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

Composur, a Patient-centric, Phase IV, Open-label, Prospective, Real World US Study to Evaluate Vibegron on Patient Treatment Satisfaction, Quality of Life, and Healthcare Resource Utilization in Overactive Bladder

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: Vibegron

• Study Type: Observational
• Enrollment (Actual): 403

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Homewood, Alabama, United States, 35209-5603
      • Urology Centers of Alabama
  • Arizona
    • Phoenix, Arizona, United States, 85051
      • 43rd Medical Associates
    • Tempe, Arizona, United States, 85283
      • Fiel Family and Sports Medicine, PC
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Urology Associates, PA
  • California
    • Berkley, California, United States, 94705
      • Golden Gate Urology
  • Connecticut
    • Norwalk, Connecticut, United States, 06850
      • Urology Associates of Norwalk
  • Florida
    • Hialeah, Florida, United States, 33016-1815
      • Urological Research Network
    • Jacksonville, Florida, United States, 32209
      • University of Florida Health Jacksonville Facility Clinic
    • Miami, Florida, United States, 33136
      • University of Miami Miller School of Medicine
    • Miami Springs, Florida, United States, 33166
      • South Florida Research Phase I-IV, Inc.
    • Tampa, Florida, United States, 33615
      • Florida Urology Partners
    • Tampa, Florida, United States, 33606
      • Tampa Urology Partners LLP
    • Winter Haven, Florida, United States, 33880
      • Clinical Research of Central Florida - Winter Haven
  • Georgia
    • Cartersville, Georgia, United States, 30120
      • Georgia Urology
    • Sandy Springs, Georgia, United States, 30328
      • WR-Mount Vernon Clinical Research, LLC
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Idaho Urologic Institute
  • Illinois
    • Maywood, Illinois, United States, 60153-3328
      • Loyola University Medical Center
    • Urbana, Illinois, United States, 61801
      • Carle Foundation Hospital
  • Indiana
    • Avon, Indiana, United States, 46123
      • American Health Network of Indiana, LLC
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • The University of Kansas Health System
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • DelRicht Research
    • Shreveport, Louisiana, United States, 71106
      • Regional Urology, LLC
  • Maryland
    • Owings Mills, Maryland, United States, 21117
      • Chesapeake Urology Research Associates
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Hospital and Medical Center
    • Watertown, Massachusetts, United States, 02472
      • Bay State Clinical Trials, Inc.
  • Michigan
    • Saginaw, Michigan, United States, 48602
      • Valley Ob-Gyn Clinic, PC
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Regents of the University of Minnesota
    • Sartell, Minnesota, United States, 56377
      • Adult & Pediatric Urology
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • SVG Clinical
  • New Jersey
    • Bloomfield, New Jersey, United States, 07003
      • New Jersey Urology Cancer Treatment Center
    • Lawrenceville, New Jersey, United States, 08648
      • Lawrence OB-GYN Associates, P.C.
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers - Robert Wood Johnson Medical School
  • New York
    • Buffalo, New York, United States, 14203
      • Circuit Clinical
    • Garden City, New York, United States, 11530
      • AccuMed Research Associates, Inc.
    • New York, New York, United States, 10065
      • Weill Cornell Medical College
    • New York, New York, United States, 10016
      • Manhattan Medical Research Practice, PLLC
    • New York, New York, United States, 10017
      • NYU Grossman school of Medicine
    • Poughkeepsie, New York, United States, 12603
      • Premier Medical Group of the Hudson Valley, PC
    • Syracuse, New York, United States, 13210
      • AMP Urology
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Atrium Health Infectious Diseases Kenilworth
    • Greensboro, North Carolina, United States, 27403
      • Alliance Urology Specialists
    • Hamlet, North Carolina, United States, 28345
      • FirstHealth Urogynecology
    • Raleigh, North Carolina, United States, 27612
      • Associated Urologists of North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Wake Forest Baptist Health
    • Winston-Salem, North Carolina, United States, 27103
      • Ardmore Family Practice, PA
  • Ohio
    • Cincinnati, Ohio, United States, 45014
      • Obstetrics and Gynecology Associates, Inc.
    • Cincinnati, Ohio, United States, 45211-6301
      • TriHealth
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati Physicians Obstetrics & Gynecology
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Middleburg Heights, Ohio, United States, 44130
      • Clinical Research Solutions
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Institute for Female Pelvic Medicine
    • King Of Prussia, Pennsylvania, United States, 19406
      • Center for Urogynecology and Pelvic Health
    • Philadelphia, Pennsylvania, United States, 19014
      • University of Pennsylvania
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina (MUSC)
    • West Columbia, South Carolina, United States, 29169
      • Southern Urogynecology
  • Texas
    • Arlington, Texas, United States, 76017
      • Urology Partners
    • Cedar Park, Texas, United States, 78613
      • Medicus Alliance Clinical Research Organization Inc.
    • Dallas, Texas, United States, 75246
      • Urology Clinics of North Texas
    • Round Rock, Texas, United States, 78681
      • North Austin Urology
    • Sugar Land, Texas, United States, 77479
      • Medicus Alliance Clinical Research Organization Inc.
  • Utah
    • Ogden, Utah, United States, 84405
      • Advanced Research Institute
  • West Virginia
    • Morgantown, West Virginia, United States, 26506-9186
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort A Vibegron; Participants with previous anticholinergic therapy experience will receive vibegron as per the United States (U.S.) label.	Drug: Vibegron; Vibegron to be administered.; Other Names: GEMTESA
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; Vibegron to be administered.; Other Names: GEMTESA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Percentage of Participants Discontinuing Vibegron Treatment for the Indicated Reasons	Month 3, Month 6 and Month 12
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

Collaborators and Investigators

• Sponsor: Urovant Sciences GmbH
• Investigators: Study Director: Study Director, Urovant Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2021
• Primary Completion (Actual): July 22, 2024
• Study Completion (Actual): July 26, 2024

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: September 29, 2021
• First Posted (Actual): October 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Urge urinary incontinence; OAB; Vibegron; Beta-3 adrenergic receptor (β3-AR) agonists; Urinary bladder, overactive
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder Diseases; Urinary Bladder, Overactive
• Other Study ID Numbers: URO-901-4001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes