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

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05067478
• Other study ID #: URO-901-4001
• Status: Active, not recruiting
• Start date: October 28, 2021
• Est. completion date: September 2024

Study information

• Verified date: September 2023
• Source: Urovant Sciences GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Vibegron
Vibegron to be administered.

Locations

Country	Name	City	State
United States	Institute for Female Pelvic Medicine	Allentown	Pennsylvania
United States	Urology Partners	Arlington	Texas
United States	American Health Network of Indiana, LLC	Avon	Indiana
United States	Golden Gate Urology	Berkeley	California
United States	New Jersey Urology Cancer Treatment Center	Bloomfield	New Jersey
United States	Circuit Clinical	Buffalo	New York
United States	Lahey Hospital and Medical Center	Burlington	Massachusetts
United States	Georgia Urology	Cartersville	Georgia
United States	Medicus Alliance Clinical Research Organization Inc.	Cedar Park	Texas
United States	Medical University of South Carolina (MUSC)	Charleston	South Carolina
United States	Atrium Health Infectious Diseases Kenilworth	Charlotte	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	Cleveland Clinic	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Urology Clinics of North Texas	Dallas	Texas
United States	AccuMed Research Associates, Inc.	Garden City	New York
United States	Alliance Urology Specialists	Greensboro	North Carolina
United States	FirstHealth Urogynecology	Hamlet	North Carolina
United States	Urological Research Network	Hialeah	Florida
United States	Urology Centers of Alabama	Homewood	Alabama
United States	University of Florida Health Jacksonville Facility Clinic	Jacksonville	Florida
United States	The University of Kansas Health System	Kansas City	Kansas
United States	Center for Urogynecology and Pelvic Health	King Of Prussia	Pennsylvania
United States	SVG Clinical	Las Vegas	Nevada
United States	Lawrence OB-GYN Associates, P.C.	Lawrenceville	New Jersey
United States	Arkansas Urology Associates, PA	Little Rock	Arkansas
United States	Loyola University Medical Center	Maywood	Illinois
United States	Idaho Urologic Institute	Meridian	Idaho
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	Clinical Research Solutions	Middleburg Heights	Ohio
United States	Regents of the University of Minnesota	Minneapolis	Minnesota
United States	West Virginia University	Morgantown	West Virginia
United States	Rutgers - Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	DelRicht Research	New Orleans	Louisiana
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	Urology Associates of Norwalk	Norwalk	Connecticut
United States	Advanced Research Institute	Ogden	Utah
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Chesapeake Urology Research Associates	Owings Mills	Maryland
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	43rd Medical Associates	Phoenix	Arizona
United States	Premier Medical Group of the Hudson Valley, PC	Poughkeepsie	New York
United States	Associated Urologists of North Carolina	Raleigh	North Carolina
United States	North Austin Urology	Round Rock	Texas
United States	Valley OB-GYN Clinic, PC	Saginaw	Michigan
United States	WR-Mount Vernon Clinical Research, LLC	Sandy Springs	Georgia
United States	Adult & Pediatric Urology	Sartell	Minnesota
United States	Regional Urology, LLC	Shreveport	Louisiana
United States	Medicus Alliance Clinical Research Organization Inc.	Sugar Land	Texas
United States	AMP Urology	Syracuse	New York
United States	Florida Urology Partners	Tampa	Florida
United States	Tampa Urology Partners LLP	Tampa	Florida
United States	Fiel Family and Sports Medicine, PC	Tempe	Arizona
United States	Carle Foundation Hospital	Urbana	Illinois
United States	Bay State Clinical Trials, Inc.	Watertown	Massachusetts
United States	Southern Urogynecology	West Columbia	South Carolina
United States	Ardmore Family Practice, PA	Winston-Salem	North Carolina
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina
United States	Clinical Research of Central Florida - Winter Haven	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Urovant Sciences GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)		Up to Month 12
Secondary	Mean Duration of Vibegron Treatment		Month 3, Month 6 and Month 12
Secondary	Number of Participants Discontinuing Vibegron Treatment for the Indicated Reasons		Month 3, Month 6 and Month 12
Secondary	Percentage of Participants Discontinuing Vibegron Treatment for the Indicated Reasons		Month 3, Month 6 and Month 12