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This study will evaluate the treatment satisfaction, discontinuation, reasons for discontinuation, quality of life, healthcare resource utilization, and safety with Vibegron for the treatment of OAB in the context of real-world clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A Vibegron | Participants with previous anticholinergic therapy experience will receive vibegron as per the United States (U.S.) label. |
| |
| Cohort B Vibegron | Participants with previous mirabegron monotherapy or mirabegron plus solifenacin or combination therapy experience will receive vibegron as per the U.S. label. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vibegron | Drug | Vibegron to be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Satisfaction Domain Score as Assessed by the Overactive Bladder Satisfaction with Treatment Questionnaire (OAB-SAT-q) | The OAB-SAT-q is an 11-item questionnaire designed to assess participant's satisfaction with overactive bladder treatment in the clinical setting. It includes 3 subscales (satisfaction, side effects, endorsement) and 2 single-item assessments (convenience, preference), with a 4-week recall period. The OAB-SAT-q is scored by domains ranging from 0-100. Scores for the Convenience item range from 0-100. The Preference item is calculated as a percentage. Higher scores indicate higher levels of treatment satisfaction, endorsement, and convenience. | Month 3 |
| Mean Satisfaction Domain Score as Assessed by the OAB-SAT-q | The OAB-SAT-q is an 11-item questionnaire designed to assess participant's satisfaction with overactive bladder treatment in the clinical setting. It includes 3 subscales (satisfaction, side effects, endorsement) and 2 single-item assessments (convenience, preference), with a 4-week recall period. The OAB-SAT-q is scored by domains ranging from 0-100. Scores for the Convenience item range from 0-100. The Preference item is calculated as a percentage. Higher scores indicate higher levels of treatment satisfaction, endorsement, and convenience. | Month 6 |
| Mean Satisfaction Domain Score as Assessed by the OAB-SAT-q | The OAB-SAT-q is an 11-item questionnaire designed to assess participant's satisfaction with overactive bladder treatment in the clinical setting. It includes 3 subscales (satisfaction, side effects, endorsement) and 2 single-item assessments (convenience, preference), with a 4-week recall period. The OAB-SAT-q is scored by domains ranging from 0-100. Scores for the Convenience item range from 0-100. The Preference item is calculated as a percentage. Higher scores indicate higher levels of treatment satisfaction, endorsement, and convenience. | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Positive Responders to Individual Treatment Satisfaction Questions 1-3 and 11 as Assessed by the OAB-SAT-q | Month 3, Month 6 and Month 12 | |
| Mean Scores on the Side Effects, Endorsement, Convenience, and Preference Domains as Assessed by the OAB-SAT-q |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be recruited from primary care settings such as Family Practice, Urogynecology, and Urology practices
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Urovant Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology Centers of Alabama | Homewood | Alabama | 35209-5603 | United States | ||
| 43rd Medical Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40176006 | Derived | Dmochowski RR, Rovner ES, Kennelly MJ, Newman DK, Xavier K, Thomas E, Snyder D, Abedinzadeh L. Satisfaction and persistence with vibegron in the first 6 months of overactive bladder treatment: interim results of the phase 4, real-world COMPOSUR study. BMC Urol. 2025 Apr 2;25(1):66. doi: 10.1186/s12894-025-01742-6. | |
| 37095473 | Derived |
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Urovant is committed to sharing participant-level data and supporting clinical documents from eligible studies with qualified external researchers. Data requests will be reviewed and approved on the basis of scientific merit. All data provided will be anonymized according to applicable laws and regulations.
The data will be made available within 24 months after study completion and will be accessible for a time frame appropriate for the approved proposal.
Access to these clinical trial data can be requested by emailing medinfo@urovant.com and will be provided following Urovant review and approval of a research proposal and execution of a Data Sharing Agreement (DSA).
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 22, 2025 | |
| Reset | Aug 7, 2025 | |
| Release | Oct 18, 2025 |
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| Month 3, Month 6 and Month 12 |
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Up to Month 12 |
| Mean Duration of Vibegron Treatment | Month 3, Month 6 and Month 12 |
| Number of Participants Discontinuing Vibegron Treatment for the Indicated Reasons | Month 3, Month 6 and Month 12 |
| Percentage of Participants Discontinuing Vibegron Treatment for the Indicated Reasons | Month 3, Month 6 and Month 12 |
| Phoenix |
| Arizona |
| 85051 |
| United States |
| Fiel Family and Sports Medicine, PC | Tempe | Arizona | 85283 | United States |
| Arkansas Urology Associates, PA | Little Rock | Arkansas | 72211 | United States |
| Golden Gate Urology | Berkley | California | 94705 | United States |
| Urology Associates of Norwalk | Norwalk | Connecticut | 06850 | United States |
| Urological Research Network | Hialeah | Florida | 33016-1815 | United States |
| University of Florida Health Jacksonville Facility Clinic | Jacksonville | Florida | 32209 | United States |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
| South Florida Research Phase I-IV, Inc. | Miami Springs | Florida | 33166 | United States |
| Tampa Urology Partners LLP | Tampa | Florida | 33606 | United States |
| Florida Urology Partners | Tampa | Florida | 33615 | United States |
| Clinical Research of Central Florida - Winter Haven | Winter Haven | Florida | 33880 | United States |
| Georgia Urology | Cartersville | Georgia | 30120 | United States |
| WR-Mount Vernon Clinical Research, LLC | Sandy Springs | Georgia | 30328 | United States |
| Idaho Urologic Institute | Meridian | Idaho | 83642 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153-3328 | United States |
| Carle Foundation Hospital | Urbana | Illinois | 61801 | United States |
| American Health Network of Indiana, LLC | Avon | Indiana | 46123 | United States |
| The University of Kansas Health System | Kansas City | Kansas | 66160 | United States |
| DelRicht Research | New Orleans | Louisiana | 70115 | United States |
| Regional Urology, LLC | Shreveport | Louisiana | 71106 | United States |
| Chesapeake Urology Research Associates | Owings Mills | Maryland | 21117 | United States |
| Lahey Hospital and Medical Center | Burlington | Massachusetts | 01805 | United States |
| Bay State Clinical Trials, Inc. | Watertown | Massachusetts | 02472 | United States |
| Valley OB-GYN Clinic, PC | Saginaw | Michigan | 48602 | United States |
| Regents of the University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Adult & Pediatric Urology | Sartell | Minnesota | 56377 | United States |
| SVG Clinical | Las Vegas | Nevada | 89128 | United States |
| New Jersey Urology Cancer Treatment Center | Bloomfield | New Jersey | 07003 | United States |
| Lawrence OB-GYN Associates, P.C. | Lawrenceville | New Jersey | 08648 | United States |
| Rutgers - Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | United States |
| Circuit Clinical | Buffalo | New York | 14203 | United States |
| AccuMed Research Associates, Inc. | Garden City | New York | 11530 | United States |
| Manhattan Medical Research Practice, PLLC | New York | New York | 10016 | United States |
| NYU Grossman School of Medicine | New York | New York | 10017 | United States |
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| Premier Medical Group of the Hudson Valley, PC | Poughkeepsie | New York | 12603 | United States |
| AMP Urology | Syracuse | New York | 13210 | United States |
| Atrium Health Infectious Diseases Kenilworth | Charlotte | North Carolina | 28207 | United States |
| Alliance Urology Specialists | Greensboro | North Carolina | 27403 | United States |
| FirstHealth Urogynecology | Hamlet | North Carolina | 28345 | United States |
| Associated Urologists of North Carolina | Raleigh | North Carolina | 27612 | United States |
| Ardmore Family Practice, PA | Winston-Salem | North Carolina | 27103 | United States |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27103 | United States |
| Obstetrics and Gynecology Associates, Inc. | Cincinnati | Ohio | 45014 | United States |
| TriHealth | Cincinnati | Ohio | 45211-6301 | United States |
| University of Cincinnati Physicians Obstetrics & Gynecology | Cincinnati | Ohio | 45267 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Clinical Research Solutions | Middleburg Heights | Ohio | 44130 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Institute for Female Pelvic Medicine | Allentown | Pennsylvania | 18103 | United States |
| Center for Urogynecology and Pelvic Health | King of Prussia | Pennsylvania | 19406 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19014 | United States |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | United States |
| Southern Urogynecology | West Columbia | South Carolina | 29169 | United States |
| Urology Partners | Arlington | Texas | 76017 | United States |
| Medicus Alliance Clinical Research Organization Inc. | Cedar Park | Texas | 78613 | United States |
| Urology Clinics of North Texas | Dallas | Texas | 75246 | United States |
| North Austin Urology | Round Rock | Texas | 78681 | United States |
| Medicus Alliance Clinical Research Organization Inc. | Sugar Land | Texas | 77479 | United States |
| Advanced Research Institute | Ogden | Utah | 84405 | United States |
| West Virginia University | Morgantown | West Virginia | 26506-9186 | United States |
| Dmochowski RR, Rovner ES, Kennelly MJ, Newman DK, Abedinzadeh L, Snyder D, Thomas E, Haag-Molkenteller C, Rosenberg MT. Study design of a phase 4, real-world study (COMPOSUR) to evaluate vibegron in patients with overactive bladder. BMC Urol. 2023 Apr 24;23(1):64. doi: 10.1186/s12894-023-01240-7. |
| Reset | Nov 4, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 22, 2025 | Aug 7, 2025 | |||
| Oct 18, 2025 | Nov 4, 2025 |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
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| ID | Term |
|---|---|
| C000608232 | N-(4-((5-(hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo(1,2-a)pyrimidine-6-carboxamide |
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