Trial | Phase | Enrollment | Study Type | Start Date | Status |
[NCT01291316] | Phase 1/Phase 2 | 25 participants (Actual) | Interventional | 2010-04-30 | Completed |
Linking Altered Central Pain Processing and Genetic Polymorphism to Drug Efficacy in Chronic Low Back Pain [NCT01179828] | Phase 3 | 150 participants (Actual) | Interventional | 2010-07-31 | Completed |
International, Multicenter, Open-label, Randomized, Comparative Clinical Study of Efficiency and Safety of Medicinal Product Uritos® (Imidafenacin, Film-coated Tablets; 0,1 mg, Kyorin Pharmaceutical Co. Ltd, Japan) and Urotol® (Tolterodine, Film-coated Ta [NCT03575702] | Phase 3 | 300 participants (Actual) | Interventional | 2016-07-18 | Completed |
STUDY The Effect of HNF-4A G60D Variant on the In VIVO CYP2D6 Activity By Tolterodine Pharmacokinetic Study [NCT01181505] | Phase 1 | 31 participants (Actual) | Interventional | 2007-01-31 | Completed |
An International Phase 3, Randomized, Double-Blind, Placebo- and Active (Tolterodine)-Controlled Multicenter Study to Evaluate the Safety and Efficacy of Vibegron in Patients With Symptoms of Overactive Bladder [NCT03492281] | Phase 3 | 1,530 participants (Actual) | Interventional | 2018-03-26 | Completed |
Effect of Combined Use of Tolterodine and Continuous Positive Airway Pressure vs Continuous Positive Airway Pressure Only Treatment on Overactive Bladder Symptoms in Women With Moderate-to-severe Obstructive Sleep Apnea Syndrome: A Randomized Clinical Tri [NCT05250245] | Phase 4 | 60 participants (Actual) | Interventional | 2020-06-01 | Completed |
Double Blind Exploratory Three Arm Randomized Trial to Evaluate the Safety and Efficacy of Herbal Preparation 'Herbmed Plus' in Ureteral Stent Discomfort [NCT01356355] | Phase 2 | 140 participants (Actual) | Interventional | 2012-04-30 | 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 |
[NCT01282840] | | 676 participants (Actual) | Interventional | 2010-07-20 | Completed |
Behavior Enhances Drug Reduction of Incontinence [NCT00090584] | | 307 participants (Actual) | Interventional | 2004-08-31 | Completed |
An International Phase 3, Randomized, Double-Blind, Active (Tolterodine)-Controlled Multicenter Extension Study to Evaluate the Long-Term Safety and Efficacy of Vibegron in Patients With Symptoms of Overactive Bladder [NCT03583372] | Phase 3 | 506 participants (Actual) | Interventional | 2018-06-14 | Completed |
Comparisons of the Impact of Monotherapy With Mirabegron or Tolterodine Versus Combined Treatment With Mirabegron and Tolterodine on Autonomic Function and Bladder Blow Flow in Women With Overactive Bladder Syndrome: a Randomized Controlled Study [NCT05946902] | Phase 4 | 150 participants (Anticipated) | Interventional | 2023-09-12 | Recruiting |
Efficacy Comparison Between Different Management Strategies for Consistent Overactive Bladder (OAB) in Patients With Spinal Vascular Malformations After Surgery [NCT03280316] | | 100 participants (Anticipated) | Interventional | 2023-01-31 | Not yet recruiting |
Effects of Amitriptyline on Central Pain Processing in Healthy Volunteers Depending on CYP Pharmacogenetics [NCT02256956] | Phase 4 | 48 participants (Actual) | Interventional | 2014-11-30 | Completed |
A Placebo Controlled Randomized, 12-week, Dose-ranging, Double-blind Study Versus Placebo Using Tolterodine as a Study Calibrator, to Evaluate Efficacy and Safety of SSR240600C in Women With Overactive Bladder Including Urge Urinary Incontinence [NCT00564226] | Phase 2 | 345 participants (Actual) | Interventional | 2007-11-30 | Completed |
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 Phase IIb Randomized, Placebo- and Active Comparator (Tolterodine)-Controlled, 2-Part Clinical Study of the Efficacy and Safety of MK-4618 in Patients With Overactive Bladder A 52-week Extension to: A Phase IIb Randomized, Placebo- and Active Comparator [NCT01314872] | Phase 2 | 1,395 participants (Actual) | Interventional | 2011-03-31 | Completed |
A Randomised, Multi-Centre, Double-Blind, Placebo and Active-Controlled, 5-Way Parallel Group Study to Investigate the Efficacy, Safety and Tolerability of ONO-8539 in Patients With Overactive Bladder [NCT00876421] | Phase 2 | 435 participants (Actual) | Interventional | 2009-04-30 | Completed |
Low Dose Tadalafil 5mg for Treatment of Female Overactive Bladder Syndrome :6 Months Follow up [NCT04500860] | Phase 1 | 90 participants (Actual) | Interventional | 2020-12-01 | Completed |
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 |
Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics [NCT04090190] | Phase 4 | 20 participants (Actual) | Interventional | 2019-10-30 | Completed |
Effects of Amitriptyline on Central Pain Processing in Healthy Volunteers Depending on CYP Pharmacogenetics [NCT02256943] | Phase 4 | 48 participants (Actual) | Interventional | 2014-11-30 | Completed |
Exploring Predictors of Symptoms Relapse After Discontinuation of Successful Treatment With a Tolterodine Prolonged Release Capsules (4 mg, Once Daily) in Overactive Bladder Patients: A Prospective Randomized Multicenter Trial [NCT00730535] | Phase 4 | 173 participants (Actual) | Interventional | 2006-08-31 | Completed |
A Phase 2, 26 Week, Multicentre, Randomized Double Blind, Placebo-Controlled, Crossover Study Evaluating the Efficacy and Safety of Tolterodine, Pregabalin and a Tolterodine-Pregabalin Combination for Idiopathic Overactive Bladder [NCT00746681] | Phase 2 | 188 participants (Actual) | Interventional | 2005-12-31 | 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 |
Double-Blind Crossover Comparative Ambulatory Urodynamic Monitoring (AUM) Study of Tolterodine PR and Propiverine in Korean Patients With Overactive Bladder (OAB) [NCT00646880] | Phase 3 | 41 participants (Actual) | Interventional | 2003-03-31 | Completed |
Assessment of Patient-reported Goal Attainment in the Treatment of Female Overactive Bladder (Phase Ⅳ) [NCT00836381] | Phase 4 | 56 participants (Actual) | Interventional | 2009-02-28 | Completed |
Effects of THVD-201 on Pharmacokinetics and Pharmacodynamics of Tolterodine in Healthy Subjects [NCT01036035] | Phase 1 | 18 participants (Actual) | Interventional | 2009-09-30 | Completed |
Effects of Gaba-a-Agonists on Pain Mechanisms: An Experimental Study in Healthy Volunteers [NCT01011036] | Phase 3 | 17 participants (Actual) | Interventional | 2009-12-31 | Completed |
Randomized Controlled Trial of Tolterodine in Combination With or Without Low-Dose Intravaginal Estradiol Cream for the Treatment of Overactive Bladder in Post-Menopausal Women [NCT00465894] | | 58 participants (Actual) | Interventional | 2007-04-30 | Completed |
A 3-way Cross-over, Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess Pharmacologic Effects of a 7-day Exposure to Darifenacin 15 mg o.d. and Tolterodine ER 4 mg o.d. on Cardiovascular Parameters in Healthy Subjects 50 Years of Age [NCT00703703] | Phase 1 | 117 participants (Actual) | Interventional | 2008-05-31 | Completed |
Symptom Specific Effectiveness of Tolterodine ER 4 mg in Patients With Symptoms of Overactive Bladder (OAB) in a Primary Care Setting. A Phase IV, Open-label, Single-arm, Non-randomized, Trial in Adult Patients With OAB. [NCT00645281] | Phase 4 | 896 participants (Actual) | Interventional | 2004-03-31 | Completed |
A Randomized, Double-Blind, Parallel Group, Placebo and Active Controlled, Multicenter Study to Assess the Efficacy and Safety of Mirabegron in Subjects With Symptoms of Overactive Bladder [NCT00689104] | Phase 3 | 2,336 participants (Actual) | Interventional | 2008-04-28 | Completed |
The Clinical Efficacy of Pelvic Organ Prolapse Surgery [NCT02599311] | Phase 3 | 1,000 participants (Anticipated) | Interventional | 2015-08-31 | Recruiting |
Special Investigation For Long Term Use Of Detrusitol (Regulatory Post Marketing Commitment Plan). [NCT00795509] | | 374 participants (Actual) | Observational | 2007-08-31 | Completed |
12-Week, Randomized, Double-Blind, Double-Dummy,Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Comparison To Tolterodine ER In Patients With Overactive Bladder (OAB) [NCT00444925] | Phase 3 | 1,712 participants (Actual) | Interventional | 2007-04-30 | Completed |
12-Week, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Comparison To Tolterodine ER In Patients With Overactive Bladder. [NCT00611026] | Phase 3 | 2,417 participants (Actual) | Interventional | 2008-02-29 | Completed |
Efficacy Study of Tamsulosin and Tolterodine Treatment of Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome and Lower Urinary Tract Symptoms [NCT00913315] | | 30 participants (Anticipated) | Interventional | 2009-08-31 | Not yet recruiting |
Is There A Synergic Effect Of Topical Oestrogens When Associated To Antimuscarinics In The Treatment Of Symptomatic Detrusor Overactivity [NCT00648310] | Phase 2/Phase 3 | 0 participants | Interventional | 2004-01-31 | Completed |
Phase III Study of YM178 - A Placebo-controlled, Double-blind, Group Comparison Study in Patients With Overactive Bladder [NCT00966004] | Phase 3 | 1,139 participants (Actual) | Interventional | 2009-07-31 | Completed |
A Randomized, Double-Blind, Parallel Group, Active Controlled, Multi-center Long-term Study to Assess the Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) 50 mg qd and 100 mg qd in Subjects With Symptoms of Overactive Bladder [NCT00688688] | Phase 3 | 2,792 participants (Actual) | Interventional | 2008-04-25 | Completed |
A Randomized, Double-blind, Placebo and Active-controlled Efficacy and Safety Study of SSR240600C in Patients With Overactive Bladder (OAB) or Urge Urinary Incontinence (UUI) [NCT00174798] | Phase 2 | 118 participants (Actual) | Interventional | 2005-05-31 | Completed |
"Comparison of the Efficacy and Safety of Combination Treatment With Doxazosin Plus TolterodineSR 2 mg vs Doxazosin Plus TolterodineSR 4 mg in Men With an OAB/BPO: Randomized Controlled Study" [NCT00922506] | Phase 4 | 83 participants (Actual) | Interventional | 2009-05-31 | Completed |
A Randomized, Double Blind, Placebo Controlled, Phase III Study of KUC-7483 in Patients With Overactive Bladder [NCT01004315] | Phase 3 | 750 participants (Anticipated) | Interventional | | Completed |
Phase III Study of YM178: A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multi-center Study in Subjects With Symptoms of Overactive Bladder [NCT01043666] | Phase 3 | 1,126 participants (Actual) | Interventional | 2009-12-31 | Completed |
A 3-Way Cross-Over, Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Pharmacologic Effects of a 7-Day Exposure to Darifenacin 15 mg o.d. and Tolterodine ER 4 mg o.d on Cardiovascular Parameters in Healthy Subjects 50 Years of [NCT00413790] | Phase 4 | 162 participants (Actual) | Interventional | 2006-11-30 | Completed |
Post-Marketing Study of Mirabegron - A Pharmacokinetic Study to Assess Drug-Drug Interaction Between Mirabegron and Tolterodine - [NCT01964183] | Phase 4 | 24 participants (Actual) | Interventional | 2013-06-30 | Completed |
Cognitive, Urinary, and Functional Trajectories of Older Women Using Pharmacologic Treatment Strategies for Urgency Incontinence [NCT05362292] | Phase 4 | 270 participants (Anticipated) | Interventional | 2022-10-04 | Recruiting |
A Randomized, Double-blind, Parallel Group, Proof of Concept Study of YM178 in Comparison With Placebo and Tolterodine in Patients With Symptomatic Overactive Bladder [NCT01604928] | Phase 2 | 260 participants (Actual) | Interventional | 2004-04-30 | Completed |
Effect of Long Acting Anticholinergic on Nocturnal Incontinence After Radical Cystectomy and Orthotopic Neobladder. A Randomized Placebo-controlled Crossover Study [NCT02877901] | Phase 2/Phase 3 | 120 participants (Actual) | Interventional | 2016-05-31 | Completed |
Exploratory, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single Center, Web-Based Phase IV Pilot Methodology Trial To Evaluate The Efficacy And Safety Of Tolterodine ER In Subjects With Overactive Bladder [NCT01302938] | Phase 4 | 18 participants (Actual) | Interventional | 2011-03-31 | Terminated(stopped due to Stop date for randomization: 31/5/2012. Recruitment terminated due to lack of recruitment. No new safety issues were identified.) |
A Comparison Study on Efficacies of Electrical Pudendal Nerve Stimulation and Tolterodine Tartrate for Urgency-Frequency Syndrome in Women [NCT02723279] | | 120 participants (Actual) | Interventional | 2016-04-30 | Completed |
Combined Behavioral and Drug Treatment of Overactive Bladder in Men [NCT01175382] | Phase 2/Phase 3 | 204 participants (Actual) | Interventional | 2010-07-31 | 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 |
The Applicability of the OAB Assessment Tool for Evaluation of Treatment Efficacy of Overactive Bladder. [NCT00313924] | Phase 4 | 100 participants | Interventional | 2006-02-28 | Recruiting |
Effects of Tolterodine, a Non-Specific Muscarinic Antagonist, on Gastrointestinal Transit in Healthy Subjects [NCT00332137] | Phase 2 | 36 participants | Interventional | 2005-09-30 | Completed |
A Multi-centre, Randomised, Placebo Controlled, Double Blind, Parallel Group Study in Female Patients to Evaluate Whether Tolterodine ER Can Reverse the Increased Bladder Wall Thickness in Patients With Overactive Bladder. [NCT00137397] | Phase 4 | 80 participants | Interventional | 2004-11-30 | Completed |
A Multicenter, Randomized, Double-Blind, Parallel Group, Phase II, Forced Dose Titration Study to Investigate the Efficacy and Safety of 400mg and 600mg ELB245 Given Once Daily for 12 Weeks (8 + 4 Weeks) Versus Placebo and Versus 4mg Tolterodine Given Onc [NCT00439192] | Phase 2 | 275 participants (Anticipated) | Interventional | 2007-02-28 | Terminated(stopped due to side effect profile did not match expectations) |
A Multi-Center, Double-Phase, Randomized, Double-Blind, Placebo Controlled (12-Week Double-Blind Followed by 12-Week Open-Label) Study Evaluating the Effect of Tolterodine ER on Urgency Urinary Incontinence (UUI), Urgency, Frequency, Sexual Quality of Lif [NCT00143481] | Phase 4 | 400 participants | Interventional | 2005-03-31 | Completed |
A Randomized, Double Blind, Placebo Controlled, Four Arm (Placebo, Tolterodine ER, Tamsulosin, and Tolterodine ER Plus Tamsulosin) Study To Evaluate The Clinical Efficacy And Safety Of Tolterodine ER 4 mg In Men Who Have Frequency and Urgency, With Or Wit [NCT00147654] | Phase 4 | 830 participants | Interventional | 2004-11-30 | Completed |
A Phase III Randomized, Double-Blind, Double Dummy, Multi-Center Study To Compare The Efficacy, Safety And Tolerability Of Tolterodine Extended Release Capsule With Tolterodine Immediate Release Tablet In Subjects With Symptoms Of Overactive Bladder [NCT00139724] | Phase 3 | 260 participants (Actual) | Interventional | 2005-05-31 | Completed |
A Randomized, Double-blind, Placebo-controlled, Study of Safety and Efficacy of Dutasteride in Combination With Tolterodine ER or Placebo in Men With Lower Urinary Tract Symptoms (LUTS) Including Urgency and Frequency [NCT00939120] | Phase 4 | 46 participants (Actual) | Interventional | 2009-07-31 | Completed |
A Randomized, Double-Blind, Placebo-Controlled, Three Arm Study To Evaluate The Effects Of Tolterodine ER 4 mg Vs. Placebo Vs. Oxybutynin ER On Memory And Other Cognitive Abilities In Elderly Subjects [NCT00411437] | Phase 4 | 220 participants | Interventional | 2006-12-31 | Completed |
Evaluation of Sympathetic Skin Responses and Heart Rate Variability as Objective Measures of Bladder Sensation - a Double Blind Third Party Open Placebo Controlled Randomised Study Using a Single Dose of Tolterodine in Patients With Idiopathic Overactive [NCT00481728] | Phase 1 | 28 participants (Anticipated) | Interventional | 2007-06-30 | Completed |
Is the a Difference Between Rehabilitation Treatment, Pelvic Floor Muscle Training, Bladder Training and Anticholinergic Drug Treatment in UUI in the Long Term: A Study of Impairment, Quality of Life, and Cost Effectiveness [NCT00498888] | | 164 participants (Actual) | Interventional | 2007-06-30 | Completed |
Randomized Pilot Study on the Treatment of Mixed Urinary Incontinence: Pharmacological Treatment (Tolterodine SR) vs Surgery With Tension Free Vaginal Tape [NCT00523068] | Phase 4 | 40 participants (Anticipated) | Interventional | 2007-09-30 | Not yet recruiting |
Phase III Study of Propiverine Hydrochloride Extended-Release Capsule in the Treatment of Overactive Bladder (OAB) in Chinese Population With Urgent Micturition, Frequent Micturition and/or Urge Urinary Incontinence [NCT01512004] | Phase 3 | 324 participants (Actual) | Interventional | 2010-01-31 | 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 |
A Single-Dose Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial Extended Release Capsules [NCT01521767] | Phase 1 | 16 participants (Actual) | Interventional | 2011-10-31 | Completed |
A Global Phase IV, Double-Blind, Placebo-Controlled, Randomized Trial To Evaluate The Effectiveness Of Detrusitol Sr 4mg On Patient's Perception Of Bladder Condition (PPBC). [NCT00143377] | Phase 4 | 600 participants | Interventional | 2004-09-30 | Completed |
Overactive Bladder Innovative Therapy Trial [NCT00448175] | Phase 4 | 100 participants (Actual) | Interventional | 2006-06-30 | Completed |
A Randomized, Placebo Controlled, Crossover Study to Evaluate the Effects of Tolterodine Tartrate on Urodynamic Parameters in Patients With Overactive Bladder [NCT00768521] | Phase 1 | 20 participants (Actual) | Interventional | 2008-09-03 | Completed |
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Standardization of Fluid Intake on the Variability of Measured Voiding Parameters in Female Patients With Idiopathic Overactive Bladder [NCT00553657] | Phase 1 | 55 participants (Actual) | Interventional | 2007-08-31 | Completed |
A Multicenter, Multiphase, Single Arm, Open Label Study To Evaluate The Effects Of Tolterodine ER In Conjunction With Behavioral Intervention On Subject Satisfaction And Over- Active Bladder Symptoms (Urgency Urinary Incontinence (UUI), Urgency, Frequency [NCT00230789] | Phase 4 | 417 participants | Interventional | 2005-10-31 | Completed |
"A Randomized, Double Blind, Placebo Controlled Detrol LA Add-On To Alpha-Blocker Study In Men With Persistent Overactive Bladder Symptoms Of Urinary Frequency And Urgency With/Without Urgency Incontinence After Previous Monotherapy With Alpha Blocker." [NCT00282932] | Phase 4 | 600 participants | Interventional | 2006-01-31 | 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 |
Flexibly adding-on Second Antimuscarinic Agent to the First Antimuscarinics for Refractory Overactive Bladder Syndrome - A Prospective Randomized Controlled Comparative Study With Mono-antimuscarinic Therapy [NCT01824420] | Phase 4 | 129 participants (Actual) | Interventional | 2013-03-31 | Completed |
Combination Versus Monotherapy With Alpha Blocker and Anticholinergics to Relieve Urinary Stent Symptoms [NCT01741454] | Phase 4 | 181 participants (Actual) | Interventional | 2012-11-30 | Completed |
Phase One of Study on Urinary Stent Complications and Treatment [NCT01530243] | Phase 2/Phase 3 | 104 participants (Actual) | Interventional | 2012-01-31 | Completed |
A Parallel, Double-blind Comparison of Tolterodine vs. Placebo Treatments for Nocturia in Postmenopausal Women. [NCT00323635] | Phase 4 | 19 participants (Actual) | Interventional | 2006-04-30 | Terminated(stopped due to New department chairman instructed PI to discontinue study.) |
[NCT02436889] | Phase 4 | 23 participants (Actual) | Interventional | 2016-02-29 | Completed |
Multicenter, Randomized, Double-blind, Parallel, Active Control, Phase III Clinical Study to Assess the Efficacy and Safety of THVD-201 in Patients With Overactive Bladder Including an Open-label, Extension Study [NCT02485067] | Phase 3 | 384 participants (Actual) | Interventional | 2015-01-31 | Completed |
Postmarketing Observational Study of Tolterodine Treatment on Overactive Bladder in Real Life Setting [NCT01488578] | | 11,157 participants (Actual) | Observational | 2006-12-31 | Completed |
Antimuscarinics as the First-line Treatment for Male With International Prostate Symptom Score (IPSS) Voiding-to-storage Subscore Rati (IPSS-V/S)≤1-- A Prospective Randomized Study Comparing With α-blockers [NCT01661621] | Phase 4 | 395 participants (Actual) | Interventional | 2012-08-31 | Completed |
Protocol for Brain-Centered Therapy Versus Medication for Urgency Urinary Incontinence An RCT: Hypnotherapy Or Pharmacotherapy [NCT01829425] | | 165 participants (Actual) | Interventional | 2013-04-22 | Completed |
A Multi-centre, Double-blind, Randomised Trial Investigating the Efficacy and Safety of a Combination Therapy, Desmopressin and Tolterodine, for Treatment of Overactive Bladder With Nocturia in Women [NCT01729819] | Phase 2 | 106 participants (Actual) | Interventional | 2013-01-31 | Completed |
A Placebo and Active-Comparator Controlled Multiple-Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of MK-4618 in Patients With Overactive Bladder [NCT01500382] | Phase 1 | 4 participants (Actual) | Interventional | 2012-02-27 | Terminated(stopped due to This study was terminated early due to insufficient recruitment.) |
A Prospective, Double-Blind, Randomized, Two-Period Crossover, Multi-Center Study to Evaluate the Tolerability and Patient Preference Between Myrbetriq® and Detrol® LA in Subjects With Overactive Bladder (OAB) [NCT02138747] | Phase 4 | 376 participants (Actual) | Interventional | 2014-07-24 | 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 |
NCT00090584 (9) [back to overview] | Symptom Improvement |
NCT00090584 (9) [back to overview] | Satisfaction |
NCT00090584 (9) [back to overview] | Satisfaction |
NCT00090584 (9) [back to overview] | Change in Incontinence Episodes |
NCT00090584 (9) [back to overview] | Proportion of Women Who Meet Definition of Success |
NCT00090584 (9) [back to overview] | Symptom Distress |
NCT00090584 (9) [back to overview] | Change in Voids Per Day |
NCT00090584 (9) [back to overview] | Symptom Improvement |
NCT00090584 (9) [back to overview] | Symptom Bother |
NCT00444925 (19) [back to overview] | Percent Change From Baseline of UUI Episodes Per 24 Hours. |
NCT00444925 (19) [back to overview] | Percent Change From Baseline of Micturitions Per 24 Hours. |
NCT00444925 (19) [back to overview] | Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours. |
NCT00444925 (19) [back to overview] | Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours. |
NCT00444925 (19) [back to overview] | Percent Change From Baseline of Urgency Episodes Per 24 Hours. |
NCT00444925 (19) [back to overview] | Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 1 and Week 4. |
NCT00444925 (19) [back to overview] | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (End of Treatment). |
NCT00444925 (19) [back to overview] | Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12 (End of Treatment). |
NCT00444925 (19) [back to overview] | Change From Baseline in Frequency-Urgency Sum (Formerly Known as Urinary Sensations Scale Sum in Protocol) Per 24 Hours. |
NCT00444925 (19) [back to overview] | Change From Baseline in Mean Number of Micturitions Per 24 Hours. |
NCT00444925 (19) [back to overview] | Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours. |
NCT00444925 (19) [back to overview] | Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours. |
NCT00444925 (19) [back to overview] | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours. |
NCT00444925 (19) [back to overview] | Change From Baseline in Mean USS Rating Per Micturition Per 24 Hours. |
NCT00444925 (19) [back to overview] | Change From Baseline in Mean Voided Volume Per Micturition. |
NCT00444925 (19) [back to overview] | Change From Baseline in OAB-q: Health Related Quality of Life (HRQL) at Week 12 (End of Treatment). |
NCT00444925 (19) [back to overview] | Change From Baseline in Patient Perception of Bladder Condition (PPBC). |
NCT00444925 (19) [back to overview] | Change From Baseline in Urgency Perception Scale (UPS). UPS Equals Patient Perception of Urgency Scale (PPUS) in Protocol. |
NCT00444925 (19) [back to overview] | Diary Dry Rates |
NCT00448175 (1) [back to overview] | Frequency of Voids at 12 Weeks |
NCT00465894 (13) [back to overview] | Subjective Patient Change in Irritative Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I) |
NCT00465894 (13) [back to overview] | Subjective Patient Change in Irritative Urinary Symptoms As Measured By the 3-Day Voiding Diary |
NCT00465894 (13) [back to overview] | Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score |
NCT00465894 (13) [back to overview] | Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I) |
NCT00465894 (13) [back to overview] | Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ) |
NCT00465894 (13) [back to overview] | Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ) |
NCT00465894 (13) [back to overview] | Evaluate Subjective Patient Change in Irritative Urinary Symptoms |
NCT00465894 (13) [back to overview] | Subjective Patient Change in Irritative Urinary Symptoms |
NCT00465894 (13) [back to overview] | Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Health Related Quality of Life (HRQL) |
NCT00465894 (13) [back to overview] | Subjective Patient Change in Irritative Urinary Symptoms |
NCT00465894 (13) [back to overview] | Subjective Patient Change in Irritative Urinary Symptoms |
NCT00465894 (13) [back to overview] | Subjective Patient Change in Irritative Urinary Symptoms |
NCT00465894 (13) [back to overview] | Subjective Patient Change in Irritative Urinary Symptoms |
NCT00611026 (20) [back to overview] | Percent Change From Baseline of UUI Episodes Per 24 Hours |
NCT00611026 (20) [back to overview] | Post-hoc Adverse Events (AEs) |
NCT00611026 (20) [back to overview] | Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours |
NCT00611026 (20) [back to overview] | Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary) |
NCT00611026 (20) [back to overview] | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 |
NCT00611026 (20) [back to overview] | Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12 |
NCT00611026 (20) [back to overview] | Change From Baseline in Frequency-Urgency Sum (FUS) Per 24 Hours (Synonymous With USS Sum in the Study Protocol) |
NCT00611026 (20) [back to overview] | Change From Baseline in Mean Number of Micturitions Per 24 Hours |
NCT00611026 (20) [back to overview] | Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours |
NCT00611026 (20) [back to overview] | Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours |
NCT00611026 (20) [back to overview] | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1 and Week 4 |
NCT00611026 (20) [back to overview] | Change From Baseline in Mean Urinary Sensation Scale (USS) Rating Per Micturition Per 24 Hours. |
NCT00611026 (20) [back to overview] | Change From Baseline in Mean Voided Volume Per Micturition |
NCT00611026 (20) [back to overview] | Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Health Related Quality of Life (HRQL) at Week 12 |
NCT00611026 (20) [back to overview] | Change From Baseline in Patient Perception of Bladder Condition (PPBC) |
NCT00611026 (20) [back to overview] | Change From Baseline in Urgency Perception Scale (UPS). UPS Formerly Known as Patient Perception of Urgency Scale (PPUS) in the Protocol. |
NCT00611026 (20) [back to overview] | Diary Dry Rate: Percentage of Participants With no Urgency Urinary Incontinence (UUI) in the 3-day Bladder Diary |
NCT00611026 (20) [back to overview] | Percent Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary) |
NCT00611026 (20) [back to overview] | Percent Change From Baseline of Micturitions Per 24 Hours |
NCT00611026 (20) [back to overview] | Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours |
NCT00688688 (28) [back to overview] | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score |
NCT00688688 (28) [back to overview] | Change From Baseline to Month 12 and Final Visit in Treatment Satisfaction-visual Analog Scale (TS-VAS) |
NCT00688688 (28) [back to overview] | Change From Baseline to Month 12 and Final Visit in Patient Perception of Bladder Condition (PPBC) |
NCT00688688 (28) [back to overview] | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score |
NCT00688688 (28) [back to overview] | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score |
NCT00688688 (28) [back to overview] | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score |
NCT00688688 (28) [back to overview] | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score |
NCT00688688 (28) [back to overview] | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) |
NCT00688688 (28) [back to overview] | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit |
NCT00688688 (28) [back to overview] | Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs) |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working |
NCT00688688 (28) [back to overview] | Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 3, 6, 12 and Final Visit in Number of Non-study Related Visits to Physician |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition |
NCT00688688 (28) [back to overview] | Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours |
NCT00689104 (31) [back to overview] | Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit |
NCT00689104 (31) [back to overview] | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score |
NCT00689104 (31) [back to overview] | Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours |
NCT00689104 (31) [back to overview] | Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours |
NCT00689104 (31) [back to overview] | Change From Baseline to Final Visit in Mean Volume Voided Per Micturition |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours |
NCT00689104 (31) [back to overview] | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score |
NCT00689104 (31) [back to overview] | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score |
NCT00689104 (31) [back to overview] | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score |
NCT00689104 (31) [back to overview] | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC) |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS) |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours |
NCT00689104 (31) [back to overview] | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit |
NCT00689104 (31) [back to overview] | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit |
NCT00768521 (2) [back to overview] | Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 1 on Tolterodine 4 mg and Placebo |
NCT00768521 (2) [back to overview] | Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo |
NCT00795509 (2) [back to overview] | Adverse Drug Reaction Not Expected From the Japanese Package Insert. Number of Unlisted Treatment Related Adverse Events (TRAEs). |
NCT00795509 (2) [back to overview] | Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs). |
NCT00939120 (9) [back to overview] | Maximum Urine Flow Rate (Qmax). |
NCT00939120 (9) [back to overview] | Patient Perception of Bladder Condition (PPBC) |
NCT00939120 (9) [back to overview] | Post-void Residual (PVR) Volume |
NCT00939120 (9) [back to overview] | Overactive Bladder Questionnaire (OABq) |
NCT00939120 (9) [back to overview] | Urine Voided Volume (Voiding) |
NCT00939120 (9) [back to overview] | International Prostate Symptoms Score, Voiding Subscore |
NCT00939120 (9) [back to overview] | Acute Urinary Retention (AUR) |
NCT00939120 (9) [back to overview] | International Prostate Symptoms Score (IPSS), Storage Subscore |
NCT00939120 (9) [back to overview] | International Prostate Symptoms Score (IPSS), Total |
NCT01175382 (18) [back to overview] | Change in Frequency of Urination From 6 Weeks to 12 Weeks (Last Observation Carried Forward) |
NCT01175382 (18) [back to overview] | Change in Frequency of Urination After 6-week Intervention (Last Observation Carried Forward) |
NCT01175382 (18) [back to overview] | Change in Frequency of Urination From Baseline to 12 Weeks (Last Observation Carried Forward) |
NCT01175382 (18) [back to overview] | Change in Nocturia From Baseline to 6 Weeks (Last Observation Carried Forward) |
NCT01175382 (18) [back to overview] | Change in International Prostate Symptom Score (I-PSS) From Baseline to 12 Weeks (Last Observation Carried Forward) |
NCT01175382 (18) [back to overview] | Change in International Prostate Symptom Score (I-PSS) From Baseline to 6 Weeks. (Last Observation Carried Forward) |
NCT01175382 (18) [back to overview] | Change in International Prostate Symptom Score (IPSS) From 6 to 12 Weeks (Last Observation Carried Forward) |
NCT01175382 (18) [back to overview] | Change in Nocturia From 6 Weeks to 12 Weeks (Last Observation Carried Forward) |
NCT01175382 (18) [back to overview] | Change in Nocturia Measured From Baseline to 12 Weeks (Last Observation Carried Forward) |
NCT01175382 (18) [back to overview] | Change in Overactive Bladder Questionnaire (OAB-q) From 6 to 12 Weeks (Last Observation Carried Forward) |
NCT01175382 (18) [back to overview] | Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 12 Weeks (Last Observation Carried Forward) |
NCT01175382 (18) [back to overview] | Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 6 Weeks (Last Observation Carried Forward) |
NCT01175382 (18) [back to overview] | Change in Urgency From Baseline to 6 Weeks (Last Observation Carried Forward) |
NCT01175382 (18) [back to overview] | Change in Urgency Score From 6 Weeks to 12 Weeks (Last Observation Carried Forward) |
NCT01175382 (18) [back to overview] | Change in Urinary Incontinence Episodes From Baseline to 12 Weeks (Last Observation Carried Forward) |
NCT01175382 (18) [back to overview] | Change in Urinary Incontinence From 6 Weeks to 12 Weeks (Last Observation Carried Forward) |
NCT01175382 (18) [back to overview] | Change in Urinary Incontinence From Baseline to 6 Weeks (Last Observation Carried Forward) |
NCT01175382 (18) [back to overview] | Change in Urgency Score From Baseline to 12 Weeks (Last Observation Carried Forward) |
NCT01302938 (20) [back to overview] | Change From Baseline in Mean Voided Volume Per Micturition at Week 1, 4 and 12 |
NCT01302938 (20) [back to overview] | Participant Perception Regarding Recommending a Friend to Enter Similar Study |
NCT01302938 (20) [back to overview] | Participant Perception Regarding Received Treatment in the Study |
NCT01302938 (20) [back to overview] | Participant Perception Regarding Cell Phone Diary |
NCT01302938 (20) [back to overview] | Number of Participants Who Discontinued the Study Due to Adverse Events |
NCT01302938 (20) [back to overview] | Number of Participants With Laboratory Abnormalities |
NCT01302938 (20) [back to overview] | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 |
NCT01302938 (20) [back to overview] | Change From Baseline in Health Related Quality of Life (HRQL) Social Domain Score at Week 12 |
NCT01302938 (20) [back to overview] | Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12 |
NCT01302938 (20) [back to overview] | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 1 and 4 |
NCT01302938 (20) [back to overview] | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12 |
NCT01302938 (20) [back to overview] | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) |
NCT01302938 (20) [back to overview] | Number of Participants With Response Regarding Source of First Information About Study |
NCT01302938 (20) [back to overview] | Participant Perception Regarding Satisfaction Related to Study |
NCT01302938 (20) [back to overview] | Number of Participants With Reason for Participation in the Study |
NCT01302938 (20) [back to overview] | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 |
NCT01302938 (20) [back to overview] | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 |
NCT01302938 (20) [back to overview] | Number of Participants With Adverse Events (AEs) by Relatedness and Severity |
NCT01302938 (20) [back to overview] | Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12 |
NCT01302938 (20) [back to overview] | Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1, 4 and 12 |
NCT01314872 (12) [back to overview] | Extension Study: Number of Participants Who Experienced an Adverse Event (AE) |
NCT01314872 (12) [back to overview] | Extension Study: Change From Baseline in Average Daily Number of Urge Incontinence Episodes at Week 52 |
NCT01314872 (12) [back to overview] | Extension Study: Change From Baseline in Average Daily Number of Total Incontinence Episodes at Week 52 |
NCT01314872 (12) [back to overview] | Extension Study: Change From Baseline in Average Daily Micturitions at Week 52 |
NCT01314872 (12) [back to overview] | Extension Study: Change From Baseline in Average Daily Number of Strong Urge Episodes at Week 52 |
NCT01314872 (12) [back to overview] | Base Study/Part 1: Change From Baseline in Average Daily Number of Strong Urge Episodes at Week 8 |
NCT01314872 (12) [back to overview] | Base Study/Part 1 + Part 2: Number of Participants Who Experienced an Adverse Event (AE) |
NCT01314872 (12) [back to overview] | Base Study/Part 1 + Part 2: Number of Participants Who Had Study Medication Withdrawn Due to an AE |
NCT01314872 (12) [back to overview] | Base Study/Part 1: Change From Baseline in Average Daily Micturitions at Week 8 |
NCT01314872 (12) [back to overview] | Base Study/Part 1: Change From Baseline in Average Daily Number of Total Incontinence Episodes at Week 8 |
NCT01314872 (12) [back to overview] | Base Study/Part 1: Change From Baseline in Number of Urge Incontinence Episodes at Week 8 |
NCT01314872 (12) [back to overview] | Extension Study: Number of Participants Who Had Study Medication Withdrawn Due to an AE |
NCT01488578 (16) [back to overview] | Risk Factors for the Proportion of Responders of Tolterodine-Severity of Overactive Bladder |
NCT01488578 (16) [back to overview] | Risk Factors for the Proportion of Responders of Tolterodine-Previous Treatment |
NCT01488578 (16) [back to overview] | Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinations Per Day (During Sleep) |
NCT01488578 (16) [back to overview] | Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies |
NCT01488578 (16) [back to overview] | Risk Factors for the Proportion of Responders of Tolterodine-Gender |
NCT01488578 (16) [back to overview] | Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs |
NCT01488578 (16) [back to overview] | Risk Factors for the Proportion of Responders of Tolterodine-Complications |
NCT01488578 (16) [back to overview] | Risk Factors for the Proportion of Responders of Tolterodine-Age |
NCT01488578 (16) [back to overview] | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Tolterodine - Comorbidity of Prostatic Hypertrophy |
NCT01488578 (16) [back to overview] | Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs). |
NCT01488578 (16) [back to overview] | Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinary Incontinence Episodes Per Day |
NCT01488578 (16) [back to overview] | Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants |
NCT01488578 (16) [back to overview] | Number of Participants With an Investigator's Assessment of Clinical Outcome at End of the Study. |
NCT01488578 (16) [back to overview] | Confirmation of Frequent Treatment Related Adverse Events (TRAEs) at the End of Observation Period. |
NCT01488578 (16) [back to overview] | "Number of Participants Which Was Evaluated as Degree of Satisfaction." |
NCT01488578 (16) [back to overview] | Risk Factors for the Proportion of Responders of Tolterodine-Urinary Urgency |
NCT01500382 (2) [back to overview] | Number of Participants Who Experienced an Adverse Event (AE) |
NCT01500382 (2) [back to overview] | Number of Participants Who Discontinued Use of Study Drug Due to an AE |
NCT01530243 (3) [back to overview] | Lower Urinary Tract Symptoms (LUTS) |
NCT01530243 (3) [back to overview] | Pain |
NCT01530243 (3) [back to overview] | Quality of Life |
NCT01661621 (8) [back to overview] | The Global Response Assessment (GRA) After the Treatment Day |
NCT01661621 (8) [back to overview] | The International Prostate Symptom Score (IPSS) Quality of Life (QoL) Score After the Treatment Day |
NCT01661621 (8) [back to overview] | The International Prostate Symptom Score (IPSS) Questionnaires After the Treatment Day |
NCT01661621 (8) [back to overview] | The IPSS Subscore (IPSS Storage) Questionnaires After the Treatment Day |
NCT01661621 (8) [back to overview] | The IPSS Subscore (IPSS Voiding) Questionnaires After the Treatment Day |
NCT01661621 (8) [back to overview] | The Voided Volume After the Treatment Day |
NCT01661621 (8) [back to overview] | The Maximum Flow Rate (Qmax) After the Treatment Day |
NCT01661621 (8) [back to overview] | The Postvoid Residual Volume (PVR) After the Treatment Day |
NCT01729819 (6) [back to overview] | Change in Mean Nocturnal Urine Volume From Baseline |
NCT01729819 (6) [back to overview] | Change in Mean Number of Nocturnal Voids From Baseline |
NCT01729819 (6) [back to overview] | Change in Mean Time to First Nocturnal Void From Baseline |
NCT01729819 (6) [back to overview] | Responder Status |
NCT01729819 (6) [back to overview] | Change in the Impact on Sleep as Measured by the Sleep Rating Scales From Baseline |
NCT01729819 (6) [back to overview] | Onset of Effect as Seen in Change in Mean Number of Nocturnal Voids From Baseline for Each Visit During Three Months of Treatment |
NCT01741454 (4) [back to overview] | Ureteral Stent Symptom Questionnaire Score |
NCT01741454 (4) [back to overview] | Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion |
NCT01741454 (4) [back to overview] | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal |
NCT01741454 (4) [back to overview] | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion |
NCT01829425 (12) [back to overview] | Percent Change in Urgency Urinary Incontinence Episodes |
NCT01829425 (12) [back to overview] | Percent Change in Urgency Urinary Incontinence Episodes |
NCT01829425 (12) [back to overview] | Voids on Bladder Diary |
NCT01829425 (12) [back to overview] | Voids on Bladder Diary |
NCT01829425 (12) [back to overview] | Overactive Bladder Questionnaire Short Form Quality of Life |
NCT01829425 (12) [back to overview] | Overactive Bladder Questionnaire Short Form Quality of Life |
NCT01829425 (12) [back to overview] | Overactive Bladder Questionnaire Short Form Quality of Life |
NCT01829425 (12) [back to overview] | Overactive Bladder Questionnaire Short Form Symptom Bother |
NCT01829425 (12) [back to overview] | Voids on Bladder Diary |
NCT01829425 (12) [back to overview] | Overactive Bladder Questionnaire Short Form Symptom Bother |
NCT01829425 (12) [back to overview] | Percent Change in Urgency Urinary Incontinence Episodes |
NCT01829425 (12) [back to overview] | Overactive Bladder Questionnaire Short Form Symptom Bother |
NCT02138747 (13) [back to overview] | Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Improvement in Day-to-Day Life Due to OAB Medication |
NCT02138747 (13) [back to overview] | Change From Baseline to End of Treatment (EOT) in Mean Number of Incontinence Episodes Per 24 Hours |
NCT02138747 (13) [back to overview] | Change From Baseline to End of Treatment (EOT) in Number of Micturitions Per 24 Hours |
NCT02138747 (13) [back to overview] | Participants Tolerability Assessed by the Medication Tolerability Scale of the Overactive Bladder-Satisfaction (OAB-S) Questionnaire at the End of Treatment (EOT) |
NCT02138747 (13) [back to overview] | Scale of the OAB-S Questionnaire at the End of Treatment Period: Impact on Daily Living With OAB. |
NCT02138747 (13) [back to overview] | Scale of the OAB-S Questionnaire at the End of Treatment Period: OAB Control |
NCT02138747 (13) [back to overview] | Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Interruption of Day-to-Day Life Due to OAB |
NCT02138747 (13) [back to overview] | Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Participant's Fulfillment of OAB Medication Expectations |
NCT02138747 (13) [back to overview] | Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Willingness to Continue OAB Medication |
NCT02138747 (13) [back to overview] | Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Satisfaction With OAB Medication |
NCT02138747 (13) [back to overview] | Scale of the OAB-S Questionnaire at the End of Treatment Period: Satisfaction With OAB Control |
NCT02138747 (13) [back to overview] | Number of Participants With Adverse Events |
NCT02138747 (13) [back to overview] | Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods. |
NCT02294396 (16) [back to overview] | Change From Baseline in the Mean Volume Voided Per Micturition |
NCT02294396 (16) [back to overview] | Change From Baseline in the Mean Number of Urgency Episodes Per 24 Hours |
NCT02294396 (16) [back to overview] | Change From Baseline in the Mean Number of Urge Incontinence Episodes Per 24 Hours |
NCT02294396 (16) [back to overview] | Change From Baseline in the Mean Number of Nocturia Episodes Per Night |
NCT02294396 (16) [back to overview] | Change From Baseline in the Mean Number of Micturitions Per 24 Hours |
NCT02294396 (16) [back to overview] | Change From Baseline in the Mean Number of Incontinence Episodes Per 24 Hours |
NCT02294396 (16) [back to overview] | Change From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score |
NCT02294396 (16) [back to overview] | Change From Baseline in Postvoid Residual (PVR) Volume |
NCT02294396 (16) [back to overview] | Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Symptom Severity Score |
NCT02294396 (16) [back to overview] | Change From Baseline in OAB-q SF Total HRQL Score |
NCT02294396 (16) [back to overview] | Number of Participants Who Achieved Normalization of the Mean Number of Nocturia Episodes Per 24 Hours |
NCT02294396 (16) [back to overview] | Number of Participants Who Achieved Normalization for OABSS Total Score |
NCT02294396 (16) [back to overview] | Number for Participants Who Achieved Normalization of the Mean Number of Urgency Episodes Per 24 Hours |
NCT02294396 (16) [back to overview] | Number for Participants Who Achieved Normalization of the Mean Number of Micturitions Per 24 Hours |
NCT02294396 (16) [back to overview] | Number for Participants Who Achieved Normalization of the Mean Number of Incontinence Episodes Per 24 Hours |
NCT02294396 (16) [back to overview] | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
NCT02436889 (5) [back to overview] | Change From Baseline in Trail Making Test, Trail A Score at 8 Weeks |
NCT02436889 (5) [back to overview] | Change From Baseline in California Verbal Learning Test (CVLT) Score at 8 Weeks |
NCT02436889 (5) [back to overview] | Change From Baseline in Urge Incontinence Episodes Per Day on a Voiding Diary at 8 Weeks. |
NCT02436889 (5) [back to overview] | Change From Baseline in Total Urinary Incontinence Frequency Measured by a Voiding Diary at 8 Weeks |
NCT02436889 (5) [back to overview] | Change From Baseline in Short Physical Performance Battery (SPPB) Score at 8 Weeks |
NCT03492281 (15) [back to overview] | Percentage of OAB Wet Participants With at Least a 50% Reduction From Baseline in Total Incontinence Episodes Per 24 Hours at Week 12 |
NCT03492281 (15) [back to overview] | Percentage of OAB Wet Participants With a 100% Reduction From Baseline in UUI Episodes Per 24 Hours at Week 12 |
NCT03492281 (15) [back to overview] | Percentage of All OAB Participants With at Least a 50% Reduction From Baseline in Urgency Episodes Per 24 Hours at Week 12 |
NCT03492281 (15) [back to overview] | Percentage of All OAB Participants With an Average Number of Micturitions < 8 Per 24 Hours at Week 12 |
NCT03492281 (15) [back to overview] | CFB at Week 12 in the Symptom Bother Score From the OAB-q LF (1-week Recall) in All OAB Participants |
NCT03492281 (15) [back to overview] | CFB at Week 12 in the Health-related Quality of Life (HRQL) Total Score From the OAB-q LF (1-week Recall) in All OAB Participants |
NCT03492281 (15) [back to overview] | CFB at Week 12 in the Coping Score From the Overactive Bladder Questionnaire Long Form (OAB-q LF, 1-week Recall) in All OAB Participants |
NCT03492281 (15) [back to overview] | CFB at Week 12 in the Average Volume Voided Per Micturition in All OAB Participants |
NCT03492281 (15) [back to overview] | CFB at Week 12 in the Average Number of Urgency Episodes Over 24 Hours in All OAB Participants |
NCT03492281 (15) [back to overview] | CFB at Week 12 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants |
NCT03492281 (15) [back to overview] | CFB at Week 12 in the Average Number of Total Incontinence Episodes Over 24 Hours in OAB Wet Participants |
NCT03492281 (15) [back to overview] | CFB at Week 12 in Overall Control Over Bladder Symptoms Based on Patient Global Impression of Control (PGI-Control) in All OAB Participants |
NCT03492281 (15) [back to overview] | CFB at Week 12 in Overall Bladder Symptoms Based on Patient Global Impression of Severity (PGI-Severity) in All OAB Participants |
NCT03492281 (15) [back to overview] | Change From Baseline (CFB) at Week 12 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants |
NCT03492281 (15) [back to overview] | Percentage of OAB Wet Participants With at Least a 75% Reduction From Baseline in UUI Episodes Per 24 Hours at Week 12 |
NCT03575702 (15) [back to overview] | Changes in the Volume of Residual Urine |
NCT03575702 (15) [back to overview] | Changes in the Overactive Bladder Symptom Score According to Overactive Bladder (OAB) Awareness Tool Questionnaire at 2, 4, 8 and 12 Week |
NCT03575702 (15) [back to overview] | Change in the Mean Weekly Number of Incontinence Episodes at Week 12 |
NCT03575702 (15) [back to overview] | Change in the Mean Number of Incontinence Episodes at Week 2, 4 and 8 |
NCT03575702 (15) [back to overview] | Change in the Mean Nighttime Number of Incontinence Episodes at Week 12 |
NCT03575702 (15) [back to overview] | Change in the Mean Daytime Number of Incontinence Episodes at Week 12 |
NCT03575702 (15) [back to overview] | Number of Patients With Adverse Events (AEs) |
NCT03575702 (15) [back to overview] | Number of Patients With Clinically Significant Changes in ECG Parameters |
NCT03575702 (15) [back to overview] | Number of Patients With Clinically Significant Vital Signs Changes |
NCT03575702 (15) [back to overview] | Number of Patients With Serious Adverse Events (SAEs) |
NCT03575702 (15) [back to overview] | Change in the EQ-5D-based Quality of Life at Week 12 |
NCT03575702 (15) [back to overview] | Change in the Mean Daily Number of Incontinence Episodes at Week 12 |
NCT03575702 (15) [back to overview] | Change in the Mean Daily Number of Urination Episodes at Week 12 |
NCT03575702 (15) [back to overview] | Change in the Mean Daily Number of Urination Episodes at Week 2, 4 and 8 Visit as Compared to the Treatment Initiation Visit |
NCT03575702 (15) [back to overview] | Number of Patients With Clinically Significant Changes in Laboratory Parameters |
NCT03583372 (5) [back to overview] | CFB at Week 52 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants |
NCT03583372 (5) [back to overview] | CFB at Week 52 in the Average Number of Urgency Episodes (Need to Urinate Immediately) Over 24 Hours in All OAB Participants |
NCT03583372 (5) [back to overview] | Change From Baseline (CFB) at Week 52 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants |
NCT03583372 (5) [back to overview] | Number of Participants With the Indicated Type of Treatment-emergent Adverse Event |
NCT03583372 (5) [back to overview] | CFB at Week 52 in the Average Number of Total Urinary Incontinence Episodes Over 24 Hours in OAB Wet Participants |
NCT04090190 (2) [back to overview] | The Effectiveness of Anticholinergic Treatment in Relation to the Urinary Microbiome. Culture to Standard Culture Media Will Pickup Aerobic Bacteria and Yeasts After DNA Extraction and End Point PCR for 16S rDNA Genes. |
NCT04090190 (2) [back to overview] | Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu. |
Symptom Improvement
"Number of women who responded much better or better to question: Overall, do you feel that you are much better, better, about the same, worse or much worse?" (NCT00090584)
Timeframe: 8 months
Intervention | participants (Number) |
---|
Combination Therapy | 80 |
Drug Therapy Alone | 54 |
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Satisfaction
"Number of women who responded completely satisfied to question, How satisfied are you with your progress?" (NCT00090584)
Timeframe: 10 weeks
Intervention | participants (Number) |
---|
Combination at 10 Weeks | 71 |
Drug Only at 10 Weeks | 55 |
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Satisfaction
"Number of women who responded completely satisfied to question How satisfied are you with your progress?" (NCT00090584)
Timeframe: 8 months
Intervention | participants (Number) |
---|
Combination Therapy | 38 |
Drug Therapy Alone | 25 |
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Change in Incontinence Episodes
Change from baseline to 10 weeks in number of incontinence episodes per week as reported on bladder diary. (NCT00090584)
Timeframe: Baseline and 10 weeks
Intervention | incontinence episodes per week (Mean) |
---|
Combination Therapy | -20.4 |
Drug Therapy Alone | -18.5 |
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Proportion of Women Who Meet Definition of Success
Proportion of women who meet definition of success: not taking drug or receiving other urge UI therapy (i.e., neuromodulation, botox injections, myomectomy, electrical stimulation, or any intravesical therapy) and not taking a tricyclic antidepressant or duloxetine at 8 months; and a >70% reduction in number of incontinence episodes as compared to baseline. (NCT00090584)
Timeframe: 8 months
Intervention | participants (Number) |
---|
Combination Therapy | 43 |
Drug Therapy Alone | 41 |
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Symptom Distress
Urogenital distress inventory (UDI). Higher score indicates greater distress. Possible range 0 to 300. (NCT00090584)
Timeframe: baseline, 10 weeks and 8 months
Intervention | units on a scale (Mean) |
---|
Combination at Baseline | 121.4 |
Combination at 10 Weeks | 47.3 |
Combiniation at 8 Months | 61.9 |
Drug Only at Baseline | 118.2 |
Drug Only at 10 Weeks | 58.1 |
Drug Only at 8 Months | 83.3 |
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Change in Voids Per Day
Change from baseline to 10 weeks in frequency of voids per day as reported on bladder diary (NCT00090584)
Timeframe: baseline and 10 weeks
Intervention | voids per day (Mean) |
---|
Combination Therapy | -0.5 |
Drug Therapy Alone | 0.3 |
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Symptom Improvement
"Number of women who responded much better or better to question: Overall, do you feel that you are much better, better, about the same, worse or much worse?" (NCT00090584)
Timeframe: 10 weeks
Intervention | participants (Number) |
---|
Combination Therapy | 120 |
Drug Therapy Alone | 106 |
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Symptom Bother
Disease specific overactive bladder scale (OAB-q). HIgher score indicates greater bother. Possible range 0 to 100. (NCT00090584)
Timeframe: baseline, 10 weeks and 8 months
Intervention | units on a scale (Mean) |
---|
Combination at Baseline | 59.9 |
Combination at 10 Weeks | 23.1 |
Combiniation at 8 Months | 29.0 |
Drug Only at Baseline | 60.0 |
Drug Only at 10 Weeks | 29.6 |
Drug Only at 8 Months | 39.6 |
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Percent Change From Baseline of UUI Episodes Per 24 Hours.
UUI episodes per 24 hours calculated as total number of micturitions with USS of 5 in diary. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100. (NCT00444925)
Timeframe: Baseline, Week 1, Week 4, Week 12
Intervention | percent change (Median) |
---|
| Week 1 (n=302, 614, 612) | Week 4 [LOCF] (n=307, 626, 618) | Week 12 [LOCF] (n=307, 626, 619) |
---|
Fesoterodine | -53.6 | -93.2 | -100.0 |
,Placebo | -28.6 | -60.0 | -82.1 |
,Tolterodine ER | -55.1 | -85.7 | -100.0 |
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Percent Change From Baseline of Micturitions Per 24 Hours.
Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100% *(Week 12 or 4 - baseline)/baseline). (NCT00444925)
Timeframe: Baseline, Week 1, Week 4, Week 12
Intervention | percent change (Median) |
---|
| Week 1 (n=307, 622, 623) | Week 4 [LOCF] (n=313, 634, 627) | Week 12 [LOCF] (n=313, 634, 628) |
---|
Fesoterodine | -7.9 | -14.8 | -18.9 |
,Placebo | -2.7 | -10.3 | -12.1 |
,Tolterodine ER | -7.7 | -15.0 | -16.2 |
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Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours.
Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100% *(Week 12 or 4 - baseline)/baseline). Nocturnal (Bedtime) was defined as the time the subject went to bed until he/she arose to start the next day. (NCT00444925)
Timeframe: Baseline, Week 1, Week 4, Week 12
Intervention | percent change (Median) |
---|
| Week 1 (n=288, 584, 596) | Week 4 [LOCF] (n=293, 596, 600) | Week 12 [LOCF] (n=293, 596, 601) |
---|
Fesoterodine | 0.0 | -20.0 | -28.6 |
,Placebo | -10.0 | -22.2 | -25.0 |
,Tolterodine ER | -12.5 | -25.0 | -27.9 |
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Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours.
Percent change calculated as change in severe urgency episodes (USS rating >= to 4 in diary ) per 24 hours at that visit divided by the baseline number of severe urgency episodes per 24 hours, multiplied by 100. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). (NCT00444925)
Timeframe: Baseline, Week 1, Week 4, Week 12
Intervention | percent change (Median) |
---|
| Week 1 (n=306, 618, 618) | Week 4 [LOCF] (n=311, 630, 624) | Week 12 [LOCF] (n=311, 630, 625) |
---|
Fesoterodine | -25.0 | -54.5 | -71.4 |
,Placebo | -9.4 | -25.0 | -48.0 |
,Tolterodine ER | -25.0 | -45.8 | -63.4 |
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Percent Change From Baseline of Urgency Episodes Per 24 Hours.
Percent change of urgency episodes (USS rating >= to 3 in diary) per 24 hours calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100. USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). (NCT00444925)
Timeframe: Baseline, Week 1, Week 4, Week 12
Intervention | percent change (Median) |
---|
| Week 1 (n=306, 619, 621) | Week 4 [LOCF] (n=311,631, 627) | Week 12 [LOCF] (n=311, 631, 628) |
---|
Fesoterodine | -9.7 | -26.9 | -37.9 |
,Placebo | -5.6 | -11.4 | -17.6 |
,Tolterodine ER | -12.5 | -23.1 | -30.8 |
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Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 1 and Week 4.
UUI episodes per 24 hours calculated as total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline. (NCT00444925)
Timeframe: Baseline, Week 1, Week 4
Intervention | number of episodes per 24 hours (Mean) |
---|
| Week 1 (n=302, 614, 612) | Week 4 [LOCF] (n=307, 626, 618) |
---|
Fesoterodine | -0.95 | -1.52 |
,Placebo | -0.54 | -1.06 |
,Tolterodine ER | -0.92 | -1.40 |
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Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (End of Treatment).
UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change: mean at observation minus mean at baseline. (NCT00444925)
Timeframe: Baseline, Week 12
Intervention | number of episodes per 24 hours (Mean) |
---|
Placebo | -1.46 |
Tolterodine ER | -1.61 |
Fesoterodine | -1.72 |
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Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12 (End of Treatment).
Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/by raw score range * 100]. Higher transformed scores indicative of greater symptom bother. Negative change in Symptom Bother score indicates improvement. Change calculated as score at observation minus score at baseline. (NCT00444925)
Timeframe: Baseline, Week 12
Intervention | score on scale (Least Squares Mean) |
---|
Placebo | -16.3 |
Tolterodine ER | -22.5 |
Fesoterodine | -27.1 |
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Change From Baseline in Mean Number of Micturitions Per 24 Hours.
The mean number of micturitions was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Change calculated as mean at observation minus mean at baseline. (NCT00444925)
Timeframe: Baseline, Week 1, Week 4, Week 12
Intervention | number of micturitions per 24 hours (Least Squares Mean) |
---|
| Week 1 (n=307, 622, 623) | Week 4 [LOCF] (n= 313, 634, 627) | Week 12 [LOCF] (n= 313, 634, 628) |
---|
Fesoterodine | -1.0 | -1.9 | -2.2 |
,Placebo | -0.5 | -1.2 | -1.5 |
,Tolterodine ER | -1.0 | -1.8 | -2.1 |
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Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours.
Mean number of nocturnal micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Nocturnal (Bedtime) was defined as the time the subject went to bed until he/she arose to start the next day. (NCT00444925)
Timeframe: Baseline, Week 1, Week 4, Week 12
Intervention | nocturnal micturitions per 24 hours (Least Squares Mean) |
---|
| Week 1 (n=288, 584, 596) | Week 4 [LOCF] (n=293, 596, 600) | Week 12 [LOCF] (n=293, 596, 601) |
---|
Fesoterodine | -0.2 | -0.5 | -0.6 |
,Placebo | -0.1 | -0.4 | -0.5 |
,Tolterodine ER | -0.3 | -0.5 | -0.6 |
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Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours.
Mean number of severe urgency episodes (USS rating >= to 4 in diary ) per 24 hours: sum of all micturitions divided by total number of diary days collected at that visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline. (NCT00444925)
Timeframe: Baseline, Week 1, Week 4, Week 12
Intervention | severe urgency episodes per 24 hours (Least Squares Mean) |
---|
| Week 1 (n=306, 618, 618) | Week 4 [LOCF] (n=311, 630, 624) | Week 12 [LOCF] (n=311, 630, 625) |
---|
Fesoterodine | -1.2 | -2.4 | -3.0 |
,Placebo | -0.4 | -1.2 | -1.9 |
,Tolterodine ER | -1.3 | -2.2 | -2.8 |
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Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours.
Mean number urgency episodes (USS rating >= to 3 in diary) per 24 hours calculated as sum of all micturitions divided by total number of diary days collected at visit. USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline. (NCT00444925)
Timeframe: Baseline, Week 1, Week 4, Week 12
Intervention | urgency episodes per 24 hours (Least Squares Mean) |
---|
| Week 1 (n=306, 619, 621) | Week 4 [LOCF] (n=311, 631, 627) | Week 12 [LOCF] (n=311, 631, 628) |
---|
Fesoterodine | -1.1 | -2.6 | -3.5 |
,Placebo | -0.4 | -1.2 | -2.0 |
,Tolterodine ER | -1.3 | -2.4 | -3.1 |
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Change From Baseline in Mean USS Rating Per Micturition Per 24 Hours.
Mean USS rating calculated as the sum of rating scores on USS per 24 hours divided by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline. (NCT00444925)
Timeframe: Baseline, Week 1, Week 4, Week 12
Intervention | score on scale (Least Squares Mean) |
---|
| Week 1 (n=306, 619, 621) | Week 4 [LOCF] (n=311, 631, 627) | Week 12 [LOCF] (n=311, 631, 628) |
---|
Fesoterodine | -0.2 | -0.5 | -0.7 |
,Placebo | -0.1 | -0.2 | -0.4 |
,Tolterodine ER | -0.2 | -0.4 | -0.6 |
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Change From Baseline in Mean Voided Volume Per Micturition.
Mean voided volume calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 in the 3-day diary at that visit. (NCT00444925)
Timeframe: Baseline, Week 1, Week 4, Week 12
Intervention | voided volume per micturition (Least Squares Mean) |
---|
| Week 1 (n=306, 622, 623) | Week 4 [LOCF] (n=313, 633, 625) | Week 12 [LOCF] (n=313, 633, 626) |
---|
Fesoterodine | 18.7 | 30.5 | 32.9 |
,Placebo | 11.0 | 14.0 | 16.8 |
,Tolterodine ER | 19.2 | 25.7 | 23.5 |
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Change From Baseline in Patient Perception of Bladder Condition (PPBC).
Number of subjects in 4-point category: >= to 2 points improvement [major improvement]; 1 point improvement [minor improvement]; no change; deterioration, based on PPBC score (rated on 6-point scale: 1=no problems at all; 6=many severe problems). Score change: score at observation minus score at baseline; re-scaled to 4-point categorical variables. (NCT00444925)
Timeframe: Baseline, Week 1, Week, 4, Week 12
Intervention | participants (Number) |
---|
| Week 1 (n=309, 625, 623), >=2 points improvement | Week 1, 1-point improvement | Week 1, no change | Week 1, deterioration | Week 4 (n=313, 632, 629), >=2 points improvement | Week 4, 1-point improvement | Week 4, no change | Week 4, deterioration | Week 12 (n=313, 632, 630), >=2 points improvement | Week 12, 1-point improvement | Week 12, no change | Week 12, deterioration |
---|
Fesoterodine | 102 | 186 | 286 | 49 | 196 | 224 | 176 | 33 | 254 | 198 | 148 | 30 |
,Placebo | 32 | 94 | 147 | 36 | 57 | 95 | 127 | 34 | 67 | 102 | 111 | 33 |
,Tolterodine ER | 79 | 181 | 306 | 59 | 169 | 201 | 203 | 59 | 210 | 189 | 171 | 62 |
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Change From Baseline in Urgency Perception Scale (UPS). UPS Equals Patient Perception of Urgency Scale (PPUS) in Protocol.
Number of subjects in 3-point category: improvement [>=1-point improvement]; no change; deterioration [>=1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables. (NCT00444925)
Timeframe: Baseline, Week 1, Week 4, Week 12
Intervention | participants (Number) |
---|
| Week 1 (n=309, 627, 624), improvement | Week 1, no change | Week 1, deterioration | Week 4 (n=313, 633, 629), improvement | Week 4, no change | Week 4, deterioration | Week 12 (n=313, 633, 630), improvement | Week 12, no change | Week 12, deterioration |
---|
Fesoterodine | 171 | 413 | 40 | 256 | 348 | 25 | 291 | 314 | 25 |
,Placebo | 68 | 218 | 23 | 98 | 194 | 21 | 112 | 181 | 20 |
,Tolterodine ER | 162 | 438 | 27 | 238 | 362 | 33 | 254 | 344 | 35 |
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Diary Dry Rates
Diary dry rate: number of subjects with no urgency urinary incontinence episode reported in the 3 day diary at the respective time-point; based on USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). (NCT00444925)
Timeframe: Week 1, Week 4, Week 12
Intervention | participants (Number) |
---|
| Week 1 | Week 4 | Week 12 |
---|
Fesoterodine | 159 | 306 | 396 |
,Placebo | 54 | 97 | 138 |
,Tolterodine ER | 153 | 290 | 358 |
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Frequency of Voids at 12 Weeks
To demonstrate that the Urgent PC system is as effective as or more effective (noninferior) than tolterodine (Detrol LA) in changing the frequency of urinary voids per day after 12 weeks of therapy. The voiding diaries completed at 12 weeks were compared to the baseline voiding diaries. (NCT00448175)
Timeframe: Baseline to 12 weeks
Intervention | Voids/day (Mean) |
---|
Urgent PC Treatment Arm | -2.4 |
4mg Daily Tolterodine | -2.5 |
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Subjective Patient Change in Irritative Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I)
Assessment measured using the Patient Global Impression of Improvement (PGI-I), patient perception of improvement. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 being very much better to 7 being very much worse. Each level achieved(movement towards 1), is considered an improvement. (NCT00465894)
Timeframe: Baseline through 52 weeks
Intervention | percentage of participants (Number) |
---|
Group 1: Extended Release Tolterodine + Intravaginal Estradiol | 85 |
Group 2: Intravaginal Estradiol Cream | 85 |
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Subjective Patient Change in Irritative Urinary Symptoms As Measured By the 3-Day Voiding Diary
Number of voids and accidents/leakage per 3 day diary. A void is a voluntary and intentional event. An accident is involuntary and unintentional. (NCT00465894)
Timeframe: From baseline through 12 weeks of Intervention
Intervention | events (Mean) |
---|
| Number of voids | Number of voids 12 week follow-up | Number of accidents/leakage | Number of accidents/leakage at 12 weeks |
---|
Group 1: Extended Release Tolterodine | 30.4 | 26.3 | 10.8 | 7.2 |
,Group 2: Intravaginal Estradiol Cream | 26.4 | 24.6 | 11.9 | 7.7 |
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Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother. (NCT00465894)
Timeframe: From baseline through 12 Weeks of Intervention
Intervention | units on a scale (Mean) |
---|
| Baseline | 12 Weeks |
---|
Group 1: Extended Release Tolterodine | 65.4 | 46.7 |
,Group 2: Intravaginal Estradiol Cream | 61.6 | 45.4 |
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Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I)
Assessment measured using the Patient Global Impression of Improvement (PGI-I), patient perception of improvement. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 being very much better to 7 being very much worse. Each level achieved(movement towards 1), is considered an improvement. (NCT00465894)
Timeframe: Baseline through 24 weeks
Intervention | percentage of participants (Number) |
---|
Group 1: Extended Release Tolterodine + Intravaginal Estradiol | 77 |
Group 2: Intravaginal Estradiol Cream + Tolterodine | 77 |
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Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ)
"As measured by the Patient Satisfaction Questionnaire (PSQ). The PSQ consists of a single question, How satisfied are you with your progress since your treatment in which the 3 possible responses are completely satisfied, somewhat satisfied, and not satisfied. The goal of treatment was to move all participants to completely satisfied." (NCT00465894)
Timeframe: Baseline through 24 weeks
Intervention | percentage of participants (Number) |
---|
Group 1: Extended Release Tolterodine + Intravaginal Estradiol | 88 |
Group 2: Intravaginal Estradiol Cream + Tolterodine | 88 |
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Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ)
"As measured by the Patient Satisfaction Questionnaire (PSQ).The PSQ consists of a single question, How satisfied are you with your progress since your treatment in which the 3 possible responses are completely satisfied, somewhat satisfied, and not satisfied. The goal of treatment was to move all participants to completely satisfied." (NCT00465894)
Timeframe: Baseline through 52 Weeks
Intervention | percentage of participants (Number) |
---|
Group 1: Extended Release Tolterodine + Intravaginal Estradiol | 84 |
Group 2: Intravaginal Estradiol Cream | 84 |
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Evaluate Subjective Patient Change in Irritative Urinary Symptoms
"Assessment measured using the Patient Global Impression of Improvement (PGI-I), patient perception of improvement. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 being very much better to 7 being very much worse.~Frequencies of each response was reported. Each level achieved (movement towards 1), is considered an improvement." (NCT00465894)
Timeframe: From baseline through 12 Weeks of Intervention
Intervention | participants (Number) |
---|
| Very Much Better | Much Better | A Little Better | No Change | A Litlle Worse |
---|
Group 1: Extended Release Tolterodine | 3 | 8 | 8 | 5 | 1 |
,Group 2: Intravaginal Estradiol Cream | 0 | 7 | 12 | 5 | 0 |
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Subjective Patient Change in Irritative Urinary Symptoms
"This was measured using the Patient Satisfaction Questionnaire (PSQ). The PSQ consists of a single question, How satisfied are you with your progress since your treatment in which the 3 possible responses are completely satisfied, somewhat satisfied, and not satisfied. The goal of treatment was to move all participants to completely satisfied." (NCT00465894)
Timeframe: From baseline through 12 Weeks of Intervention
Intervention | participants (Number) |
---|
| Completely Satisfied | Somewhat Satisfied | Not Satisfied |
---|
Extended Release Tolterodine LA | 5 | 13 | 6 |
,Intravaginal Estradiol Cream | 3 | 13 | 8 |
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Subjective Patient Change in Irritative Urinary Symptoms
Assessment made using the Health Related Quality of Life (HRQL) portion of the OAB-q. The second part of the OAB-q, the HRQL consists of 25 questions that assesses HRQL which addresses coping, concern, sleep and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life. (NCT00465894)
Timeframe: Baseline through 52 weeks
Intervention | units on a scale (Mean) |
---|
Group 1: Extended Release Tolterodine + Intravaginal Estradiol | 26.8 |
Group 2: Intravaginal Estradiol Cream | 19.7 |
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Subjective Patient Change in Irritative Urinary Symptoms
Assessment made using the Health Related Quality of Life (HRQL) portion of the OAB-q. The second part of the OAB-q, the HRQL consists of 25 questions that assesses HRQL which addresses coping, concern, sleep and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life. (NCT00465894)
Timeframe: Baseline to 24 weeks
Intervention | units on a scale (Mean) |
---|
Group 1: Extended Release Tolterodine + Intravaginal Estradiol | 19.3 |
Group 2: Intravaginal Estradiol Cream + Tolterodine | 20.9 |
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Subjective Patient Change in Irritative Urinary Symptoms
The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother. (NCT00465894)
Timeframe: Baseline through 52 weeks
Intervention | units on a scale (Mean) |
---|
Group 1: Extended Release Tolterodine + Intravaginal Estradiol | -23.4 |
Intravaginal Estradiol Cream + Tolterodine | -31.3 |
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Subjective Patient Change in Irritative Urinary Symptoms
The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother. (NCT00465894)
Timeframe: Baseline to 24 weeks
Intervention | units on a scale (Mean) |
---|
Group 1: Extended Release Tolterodine + Intravaginal Estradiol | -25.4 |
Group 2: Intravaginal Estradiol Cream + Tolterodine | -28.7 |
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Percent Change From Baseline of UUI Episodes Per 24 Hours
"UUI episodes per 24 hours calculated as total number of micturitions with USS of 5 in diary. USS is 5-item scale measuring urinary urgency; range is~1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100." (NCT00611026)
Timeframe: Baseline, Week 1, Week 4, Week 12
Intervention | percent change (Median) |
---|
| Week 1 (n=442, 911, 899) | Week 4 [LOCF] (n=448, 922, 908) | Week 12 [LOCF] (n=448, 926, 908) |
---|
Fesoterodine | -50.0 | -100.0 | -100.0 |
,Placebo | -40.8 | -75.0 | -100.0 |
,Tolterodine ER | -50.0 | -88.9 | -100.0 |
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Post-hoc Adverse Events (AEs)
An adverse event is any untoward medical occurrence in a clinical investigation in which the participant was administered a product or medical device; the event does not necessarily need to have a causal relationship with the treatment or usage. (NCT00611026)
Timeframe: Baseline up to Week 12
Intervention | events (Number) |
---|
| Constipation | Fingers tingling | Finger numbness | Hypertension | Diabetes mellitus | Abdominal distension and discomfort | Tina pedis | Tingling sensation/decreased sensation of fingers | Dyspepsia | Abdominal bloating |
---|
Fesoterodine | 0 | 1 | 1 | 2 | 2 | 1 | 1 | 1 | 1 | 1 |
,Tolterodine ER | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours
Percent change calculated as change in severe urgency episodes (USS rating ≥4 in diary ) per 24 hours at that visit divided by the baseline number of severe urgency episodes per 24 hours, multiplied by 100. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). (NCT00611026)
Timeframe: Baseline, Week 1, Week 4, Week 12
Intervention | percent change (Median) |
---|
| Week 1 (n=446, 915, 902) | Week 4 [LOCF] (n=452, 926, 911) | Week 12 [LOCF] (n=452, 930, 911) |
---|
Fesoterodine | -25.0 | -61.1 | -79.3 |
,Placebo | -19.7 | -41.7 | -61.0 |
,Tolterodine ER | -24.1 | -55.6 | -69.2 |
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Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)
Urgency Urinary episodes per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of ≥3 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). (NCT00611026)
Timeframe: Baseline, Week 1, Week 4, Week 12
Intervention | episodes per 24 hours (Least Squares Mean) |
---|
| Week 1 (n=447, 918, 906) | Week 4 [LOCF] (n=453, 929, 915) | Week 12 [LOCF] (n=453, 933, 915) |
---|
Fesoterodine | -1.2 | -3.1 | -4.2 |
,Placebo | -0.8 | -1.9 | -3.2 |
,Tolterodine ER | -1.0 | -2.5 | -3.5 |
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Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12
UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). (NCT00611026)
Timeframe: Baseline, Week 12
Intervention | episodes per 24 hours (Mean) |
---|
Placebo | -1.62 |
Tolterodine ER | -1.74 |
Fesoterodine | -1.95 |
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Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12
Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother. Negative change in Symptom Bother Score indicates improvement. (NCT00611026)
Timeframe: Baseline, Week 12
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -21.8 |
Tolterodine ER | -24.3 |
Fesoterodine | -28.9 |
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Change From Baseline in Frequency-Urgency Sum (FUS) Per 24 Hours (Synonymous With USS Sum in the Study Protocol)
Frequency-Urgency Sum per 24 hours calculated as mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). (NCT00611026)
Timeframe: Baseline, Week 1, Week 4, Week 12
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=447, 918, 906) | Week 4 [LOCF] (n=453, 929, 915) | Week 12 [LOCF] (n=453, 933, 915) |
---|
Fesoterodine | -5.5 | -12.0 | -15.6 |
,Placebo | -4.0 | -8.1 | -12.0 |
,Tolterodine ER | -4.8 | -10.1 | -13.2 |
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Change From Baseline in Mean Number of Micturitions Per 24 Hours
The mean number of micturitions was calculated as the total number of micturitions divided by the total number of diary days collected at that visit. (NCT00611026)
Timeframe: Baseline, Week 1, Week 4, Week 12
Intervention | micturitions per 24 hours (Least Squares Mean) |
---|
| Week 1 (n=448, 921, 908) | Week 4 [LOCF] (n=454, 931, 916) | Week 12 [LOCF] (n=454, 935, 916) |
---|
Fesoterodine | -1.0 | -2.1 | -2.6 |
,Placebo | -0.8 | -1.5 | -2.0 |
,Tolterodine ER | -1.0 | -1.8 | -2.3 |
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Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours
Mean number of nocturnal micturitions per 24 hours was calculated as the total number of all micturitions divided by the total number of diary days collected at that visit. Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day. (NCT00611026)
Timeframe: Baseline, Week 1, Week 4, Week 12
Intervention | nocturnal micturitions per 24 hours (Least Squares Mean) |
---|
| Week 1 (n=432, 879, 871) | Week 4 [LOCF] (n=437, 888, 879) | Week 12 [LOCF] (n=437, 892, 879) |
---|
Fesoterodine | -0.3 | -0.5 | -0.7 |
,Placebo | -0.2 | -0.4 | -0.5 |
,Tolterodine ER | -0.3 | -0.5 | -0.6 |
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Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours
Mean number of severe urgency episodes (USS rating ≥4 in diary ) per 24 hours calculated as the total number of micturitions with USS ≥4 divided by total number of diary days collected at that visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). (NCT00611026)
Timeframe: Baseline, Week 1, Week 4, Week 12
Intervention | severe urgency episodes per 24 hours (Mean) |
---|
| Week 1 (n=446, 915, 902) | Week 4 [LOCF] (n=452, 926, 911) | Week 12 [LOCF] (n=452, 930, 911) |
---|
Fesoterodine | -1.58 | -3.21 | -4.08 |
,Placebo | -1.14 | -2.14 | -3.01 |
,Tolterodine ER | -1.34 | -2.71 | -3.39 |
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Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1 and Week 4
UUI episodes per 24 hours calculated as total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). (NCT00611026)
Timeframe: Baseline, Week 1, Week 4
Intervention | episodes per 24 hours (Mean) |
---|
| Week 1 (n=442, 911, 899) | Week 4 [LOCF] (n=448, 922, 908) |
---|
Fesoterodine | -1.03 | -1.68 |
,Placebo | -0.80 | -1.31 |
,Tolterodine ER | -0.95 | -1.52 |
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Change From Baseline in Mean Urinary Sensation Scale (USS) Rating Per Micturition Per 24 Hours.
Mean USS rating calculated as the sum of rating scores on USS per 24 hours divided by the total number of micturitions per 24 hours with non-missing rating at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). (NCT00611026)
Timeframe: Baseline, Week 1, Week 4, Week 12
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=447, 918, 906) | Week 4 [LOCF] (n=453, 929, 915) | Week 12 [LOCF] (n=453, 933, 915) |
---|
Fesoterodine | -0.2 | -0.5 | -0.7 |
,Placebo | -0.2 | -0.3 | -0.6 |
,Tolterodine ER | -0.2 | -0.4 | -0.6 |
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Change From Baseline in Mean Voided Volume Per Micturition
Mean voided volume in milliliters (mL) calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 in the 3-day diary at that visit. (NCT00611026)
Timeframe: Baseline, Week 1, Week 4, Week 12
Intervention | mL (Mean) |
---|
| Week 1 (n=447, 917, 895) | Week 4 [LOCF] (n=452, 927, 909) | Week 12 [LOCF] (n=452, 930, 912) |
---|
Fesoterodine | 18.63 | 32.26 | 34.47 |
,Placebo | 9.80 | 14.27 | 17.34 |
,Tolterodine ER | 15.65 | 26.43 | 28.43 |
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Change From Baseline in Patient Perception of Bladder Condition (PPBC)
Number of participants in 4-point category: ≥2 points improvement (major improvement; negative change from baseline); 1 point improvement (minor improvement); no change; deterioration (positive change from baseline), based on PPBC score (rated on 6-point scale: 1=no problems at all; 6=many severe problems). Score change: score at observation minus score at baseline; re-scaled to 4-point categorical variables. (NCT00611026)
Timeframe: Baseline, Week 1, Week, 4, Week 12
Intervention | participants (Number) |
---|
| Week 1 (n=452, 931, 913) ≥2 points improvement | Week 1: 1-point improvement | Week 1: no change | Week 1: deterioration | Week 4 (n=455, 937, 918) ≥2 points improvement | Week 4: 1-point improvement | Week 4: no change | Week 4: deterioration | Week 12 (n=455, 937, 918) ≥2 points improvement | Week 12: 1-point improvement | Week 12: no change | Week 12: deterioration |
---|
Fesoterodine | 144 | 280 | 428 | 61 | 334 | 280 | 250 | 54 | 440 | 236 | 189 | 53 |
,Placebo | 43 | 144 | 210 | 55 | 111 | 124 | 172 | 48 | 166 | 106 | 133 | 50 |
,Tolterodine ER | 138 | 278 | 434 | 81 | 290 | 298 | 285 | 64 | 379 | 250 | 249 | 59 |
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Diary Dry Rate: Percentage of Participants With no Urgency Urinary Incontinence (UUI) in the 3-day Bladder Diary
Diary dry rate: percentage of participants with no urgency urinary incontinence episode reported in the 3 day diary at the respective time-point; based on USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). (NCT00611026)
Timeframe: Week 1, Week 4, Week 12
Intervention | percentage of participants (Number) |
---|
| Week 1 (n=422, 911, 899) | Week 4 [LOCF] (n=448, 922, 908) | Week 12 [LOCF] (n=448, 926, 908) |
---|
Fesoterodine | 25.1 | 51.1 | 63.2 |
,Placebo | 17.6 | 39.5 | 53.8 |
,Tolterodine ER | 24.5 | 46.7 | 58.1 |
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Percent Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)
Percent change from baseline in mean number of Urgency Urinary episodes per 24 hours (Urinary Sensation Scale ≥3 in the diary). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100. (NCT00611026)
Timeframe: Baseline, Week 1, Week 4, Week 12
Intervention | percent change (Median) |
---|
| Week 1 (n=447, 918, 906) | Week 4 [LOCF] (n=453, 929, 915) | Week 12 [LOCF] (n=453, 933, 915) |
---|
Fesoterodine | -11.8 | -32.1 | -45.5 |
,Placebo | -9.4 | -17.2 | -31.0 |
,Tolterodine ER | -12.0 | -26.3 | -37.5 |
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Percent Change From Baseline of Micturitions Per 24 Hours
Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100%*(Week 1 or 4 or 12 - baseline)/baseline). (NCT00611026)
Timeframe: Baseline, Week 1, Week 4, Week 12
Intervention | percent change (Median) |
---|
| Week 1 (n=448, 921, 908) | Week 4 [LOCF] (n=454, 931, 916) | Week 12 [LOCF] (n=454, 935, 916) |
---|
Fesoterodine | -9.0 | -18.9 | -23.5 |
,Placebo | -7.1 | -13.4 | -18.2 |
,Tolterodine ER | -9.4 | -16.7 | -20.8 |
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Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours
Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100%*(Week 1 or 4 or 12 - baseline)/baseline). Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day. (NCT00611026)
Timeframe: Baseline, Week 1, Week 4, Week 12
Intervention | percent change (Median) |
---|
| Week 1 (n=432, 879, 871) | Week 4 [LOCF] (n=437, 888, 879) | Week 12 [LOCF] (n=437, 892, 879) |
---|
Fesoterodine | -12.5 | -25.0 | -33.3 |
,Placebo | -7.7 | -20.0 | -27.3 |
,Tolterodine ER | -14.3 | -25.0 | -33.3 |
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Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00688688)
Timeframe: Baseline and Month 12
Intervention | participants (Number) |
---|
| Not anxious -> Not anxious | Not anxious -> Moderately anxious | Not anxious -> Extremely anxious | Not anxious -> Missing data | Moderately anxious -> Not anxious | Moderately anxious -> Moderately anxious | Moderately anxious -> Extremely anxious | Moderately anxious -> Missing data | Extremely anxious -> Not anxious | Extremely anxious -> Moderately anxious | Extremely anxious -> Extremely anxious | Extremely anxious -> Missing data | Missing data -> Not anxious | Missing data -> Moderately anxious | Missing data -> Extremely anxious | Missing data -> Missing data |
---|
Mirabegron 100 mg | 453 | 34 | 3 | 1 | 99 | 181 | 9 | 2 | 5 | 9 | 5 | 0 | 0 | 1 | 0 | 0 |
,Mirabegron 50 mg | 413 | 43 | 3 | 3 | 108 | 174 | 7 | 1 | 3 | 8 | 15 | 0 | 7 | 4 | 0 | 0 |
,Tolterodine ER 4 mg | 429 | 43 | 1 | 2 | 105 | 169 | 11 | 2 | 3 | 14 | 6 | 0 | 3 | 2 | 1 | 0 |
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Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. Least squares (LS) means were generated from the analysis of covariance (ANCOVA) model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate. (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12
Intervention | incontinence episodes (Least Squares Mean) |
---|
| Month 1 [N=478; 479; 485] | Month 3 [N=447; 443; 452] | Month 6 [N=409; 428; 418] | Month 9 [N=387; 402; 391] | Month 12 [N=370; 387; 379] | Final Visit (LOCF) [N=479; 483; 488] |
---|
Mirabegron 100 mg | -1.03 | -1.28 | -1.27 | -1.32 | -1.19 | -1.24 |
,Mirabegron 50 mg | -0.94 | -1.10 | -1.11 | -1.17 | -1.14 | -1.01 |
,Tolterodine ER 4 mg | -0.96 | -1.09 | -1.17 | -1.26 | -1.36 | -1.26 |
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Change From Baseline to Month 12 and Final Visit in Treatment Satisfaction-visual Analog Scale (TS-VAS)
The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). A positive change from baseline indicates improvement. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. (NCT00688688)
Timeframe: Baseline and Month 12
Intervention | scores on a scale (Least Squares Mean) |
---|
| Month 12 [N=599; 620; 613] | Final Visit (LOCF) [N=654; 676; 676] |
---|
Mirabegron 100 mg | 2.27 | 2.11 |
,Mirabegron 50 mg | 2.27 | 2.08 |
,Tolterodine ER 4 mg | 2.52 | 2.27 |
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Change From Baseline to Month 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)
"The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement.~LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate." (NCT00688688)
Timeframe: Baseline and Month 12
Intervention | scores on a scale (Least Squares Mean) |
---|
| Month 12 [N=601; 616; 611] | Final Visit (LOCF) [N=655; 673; 673] |
---|
Mirabegron 100 mg | -0.9 | -0.9 |
,Mirabegron 50 mg | -0.8 | -0.8 |
,Tolterodine ER 4 mg | -0.9 | -0.8 |
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Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit. (NCT00688688)
Timeframe: Baseline and Month 12
Intervention | participants (Number) |
---|
| No problem -> No problem | No problem -> Some problems | No problem -> Unable to perform usual activities | No problem -> Missing data | Some problems -> No problems | Some problems -> Some problems | Some problems-> Unable to perform usual activities | Some problems -> Missing data | Unable to perform usual activities -> No problems | Unable to perform usual activities-> Some problems | Unable to perform -> Unable to perform | Unable to perform usual activities -> Missing data | Missing data -> No problem | Missing data -> Some problems | Missing data -> Unable to perform usual activities | Missing data -> Missing data |
---|
Mirabegron 100 mg | 569 | 55 | 1 | 1 | 88 | 76 | 2 | 2 | 2 | 4 | 0 | 2 | 0 | 0 | 0 | 0 |
,Mirabegron 50 mg | 536 | 40 | 2 | 3 | 97 | 94 | 1 | 1 | 0 | 2 | 2 | 10 | 1 | 0 | 0 | 0 |
,Tolterodine ER 4 mg | 542 | 53 | 2 | 1 | 96 | 79 | 1 | 3 | 0 | 5 | 1 | 7 | 1 | 0 | 0 | 0 |
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Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and evaluating health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00688688)
Timeframe: Baseline and Month 12
Intervention | participants (Number) |
---|
| No problem -> No problem | No problem -> Some problems | No problem -> Unable to wash or dress myself | No problem -> Missing data | Some problems -> No problems | Some problems -> Some problems | Some problems -> Unable to wash or dress myself | Some problems -> Missing data | Unable to wash or dress myself -> No problems | Unable to wash or dress myself -> Some problems | Unable to wash or dress -> Unable to wash or dress | Unable to wash or dress myself -> Missing data | Missing data -> No problem | Missing data -> Some problems | Missing data -> Unable to wash or dress myself | Missing data -> Missing data |
---|
Mirabegron 100 mg | 735 | 15 | 0 | 4 | 19 | 25 | 0 | 0 | 2 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
,Mirabegron 50 mg | 718 | 16 | 1 | 4 | 19 | 18 | 0 | 0 | 0 | 0 | 0 | 0 | 13 | 0 | 0 | 0 |
,Tolterodine ER 4 mg | 720 | 23 | 3 | 4 | 13 | 20 | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 0 | 0 | 0 |
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Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and evaluating health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00688688)
Timeframe: Baseline and Month 12
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 100 mg | 396 | 69 | 2 | 2 | 107 | 196 | 5 | 2 | 4 | 6 | 10 | 0 | 3 | 0 | 0 | 0 |
,Mirabegron 50 mg | 398 | 54 | 4 | 4 | 104 | 173 | 14 | 1 | 3 | 13 | 10 | 0 | 8 | 3 | 0 | 0 |
,Tolterodine ER 4 mg | 398 | 63 | 4 | 2 | 105 | 182 | 8 | 2 | 4 | 9 | 8 | 0 | 6 | 0 | 0 | 0 |
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Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and evaluating health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems in walking about; I have some problems in walking about; I am confined to bed.~In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00688688)
Timeframe: Baseline and Month 12
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 to bed -> No problems | Confined to bed -> Some problems | Confined to bed -> Confined to bed | Confined to bed -> Missing data | Missing data -> No problem | Missing data -> Some problems | Missing data -> Confined to bed | Missing data -> Missing data |
---|
Mirabegron 100 mg | 601 | 42 | 1 | 3 | 55 | 97 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
,Mirabegron 50 mg | 567 | 36 | 1 | 4 | 64 | 105 | 1 | 0 | 0 | 0 | 0 | 0 | 11 | 0 | 0 | 0 |
,Tolterodine ER 4 mg | 573 | 39 | 0 | 2 | 62 | 106 | 0 | 2 | 0 | 0 | 0 | 0 | 7 | 0 | 0 | 0 |
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Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC)
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a one point improvement from Baseline to post-baseline and a major improvement was defined as at least a two point improvement from Baseline to post-baseline in PPBC score. (NCT00688688)
Timeframe: Baseline and Month 12
Intervention | percentage of participants (Number) |
---|
| Improvement: Month12 [N=616; 630; 620] | Improvement: Final Visit [N=671; 688; 684] | Major Improvement: Month 12 [N=616; 630; 620] | Major Improvement: Final Visit [N=671; 688; 684] |
---|
Mirabegron 100 mg | 60.6 | 59.6 | 29.7 | 28.2 |
,Mirabegron 50 mg | 55.7 | 52.9 | 27.4 | 26.2 |
,Tolterodine ER 4 mg | 56.6 | 54.4 | 28.2 | 26.6 |
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Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit
The percentage of participants with at least a 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary. (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12
Intervention | percentage of participants (Number) |
---|
| Month 1 [N=478; 479; 485] | Month 3 [N=447; 443; 452] | Month 6 [N=409; 428; 418] | Month 9 [N=387; 402; 391] | Month 12 [N=370; 387; 379] | Final Visit (LOCF) [N=479; 483; 488] |
---|
Mirabegron 100 mg | 57.0 | 66.1 | 66.8 | 67.2 | 68.5 | 66.3 |
,Mirabegron 50 mg | 58.2 | 61.7 | 65.5 | 65.6 | 67.6 | 63.7 |
,Tolterodine ER 4 mg | 56.3 | 61.5 | 63.9 | 66.0 | 71.2 | 66.8 |
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Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs)
"An adverse event (AE) was defined as any untoward medical occurrence in a patient administered a study drug and which did not necessarily have a causal relationship with the treatment. The investigator assessed the severity of each AE, including abnormal laboratory values, as follows:~Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities." (NCT00688688)
Timeframe: From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months.
Intervention | participants (Number) |
---|
| Mild adverse events | Moderate adverse events | Severe adverse events |
---|
Mirabegron 100 mg | 240 | 211 | 52 |
,Mirabegron 50 mg | 222 | 212 | 51 |
,Tolterodine ER 4 mg | 251 | 218 | 39 |
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Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement. (NCT00688688)
Timeframe: Baseline and Months 3, 6 and 12
Intervention | Percent work time missed (Mean) |
---|
| Month 3 [N=215; 217; 211] | Month 6 [N=183; 203; 200] | Month 12 [N=181; 185; 188] | Final Visit (LOCF) [N=245; 256; 249] |
---|
Mirabegron 100 mg | -1.0 | -1.5 | -0.8 | -0.9 |
,Mirabegron 50 mg | -0.06 | -1.3 | -0.5 | -0.5 |
,Tolterodine ER 4 mg | -0.6 | -0.7 | -1.2 | -0.8 |
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Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. (NCT00688688)
Timeframe: Baseline and Months 3, 6 and 12
Intervention | Percent overall work impairment (Mean) |
---|
| Month 3 [N=208; 208; 204] | Month 6 [N=181; 195; 193] | Month 12 [N=175; 177; 183] | Final Visit (LOCF) [N=240; 250; 244] |
---|
Mirabegron 100 mg | -10.9 | -13.0 | -14.1 | -12.4 |
,Mirabegron 50 mg | -11.4 | -12.4 | -11.5 | -11.2 |
,Tolterodine ER 4 mg | -11.0 | -11.1 | -13.6 | -11.5 |
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Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
The involuntary leakage of urine accompanied or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0=No urgency; 1=Mild urgency; 2=Moderate urgency, could postpone voiding a short time; 3=Severe urgency, could not postpone voiding; 4=Urge incontinence, leaked before arriving to toilet. LS means are from the ANCOVA model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate. (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12
Intervention | urgency incontinence episodes (Least Squares Mean) |
---|
| Month 1 [N=471; 467; 471] | Month 3 [N=441; 432; 440] | Month 6 [N=404; 417; 408] | Month 9 [N=382; 392; 382] | Month 12 [N=366; 377; 371] | Final Visit (LOCF) [N=472; 471; 474] |
---|
Mirabegron 100 mg | -1.04 | -1.23 | -1.32 | -1.33 | -1.20 | -1.23 |
,Mirabegron 50 mg | -0.92 | -1.05 | -1.13 | -1.13 | -1.17 | -1.01 |
,Tolterodine ER 4 mg | -0.95 | -1.06 | -1.11 | -1.25 | -1.29 | -1.21 |
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Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. (NCT00688688)
Timeframe: Baseline and Months 3, 6 and 12
Intervention | Percent impairment while working (Mean) |
---|
| Month 3 [N=233; 236; 231] | Month 6 [N=207; 216; 213] | Month 12 [N=194; 196; 201] | Final Visit (LOCF) [N=261; 272; 265] |
---|
Mirabegron 100 mg | -9.9 | -11.9 | -14.4 | -11.8 |
,Mirabegron 50 mg | -10.6 | -13.0 | -11.9 | -10.9 |
,Tolterodine ER 4 mg | -10.9 | -11.1 | -12.3 | -10.6 |
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Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit
The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient. (NCT00688688)
Timeframe: Months 1, 3, 6, 9 and 12
Intervention | percentage of participants (Number) |
---|
| Month 1 [N=478; 479; 485] | Month 3 [N=447; 443; 452] | Month 6 [N=409; 428; 418] | Month 9 [N=387; 402; 391] | Month 12 [N=370; 387; 379] | Final Visit (LOCF) [N=479; 483; 488] |
---|
Mirabegron 100 mg | 36.7 | 45.4 | 45.1 | 46.8 | 47.5 | 45.8 |
,Mirabegron 50 mg | 35.4 | 40.9 | 43.3 | 47.5 | 47.8 | 43.4 |
,Tolterodine ER 4 mg | 33.4 | 39.2 | 43.5 | 44.2 | 49.1 | 45.1 |
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Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. (NCT00688688)
Timeframe: Baseline and Months 3, 6 and 12
Intervention | Percent activity impairment (Mean) |
---|
| Month 3 [N=691; 690; 692] | Month 6 [N=640; 663; 651] | Month 12 [N=582; 603; 598] | Final Visit (LOCF) [N=728; 737; 733] |
---|
Mirabegron 100 mg | -13.7 | -15.6 | -15.2 | -13.9 |
,Mirabegron 50 mg | -12.0 | -14.0 | -13.3 | -12.5 |
,Tolterodine ER 4 mg | -12.3 | -13.4 | -15.0 | -12.8 |
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Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours
"The average number of times a patient records a new pad used per day during the 3-day micturition diary period.~LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate." (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12
Intervention | pads (Least Squares Mean) |
---|
| Month 1 [N=324; 305; 313] | Month 3 [N=307; 280; 286] | Month 6 [N=277; 271; 264] | Month 9 [N=264; 255; 250] | Month 12 [N=254; 247; 241] | Final Visit (LOCF) [N=325; 307; 314] |
---|
Mirabegron 100 mg | -0.79 | -0.94 | -0.94 | -0.96 | -0.92 | -0.88 |
,Mirabegron 50 mg | -0.75 | -0.80 | -0.88 | -0.99 | -0.87 | -0.81 |
,Tolterodine ER 4 mg | -0.79 | -0.95 | -0.99 | -0.99 | -1.13 | -1.02 |
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Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from Baseline indicates improvement. (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12
Intervention | scores on a scale (Mean) |
---|
| Month 1 [N=767; 787; 770] | Month 3 [N=734; 740; 731] | Month 6 [N=676; 697; 678] | Month 9 [N=645; 665; 637] | Month 12 [N=615; 637; 612] | Final Visit (LOCF) [N=776; 797; 777] |
---|
Mirabegron 100 mg | 3.9 | 5.4 | 6.4 | 6.5 | 6.8 | 5.9 |
,Mirabegron 50 mg | 3.8 | 5.0 | 6.5 | 6.6 | 8.2 | 6.8 |
,Tolterodine ER 4 mg | 3.1 | 4.3 | 5.2 | 6.3 | 7.9 | 6.0 |
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Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score
"Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the patient on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.~LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate." (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12
Intervention | scores on a scale (Least Squares Mean) |
---|
| Month 1 [N=775; 784; 771] | Month 3 [N=736; 733; 739] | Month 6 [N=680; 699; 682] | Month 9 [N=649; 661; 639] | Month 12 [N=622; 636; 612] | Final Visit (LOCF) [N=779; 795; 781] |
---|
Mirabegron 100 mg | -12.5 | -16.1 | -16.5 | -15.6 | -15.7 | -14.8 |
,Mirabegron 50 mg | -10.5 | -13.4 | -14.5 | -14.2 | -14.1 | -13.1 |
,Tolterodine ER 4 mg | -11.5 | -13.5 | -14.6 | -14.3 | -16.3 | -14.3 |
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Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition
The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. LS means were generated from the ANCOVA model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate. (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12
Intervention | mL (Least Squares Mean) |
---|
| Month 1 [N=785; 797; 786] | Month 3 [N=741; 741; 735] | Month 6 [N=684; 705; 684] | Month 9 [N=655; 667; 645] | Month 12 [N=626; 642; 623] | Final Visit (LOCF) [N=789; 802; 791] |
---|
Mirabegron 100 mg | 16.7 | 20.4 | 23.0 | 23.5 | 24.3 | 21.5 |
,Mirabegron 50 mg | 12.1 | 14.8 | 18.6 | 20.5 | 18.5 | 17.5 |
,Tolterodine ER 4 mg | 16.0 | 17.4 | 18.8 | 17.9 | 18.9 | 18.1 |
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Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram
"An abnormality identified during a medical test was defined as an AE if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant. The Investigator assessed each AE for causal relationship (not related, possible or probable) to study drug. A serious AE (SAE) was any untoward medical occurrence that: resulted in death, was life-threatening, resulted in significant disability/incapacity or congenital anomaly/birth defect, required or prolonged hospitalization or was a medically important event.~The data reported represent the number of participants with adverse events in each category." (NCT00688688)
Timeframe: From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months.
Intervention | participants (Number) |
---|
| Adverse events | Treatment-related adverse events (TRAEs) | Deaths | Serious adverse events (SAEs) | Treatment-related serious adverse events | AEs leading to study drug discontinuation | TRAEs leading to study drug discontinuation |
---|
Mirabegron 100 mg | 503 | 192 | 0 | 51 | 4 | 50 | 29 |
,Mirabegron 50 mg | 485 | 213 | 2 | 42 | 10 | 48 | 35 |
,Tolterodine ER 4 mg | 508 | 224 | 2 | 44 | 5 | 46 | 31 |
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Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. Least squares (LS) means were generated from the analysis of covariance (ANCOVA) model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate. (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12
Intervention | micturitions (Least Squares Mean) |
---|
| Month 1 [N=786; 797; 786] | Month 3 [N=742; 741; 735] | Month 6 [N=684; 705; 684] | Month 9 [N=656; 667; 645] | Month 12 [N=627; 642; 623] | Final Visit (LOCF) [N=789; 802; 791] |
---|
Mirabegron 100 mg | -1.10 | -1.46 | -1.43 | -1.37 | -1.46 | -1.41 |
,Mirabegron 50 mg | -0.94 | -1.13 | -1.25 | -1.33 | -1.30 | -1.27 |
,Tolterodine ER 4 mg | -1.02 | -1.27 | -1.30 | -1.38 | -1.50 | -1.39 |
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Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency
Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS means are generated from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12
Intervention | scores on a scale (Least Squares Mean) |
---|
| Month 1 [N=784; 793; 780] | Month 3 [N=739; 738; 733] | Month 6 [N=684; 702; 680] | Month 9 [N=654; 666; 643] | Month 12 [N=622; 638; 621] | Final Visit (LOCF) [N=789; 801; 788] |
---|
Mirabegron 100 mg | -0.19 | -0.28 | -0.32 | -0.30 | -0.31 | -0.29 |
,Mirabegron 50 mg | -0.18 | -0.21 | -0.29 | -0.30 | -0.33 | -0.29 |
,Tolterodine ER 4 mg | -0.17 | -0.24 | -0.27 | -0.31 | -0.32 | -0.27 |
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Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours
"Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary.~LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate." (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12
Intervention | nocturia episodes (Least Squares Mean) |
---|
| Month 1 [N=690; 698; 690] | Month 3 [N=654; 651; 643] | Month 6 [N=604; 618; 602] | Month 9 [N=580; 583; 567] | Month 12 [N=554; 562; 550] | Final Visit (LOCF) [N=693; 703; 693] |
---|
Mirabegron 100 mg | -0.29 | -0.45 | -0.38 | -0.41 | -0.40 | -0.39 |
,Mirabegron 50 mg | -0.26 | -0.41 | -0.42 | -0.50 | -0.48 | -0.46 |
,Tolterodine ER 4 mg | -0.29 | -0.37 | -0.35 | -0.39 | -0.46 | -0.43 |
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Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
The average number of urgency episodes (the sudden, compelling desire to pass urine that is difficult to defer) derived from episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0=No urgency; 1=Mild urgency; 2=Moderate urgency, could delay voiding a short time; 3=Severe urgency, could not delay voiding; 4=Urge incontinence, leaked before arriving to the toilet. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12
Intervention | urgency episodes (Least Squares Mean) |
---|
| Month 1 [N=783; 791; 780] | Month 3 [N=738; 737; 733] | Month 6 [N=683; 701; 680] | Month 9 [N=653; 665; 643] | Month 12 [N=621; 637; 621] | Final Visit (LOCF) [N=788; 799; 788] |
---|
Mirabegron 100 mg | -1.31 | -1.83 | -1.95 | -1.71 | -1.79 | -1.80 |
,Mirabegron 50 mg | -1.30 | -1.37 | -1.75 | -1.77 | -1.81 | -1.62 |
,Tolterodine ER 4 mg | -1.11 | -1.55 | -1.63 | -1.78 | -1.89 | -1.63 |
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Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit
The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient. (NCT00689104)
Timeframe: Weeks 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 4 [N=291; 293; 281; 299] | Week 8 [N=280; 277; 268; 292] | Week 12 [N=275; 272; 262; 276] | Final Visit (LOCF) [N=291; 293; 281; 300] |
---|
Mirabegron 100 mg | 32.0 | 45.1 | 43.9 | 43.8 |
,Mirabegron 50 mg | 32.1 | 42.6 | 46.3 | 45.1 |
,Placebo | 28.9 | 34.3 | 41.1 | 40.5 |
,Tolterodine SR 4 mg | 33.4 | 41.8 | 48.6 | 47.3 |
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Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems in walking about; I have some problems in walking about; I am confined to bed.~In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00689104)
Timeframe: Baseline and Week 12
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 100 mg | 334 | 18 | 0 | 1 | 40 | 82 | 0 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
,Mirabegron 50 mg | 340 | 26 | 1 | 2 | 44 | 59 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
,Placebo | 334 | 27 | 0 | 2 | 37 | 78 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
,Tolterodine SR 4 mg | 330 | 28 | 0 | 1 | 38 | 73 | 1 | 0 | 0 | 0 | 0 | 0 | 3 | 1 | 0 | 0 |
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Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Week 12 (final visit)
Intervention | Incontinence episodes (Least Squares Mean) |
---|
Placebo | -1.17 |
Mirabegron 50 mg | -1.57 |
Mirabegron 100 mg | -1.46 |
Tolterodine SR 4 mg | -1.27 |
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Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Week 12
Intervention | micturitions (Least Squares Mean) |
---|
Placebo | -1.34 |
Mirabegron 50 mg | -1.93 |
Mirabegron 100 mg | -1.77 |
Tolterodine SR 4 mg | -1.59 |
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Change From Baseline to Final Visit in Mean Volume Voided Per Micturition
The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Week 12
Intervention | mL (Least Squares Mean) |
---|
Placebo | 12.3 |
Mirabegron 50 mg | 24.2 |
Mirabegron 100 mg | 25.6 |
Tolterodine SR 4 mg | 25.0 |
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Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Week 4
Intervention | Incontinence episodes (Least Squares Mean) |
---|
Placebo | -0.65 |
Mirabegron 50 mg | -1.04 |
Mirabegron 100 mg | -1.03 |
Tolterodine SR 4 mg | -1.00 |
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Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Week 4
Intervention | micturitions (Least Squares Mean) |
---|
Placebo | -0.77 |
Mirabegron 50 mg | -1.16 |
Mirabegron 100 mg | -1.29 |
Tolterodine SR 4 mg | -1.10 |
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Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00689104)
Timeframe: Baseline and Week 12
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 100 mg | 209 | 50 | 2 | 1 | 76 | 114 | 5 | 1 | 1 | 12 | 5 | 0 | 1 | 1 | 0 | 0 |
,Mirabegron 50 mg | 211 | 32 | 2 | 2 | 71 | 128 | 8 | 0 | 2 | 12 | 4 | 0 | 1 | 0 | 0 | 0 |
,Placebo | 210 | 36 | 4 | 0 | 70 | 129 | 2 | 2 | 3 | 13 | 10 | 0 | 0 | 1 | 0 | 0 |
,Tolterodine SR 4 mg | 197 | 37 | 2 | 1 | 69 | 132 | 7 | 0 | 4 | 12 | 9 | 0 | 3 | 1 | 1 | 0 |
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Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00689104)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No problem -> No problem | No problem -> Some problems | No problem -> Unable to wash or dress myself | No problem -> Missing data | Some problems -> No problems | Some problems -> Some problems | Some problems -> Unable to wash or dress myself | Some problems -> Missing data | Unable to wash or dress myself -> No problems | Unable to wash or dress myself -> Some problems | Unable to wash or dress -> Unable to wash or dress | Unable to wash or dress myself -> Missing data | Missing data -> No problem | Missing data -> Some problems | Missing data -> Unable to wash or dress myself | Missing data -> Missing data |
---|
Mirabegron 100 mg | 439 | 17 | 0 | 2 | 8 | 10 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
,Mirabegron 50 mg | 445 | 9 | 0 | 2 | 9 | 6 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
,Placebo | 437 | 7 | 0 | 2 | 18 | 14 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
,Tolterodine SR 4 mg | 432 | 12 | 1 | 1 | 9 | 15 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 1 | 0 | 0 |
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Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit. (NCT00689104)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No problem -> No problem | No problem -> Some problems | No problem -> Unable to perform usual activities | No problem -> Missing data | Some problems -> No problems | Some problems -> Some problems | Some problems-> Unable to perform usual activities | Some problems -> Missing data | Unable to perform usual activities -> No problems | Unable to perform usual activities-> Some problems | Unable to perform -> Unable to perform | Unable to perform usual activities -> Missing data | Missing data -> No problem | Missing data -> Some problems | Missing data -> Unable to perform usual activities | Missing data -> Missing data |
---|
Mirabegron 100 mg | 327 | 25 | 3 | 1 | 51 | 63 | 0 | 1 | 1 | 3 | 2 | 0 | 1 | 0 | 0 | 0 |
,Mirabegron 50 mg | 316 | 18 | 2 | 1 | 82 | 48 | 0 | 1 | 1 | 1 | 1 | 0 | 2 | 0 | 0 | 0 |
,Placebo | 298 | 25 | 0 | 2 | 73 | 75 | 2 | 0 | 0 | 2 | 0 | 0 | 2 | 1 | 0 | 0 |
,Tolterodine SR 4 mg | 283 | 39 | 0 | 1 | 68 | 73 | 0 | 0 | 2 | 3 | 1 | 0 | 4 | 1 | 0 | 0 |
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Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00689104)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| Not anxious -> Not anxious | Not anxious -> Moderately anxious | Not anxious -> Extremely anxious | Not anxious -> Missing data | Moderately anxious -> Not anxious | Moderately anxious -> Moderately anxious | Moderately anxious -> Extremely anxious | Moderately anxious -> Missing data | Extremely anxious -> Not anxious | Extremely anxious -> Moderately anxious | Extremely anxious -> Extremely anxious | Extremely anxious -> Missing data | Missing data -> Not anxious | Missing data -> Moderately anxious | Missing data -> Extremely anxious | Missing data -> Missing data |
---|
Mirabegron 100 mg | 232 | 19 | 1 | 2 | 88 | 105 | 10 | 0 | 1 | 11 | 8 | 0 | 1 | 0 | 0 | 0 |
,Mirabegron 50 mg | 224 | 30 | 1 | 0 | 74 | 111 | 5 | 1 | 4 | 12 | 9 | 1 | 1 | 0 | 0 | 0 |
,Placebo | 219 | 37 | 2 | 1 | 76 | 108 | 9 | 1 | 3 | 12 | 9 | 0 | 2 | 1 | 0 | 0 |
,Tolterodine SR 4 mg | 217 | 21 | 3 | 0 | 71 | 122 | 12 | 1 | 4 | 18 | 2 | 0 | 3 | 1 | 0 | 0 |
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Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A negative change from Baseline score indicates improvement. (NCT00689104)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Least Squares Mean) |
---|
| Week 12 [N=425; 410; 421; 417] | Final Visit (LOCF) [N=433; 416; 429; 426] |
---|
Mirabegron 100 mg | -0.1 | -1.1 |
,Mirabegron 50 mg | -1.1 | -1.0 |
,Placebo | -0.8 | -0.8 |
,Tolterodine SR 4 mg | -1.0 | -1.0 |
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Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS)
The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A positive change from baseline indicates improvement. (NCT00689104)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Least Squares Mean) |
---|
| Week 12 [N=421; 410; 420; 416] | Final Visit (LOCF) [N=428; 414; 427; 425] |
---|
Mirabegron 100 mg | 2.67 | 2.66 |
,Mirabegron 50 mg | 2.57 | 2.55 |
,Placebo | 1.92 | 1.89 |
,Tolterodine SR 4 mg | 2.44 | 2.44 |
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Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment. A negative change from baseline indicates improvement. (NCT00689104)
Timeframe: Baseline and Week 12
Intervention | percent activity impairment (Mean) |
---|
| Week 12 [N=409; 395; 409; 400] | Final Visit (LOCF) [N=419; 400; 417; 409] |
---|
Mirabegron 100 mg | -14.5 | -14.4 |
,Mirabegron 50 mg | -15.0 | -14.9 |
,Placebo | -11.2 | -11.0 |
,Tolterodine SR 4 mg | -14.7 | -14.3 |
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Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. (NCT00689104)
Timeframe: Baseline and Week 12
Intervention | percent impairment while working (Mean) |
---|
| Week 12 [N=116; 128; 104; 114] | Final Visit (LOCF) [N=118; 130; 106; 115] |
---|
Mirabegron 100 mg | -10.8 | -10.8 |
,Mirabegron 50 mg | -12.5 | -12.8 |
,Placebo | -8.3 | -8.1 |
,Tolterodine SR 4 mg | -6.7 | -6.6 |
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Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. (NCT00689104)
Timeframe: Baseline and Week 12
Intervention | percent overall work impairment (Mean) |
---|
| Week 12 [N=104; 117; 98; 104] | Final Visit (LOCF) [N=106; 119; 99; 105] |
---|
Mirabegron 100 mg | -11.6 | -11.5 |
,Mirabegron 50 mg | -13.2 | -13.6 |
,Placebo | -7.9 | -7.7 |
,Tolterodine SR 4 mg | -5.8 | -5.8 |
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Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement. (NCT00689104)
Timeframe: Baseline and Week 12
Intervention | percent work time missed (Mean) |
---|
| Week 12 [N=111; 120; 109; 113] | Final Visit (LOCF) [N=113; 122; 110; 114] |
---|
Mirabegron 100 mg | -1.7 | -1.7 |
,Mirabegron 50 mg | -1.9 | -1.8 |
,Placebo | -0.2 | -0.2 |
,Tolterodine SR 4 mg | -1.2 | -1.2 |
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Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition
The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 4, 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | mL (Least Squares Mean) |
---|
| Week 4 [N=479; 470; 477; 474] | Week 8 [N=463; 449; 455; 461] | Week 12 [N=452; 437; 447; 438] |
---|
Mirabegron 100 mg | 20.3 | 25.3 | 25.7 |
,Mirabegron 50 mg | 20.1 | 20.7 | 25.3 |
,Placebo | 9.8 | 11.7 | 11.9 |
,Tolterodine SR 4 mg | 21.4 | 25.9 | 25.8 |
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Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency
Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | Scores on a scale (Least Squares Mean) |
---|
| Week 4 [N=476; 469; 472; 471] | Week 8 [N=460; 447; 451; 456] | Week 12 [N=450; 434; 442; 434] | Final Visit (LOCF) [N=480; 472; 475; 473] |
---|
Mirabegron 100 mg | -0.21 | -0.27 | -0.31 | -0.30 |
,Mirabegron 50 mg | -0.19 | -0.26 | -0.33 | -0.31 |
,Placebo | -0.08 | -0.16 | -0.22 | -0.22 |
,Tolterodine SR 4 mg | -0.21 | -0.25 | -0.30 | -0.29 |
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Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours
"Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate." (NCT00689104)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | nocturia episodes (Least Squares Mean) |
---|
| Week 4 [N=428; 422; 422; 432] | Week 8 [N=414; 404; 403; 419] | Week 12 [N=404; 393; 395; 399] | Final Visit (LOCF) [N=428; 423; 422; 433] |
---|
Mirabegron 100 mg | -0.34 | -0.48 | -0.47 | -0.50 |
,Mirabegron 50 mg | -0.27 | -0.41 | -0.57 | -0.56 |
,Placebo | -0.25 | -0.30 | -0.41 | -0.41 |
,Tolterodine SR 4 mg | -0.29 | -0.39 | -0.44 | -0.45 |
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Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours
"The average number of times a patient records a new pad used per day during the 3-day micturition diary period.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate." (NCT00689104)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | pads (Least Squares Mean) |
---|
| Week 4 [N=209; 183; 195; 181] | Week 8 [N=204; 176; 183; 177] | Week 12 [N=200; 172; 181; 165] | Final Visit (LOCF) [N=209; 183; 195; 181] |
---|
Mirabegron 100 mg | -0.81 | -1.03 | -1.11 | -1.12 |
,Mirabegron 50 mg | -0.73 | -1.02 | -1.26 | -1.17 |
,Placebo | -0.45 | -0.72 | -0.99 | -0.95 |
,Tolterodine SR 4 mg | -0.67 | -0.77 | -0.95 | -0.95 |
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Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours
The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | Urgency episodes (Least Squares Mean) |
---|
| Week 4 [N=475; 469; 471; 470] | Week 8 [N=460; 446; 450; 456] | Week 12 [N=450; 433; 441; 434] | Final Visit (LOCF) [N=479; 470; 474; 472] |
---|
Mirabegron 100 mg | -1.54 | -1.90 | -2.00 | -1.96 |
,Mirabegron 50 mg | -1.39 | -1.90 | -2.35 | -2.25 |
,Placebo | -0.89 | -1.28 | -1.65 | -1.65 |
,Tolterodine SR 4 mg | -1.63 | -1.91 | -2.16 | -2.07 |
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Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | Urgency incontinence episodes (Least Squares Mean) |
---|
| Week 4 [N=283; 286; 276; 288] | Week 8 [N=273; 272; 263; 281] | Week 12 [N=269; 267; 257; 265] | Final Visit (LOCF) [N=283; 286; 276; 289] |
---|
Mirabegron 100 mg | -1.00 | -1.32 | -1.32 | -1.33 |
,Mirabegron 50 mg | -0.98 | -1.27 | -1.52 | -1.46 |
,Placebo | -0.63 | -0.94 | -1.12 | -1.11 |
,Tolterodine SR 4 mg | -1.01 | -0.99 | -1.19 | -1.18 |
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Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score
"Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate." (NCT00689104)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | Scores on a scale (Least Squares Mean) |
---|
| Week 4 [N=472; 460; 470; 467] | Week 8 [N=455; 441; 450; 451] | Week 12 [N=445; 424; 435; 433] | Final Visit (LOCF) [N=475; 465; 473; 469] |
---|
Mirabegron 100 mg | -13.8 | -17.6 | -20.0 | -19.9 |
,Mirabegron 50 mg | -13.0 | -17.8 | -20.3 | -19.6 |
,Placebo | -9.7 | -13.3 | -15.3 | -14.9 |
,Tolterodine SR 4 mg | -13.8 | -17.1 | -18.5 | -18.4 |
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Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement. (NCT00689104)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | Scores on a scale (Mean) |
---|
| Week 4 [N=466; 459; 468; 461] | Week 8 [N=451; 443; 447; 447] | Week 12 [N=443; 423; 437; 429] | Final Visit (LOCF) [N=470; 466; 472; 467] |
---|
Mirabegron 100 mg | 4.4 | 6.8 | 8.2 | 8.1 |
,Mirabegron 50 mg | 3.3 | 5.5 | 7.1 | 6.5 |
,Placebo | 3.1 | 4.5 | 6.7 | 6.4 |
,Tolterodine SR 4 mg | 3.2 | 6.0 | 6.9 | 6.4 |
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Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Weeks 8 and 12
Intervention | Incontinence episodes (Least Squares Mean) |
---|
| Week 8 [N=280; 277; 268; 292] | Week 12 [N=275; 272; 262; 276] |
---|
Mirabegron 100 mg | -1.40 | -1.45 |
,Mirabegron 50 mg | -1.29 | -1.62 |
,Placebo | -1.00 | -1.18 |
,Tolterodine SR 4 mg | -1.02 | -1.27 |
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Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Weeks 8 and 12
Intervention | micturitions (Least Squares Mean) |
---|
| Week 8 [N=463; 450; 455; 461] | Week 12 [N=452; 437; 447; 438] |
---|
Mirabegron 100 mg | -1.66 | -1.78 |
,Mirabegron 50 mg | -1.64 | -2.02 |
,Placebo | -1.15 | -1.33 |
,Tolterodine SR 4 mg | -1.43 | -1.60 |
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Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit
The percentage of participants with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary. (NCT00689104)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 4 [N=291; 293; 281; 299] | Week 8 [N=280; 277; 268; 292] | Week 12 [N=275; 272; 262; 276] | Final Visit (LOCF) [N=291; 293; 281; 300] |
---|
Mirabegron 100 mg | 54.4 | 68.3 | 67.9 | 67.6 |
,Mirabegron 50 mg | 57.3 | 67.9 | 73.5 | 72.2 |
,Placebo | 46.0 | 53.9 | 61.5 | 60.1 |
,Tolterodine SR 4 mg | 56.5 | 64.4 | 69.6 | 68.3 |
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Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1 point improvement from Baseline to post-baseline and a major improvement was defined as at least a 2 point improvement from Baseline to post-baseline in PPBC score. (NCT00689104)
Timeframe: Baseline and Week 12
Intervention | percentage of participants (Number) |
---|
| Improvement: Week 12 [N=425; 410;421; 417] | Improvement: Final Visit [N=433; 416; 429; 426] | Major Improvement: Week 12 [N=425; 410; 421; 417] | Major Improvement: Final Visit [N=433;416;429;426] |
---|
Mirabegron 100 mg | 62.7 | 62.2 | 34.0 | 33.6 |
,Mirabegron 50 mg | 61.5 | 61.3 | 29.5 | 29.1 |
,Placebo | 56.9 | 56.6 | 28.5 | 28.2 |
,Tolterodine SR 4 mg | 65.2 | 65.0 | 31.7 | 31.5 |
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Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 1 on Tolterodine 4 mg and Placebo
Change from baseline in maximum cystometric capacity at 4 hours post dose 1 on tolterodine 4 mg and placebo (analysis on natural log transformed data) (NCT00768521)
Timeframe: 4 hours post dose 1
Intervention | Percentage change (Least Squares Mean) |
---|
Tolterodine | 0.92 |
Placebo | 0.91 |
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Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo
Change from baseline in maximum cystometric capacity at 4 hours post dose 7 on tolterodine 4 mg and placebo (analysis on natural log transformed data) (NCT00768521)
Timeframe: 4 hours post dose 7
Intervention | Percentage change (Least Squares Mean) |
---|
Tolterodine | 1.15 |
Placebo | 0.94 |
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Maximum Urine Flow Rate (Qmax).
To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: maximum urine flow rate (Qmax) measured via uroflowmetry. (NCT00939120)
Timeframe: 12 months
Intervention | mL/sec (Mean) |
---|
Tolterodine ER 4mg + Dutasteride 0.5mg | 11.7 |
Placebo + Dutasteride 0.5mg | 12.9 |
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Patient Perception of Bladder Condition (PPBC)
To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: participant reported patient perception of bladder condition (PPBC), one question scored from 1-6, higher scores indicating more severe symptoms. (NCT00939120)
Timeframe: 12 months
Intervention | units on a scale (Mean) |
---|
Tolterodine ER 4mg + Dutasteride 0.5mg | 3.6 |
Placebo + Dutasteride 0.5mg | 3.0 |
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Post-void Residual (PVR) Volume
To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: post-voiding residual volume measured via ultrasound. (NCT00939120)
Timeframe: 12 months
Intervention | mL (Mean) |
---|
Tolterodine ER 4mg + Dutasteride 0.5mg | 101.7 |
Placebo + Dutasteride 0.5mg | 75.8 |
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Overactive Bladder Questionnaire (OABq)
To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: overactive bladder questionnaire (OABq) - 33 questions scored via 1-6 (higher scores indicate more severe symptoms), thus values ranged from 33-198. (NCT00939120)
Timeframe: 12 months
Intervention | units on a scale (Mean) |
---|
Tolterodine ER 4mg + Dutasteride 0.5mg | 80.2 |
Placebo + Dutasteride 0.5mg | 67.7 |
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Urine Voided Volume (Voiding)
To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: urine voided volume (voiding) measured by uroflowmetry. (NCT00939120)
Timeframe: 12 months
Intervention | mL (Mean) |
---|
Tolterodine ER 4mg + Dutasteride 0.5mg | 219.9 |
Placebo + Dutasteride 0.5mg | 232.9 |
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International Prostate Symptoms Score, Voiding Subscore
To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: voiding subscore of international prostate symptoms score (IPSS) - 4 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-20. (NCT00939120)
Timeframe: 12 months
Intervention | units on a scale (Mean) |
---|
Tolterodine ER 4mg + Dutasteride 0.5mg | 7.5 |
Placebo + Dutasteride 0.5mg | 7.0 |
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Acute Urinary Retention (AUR)
To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: acute urinary attention (AUR) - inability to urinate requiring catheterization. (NCT00939120)
Timeframe: 12 months
Intervention | participants (Number) |
---|
Tolterodine ER 4mg + Dutasteride 0.5mg | 0 |
Placebo + Dutasteride 0.5mg | 0 |
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International Prostate Symptoms Score (IPSS), Storage Subscore
To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: storage subscore international prostate symptoms score (IPSS) - 3 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-15. (NCT00939120)
Timeframe: 12 months
Intervention | units on a scale (Mean) |
---|
Tolterodine ER 4mg + Dutasteride 0.5mg | 7.9 |
Placebo + Dutasteride 0.5mg | 7.5 |
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International Prostate Symptoms Score (IPSS), Total
To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: total international prostate symptoms score (IPSS) - 7 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-35. (NCT00939120)
Timeframe: 12 months
Intervention | units on a scale (Mean) |
---|
Tolterodine ER 4mg + Dutasteride 0.5mg | 15.4 |
Placebo + Dutasteride 0.5mg | 14.5 |
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Change in Frequency of Urination From 6 Weeks to 12 Weeks (Last Observation Carried Forward)
Bladder diaries completed by subjects prior to randomization and following each phase of treatment were used to calculate changes in frequency of urination. (NCT01175382)
Timeframe: Change from 6 weeks to 12 weeks
Intervention | Voids per day (Mean) |
---|
Behavioral Treatment Alone | 0.7 |
Drug Therapy (Tolterodine + Tamsulosin) | 1.4 |
Combined Behavioral + Drug Therapy | 0.2 |
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Change in Frequency of Urination After 6-week Intervention (Last Observation Carried Forward)
Bladder diaries completed by subjects prior to randomization and following the first phase of treatment was used to calculate changes in frequency of urination. (NCT01175382)
Timeframe: From Baseline to 6 Weeks
Intervention | voids per day (Mean) |
---|
Behavioral Treatment Alone | 2.7 |
Drug Therapy (Tolterodine + Tamsulosin) | 1.5 |
Combined Behavioral + Drug Therapy | 3.3 |
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Change in Frequency of Urination From Baseline to 12 Weeks (Last Observation Carried Forward)
Bladder diaries completed by subjects prior to randomization and following the second phase of treatment were used to calculate changes in frequency of urination (NCT01175382)
Timeframe: Baseline to 12 weeks
Intervention | Voids per day (Mean) |
---|
Behavioral Treatment Alone | 3.3 |
Drug Therapy (Tolterodine + Tamsulosin) | 2.9 |
Combined Behavioral + Drug Therapy | 3.5 |
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Change in Nocturia From Baseline to 6 Weeks (Last Observation Carried Forward)
Bladder diaries completed prior to randomization and following each phase of treatment will be used to calculate changes in frequency of nocturia. (NCT01175382)
Timeframe: From Baseline to 6 Weeks
Intervention | voids per night (Mean) |
---|
Behavioral Treatment Alone | 0.7 |
Drug Therapy (Tolterodine + Tamsulosin) | 0.4 |
Combined Behavioral + Drug Therapy | 0.8 |
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Change in International Prostate Symptom Score (I-PSS) From Baseline to 12 Weeks (Last Observation Carried Forward)
Change from Baseline to 12 weeks on the International Prostate Symptom Score (I-PSS) to measure urinary symptoms related to BPH. The I-PSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). (NCT01175382)
Timeframe: From Baseline to 12 weeks
Intervention | units on a scale (Mean) |
---|
Behavioral Treatment Alone | 6.7 |
Drug Therapy (Tolterodine + Tamsulosin) | 6.7 |
Combined Behavioral + Drug Therapy | 8.8 |
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Change in International Prostate Symptom Score (I-PSS) From Baseline to 6 Weeks. (Last Observation Carried Forward)
Change from baseline to 6 weeks on the International Prostate Symptom Score (IPSS) to measure urinary symptoms related to benign prostatic hypertrophy (BPH). The I-PSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). (NCT01175382)
Timeframe: From Baseline to 6 Weeks
Intervention | units on a scale (Mean) |
---|
Behavioral Treatment Alone | 4.0 |
Drug Therapy (Tolterodine + Tamsulosin) | 4.4 |
Combined Behavioral + Drug Therapy | 7.9 |
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Change in International Prostate Symptom Score (IPSS) From 6 to 12 Weeks (Last Observation Carried Forward)
Change from 6 weeks to 12 weeks on the International Prostate Symptom Score (IPSS) to measure urinary symptoms related to BPH.The I-PSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). (NCT01175382)
Timeframe: Change from 6 weeks to 12 weeks
Intervention | units on a scale (Mean) |
---|
Behavioral Treatment Alone | 2.7 |
Drug Therapy (Tolterodine + Tamsulosin) | 2.2 |
Combined Behavioral + Drug Therapy | 0.8 |
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Change in Nocturia From 6 Weeks to 12 Weeks (Last Observation Carried Forward)
Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in frequency of nocturia (NCT01175382)
Timeframe: Change from 6 weeks to 12 weeks
Intervention | Voids per night (Mean) |
---|
Behavioral Treatment Alone | 0.1 |
Drug Therapy (Tolterodine + Tamsulosin) | 0.3 |
Combined Behavioral + Drug Therapy | 0.1 |
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Change in Nocturia Measured From Baseline to 12 Weeks (Last Observation Carried Forward)
Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in the frequency nocturia (NCT01175382)
Timeframe: From Baseline to 12 weeks
Intervention | voids per night (Mean) |
---|
Behavioral Treatment Alone | 0.8 |
Drug Therapy (Tolterodine + Tamsulosin) | 0.7 |
Combined Behavioral + Drug Therapy | 0.9 |
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Change in Overactive Bladder Questionnaire (OAB-q) From 6 to 12 Weeks (Last Observation Carried Forward)
Change from 6 weeks to 12 weeks on the OAB-q to measure symptom bother and condition-specific health-related quality of life. This questionnaire asks about how much you have been bothered by selected bladder symptoms during the past 4 weeks. Scale ranges from 8 to 48 with higher scores indicating a greater degree of bother. (NCT01175382)
Timeframe: Change from 6 week to 12 weeks
Intervention | units on a scale (Mean) |
---|
Behavioral Treatment Alone | 17.3 |
Drug Therapy (Tolterodine + Tamsulosin) | 10.8 |
Combined Behavioral + Drug Therapy | 4.6 |
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Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 12 Weeks (Last Observation Carried Forward)
Change from baseline to 12 weeks on the OAB-q to measure symptom bother and condition-specific health-related quality of life. This questionnaire asks about how much you have been bothered by selected bladder symptoms during the past 4 weeks. Scale ranges from 8 to 48 with higher scores indicating a greater degree of bother. (NCT01175382)
Timeframe: From Baseline to 12 weeks
Intervention | units on a scale (Mean) |
---|
Behavioral Treatment Alone | 37.3 |
Drug Therapy (Tolterodine + Tamsulosin) | 31.0 |
Combined Behavioral + Drug Therapy | 42.1 |
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Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 6 Weeks (Last Observation Carried Forward)
Change from baseline on the OAB-q to measure symptom bother and condition-specific health-related quality of life. This questionnaire asks about how much you have been bothered by selected bladder symptoms during the past 4 weeks. Scale ranges from 8 to 48 with higher scores indicating a greater degree of bother. (NCT01175382)
Timeframe: From Baseline to 6 Weeks
Intervention | units on a scale (Mean) |
---|
Behavioral Treatment Alone | 19.9 |
Drug Therapy (Tolterodine + Tamsulosin) | 20.2 |
Combined Behavioral + Drug Therapy | 37.5 |
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Change in Urgency From Baseline to 6 Weeks (Last Observation Carried Forward)
Bladder diaries completed prior to randomization and following each phase of treatment will be used to calculate changes in urgency associated with each void and incontinent episode using the Indevus Urgency Severity Scale (IUSS). IUSS asks patients about the degree of urgency, as meant to describe the urge to urinate. Patients are asked to rate the degree of urgency and its impact on the completion of activity or tasks during the time that the urgency sensation is present and before reaching the toilet for a toilet void. Four distinct, subjective degrees of urgency severity were identified, including 1) no sensation of urgency, 2) awareness of urgency but easily tolerated, 3) urgency that is somewhat uncomfortable and 4) extreme urgency discomfort. (NCT01175382)
Timeframe: From Baseline to 6 Weeks
Intervention | units on a scale (Mean) |
---|
Behavioral Treatment Alone | -0.1 |
Drug Therapy (Tolterodine + Tamsulosin) | 0.1 |
Combined Behavioral + Drug Therapy | 0.2 |
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Change in Urgency Score From 6 Weeks to 12 Weeks (Last Observation Carried Forward)
Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in urgency associated with each void and incontinent episode using the Indevus Urgency Severity Scale (IUSS). IUSS asks patients about the degree of urgency, as meant to describe the urge to urinate. Patients are asked to rate the degree of urgency and its impact on the completion of activity or tasks during the time that the urgency sensation is present and before reaching the toilet for a toilet void. Four distinct, subjective degrees of urgency severity were identified, including 1) no sensation of urgency, 2) awareness of urgency but easily tolerated, 3) urgency that is somewhat uncomfortable and 4) extreme urgency discomfort. (NCT01175382)
Timeframe: Change from 6 weeks to 12 weeks
Intervention | units on a scale (Mean) |
---|
Behavioral Treatment Alone | 0.1 |
Drug Therapy (Tolterodine + Tamsulosin) | 0.1 |
Combined Behavioral + Drug Therapy | 0.1 |
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Change in Urinary Incontinence Episodes From Baseline to 12 Weeks (Last Observation Carried Forward)
Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in frequency of urination (NCT01175382)
Timeframe: From Baseline to 12 weeks
Intervention | voids per day (Mean) |
---|
Behavioral Treatment Alone | 4.6 |
Drug Therapy (Tolterodine + Tamsulosin) | 4.6 |
Combined Behavioral + Drug Therapy | 5.2 |
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Change in Urinary Incontinence From 6 Weeks to 12 Weeks (Last Observation Carried Forward)
Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in frequency of incontinence episodes. (NCT01175382)
Timeframe: Change from 6 weeks to 12 weeks
Intervention | Episodes per week (Mean) |
---|
Behavioral Treatment Alone | 1.3 |
Drug Therapy (Tolterodine + Tamsulosin) | 1.5 |
Combined Behavioral + Drug Therapy | 0.0 |
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Change in Urinary Incontinence From Baseline to 6 Weeks (Last Observation Carried Forward)
Bladder diaries completed prior to randomization and following each phase of treatment will be used to calculate changes in frequency of incontinence episodes. (NCT01175382)
Timeframe: From Baseline to 6 Weeks
Intervention | episodes per week (Mean) |
---|
Behavioral Treatment Alone | 3.4 |
Drug Therapy (Tolterodine + Tamsulosin) | 3.1 |
Combined Behavioral + Drug Therapy | 5.2 |
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Change in Urgency Score From Baseline to 12 Weeks (Last Observation Carried Forward)
Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in frequency of urgency associated with each void and incontinent episode using the Indevus Urgency Severity Scale (IUSS). IUSS asks patients about the degree of urgency, as meant to describe the urge to urinate. Patients are asked to rate the degree of urgency and its impact on the completion of activity or tasks during the time that the urgency sensation is present and before reaching the toilet for a toilet void. Four distinct, subjective degrees of urgency severity were identified, including 1) no sensation of urgency, 2) awareness of urgency but easily tolerated, 3) urgency that is somewhat uncomfortable and 4) extreme urgency discomfort. (NCT01175382)
Timeframe: From Baseline to 12 weeks
Intervention | units on a scale (Mean) |
---|
Behavioral Treatment Alone | 0.0 |
Drug Therapy (Tolterodine + Tamsulosin) | 0.1 |
Combined Behavioral + Drug Therapy | 0.2 |
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Change From Baseline in Mean Voided Volume Per Micturition at Week 1, 4 and 12
Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 at that visit. Baseline values for each time point were calculated separately considering only those participants who were evaluable at the given time point. (NCT01302938)
Timeframe: Baseline, Week 1, 4, 12
Intervention | milliliter (mL) (Mean) |
---|
| Baseline for Week 1 (n=10,5) | Baseline for Week 4 (n=11,6) | Baseline for Week 12 (n=11,6) | Change at Week 1 (n=10,5) | Change at Week 4 (n=11,6) | Change at Week 12 (n=11,6) |
---|
Placebo | 194.2 | 185.2 | 185.2 | 27.9 | 19.2 | -10.1 |
,Tolterodine | 163.7 | 161.2 | 161.2 | 49.8 | 45.2 | 31.9 |
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Participant Perception Regarding Recommending a Friend to Enter Similar Study
"PEQ is a web-based self-administered, exploratory questionnaire that assesses the participant's perception of trial method. Number of participants who responded to question 6, How likely would you be to recommend a friend to enter a similar study? are reported." (NCT01302938)
Timeframe: Week 12
Intervention | participants (Number) |
---|
| Very likely | Somewhat likely | Neither |
---|
Entire Study Population | 11 | 5 | 1 |
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Participant Perception Regarding Received Treatment in the Study
"PEQ is a web-based self-administered, exploratory questionnaire that assesses the participant's perception of trial method. Number of participants who responded to question 5, What treatment did you think you were on? are reported." (NCT01302938)
Timeframe: Week 12
Intervention | participants (Number) |
---|
| Placebo | Tolterodine |
---|
Placebo | 4 | 2 |
,Tolterodine | 3 | 8 |
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Participant Perception Regarding Cell Phone Diary
"PEQ:self-administered, assesses participants perception of trial method. Question4, How satisfied were you with items? on scale 1(very easy) to 5(very difficult)- a: teaching video explaining CP use; recording urinations using CP; size of text on CP; sending your urinary information(inf) using your CP, e: overall, suitability for capturing urinations as they happened." (NCT01302938)
Timeframe: Week 12
Intervention | participants (Number) |
---|
| CP use video: neither difficult nor easy | CP use video: somewhat easy | CP use video: very easy | Recording urinations using CP: somewhat easy | Recording urinations using CP: very easy | CP text size: neither difficult nor easy | CP text size: somewhat easy | CP text size: very easy | Sending urinary inf using CP: somewhat easy | Sending urinary inf using CP: very easy | Overall: neither difficult nor easy | Overall: somewhat easy | Overall: very easy |
---|
Entire Study Population | 1 | 4 | 12 | 3 | 14 | 1 | 4 | 12 | 4 | 13 | 1 | 3 | 13 |
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Number of Participants Who Discontinued the Study Due to Adverse Events
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. (NCT01302938)
Timeframe: Baseline up to 28 days after last dose
Intervention | participants (Number) |
---|
Tolterodine | 1 |
Placebo | 0 |
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Number of Participants With Laboratory Abnormalities
Criteria for potentially clinically significant (PCS) laboratory values: Hemoglobin, hematocrit, red blood cell less than (<) 0.8 lower limit of normal(LLN); platelet <0.5 LLN, >1.75 upper LN (ULN);white blood cell <0.6 LLN, >1.5 ULN; lymphocyte, total neutrophil(absolute[AL]),Total protein, albumin, phosphate <0.8 LLN, >1.2 ULN; basophil, eosinophil, monocyte >1.2ULN; Total bilirubin >1.5ULN; aspartate, alanine aminotransferase, alkaline phosphatase >3ULN; Blood urea nitrogen, creatinine >1.3ULN; sodium <0.95LLN, >1.05ULN; potassium, chloride, bicarbonate, calcium <0.9LLN, >1.1ULN. (NCT01302938)
Timeframe: Week 12
Intervention | participants (Number) |
---|
Tolterodine | 1 |
Placebo | 1 |
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Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12
OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains (range): concern(7-42), coping(8-48), sleep(5-30), and social function(5-30). Total HRQL score (25-125) derived as sum of HRQL domains. Transformed score range 0 to 100 (HRQL domain or total) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicate better HRQL. (NCT01302938)
Timeframe: Baseline, Week 12
Intervention | units on a scale (Mean) |
---|
| Baseline: Coping Subscale | Baseline: Concern Subscale | Baseline: Sleep Subscale | Baseline: Total HRQL Score | Change at Week 12: Coping Subscale | Change at Week 12: Concern Subscale | Change at Week 12: Sleep Subscale | Change at Week 12: Total HRQL Score |
---|
Placebo | 56.3 | 53.8 | 55.3 | 58.5 | 13.8 | 16.7 | 8.0 | 12.0 |
,Tolterodine | 50.0 | 41.7 | 49.2 | 54.1 | 26.3 | 29.4 | 21.6 | 22.5 |
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Change From Baseline in Health Related Quality of Life (HRQL) Social Domain Score at Week 12
OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains (range): concern(7-42), coping(8-48), sleep(5-30), and social function(5-30). Total HRQL score (25-125) derived as sum of HRQL domains. Transformed score range 0 to 100 (HRQL domain or total) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicate better HRQL. (NCT01302938)
Timeframe: Baseline, Week 12
Intervention | units on a scale (Median) |
---|
| Baseline | Change at Week 12 |
---|
Placebo | 92.0 | 2.0 |
,Tolterodine | 84.0 | 10.0 |
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Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 1 and 4
Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine. The mean number of micturitions per 24 hours was calculated as the total number of micturitions divided by the total number of diary days collected at that visit. Baseline values for each time point were calculated separately considering only those participants who were evaluable at the given time point. (NCT01302938)
Timeframe: Baseline, Week 1, 4
Intervention | micturitions per 24 hours (Mean) |
---|
| Baseline for Week 1 (n=10,5) | Baseline for Week 4 (n=11,6) | Change at Week 1 (n=10,5) | Change at Week 4 (n=11,6) |
---|
Placebo | 9.9 | 9.9 | -0.7 | -1.0 |
,Tolterodine | 11.7 | 11.5 | -0.6 | -2.4 |
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Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12
Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with Urinary Sensation Scale (USS) rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine. The mean number of micturitions per 24 hours was calculated as the total number of micturitions divided by the total number of diary days collected at that visit. (NCT01302938)
Timeframe: Baseline, Week 12
Intervention | micturitions per 24 hours (Mean) |
---|
| Baseline | Change at Week 12 |
---|
Placebo | 9.9 | -0.3 |
,Tolterodine | 11.5 | -2.6 |
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Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. (NCT01302938)
Timeframe: Baseline up to 28 days after last dose
Intervention | participants (Number) |
---|
| AEs | SAEs |
---|
Placebo | 3 | 0 |
,Tolterodine | 6 | 0 |
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Number of Participants With Reason for Participation in the Study
"PEQ is a web-based self-administered, exploratory questionnaire that assesses the participant's perception of trial method. Number of participants who responded to question 2, What led you to participate given the study drug is already available? are reported." (NCT01302938)
Timeframe: Week 12
Intervention | participants (Number) |
---|
| Contribute to research | Experience internet research study and try it out | Ease of participation | Free medication | Payment for participation |
---|
Entire Study Population | 8 | 2 | 3 | 3 | 1 |
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Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12
PPUS: a self-administered, single-item, validated questionnaire that measures the participant's perception of urinary urgency. It is sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine [without leaking] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she is doing before going to toilet [without leaking]). Results categorized as SC from baseline on 3-point scale: improvement (positive SC), no change (SC 0), deterioration (negative SC). (NCT01302938)
Timeframe: Baseline (Bl), Week 1, 4, 12
Intervention | participants (Number) |
---|
| Bl,Week 1:Not able to hold urine (n=11,5) | Bl,Week 1:Able to hold until reach toilet (n=11,5) | Bl,Week 1:Able to finish what I am doing (n=11,5) | Bl,Week 4:Not able to hold urine (n=12,6) | Bl,Week 4:Able to hold until reach toilet (n=12,6) | Bl,Week 4:Able to finish what I am doing (n=12,6) | Bl,Week 12:Not able to hold urine (n=12,6) | Bl,Week 12:Able to hold until reach toilet(n=12,6) | Bl,Week 12:Able to finish what I am doing (n=12,6) | Week 1:Improvement (n=11,5) | Week 1:No change (n=11,5) | Week 1:Deterioration (n=11,5) | Week 4:Improvement (n=12,6) | Week 4:No change (n=12,6) | Week 4:Deterioration (n=12,6) | Week 12:Improvement (n=12,6) | Week 12:No change (n=12,6) | Week 12:Deterioration (n=12,6) |
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Placebo | 1 | 3 | 1 | 1 | 4 | 1 | 1 | 4 | 1 | 1 | 3 | 1 | 0 | 5 | 1 | 1 | 4 | 1 |
,Tolterodine | 6 | 4 | 1 | 6 | 5 | 1 | 6 | 5 | 1 | 4 | 6 | 1 | 4 | 7 | 1 | 6 | 6 | 0 |
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Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12
PPBC: self-administered,single-item questionnaire to describe participant's perception of bladder-related problems. PPBC assessed on 6-point scale:1=no problems at all,2=some very minor problems,3=some minor problems,4=some moderate problems,5=severe problems,6=many severe problems. Results categorized as score change (SC) from baseline on 2-point scale:improvement (negative SC),no improvement (SC 0 or more) and on 4-point scale:major improvement (SC is negative in magnitude of 2 or more), minor improvement (SC is negative in magnitude of 1), no change (SC= 0),deterioration (positive SC). (NCT01302938)
Timeframe: Baseline, Week 1, 4, 12
Intervention | participants (Number) |
---|
| Baseline, Week 1: No Problems at all (n=11,5) | Baseline, Week 1:Some Very Minor Problems(n=11,5) | Baseline, Week 1: Some Minor Problems (n=11,5) | Baseline, Week 1:Some Moderate Problems(n=11,5) | Baseline, Week 1: Severe Problems (n=11,5) | Baseline, Week 1: Many Severe Problems (n=11,5) | Baseline, Week 4: No Problems at all (n=12,6) | Baseline, Week 4: Some Very Minor Problems(n=12,6) | Baseline, Week 4: Some Minor Problems (n=12,6) | Baseline, Week 4: Some Moderate Problems (n=12,6) | Baseline, Week 4: Severe Problems (n=12,6) | Baseline, Week 4: Many Severe Problems (n=12,6) | Baseline, Week 12: No Problems at all (n=12,6) | Baseline, Week12: Some Very Minor Problems(n=12,6) | Baseline, Week 12: Some Minor Problems (n=12,6) | Baseline, Week 12: Some Moderate Problems (n=12,6) | Baseline, Week 12: Severe Problems (n=12,6) | Baseline, Week 12: Many Severe Problems (n=12,6) | Week 1:Improvement (2-point scale) (n=11,5) | Week 1:No improvement (2-point scale) (n=11,5) | Week 1:Major improvement (4-point scale) (n=11,5) | Week 1:Minor improvement (4-point scale) (n=11,5) | Week 1:No Change (4-point scale) (n=11,5) | Week 1:Deterioration (4-point scale) (n=11,5) | Week 4:Improvement (2-point scale) (n=12,6) | Week 4:No improvement (2-point scale) (n=12,6) | Week 4:Major improvement (4-point scale) (n=12,6) | Week 4:Minor improvement (4-point scale) (n=12,6) | Week 4:No Change (4-point scale) (n=12,6) | Week 4:Deterioration (4-point scale) (n=12,6) | Week 12:Improvement (2-point scale) (n=12,6) | Week 12:No improvement (2-point scale) (n=12,6) | Week 12:Major improvement (4-point scale) (n=12,6) | Week 12:Minor improvement (4-point scale) (n=12,6) | Week 12:No Change (4-point scale) (n=12,6) | Week 12:Deterioration (4-point scale) (n=12,6) |
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Placebo | 0 | 0 | 1 | 2 | 1 | 1 | 0 | 0 | 2 | 2 | 1 | 1 | 0 | 0 | 2 | 2 | 1 | 1 | 2 | 3 | 1 | 1 | 1 | 2 | 3 | 3 | 1 | 2 | 2 | 1 | 4 | 2 | 1 | 3 | 2 | 0 |
,Tolterodine | 0 | 0 | 1 | 2 | 8 | 0 | 0 | 0 | 1 | 3 | 8 | 0 | 0 | 0 | 1 | 3 | 8 | 0 | 7 | 4 | 2 | 5 | 3 | 1 | 7 | 5 | 4 | 3 | 5 | 0 | 9 | 3 | 7 | 2 | 3 | 0 |
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Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12
OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (not at all) to 6 (a very great deal). Symptom bother score derived as sum of scores for items 1 to 8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother. (NCT01302938)
Timeframe: Baseline, Week 12
Intervention | units on a scale (Mean) |
---|
| Baseline | Change at Week 12 |
---|
Placebo | 54.6 | -12.5 |
,Tolterodine | 66.5 | -27.8 |
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Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1, 4 and 12
UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Baseline values for each time point were calculated separately considering only those participants who were evaluable at the given time point. (NCT01302938)
Timeframe: Baseline, Week 1, 4, 12
Intervention | episodes per 24 hours (Median) |
---|
| Baseline for Week 1 (n=10,5) | Baseline for Week 4 (n=11,6) | Baseline for Week 12 (n=11,6) | Change at Week 1 (n=10,5) | Change at Week 4 (n=11,6) | Change at Week 12 (n=11,6) |
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Placebo | 2.3 | 2.3 | 2.3 | -0.7 | -1.9 | -1.2 |
,Tolterodine | 3.2 | 2.7 | 2.7 | -1.0 | -1.3 | -1.7 |
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Extension Study: Number of Participants Who Experienced an Adverse Event (AE)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. (NCT01314872)
Timeframe: Extension: up to 54 weeks (including 2-week follow-up)
Intervention | Participants (Number) |
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Extension Study: Vibegron 50 mg | 134 |
Extension Study: Vibegron 100 mg | 157 |
Extension Study: Tolterodine ER 4 mg | 158 |
Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg | 82 |
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Extension Study: Change From Baseline in Average Daily Number of Urge Incontinence Episodes at Week 52
Participants were required to keep a voiding diary, recording the occurrence of each urge incontinence episode. The average daily number of urge incontinence episodes was calculated as the total number of times a participant experienced such an episode during 52-week Extension Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study. (NCT01314872)
Timeframe: Baseline and Week 52 of Extension Study
Intervention | Urge incontinence episodes (Least Squares Mean) |
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Extension Study: Vibegron 50 mg | -2.43 |
Extension Study: Vibegron 100 mg | -2.15 |
Extension Study: Tolterodine ER 4 mg | -2.23 |
Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg | -2.44 |
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Extension Study: Change From Baseline in Average Daily Number of Total Incontinence Episodes at Week 52
Participants were required to keep a voiding diary, recording the occurrence of each total incontinence episode. The average daily number of total incontinence episodes was calculated as the total number of times a participant experienced such an episode during 52-week Extension Study, divided by the total divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study. (NCT01314872)
Timeframe: Baseline and Week 52 of Extension Study
Intervention | Incontinence episodes (Least Squares Mean) |
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Extension Study: Vibegron 50 mg | -2.70 |
Extension Study: Vibegron 100 mg | -2.42 |
Extension Study: Tolterodine ER 4 mg | -2.50 |
Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg | -2.48 |
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Extension Study: Change From Baseline in Average Daily Micturitions at Week 52
Participants were required to keep a voiding diary, recording the daily occurrence of each micturition. The average daily number of micturitions was calculated as the total number of recorded micturitions that occurred during the 52-week Extension Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study. (NCT01314872)
Timeframe: Baseline and Week 52 of Extension Study
Intervention | Micturitions (Least Squares Mean) |
---|
Extension Study: Vibegron 50 mg | -2.53 |
Extension Study: Vibegron 100 mg | -2.77 |
Extension Study: Tolterodine ER 4 mg | -2.15 |
Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg | -3.25 |
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Extension Study: Change From Baseline in Average Daily Number of Strong Urge Episodes at Week 52
Participants were required to keep a voiding diary, recording the occurrence of each strong urge episode. The average daily number of strong urge episodes was calculated as the total number of times a participant experienced such an episode during 52-week Extension Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study. (NCT01314872)
Timeframe: Baseline and Week 52 of Extension Study
Intervention | Strong urge episodes (Least Squares Mean) |
---|
Extension Study: Vibegron 50 mg | -3.11 |
Extension Study: Vibegron 100 mg | -3.42 |
Extension Study: Tolterodine ER 4 mg | -2.94 |
Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg | -4.18 |
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Base Study/Part 1: Change From Baseline in Average Daily Number of Strong Urge Episodes at Week 8
Participants were required to keep a voiding diary, recording the occurrence of each strong urge episode. The average daily number of strong urge episodes was calculated as the total number of times a participant experienced such an episode over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of strong urge episodes that occurred during the week of placebo run-in prior to Week 0 visit. (NCT01314872)
Timeframe: Baseline and Week 8
Intervention | Strong urge episodes (Least Squares Mean) |
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Part 1: Placebo | -1.59 |
Part 1: Vibegron 3 mg | -1.77 |
Part 1: Vibegron 15 mg | -2.27 |
Part 1: Vibegron 50 mg | -2.36 |
Part 1: Vibegron 100 mg | -2.83 |
Part 1: Tolterodine ER 4 mg | -2.53 |
Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg | -2.73 |
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Base Study/Part 1 + Part 2: Number of Participants Who Experienced an Adverse Event (AE)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. (NCT01314872)
Timeframe: Part 1: up to 8 weeks; Part 2: up to 4 weeks. The time frame was an additional 2 weeks for participants not continuing to the Extension Study.
Intervention | Participants (Number) |
---|
Part 1: Placebo | 66 |
Part 1: Vibegron 3 mg | 55 |
Part 1: Vibegron 15 mg | 70 |
Part 1: Vibegron 50 mg | 62 |
Part 1: Vibegron 100 mg | 70 |
Part 1: Tolterodine ER 4 mg | 68 |
Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg | 69 |
Part 2: Placebo | 22 |
Part 2: Vibegron 100 mg | 37 |
Part 2: Tolterodine ER 4 mg | 48 |
Part 2: Vibegron 100 mg + Tolterodine ER 4 mg | 40 |
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Base Study/Part 1 + Part 2: Number of Participants Who Had Study Medication Withdrawn Due to an AE
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. (NCT01314872)
Timeframe: Part 1: up to 8 weeks; Part 2: up to 4 weeks
Intervention | Participants (Number) |
---|
Part 1: Placebo | 3 |
Part 1: Vibegron 3 mg | 3 |
Part 1: Vibegron 15 mg | 4 |
Part 1: Vibegron 50 mg | 2 |
Part 1: Vibegron 100 mg | 2 |
Part 1: Tolterodine ER 4 mg | 4 |
Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg | 3 |
Part 2: Placebo | 2 |
Part 2: Vibegron 100 mg | 4 |
Part 2: Tolterodine ER 4 mg | 0 |
Part 2: Vibegron 100 mg + Tolterodine ER 4 mg | 2 |
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Base Study/Part 1: Change From Baseline in Average Daily Micturitions at Week 8
Participants were required to keep a voiding diary, recording the occurrence of each micturition. The average daily number of micturitions was calculated as the total number of micturitions that occurred over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of daily micturitions that occurred during the week of placebo run-in prior to Week 0 visit. (NCT01314872)
Timeframe: Baseline and Week 8
Intervention | Micturitions (Least Squares Mean) |
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Part 1: Placebo | -1.16 |
Part 1: Vibegron 3 mg | -1.62 |
Part 1: Vibegron 15 mg | -1.61 |
Part 1: Vibegron 50 mg | -1.80 |
Part 1: Vibegron 100 mg | -2.07 |
Part 1: Tolterodine ER 4 mg | -1.71 |
Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg | -2.05 |
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Base Study/Part 1: Change From Baseline in Average Daily Number of Total Incontinence Episodes at Week 8
Participants were required to keep a voiding diary, recording the occurrence of each total incontinence episode. The average daily number of total incontinence episodes was calculated as the total number of times a participant experienced such an episode over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of total incontinence episodes that occurred during the week of placebo run-in prior to Week 0 visit. (NCT01314872)
Timeframe: Baseline and Week 8
Intervention | Incontinence episodes (Least Squares Mean) |
---|
Part 1: Placebo | -1.52 |
Part 1: Vibegron 3 mg | -1.71 |
Part 1: Vibegron 15 mg | -2.01 |
Part 1: Vibegron 50 mg | -2.13 |
Part 1: Vibegron 100 mg | -2.11 |
Part 1: Tolterodine ER 4 mg | -1.86 |
Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg | -2.00 |
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Base Study/Part 1: Change From Baseline in Number of Urge Incontinence Episodes at Week 8
Participants were required to keep a voiding diary, recording the occurrence of each total incontinence episode. The average daily number of total incontinence episodes was calculated as the total number of times a participant experienced such an episode over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of total incontinence episodes that occurred during the week of placebo run-in prior to Week 0 visit. (NCT01314872)
Timeframe: Baseline and Week 8
Intervention | Urge incontinence episodes (Least Squares Mean) |
---|
Part 1: Placebo | -1.24 |
Part 1: Vibegron 3 mg | -1.52 |
Part 1: Vibegron 15 mg | -1.81 |
Part 1: Vibegron 50 mg | -1.95 |
Part 1: Vibegron 100 mg | -1.95 |
Part 1: Tolterodine ER 4 mg | -1.69 |
Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg | -1.71 |
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Extension Study: Number of Participants Who Had Study Medication Withdrawn Due to an AE
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. (NCT01314872)
Timeframe: Extension: up to 52 weeks
Intervention | Participants (Number) |
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Extension Study: Vibegron 50 mg | 11 |
Extension Study: Vibegron 100 mg | 14 |
Extension Study: Tolterodine ER 4 mg | 24 |
Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg | 7 |
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Risk Factors for the Proportion of Responders of Tolterodine-Severity of Overactive Bladder
Number of participants with responders of tolterodine to determine whether mild, moderate or severe is significant risk factor. (NCT01488578)
Timeframe: 12 week
Intervention | participants (Number) |
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Mild | 2426 |
Moderate | 3709 |
Severe | 401 |
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Risk Factors for the Proportion of Responders of Tolterodine-Previous Treatment
Number of participants with response to tolterodine to determine whether with or without previous treatment is significant risk factor. (NCT01488578)
Timeframe: 12 week
Intervention | participants (Number) |
---|
With Previous Treatment | 698 |
Without Previous Treatment | 5753 |
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Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinations Per Day (During Sleep)
Number of participants with responders of tolterodine to determine the Number of urinations per day (during sleep) is significant risk factor. (NCT01488578)
Timeframe: 12 week
Intervention | participants (Number) |
---|
No Urination | 370 |
1 Urination | 882 |
2 Urinations | 1380 |
>= 3 Urinations | 3523 |
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Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies
Number of participants with responders of tolterodine to determine whether with or without Non-drug therapies is significant risk factor. (NCT01488578)
Timeframe: 12 week
Intervention | participants (Number) |
---|
With Non-drug Therapies | 317 |
Without Non-drug Therapies | 6219 |
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Risk Factors for the Proportion of Responders of Tolterodine-Gender
Number of participants with responders of tolterodine to determine whether male or female is significant risk factor. (NCT01488578)
Timeframe: 12 week
Intervention | participants (Number) |
---|
Male | 2745 |
Female | 3791 |
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Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs
Number of participants with responders of tolterodine to determine whether with or without concomitant drugs is significant risk factor. (NCT01488578)
Timeframe: 12 week
Intervention | participants (Number) |
---|
With Concomitant Drugs | 3483 |
Without Concomitant Drugs | 3053 |
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Risk Factors for the Proportion of Responders of Tolterodine-Complications
Number of participants with responders of tolterodine to determine whether with or without complications is significant risk factor. (NCT01488578)
Timeframe: 12 week
Intervention | participants (Number) |
---|
With Complications | 3960 |
Without Complications | 2576 |
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Risk Factors for the Proportion of Responders of Tolterodine-Age
Number of participants with responders of tolterodine to determine whether <65 years or >=65 years is significant risk factor. (NCT01488578)
Timeframe: 12 week
Intervention | participants (Number) |
---|
<65 Years | 2060 |
>=65 Years | 4476 |
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Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinary Incontinence Episodes Per Day
Number of participants with responders of tolterodine to determine the Number of urinary incontinence episodes per day is significant risk factor. (NCT01488578)
Timeframe: 12 week
Intervention | participants (Number) |
---|
1 to 2 Episodes | 1670 |
3 to 4 Episodes | 710 |
>= 5 Episodes | 254 |
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Number of Participants With an Investigator's Assessment of Clinical Outcome at End of the Study.
Clinical overall effectiveness was evaluated by investigators based on clinical symptoms, etc, at the end of observation period. (NCT01488578)
Timeframe: 12 week
Intervention | participants (Number) |
---|
| Effective | Not effective |
---|
Tolterodine Tartrate | 6536 | 1244 |
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"Number of Participants Which Was Evaluated as Degree of Satisfaction."
Participant satisfaction was evaluated by investigators based on questioning the participants at the end of observation period using choices: Satisfied, Dissatisfied, Neither of the above. (NCT01488578)
Timeframe: 12 week
Intervention | participants (Number) |
---|
| Satisfied | Dissatisfied | Neither of the above | Unknown |
---|
Tolterodine Tartrate | 5609 | 1033 | 963 | 175 |
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Risk Factors for the Proportion of Responders of Tolterodine-Urinary Urgency
Number of participants with responders of tolterodine to determine whether with or without Urinary urgency is significant risk factor. (NCT01488578)
Timeframe: 12 week
Intervention | participants (Number) |
---|
With Urinary Urgency | 5529 |
Without Urinary Urgency | 829 |
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Number of Participants Who Experienced an Adverse Event (AE)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. (NCT01500382)
Timeframe: Up to 6 weeks (up to 3 weeks in Period 1 and up to 3 weeks in Period 2)
Intervention | Participants (Number) |
---|
Vibegron 100 mg | 0 |
Vibegron 100 mg + Tolterodine ER 4 mg | 0 |
Vibegron 50 mg | 0 |
Placebo | 0 |
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Number of Participants Who Discontinued Use of Study Drug Due to an AE
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. The number of participants who discontinued study drug due to an AE were reported. (NCT01500382)
Timeframe: Up to 6 weeks (up to 3 weeks in Period 1 and up to 3 weeks in Period 2)
Intervention | Participants (Number) |
---|
Vibegron 100 mg | 0 |
Vibegron 100 mg + Tolterodine ER 4 mg | 0 |
Vibegron 50 mg | 0 |
Placebo | 0 |
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Lower Urinary Tract Symptoms (LUTS)
LUTS was evaluated using the International Prostate Symptom Score (IPSS) questionnaire perioperatively. The IPSS constitutes of seven questions assigned score from 0 to 5 to evaluate the severity of LUTS in patients. Total scoring of IPSS ranges from 0 to 35, asymptomatic to very symptomatic. The more the score on scale is, the worse the outcome is.Therefore, the higher values represent worse outcomes. (NCT01530243)
Timeframe: Expected average of 2 weeks
Intervention | units on a scale (Mean) |
---|
Placebo | 11.12 |
Terazosin | 4.39 |
Tolterodine | 7.21 |
Tolterodine + Terazosin | 5.58 |
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Pain
The visual analogue scale (VAS) was used to evaluate the pain at the time of voiding. This VAS scoring ranges from 0 to 10. The higher values represent worse outcomes, having more pain. (NCT01530243)
Timeframe: Expected 2 weeks later
Intervention | units on a scale (Mean) |
---|
Placebo | 4.16 |
Terazosin | 3.21 |
Tolterodine | 1.34 |
Tolterodine + Terazosin | 1.37 |
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Quality of Life
The Quality of life of patients was evaluated using single question in IPSS questionnaire in which each of patients received scoring from 0 to 6. The higher values represent the worse quality of life. (NCT01530243)
Timeframe: Expected 2 weeks later
Intervention | units on a scale (Mean) |
---|
Placebo | 3.37 |
Terazosin | 2 |
Tolterodine | 2.30 |
Tolterodine + Terazosin | 0.95 |
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The Global Response Assessment (GRA) After the Treatment Day
"Efficacy Using global response assessment (GRA) to compare the efficacy in Group 1 and Group 2 from baseline to 1month.~The global response assessment on a 6-point scale ranging from 1 No problems at all to 6 Many severe problems.~Changes of the global response assessment (GRA) improved or reduction by 1 points.~Change = Baseline minus Month 1 value~Safety:~Systemic adverse events such as difficult urination, dry mouth, dry eye, blurred vision, constipation, dizziness or general weakness" (NCT01661621)
Timeframe: 1 month after initial treatment
Intervention | participants (Number) |
---|
| GRA≥1 | GRA<1 |
---|
Group 1 | 89 | 27 |
,Group 2 | 218 | 61 |
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The International Prostate Symptom Score (IPSS) Quality of Life (QoL) Score After the Treatment Day
"Efficacy:~Using the the the International Prostate Symptom Score (IPSS) quality of life (QoL) score to compare the efficacy in Group 1 and Group 2 from baseline to 1month.~The IPSS quality of life question score on a 7-point scale ranging from 0 Delighted to 6 Terrible.~IPSS-QoL ranges 0 to 6 (Delighted to Terrible)~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness" (NCT01661621)
Timeframe: Baseline and 1 month
Intervention | units on a scale (Mean) |
---|
| Baseline | 1 month |
---|
Group 1 | 3.91 | 2.82 |
,Group 2 | 3.88 | 2.82 |
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The International Prostate Symptom Score (IPSS) Questionnaires After the Treatment Day
"Efficacy:~Using the total International Prostate Symptom Score (IPSS) to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.~The International Prostate Symptom Score (IPSS) is an 7 symptom questions including 4 voiding questions (IPSS-voiding), 3 storage questions (IPSS-Storage) The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always.~Total IPSS score = IPSS-voiding + IPSS-Storage Rang = 0 to 35 (asymptomatic to very symptomatic). Mild = 0 to 7; Moderate = 8 to 19; Severe = 20 to 35~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness" (NCT01661621)
Timeframe: Baseline and 1 month
Intervention | units on a scale (Mean) |
---|
| Baseline | 1 month |
---|
Group 1 | 14.8 | 11.2 |
,Group 2 | 18.0 | 10.8 |
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The IPSS Subscore (IPSS Storage) Questionnaires After the Treatment Day
"Efficacy:~Using the the IPSS subscore (IPSS Storage) to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.~The IPSS subscore (IPSS Storage) is a 3 symptom questions. The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.~The total IPSS Storage score can therefore range from 0 to 15 (asymptomatic to very symptomatic).~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness" (NCT01661621)
Timeframe: Baseline and 1 month
Intervention | units on a scale (Mean) |
---|
| Baseline | 1 month |
---|
Group 1 | 9.51 | 6.40 |
,Group 2 | 5.70 | 4.31 |
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The IPSS Subscore (IPSS Voiding) Questionnaires After the Treatment Day
"Efficacy:~Using the the IPSS subscore (IPSS Voiding) questionnaires to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.~The IPSS subscore (IPSS Voiding) questionnaires is a 4 symptom questions. The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.~The total IPSS Voiding score can therefore range from 0 to 20 (asymptomatic to very symptomatic).~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness" (NCT01661621)
Timeframe: Baseline and 1 month
Intervention | units on a scale (Mean) |
---|
| Baseline | 1 month |
---|
Group 1 | 5.31 | 4.84 |
,Group 2 | 12.3 | 6.49 |
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The Voided Volume After the Treatment Day
"Efficacy:~Net change used the the voided volume in Group 1 and Group 2 from baseline to 1 month.~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness" (NCT01661621)
Timeframe: Baseline and 1 month
Intervention | mL (Mean) |
---|
| Baseline | 1 month |
---|
Group 1 | 212.5 | 231.6 |
,Group 2 | 244.0 | 268.3 |
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The Maximum Flow Rate (Qmax) After the Treatment Day
"Efficacy:~Net change used the the maximum flow rate (Qmax) in Group 1 and Group 2 from baseline to 1 month.~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness" (NCT01661621)
Timeframe: Baseline and 1 month
Intervention | mL/s (Mean) |
---|
| Baseline | 1 month |
---|
Group 1 | 13.1 | 13.6 |
,Group 2 | 11.4 | 13.6 |
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The Postvoid Residual Volume (PVR) After the Treatment Day
"Efficacy:~Net change used the the postvoid residual volume (PVR) in Group 1 and Group 2 from baseline to 1 month.~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness" (NCT01661621)
Timeframe: Baseline and 1 month
Intervention | mL (Mean) |
---|
| Baseline | 1 month |
---|
Group 1 | 50.1 | 60.4 |
,Group 2 | 53.9 | 42.9 |
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Change in Mean Nocturnal Urine Volume From Baseline
The mean nocturnal urine volume was derived from the three-day urine volume diary. The nocturnal volume was defined as the sum of the volumes for all nocturnal voids including the volume of the first morning void within 30 min of waking up in the morning. (NCT01729819)
Timeframe: Baseline to 3 months of treatment
Intervention | mL (Least Squares Mean) |
---|
Combination | -156.6 |
Tolterodine | -92.46 |
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Change in Mean Number of Nocturnal Voids From Baseline
A nocturnal void was defined as a void occurring at least 5 minutes after going to bed, but before getting up the next morning. The mean estimate was the average over 3 consecutive 24-hour periods prior to the respective visit as captured in the voiding and sleep diary. (NCT01729819)
Timeframe: Baseline to 3 months of treatment
Intervention | Voids (Least Squares Mean) |
---|
Combination | -1.63 |
Tolterodine | -1.29 |
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Change in Mean Time to First Nocturnal Void From Baseline
The time to first nocturnal void was defined as the time from going to bed with the intention of sleeping until first nocturnal void or until waking in the morning in the case there is no nocturnal void. The time to first void was calculated as the average over three consecutive 24-hour periods prior to the respective visits. (NCT01729819)
Timeframe: Baseline to 3 months of treatment
Intervention | Minutes (Least Squares Mean) |
---|
Combination | 118.19 |
Tolterodine | 100.19 |
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Responder Status
Responder status was defined as ≥33% decrease in the mean number of nocturnal void and at least one night with no voids out of the 3-day diary period. (NCT01729819)
Timeframe: Baseline to 3 months of treatment
Intervention | Proportion of responders (Number) |
---|
Combination | 0.40 |
Tolterodine | 0.29 |
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Change in the Impact on Sleep as Measured by the Sleep Rating Scales From Baseline
An electronic diary was used in the trial to document the impact on sleep quality (sleep rating scales). The sleep rating scales included three questions that ranged from 0 (poor) to 10 (good). The average of each question for each visit was summarised and the change from baseline was analysed longitudinally during the three months of treatment. (NCT01729819)
Timeframe: Baseline to 3 months of treatment
Intervention | Score on scale (Least Squares Mean) |
---|
| From very tired to wide awake, how do you feel now | Rate how refreshed you feel now | Rate the quality of your sleep last night |
---|
Combination | 1.76 | 1.81 | 1.95 |
,Tolterodine | 1.33 | 1.46 | 1.67 |
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Onset of Effect as Seen in Change in Mean Number of Nocturnal Voids From Baseline for Each Visit During Three Months of Treatment
A nocturnal void was defined as a void occurring at least 5 minutes after going to bed, but before getting up the next morning. The mean estimate was the average over 3 consecutive 24-hour periods prior to the respective visit as captured in the voiding and sleep diary. (NCT01729819)
Timeframe: Baseline to 3 months of treatment
Intervention | Voids (Least Squares Mean) |
---|
| Month 1 | Month 2 | Month 3 | Overall (during the three months) |
---|
Treatment Difference (Combination-tolterodine) | -0.19 | -0.44 | -0.43 | -0.35 |
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Ureteral Stent Symptom Questionnaire Score
The ureteral stent symptom questionnaire contains 36 items from the 5 subscales: urinary index (11-items, total range of scores 11-54, The range of the mean score is 1-4.9), pain (8-items, total range of scores 5-27. Two items are not included in the calculation. The range of the mean score is 0.83-4.5), general health (6-items, total range of scores 4-28. The range of the mean score is 0.67-4.67), work (if stent influence patients work; 7-items, total range of scores 3-15. Four items are not included in the calculation. The range of the mean score is 1-5), and sexual matters (4-items, total range of scores 2-10. Two items are not included in the calculation. The range of the mean score is 1-5). In all cases, higher scores indicate worse outcomes. The score for each subscale is summed and divided by the number of items on the subscale. The group mean for each subscale is reported, the score is not normalized. (NCT01741454)
Timeframe: 42-48 hours post-stent insertion
Intervention | score on a scale (Mean) |
---|
| Urinary index | Pain score | General health score | Work | Sexual matters |
---|
Tamsulosin Plus Placebo 21-day Treatment | 2.98 | 2.9 | 2.64 | 2.1 | 1.83 |
,Tamsulosin Plus Placebo 7-day Treatment | 2.95 | 2.66 | 2.35 | 2.04 | 2.07 |
,Tamsulosin Plus Tolterodine ER 21-day Treatment | 2.83 | 2.71 | 2.78 | 1.79 | 1.75 |
,Tamsulosin Plus Tolterodine ER 7-day Treatment | 2.91 | 2.89 | 2.69 | 2.92 | 2 |
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Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion
The ureteral stent symptom questionnaire contains 36 items from the 5 subscales: urinary index (11-items, total range of scores 11-54, The range of the mean score is 1-4.9), pain (8-items, total range of scores 5-27. Two items are not included in the calculation. The range of the mean score is 0.83-4.5), general health (6-items, total range of scores 4-28. The range of the mean score is 0.67-4.67), work (if stent influence patients work; 7-items, total range of scores 3-15. Four items are not included in the calculation. The range of the mean score is 1-5), and sexual matters (4-items, total range of scores 2-10. Two items are not included in the calculation. The range of the mean score is 1-5). In all cases, higher scores indicate worse outcomes. The score for each subscale is summed and divided by the number of items on the subscale. The group mean for each subscale is reported, the score is not normalized. (NCT01741454)
Timeframe: 5-7 days post-stent insertion
Intervention | score on a scale (Mean) |
---|
| Urinary index | Pain score | General health score | Work | Sexual matters |
---|
Tamsulosin Plus Placebo 21-day Treatment | 2.49 | 2.58 | 2.52 | 1.94 | 1.75 |
,Tamsulosin Plus Placebo 7-day Treatment | 2.46 | 2.39 | 2.34 | 2.81 | 1.5 |
,Tamsulosin Plus Tolterodine ER 21-day Treatment | 2.46 | 2.4 | 2.28 | 1.47 | 2.9 |
,Tamsulosin Plus Tolterodine ER 7-day Treatment | 2.55 | 2.49 | 2.33 | 2.61 | 1.59 |
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Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal
The ureteral stent symptom questionnaire contains 36 items from the 5 subscales: urinary index (11-items, total range of scores 11-54, The range of the mean score is 1-4.9), pain (8-items, total range of scores 5-27. Two items are not included in the calculation. The range of the mean score is 0.83-4.5), general health (6-items, total range of scores 4-28. The range of the mean score is 0.67-4.67), work (if stent influence patients work; 7-items, total range of scores 3-15. Four items are not included in the calculation. The range of the mean score is 1-5), and sexual matters (4-items, total range of scores 2-10. Two items are not included in the calculation. The range of the mean score is 1-5). In all cases, higher scores indicate worse outcomes. The score for each subscale is summed and divided by the number of items on the subscale. The group mean for each subscale is reported, the score is not normalized. (NCT01741454)
Timeframe: Up to 24 hours after stent removal. Removal will occur 5 to 7 days after insertion.
Intervention | score on a scale (Mean) |
---|
| Urinary index | Pain score | General health score | Work | Sexual matters |
---|
Tamsulosin Plus Placebo 21-day Treatment | 1.85 | 1.97 | 1.84 | 2.13 | 1.58 |
,Tamsulosin Plus Placebo 7-day Treatment | 1.72 | 1.66 | 1.73 | 1.57 | 1.42 |
,Tamsulosin Plus Tolterodine ER 21-day Treatment | 2.14 | 2.08 | 1.99 | 1.56 | 2.42 |
,Tamsulosin Plus Tolterodine ER 7-day Treatment | 1.91 | 1.66 | 1.67 | 1.41 | 1.3 |
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Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion
The ureteral stent symptom questionnaire contains 36 items from the 5 subscales: urinary index (11-items, total range of scores 11-54, The range of the mean score is 1-4.9), pain (8-items, total range of scores 5-27. Two items are not included in the calculation. The range of the mean score is 0.83-4.5), general health (6-items, total range of scores 4-28. The range of the mean score is 0.67-4.67), work (if stent influence patients work; 7-items, total range of scores 3-15. Four items are not included in the calculation. The range of the mean score is 1-5), and sexual matters (4-items, total range of scores 2-10. Two items are not included in the calculation. The range of the mean score is 1-5). In all cases, higher scores indicate worse outcomes. The score for each subscale is summed and divided by the number of items on the subscale. The group mean for each subscale is reported, the score is not normalized. (NCT01741454)
Timeframe: Up to 24 hours prior to stent insertion
Intervention | score on a scale (Mean) |
---|
| Urinary index | Pain score | General health score | Work | Sexual matters |
---|
Tamsulosin Plus Placebo 21-day Treatment | 2.02 | 2.49 | 2.15 | 2.05 | 1.77 |
,Tamsulosin Plus Placebo 7-day Treatment | 1.76 | 1.95 | 1.87 | 1.65 | 1.60 |
,Tamsulosin Plus Tolterodine ER 21-day Treatment | 1.93 | 1.88 | 2.07 | 1.18 | 1.57 |
,Tamsulosin Plus Tolterodine ER 7-day Treatment | 1.84 | 2.13 | 2.04 | 1.76 | 1.41 |
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Percent Change in Urgency Urinary Incontinence Episodes
Percent change in median UUI episodes from baseline to 12 months with comparison made between hypnotherapy & pharmacotherapy (NCT01829425)
Timeframe: 12 months
Intervention | percentage change in median UUI episodes (Median) |
---|
Hypnotherapy | 85.7 |
Anticholinergic Medications | 80.0 |
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Percent Change in Urgency Urinary Incontinence Episodes
Percent change in UUI episodes from baseline to 2 months with comparison made between hypnotherapy & pharmacotherapy (NCT01829425)
Timeframe: Baseline and 2 month follow-up
Intervention | percentage change in median UUI episodes (Median) |
---|
Hypnotherapy | 73 |
Anticholinergic Medications | 88.6 |
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Voids on Bladder Diary
number of voids on 3-day bladder diary (NCT01829425)
Timeframe: 12 months
Intervention | counts (Mean) |
---|
Hypnotherapy | 25.74 |
Anticholinergic Medications | 25.37 |
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Voids on Bladder Diary
Total Number of voids on 3-day bladder diary. (NCT01829425)
Timeframe: 2 months
Intervention | counts (Mean) |
---|
Hypnotherapy | 26.4 |
Anticholinergic Medications | 25.35 |
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Voids on Bladder Diary
number of voids on 3-day bladder diary (NCT01829425)
Timeframe: 6 months
Intervention | counts (Mean) |
---|
Hypnotherapy | 25.58 |
Anticholinergic Medications | 24.28 |
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Percent Change in Urgency Urinary Incontinence Episodes
Differences comparing hypnotherapy to pharmacotherapy percent change in median UUI episodes (NCT01829425)
Timeframe: 6 months
Intervention | percentage change in median UUI episodes (Median) |
---|
Hypnotherapy | 85.7 |
Anticholinergic Medications | 83.3 |
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Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Improvement in Day-to-Day Life Due to OAB Medication
Overall assessment of improvement in day-to-day life due to OAB medication was assessed on a scale from 1 to 5, with higher scores indicating greater improvement in day-to-day life due to current OAB medication. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)
Intervention | Units on a Scale (Mean) |
---|
Mirabegron | 3.43 |
Tolterodine ER | 3.46 |
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Change From Baseline to End of Treatment (EOT) in Mean Number of Incontinence Episodes Per 24 Hours
(NCT02138747)
Timeframe: Baseline and EOT (Period 1-Week 8 and Period 2- Week 18)
Intervention | Incontinence Episodes (Least Squares Mean) |
---|
Mirabegron | -1.51 |
Tolterodine ER | -1.46 |
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Change From Baseline to End of Treatment (EOT) in Number of Micturitions Per 24 Hours
(NCT02138747)
Timeframe: Baseline and EOT (Period 1-Week 8 and Period 2- Week 18)
Intervention | Micturitions (Least Squares Mean) |
---|
Mirabegron | -2.06 |
Tolterodine ER | -1.95 |
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Participants Tolerability Assessed by the Medication Tolerability Scale of the Overactive Bladder-Satisfaction (OAB-S) Questionnaire at the End of Treatment (EOT)
The medication tolerability scale measured the level of bothersomeness related to the occurrence of a side effect that was known to be related to the approved OAB medication (i.e., constipation, dry mouth, drowsiness, headache, nausea and blurred vision). The OAB medication tolerability score was calculated as a sum of the responses and converted to a scale from 0 to 100, where higher score indicates better perceived OAB medication tolerability (less bother from side-effects). (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)
Intervention | Units on a Scale (Least Squares Mean) |
---|
Mirabegron | 86.29 |
Tolterodine ER | 83.40 |
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Scale of the OAB-S Questionnaire at the End of Treatment Period: Impact on Daily Living With OAB.
Impact on daily living with the OAB was scored from 0 to 100, with higher scores indicating greater satisfaction with ability to perform daily activities. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)
Intervention | Units on a Scale (Mean) |
---|
Mirabegron | 72.98 |
Tolterodine ER | 71.92 |
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Scale of the OAB-S Questionnaire at the End of Treatment Period: OAB Control
OAB control was scored from 0 to 100, with higher scores indicating better OAB control. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)
Intervention | Units on a Scale (Mean) |
---|
Mirabegron | 64.49 |
Tolterodine ER | 63.38 |
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Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Interruption of Day-to-Day Life Due to OAB
Overall assessment of interruption of day-to-day life due to OAB was assessed on a scale from 1 to 5, with higher scores indicating less interruption of day-to-day life due to OAB symptoms. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)
Intervention | Unit on a Scale (Mean) |
---|
Mirabegron | 3.00 |
Tolterodine ER | 3.02 |
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Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Participant's Fulfillment of OAB Medication Expectations
The final item score for overall assessment of patient's fulfillment of OAB medication expectations ranged from 1 to 5, with higher scores indicating better fulfillment of OAB medication expectations. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)
Intervention | Units on a Scale (Mean) |
---|
Mirabegron | 3.10 |
Tolterodine ER | 3.08 |
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Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Willingness to Continue OAB Medication
Overall assessment of willingness to continue OAB medication, was assessed on a scale from 1 to 5, with higher scores indicating greater desire to continue with current OAB medication. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)
Intervention | Units on a Scale (Mean) |
---|
Mirabegron | 3.69 |
Tolterodine ER | 3.69 |
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Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Satisfaction With OAB Medication
Overall satisfaction with OAB medication was assessed on a scale of 1 to 5, with higher scores indicating greater satisfaction with current OAB medication. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)
Intervention | Units on a Scale (Mean) |
---|
Mirabegron | 3.70 |
Tolterodine ER | 3.66 |
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Scale of the OAB-S Questionnaire at the End of Treatment Period: Satisfaction With OAB Control
Satisfaction with OAB control was scored from 0 to 100 with higher scores indicating greater satisfaction with OAB control. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)
Intervention | Units on a Scale (Mean) |
---|
Mirabegron | 69.17 |
Tolterodine ER | 68.31 |
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Number of Participants With Adverse Events
Safety was assessed by evaluation of treatment-emergent adverse events (TEAEs; frequency, severity, seriousness and relationship to study drug), AEs of special interest, vital signs (SBP, DBP, body temperature and pulse rate) and laboratory tests (liver function tests [LFTs]). Treatment-Emergent Adverse Event (TEAEs) were defined as any adverse event starting or worsening in the period from first dose of double-blind study drug until 15 days after last dose of double-blind study drug. (NCT02138747)
Timeframe: Baseline to EOT (Week 18) and follow up (Week 20)
Intervention | Participants (Number) |
---|
| Adverse Events (AEs) | Drug-related (AEs) | Deaths | Serious Adverse Event (SAE) | Drug-related SAEs | AEs Leading to Permanent Discontinuation of Drug | Drug-related AEs Leading to Permanent Discontinuat | SAEs Leading to Permanent Discontinuation | Drug-related SAEs Leading to Permanent Discontinu |
---|
Mirabegron | 150 | 89 | 0 | 3 | 2 | 15 | 12 | 0 | 0 |
,Tolterodine ER | 168 | 111 | 0 | 8 | 0 | 20 | 12 | 5 | 0 |
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Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods.
"Participants were asked to choose which treatment period they preferred and the degree of preference. Preference was assessed on a 5-point scale assessed at the end of period 2 (strong preference for period 1, mild preference for period 1, no preference, mild preference for period 2, strong preference for period 2). Participants who selected either a mild preference or strong preference were considered as having a preference for a specific study drug and participants who selected no preference were considered as having no preference for one study drug over the other study drug." (NCT02138747)
Timeframe: Week 18 (End of Period 2)
Intervention | Percentage of participants (Number) |
---|
| Preference for Period 1 | Preference for Period 2 | No Preference | Total With Preference |
---|
AA: Mirabegron/Mirabegron | 36.0 | 36.0 | 28.0 | 72.0 |
,AB: Mirabegron/Tolterodine ER | 29.9 | 37.8 | 32.3 | 67.7 |
,BA: Tolterodine ER /Mirabegron | 34.4 | 37.6 | 28.0 | 72.0 |
,BB: Tolterodine ER /Tolterodine ER | 23.1 | 50.0 | 26.9 | 73.1 |
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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) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 28 | Week 40 | Week 52 | End of treatment |
---|
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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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) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 28 | Week 40 | Week 52 | End of treatment |
---|
Mirabegron + Imidafenacin | -1.23 | -1.50 | -1.88 | -2.01 | -2.18 | -2.14 | -2.15 | -2.04 |
,Mirabegron + Propiverine | -1.63 | -1.90 | -2.18 | -2.36 | -2.26 | -2.27 | -2.33 | -2.24 |
,Mirabegron + Solifenacin | -1.53 | -1.78 | -2.06 | -2.30 | -2.28 | -2.14 | -2.04 | -2.03 |
,Mirabegron + Tolterodine | -1.49 | -1.89 | -2.10 | -2.26 | -2.28 | -2.19 | -2.26 | -2.07 |
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Change From Baseline in the Mean 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) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 28 | Week 40 | Week 52 | End of treatment |
---|
Mirabegron + Imidafenacin | -0.72 | -0.71 | -0.79 | -0.87 | -0.85 | -0.91 | -0.93 | -0.91 |
,Mirabegron + Propiverine | -1.00 | -1.14 | -1.25 | -1.22 | -1.10 | -1.14 | -1.14 | -1.12 |
,Mirabegron + Solifenacin | -1.13 | -1.15 | -1.20 | -1.17 | -1.26 | -1.19 | -1.23 | -1.20 |
,Mirabegron + Tolterodine | -0.96 | -1.05 | -1.13 | -1.22 | -1.18 | -1.07 | -1.15 | -1.05 |
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Change From Baseline in the Mean Number of 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 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 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 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 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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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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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 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 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 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 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) |
---|
| 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. |
---|
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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Change From Baseline in Trail Making Test, Trail A Score at 8 Weeks
Trail Making Test, Trail A Time, Range 0-150 seconds, Lower score indicates better functioning (NCT02436889)
Timeframe: Baseline and 8 weeks
Intervention | seconds (Mean) |
---|
Mirabegron | -11.34 |
Tolterodine Tartrate | 0.67 |
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Change From Baseline in California Verbal Learning Test (CVLT) Score at 8 Weeks
Range of 0-80, with the higher the score the better. (NCT02436889)
Timeframe: Baseline to Week 8
Intervention | Score on a Scale (Mean) |
---|
Mirabegron | 4.70 |
Tolterodine Tartrate | 1.59 |
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Change From Baseline in Urge Incontinence Episodes Per Day on a Voiding Diary at 8 Weeks.
The sum of urge type incontinence episodes reported by participants on a voiding diary per day. (NCT02436889)
Timeframe: Baseline and 8 weeks
Intervention | episodes per day (Mean) |
---|
Mirabegron | -1.64 |
Tolterodine Tartrate | -3.74 |
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Change From Baseline in Total Urinary Incontinence Frequency Measured by a Voiding Diary at 8 Weeks
Study participants record number of urinary incontinence episodes in a voiding diary. The total urinary incontinence frequency is the sum of urinary incontinence episodes per day. (NCT02436889)
Timeframe: Baseline to Week 8
Intervention | episodes per day (Mean) |
---|
Mirabegron | -2.04 |
Tolterodine Tartrate | -3.91 |
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Percentage of OAB Wet Participants With at Least a 50% Reduction From Baseline in Total Incontinence Episodes Per 24 Hours at Week 12
"Total incontinence is defined as having any reason for Accidental Urine Leakage and/or Accidental Urine Leakage checked, as indicated on the PVD. It is assumed that if the participant recorded a reason for leakage then the accidental urine leakage occurred. All events marked as having leakage, regardless of cause, or where Accidental Leakage was checked. were used in the analysis. Per 24 hours corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD." (NCT03492281)
Timeframe: Baseline; Week 12
Intervention | percentage of participants (Number) |
---|
| Unadjusted | Adjusted for sex |
---|
Placebo: OAB Wet | 53.8 | 49.9 |
,Tolterodine ER 4 mg: OAB Wet | 66.5 | 61.5 |
,Vibegron 75 mg: OAB Wet | 64.0 | 61.6 |
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Percentage of OAB Wet Participants With a 100% Reduction From Baseline in UUI Episodes Per 24 Hours at Week 12
"The number of UUI episodes is defined as the number of times a participant had checked urge as the main reason for the leakage in the PVD, regardless of whether more than one reason for leakage in addition to urge was checked. The average daily number of UUI episodes was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of UUI episodes that occurred on a CDD divided by the number of CCDs in the PVD. CFB was calculated as the post-BL value minus the BL value. Per 24 hours corresponds to one Diary Day (i.e., time between when participant got up for the day each morning and time participant got up for the day the next morning as recorded in the PVD)." (NCT03492281)
Timeframe: Baseline; Week 12
Intervention | percentage of participants (Number) |
---|
| Unadjusted | Adjusted for sex |
---|
Placebo: OAB Wet | 22.5 | 19.0 |
,Tolterodine ER 4 mg: OAB Wet | 26.6 | 20.9 |
,Vibegron 75 mg: OAB Wet | 28.8 | 25.3 |
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Percentage of All OAB Participants With at Least a 50% Reduction From Baseline in Urgency Episodes Per 24 Hours at Week 12
"An urgency episode is defined as the Need to Urinate Immediately as indicated on the PVD. CFB is calculated as the post-BL value minus the BL value. Per 24 hours corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD)." (NCT03492281)
Timeframe: Baseline; Week 12
Intervention | percentage of participants (Number) |
---|
| Unadjusted | Adjusted for sex |
---|
Placebo | 38.3 | 32.8 |
,Tolterodine ER 4 mg | 41.2 | 36.4 |
,Vibegron 75 mg | 43.2 | 39.5 |
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Percentage of All OAB Participants With an Average Number of Micturitions < 8 Per 24 Hours at Week 12
"A micturition/void is defined as Urinated in Toilet as indicated on the PVD. The number of micturitions is defined as the number of times a participant voided in the toilet as indicated on the PVD. A participant was defined as having an average of < 8 daily micturitions if the arithmetic mean of the number of micturitions per day in the PVD was less than 8 . Per 24 hours corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD)." (NCT03492281)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
| Unadjusted | Adjusted for sex |
---|
Placebo | 28.7 | 24.8 |
,Tolterodine ER 4 mg | 35.0 | 31.6 |
,Vibegron 75 mg | 40.1 | 37.2 |
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CFB at Week 12 in the Symptom Bother Score From the OAB-q LF (1-week Recall) in All OAB Participants
"The OAB-q LF is a validated patient-reported outcome. The first 8 questions of the OAB-q LF ask participants how much they were bothered by their bladder symptoms during the previous week. Each question has a response ranging from Not at all (= 1) to A very great deal (= 6). These questions make up the symptom bother scale. The raw score (sum of question scores [ranging from 8 to 48]) is transformed to a unified score, ranging from 0 to 100. Higher scores correspond to the symptoms having a larger bother, and lower scores represent a lower amount of bother due to symptoms. CFB is calculated as the post-BL value minus the BL value. Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), sex, region (U.S./non-U.S.), OAB type (wet/dry), BL score, and treatment by study visit interaction." (NCT03492281)
Timeframe: Baseline; Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | -12.8 |
Vibegron 75 mg | -19.6 |
Tolterodine ER 4 mg | -17.4 |
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CFB at Week 12 in the Average Volume Voided Per Micturition in All OAB Participants
"A micturition/void is defined as Urinated in Toilet as indicated on the PVD. The number of micturitions is defined as the number of times a participant voided in the toilet as indicated on the PVD. CFB is calculated as the post-BL value minus the BL value. Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), OAB type (wet/dry), sex, region (U.S./non-U.S.), BL volume (milliliters [mL]), and treatment by study visit interaction." (NCT03492281)
Timeframe: Baseline; Week 12
Intervention | mL per micturition (Least Squares Mean) |
---|
Placebo | 2.2 |
Vibegron 75 mg | 23.5 |
Tolterodine ER 4 mg | 15.5 |
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CFB at Week 12 in the Average Number of Urgency Episodes Over 24 Hours in All OAB Participants
"An urgency episode is defined as the Need to Urinate Immediately as indicated on the PVD. CFB is calculated as the post-BL value minus the BL value. Over 24 hours corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD). Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), OAB type (wet/dry), sex, region (U.S./non-U.S.), BL number of urgency episodes, and treatment by study visit interaction." (NCT03492281)
Timeframe: Baseline; Week 12
Intervention | urgency episodes over 24 hours (Least Squares Mean) |
---|
Placebo | -2.0 |
Vibegron 75 mg | -2.7 |
Tolterodine ER 4 mg | -2.5 |
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CFB at Week 12 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants
"The number of UUI episodes is defined as the number of times a participant had checked urge as the main reason for the leakage in the PVD, regardless of whether more than one reason for leakage in addition to urge was checked. The average daily number of UUI episodes was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of UUI episodes that occurred on a CDD divided by the number of CCDs in the PVD. CFB was calculated as the post-BL value minus the BL value. Per 24 hours corresponds to one Diary Day (i.e., time between when participant got up for the day each morning and time participant got up for the day the next morning as recorded in the PVD). Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), sex, region (U.S./non-U.S.), BL number of UUI episodes and treatment by study visit interaction. FAS-I=Full Analysis Set for Incontinence." (NCT03492281)
Timeframe: Baseline; Week 12
Intervention | UUI episodes per 24 hours (Least Squares Mean) |
---|
Placebo: OAB Wet | -1.4 |
Vibegron 75 mg: OAB Wet | -2.0 |
Tolterodine ER 4 mg: OAB Wet | -1.8 |
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CFB at Week 12 in the Average Number of Total Incontinence Episodes Over 24 Hours in OAB Wet Participants
"Total incontinence is defined as having any reason for Accidental Urine Leakage and/or Accidental Urine Leakage checked, as indicated on the PVD. It is assumed that if the participant recorded a reason for leakage then the accidental urine leakage occurred. CFB is calculated as the post-BL value minus the BL value. Over 24 hours corresponds to one Diary Day (i.e., time between when the par. got up for the day each morning and time the par. got up for the day the next morning as recorded in the PVD). Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), sex, region (U.S./non-U.S.), BL number of incontinence episodes, and treatment by study visit interaction. hr = hours." (NCT03492281)
Timeframe: Baseline; Week 12
Intervention | total incontinence episodes over 24 hr (Least Squares Mean) |
---|
Placebo: OAB Wet | -1.6 |
Vibegron 75 mg: OAB Wet | -2.3 |
Tolterodine ER 4 mg: OAB Wet | -2.0 |
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CFB at Week 12 in Overall Control Over Bladder Symptoms Based on Patient Global Impression of Control (PGI-Control) in All OAB Participants
The Patient Global Impression (PGI) questions are designed to assess a participant's overall impression of OAB. For the PGI-Control score, participants were asked to rate how much control they had over their OAB symptoms over the previous week with one of the following responses: 1 = complete control, 2 = a lot of control, 3 = some control, 4 = only a little control, 5 = no control. CFB is calculated as the post-BL value minus the BL value. Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), OAB type (wet/dry), sex, region (U.S./non-U.S.), BL score, and treatment by study visit interaction. (NCT03492281)
Timeframe: Baseline; Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | -0.7 |
Vibegron 75 mg | -1.0 |
Tolterodine ER 4 mg | -0.9 |
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CFB at Week 12 in Overall Bladder Symptoms Based on Patient Global Impression of Severity (PGI-Severity) in All OAB Participants
The Patient Global Impression (PGI) questions are designed to assess a participant's overall impression of OAB. For the PGI-Severity score, participants are asked to rate their OAB symptoms over the previous week with one of the following responses: 1 = none, 2 = mild, 3 = moderate, 4 = severe. CFB is calculated as the post-BL value minus the BL value. Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), OAB type (wet/dry), sex, region (U.S./non-U.S.), BL score, and treatment by study visit interaction. (NCT03492281)
Timeframe: Baseline; Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | -0.5 |
Vibegron 75 mg | -0.8 |
Tolterodine ER 4 mg | -0.7 |
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Change From Baseline (CFB) at Week 12 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants
"A micturition/void is defined as Urinated in Toilet as indicated on the Patient Voiding Diary (PVD). The number of micturitions is defined as the number of times a participant voided in the toilet as indicated on the PVD. The average daily number of micturitions was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of micturitions that occurred on a Complete Diary Day (CDD) divided by the number of CDDs in the PVD. CFB was calculated as the post-BL value minus the BL value. Per 24 hours corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD). Covariates included in the mixed model for repeated measures are study visit (Weeks 2, 4, 8, and 12), OAB type (wet/dry), sex, region (U.S./non-U.S.), BL number of micturitions, and treatment by study visit interaction. FAS=Full Analysis Set." (NCT03492281)
Timeframe: Baseline (BL); Week 12
Intervention | micturitions per 24 hours (Least Squares Mean) |
---|
Placebo | -1.3 |
Vibegron 75 mg | -1.8 |
Tolterodine ER 4 mg | -1.6 |
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Percentage of OAB Wet Participants With at Least a 75% Reduction From Baseline in UUI Episodes Per 24 Hours at Week 12
"The number of UUI episodes is defined as the number of times a participant had checked urge as the main reason for the leakage in the PVD, regardless of whether more than one reason for leakage in addition to urge was checked. The average daily number of UUI episodes was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of UUI episodes that occurred on a CDD divided by the number of CCDs in the PVD. CFB was calculated as the post-BL value minus the BL value. Per 24 hours corresponds to one Diary Day (i.e., time between when participant got up for the day each morning and time participant got up for the day the next morning as recorded in the PVD)." (NCT03492281)
Timeframe: Baseline; Week 12
Intervention | percentage of participants (Number) |
---|
| Unadjusted | Adjusted for sex |
---|
Placebo: OAB Wet | 36.8 | 32.8 |
,Tolterodine ER 4 mg: OAB Wet | 47.6 | 42.2 |
,Vibegron 75 mg: OAB Wet | 52.4 | 49.3 |
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Changes in the Volume of Residual Urine
Measured via the urine bladder ultrasound (US) (NCT03575702)
Timeframe: Baseline and Week 4, 8 and 12
Intervention | ml (Mean) |
---|
| Baseline | Change week 4 of treatment | Change week 8 of treatment | Change week 12 of treatment |
---|
Uritos® | 10.0 | -0.9 | -1.4 | -1.5 |
,Urotol® | 10.6 | -1.3 | -2.2 | -2.0 |
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Change in the Mean Weekly Number of Incontinence Episodes at Week 12
The mean weekly number of incontinence episodes was calculated as the total number of episodes per day (from 7 am to 7 am the next day) for the study period (between visits) divided by the number of weeks in the period. (NCT03575702)
Timeframe: Baseline and Week 12
Intervention | incontinence episodes per week (Mean) |
---|
| Baseline | Week 12 of treatment | Change |
---|
Uritos® | 17.2 | 3.0 | -14.5 |
,Urotol® | 16.9 | 3.2 | -13.6 |
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Change in the Mean Number of Incontinence Episodes at Week 2, 4 and 8
Separately for daily, daytime and nighttime measurements. (NCT03575702)
Timeframe: Baseline and Week 2, 4 and 8
Intervention | incontinence episodes per day (Mean) |
---|
| Baseline number of daily incontinence episodes | Change in daily incontinence episodes (week 2) | Change in daily incontinence episodes (week 4) | Change in daily incontinence episodes (week 8) | Baseline number of daytime incontinence episodes | Change in daytime incontinence episodes (week 2) | Change in daytime incontinence episodes (week 4) | Change in daytime incontinence episodes (week 8) | Baseline number of nightime incontinence episodes | Change in nighttime incontinence episodes (week 2) | Change in nighttime incontinence episodes (week 4) | Change in nighttime incontinence episodes (week 8) |
---|
Uritos® | 2.5 | -1.5 | -1.8 | -2.0 | 2.0 | -1.2 | -1.5 | -1.7 | 0.5 | -0.3 | -0.3 | -0.3 |
,Urotol® | 2.4 | -1.3 | -1.7 | -1.8 | 1.9 | -1.0 | -1.3 | -1.4 | 0.5 | -0.3 | -0.4 | -0.4 |
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Change in the Mean Nighttime Number of Incontinence Episodes at Week 12
The mean nighttime number of incontinence episodes was calculated as the total number of episodes from 11 pm to 7 am for the study period (between visits) divided by the number of days in the period. (NCT03575702)
Timeframe: Baseline and Week 12
Intervention | nighttime incontinence episode per day (Mean) |
---|
| Baseline | Week 12 of treatment | Change |
---|
Uritos® | 0.5 | 0.1 | -0.4 |
,Urotol® | 0.5 | 0.1 | -0.4 |
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Change in the Mean Daytime Number of Incontinence Episodes at Week 12
The mean daytime number of incontinence episodes was calculated as the total number of episodes from 7 am to 11 pm for the study period (between visits) divided by the number of days in the period. (NCT03575702)
Timeframe: Baseline and Week 12
Intervention | daytime incontinence episodes per day (Mean) |
---|
| Baseline | Week 12 of treatment | Change |
---|
Uritos® | 2.0 | 0.4 | -1.7 |
,Urotol® | 1.9 | 0.4 | -1.5 |
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Number of Patients With Adverse Events (AEs)
(NCT03575702)
Timeframe: Up to 35 days after the end of treatment
Intervention | Participants (Count of Participants) |
---|
Uritos® | 70 |
Urotol® | 72 |
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Number of Patients With Clinically Significant Changes in ECG Parameters
(NCT03575702)
Timeframe: Week 12 of treatment
Intervention | Participants (Count of Participants) |
---|
Uritos® | 0 |
Urotol® | 0 |
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Number of Patients With Clinically Significant Vital Signs Changes
(NCT03575702)
Timeframe: Week 12 of treatment
Intervention | Participants (Count of Participants) |
---|
Uritos® | 0 |
Urotol® | 0 |
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Number of Patients With Serious Adverse Events (SAEs)
(NCT03575702)
Timeframe: Up to 35 days after the end of treatment
Intervention | Participants (Count of Participants) |
---|
Uritos® | 0 |
Urotol® | 0 |
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Change in the EQ-5D-based Quality of Life at Week 12
"The Euro Quality of Life five Dimensions questionnaire ( EQ-5D, version EQ-5D-5L) is a validated questionnaire for the assessment of health-related quality of life. It consists of a questionnaire and a visual analogue scale (EQ-VAS). The self-assessment questionnaire is self-reported description of the subject's current health in 5 dimensions i.e., mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The subject is asked to assess their own current level of function in each dimension by 5-level scale from no problems to significant problem grades. The EQ-VAS is a self-rated health status using a VAS in mm from 0 (the worse health status) to 100 (the best health status). The EQ-VAS records the subject's perceptions of their own current overall health quantitatively in mm and can be used to monitor changes with time. The results of patients assessment by VAS are presented." (NCT03575702)
Timeframe: Baseline and Week 12
Intervention | score on a scale, mm (Mean) |
---|
| Baseline | Week 12 of treatment | Change (week 12) |
---|
Uritos® | 67.7 | 81.7 | 13.8 |
,Urotol® | 66.8 | 79.5 | 12.5 |
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Change in the Mean Daily Number of Incontinence Episodes at Week 12
The mean daily number of incontinence episodes was calculated as the total number of episodes (on the basis of the data that patients entered into their diaries) per day (from 7 am to 7 am the next day) for the study period (between visits) divided by the number of days in the period. (NCT03575702)
Timeframe: Baseline and Week 12
Intervention | incontinence episodes per day (Mean) |
---|
| Baseline | Week 12 of treatment | Change |
---|
Uritos® | 2.5 | 0.4 | -2.1 |
,Urotol® | 2.4 | 0.5 | -1.9 |
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Change in the Mean Daily Number of Urination Episodes at Week 12
The mean daily number of urination episodes was calculated as the total number of episodes (on the basis of the data that patients entered into their diaries) per day (from 7 am to 7 am the next day) for the study period (between visits) divided by the number of days in the period. (NCT03575702)
Timeframe: Baseline and Week 12
Intervention | urination episodes per day (Mean) |
---|
| Baseline | Week 12 of treatment | Change |
---|
Uritos® | 12.5 | 9.0 | -3.6 |
,Urotol® | 11.9 | 8.6 | -3.4 |
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Change in the Mean Daily Number of Urination Episodes at Week 2, 4 and 8 Visit as Compared to the Treatment Initiation Visit
The mean daily number of incontinence episodes was calculated as the total number of episodes (on the basis of the data that patients entered into their diaries) per day (from 7 am to 7 am the next day) for the study period (between visits) divided by the number of days in the period. (NCT03575702)
Timeframe: Baseline and Week 2, 4 and 8
Intervention | urination episodes per day (Mean) |
---|
| Baseline | Week 2 of treatment | Change (week 2) | Week 4 of treatment | Change (week 4) | Week 8 of treatment | Change (week 8) |
---|
Uritos® | 12.5 | 10.6 | -1.9 | 9.6 | -2.8 | 9.4 | -3.2 |
,Urotol® | 11.9 | 10.3 | -1.6 | 9.4 | -2.6 | 8.9 | -3.1 |
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Number of Patients With Clinically Significant Changes in Laboratory Parameters
Including blood chemistry, blood count and urinalysis (NCT03575702)
Timeframe: Week 8 and 12
Intervention | Participants (Count of Participants) |
---|
| Week 8 of treatment | Week 12 of treatment |
---|
Uritos® | 2 | 1 |
,Urotol® | 1 | 3 |
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CFB at Week 52 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants
"The number of UUI episodes is defined as the number of times a participant had checked urge as the main reason for the leakage in the PVD, regardless of whether more than one reason for leakage in addition to urge was checked. The average daily number of UUI episodes was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of UUI episodes that occurred on a CDD divided by the number of CDDs in the PVD. CFB was calculated as the post-BL value minus the BL value. Per 24 hours corresponds to one Diary Day (i.e., time between when participant got up for the day each morning and time participant got up for the day the next morning as recorded in the PVD). Covariates included in the MMRM were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: sex. Only participants with evaluable data were analyzed." (NCT03583372)
Timeframe: Baseline; Week 52
Intervention | UUI episodes per 24 hours (Least Squares Mean) |
---|
52 Weeks Vibegron 75 mg | -2.2 |
52 Weeks Tolterodine ER 4 mg | -1.7 |
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Change From Baseline (CFB) at Week 52 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants
"A micturition/void is defined as Urinated in Toilet as indicated on the Patient Voiding Diary (PVD). The number of micturitions is defined as the number of times a participant voided in the toilet as indicated in the PVD. The average daily number of micturitions was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of micturitions that occurred on a Complete Diary Day (CDD) divided by the number of CDDs in the PVD. CFB was calculated as the post-BL value minus the BL value. Per 24 hours corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD). Covariates included in the mixed model for repeated measures (MMRM) were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: OAB type (Wet versus Dry) and sex." (NCT03583372)
Timeframe: Baseline; Week 52
Intervention | micturitions per 24 hours (Least Squares Mean) |
---|
52 Weeks Vibegron 75 mg | -2.4 |
52 Weeks Tolterodine ER 4 mg | -2.0 |
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Number of Participants With the Indicated Type of Treatment-emergent Adverse Event
Adverse events were collected in participants with overactive bladder (OAB) who previously completed treatment in Study RVT-901-3003. The treatment-emergent period was defined as the period of time from the first dose date of the active double-blind study treatment, whether in Study RVT-901-3003 or Study RVT-901-3004, through 28 days after the last dose of study treatment, or the date of initiation of another investigational agent or surgical intervention, whichever occurred first. (NCT03583372)
Timeframe: up to 56 weeks
Intervention | participants (Number) |
---|
| Any TEAE | Any study drug-related TEAE | Any Grade ≥ 3 TEAE | Any Grade ≥ 3 study drug-related TEAE | Any treatment-emergent (TE) SAE | Any study drug-related TE SAE | Any TEAE leading to discontinuation of study drug | Any TEAE of clinical interest | Any study drug-related TEAE of clinical interest |
---|
Overall Tolterodine ER 4 mg | 126 | 46 | 8 | 1 | 10 | 2 | 8 | 32 | 10 |
,Overall Vibegron 75 mg | 171 | 59 | 10 | 1 | 9 | 1 | 4 | 41 | 14 |
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CFB at Week 52 in the Average Number of Total Urinary Incontinence Episodes Over 24 Hours in OAB Wet Participants
"The number of total incontinence episodes is defined as the number of times a participant had checked the accidental urine leakage box in the PVD, including for reasons of urge, stress, or other. CFB was calculated as the post-BL value minus the BL value. Over 24 hours corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD). Covariates included in the MMRM were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: sex. hr = hour." (NCT03583372)
Timeframe: Baseline; Week 52
Intervention | Urinary incontinence episodes over 24 hr (Least Squares Mean) |
---|
52 Weeks Vibegron 75 mg | -2.5 |
52 Weeks Tolterodine ER 4 mg | -1.9 |
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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) |
---|
| 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 |
---|
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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