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

Sponsor
Urovant Sciences GmbH (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05067478
Collaborator
(none)
400
Enrollment
68
Locations
26.1
Anticipated Duration (Months)
5.9
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Oct 28, 2021
Anticipated Primary Completion Date :
Jul 29, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm 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 75 milligram (mg) tablet to be administered orally once daily (as per the U.S. label)
Other Names:
  • GEMTESA

    		•
    Cohort B Vibegron

    Participants with previous mirabegron monotherapy or mirabegron plus solifenacin or mirabegron and anticholinergic therapy experience will receive vibegron as per the U.S. label.

    Drug: Vibegron
    Vibegron 75 milligram (mg) tablet to be administered orally once daily (as per the U.S. label)
    Other Names:
  • GEMTESA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean Satisfaction Domain Score as Assessed by the Overactive Bladder Satisfaction with Treatment Questionnaire (OAB-SAT-q) [Month 3, Month 6 and Month 12]

    2. Percentage of Positive Responders to Individual Treatment Satisfaction Questions 1-3 and 11 as Assessed by the OAB-SAT-q [Month 3]

    3. Percentage of Positive Responders to Individual Treatment Satisfaction Questions 1-3 and 11 as Assessed by the OAB-SAT-q [Month 6]

    4. Percentage of Positive Responders to Individual Treatment Satisfaction Questions 1-3 and 11 as Assessed by the OAB-SAT-q [Month 12]

    Secondary Outcome Measures

    1. 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]

    2. Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) [Up to Month 12]

    3. Mean Duration of Vibegron Treatment [Month 3, Month 6 and Month 12]

    4. Number of Participants Discontinuing Vibegron Treatment for the Indicated Reasons [Month 3, Month 6 and Month 12]

    5. Percentage of Participants Discontinuing Vibegron Treatment for the Indicated Reasons [Month 3, Month 6 and Month 12]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 mirabegron monotherapy and/or mirabegron plus solifenacin and/or previous exposure to anticholinergics 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Urology Centers of Alabama Homewood Alabama United States 35209-5603
    2 43rd Medical Associates Phoenix Arizona United States 85051
    3 Arkansas Urology Associates, PA Little Rock Arkansas United States 72211
    4 Golden Gate Urology Berkeley California United States 94705
    5 Urology Associates of Norwalk Norwalk Connecticut United States 06850
    6 Innovative Research of West Florida, Inc. Clearwater Florida United States 33756
    7 Urological Research Network Hialeah Florida United States 33016-1815
    8 University of Florida Health Jacksonville Facility Clinic Jacksonville Florida United States 32209
    9 South Florida Research Phase I-IV, Inc. Miami Springs Florida United States 33166
    10 University of Miami Miller School of Medicine Miami Florida United States 33136
    11 Mount Sinai Primary & Specialty Care Midtown Miami Florida United States 33137
    12 Tampa Urology Partners LLP Tampa Florida United States 33606
    13 Florida Urology Partners Tampa Florida United States 33615
    14 Clinical Research of Central Florida - Winter Haven Winter Haven Florida United States 33880
    15 Georgia Urology Cartersville Georgia United States 30120
    16 WR-Mount Vernon Clinical Research, LLC Sandy Springs Georgia United States 30328
    17 Idaho Urologic Institute Meridian Idaho United States 83642
    18 Loyola University Medical Center Maywood Illinois United States 60153-3328
    19 Carle Foundation Hospital Urbana Illinois United States 61801
    20 American Health Network of Indiana, LLC Avon Indiana United States 46123
    21 Women's Health Advantage Fort Wayne Indiana United States 46825
    22 The University of Kansas Health System Kansas City Kansas United States 66160
    23 DelRicht Research New Orleans Louisiana United States 70115
    24 Regional Urology, LLC Shreveport Louisiana United States 71106
    25 Chesapeake Urology Research Associates Owings Mills Maryland United States 21117
    26 Lahey Hospital and Medical Center Burlington Massachusetts United States 01805
    27 Bay State Clinical Trials, Inc. Watertown Massachusetts United States 02472
    28 Michigan Center of Medical Research Farmington Hills Michigan United States 48334
    29 Valley OB-GYN Clinic, PC Saginaw Michigan United States 48602
    30 Regents of the University of Minnesota Minneapolis Minnesota United States 55455
    31 Adult & Pediatric Urology Sartell Minnesota United States 56377
    32 SVG Clinical Las Vegas Nevada United States 89128
    33 New Jersey Urology Cancer Treatment Center Bloomfield New Jersey United States 07003
    34 Premier Urology Group Edison New Jersey United States 08837
    35 Lawrence OB-GYN Associates, P.C. Lawrenceville New Jersey United States 08648
    36 Rutgers - Robert Wood Johnson Medical School New Brunswick New Jersey United States 08901
    37 Circuit Clinical Buffalo New York United States 14203
    38 AccuMed Research Associates, Inc. Garden City New York United States 11530
    39 Manhattan Medical Research Practice, PLLC New York New York United States 10016
    40 NYU Grossman School of Medicine New York New York United States 10017
    41 Weill Cornell Medical College New York New York United States 10065
    42 Premier Medical Group of the Hudson Valley, PC Poughkeepsie New York United States 12603
    43 AMP Urology Syracuse New York United States 13210
    44 Atrium Health Infectious Diseases Kenilworth Charlotte North Carolina United States 28207
    45 Alliance Urology Specialists Greensboro North Carolina United States 27403
    46 FirstHealth Urogynecology Hamlet North Carolina United States 28345
    47 Associated Urologists of North Carolina Raleigh North Carolina United States 27612
    48 M3 Wake Research, Inc. Raleigh North Carolina United States 27612
    49 Ardmore Family Practice, PA Winston-Salem North Carolina United States 27103
    50 Wake Forest Baptist Health Winston-Salem North Carolina United States 27103
    51 Obstetrics and Gynecology Associates, Inc. Cincinnati Ohio United States 45014
    52 TriHealth Cincinnati Ohio United States 45211-6301
    53 University of Cincinnati Physicians Obstetrics & Gynecology Cincinnati Ohio United States 45267
    54 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106
    55 Clinical Research Solutions Middleburg Heights Ohio United States 44130
    56 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    57 Institute for Female Pelvic Medicine Allentown Pennsylvania United States 18103
    58 University of Pennsylvania Philadelphia Pennsylvania United States 19014
    59 Medical University of South Carolina (MUSC) Charleston South Carolina United States 29425
    60 Southern Urogynecology West Columbia South Carolina United States 29169
    61 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    62 Urology Partners Arlington Texas United States 76017
    63 Medicus Alliance Clinical Research Organization Inc. Cedar Park Texas United States 78613
    64 Urology Clinics of North Texas Dallas Texas United States 75246
    65 North Austin Urology Round Rock Texas United States 78681
    66 Medicus Alliance Clinical Research Organization Inc. Sugar Land Texas United States 77479
    67 Advanced Research Institute Ogden Utah United States 84405
    68 West Virginia University Morgantown West Virginia United States 26506-9186

    Sponsors and Collaborators

    • Urovant Sciences GmbH

    Investigators

    • Study Director: Study Director, Urovant Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Urovant Sciences GmbH
    ClinicalTrials.gov Identifier:
    NCT05067478
    Other Study ID Numbers:
    • URO-901-4001
    First Posted:
    Oct 5, 2021
    Last Update Posted:
    Jun 10, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by Urovant Sciences GmbH
    Vibegron
    Urinary bladder, overactive
    Beta-3 adrenergic receptor (β3-AR) agonists
    Urge urinary incontinence
    OAB
    Additional relevant MeSH terms:
    Urinary Bladder, Overactive

    Study Results

    No Results Posted as of Jun 10, 2022