Composur: Study to Understand the Performance of Vibegron in Participants with Overactive Bladder (OAB)
NCT ID: NCT05067478
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
403 participants
OBSERVATIONAL
2021-10-28
2024-07-26
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort A Vibegron
Participants with previous anticholinergic therapy experience will receive vibegron as per the United States (U.S.) label.
Vibegron
Vibegron to be administered.
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.
Vibegron
Vibegron to be administered.
Interventions
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Vibegron
Vibegron to be administered.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Symptoms of OAB for at least 3 months prior to the Baseline Visit
* Willing and able to complete electronic patient-reported outcomes questionnaires monthly for a minimum of 1 year
* Previous exposure to anticholinergics or mirabegron monotherapy and/or mirabegron plus solifenacin combination therapy prior to initiation of vibegron
Exclusion Criteria
* History of OAB treatment with botulinum toxin A; sacral neuromodulation; percutaneous tibial nerve stimulation; external beam radiation therapy; urinary stents within the last 6 months; pelvic or lower urinary tract surgery within the last 6 months; and urethral catheterizations within the last 3 months prior to the Baseline Visit
* History of mixed incontinence where stress incontinence is the predominant form (as determined by the investigator)
* Participants at risk of urinary retention (as determined by the investigator)
* Neurologic conditions associated with OAB symptoms, e.g., multiple sclerosis
* Pregnant or breastfeeding or plans to do so during the study
* Use of vibegron prior to the Baseline Visit either prescribed or in a previous vibegron clinical trial where the participant was on vibegron
* Anyone who, at the discretion of the investigator, is not suitable for treatment with a beta 3 agonist for OAB for any reason
18 Years
ALL
No
Sponsors
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Urovant Sciences GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Urovant Sciences
Locations
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Urology Centers of Alabama
Homewood, Alabama, United States
43rd Medical Associates
Phoenix, Arizona, United States
Fiel Family and Sports Medicine, PC
Tempe, Arizona, United States
Arkansas Urology Associates, PA
Little Rock, Arkansas, United States
Golden Gate Urology
Berkley, California, United States
Urology Associates of Norwalk
Norwalk, Connecticut, United States
Urological Research Network
Hialeah, Florida, United States
University of Florida Health Jacksonville Facility Clinic
Jacksonville, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
South Florida Research Phase I-IV, Inc.
Miami Springs, Florida, United States
Tampa Urology Partners LLP
Tampa, Florida, United States
Florida Urology Partners
Tampa, Florida, United States
Clinical Research of Central Florida - Winter Haven
Winter Haven, Florida, United States
Georgia Urology
Cartersville, Georgia, United States
WR-Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, United States
Idaho Urologic Institute
Meridian, Idaho, United States
Loyola University Medical Center
Maywood, Illinois, United States
Carle Foundation Hospital
Urbana, Illinois, United States
American Health Network of Indiana, LLC
Avon, Indiana, United States
The University of Kansas Health System
Kansas City, Kansas, United States
DelRicht Research
New Orleans, Louisiana, United States
Regional Urology, LLC
Shreveport, Louisiana, United States
Chesapeake Urology Research Associates
Owings Mills, Maryland, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, United States
Valley OB-GYN Clinic, PC
Saginaw, Michigan, United States
Regents of the University of Minnesota
Minneapolis, Minnesota, United States
Adult & Pediatric Urology
Sartell, Minnesota, United States
SVG Clinical
Las Vegas, Nevada, United States
New Jersey Urology Cancer Treatment Center
Bloomfield, New Jersey, United States
Lawrence OB-GYN Associates, P.C.
Lawrenceville, New Jersey, United States
Rutgers - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Circuit Clinical
Buffalo, New York, United States
AccuMed Research Associates, Inc.
Garden City, New York, United States
Manhattan Medical Research Practice, PLLC
New York, New York, United States
NYU Grossman School of Medicine
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Premier Medical Group of the Hudson Valley, PC
Poughkeepsie, New York, United States
AMP Urology
Syracuse, New York, United States
Atrium Health Infectious Diseases Kenilworth
Charlotte, North Carolina, United States
Alliance Urology Specialists
Greensboro, North Carolina, United States
FirstHealth Urogynecology
Hamlet, North Carolina, United States
Associated Urologists of North Carolina
Raleigh, North Carolina, United States
Ardmore Family Practice, PA
Winston-Salem, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Obstetrics and Gynecology Associates, Inc.
Cincinnati, Ohio, United States
TriHealth
Cincinnati, Ohio, United States
University of Cincinnati Physicians Obstetrics & Gynecology
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Clinical Research Solutions
Middleburg Heights, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Institute for Female Pelvic Medicine
Allentown, Pennsylvania, United States
Center for Urogynecology and Pelvic Health
King of Prussia, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Southern Urogynecology
West Columbia, South Carolina, United States
Urology Partners
Arlington, Texas, United States
Medicus Alliance Clinical Research Organization Inc.
Cedar Park, Texas, United States
Urology Clinics of North Texas
Dallas, Texas, United States
North Austin Urology
Round Rock, Texas, United States
Medicus Alliance Clinical Research Organization Inc.
Sugar Land, Texas, United States
Advanced Research Institute
Ogden, Utah, United States
West Virginia University
Morgantown, West Virginia, United States
Countries
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References
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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.
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.
Other Identifiers
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URO-901-4001
Identifier Type: -
Identifier Source: org_study_id