Clinical trial NCT05067478: Composur: Study to Understand the Performance of Vibegron in Participants with Overactive Bladder (OAB)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder
Keywords: Vibegron
Urinary bladder, overactive
Beta-3 adrenergic receptor (β3-AR) agonists
Urge urinary incontinence
OAB
Lead sponsor: Urovant Sciences GmbH
Sponsor class: INDUSTRY
First posted: 2021-10-05
Enrollment: 403
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Satisfaction Domain Score as Assessed by the Overactive Bladder Satisfaction with Treatment Questionnaire (OAB-SAT-q)
timeFrame: Month 3
measure: Mean Satisfaction Domain Score as Assessed by the OAB-SAT-q
timeFrame: Month 6
measure: Mean Satisfaction Domain Score as Assessed by the OAB-SAT-q
timeFrame: Month 12
Secondary outcomes:
measure: Percentage of Positive Responders to Individual Treatment Satisfaction Questions 1-3 and 11 as Assessed by the OAB-SAT-q
timeFrame: Month 3, Month 6 and Month 12
measure: Mean Scores on the Side Effects, Endorsement, Convenience, and Preference Domains as Assessed by the OAB-SAT-q
timeFrame: Month 3, Month 6 and Month 12
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
timeFrame: Up to Month 12
measure: Mean Duration of Vibegron Treatment
timeFrame: Month 3, Month 6 and Month 12
measure: Number of Participants Discontinuing Vibegron Treatment for the Indicated Reasons
timeFrame: Month 3, Month 6 and Month 12
measure: Percentage of Participants Discontinuing Vibegron Treatment for the Indicated Reasons
timeFrame: Month 3, Month 6 and Month 12
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers of Alabama
state: Alabama
city: Phoenix
country: United States
facility: 43rd Medical Associates
state: Arizona
city: Tempe
country: United States
facility: Fiel Family and Sports Medicine, PC
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Urology Associates, PA
state: Arkansas
city: Berkley
country: United States
facility: Golden Gate Urology
state: California
city: Norwalk
country: United States
facility: Urology Associates of Norwalk
state: Connecticut
city: Hialeah
country: United States
facility: Urological Research Network
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Health Jacksonville Facility Clinic
state: Florida
city: Miami Springs
country: United States
facility: South Florida Research Phase I-IV, Inc.
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Tampa
country: United States
facility: Tampa Urology Partners LLP
state: Florida
city: Tampa
country: United States
facility: Florida Urology Partners
state: Florida
city: Winter Haven
country: United States
facility: Clinical Research of Central Florida - Winter Haven
state: Florida
city: Cartersville
country: United States
facility: Georgia Urology
state: Georgia
city: Sandy Springs
country: United States
facility: WR-Mount Vernon Clinical Research, LLC
state: Georgia
city: Meridian
country: United States
facility: Idaho Urologic Institute
state: Idaho
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Avon
country: United States
facility: American Health Network of Indiana, LLC
state: Indiana
city: Kansas City
country: United States
facility: The University of Kansas Health System
state: Kansas
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
city: Owings Mills
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Burlington
country: United States
facility: Lahey Hospital and Medical Center
state: Massachusetts
city: Watertown
country: United States
facility: Bay State Clinical Trials, Inc.
state: Massachusetts
city: Saginaw
country: United States
facility: Valley OB-GYN Clinic, PC
state: Michigan
city: Minneapolis
country: United States
facility: Regents of the University of Minnesota
state: Minnesota
city: Sartell
country: United States
facility: Adult & Pediatric Urology
state: Minnesota
city: Las Vegas
country: United States
facility: SVG Clinical
state: Nevada
city: Bloomfield
country: United States
facility: New Jersey Urology Cancer Treatment Center
state: New Jersey
city: Lawrenceville
country: United States
facility: Lawrence OB-GYN Associates, P.C.
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers - Robert Wood Johnson Medical School
state: New Jersey
city: Buffalo
country: United States
facility: Circuit Clinical
state: New York
city: Garden City
country: United States
facility: AccuMed Research Associates, Inc.
state: New York
city: New York
country: United States
facility: Manhattan Medical Research Practice, PLLC
state: New York
city: New York
country: United States
facility: NYU Grossman School of Medicine
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley, PC
state: New York
city: Syracuse
country: United States
facility: AMP Urology
state: New York
city: Charlotte
country: United States
facility: Atrium Health Infectious Diseases Kenilworth
state: North Carolina
city: Greensboro
country: United States
facility: Alliance Urology Specialists
state: North Carolina
city: Hamlet
country: United States
facility: FirstHealth Urogynecology
state: North Carolina
city: Raleigh
country: United States
facility: Associated Urologists of North Carolina
state: North Carolina
city: Winston-Salem
country: United States
facility: Ardmore Family Practice, PA
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Cincinnati
country: United States
facility: Obstetrics and Gynecology Associates, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: TriHealth
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Physicians Obstetrics & Gynecology
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Middleburg Heights
country: United States
facility: Clinical Research Solutions
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Allentown
country: United States
facility: Institute for Female Pelvic Medicine
state: Pennsylvania
city: King Of Prussia
country: United States
facility: Center for Urogynecology and Pelvic Health
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: West Columbia
country: United States
facility: Southern Urogynecology
state: South Carolina
city: Arlington
country: United States
facility: Urology Partners
state: Texas
city: Cedar Park
country: United States
facility: Medicus Alliance Clinical Research Organization Inc.
state: Texas
city: Dallas
country: United States
facility: Urology Clinics of North Texas
state: Texas
city: Round Rock
country: United States
facility: North Austin Urology
state: Texas
city: Sugar Land
country: United States
facility: Medicus Alliance Clinical Research Organization Inc.
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: Urovant Sciences
name: Study Director
role: STUDY_DIRECTOR
References: