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

December 20, 2024 updated by: Urovant Sciences GmbH

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
403

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Satisfaction Domain Score as Assessed by the Overactive Bladder Satisfaction with Treatment Questionnaire (OAB-SAT-q)
Time Frame: Month 3
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
Time Frame: Month 6
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
Time Frame: Month 12
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Mean Scores on the Side Effects, Endorsement, Convenience, and Preference Domains as Assessed by the OAB-SAT-q
Time Frame: Month 3, Month 6 and Month 12
Month 3, Month 6 and Month 12
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time Frame: Up to Month 12
Up to Month 12
Mean Duration of Vibegron Treatment
Time Frame: Month 3, Month 6 and Month 12
Month 3, Month 6 and Month 12
Number of Participants Discontinuing Vibegron Treatment for the Indicated Reasons
Time Frame: Month 3, Month 6 and Month 12
Month 3, Month 6 and Month 12
Percentage of Participants Discontinuing Vibegron Treatment for the Indicated Reasons
Time Frame: Month 3, Month 6 and Month 12
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
Time Frame: Month 3, Month 6 and Month 12
Month 3, Month 6 and Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Urovant Sciences GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director, Urovant Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 28, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 22, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings