Composur: Study to Understand the Performance of Vibegron in Participants with Overactive Bladder (OAB)

NCT05067478 | Completed FDA Drug

• 1 other identifier: URO-901-4001
• Study Type: observational
• Target: 403
• Locations: 1 country
• Sites: 64

Brief Summary

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.

Conditions

Overactive Bladder

Keywords

Vibegron; Urinary bladder, overactive; Beta-3 adrenergic receptor (β3-AR) agonists; Urge urinary incontinence; OAB

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (6)

• 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

  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

Study Arms (2)

Cohort A Vibegron

Participants with previous anticholinergic therapy experience will receive vibegron as per the United States (U.S.) label.

Drug: Vibegron

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.

Drug: Vibegron

Interventions

Vibegron DRUG

Vibegron to be administered.

Also known as: GEMTESA

Cohort A Vibegron; Cohort B Vibegron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be recruited from primary care settings such as Family Practice, Urogynecology, and Urology practices

You may qualify if:

• Diagnosis of overactive bladder (OAB) with or without urgency urinary incontinence
• 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

You may not qualify if:

• Any contraindication to the use of vibegron per the United States label
• 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

Sponsors & Collaborators

• Urovant Sciences GmbH: lead

Study Sites (64)

Urology Centers of Alabama

Homewood, Alabama, 35209-5603, United States

Location

43rd Medical Associates

Phoenix, Arizona, 85051, United States

Location

Fiel Family and Sports Medicine, PC

Tempe, Arizona, 85283, United States

Location

Arkansas Urology Associates, PA

Little Rock, Arkansas, 72211, United States

Location

Golden Gate Urology

Berkley, California, 94705, United States

Location

Urology Associates of Norwalk

Norwalk, Connecticut, 06850, United States

Location

Urological Research Network

Hialeah, Florida, 33016-1815, United States

Location

University of Florida Health Jacksonville Facility Clinic

Jacksonville, Florida, 32209, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

South Florida Research Phase I-IV, Inc.

Miami Springs, Florida, 33166, United States

Location

Tampa Urology Partners LLP

Tampa, Florida, 33606, United States

Location

Florida Urology Partners

Tampa, Florida, 33615, United States

Location

Clinical Research of Central Florida - Winter Haven

Winter Haven, Florida, 33880, United States

Location

Georgia Urology

Cartersville, Georgia, 30120, United States

Location

WR-Mount Vernon Clinical Research, LLC

Sandy Springs, Georgia, 30328, United States

Location

Idaho Urologic Institute

Meridian, Idaho, 83642, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153-3328, United States

Location

Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

American Health Network of Indiana, LLC

Avon, Indiana, 46123, United States

Location

The University of Kansas Health System

Kansas City, Kansas, 66160, United States

Location

DelRicht Research

New Orleans, Louisiana, 70115, United States

Location

Regional Urology, LLC

Shreveport, Louisiana, 71106, United States

Location

Chesapeake Urology Research Associates

Owings Mills, Maryland, 21117, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

Bay State Clinical Trials, Inc.

Watertown, Massachusetts, 02472, United States

Location

Valley OB-GYN Clinic, PC

Saginaw, Michigan, 48602, United States

Location

Regents of the University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Adult & Pediatric Urology

Sartell, Minnesota, 56377, United States

Location

SVG Clinical

Las Vegas, Nevada, 89128, United States

Location

New Jersey Urology Cancer Treatment Center

Bloomfield, New Jersey, 07003, United States

Location

Lawrence OB-GYN Associates, P.C.

Lawrenceville, New Jersey, 08648, United States

Location

Rutgers - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

Circuit Clinical

Buffalo, New York, 14203, United States

Location

AccuMed Research Associates, Inc.

Garden City, New York, 11530, United States

Location

Manhattan Medical Research Practice, PLLC

New York, New York, 10016, United States

Location

NYU Grossman School of Medicine

New York, New York, 10017, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Premier Medical Group of the Hudson Valley, PC

Poughkeepsie, New York, 12603, United States

Location

AMP Urology

Syracuse, New York, 13210, United States

Location

Atrium Health Infectious Diseases Kenilworth

Charlotte, North Carolina, 28207, United States

Location

Alliance Urology Specialists

Greensboro, North Carolina, 27403, United States

Location

FirstHealth Urogynecology

Hamlet, North Carolina, 28345, United States

Location

Associated Urologists of North Carolina

Raleigh, North Carolina, 27612, United States

Location

Ardmore Family Practice, PA

Winston-Salem, North Carolina, 27103, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27103, United States

Location

Obstetrics and Gynecology Associates, Inc.

Cincinnati, Ohio, 45014, United States

Location

TriHealth

Cincinnati, Ohio, 45211-6301, United States

Location

University of Cincinnati Physicians Obstetrics & Gynecology

Cincinnati, Ohio, 45267, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Clinical Research Solutions

Middleburg Heights, Ohio, 44130, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Institute for Female Pelvic Medicine

Allentown, Pennsylvania, 18103, United States

Location

Center for Urogynecology and Pelvic Health

King of Prussia, Pennsylvania, 19406, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19014, United States

Location

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

Location

Southern Urogynecology

West Columbia, South Carolina, 29169, United States

Location

Urology Partners

Arlington, Texas, 76017, United States

Location

Medicus Alliance Clinical Research Organization Inc.

Cedar Park, Texas, 78613, United States

Location

Urology Clinics of North Texas

Dallas, Texas, 75246, United States

Location

North Austin Urology

Round Rock, Texas, 78681, United States

Location

Medicus Alliance Clinical Research Organization Inc.

Sugar Land, Texas, 77479, United States

Location

Advanced Research Institute

Ogden, Utah, 84405, United States

Location

West Virginia University

Morgantown, West Virginia, 26506-9186, United States

Location

Related Publications (2)

• 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.

  PMID: 40176006 DERIVED

• 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.

  PMID: 37095473 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Interventions

N-(4-((5-(hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo(1,2-a)pyrimidine-6-carboxamide

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders

Study Officials

• Study Director

  Urovant Sciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: October 5, 2021
• Study Start: October 28, 2021
• Primary Completion: July 22, 2024
• Study Completion: July 26, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 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 Criteria: 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).

Locations

US (64)