A Study to Examine the Safety and Efficacy of a New Drug in Patients With Symptoms of Overactive Bladder (OAB)

Overactive Bladder Clinical Trial

— Empowur  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03492281
• Other study ID #: RVT-901-3003
• Secondary ID: 2017-003293-14
• Status: Completed
• Phase: Phase 3
• Start date: March 26, 2018
• Est. completion date: February 4, 2019

Study information

• Verified date: February 2021
• Source: Urovant Sciences GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in patients with OAB.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1530
• Est. completion date: February 4, 2019
• Est. primary completion date: January 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Has a history of OAB for at least 3 months prior to the Screening Visit.

2. Meets either the OAB Wet or OAB Dry criteria.

Exclusion Criteria:

Urology Medical History

1. Patient had an average total daily urine volume > 3000 mL in the past 6 months or during the 14-day Run-in Period.

2. Has lower urinary tract pathology that could, in the opinion of the Investigator, be responsible for urgency, frequency, or incontinence.

3. Has a history of surgery to correct stress urinary incontinence, pelvic organ prolapse, or procedural treatments for BPH within 6 months of Screening.

4. Has current history or evidence of Stage 2 or greater pelvic organ prolapse (prolapse extends beyond the hymenal ring).

5. Patient is currently using a pessary for the treatment of pelvic organ prolapse.

6. Has a known history of elevated post-void residual volume defined as greater than 150 mL.

7. Has undergone bladder training or electrostimulation within 28 days prior to Screening or plans to initiate either during the study.

8. Has an active or recurrent (> 3 episodes per year) urinary tract infection by clinical symptoms or pre-defined laboratory criteria.

9. Has a requirement for an indwelling catheter or intermittent catheterization.

10. Has received an intradetrusor injection of botulinum toxin within 9 months prior to Screening.

11. Has uncontrolled hyperglycemia (defined as fasting blood glucose > 150 mg/dL or 8.33 mmol/L and/or non-fasting blood glucose > 200 mg/dL or 11.1 mmol/L) or, if in the opinion of the Investigator, is uncontrolled.

12. Has evidence of diabetes insipidus.

13. Is pregnant, breast-feeding, or is planning to conceive within the projected duration of the study.

14. Has a concurrent malignancy or history of any malignancy within 5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.

15. Has uncontrolled hypertension (systolic blood pressure of = 180 mmHg and/or diastolic blood pressure of = 100 mmHg) or has a resting heart rate (by pulse) > 100 beats per minute.

16. Has narrow angle glaucoma (primary open angle glaucoma is not excluded).

17. Has a history of cerebral vascular accident, transient ischemic attack, unstable angina, myocardial infarction, coronary artery interventions (e.g., coronary artery bypass grafting or percutaneous coronary interventions [e.g., angioplasty, stent insertion]), or neurovascular interventions (e.g., carotid artery stenting) within 6 months prior to the Screening Visit. Has a known history of liver disease.

18. Has a history of injury, surgery, or neurodegenerative diseases (e.g., multiple sclerosis, Parkinson's) that could affect the lower urinary tract or its nerve supply.

19. Has hematuria, including microscopic hematuria according to pre-defined criteria.

20. Has clinically significant electrocardiogram (ECG) abnormality.

21. Has alanine aminotransferase or aspartate aminotransferase > 2.0 times the upper limit of normal (ULN), or bilirubin (total bilirubin) > 1.5 x ULN (or > 2.0 x ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome).

22. Has an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2.

23. Has an allergy, intolerance, or a history of a significant clinical or laboratory adverse experience associated with any of the active or inactive components of the vibegron formulation or tolterodine formulation.

24. Is currently participating or has participated in a study with an investigational compound or device within 28 days prior to signing informed consent, or has participated in any previous study with vibegron.

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• vibegron
single daily oral dose of vibegron 75 mg for 12 weeks
• Vibegron placebo
placebo to match vibegron (experimental drug)
• Tolterodine Tartrate ER
single daily oral dose of tolterodine tartrate ER 4 mg for 12 weeks
• Tolterodine placebo
placebo to match tolterodine (active comparator)

Locations

Country	Name	City	State
Canada	Manna Research (Quebec)	Levis	Quebec
Canada	Recherche GCP Research	Montreal	Quebec
Canada	Manna Research (Montreal)	Montréal	Quebec
Canada	Central Alberta Research Clinic	Red Deer	Alberta
Canada	Diex Research Sherbrooke Inc.	Sherbrooke	Quebec
Canada	PrimeHealth Clinical Research	Toronto	Ontario
Canada	Silverado Research Inc.	Victoria	British Columbia
Hungary	Obudai Egeszsegugyi Centrum Kft.	Budapest
Hungary	Szarka Ödön Egyesitett Egeszsegügyi es Szocialis Intezmeny	Csongrád
Hungary	Szent Anna Private Surgery	Debrecen
Hungary	Mediroyal Prevention Center	Kecskemét
Hungary	Uro-clin Ltd	Pécs
Latvia	Daugavpils Regional Hospital	Daugavpils
Latvia	Pauls Stradins Clinical University Hospital	Riga
Latvia	Uro Ltd.	Riga
Lithuania	Public Institution Republican Klaipda Hospital	Klaipeda
Lithuania	Vilnius	Vilnius
Lithuania	Vilnius city Clinical hospital	Vilnius
Poland	Klimed Marek Klimkiewicz	Bialystok	Woj. Podlaskie
Poland	ETG Lodz	Lódz	Woj. Lodzkie
Poland	NZOZ NOVITA Specjalistyczne Gabinety Lekarskie	Lublin	Woj. Lubelskie
Poland	NZOZ Centrum Urologiczne sp. z o.o.	Myslowice	Woj. Slaskie
Poland	Nzoz Heureka	Piaseczno	Woj. Mazowieckie
Poland	Poradnia Urologiczna EuroMediCare Szpital Specjalistyczny z Przychodnia	Wroclaw	Woj. Dolnoslaskie
United States	AccumetRx Clinical Research - Division of Urology Group of New Mexico	Albuquerque	New Mexico
United States	Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico
United States	Dream Team Clinical Research LLC	Anaheim	California
United States	Millennium Clinical Trials	Arlington	Virginia
United States	Innovative Medical Research of South Florida Inc.	Aventura	Florida
United States	Pioneer Clinical Research, LLC	Bellevue	Nebraska
United States	Hassman Research Institute	Berlin	New Jersey
United States	Montana Health Research Institute Inc.	Billings	Montana
United States	United Medical Associates	Binghamton	New York
United States	Achieve Clinical Research	Birmingham	Alabama
United States	Central Alabama Research	Birmingham	Alabama
United States	Elite Clinical Trials	Blackfoot	Idaho
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Progressive Clinical Research	Bountiful	Utah
United States	PAB Clinical Research	Brandon	Florida
United States	PMG Research of Bristol LLC	Bristol	Tennessee
United States	Investigators Research Group LLC	Brownsburg	Indiana
United States	DiscoveResearch Inc.	Bryan	Texas
United States	Seattle Urology Research	Burien	Washington
United States	Hope Clinical Research	Canoga Park	California
United States	PMG Research of Cary	Cary	North Carolina
United States	Core Healthcare Group	Cerritos	California
United States	Clinical Trials of South Carolina	Charleston	South Carolina
United States	Pharmacorp Clinical Trials Inc.	Charleston	South Carolina
United States	PMG Research of Charlotte LLC	Charlotte	North Carolina
United States	WR - ClinSearch LLC	Chattanooga	Tennessee
United States	Sentral Clinical Research Services	Cincinnati	Ohio
United States	Innovative Research of West FL Inc.	Clearwater	Florida
United States	Rapid Medical Research	Cleveland	Ohio
United States	Aventiv Research, Inc.	Columbus	Ohio
United States	Buckeye Health and Research	Columbus	Ohio
United States	Universal Medical and Research Center LLC	Coral Gables	Florida
United States	Top Medical Research Inc.	Cutler Bay	Florida
United States	Providence Health Partners	Dayton	Ohio
United States	Avail Clinical Research	DeLand	Florida
United States	Jesscan Medical Research	Delray Beach	Florida
United States	Horizons Clinical Research Center	Denver	Colorado
United States	Lynn Institute of Denver	Denver	Colorado
United States	WR Global Medical Research	DeSoto	Texas
United States	Revival Research	Doral	Florida
United States	Greater Providence Clinical Research, LLC	East Providence	Rhode Island
United States	Riverside Clinical Research	Edgewater	Florida
United States	Premier Urology Group LLC	Edison	New Jersey
United States	Regional Clinical Research Inc.	Endwell	New York
United States	HWC Womens Research Center	Englewood	Ohio
United States	Urologic Research and Consulting LLC	Englewood	New Jersey
United States	Evanston Premier Healthcare Research	Evanston	Illinois
United States	MediSphere Medical Research Center	Evansville	Indiana
United States	KO Clinical Research	Fort Lauderdale	Florida
United States	Piedmont Research Partners	Fort Mill	South Carolina
United States	Research Center of Fresno Inc.	Fresno	California
United States	AccuMed Research Associates	Garden City	New York
United States	PharmQuest	Greensboro	North Carolina
United States	DeGarmo Institute of Medical Research	Greer	South Carolina
United States	Fundamental Research LLC	Gulf Shores	Alabama
United States	Clinical Investigation Specialists Inc.	Gurnee	Illinois
United States	Chesapeake Urology Research Associates	Hanover	Maryland
United States	Drug Trials America	Hartsdale	New York
United States	American Clinical Trials	Hawaiian Gardens	California
United States	A.G.A Clinical Trials	Hialeah	Florida
United States	Best Quality Research, Inc.	Hialeah	Florida
United States	Indago Research Health Center	Hialeah	Florida
United States	Vital Pharm Research Inc.	Hialeah	Florida
United States	Peters Medical Research	High Point	North Carolina
United States	Advances in Health	Houston	Texas
United States	BI Research Center	Houston	Texas
United States	Centex Studies Inc.	Houston	Texas
United States	Discovery MM Services Inc.	Houston	Texas
United States	Pioneer Research Solutions	Houston	Texas
United States	Marvel Clinical Research	Huntington Beach	California
United States	Longwood Research	Huntsville	Alabama
United States	Protenium Clinical Research	Hurst	Texas
United States	Leonard Maliver MD Antria, Inc.	Indiana	Pennsylvania
United States	The Jackson Clinic	Jackson	Tennessee
United States	Smart Medical Research Inc.	Jackson Heights	New York
United States	The Clinical Trial Center LLC	Jenkintown	Pennsylvania
United States	MultiSpecialty Clinical Research, Inc.	Johnson City	Tennessee
United States	Health Awareness, Inc.	Jupiter	Florida
United States	Discovery MM Services Inc.	Katy	Texas
United States	Volunteer Research Group - NOCCR	Knoxville	Tennessee
United States	Grossmont Center for Clinical Research	La Mesa	California
United States	Barrett Clinic P.C.	La Vista	Nebraska
United States	Prime-Care Clinical Research	Laguna Hills	California
United States	Centex Studies Inc.	Lake Charles	Louisiana
United States	Green and Seidner Family Practice Associates P.C.	Lansdale	Pennsylvania
United States	Clinical Research Consortium	Las Vegas	Nevada
United States	Excel Clinical Research	Las Vegas	Nevada
United States	Sheldon Freedman MD Ltd	Las Vegas	Nevada
United States	Lawrence OB-GYN Clinical Research LLC	Lawrenceville	New Jersey
United States	Central Kentucky Research Associates Inc.	Lexington	Kentucky
United States	Women's Clinic of Lincoln PC	Lincoln	Nebraska
United States	Long Beach Clinical Trial Services Inc.	Long Beach	California
United States	Long Beach Clinical Trials LLC	Long Beach	California
United States	Downtown L.A. Research Center Inc.	Los Angeles	California
United States	Urology Group of Southern California	Los Angeles	California
United States	L-MARC Research Center	Louisville	Kentucky
United States	Adams Patterson Gynecology and Obstetrics	Memphis	Tennessee
United States	Advanced Clinical Research	Meridian	Idaho
United States	Advanced Medical Research Institute	Miami	Florida
United States	AppleMed Research Group LLC	Miami	Florida
United States	LCC Medical Research Institute Inc.	Miami	Florida
United States	Miami Clinical Research	Miami	Florida
United States	Nuren Medical Research Center	Miami	Florida
United States	San Marcus Research Clinic Inc.	Miami	Florida
United States	Clinical Research Solutions	Middleburg Heights	Ohio
United States	Clinical Research Consulting LLC	Milford	Connecticut
United States	Montana Medical Research	Missoula	Montana
United States	Discovery MM Services Inc.	Missouri City	Texas
United States	Coastal Clinical Research Inc.	Mobile	Alabama
United States	PMG Research of Charleston LLC	Moncks Corner	South Carolina
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	PMG Research of Charleston LLC	Mount Pleasant	South Carolina
United States	Tri Valley Urology Medical Group	Murrieta	California
United States	Family Medicine of SayeBrook LLC	Myrtle Beach	South Carolina
United States	Clinical Research Associates Inc.	Nashville	Tennessee
United States	BTC of New Bedford	New Bedford	Massachusetts
United States	Coastal Connecticut Research LLC	New London	Connecticut
United States	DelRicht Research	New Orleans	Louisiana
United States	Bayside Clinical Research	New Port Richey	Florida
United States	Suncoast Clinical Research Inc.	New Port Richey	Florida
United States	Health Research of Hampton Roads Inc.	Newport News	Virginia
United States	Meridian Clinical Research LLC	Norfolk	Nebraska
United States	Regeneris Medical	North Attleboro	Massachusetts
United States	Infinity Medical Research Inc.	North Dartmouth	Massachusetts
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Adult and Pediatric Urology P.C.	Omaha	Nebraska
United States	Quality Clinical Research Inc.	Omaha	Nebraska
United States	Compass Research LLC	Orlando	Florida
United States	In-Quest Medical Research, LLC	Peachtree Corners	Georgia
United States	Palmetto Institute of Clinical Research Inc.	Pelzer	South Carolina
United States	South Broward Research LLC	Pembroke Pines	Florida
United States	Clinical Research of Philadelphia LLC	Philadelphia	Pennsylvania
United States	Preferred Primary Care Physicians Inc.	Pittsburgh	Pennsylvania
United States	Preferred Primary Care Physicians Inc.	Pittsburgh	Pennsylvania
United States	Research Protocol Management Specialists Hills ObGyn Associates Inc	Pittsburgh	Pennsylvania
United States	Village Health Partners ACRC Trials	Plano	Texas
United States	Clinical Research Center of Florida	Pompano Beach	Florida
United States	Poplar Bluff Urology	Poplar Bluff	Missouri
United States	ProHealth Care AssociatesLLP	Port Jefferson	New York
United States	Beacon Clinical Research	Quincy	Massachusetts
United States	Associated Urologists of North Carolina	Raleigh	North Carolina
United States	Raleigh Medical Group PMG Research of Raleigh	Raleigh	North Carolina
United States	Remidica LLC	Rochester	Michigan
United States	Rochester Clinical Research Inc.	Rochester	New York
United States	Northern California Research	Sacramento	California
United States	Saginaw Valley Medical Research	Saginaw	Michigan
United States	Pinellas Urology	Saint Petersburg	Florida
United States	PMG Research of Salisbury	Salisbury	North Carolina
United States	Wasatch Clinical Research LLC	Salt Lake City	Utah
United States	Bandera Family Health Care	San Antonio	Texas
United States	Clinical Trials of Texas Inc.	San Antonio	Texas
United States	San Bernadino Urological Associates	San Bernardino	California
United States	Artemis Institute for Clinical Research	San Diego	California
United States	WR MCCCR	San Diego	California
United States	Artemis Institute for Clinical Research	San Marcos	California
United States	CentraCare Clinic Adult & Pediatric Urology	Sartell	Minnesota
United States	Meridian Clinical Research LLC	Savannah	Georgia
United States	Seattle Women's: Health, Research, Gynecology	Seattle	Washington
United States	Regional Urology LLC	Shreveport	Louisiana
United States	Hillcrest Clinical Research LLC	Simpsonville	South Carolina
United States	Frontier Clinical Research, LLC	Smithfield	Pennsylvania
United States	North Spokane Womens Health	Spokane	Washington
United States	Clinova Clinical Trials	Spring	Texas
United States	Meridien Research	Spring Hill	Florida
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	Palmetto Clinical Research	Summerville	South Carolina
United States	Clinical Research of West Florida	Tampa	Florida
United States	Clinical Research Consortium	Tempe	Arizona
United States	Bioclinica Research	The Villages	Florida
United States	Eclipse Clinical Research	Tucson	Arizona
United States	Noble Clinical Research	Tucson	Arizona
United States	Preferred Primary Care Physicians Inc.	Uniontown	Pennsylvania
United States	Empire Clinical Research	Upland	California
United States	PEAK Research LLC	Upper Saint Clair	Pennsylvania
United States	Bayview Research Group LLC	Valley Village	California
United States	Family Practice Center of Wadsworth Inc. - New Venture Medical Research	Wadsworth	Ohio
United States	Omega Medical Research	Warwick	Rhode Island
United States	Chase Medical Research, LLC	Waterbury	Connecticut
United States	Bay State Clinical Trials Inc.	Watertown	Massachusetts
United States	Asclepes Research Centers	Weeki Wachee	Florida
United States	Advanced Clinical Research	West Jordan	Utah
United States	Heartland Research Associates LLC	Wichita	Kansas
United States	Heartland Research Associates LLC	Wichita	Kansas
United States	Upstate Clinical Research Associates LLC	Williamsville	New York
United States	Ohio Clinical Research LLC	Willoughby Hills	Ohio
United States	PMG Research	Wilmington	North Carolina
United States	PMG Research of Wilmington, LLC	Wilmington	North Carolina
United States	Carolina Medical Trials LLC	Winston-Salem	North Carolina
United States	PMG Research of Winston-Salem	Winston-Salem	North Carolina
United States	Clinical Research of Central Florida	Winter Haven	Florida
United States	North Georgia Clinical Research	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Urovant Sciences GmbH

Countries where clinical trial is conducted

United States,  Canada,  Hungary,  Latvia,  Lithuania,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (BL); Week 12
Primary	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.	Baseline; Week 12
Secondary	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.	Baseline; Week 12
Secondary	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).	Baseline; Week 12
Secondary	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).	Baseline; Week 12
Secondary	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).	Baseline; Week 12
Secondary	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.	Baseline; Week 12
Secondary	CFB at Week 12 in the Coping Score From the Overactive Bladder Questionnaire Long Form (OAB-q LF, 1-week Recall) in All OAB Participants	The OAB-q LF is a validated patient-reported outcome. 8 questions of the OAB-q LF ask participants how well they have coped with their bladder symptoms during the previous week, as a measure of quality of life. Each question has a response ranging from "not coping" (= 1) to "coping well" (= 6). These questions make up the coping scale. The raw score (sum of question scores [ranging from 8 to 48]) is transformed to a unified score, ranging from 0 to 100. Higher scores correspond to a higher quality of life, and lower scores represent a lower quality of life. CFB is calculated as the post-BL value minus the BL value. Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), sex, region (U.S./non-U.S.), OAB type (wet/dry), BL score, and treatment by study visit interaction.	Baseline; Week 12
Secondary	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.	Baseline; Week 12
Secondary	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	The OAB-q LF is a validated patient-reported outcome. The 25 questions comprising the Coping, Concern, Sleep and Social Interaction subscales of the OAB-q LF ask participants how much their symptoms have affected their life over the last week. Each question has a response ranging from "None of the time" (= 1) to "All of the time" (= 6). The raw score (sum of question scores for the 4 subscales [ranging from 25 to 150]) is transformed to a unified score, ranging from 0 to 100. Higher scores correspond to a higher quality of life, and lower scores represent a lower quality of life. CFB is calculated as the post-BL value minus the BL value. Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), sex, region (U.S./non-U.S.), OAB type (wet/dry), BL score, and treatment by study visit interaction.	Baseline; Week 12
Secondary	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.	Baseline; Week 12
Secondary	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).	Week 12
Secondary	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.	Baseline; Week 12
Secondary	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.	Baseline; Week 12
Secondary	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.	Baseline; Week 12