 12 | 2 | 20 | 17 |
,Solifenacin 5 mg + Mirabegron 50 mg | 314 | 150 | 0 | 19 | 3 | 22 | 19 |
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Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT
An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The number of urgency incontinence episodes was the number of times a participant recorded an urgency incontinence episode on valid diary days during the 7-day micturition diary period prior to each visit. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | urgency incontinence episodes (Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 13.36 | 10.65 | 8.84 | 9.37 |
,Mirabegron 50 mg | 11.46 | 10.09 | 8.32 | 8.63 |
,Placebo | 15.76 | 12.77 | 12.00 | 11.69 |
,Solifenacin 5 mg | 13.19 | 10.41 | 9.29 | 9.29 |
,Solifenacin 5 mg + Mirabegron 25 mg | 10.22 | 7.58 | 5.86 | 6.25 |
,Solifenacin 5 mg + Mirabegron 50 mg | 9.33 | 7.31 | 6.27 | 6.15 |
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Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT
The PGIC was a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved). (NCT01972841)
Timeframe: Week 12 and EoT (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
| Week 12: Very much improved | Week 12: Much improved | Week 12: Minimally improved | Week 12: No change | Week 12: Minimally worse | Week 12: Much worse | Week 12: Very much worse | EoT: Very much improved | EoT: Much improved | EoT: Minimally improved | EoT: No change | EoT: Minimally worse | EoT: Much worse | EoT: Very much worse |
---|
Mirabegron 25 mg | 13.9 | 32.9 | 26.8 | 12.9 | 1.5 | 1.0 | 0.5 | 13.9 | 33.2 | 26.8 | 13.4 | 1.5 | 1.0 | 0.5 |
,Mirabegron 50 mg | 15.1 | 34.8 | 26.5 | 9.7 | 2.2 | 1.2 | 0.7 | 15.1 | 34.8 | 27.0 | 10.2 | 2.2 | 1.2 | 0.7 |
,Placebo | 8.4 | 29.7 | 29.7 | 17.5 | 4.1 | 1.0 | 0.5 | 8.4 | 30.4 | 29.9 | 18.2 | 4.1 | 1.0 | 0.5 |
,Solifenacin 5 mg | 13.5 | 40.5 | 25.8 | 8.9 | 1.7 | 0.5 | 0.5 | 13.5 | 41.0 | 26.3 | 9.6 | 1.7 | 0.7 | 0.5 |
,Solifenacin 5 mg + Mirabegron 25 mg | 19.8 | 39.8 | 22.2 | 7.7 | 0.8 | 0.2 | 0.2 | 20.0 | 40.0 | 22.6 | 7.9 | 0.8 | 0.4 | 0.2 |
,Solifenacin 5 mg + Mirabegron 50 mg | 27.1 | 34.0 | 20.7 | 7.3 | 0.8 | 0 | 0.5 | 27.1 | 34.6 | 21.3 | 7.4 | 0.8 | 0 | 0.6 |
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Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT
The percentage of participants with micturition frequency normalization was defined as any participant who had ≥ 8 micturitions/24 hours at baseline and < 8 micturitions/24 h postbaseline at weeks 4, 8, 12 and EoT. (NCT01972841)
Timeframe: Weeks 4, 8 , 12 and EoT (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 30.8 | 37.9 | 42.3 | 42.1 |
,Mirabegron 50 mg | 25.4 | 34.5 | 40.7 | 40.1 |
,Placebo | 24.1 | 28.7 | 29.7 | 31.1 |
,Solifenacin 5 mg | 31.1 | 37.0 | 44.9 | 45.0 |
,Solifenacin 5 mg + Mirabegron 25 mg | 36.0 | 45.3 | 50.8 | 51.3 |
,Solifenacin 5 mg + Mirabegron 50 mg | 37.7 | 49.0 | 53.1 | 52.6 |
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Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT
The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 27.9 | 44.7 | 51.7 | 48.5 |
,Mirabegron 50 mg | 37.7 | 50.1 | 54.9 | 53.9 |
,Placebo | 23.2 | 35.6 | 40.6 | 40.9 |
,Solifenacin 5 mg | 34.5 | 51.3 | 56.9 | 56.0 |
,Solifenacin 5 mg + Mirabegron 25 mg | 39.9 | 53.8 | 62.0 | 59.9 |
,Solifenacin 5 mg + Mirabegron 50 mg | 42.9 | 57.7 | 65.4 | 63.8 |
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Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT
The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by ≥ 10 points) on the OAB-q HRQL total score at weeks 4, 8, 12 and EoT. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 28.3 | 43.2 | 48.3 | 46.0 |
,Mirabegron 50 mg | 39.8 | 46.1 | 53.5 | 52.9 |
,Placebo | 23.2 | 32.9 | 39.2 | 39.1 |
,Solifenacin 5 mg | 37.7 | 48.4 | 54.8 | 54.0 |
,Solifenacin 5 mg + Mirabegron 25 mg | 40.4 | 54.1 | 61.6 | 59.0 |
,Solifenacin 5 mg + Mirabegron 50 mg | 40.5 | 53.0 | 59.2 | 58.2 |
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Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT
The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by ≥ 10 points) on the OAB-q Symptom Bother score at weeks 4, 8, 12 and EoT. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 34.8 | 50.0 | 55.7 | 54.0 |
,Mirabegron 50 mg | 45.7 | 51.5 | 59.4 | 58.2 |
,Placebo | 28.6 | 39.8 | 45.0 | 45.2 |
,Solifenacin 5 mg | 44.9 | 56.5 | 63.1 | 62.6 |
,Solifenacin 5 mg + Mirabegron 25 mg | 47.8 | 63.1 | 66.7 | 65.2 |
,Solifenacin 5 mg + Mirabegron 50 mg | 52.3 | 63.5 | 69.5 | 68.2 |
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Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT
The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per24 hours compared to baseline, minimal important difference reached (improvement by ≥ 10 points) on the HRQL total score, and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 20.6 | 36.9 | 42.0 | 39.1 |
,Mirabegron 50 mg | 30.0 | 38.9 | 45.6 | 44.8 |
,Placebo | 15.2 | 24.9 | 33.3 | 33.3 |
,Solifenacin 5 mg | 28.6 | 43.0 | 49.9 | 49.2 |
,Solifenacin 5 mg + Mirabegron 25 mg | 32.7 | 46.3 | 54.5 | 51.6 |
,Solifenacin 5 mg + Mirabegron 50 mg | 33.4 | 46.8 | 54.2 | 52.8 |
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Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT
The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline, minimal important difference reached (improvement by ≥ 10 points) on the OAB-q Symptom Bother score, and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 24.0 | 41.3 | 47.7 | 45.0 |
,Mirabegron 50 mg | 33.6 | 43.2 | 49.6 | 48.4 |
,Placebo | 17.8 | 29.7 | 35.8 | 36.1 |
,Solifenacin 5 mg | 31.4 | 47.8 | 54.5 | 53.3 |
,Solifenacin 5 mg + Mirabegron 25 mg | 37.5 | 51.6 | 58.2 | 56.3 |
,Solifenacin 5 mg + Mirabegron 50 mg | 40.2 | 54.7 | 62.0 | 60.3 |
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Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT
The percentage of participants with ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | End of treaetment |
---|
Mirabegron 25 mg | 52.8 | 65.3 | 66.9 | 65.4 |
,Mirabegron 50 mg | 60.3 | 69.7 | 73.8 | 72.4 |
,Placebo | 48.9 | 56.4 | 59.8 | 59.8 |
,Solifenacin 5 mg | 58.1 | 72.7 | 74.1 | 71.9 |
,Solifenacin 5 mg + Mirabegron 25 mg | 63.1 | 71.6 | 76.6 | 75.7 |
,Solifenacin 5 mg + Mirabegron 50 mg | 62.7 | 75.4 | 80.0 | 78.4 |
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Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT
The percentage of participants with ≥ 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT). (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 52.8 | 62.2 | 62.4 | 61.0 |
,Mirabegron 50 mg | 59.7 | 65.3 | 69.1 | 68.3 |
,Placebo | 45.3 | 51.2 | 57.7 | 56.8 |
,Solifenacin 5 mg | 61.7 | 66.2 | 71.7 | 71.2 |
,Solifenacin 5 mg + Mirabegron 25 mg | 62.9 | 71.5 | 76.3 | 74.5 |
,Solifenacin 5 mg + Mirabegron 50 mg | 61.3 | 69.3 | 71.8 | 71.1 |
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Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT
The percentage of participants with ≥ 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT). (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 62.6 | 71.6 | 72.1 | 71.2 |
,Mirabegron 50 mg | 69.9 | 73.4 | 78.4 | 77.1 |
,Placebo | 56.4 | 62.2 | 66.0 | 65.3 |
,Solifenacin 5 mg | 73.9 | 79.2 | 82.4 | 81.2 |
,Solifenacin 5 mg + Mirabegron 25 mg | 73.9 | 83.9 | 83.5 | 82.8 |
,Solifenacin 5 mg + Mirabegron 50 mg | 75.8 | 82.8 | 85.1 | 84.3 |
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Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)
Vital signs (blood pressure and pulse rate) were monitored using ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Intervention | mmHg (Least Squares Mean) |
---|
| Week 4: 24-hour mean | Week 4: mean daytime | Week 4: mean nighttime | Week 12: 24-hour mean | Week 12: mean daytime | Week 12: mean nighttime | End of treatment: 24-hour mean | End of treatment: mean daytime | End of treatment: mean nighttime |
---|
Mirabegron 25 mg | -0.86 | -0.36 | -0.97 | -0.93 | -0.54 | -1.39 | -1.41 | -0.98 | -2.00 |
,Mirabegron 50 mg | 0.22 | -0.33 | 0.40 | -0.19 | -0.40 | -0.03 | -0.11 | -0.69 | 0.08 |
,Placebo | -0.70 | -1.25 | -0.12 | -0.80 | -0.85 | -0.49 | -0.96 | -1.17 | -0.41 |
,Solifenacin 5 mg | 0.25 | -0.77 | 0.48 | 0.43 | -0.33 | 0.92 | 0.05 | -0.79 | 0.71 |
,Solifenacin 5 mg + Mirabegron 25 mg | 0.03 | -0.40 | 0.93 | -0.37 | -0.06 | 0.23 | -0.02 | -0.18 | 0.56 |
,Solifenacin 5 mg + Mirabegron 50 mg | 0.38 | 0.07 | 0.47 | 0.31 | -0.18 | 0.49 | 0.25 | -0.36 | 0.61 |
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Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT
The percentage of participants with a major (≥ 2 points) improvement from baseline in PPBC at weeks 4, 8, 12 and EoT. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 20.6 | 33.3 | 39.0 | 37.2 |
,Mirabegron 50 mg | 22.4 | 35.0 | 42.3 | 40.7 |
,Placebo | 15.9 | 27.0 | 29.6 | 29.5 |
,Solifenacin 5 mg | 27.4 | 40.5 | 44.5 | 42.6 |
,Solifenacin 5 mg + Mirabegron 25 mg | 31.1 | 42.7 | 50.7 | 49.7 |
,Solifenacin 5 mg + Mirabegron 50 mg | 31.1 | 46.4 | 52.9 | 51.2 |
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Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT
The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 3 days prior to weeks 4, 8, 12 and EoT. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | percentage of particpants (Number) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 24.9 | 35.3 | 42.5 | 40.6 |
,Mirabegron 50 mg | 27.6 | 40.7 | 47.4 | 46.3 |
,Placebo | 23.2 | 28.7 | 38.0 | 37.6 |
,Solifenacin 5 mg | 28.9 | 38.3 | 42.7 | 42.9 |
,Solifenacin 5 mg + Mirabegron 25 mg | 35.1 | 45.3 | 52.3 | 50.7 |
,Solifenacin 5 mg + Mirabegron 50 mg | 37.3 | 48.2 | 52.7 | 52.2 |
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Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT
The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 7 days prior to weeks 4, 8, 12 and EoT. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 13.1 | 24.4 | 32.2 | 30.6 |
,Mirabegron 50 mg | 16.7 | 29.8 | 35.0 | 34.0 |
,Placebo | 12.8 | 19.1 | 29.1 | 28.6 |
,Solifenacin 5 mg | 17.7 | 28.2 | 31.9 | 31.5 |
,Solifenacin 5 mg + Mirabegron 25 mg | 23.9 | 36.6 | 42.4 | 40.9 |
,Solifenacin 5 mg + Mirabegron 50 mg | 26.0 | 38.4 | 43.7 | 43.1 |
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PGIC Scale: Impression in General Health at Week 12 and EoT
The PGIC was a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved). (NCT01972841)
Timeframe: Week 12 and EoT (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
| Week 12: Very much improved | Week 12: Much improved | Week 12: Minimally improved | Week 12: No change | Week 12: Minimally worse | Week 12: Much worse | Week 12: Very much worse | End of treatment: Very much improved | End of treatment: Much improved | End of treatment: Minimally improved | End of treatment:No change | End of treatment: Minimally worse | End of treatment: Much worse | End of treatment: Very much worse |
---|
Mirabegron 25 mg | 8.0 | 28.0 | 21.5 | 27.8 | 2.9 | 0.7 | 0.5 | 8.0 | 28.0 | 21.5 | 28.3 | 2.9 | 0.7 | 0.7 |
,Mirabegron 50 mg | 7.3 | 29.2 | 22.4 | 27.5 | 2.2 | 1.2 | 0.5 | 7.3 | 29.2 | 22.9 | 27.7 | 2.4 | 1.2 | 0.5 |
,Placebo | 4.8 | 23.9 | 23.9 | 31.8 | 4.3 | 1.7 | 0.2 | 4.8 | 24.2 | 24.4 | 32.3 | 4.3 | 1.9 | 0.5 |
,Solifenacin 5 mg | 7.7 | 31.8 | 24.1 | 25.3 | 1.4 | 0.5 | 0.5 | 7.7 | 31.8 | 24.1 | 26.5 | 1.9 | 0.5 | 0.7 |
,Solifenacin 5 mg + Mirabegron 25 mg | 10.3 | 33.4 | 20.1 | 23.9 | 2.5 | 0.5 | 0.2 | 10.3 | 33.6 | 20.2 | 24.3 | 2.8 | 0.5 | 0.2 |
,Solifenacin 5 mg + Mirabegron 50 mg | 14.6 | 30.2 | 20.9 | 21.6 | 2.2 | 0.1 | 0.6 | 14.6 | 30.4 | 21.3 | 21.9 | 2.7 | 0.2 | 0.7 |
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Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Intervention | nnHg (Least Squares Mean) |
---|
| Week 4 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | -1.08 | 0.15 | 0.27 |
,Mirabegron 50 mg | -0.20 | -1.90 | -0.96 |
,Placebo | -0.76 | 0.53 | 0.87 |
,Solifenacin 5 mg | -1.60 | -0.66 | -1.67 |
,Solifenacin 5 mg + Mirabegron 25 mg | 0.39 | -1.24 | -0.98 |
,Solifenacin 5 mg + Mirabegron 50 mg | -0.56 | 0.46 | 0.52 |
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Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment
(NCT01972841)
Timeframe: Baseline and week 12 and EoT (up to 12 weeks)
Intervention | percentage of overall work impairment (Mean) |
---|
| Week 12 | End of treatment |
---|
Mirabegron 25 mg | -15.70 | -15.70 |
,Mirabegron 50 mg | -12.92 | -13.05 |
,Placebo | -12.23 | -12.14 |
,Solifenacin 5 mg | -12.31 | -12.42 |
,Solifenacin 5 mg + Mirabegron 25 mg | -16.31 | -16.07 |
,Solifenacin 5 mg + Mirabegron 50 mg | -13.97 | -13.76 |
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Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working
(NCT01972841)
Timeframe: Baseline and week 12 and EoT (up to 12 weeks)
Intervention | percentage of impairment while working (Mean) |
---|
| Week 12 | End of treatment |
---|
Mirabegron 25 mg | -14.96 | -14.96 |
,Mirabegron 50 mg | -12.25 | -12.37 |
,Placebo | -11.27 | -11.18 |
,Solifenacin 5 mg | -10.85 | -10.98 |
,Solifenacin 5 mg + Mirabegron 25 mg | -14.69 | -14.58 |
,Solifenacin 5 mg + Mirabegron 50 mg | -13.07 | -12.87 |
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Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment
(NCT01972841)
Timeframe: Baseline and week 12 and EoT (up to 12 weeks)
Intervention | percentage of activity impairment (Mean) |
---|
| Week 12 | End of treatment |
---|
Mirabegron 25 mg | -16.89 | -16.72 |
,Mirabegron 50 mg | -14.99 | -15.05 |
,Placebo | -11.49 | -11.55 |
,Solifenacin 5 mg | -16.19 | -16.05 |
,Solifenacin 5 mg + Mirabegron 25 mg | -19.60 | -19.45 |
,Solifenacin 5 mg + Mirabegron 50 mg | -18.92 | -18.76 |
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Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed
The WPAI:SHP was a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes were expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement. (NCT01972841)
Timeframe: Baseline and week 12 and EoT (up to 12 weeks)
Intervention | percentage of work time missed (Mean) |
---|
| Week 12 | End of treatment |
---|
Mirabegron 25 mg | -0.33 | -0.33 |
,Mirabegron 50 mg | -1.72 | -1.71 |
,Placebo | -2.98 | -2.96 |
,Solifenacin 5 mg | -2.47 | -2.44 |
,Solifenacin 5 mg + Mirabegron 25 mg | -2.06 | -1.48 |
,Solifenacin 5 mg + Mirabegron 50 mg | -2.59 | -2.55 |
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Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility
The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). (NCT01972841)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> unable to walk about | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> unable to walk about | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> unable to walk about | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> unable to walk about | Severe problems -> no data | Unable to walk about -> no problems | Unable to walk about -> slight problems | Unable to walk about -> moderate problems | Unable to walk about -> severe problems | Unable to walk about -> unable to walk about | Unable to walk about -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> unable to walk about | No data -> no data |
---|
Mirabegron 25 mg | 239 | 20 | 12 | 3 | 1 | 4 | 35 | 20 | 6 | 0 | 0 | 3 | 7 | 10 | 12 | 5 | 0 | 1 | 5 | 7 | 4 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 7 | 0 | 3 | 1 | 0 | 0 |
,Mirabegron 50 mg | 225 | 25 | 9 | 3 | 0 | 5 | 35 | 24 | 4 | 3 | 0 | 0 | 25 | 10 | 10 | 4 | 0 | 0 | 9 | 3 | 8 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 1 | 1 | 0 | 0 | 1 |
,Placebo | 204 | 16 | 11 | 1 | 0 | 2 | 33 | 27 | 11 | 5 | 0 | 2 | 17 | 18 | 21 | 10 | 0 | 1 | 3 | 6 | 5 | 8 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 12 | 1 | 0 | 0 | 0 | 1 |
,Solifenacin 5 mg | 227 | 22 | 8 | 1 | 0 | 4 | 30 | 19 | 6 | 1 | 0 | 0 | 18 | 22 | 13 | 2 | 1 | 1 | 7 | 4 | 8 | 8 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 6 | 2 | 0 | 2 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 25 mg | 449 | 41 | 20 | 1 | 0 | 6 | 76 | 40 | 19 | 2 | 0 | 0 | 31 | 24 | 33 | 8 | 1 | 0 | 12 | 13 | 15 | 11 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 15 | 4 | 0 | 2 | 0 | 1 |
,Solifenacin 5 mg + Mirabegron 50 mg | 452 | 38 | 10 | 2 | 1 | 9 | 60 | 49 | 9 | 2 | 0 | 2 | 46 | 25 | 35 | 10 | 1 | 2 | 17 | 8 | 15 | 13 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 16 | 2 | 2 | 0 | 0 | 0 |
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Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities
The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). (NCT01972841)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | participants (Number) |
---|
| No problems -> No problems | No problems -> Slight problems | No problems -> Moderate problems | No problems -> Severe problems | No problems -> unable to do usual activities | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems ->unable to do usual activities | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems ->unable to do usual activities | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> unable to do usual activities | Severe problems -> no data | Unable to do usual activities -> no problems | Unable to do usual activities -> slight problems | Unable to do usual activities -> moderate problems | Unable to do usual activities -> severe problems | Unable to do usual activities -> unable to do usu. | Unable to do usual activities -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> unable to do usual activities | No data -> no data |
---|
Mirabegron 25 mg | 228 | 25 | 5 | 0 | 0 | 5 | 41 | 29 | 9 | 0 | 0 | 2 | 13 | 9 | 11 | 3 | 0 | 1 | 3 | 4 | 7 | 1 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 7 | 2 | 2 | 0 | 0 | 0 |
,Mirabegron 50 mg | 219 | 28 | 9 | 1 | 0 | 4 | 52 | 23 | 3 | 2 | 0 | 0 | 15 | 16 | 9 | 0 | 0 | 2 | 7 | 6 | 5 | 1 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 2 | 3 | 0 | 0 | 0 | 1 |
,Placebo | 196 | 37 | 9 | 2 | 0 | 2 | 45 | 28 | 15 | 2 | 0 | 2 | 14 | 12 | 15 | 1 | 0 | 1 | 7 | 3 | 6 | 4 | 0 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 12 | 1 | 0 | 0 | 0 | 1 |
,Solifenacin 5 mg | 223 | 25 | 8 | 0 | 0 | 3 | 52 | 25 | 8 | 0 | 0 | 3 | 13 | 14 | 12 | 1 | 0 | 0 | 6 | 2 | 6 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 7 | 1 | 2 | 0 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 25 mg | 434 | 37 | 13 | 1 | 1 | 5 | 98 | 64 | 18 | 2 | 0 | 2 | 44 | 29 | 25 | 3 | 0 | 0 | 7 | 8 | 9 | 2 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 18 | 1 | 2 | 0 | 0 | 1 |
,Solifenacin 5 mg + Mirabegron 50 mg | 451 | 48 | 11 | 1 | 1 | 8 | 95 | 56 | 12 | 3 | 0 | 4 | 26 | 30 | 17 | 3 | 1 | 1 | 11 | 8 | 7 | 9 | 0 | 0 | 2 | 1 | 1 | 0 | 0 | 0 | 15 | 3 | 2 | 0 | 0 | 0 |
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Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care
The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). (NCT01972841)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> unable to wash/dress myself | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> unable to wash/dress myself | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> unable to wash/dress myself | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> unable to wash/dress myself | Severe problems -> no data | Unable to wash/dress myself -> no problems | Unable to wash/dress myself -> slight problems | Unable to wash/dress myself -> moderate problems | Unable to wash/dress myself -> severe problems | Unable to wash/dress myself -> unable to w/d | Unable to wash/dress myself -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> unable to wash/dress myself | No data -> no data |
---|
Mirabegron 25 mg | 324 | 17 | 5 | 0 | 0 | 8 | 13 | 10 | 4 | 0 | 0 | 0 | 8 | 1 | 1 | 0 | 0 | 0 | 2 | 0 | 2 | 3 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 8 | 2 | 1 | 0 | 0 | 0 |
,Mirabegron 50 mg | 336 | 9 | 6 | 1 | 1 | 6 | 16 | 12 | 1 | 0 | 0 | 0 | 3 | 8 | 2 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 3 | 2 | 0 | 0 | 0 | 1 |
,Placebo | 311 | 21 | 9 | 0 | 1 | 4 | 17 | 10 | 2 | 2 | 0 | 1 | 6 | 3 | 9 | 0 | 0 | 0 | 2 | 1 | 1 | 3 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 13 | 0 | 0 | 0 | 0 | 1 |
,Solifenacin 5 mg | 319 | 20 | 3 | 1 | 0 | 5 | 25 | 12 | 2 | 0 | 0 | 1 | 2 | 3 | 6 | 0 | 0 | 0 | 1 | 3 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 8 | 1 | 1 | 0 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 25 mg | 652 | 22 | 12 | 1 | 0 | 6 | 35 | 22 | 3 | 1 | 0 | 1 | 17 | 9 | 8 | 2 | 0 | 0 | 3 | 3 | 7 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 20 | 1 | 0 | 0 | 0 | 1 |
,Solifenacin 5 mg + Mirabegron 50 mg | 647 | 26 | 4 | 1 | 0 | 12 | 33 | 26 | 7 | 2 | 0 | 0 | 18 | 7 | 9 | 1 | 0 | 1 | 4 | 3 | 3 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 18 | 0 | 2 | 0 | 0 | 0 |
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Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort
The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). (NCT01972841)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | participants (Number) |
---|
| No pain/discomfort -> no pain/discomfort | No pain/discomfort -> slight pain/discomfort | No pain/discomfort -> moderate pain/discomfort | No pain/discomfort -> severe pain/discomfort | No pain/discomfort -> extreme pain/discomfort | No pain/discomfort -> no data | Slight pain/discomfort -> no pain/discomfort | Slight pain/discomfort -> slight pain/discomfort | Slight pain/discomfort -> moderate pain/discomfort | Slight pain/discomfort -> severe pain/discomfort | Slight pain/discomfort -> exteme pain/discomfort | Slight pain/discomfort -> no data | Moderate pain/discomfort -> no pain/discomfort | Moderate pain/discomfort -> slight pain/discomfort | Moderate pain/discomfort -> moderate pain/discomf | Moderate pain/discomfort -> severe pain/discomfort | Moderate pain/discomfort -> extreme pain/discomf | Moderate pain/discomfort -> no data | Severe pain/discomfort -> no pain/discomfort | Severe pain/discomfort -> slight pain/discomfort | Severe pain/discomfort -> moderate pain/discomfort | Severe pain/discomfort -> severe pain/discomfort | Severe pain/discomfort -> extreme pain/discomfort | Severe pain/discomfort -> no data | Extreme pain/discomfort -> no pain/discomfort | Extreme pain/discomfort -> slight pain/discomfort | Extreme pain/discomfort -> moderate pain/discom. | Extreme pain/discomfort -> severe pain/discomfort | Extreme pain/discomfort -> extreme pain/discomfort | Extreme pain/discomfort -> no data | No data -> no pain/discomfort | No data -> slight pain/discomfort | No data -> moderate pain/discomfort | No data -> severe pain/discomfort | No data -> extreme pain/discomfort | No data -> no data |
---|
Mirabegron 25 mg | 175 | 29 | 9 | 0 | 0 | 3 | 51 | 49 | 11 | 0 | 0 | 5 | 14 | 15 | 13 | 5 | 0 | 0 | 4 | 4 | 4 | 3 | 1 | 0 | 0 | 0 | 2 | 2 | 0 | 0 | 5 | 2 | 4 | 0 | 0 | 0 |
,Mirabegron 50 mg | 153 | 37 | 17 | 3 | 0 | 4 | 44 | 45 | 14 | 2 | 1 | 2 | 24 | 20 | 16 | 3 | 0 | 0 | 3 | 6 | 6 | 1 | 1 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 3 | 2 | 0 | 0 | 0 | 1 |
,Placebo | 131 | 38 | 10 | 0 | 0 | 2 | 53 | 54 | 12 | 3 | 2 | 2 | 20 | 23 | 31 | 4 | 0 | 1 | 2 | 3 | 8 | 4 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 11 | 2 | 0 | 0 | 0 | 1 |
,Solifenacin 5 mg | 154 | 33 | 13 | 3 | 0 | 2 | 46 | 47 | 18 | 0 | 0 | 2 | 23 | 22 | 15 | 1 | 0 | 1 | 1 | 4 | 11 | 4 | 0 | 0 | 0 | 2 | 0 | 2 | 0 | 1 | 6 | 2 | 2 | 0 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 25 mg | 290 | 74 | 19 | 3 | 1 | 3 | 117 | 94 | 15 | 6 | 0 | 2 | 45 | 46 | 34 | 4 | 1 | 1 | 8 | 11 | 15 | 7 | 1 | 1 | 1 | 1 | 1 | 3 | 1 | 0 | 14 | 6 | 1 | 0 | 0 | 1 |
,Solifenacin 5 mg + Mirabegron 50 mg | 317 | 51 | 20 | 1 | 0 | 8 | 105 | 101 | 19 | 3 | 0 | 4 | 46 | 45 | 40 | 6 | 0 | 1 | 12 | 7 | 11 | 8 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 14 | 3 | 3 | 0 | 0 | 0 |
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Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression
The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). (NCT01972841)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | participants (Number) |
---|
| Not anxious -> not anxious | Not anxious -> slightly anxious | Not anxious -> moderately anxious | Not anxious -> severely anxious | Not anxious -> extremely anxious | Not anxious -> no data | Slightly anxious -> not anxious | Slightly anxious -> slightly anx | Slightly anxious -> moderately anxious | Slightly anxious -> severely anxious | Slightly anxious -> extremely anxious | Slightly anxious -> no data | Moderately anxious -> not anxious | Moderately anxious -> slightly anxious | Moderately anxious -> moderately anxious | Moderately anxious -> severely anxious | Moderately anxious -> extremely anxious | Moderately anxious -> no data | Severely anxious -> not anxious | Severely anxious -> slightly anxious | Severely anxious -> moderately anxious | Severely anxious -> severely anxious | Severely anxious -> extremely anxious | Severely anxious -> no data | Extremely anxious -> not anxious | Extremely anxious -> slightly anxious | Extremely anxious -> moderately anxious | Extremely anxious -> severely anxious | Extremely anxious -> extremely anxious | Extremely anxious -> no data | No data -> not anxious | No data -> slightly anxious | No data -> moderately anxious | No data -> severely anxious | No data -> extremely anxious | No data -> no data |
---|
Mirabegron 25 mg | 176 | 27 | 6 | 2 | 0 | 3 | 60 | 40 | 16 | 2 | 0 | 3 | 13 | 17 | 7 | 3 | 1 | 1 | 5 | 3 | 7 | 1 | 0 | 1 | 1 | 2 | 1 | 1 | 0 | 0 | 8 | 1 | 2 | 0 | 0 | 0 |
,Mirabegron 50 mg | 187 | 25 | 6 | 5 | 1 | 2 | 54 | 45 | 12 | 2 | 0 | 2 | 12 | 19 | 11 | 0 | 0 | 2 | 6 | 4 | 2 | 2 | 0 | 1 | 0 | 1 | 1 | 1 | 2 | 0 | 3 | 2 | 0 | 0 | 0 | 1 |
,Placebo | 157 | 42 | 7 | 0 | 0 | 2 | 42 | 49 | 17 | 4 | 0 | 2 | 12 | 19 | 17 | 2 | 0 | 1 | 7 | 3 | 5 | 10 | 1 | 0 | 2 | 2 | 1 | 0 | 0 | 0 | 9 | 4 | 0 | 0 | 0 | 1 |
,Solifenacin 5 mg | 166 | 29 | 8 | 1 | 0 | 1 | 59 | 40 | 17 | 2 | 0 | 5 | 22 | 14 | 10 | 1 | 0 | 0 | 6 | 5 | 6 | 5 | 1 | 0 | 0 | 2 | 1 | 3 | 1 | 0 | 6 | 2 | 2 | 0 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 25 mg | 360 | 45 | 13 | 2 | 0 | 3 | 122 | 79 | 18 | 5 | 1 | 3 | 42 | 43 | 18 | 8 | 1 | 1 | 12 | 11 | 6 | 5 | 0 | 0 | 2 | 2 | 2 | 0 | 1 | 0 | 13 | 6 | 1 | 0 | 1 | 1 |
,Solifenacin 5 mg + Mirabegron 50 mg | 370 | 50 | 11 | 1 | 1 | 6 | 134 | 65 | 16 | 5 | 0 | 4 | 35 | 41 | 23 | 7 | 1 | 3 | 8 | 6 | 7 | 2 | 3 | 0 | 1 | 3 | 1 | 1 | 2 | 0 | 14 | 3 | 2 | 1 | 0 | 0 |
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Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS)
The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement. (NCT01972841)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | 1.42 |
Mirabegron 25 mg | 2.16 |
Mirabegron 50 mg | 2.18 |
Solifenacin 5 mg | 2.28 |
Solifenacin 5 mg + Mirabegron 25 mg | 2.53 |
Solifenacin 5 mg + Mirabegron 50 mg | 2.55 |
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Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consisted of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement. (NCT01972841)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | -19.45 |
Mirabegron 25 mg | -23.93 |
Mirabegron 50 mg | -26.14 |
Solifenacin 5 mg | -26.44 |
Solifenacin 5 mg + Mirabegron 25 mg | -31.06 |
Solifenacin 5 mg + Mirabegron 50 mg | -32.24 |
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Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT
The percentage of participants with ≥ 50% decrease from baseline in mean number of incontinence episodes per 24 hours at each time point (weeks 4, 8, 12 and EoT). (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 45.3 | 61.8 | 66.4 | 64.5 |
,Mirabegron 50 mg | 56.7 | 63.7 | 70.2 | 69.0 |
,Placebo | 41.1 | 54.9 | 58.6 | 59.5 |
,Solifenacin 5 mg | 53.2 | 65.3 | 71.0 | 70.5 |
,Solifenacin 5 mg + Mirabegron 25 mg | 57.2 | 69.8 | 75.9 | 74.5 |
,Solifenacin 5 mg + Mirabegron 50 mg | 60.6 | 70.6 | 76.1 | 75.7 |
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Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Intervention | mmHg (Least Squares Mean) |
---|
| Week 4 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 0.09 | -0.45 | -0.71 |
,Mirabegron 50 mg | -0.65 | -0.31 | -0.71 |
,Placebo | -1.24 | -1.74 | -1.85 |
,Solifenacin 5 mg | -0.48 | -1.49 | -1.22 |
,Solifenacin 5 mg + Mirabegron 25 mg | -0.22 | 0.48 | 0.44 |
,Solifenacin 5 mg + Mirabegron 50 mg | -0.71 | -0.03 | -0.80 |
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Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours
A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period. (NCT01972841)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | micturitions (Least Squares Mean) |
---|
Placebo | -1.64 |
Mirabegron 25 mg | -2.00 |
Mirabegron 50 mg | -2.03 |
Solifenacin 5 mg | -2.20 |
Solifenacin 5 mg + Mirabegron 25 mg | -2.49 |
Solifenacin 5 mg + Mirabegron 50 mg | -2.59 |
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Change From Baseline to EoT in Corrected Micturition Frequency
Corrected micturition frequency was defined as the mean number of micturitions per 24 hours that participants had at end of treatment if their fluid intake had remained unchanged since baseline. (NCT01972841)
Timeframe: Baseline and Week 12
Intervention | micturitions (Least Squares Mean) |
---|
Placebo | 0.15 |
Mirabegron 25 mg | -0.17 |
Mirabegron 50 mg | -0.97 |
Solifenacin 5 mg | -1.28 |
Solifenacin 5 mg + Mirabegron 25 mg | -1.10 |
Solifenacin 5 mg + Mirabegron 50 mg | -1.52 |
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Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes
(NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12, and EoT (up to 12 weeks)
Intervention | nocturia episodes (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | -2.25 | -2.70 | -2.77 | -2.91 |
,Mirabegron 50 mg | -1.80 | -2.41 | -2.73 | -2.75 |
,Placebo | -1.27 | -1.94 | -1.95 | -2.05 |
,Solifenacin 5 mg | -1.79 | -2.60 | -2.89 | -2.81 |
,Solifenacin 5 mg + Mirabegron 25 mg | -2.39 | -3.13 | -3.49 | -3.42 |
,Solifenacin 5 mg + Mirabegron 50 mg | -2.50 | -3.48 | -3.96 | -3.96 |
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Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period. (NCT01972841)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | incontinence episodes (Least Squares Mean) |
---|
Placebo | -1.34 |
Mirabegron 25 mg | -1.70 |
Mirabegron 50 mg | -1.76 |
Solifenacin 5 mg | -1.79 |
Solifenacin 5 mg + Mirabegron 25 mg | -2.04 |
Solifenacin 5 mg + Mirabegron 50 mg | -1.98 |
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Change From Baseline to EoT in Mean Volume Voided Per Micturition
The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period. (NCT01972841)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | mL (Least Squares Mean) |
---|
Placebo | 8.44 |
Mirabegron 25 mg | 13.32 |
Mirabegron 50 mg | 21.99 |
Solifenacin 5 mg | 30.99 |
Solifenacin 5 mg + Mirabegron 25 mg | 34.84 |
Solifenacin 5 mg + Mirabegron 50 mg | 39.73 |
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Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Intervention | bpm (Least Squares Mean) |
---|
| Week 4 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 2.39 | 1.22 | 0.82 |
,Mirabegron 50 mg | 3.68 | 1.87 | 3.41 |
,Placebo | 0.02 | 0.10 | -0.43 |
,Solifenacin 5 mg | 0.47 | 0.37 | -1.25 |
,Solifenacin 5 mg + Mirabegron 25 mg | -0.91 | 0.15 | 0.34 |
,Solifenacin 5 mg + Mirabegron 50 mg | 0.67 | 1.39 | 1.25 |
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Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax (time to maximum concentration) window of mirabegron and solifenacin was from 4-6 hours postdose. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Intervention | mmHg (Least Squares Mean) |
---|
| Week 4 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 0.34 | -2.13 | -2.19 |
,Mirabegron 50 mg | -1.03 | -1.64 | -1.94 |
,Placebo | -2.71 | -4.86 | -4.40 |
,Solifenacin 5 mg | -1.77 | -3.15 | -3.64 |
,Solifenacin 5 mg + Mirabegron 25 mg | -1.55 | -0.26 | -0.61 |
,Solifenacin 5 mg + Mirabegron 50 mg | -1.47 | 0.60 | -0.98 |
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Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Intervention | bpm (Least Squares Mean) |
---|
| Week 4 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 0.46 | -0.04 | 0.45 |
,Mirabegron 50 mg | 1.54 | 1.15 | 1.14 |
,Placebo | 1.16 | 3.35 | 2.48 |
,Solifenacin 5 mg | 0.78 | 3.49 | 3.16 |
,Solifenacin 5 mg + Mirabegron 25 mg | -0.68 | -0.53 | -0.02 |
,Solifenacin 5 mg + Mirabegron 50 mg | -0.51 | 1.48 | 1.80 |
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Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Intervention | mmHg (Least Squares Mean) |
---|
| Week 4 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 0.14 | -2.45 | -1.38 |
,Mirabegron 50 mg | -0.69 | -4.55 | -2.30 |
,Placebo | -0.71 | 1.18 | 1.15 |
,Solifenacin 5 mg | 0.85 | -1.63 | -0.97 |
,Solifenacin 5 mg + Mirabegron 25 mg | -1.61 | 0.68 | 0.25 |
,Solifenacin 5 mg + Mirabegron 50 mg | 0.41 | 0.62 | 0.68 |
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Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours
(NCT01972841)
Timeframe: Baseline and weeks 4, 8 and 12
Intervention | incontinence episodes (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 |
---|
Mirabegron 25 mg | -1.07 | -1.51 | -1.76 |
,Mirabegron 50 mg | -1.24 | -1.57 | -1.81 |
,Placebo | -0.74 | -1.20 | -1.30 |
,Solifenacin 5 mg | -1.24 | -1.66 | -1.80 |
,Solifenacin 5 mg + Mirabegron 25 mg | -1.38 | -1.79 | -2.08 |
,Solifenacin 5 mg + Mirabegron 50 mg | -1.50 | -1.84 | -1.98 |
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Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours
(NCT01972841)
Timeframe: Baseline and weeks 4, 8 and 12
Intervention | micturitions (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 |
---|
Mirabegron 25 mg | -1.46 | -1.95 | -2.01 |
,Mirabegron 50 mg | -1.44 | -1.89 | -2.03 |
,Placebo | -1.02 | -1.43 | -1.51 |
,Solifenacin 5 mg | -1.39 | -1.84 | -2.22 |
,Solifenacin 5 mg + Mirabegron 25 mg | -1.67 | -2.23 | -2.47 |
,Solifenacin 5 mg + Mirabegron 50 mg | -1.91 | -2.42 | -2.60 |
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Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition
(NCT01972841)
Timeframe: Baseline and weeks 4, 8 and 12
Intervention | mL (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 |
---|
Mirabegron 25 mg | 10.08 | 10.96 | 12.88 |
,Mirabegron 50 mg | 15.52 | 17.73 | 22.40 |
,Placebo | 6.95 | 9.00 | 8.70 |
,Solifenacin 5 mg | 24.23 | 27.55 | 31.89 |
,Solifenacin 5 mg + Mirabegron 25 mg | 25.54 | 32.94 | 35.52 |
,Solifenacin 5 mg + Mirabegron 50 mg | 28.99 | 36.51 | 41.28 |
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Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score
The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion in the OAB-q (seen in this outcome measure) consisted of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement. (NCT01972841)
Timeframe: Baseline and weeks 4, 8 and 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 |
---|
Mirabegron 25 mg | -17.05 | -22.79 | -24.44 |
,Mirabegron 50 mg | -18.98 | -23.54 | -26.80 |
,Placebo | -13.84 | -17.35 | -19.94 |
,Solifenacin 5 mg | -19.53 | -24.69 | -26.72 |
,Solifenacin 5 mg + Mirabegron 25 mg | -23.46 | -29.10 | -31.70 |
,Solifenacin 5 mg + Mirabegron 50 mg | -25.19 | -30.04 | -33.15 |
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Change From Baseline to Weeks 4, 8 and 12 in TS-VAS
The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement. (NCT01972841)
Timeframe: Baseline and week 4, 8 and 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 |
---|
Mirabegron 25 mg | 1.68 | 2.16 | 2.24 |
,Mirabegron 50 mg | 1.77 | 2.09 | 2.23 |
,Placebo | 1.14 | 1.50 | 1.47 |
,Solifenacin 5 mg | 1.82 | 2.20 | 2.32 |
,Solifenacin 5 mg + Mirabegron 25 mg | 2.06 | 2.48 | 2.58 |
,Solifenacin 5 mg + Mirabegron 50 mg | 2.13 | 2.48 | 2.63 |
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Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours
The mean number of nocturia episodes per 24hr was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit. (NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | nocturia episodes (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatmemt |
---|
Mirabegron 25 mg | -0.31 | -0.37 | -0.38 | -0.40 |
,Mirabegron 50 mg | -0.25 | -0.35 | -0.39 | -0.39 |
,Placebo | -0.17 | -0.27 | -0.26 | -0.27 |
,Solifenacin 5 mg | -0.24 | -0.36 | -0.41 | -0.39 |
,Solifenacin 5 mg + Mirabegron 25 mg | -0.33 | -0.44 | -0.49 | -0.48 |
,Solifenacin 5 mg + Mirabegron 50 mg | -0.35 | -0.50 | -0.56 | -0.56 |
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Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT
The number of incontinence-free days was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | incontinence-free days (Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 2.48 | 3.17 | 3.69 | 3.51 |
,Mirabegron 50 mg | 2.98 | 3.63 | 3.96 | 3.89 |
,Placebo | 2.25 | 2.92 | 3.19 | 3.16 |
,Solifenacin 5 mg | 2.74 | 3.31 | 3.68 | 3.61 |
,Solifenacin 5 mg + Mirabegron 25 mg | 3.08 | 3.88 | 4.33 | 4.20 |
,Solifenacin 5 mg + Mirabegron 50 mg | 3.37 | 4.01 | 4.25 | 4.23 |
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Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6
Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Week 6 visit
Intervention | percentage of days with incontinence (Number) |
---|
| 06:00-07:00 | 07:00-08:00 | 08:00-09:00 | 09:00-10:00 | 10:00-11:00 | 11:00-12:00 | 12:00-13:00 | 13:00-14:00 | 14:00-15:00 | 15:00-16:00 | 16:00-17:00 | 17:00-18:00 | 18:00-19:00 | 19:00-20:00 | 20:00-21:00 | 21:00-22:00 | 22:00-23:00 | 23:00-00:00 | 00:00-01:00 | 01:00-02:00 | 02:00-03:00 | 03:00-04:00 | 04:00-05:00 | 05:00-06:00 |
---|
Solifenacin Succinate | 25.0 | 18.3 | 11.7 | 11.7 | 20.0 | 20.0 | 13.3 | 6.7 | 11.7 | 26.7 | 21.7 | 23.3 | 15.0 | 25.0 | 10.0 | 23.3 | 5.0 | 5.0 | 0 | 0 | 3.3 | 1.7 | 3.3 | 5.0 |
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Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9
Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Week 9 visit
Intervention | percentage of days with incontinence (Number) |
---|
| 06:00-07:00 | 07:00-08:00 | 08:00-09:00 | 09:00-10:00 | 10:00-11:00 | 11:00-12:00 | 12:00-13:00 | 13:00-14:00 | 14:00-15:00 | 15:00-16:00 | 16:00-17:00 | 17:00-18:00 | 18:00-19:00 | 19:00-20:00 | 20:00-21:00 | 21:00-22:00 | 22:00-23:00 | 23:00-00:00 | 00:00-01:00 | 01:00-02:00 | 02:00-03:00 | 03:00-04:00 | 04:00-05:00 | 05:00-06:00 |
---|
Solifenacin Succinate | 14.3 | 20.6 | 9.5 | 9.5 | 25.4 | 22.2 | 11.1 | 11.1 | 12.7 | 22.2 | 20.6 | 20.6 | 11.1 | 15.9 | 14.3 | 11.1 | 6.3 | 4.8 | 1.6 | 3.2 | 1.6 | 3.2 | 1.6 | 9.5 |
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Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3
Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Week 3 visit
Intervention | percentage of days with incontinence (Number) |
---|
| 06:00-07:00 | 07:00-08:00 | 08:00-09:00 | 09:00-10:00 | 10:00-11:00 | 11:00-12:00 | 12:00-13:00 | 13:00-14:00 | 14:00-15:00 | 15:00-16:00 | 16:00-17:00 | 17:00-18:00 | 18:00-19:00 | 19:00-20:00 | 20:00-21:00 | 21:00-22:00 | 22:00-23:00 | 23:00-00:00 | 00:00-01:00 | 01:00-02:00 | 02:00-03:00 | 03:00-04:00 | 04:00-05:00 | 05:00-06:00 |
---|
Solifenacin Succinate | 17.5 | 25.4 | 11.1 | 22.2 | 22.2 | 14.3 | 15.9 | 15.9 | 20.6 | 20.6 | 15.9 | 20.6 | 14.3 | 27.0 | 19.0 | 19.0 | 3.2 | 7.9 | 4.8 | 3.2 | 1.6 | 1.6 | 0 | 9.5 |
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Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 20 cmH20 Detrusor Pressure
Bladder volume as assessed by urodynamics. (NCT01981954)
Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 52
Intervention | mL (Mean) |
---|
| Week 3 | Week 6 | Week 9 | Week 12 | Week 24 | Week 52 |
---|
Solifenacin Succinate | 52.4 | 65.5 | 52.0 | 53.9 | 40.1 | 75.4 |
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Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC)
MCC was the volume instilled into the bladder prior to leakage or end of bladder-filling (whichever was reached first), as assessed by urodynamics (procedure: the bladder was to be filled until voiding/leakage began, or until it was stopped because either the participant experienced pain or discomfort or 135% of expected bladder capacity [EBC] was reached for participants ≥ 2 years or of maximum catheterized volume [MCV] for participants aged 6 months to < 2 years; the participants' bladder was emptied via catheterization). (NCT01981954)
Timeframe: Baseline and Week 24
Intervention | mL (Mean) |
---|
Solifenacin Succinate | 37.0 |
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Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Behaviour Score
The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). (NCT01981954)
Timeframe: Baseline and Weeks 24, 52
Intervention | units on a scale (Mean) |
---|
| Week 24 | Week 52 |
---|
Solifenacin Succinate | -1.69 | -0.06 |
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Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Change in Health Score
The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). (NCT01981954)
Timeframe: Baseline and Weeks 24, 52
Intervention | units on a scale (Mean) |
---|
| Week 24 | Week 52 |
---|
Solifenacin Succinate | 0.00 | 5.77 |
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Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Family Cohesion Impact Score
The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). (NCT01981954)
Timeframe: Baseline and Weeks 24, 52
Intervention | units on a scale (Mean) |
---|
| Week 24 | Week 52 |
---|
Solifenacin Succinate | 1.5 | -4.2 |
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Change From Baseline to Week 24 and 52 in ITQoL SF-47 - General Health Score
The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). (NCT01981954)
Timeframe: Baseline and Weeks 24, 52
Intervention | units on a scale (Mean) |
---|
| Week 24 | Week 52 |
---|
Solifenacin Succinate | 0.39 | 4.29 |
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Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Growth and Development Score
The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). (NCT01981954)
Timeframe: Baseline and Weeks 24, 52
Intervention | units on a scale (Mean) |
---|
| Week 24 | Week 52 |
---|
Solifenacin Succinate | -1.50 | 2.33 |
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Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Pain Score
The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). (NCT01981954)
Timeframe: Baseline and Weeks 24, 52
Intervention | units on a scale (Mean) |
---|
| Week 24 | Week 52 |
---|
Solifenacin Succinate | -3.47 | -0.83 |
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Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Parent-Emotional Impact Score
The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). (NCT01981954)
Timeframe: Baseline and Weeks 24, 52
Intervention | units on a scale (Mean) |
---|
| Week 24 | Week 52 |
---|
Solifenacin Succinate | -3.31 | 4.81 |
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Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Parent-Time Impact Score
The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). (NCT01981954)
Timeframe: Baseline and Weeks 24, 52
Intervention | units on a scale (Mean) |
---|
| Week 24 | Week 52 |
---|
Solifenacin Succinate | 15.2 | 7.1 |
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Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Physical Abilities Score
The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). (NCT01981954)
Timeframe: Baseline and Weeks 24, 52
Intervention | units on a scale (Mean) |
---|
| Week 24 | Week 52 |
---|
Solifenacin Succinate | 2.17 | 3.93 |
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Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Temperament and Moods Score
The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). (NCT01981954)
Timeframe: Baseline and Weeks 24, 52
Intervention | units on a scale (Mean) |
---|
| Week 24 | Week 52 |
---|
Solifenacin Succinate | -1.85 | -1.11 |
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Change From Baseline to Weeks 3, 6, 9, 12 and 52 in MCC
MCC was the volume instilled into the bladder prior to leakage or end of bladder-filling (whichever was reached first) as assessed by urodynamics (procedure: the bladder was to be filled until voiding/leakage began, or until it was stopped because either the participant experienced pain or discomfort or 135% of EBC was reached for participants ≥ 2 years or of MCV for participants aged 6 months to < 2 years. The participants' bladder was emptied via catheterization). (NCT01981954)
Timeframe: Baseline and Weeks 3, 6, 9, 12, 52
Intervention | mL (Mean) |
---|
| Week 3 | Week 6 | Week 9 | Week 12 | Week 52 |
---|
Solifenacin Succinate | 45.2 | 36.5 | 23.9 | 40.2 | 58.6 |
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Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Compliance
Bladder compliance gives an indication of the elasticity of the bladder wall. Bladder compliance was calculated by dividing the change in volume during the filling of the bladder by the change in detrusor pressure during that change in bladder volume using urodynamic assessments. The values for bladder volume and detrusor pressure at the beginning and end of filling were taken and used. (NCT01981954)
Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 52
Intervention | mL/cmH2O (Mean) |
---|
| Week 3 | Week 6 | Week 9 | Week 12 | Week 24 | Week 52 |
---|
Solifenacin Succinate | 4.55 | 5.45 | 10.00 | 4.14 | 5.10 | 5.94 |
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Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 10 cmH20 Detrusor Pressure
Bladder volume as assessed by urodynamics. (NCT01981954)
Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 52
Intervention | mL (Mean) |
---|
| Week 3 | Week 6 | Week 9 | Week 12 | Week 24 | Week 52 |
---|
Solifenacin Succinate | 31.9 | 47.8 | 31.5 | 30.1 | 28.7 | 49.4 |
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Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 30 cmH20 Detrusor Pressure
Bladder volume as assessed by urodynamics. (NCT01981954)
Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 52
Intervention | mL (Mean) |
---|
| Week 3 | Week 6 | Week 9 | Week 12 | Week 24 | Week 52 |
---|
Solifenacin Succinate | 101.9 | -2.3 | 76.0 | 74.7 | 67.5 | 93.6 |
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Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume Until First Detrusor Contraction (> 15 cmH2O)
Bladder volume as assessed by urodynamics. (NCT01981954)
Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 52
Intervention | mL (Mean) |
---|
| Week 3 | Week 6 | Week 9 | Week 12 | Week 24 | Week 52 |
---|
Solifenacin Succinate | 47.0 | 87.4 | 77.0 | 18.7 | 22.9 | 89.2 |
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Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Catheterized Volume 5 Minutes After End of Bladder-Filling
Catheterized volume was measured when the bladder was emptied via catheterization 5 minutes after the end of bladder-filling. (NCT01981954)
Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 52
Intervention | mL (Mean) |
---|
| Week 3 | Week 6 | Week 9 | Week 12 | Week 24 | Week 52 |
---|
Solifenacin Succinate | 38.6 | 41.8 | 50.5 | 50.5 | 44.0 | 59.8 |
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Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure 5 Minutes After End of Bladder-Filling
Detrusor pressure was expressed as bladder pressure minus intra-abdominal pressure as assessed by urodynamics. (NCT01981954)
Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 52
Intervention | cmH2O (Mean) |
---|
| Week 3 | Week 6 | Week 9 | Week 12 | Week 24 | Week 52 |
---|
Solifenacin Succinate | 0.9 | 1.3 | 1.2 | -4.1 | -2.0 | -2.3 |
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Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure at End of Bladder-Filling
Detrusor pressure was expressed as bladder pressure minus intra-abdominal pressure as assessed by urodynamics. (NCT01981954)
Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 52
Intervention | cmH2O (Mean) |
---|
| Week 3 | Week 6 | Week 9 | Week 12 | Week 24 | Week 52 |
---|
Solifenacin Succinate | -5.2 | -8.3 | -10.3 | -0.6 | -1.0 | -9.8 |
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Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until Leakage or End of Bladder-Filling
(NCT01981954)
Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 52
Intervention | contractions (Mean) |
---|
| Week 3 | Week 6 | Week 9 | Week 12 | Week 24 | Week 52 |
---|
Solifenacin Succinate | -3.4 | -4.2 | -6.3 | -6.8 | -7.0 | -7.2 |
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Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average Catheterized Volume Per Catheterization
The average catheterized volume per catheterization was calculated using all available (non-zero) catheterized volumes recorded over both of the 2 measuring days in the diary, whether or not these 2 days were concurrent. Catheterized volumes were recorded for 2 days in a participant diary prior to each visit. Four to six catheterizations were performed every day. (NCT01981954)
Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 36, 52
Intervention | mL (Mean) |
---|
| Week 3 | Week 6 | Week 9 | Week 12 | Week 24 | Week 36 | Week 52 |
---|
Solifenacin Succinate | 21.56 | 23.93 | 25.13 | 37.64 | 34.38 | 43.79 | 40.42 |
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Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average First Morning Catheterized Volume
The first morning catheterized volume was the volume associated with the first morning catheterization. The average first morning catheterized volume was calculated as the average of the available first morning catheterized volumes recorded for the 2 measuring days in the diary, whether or not these 2 days are concurrent. (NCT01981954)
Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 36, 52
Intervention | mL (Mean) |
---|
| Week 3 | Week 6 | Week 9 | Week 12 | Week 24 | Week 36 | Week 52 |
---|
Solifenacin Succinate | 19.47 | 24.26 | 23.06 | 32.56 | 40.58 | 40.62 | 39.88 |
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Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Maximum Catheterized Volume (MCV)
The maximum catheterized volume per day was calculated using all available (non-zero) catheterized volumes recorded for the 2 measuring days in the diary, whether or not these 2 days were concurrent. The maximum value was calculated separately for each measuring day and the mean of these two values was used. (NCT01981954)
Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 36, 52
Intervention | mL (Mean) |
---|
| Week 3 | Week 6 | Week 9 | Week 12 | Week 24 | Week 36 | Week 52 |
---|
Solifenacin Succinate | 30.00 | 31.06 | 27.31 | 40.56 | 40.56 | 57.91 | 41.69 |
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Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Mean Number of Periods Between the Clean Intermittent Catheterizations (CICs) With Incontinence Per 24 Hours
Participants were required to have 4-6 CICs per day on a schedule fixed for the duration of the study. To calculate the number of periods between CICs with incontinence in a diary day, the diary day was divided into periods between CICs (i.e. inter-CIC periods). The hour period, rather than the exact time, of each CIC and incontinence episode was recorded in the diary. When an incontinence episode and a CIC were marked in the same hour period, the incontinence episode was counted as occurring prior to the CIC (when the bladder had not yet emptied), rather than after it (when the bladder had recently been emptied), i.e. the inter-CIC period ended with the hour in which the CIC was recorded. The mean number of periods between CICs with incontinence per 24 hours was the number of periods between CICs when incontinence occurred, divided by the total number of valid diary days. (NCT01981954)
Timeframe: Baseline and Weeks 3, 6, 9, 12, 24, 36, 52
Intervention | periods (Mean) |
---|
| Week 3 | Week 6 | Week 9 | Week 12 | Week 24 | Week 36 | Week 52 |
---|
Solifenacin Succinate | -1.18 | -1.38 | -1.47 | -1.25 | -1.31 | -1.06 | -1.29 |
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Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline
For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Baseline visit
Intervention | percentage of days with catheterization (Number) |
---|
| 06:00-07:00 | 07:00-08:00 | 08:00-09:00 | 09:00-10:00 | 10:00-11:00 | 11:00-12:00 | 12:00-13:00 | 13:00-14:00 | 14:00-15:00 | 15:00-16:00 | 16:00-17:00 | 17:00-18:00 | 18:00-19:00 | 19:00-20:00 | 20:00-21:00 | 21:00-22:00 | 22:00-23:00 | 23:00-00:00 | 00:00-01:00 | 01:00-02:00 | 02:00-03:00 | 03:00-04:00 | 04:00-05:00 | 05:00-06:00 |
---|
Solifenacin Succinate | 46.3 | 29.6 | 18.5 | 27.8 | 16.7 | 22.2 | 44.4 | 20.4 | 20.4 | 24.1 | 27.8 | 14.8 | 40.7 | 31.5 | 13.0 | 38.9 | 14.8 | 13.0 | 24.1 | 9.3 | 1.9 | 3.7 | 0 | 13.0 |
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Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12
For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Week 12 visit
Intervention | percentage of days with catheterization (Number) |
---|
| 06:00-07:00 | 07:00-08:00 | 08:00-09:00 | 09:00-10:00 | 10:00-11:00 | 11:00-12:00 | 12:00-13:00 | 13:00-14:00 | 14:00-15:00 | 15:00-16:00 | 16:00-17:00 | 17:00-18:00 | 18:00-19:00 | 19:00-20:00 | 20:00-21:00 | 21:00-22:00 | 22:00-23:00 | 23:00-00:00 | 00:00-01:00 | 01:00-02:00 | 02:00-03:00 | 03:00-04:00 | 04:00-05:00 | 05:00-06:00 |
---|
Solifenacin Succinate | 39.7 | 31.7 | 20.6 | 27.0 | 19.0 | 15.9 | 58.7 | 19.0 | 12.7 | 22.2 | 31.7 | 15.9 | 41.3 | 22.2 | 27.0 | 38.1 | 11.1 | 14.3 | 30.2 | 1.6 | 3.2 | 3.2 | 0 | 6.3 |
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Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24
For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Week 24 visit
Intervention | percentage of days with catheterization (Number) |
---|
| 06:00-07:00 | 07:00-08:00 | 08:00-09:00 | 09:00-10:00 | 10:00-11:00 | 11:00-12:00 | 12:00-13:00 | 13:00-14:00 | 14:00-15:00 | 15:00-16:00 | 16:00-17:00 | 17:00-18:00 | 18:00-19:00 | 19:00-20:00 | 20:00-21:00 | 21:00-22:00 | 22:00-23:00 | 23:00-00:00 | 00:00-01:00 | 01:00-02:00 | 02:00-03:00 | 03:00-04:00 | 04:00-05:00 | 05:00-06:00 |
---|
Solifenacin Succinate | 33.3 | 33.3 | 22.2 | 15.9 | 23.8 | 19.0 | 44.4 | 33.3 | 9.5 | 23.8 | 27.0 | 27.0 | 34.9 | 30.2 | 20.6 | 38.1 | 6.3 | 17.5 | 25.4 | 3.2 | 3.2 | 0 | 0 | 6.3 |
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Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3
For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Week 3 visit
Intervention | percentage of days with catheterization (Number) |
---|
| 06:00-07:00 | 07:00-08:00 | 08:00-09:00 | 09:00-10:00 | 10:00-11:00 | 11:00-12:00 | 12:00-13:00 | 13:00-14:00 | 14:00-15:00 | 15:00-16:00 | 16:00-17:00 | 17:00-18:00 | 18:00-19:00 | 19:00-20:00 | 20:00-21:00 | 21:00-22:00 | 22:00-23:00 | 23:00-00:00 | 00:00-01:00 | 01:00-02:00 | 02:00-03:00 | 03:00-04:00 | 04:00-05:00 | 05:00-06:00 |
---|
Solifenacin Succinate | 36.5 | 30.2 | 20.6 | 27.0 | 20.6 | 19.0 | 36.5 | 34.9 | 15.9 | 23.8 | 20.6 | 28.6 | 36.5 | 25.4 | 20.6 | 36.5 | 17.5 | 9.5 | 25.4 | 12.7 | 3.2 | 0 | 0 | 11.1 |
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Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36
For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Week 36 visit
Intervention | percentage of days with catheterization (Number) |
---|
| 06:00-07:00 | 07:00-08:00 | 08:00-09:00 | 09:00-10:00 | 10:00-11:00 | 11:00-12:00 | 12:00-13:00 | 13:00-14:00 | 14:00-15:00 | 15:00-16:00 | 16:00-17:00 | 17:00-18:00 | 18:00-19:00 | 19:00-20:00 | 20:00-21:00 | 21:00-22:00 | 22:00-23:00 | 23:00-00:00 | 00:00-01:00 | 01:00-02:00 | 02:00-03:00 | 03:00-04:00 | 04:00-05:00 | 05:00-06:00 |
---|
Solifenacin Succinate | 36.7 | 35.0 | 26.7 | 20.0 | 16.7 | 16.7 | 53.3 | 30.0 | 8.3 | 25.0 | 26.7 | 23.3 | 43.3 | 21.7 | 23.3 | 38.3 | 5.0 | 15.0 | 25.0 | 5.0 | 1.7 | 0 | 1.7 | 1.7 |
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Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52
For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all subjects. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Week 52 visit
Intervention | percentage of days with catheterization (Number) |
---|
| 06:00-07:00 | 07:00-08:00 | 08:00-09:00 | 09:00-10:00 | 10:00-11:00 | 11:00-12:00 | 12:00-13:00 | 13:00-14:00 | 14:00-15:00 | 15:00-16:00 | 16:00-17:00 | 17:00-18:00 | 18:00-19:00 | 19:00-20:00 | 20:00-21:00 | 21:00-22:00 | 22:00-23:00 | 23:00-00:00 | 00:00-01:00 | 01:00-02:00 | 02:00-03:00 | 03:00-04:00 | 04:00-05:00 | 05:00-06:00 |
---|
Solifenacin Succinate | 35.1 | 33.3 | 28.1 | 22.8 | 15.8 | 17.5 | 50.9 | 26.3 | 10.5 | 28.1 | 19.3 | 24.6 | 45.6 | 24.6 | 21.1 | 36.8 | 15.8 | 19.3 | 14.0 | 0 | 0 | 0 | 0 | 3.5 |
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Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6
For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Week 6 visit
Intervention | percentage of days with catheterization (Number) |
---|
| 06:00-07:00 | 07:00-08:00 | 08:00-09:00 | 09:00-10:00 | 10:00-11:00 | 11:00-12:00 | 12:00-13:00 | 13:00-14:00 | 14:00-15:00 | 15:00-16:00 | 16:00-17:00 | 17:00-18:00 | 18:00-19:00 | 19:00-20:00 | 20:00-21:00 | 21:00-22:00 | 22:00-23:00 | 23:00-00:00 | 00:00-01:00 | 01:00-02:00 | 02:00-03:00 | 03:00-04:00 | 04:00-05:00 | 05:00-06:00 |
---|
Solifenacin Succinate | 35.0 | 30.0 | 20.0 | 36.7 | 15.0 | 11.7 | 43.3 | 33.3 | 15.0 | 30.0 | 25.0 | 20.0 | 35.0 | 28.3 | 11.7 | 40.0 | 18.3 | 16.7 | 18.3 | 0 | 5.0 | 3.3 | 0 | 6.7 |
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Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9
For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Week 9 visit
Intervention | percentage of days with catheterization (Number) |
---|
| 06:00-07:00 | 07:00-08:00 | 08:00-09:00 | 09:00-10:00 | 10:00-11:00 | 11:00-12:00 | 12:00-13:00 | 13:00-14:00 | 14:00-15:00 | 15:00-16:00 | 16:00-17:00 | 17:00-18:00 | 18:00-19:00 | 19:00-20:00 | 20:00-21:00 | 21:00-22:00 | 22:00-23:00 | 23:00-00:00 | 00:00-01:00 | 01:00-02:00 | 02:00-03:00 | 03:00-04:00 | 04:00-05:00 | 05:00-06:00 |
---|
Solifenacin Succinate | 34.9 | 36.5 | 19.0 | 23.8 | 17.5 | 19.0 | 42.9 | 27.0 | 17.5 | 31.7 | 15.9 | 23.8 | 38.1 | 27.0 | 17.5 | 38.1 | 12.7 | 19.0 | 19.0 | 4.8 | 1.6 | 1.6 | 1.6 | 9.5 |
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Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline
Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Baseline visit
Intervention | percentage of days with incontinence (Number) |
---|
| 06:00-07:00 | 07:00-08:00 | 08:00-09:00 | 09:00-10:00 | 10:00-11:00 | 11:00-12:00 | 12:00-13:00 | 13:00-14:00 | 14:00-15:00 | 15:00-16:00 | 16:00-17:00 | 17:00-18:00 | 18:00-19:00 | 19:00-20:00 | 20:00-21:00 | 21:00-22:00 | 22:00-23:00 | 23:00-00:00 | 00:00-01:00 | 01:00-02:00 | 02:00-03:00 | 03:00-04:00 | 04:00-05:00 | 05:00-06:00 |
---|
Solifenacin Succinate | 27.8 | 27.8 | 16.7 | 37.0 | 25.9 | 22.2 | 35.2 | 33.3 | 25.9 | 31.5 | 37.0 | 24.1 | 24.1 | 31.5 | 14.8 | 35.2 | 14.8 | 9.3 | 13.0 | 5.6 | 1.9 | 1.9 | 1.9 | 7.4 |
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Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12
Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Week 12 visit
Intervention | percentage of days with incontinence (Number) |
---|
| 06:00-07:00 | 07:00-08:00 | 08:00-09:00 | 09:00-10:00 | 10:00-11:00 | 11:00-12:00 | 12:00-13:00 | 13:00-14:00 | 14:00-15:00 | 15:00-16:00 | 16:00-17:00 | 17:00-18:00 | 18:00-19:00 | 19:00-20:00 | 20:00-21:00 | 21:00-22:00 | 22:00-23:00 | 23:00-00:00 | 00:00-01:00 | 01:00-02:00 | 02:00-03:00 | 03:00-04:00 | 04:00-05:00 | 05:00-06:00 |
---|
Solifenacin Succinate | 17.5 | 11.1 | 9.5 | 28.6 | 22.2 | 23.8 | 25.4 | 4.8 | 9.5 | 28.6 | 12.7 | 17.5 | 17.5 | 17.5 | 12.7 | 11.1 | 9.5 | 6.3 | 4.8 | 1.6 | 1.6 | 1.6 | 0 | 7.9 |
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Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24
Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Week 24 visit
Intervention | percentage of days with incontinence (Number) |
---|
| 06:00-07:00 | 07:00-08:00 | 08:00-09:00 | 09:00-10:00 | 10:00-11:00 | 11:00-12:00 | 12:00-13:00 | 13:00-14:00 | 14:00-15:00 | 15:00-16:00 | 16:00-17:00 | 17:00-18:00 | 18:00-19:00 | 19:00-20:00 | 20:00-21:00 | 21:00-22:00 | 22:00-23:00 | 23:00-00:00 | 00:00-01:00 | 01:00-02:00 | 02:00-03:00 | 03:00-04:00 | 04:00-05:00 | 05:00-06:00 |
---|
Solifenacin Succinate | 25.4 | 14.3 | 7.9 | 15.9 | 31.7 | 23.8 | 11.1 | 11.1 | 9.5 | 25.4 | 14.3 | 30.2 | 17.5 | 19.0 | 15.9 | 7.9 | 7.9 | 6.3 | 3.2 | 3.2 | 1.6 | 0 | 0 | 4.8 |
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Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36
Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Week 36 visit
Intervention | percentage of days with incontinence (Number) |
---|
| 06:00-07:00 | 07:00-08:00 | 08:00-09:00 | 09:00-10:00 | 10:00-11:00 | 11:00-12:00 | 12:00-13:00 | 13:00-14:00 | 14:00-15:00 | 15:00-16:00 | 16:00-17:00 | 17:00-18:00 | 18:00-19:00 | 19:00-20:00 | 20:00-21:00 | 21:00-22:00 | 22:00-23:00 | 23:00-00:00 | 00:00-01:00 | 01:00-02:00 | 02:00-03:00 | 03:00-04:00 | 04:00-05:00 | 05:00-06:00 |
---|
Solifenacin Succinate | 25.0 | 13.3 | 11.7 | 18.3 | 20.0 | 20.0 | 21.7 | 13.3 | 11.7 | 31.7 | 11.7 | 16.7 | 11.7 | 30.0 | 21.7 | 18.3 | 5.0 | 11.7 | 6.7 | 3.3 | 0 | 1.7 | 1.7 | 5.0 |
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Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52
Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. (NCT01981954)
Timeframe: 3 days prior to Week 52 visit
Intervention | percentage of days with incontinence (Number) |
---|
| 06:00-07:00 | 07:00-08:00 | 08:00-09:00 | 09:00-10:00 | 10:00-11:00 | 11:00-12:00 | 12:00-13:00 | 13:00-14:00 | 14:00-15:00 | 15:00-16:00 | 16:00-17:00 | 17:00-18:00 | 18:00-19:00 | 19:00-20:00 | 20:00-21:00 | 21:00-22:00 | 22:00-23:00 | 23:00-00:00 | 00:00-01:00 | 01:00-02:00 | 02:00-03:00 | 03:00-04:00 | 04:00-05:00 | 05:00-06:00 |
---|
Solifenacin Succinate | 19.3 | 19.3 | 17.5 | 14.0 | 24.6 | 33.3 | 17.5 | 8.8 | 12.3 | 29.8 | 17.5 | 22.8 | 19.3 | 21.1 | 17.5 | 21.1 | 1.8 | 3.5 | 5.3 | 3.5 | 3.5 | 1.8 | 5.3 | 3.5 |
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Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition
The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period prior to each visit. (NCT02045862)
Timeframe: Baseline and Months 3, 6, 12
Intervention | mL (Least Squares Mean) |
---|
| Month 3 | Month 6 | Month 12 |
---|
Mirabegron 50 mg | 15.34 | 20.87 | 21.85 |
,Solifenacin 5 mg | 23.71 | 27.08 | 24.05 |
,Solifenacin 5 mg + Mirabegron 50 mg | 34.89 | 38.56 | 38.72 |
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Change From Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed
The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement. (NCT02045862)
Timeframe: Baseline and Months 6,12
Intervention | percentage of work time missed (Mean) |
---|
| Month 6 | Month 12 | EoT |
---|
Mirabegron 50 mg | -0.49 | 0.39 | -0.45 |
,Solifenacin 5 mg | -0.59 | -1.95 | -1.30 |
,Solifenacin 5 mg + Mirabegron 50 mg | -3.11 | -3.74 | -3.26 |
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Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit
The number of incontinence-free days was the number of valid diary days during the 7-day micturition diary period prior to each visit with no incontinence episodes recorded. (NCT02045862)
Timeframe: Months 1, 3, 6, 9, 12
Intervention | incontinence-free days (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 2.73 | 3.30 | 3.64 | 3.97 | 4.23 | 3.98 |
,Solifenacin 5 mg | 3.35 | 3.98 | 4.08 | 4.33 | 4.5 | 4.29 |
,Solifenacin 5 mg + Mirabegron 50 mg | 3.46 | 4.17 | 4.44 | 4.56 | 4.81 | 4.64 |
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Change From Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working
The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement. (NCT02045862)
Timeframe: Baseline and Months 6, 12
Intervention | percentage of impairment while working (Mean) |
---|
| Month 6 | Month 12 | EoT |
---|
Mirabegron 50 mg | -16.94 | -19.16 | -17.81 |
,Solifenacin 5 mg | -12.97 | -14.72 | -13.90 |
,Solifenacin 5 mg + Mirabegron 50 mg | -13.41 | -16.68 | -15.63 |
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Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment
The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement. (NCT02045862)
Timeframe: Baseline and Months 6, 12
Intervention | percentage of activity Impairment (Mean) |
---|
| Month 6 | Month 12 | EoT |
---|
Mirabegron 50 mg | -15.04 | -16.85 | -16.02 |
,Solifenacin 5 mg | -16.25 | -14.12 | -14.02 |
,Solifenacin 5 mg + Mirabegron 50 mg | -16.94 | -18.91 | -18.75 |
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Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment
The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes arre expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement. (NCT02045862)
Timeframe: Baseline and Months 6, 12
Intervention | percentage of overall work impairment (Mean) |
---|
| Month 6 | Month 12 | EoT |
---|
Mirabegron 50 mg | -16.33 | -17.83 | -16.83 |
,Solifenacin 5 mg | -12.09 | -15.38 | -14.16 |
,Solifenacin 5 mg + Mirabegron 50 mg | -13.99 | -17.27 | -16.15 |
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Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)
The number of days with < 8 micturitions was the number of valid diary days during the 7-day micturition diary period with with less than 8 micturitions per day. (NCT02045862)
Timeframe: Months 1, 3, 6, 9, 12
Intervention | days (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 1.90 | 2.07 | 2.35 | 2.38 | 2.61 | 2.52 |
,Solifenacin 5 mg | 1.60 | 2.14 | 2.34 | 2.33 | 2.58 | 2.58 |
,Solifenacin 5 mg + Mirabegron 50 mg | 2.08 | 2.66 | 2.87 | 2.93 | 3.17 | 3.10 |
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Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes was the total number of times a participant records an incontinence episode during the 7-day micturition diary period prior to each visit. (NCT02045862)
Timeframe: Months 1, 3, 6, 9, 12
Intervention | incontinence episodes (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 14.88 | 12.23 | 10.62 | 10.53 | 9.09 | 10.32 |
,Solifenacin 5 mg | 12.41 | 9.23 | 8.18 | 7.28 | 7.06 | 8.09 |
,Solifenacin 5 mg + Mirabegron 50 mg | 10.80 | 8.33 | 7.28 | 6.74 | 6.10 | 6.85 |
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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 13.05 | 17.57 | 19.68 | 19.54 | 19.47 | 18.54 |
,Solifenacin 5 mg | 15.40 | 18.38 | 20.53 | 21.21 | 21.90 | 21.13 |
,Solifenacin 5 mg + Mirabegron 50 mg | 17.58 | 21.64 | 22.73 | 23.58 | 24.86 | 24.14 |
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Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The percentage of participants with no incontinence episodes recorded during the 7-day micturition diary is reported. (NCT02045862)
Timeframe: Months 1, 3, 6, 9, 12
Intervention | percentage of participants (Number) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 17.2 | 27.0 | 32.3 | 37.1 | 41.9 | 38.9 |
,Solifenacin 5 mg | 26.4 | 35.1 | 39.9 | 43.7 | 47.3 | 45.1 |
,Solifenacin 5 mg + Mirabegron 50 mg | 27.9 | 40.0 | 44.7 | 46.9 | 52.5 | 49.7 |
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Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The percentage of participants with no incontinence episodes recorded during the last 3 days of the 7-day micturition diary is reported. (NCT02045862)
Timeframe: Months 1, 3, 6, 9, 12
Intervention | percentage of participants (Number) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 24.4 | 40.1 | 40.6 | 47.0 | 51.6 | 47.8 |
,Solifenacin 5 mg | 39.9 | 44.8 | 50.5 | 54.4 | 55.5 | 53.2 |
,Solifenacin 5 mg + Mirabegron 50 mg | 38.3 | 49.6 | 54.7 | 55.8 | 61.2 | 58.8 |
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Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT
The percentage of participants with micturition frequency normalization was defined as participants who had ≥ 8 micturitions/24 hours at baseline and < 8 micturitions/24 hours postbaseline at months 1, 3, 6, 9, 12 and EoT. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | percentage of participants (Number) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 34.5 | 36.7 | 42.3 | 44.5 | 46.3 | 46.0 |
,Solifenacin 5 mg | 29.3 | 36.6 | 43.4 | 41.9 | 44.7 | 46.3 |
,Solifenacin 5 mg + Mirabegron 50 mg | 36.8 | 46.6 | 51.4 | 52.5 | 56.4 | 55.9 |
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Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT
The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | percentage of participants (Number) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 24.9 | 31.3 | 35.0 | 37.5 | 40.6 | 38.3 |
,Solifenacin 5 mg | 28.2 | 33.9 | 38.2 | 40.9 | 40.4 | 39.8 |
,Solifenacin 5 mg + Mirabegron 50 mg | 30.7 | 42.8 | 45.4 | 47.0 | 51.9 | 50.3 |
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Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | percentage of participants (Number) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 46.7 | 58.2 | 63.2 | 67.0 | 72.9 | 69.1 |
,Solifenacin 5 mg | 55.2 | 67.0 | 71.8 | 73.6 | 75.4 | 73.1 |
,Solifenacin 5 mg + Mirabegron 50 mg | 62.0 | 73.3 | 76.6 | 77.8 | 81.3 | 79.5 |
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Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | percentage of participants (Number) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 63.7 | 69.1 | 70.4 | 70.1 | 72.8 | 70.7 |
,Solifenacin 5 mg | 67.5 | 71.3 | 74.6 | 76.1 | 74.1 | 72.4 |
,Solifenacin 5 mg + Mirabegron 50 mg | 72.8 | 81.8 | 80.5 | 82.9 | 84.4 | 82.9 |
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Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | percentage of participants (Number) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 46.6 | 53.6 | 56.9 | 57.1 | 58.4 | 56.2 |
,Solifenacin 5 mg | 53.8 | 59.4 | 62.9 | 62.9 | 62.4 | 61.6 |
,Solifenacin 5 mg + Mirabegron 50 mg | 57.0 | 64.6 | 66.1 | 67.7 | 69.0 | 68.4 |
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Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT
The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | percentage of participants (Number) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 53.0 | 61.9 | 64.6 | 65.5 | 69.7 | 66.2 |
,Solifenacin 5 mg | 59.2 | 65.7 | 68.8 | 68.9 | 73.7 | 71.4 |
,Solifenacin 5 mg + Mirabegron 50 mg | 64.1 | 72.5 | 73.8 | 75.1 | 76.9 | 76.0 |
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Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT
The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The symptom bother portion of the OAB-q consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | percentage of participants (Number) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 29.9 | 38.9 | 42.4 | 46.5 | 51.4 | 47.4 |
,Solifenacin 5 mg | 35.5 | 44.8 | 46.1 | 50.8 | 53.6 | 51.4 |
,Solifenacin 5 mg + Mirabegron 50 mg | 42.8 | 54.1 | 55.9 | 59.2 | 63.7 | 61.7 |
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Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Months 1, 3, 6, 9, 12 and EoT
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | percentage of participants (Number) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 36.1 | 47.8 | 50.4 | 53.1 | 59.2 | 55.7 |
,Solifenacin 5 mg | 46.6 | 55.5 | 56.9 | 61.9 | 60.9 | 58.2 |
,Solifenacin 5 mg + Mirabegron 50 mg | 52.6 | 65.1 | 65.8 | 69.2 | 73.2 | 70.8 |
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Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Months 1, 3, 6, 9, 12 and EoT
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | percentage of participants (Number) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 28.5 | 39.6 | 41.6 | 43.7 | 46.9 | 44.3 |
,Solifenacin 5 mg | 36.6 | 43.8 | 47.9 | 51.2 | 50.4 | 49.0 |
,Solifenacin 5 mg + Mirabegron 50 mg | 40.9 | 52.3 | 55.3 | 57.6 | 60.6 | 59.2 |
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Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | percentage of participants (Number) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 32.1 | 43.3 | 46.8 | 49.6 | 57.6 | 52.9 |
,Solifenacin 5 mg | 37.1 | 47.7 | 52.1 | 53.2 | 60.1 | 57.5 |
,Solifenacin 5 mg + Mirabegron 50 mg | 46.0 | 57.6 | 60.6 | 63.0 | 67.0 | 65.1 |
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Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT
The PGIC is a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved). (NCT02045862)
Timeframe: Month 12
Intervention | percentage of participants (Number) |
---|
| Month 12: Very much improved | Month 12: Much improved | Month 12: Minimally improved | Month 12: No change | Month 12: Minimally worse | Month 12: Much worse | Month 12: Very much worse | EoT: Very much improved | EoT: Much improved | EoT: Minimally improved | EoT: No change | EoT: Minimally worse | EoT: Much worse | EoT: Very much worse |
---|
Mirabegron 50 mg | 12.9 | 23.8 | 18.9 | 24.2 | 3.6 | 0.7 | 0.7 | 13.2 | 24.5 | 19.2 | 25.8 | 3.6 | 1.0 | 0.7 |
,Solifenacin 5 mg | 14.7 | 26.8 | 17.1 | 24.7 | 2.7 | 0 | 0.7 | 15.1 | 27.8 | 18.1 | 25.8 | 3.0 | 0.3 | 0.7 |
,Solifenacin 5 mg + Mirabegron 50 mg | 18.0 | 28.7 | 18.7 | 20.7 | 2.7 | 0.4 | 0.3 | 18.3 | 28.9 | 19.1 | 21.6 | 2.8 | 0.5 | 0.3 |
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Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT
The PGIC is a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved). (NCT02045862)
Timeframe: Month 12
Intervention | percentage of participants (Number) |
---|
| Month 12: Very much improved | Month 12: Much improved | Month 12: Minimally improved | Month 12: No change | Month 12: Minimally worse | Month 12: Much worse | Month 12: Very much worse | EoT: Very much improved | EoT: Much improved | EoT: Minimally improved | EoT: No change | EoT: Minimally worse | EoT: Much worse | EoT: Very much worse |
---|
Mirabegron 50 mg | 25.5 | 30.5 | 21.9 | 5.0 | 0.7 | 1.0 | 0.3 | 25.8 | 31.5 | 22.2 | 6.3 | 0.7 | 1.3 | 0.3 |
,Solifenacin 5 mg | 23.4 | 35.8 | 19.7 | 6.4 | 0.7 | 0.3 | 0.3 | 24.4 | 37.1 | 20.4 | 7.0 | 0.7 | 0.7 | 0.3 |
,Solifenacin 5 mg + Mirabegron 50 mg | 33.8 | 34.0 | 16.1 | 4.5 | 0.4 | 0.1 | 0.5 | 34.1 | 34.7 | 16.6 | 5.1 | 0.4 | 0.1 | 0.5 |
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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 13.24 | 16.37 | 17.77 | 18.15 | 19.10 | 17.98 |
,Solifenacin 5 mg | 15.49 | 17.64 | 19.05 | 19.74 | 19.40 | 19.22 |
,Solifenacin 5 mg + Mirabegron 50 mg | 17.60 | 21.23 | 21.73 | 22.30 | 23.30 | 23.00 |
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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 7.99 | 11.14 | 11.89 | 11.92 | 12.25 | 11.57 |
,Solifenacin 5 mg | 9.41 | 11.19 | 12.54 | 13.33 | 13.47 | 13.22 |
,Solifenacin 5 mg + Mirabegron 50 mg | 9.89 | 12.22 | 13.30 | 13.64 | 14.52 | 14.25 |
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Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS
The TS-VAS is a visual analogue scale which asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 |
---|
Mirabegron 50 mg | 1.88 | 2.10 | 2.22 | 2.24 | 2.33 |
,Solifenacin 5 mg | 1.95 | 2.06 | 2.25 | 2.28 | 2.34 |
,Solifenacin 5 mg + Mirabegron 50 mg | 2.27 | 2.57 | 2.72 | 2.74 | 2.89 |
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Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score
The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 |
---|
Mirabegron 50 mg | -16.37 | -19.69 | -20.97 | -21.41 | -23.41 |
,Solifenacin 5 mg | -20.82 | -23.13 | -24.27 | -25.82 | -25.38 |
,Solifenacin 5 mg + Mirabegron 50 mg | -22.86 | -26.88 | -27.73 | -28.45 | -30.18 |
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Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours
A micturition was defined as any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7-days before the baseline and prior to each visit. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | micturitions (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 |
---|
Mirabegron 50 mg | -1.09 | -1.63 | -1.85 | -2.03 | -2.20 |
,Solifenacin 5 mg | -1.36 | -1.87 | -2.04 | -2.03 | -2.13 |
,Solifenacin 5 mg + Mirabegron 50 mg | -1.64 | 2.16 | -2.39 | -2.42 | -2.64 |
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Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to the baseline and prior to each visit. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | incontinence episodes (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 |
---|
Mirabegron 50 mg | -0.97 | -1.31 | -1.42 | -1.53 | -1.67 |
,Solifenacin 5 mg | -1.29 | -1.71 | -1.78 | -1.90 | -1.92 |
,Solifenacin 5 mg + Mirabegron 50 mg | -1.45 | -1.78 | -1.93 | -2.00 | -2.06 |
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Change From Baseline to EoT in the Patient's Assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS)
The TS-VAS is a visual analogue scale which asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement. (NCT02045862)
Timeframe: Baseline and Week 52
Intervention | units on a scale (Least Squares Mean) |
---|
Mirabegron 50 mg | 2.19 |
Solifenacin 5 mg | 2.15 |
Solifenacin 5 mg + Mirabegron 50 mg | 2.73 |
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Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement. (NCT02045862)
Timeframe: Baseline and Week 52
Intervention | units on a scale (Least Squares Mean) |
---|
Mirabegron 50 mg | -21.96 |
Solifenacin 5 mg | -24.91 |
Solifenacin 5 mg + Mirabegron 50 mg | -29.51 |
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Change From Baseline to EoT in Mean Volume Voided Per Micturition
The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period. (NCT02045862)
Timeframe: Baseline and Week 52
Intervention | mL (Least Squares Mean) |
---|
Mirabegron 50 mg | 21.83 |
Solifenacin 5 mg | 24.90 |
Solifenacin 5 mg + Mirabegron 50 mg | 37.67 |
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Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours
A micturition was defined as any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7-days before the baseline and week 52 clinic visits. (NCT02045862)
Timeframe: Baseline and Week 52
Intervention | micturitions (Least Squares Mean) |
---|
Mirabegron 50 mg | -2.10 |
Solifenacin 5 mg | -2.16 |
Solifenacin 5 mg + Mirabegron 50 mg | -2.58 |
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Change From Baseline to EoT in Corrected Micturition Frequency
Corrected micturition frequency was defined as the mean number of micturitions per 24 hours that participants had at end of treatment if their fluid intake had remained unchanged since baseline. Corrected micturition frequency was calculated as the baseline mean volume voided per micturition multiplied by the baseline mean number of micturitions per 24 hours divided by the mean volume voided per micturition at EoT. (NCT02045862)
Timeframe: Baseline and Month 12
Intervention | micturitions (Least Squares Mean) |
---|
Mirabegron 50 mg | -0.72 |
Solifenacin 5 mg | -1.11 |
Solifenacin 5 mg + Mirabegron 50 mg | -1.51 |
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Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to the baseline and week 52 clinic visits. (NCT02045862)
Timeframe: Baseline and Week 52
Intervention | incontinence episodes (Least Squares Mean) |
---|
Mirabegron 50 mg | -1.58 |
Solifenacin 5 mg | -1.90 |
Solifenacin 5 mg + Mirabegron 50 mg | -2.03 |
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Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT
The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The HRQoL portion of the OAB-q consists of 25 HRQoL items comprising 4 HRQoL subscales, each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | percentage of participants (Number) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 25.2 | 33.3 | 36.8 | 39.0 | 44.1 | 40.1 |
,Solifenacin 5 mg | 29.0 | 39.1 | 41.2 | 44.0 | 47.6 | 45.2 |
,Solifenacin 5 mg + Mirabegron 50 mg | 35.5 | 45.9 | 49.6 | 51.3 | 54.6 | 53.3 |
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
A TEAE was defined as an adverse event (AE) observed after taking the first dose of double-blind treatment until 14 days after taking the last dose of double-blind treatment for non-serious AEs and until 30 days after taking the last dose of double-blind treatment for serious adverse events (SAEs). This included abnormal laboratory tests, vital signs or electrocardiogram data that were defined as AEs if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant in the investigator's opinion. The severity of each AE was defined according to the following: Mild (No disruption of normal daily activities); Moderate (Affected normal daily activities) and Severe (Inability to perform daily activities). (NCT02045862)
Timeframe: From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 56 weeks)
Intervention | Participants (Count of Participants) |
---|
| Any TEAEs | Mild TEAEs | Moderate TEAEs | Severe TEAEs | Drug-related TEAEs | Serious TEAEs | Drug-related Serious TEAEs | TEAEs Leading to Discontuation of Study Drug | Drug-related TEAEs Leading to Discont. of Drug | TEAEs Leading to Death |
---|
Mirabegron 50 mg | 126 | 61 | 52 | 13 | 35 | 8 | 1 | 7 | 4 | 0 |
,Solifenacin 5 mg | 134 | 69 | 58 | 7 | 42 | 8 | 0 | 5 | 4 | 0 |
,Solifenacin 5 mg + Mirabegron 50 mg | 596 | 306 | 238 | 52 | 200 | 51 | 0 | 25 | 17 | 1 |
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Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit
The number of pads used was the number of times a participant recorded a new pad used during the 7-day micturition diary period prior to each visit. (NCT02045862)
Timeframe: Months 1, 3, 6, 9, 12
Intervention | pads (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 12.67 | 9.61 | 7.99 | 7.65 | 7.60 | 9.09 |
,Solifenacin 5 mg | 12.55 | 9.47 | 9.16 | 8.91 | 8.09 | 8.54 |
,Solifenacin 5 mg + Mirabegron 50 mg | 8.75 | 7.23 | 6.51 | 6.18 | 5.70 | 6.33 |
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Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit
A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode during the 7-day micturition diary period prior to each visit. (NCT02045862)
Timeframe: Months 1, 3, 6, 9, 12
Intervention | nocturia episodes (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 8.76 | 7.93 | 7.12 | 7.40 | 6.88 | 7.13 |
,Solifenacin 5 mg | 9.23 | 7.92 | 7.86 | 7.48 | 7.39 | 7.47 |
,Solifenacin 5 mg + Mirabegron 50 mg | 8.00 | 7.17 | 6.96 | 6.84 | 6.33 | 6.51 |
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Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit
The number of incontinence-free days with < 8 micturitions per day was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded and with < 8 micturitions per day. (NCT02045862)
Timeframe: Months 1, 3, 6, 9, 12
Intervention | days (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 1.03 | 1.24 | 1.56 | 1.56 | 1.87 | 1.75 |
,Solifenacin 5 mg | 1.01 | 1.48 | 1.66 | 1.64 | 1.92 | 1.90 |
,Solifenacin 5 mg + Mirabegron 50 mg | 1.33 | 1.91 | 2.13 | 2.20 | 2.54 | 2.43 |
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Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceeded by urgency. The number of urgency incontinence episodes was the total number of urgency incontinence episodes recorded by the participant during the 7-day micturition diary period prior to each visit. (NCT02045862)
Timeframe: Months 1, 3, 6, 9, 12
Intervention | urgency incontinence episodes (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 13.14 | 10.37 | 8.97 | 8.08 | 7.73 | 8.86 |
,Solifenacin 5 mg | 11.21 | 8.12 | 7.31 | 6.51 | 6.06 | 7.04 |
,Solifenacin 5 mg + Mirabegron 50 mg | 8.99 | 6.95 | 5.88 | 5.47 | 4.88 | 5.57 |
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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consisted of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each time was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 10.96 | 14.09 | 14.84 | 14.86 | 16.53 | 16.44 |
,Solifenacin 5 mg | 14.24 | 16.71 | 17.70 | 17.73 | 18.28 | 18.32 |
,Solifenacin 5 mg + Mirabegron 50 mg | 15.82 | 19.75 | 20.09 | 21.15 | 22.17 | 21.59 |
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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours
"A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The mean number of nocturia episodes was calculated from data recorded by the participant in the micturition diary for 7 days prior to each visit." (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | nocturia episodes (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | -0.20 | -0.34 | -0.41 | -0.42 | -0.46 | -0.45 |
,Solifenacin 5 mg | -0.22 | -0.38 | -0.39 | -0.44 | -0.44 | -0.45 |
,Solifenacin 5 mg + Mirabegron 50 mg | -0.34 | -0.46 | -0.49 | -0.50 | -0.56 | -0.55 |
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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours
The mean number of pads used per 24 hours was calculated from data recorded by the participant in the micturition diary for 7 days prior to each visit. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | pads (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | -0.67 | -1.12 | -1.30 | -1.38 | -1.35 | -1.23 |
,Solifenacin 5 mg | -0.96 | -1.30 | -1.24 | -1.31 | -1.37 | -1.38 |
,Solifenacin 5 mg + Mirabegron 50 mg | -1.25 | -1.49 | -1.59 | -1.65 | -1.67 | -1.66 |
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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours
Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. An urgency episode was defined as any micturition or incontinence episode recorded by the participant in the micturition diary for 7 days prior to each visit as 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS), where 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | urgency episodes (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | -1.93 | -2.68 | -2.93 | -3.40 | -3.40 | -3.11 |
,Solifenacin 5 mg | -2.31 | -3.02 | -3.17 | -3.55 | -3.56 | -3.45 |
,Solifenacin 5 mg + Mirabegron 50 mg | -2.68 | -3.36 | -3.72 | -3.87 | -3.95 | -3.84 |
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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours
An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | urgency incontinence episodes (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | -0.93 | -1.30 | -1.40 | -1.60 | -1.60 | -1.51 |
,Solifenacin 5 mg | -1.25 | -1.64 | -1.67 | -1.78 | -1.82 | -1.81 |
,Solifenacin 5 mg + Mirabegron 50 mg | -1.43 | -1.71 | -1.86 | -1.92 | -1.98 | -1.94 |
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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes was the total number of times a participant records an incontinence episode during the 7-day micturition diary period prior to each visit. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | incontinence episodes (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | -6.77 | -9.21 | -10.36 | -10.62 | -11.84 | -11.17 |
,Solifenacin 5 mg | -9.17 | -12.05 | -12.50 | -13.51 | -13.47 | -13.37 |
,Solifenacin 5 mg + Mirabegron 50 mg | -10.31 | -12.55 | -13.49 | -14.06 | -14.43 | -14.29 |
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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode during the 7-day micturition diary period prior to each visit (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | nocturia episodes (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | -1.56 | -2.45 | -3.08 | -2.91 | -3.29 | -3.24 |
,Solifenacin 5 mg | -1.58 | -2.78 | -2.81 | -3.13 | -3.08 | -3.20 |
,Solifenacin 5 mg + Mirabegron 50 mg | -2.39 | -3.26 | -3.44 | -3.55 | -3.97 | -3.90 |
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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit
The number of pads used was the number of times a participant recorded a new pad used during the 7-day micturition diary period prior to each visit. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | pads (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | -4.74 | -7.83 | -9.09 | -9.59 | -9.39 | -8.59 |
,Solifenacin 5 mg | -6.72 | -9.21 | -8.86 | -9.33 | -9.92 | -9.89 |
,Solifenacin 5 mg + Mirabegron 50 mg | -8.89 | 10.47 | -11.12 | -11.44 | -11.66 | -11.58 |
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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The number of urgency incontinence episodes was the total number of urgency incontinence episodes recorded by the participant during the 7-day micturition diary period prior to each visit. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | urgency incontinence episodes (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | -6.45 | -9.06 | -10.09 | -11.1 | -11.27 | -10.61 |
,Solifenacin 5 mg | -8.77 | -11.48 | -11.71 | -12.6 | -12.8 | 12.66 |
,Solifenacin 5 mg + Mirabegron 50 mg | -10.1 | -11.99 | -13.0 | -13.44 | -13.8 | -13.59 |
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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)
The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | -0.84 | -1.09 | -1.11 | -1.25 | -1.29 | -1.22 |
,Solifenacin 5 mg | -0.89 | -1.08 | -1.18 | -1.31 | -1.36 | -1.34 |
,Solifenacin 5 mg + Mirabegron 50 mg | -1.05 | -1.33 | -1.42 | -1.48 | -1.59 | -1.54 |
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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume
PVR volume was assessed by ultrasonography or a bladder scanner. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | mL (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 3.179 | 4.686 | 1.596 | 3.074 | 2.002 | 1.747 |
,Solifenacin 5 mg | 4.549 | 3.233 | 3.418 | 3.436 | 4.818 | 7.382 |
,Solifenacin 5 mg + Mirabegron 50 mg | 7.894 | 7.033 | 6.708 | 8.229 | 7.946 | 8.522 |
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Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12
The average 72-h IEF is calculated based on a 72-h bladder diary. All relevant time points used in the calculation in the Time Frame (baseline, weeks 1-12) (NCT02047032)
Timeframe: baseline, weeks 1-12
Intervention | percent change (Least Squares Mean) |
---|
Solifenacin Plus PFMT | -36.49 |
Electroacupuncture | -37.83 |
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Change of Episodes From Baseline in Mean 72-h Incontinence Episodes
(NCT02047032)
Timeframe: Weeks 1-12, 13-24, 25-36
Intervention | episodes (Least Squares Mean) |
---|
| Weeks 1-12 | Weeks 13-24 | Weeks 25-36 |
---|
Electroacupuncture | -4.56 | -7.27 | -8.31 |
,Solifenacin Plus PFMT | -4.37 | -6.95 | -8.22 |
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Patient's Treatment Satisfaction Degree
The self-assessing satisfaction degree on a 5-point Likert scale (range, 1 [unsatisfied strongly] to 5 [satisfied strongly]) will be finished by participants to evaluate their satisfaction for the treatment. (NCT02047032)
Timeframe: Weeks 12, 36
Intervention | Participants (Count of Participants) |
---|
| Week 1272253229 | Week 1272253230 | Week 3672253229 | Week 3672253230 |
---|
| Satisfaction | Dissatisfaction | Marked satisfaction | No change | Marked dissatisfaction |
---|
Electroacupuncture | 62 |
Solifenacin Plus PFMT | 84 |
Electroacupuncture | 112 |
Solifenacin Plus PFMT | 80 |
Electroacupuncture | 56 |
Solifenacin Plus PFMT | 12 |
Electroacupuncture | 12 |
Solifenacin Plus PFMT | 0 |
Electroacupuncture | 1 |
Solifenacin Plus PFMT | 77 |
Electroacupuncture | 85 |
Solifenacin Plus PFMT | 90 |
Electroacupuncture | 101 |
Solifenacin Plus PFMT | 58 |
Electroacupuncture | 47 |
Solifenacin Plus PFMT | 9 |
Electroacupuncture | 11 |
Electroacupuncture | 0 |
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Patient Global Impression Improvement
Participants will be asked to finish one item evaluating their present condition. (NCT02047032)
Timeframe: Weeks 12, 36
Intervention | Participants (Count of Participants) |
---|
| Week 1272253232 | Week 1272253231 | Week 3672253232 | Week 3672253231 |
---|
| Marked improvement | Moderate improvement | No change | Moderate worsening | Slight improvement | Slight worsening | Marked worening |
---|
Electroacupuncture | 69 |
Solifenacin Plus PFMT | 52 |
Electroacupuncture | 85 |
Solifenacin Plus PFMT | 75 |
Electroacupuncture | 82 |
Solifenacin Plus PFMT | 96 |
Electroacupuncture | 8 |
Solifenacin Plus PFMT | 8 |
Solifenacin Plus PFMT | 3 |
Electroacupuncture | 0 |
Electroacupuncture | 87 |
Solifenacin Plus PFMT | 74 |
Electroacupuncture | 93 |
Solifenacin Plus PFMT | 92 |
Electroacupuncture | 55 |
Solifenacin Plus PFMT | 59 |
Electroacupuncture | 9 |
Solifenacin Plus PFMT | 9 |
Electroacupuncture | 1 |
Solifenacin Plus PFMT | 1 |
Solifenacin Plus PFMT | 0 |
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The Number of Participants Using Urine Pads
(NCT02047032)
Timeframe: Weeks 1-12, 13-24, 25-36
Intervention | Participants (Count of Participants) |
---|
| Weeks 1-12 | Weeks 13-24 | Weeks 25-36 |
---|
Electroacupuncture | 86 | 68 | 59 |
,Solifenacin Plus PFMT | 105 | 80 | 72 |
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the Amount of Urine Leakage (Grams) Measured by the 1-hour Pad Test at Weeks 4 and 12
"The performance of 1-hour pad test according to the International Incontinence Society:~Participants were instructed to void 2 hours before the pad test. On arrival, they received a pre-weighed pad and were asked to sit and drink 500 ml sodium-free water in 15 minutes. Next, they were instructed to walk for 30 minutes, including going up and down 24 stairs. On returning to the clinic, the participants were instructed to perform several activities, including standing and sitting 10 times, coughing vigorously 10 times, running for 1 minute, picking up a coin from the floor 5 times, and putting their hands under water for 1 minute. After the activities were completed, the pad was reweighed to measure the amount of urinary leakage using a gram sensitive weight scale (Xiangshan, EK3820)." (NCT02047032)
Timeframe: Weeks 4 and 12
Intervention | amount of leakage (grams) (Least Squares Mean) |
---|
| Week 4 | Week 12 |
---|
Electroacupuncture | -6.74 | -12.16 |
,Solifenacin Plus PFMT | -6.96 | -11.49 |
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Percentage of Participants With ≥50% Decrease in Average 72-h Incontinence Episode Frequency
Count the number of cases with the reduction of average 72-h incontinence episode frequency ≥50% and divide it by the number of participants at baseline. (NCT02047032)
Timeframe: Weeks 1-12, 13-24, 25-36
Intervention | Participants (Count of Participants) |
---|
| Weeks 1-12 | Weeks 13-24 | Weeks 25-36 |
---|
Electroacupuncture | 109 | 174 | 190 |
,Solifenacin Plus PFMT | 112 | 164 | 188 |
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Percentage of Change From Baseline in Mean 72-hour IEF During Weeks 13-24 and Weeks 25-36
Calculated as the same way as the primary outcome. But this outcome will be assessed at different time point. (NCT02047032)
Timeframe: baseline, weeks 13-24, week 25-36
Intervention | percent change (Least Squares Mean) |
---|
| Weeks 13-24 | Weeks 25-36 |
---|
Electroacupuncture | -58.20 | -64.20 |
,Solifenacin Plus PFMT | -56.69 | -65.48 |
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Electroacupuncture Acceptance Assessment
The acceptance of electroacupuncture will be tested within 5 minute with a 5-point scale ('0' means very difficult to accept and '4' means accept easily). Median of scores of the three times will be calculated. (NCT02047032)
Timeframe: Weeks 2, 6 and 12
Intervention | units on a scale (Median) |
---|
| Week 2 | Week 6 | Week 12 |
---|
Electroacupuncture | 3.0 | 3.0 | 3.0 |
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Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes
The average 72-h IEF (urinary incontinence, stress urinary incontinence and urgency urinary incontinence respectively) is calculated based on a 72-h bladder diary. For example, the average 72-h incontinence episodes from the 13th to 36th week equal to the sum of 72-h incontinence episodes of the 16th, 20th, 24th, 28th, 32nd, 36th weeks divided by 6. (NCT02047032)
Timeframe: Baseline, weeks 1-12, 13-24, 25-36
Intervention | percent change (Least Squares Mean) |
---|
| Change in the 72-h urgence, Weeks 1-12 | Change in the 72-h urgence, Weeks 13-24 | Change in the 72-h urgence, Weeks 25-36 | Change in the 72-h urination, Weeks 1-12 | Change in the 72-h urination, Weeks 13-24 | Change in the 72-h urination, Weeks 25-36 | Change in the 72-h nocturia, Weeks 1-12 | Change in the 72-h nocturia, Weeks 13-24 | Change in the 72-h nocturia, Weeks 25-36 |
---|
Electroacupuncture | -2.62 | -4.75 | -5.55 | -3.23 | -5.96 | -7.02 | -0.79 | -1.38 | -1.58 |
,Solifenacin Plus PFMT | -2.99 | -4.77 | -5.55 | -3.62 | -5.26 | -6.11 | -0.87 | -1.33 | -1.58 |
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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)
Intervention | Participants (Count of Participants) |
---|
Mirabegron + Solifenacin | 61 |
Mirabegron + Propiverine | 61 |
Mirabegron + Imidafenacin | 69 |
Mirabegron + Tolterodine | 71 |
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Number for Participants Who Achieved Normalization of the Mean Number of Micturitions Per 24 Hours
Normalization for the mean number of micturitions per 24 hours was defined as < 8 micturitions per 24 hours. (NCT02294396)
Timeframe: Week 52 (end of treatment)
Intervention | Participants (Count of Participants) |
---|
Mirabegron + Solifenacin | 60 |
Mirabegron + Propiverine | 47 |
Mirabegron + Imidafenacin | 47 |
Mirabegron + Tolterodine | 51 |
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Number for Participants Who Achieved Normalization of the Mean Number of Urgency Episodes Per 24 Hours
Normalization for the mean number of urgency episodes per 24 hours was defined as no urgency episode per 24 hours. (NCT02294396)
Timeframe: Week 52 (end of treatment)
Intervention | Participants (Count of Participants) |
---|
Mirabegron + Solifenacin | 70 |
Mirabegron + Propiverine | 77 |
Mirabegron + Imidafenacin | 64 |
Mirabegron + Tolterodine | 76 |
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Number of Participants Who Achieved Normalization for OABSS Total Score
Normalization for OABSS Total Score was defined as OABSS total score ≤ 2 or OABSS Question 3 score ≤ 1. (NCT02294396)
Timeframe: Week 52 (end of treatment)
Intervention | Participants (Count of Participants) |
---|
Mirabegron + Solifenacin | 98 |
Mirabegron + Propiverine | 101 |
Mirabegron + Imidafenacin | 91 |
Mirabegron + Tolterodine | 96 |
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Number of Participants Who Achieved Normalization of the Mean Number of Nocturia Episodes Per 24 Hours
Normalization for the mean number of nocturia episodes per 24 hours was defined as no nocturia episode per 24 hours. (NCT02294396)
Timeframe: Week 52 (end of treatment)
Intervention | Participants (Count of Participants) |
---|
Mirabegron + Solifenacin | 26 |
Mirabegron + Propiverine | 21 |
Mirabegron + Imidafenacin | 21 |
Mirabegron + Tolterodine | 14 |
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Change From Baseline in OAB-q SF Total HRQL Score
The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the HRQL. The HRQL section included 13 questions. For each participant, the total HRQL score was derived as a sum of scores for Questions 7 to 19. The total score ranges from 13 to 78 with higher total HRQL score indicating greater HRQL. OAB-q SF data obtained at week 0 visit were used as baseline. (NCT02294396)
Timeframe: Baseline and week 12, 28 and 52
Intervention | units on a scale (Mean) |
---|
| Week 12 | Week 28 | Week 52 | End of treatment |
---|
Mirabegron + Imidafenacin | 11.06 | 14.88 | 14.67 | 13.99 |
,Mirabegron + Propiverine | 11.35 | 13.05 | 13.89 | 12.46 |
,Mirabegron + Solifenacin | 12.07 | 15.15 | 15.99 | 14.38 |
,Mirabegron + Tolterodine | 12.05 | 12.94 | 15.06 | 14.36 |
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Change From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score
The OABSS questionnaire was a questionnaire completed by participants with 4 questions regarding their OAB symptoms. For each participant, the OABSS total score was calculated from the sum total of the score of each question. The total score ranges from 0 to 15 with higher score indicating more symptoms. The OABSS data obtained at week 0 were used as baseline. (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 28 and 52
Intervention | units on a scale (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 28 | Week 52 | End of treatment |
---|
Mirabegron + Imidafenacin | -2.4 | -3.1 | -3.4 | -3.8 | -3.9 | -4.1 | -3.9 |
,Mirabegron + Propiverine | -3.1 | -3.7 | -4.2 | -4.4 | -4.4 | -4.1 | -4.1 |
,Mirabegron + Solifenacin | -2.9 | -3.5 | -4.0 | -4.1 | -4.0 | -4.0 | -3.9 |
,Mirabegron + Tolterodine | -3.0 | -3.5 | -4.0 | -4.4 | -4.3 | -4.3 | -4.2 |
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Change From Baseline in Postvoid Residual (PVR) Volume
Measurement of PVR volume was made using either ultrasonography or urethral catheterization, provided that the same method was used for the same participant throughout the study. (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Intervention | mL (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End of treatment |
---|
Mirabegron + Imidafenacin | 6.81 | 5.77 | 7.19 | 4.04 | 2.97 | 2.79 | 5.56 | 2.19 | 2.18 | 5.19 | 3.14 | 2.22 | 2.84 | 4.52 |
,Mirabegron + Propiverine | 9.99 | 3.23 | 3.67 | 1.06 | 3.53 | 4.03 | 3.87 | 1.34 | 0.66 | 3.29 | 1.03 | 0.71 | 4.58 | 6.83 |
,Mirabegron + Solifenacin | 9.07 | 10.68 | 4.72 | 7.51 | 2.32 | 4.99 | 2.95 | 0.70 | 4.11 | 6.03 | 2.17 | 2.60 | 3.56 | 8.17 |
,Mirabegron + Tolterodine | 8.21 | 8.39 | 6.04 | 8.67 | 4.68 | 1.46 | 5.07 | 3.11 | 3.12 | 5.40 | 0.50 | 2.33 | 2.02 | 5.94 |
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Change From Baseline in the Mean Number of Incontinence Episodes Per 24 Hours
"Participants completed the patient diary (paper document) for 3 days immediately before each visit. An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urinary incontinence' was indicated, divided by the number of days on which episodes were recorded. Only participants who had an incontinence episode at baseline was included in the analysis." (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 28, 40, 52
Intervention | incontinence episodes (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 28 | Week 40 | Week 52 | End of treatment |
---|
Mirabegron + Imidafenacin | -0.81 | -0.74 | -0.86 | -0.97 | -0.99 | -0.96 | -1.02 | -1.03 |
,Mirabegron + Propiverine | -1.06 | -1.21 | -1.34 | -1.32 | -1.28 | -1.28 | -1.29 | -1.18 |
,Mirabegron + Solifenacin | -1.13 | -1.16 | -1.27 | -1.23 | -1.31 | -1.23 | -1.31 | -1.25 |
,Mirabegron + Tolterodine | -1.09 | -1.21 | -1.23 | -1.33 | -1.28 | -1.07 | -1.18 | -1.15 |
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Change From Baseline in the Mean Number of Micturitions Per 24 Hours
"Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean number of micturitions per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urinated was indicated, divided by the number of days on which episodes were recorded." (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 28, 40, 52
Intervention | micturitions (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 28 | Week 40 | Week 52 | End 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 | -2.20 | 2.33 | -1.92 | -1.80 | -1.91 |
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Change From Baseline in the Mean Number of Nocturia Episodes Per Night
"Participants completed the patient diary (paper document) for 3 days immediately before each visit. A nocturia episode was defined as waking at night 1 or more times to void. Night time was defined as the period between bedtime and the wake-up time the following day (micturitions at the same time as the wake-up time were excluded). The mean number of nocturia episodes per night was calculated by taking the sum of nocturia episodes in the patient diary where the variable urinated was indicated during the night time, divided by the number of nights. Only participants who had a nocturia episode at baseline was included in the analysis." (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 28, 40, 52
Intervention | nocturia episodes (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 28 | Week 40 | Week 52 | End of treatment |
---|
Mirabegron + Imidafenacin | -0.32 | -0.42 | -0.45 | -0.54 | -0.48 | -0.39 | -0.53 | -0.48 |
,Mirabegron + Propiverine | -0.29 | -0.37 | -0.28 | -0.37 | -0.39 | -0.45 | -0.44 | -0.38 |
,Mirabegron + Solifenacin | -0.33 | -0.42 | -0.45 | -0.49 | -0.42 | -0.53 | -0.55 | -0.47 |
,Mirabegron + Tolterodine | -0.49 | -0.44 | -0.47 | -0.50 | -0.54 | -0.54 | -0.50 | -0.48 |
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Change From Baseline in the Mean Number of Urge Incontinence Episodes Per 24 Hours
"Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urge incontinence episode was defined as any episode when both urgency and incontinence occurred concurrently. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urgency and urinary incontinence' were indicated, divided by the number of days on which episodes were recorded. Only participants who had an urge incontinence episode at baseline was included in the analysis." (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 28, 40, 52
Intervention | urge incontinence episodes (Mean) |
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| Week 4 | Week 8 | Week 12 | Week 16 | Week 28 | Week 40 | Week 52 | End of treatment |
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Mirabegron + Imidafenacin | -0.72 | -0.71 | -0.79 | -0.87 | -0.85 | -0.91 | -0.93 | -0.91 |
,Mirabegron + Propiverine | -1.00 | -1.14 | -1.25 | -1.22 | -1.10 | -1.14 | -1.14 | -1.12 |
,Mirabegron + Solifenacin | -1.13 | -1.15 | -1.20 | -1.17 | -1.26 | -1.19 | -1.23 | -1.20 |
,Mirabegron + Tolterodine | -0.96 | -1.05 | -1.13 | -1.22 | -1.18 | -1.07 | -1.15 | -1.05 |
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Change From Baseline in the Mean Number of Urgency Episodes Per 24 Hours
"Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urgency episode was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urgency was indicated, divided by the number of days on which episodes were recorded. Only participants who had an urgency episode at baseline was included in the analysis." (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 28, 40, 52
Intervention | urgency episodes (Mean) |
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| Week 4 | Week 8 | Week 12 | Week 16 | Week 28 | Week 40 | Week 52 | End of treatment |
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Mirabegron + Imidafenacin | -1.23 | -1.50 | -1.88 | -2.01 | -2.18 | -2.14 | -2.15 | -2.04 |
,Mirabegron + Propiverine | -1.63 | -1.90 | -2.18 | -2.36 | -2.26 | -2.27 | -2.33 | -2.24 |
,Mirabegron + Solifenacin | -1.53 | -1.78 | -2.06 | -2.30 | -2.28 | -2.14 | -2.04 | -2.03 |
,Mirabegron + Tolterodine | -1.49 | -1.89 | -2.10 | -2.26 | -2.28 | -2.19 | -2.26 | -2.07 |
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Change From Baseline in the Mean Volume Voided Per Micturition
"Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean volume per micturition was calculated by taking the sum of the urinary volumes where the volume voided was > 0 and where urinary incontinence was not indicated in the patient diary, divided by the number of micturitions where the volume voided was > 0 and where urinary incontinence was not indicated. Only participants who had volume voided was > 0 at baseline was included in the analysis." (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 28, 40, 52
Intervention | mL (Mean) |
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| Week 4 | Week 8 | Week 12 | Week 16 | Week 28 | Week 40 | Week 52 | End of treatment |
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Mirabegron + Imidafenacin | 20.062 | 23.820 | 27.072 | 24.489 | 29.873 | 29.826 | 36.653 | 32.854 |
,Mirabegron + Propiverine | 30.111 | 38.614 | 41.433 | 40.661 | 41.887 | 43.102 | 40.599 | 38.691 |
,Mirabegron + Solifenacin | 30.677 | 38.328 | 39.452 | 39.952 | 36.025 | 43.578 | 41.744 | 40.004 |
,Mirabegron + Tolterodine | 32.854 | 35.351 | 36.598 | 37.786 | 34.823 | 41.378 | 40.548 | 40.683 |
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAEs were defined as AEs observed after the first administration of the study drugs for the treatment period. The investigator assessed the severity of AEs, including abnormal clinical laboratory values, electrocardiogram (ECG), vital signs, as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator. (NCT02294396)
Timeframe: From first dose of study drug up to week 52
Intervention | Participants (Count of Participants) |
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| Any TEAEs | Mild | Moderate | Severe | Drug-related TEAEs | TEAEs leading to death | Drug-related TEAEs leading to death | Serious TEAEs | Drug-related serious TEAEs | TEAEs leading to withdrawal of treatment | Drug-related TEAEs leading to withdrawal of treat. |
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Mirabegron + Imidafenacin | 133 | 116 | 15 | 2 | 72 | 0 | 0 | 5 | 0 | 16 | 10 |
,Mirabegron + Propiverine | 135 | 122 | 13 | 0 | 81 | 0 | 0 | 4 | 1 | 19 | 17 |
,Mirabegron + Solifenacin | 131 | 113 | 15 | 3 | 76 | 0 | 0 | 10 | 0 | 23 | 12 |
,Mirabegron + Tolterodine | 120 | 104 | 12 | 4 | 74 | 1 | 0 | 9 | 1 | 18 | 8 |
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Number of Participants Who Reached the Maximum Allowed Dose (MAD) in Their Respective Cohort
Of the four cohorts with different dosing schedules for CPC-201, the cohort with the greatest proportion of participants to reach the donepezil MAD was determined to be the optimal administration regimen. (NCT02549196)
Timeframe: 1-7 weeks
Intervention | Participants (Count of Participants) |
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Cohort 1 | 2 |
Cohort 2 | 0 |
Cohort 1b | 1 |
Cohort 3c | 6 |
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Number of Participants With TEAEs Leading to Study Drug Discontinuation
Number of subjects who experienced any treatment-emergent adverse events (TEAEs) leading to study drug discontinuation (NCT02549196)
Timeframe: 1-7 weeks
Intervention | Participants (Count of Participants) |
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Cohort 1 | 2 |
Cohort 2 | 0 |
Cohort 1b | 1 |
Cohort 3c | 4 |
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Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu.
Statistical testing was used to determine if there was a difference in inflammatory markers in the urine of patients between baseline visit and 6 week visit. 7 markers were chosen and compared, all inflammatory markers present in urine. (NCT04090190)
Timeframe: Baseline and 6 weeks
Intervention | pg/mL (Median) |
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| Baseline CRP | Follow-up CRP | Baseline IL-12/IL-23p40 | Follow-up IL-12/IL-23p40 | Baseline MCP-1 | Follow-up MCP-1 | Baseline GM-CSF | Follow-up GM CSF | Baseline IL-1B | Follow-up IL-1B | Baseline IL-6 | Follow-up IL-6 | Baseline IL-8 | Follow-up IL-8 |
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Standard of Care Anticholinergic Treatment | 2.192 | 2.565 | 2.192 | 2.565 | 75.49 | 65.02 | 0.102 | 0.203 | 0.203 | 0.415 | 0.667 | 0.967 | 7.211 | 6.116 |
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