Overactive BladderNCT05067478
Composur: Study to Understand the Performance of Vibegron in Participants with Overactive Bladder (OAB)
An observational study of Overactive Bladder, run by Urovant Sciences GmbH at 64 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Vibegron
- How many people
- 403 participants
- Where
- 64 sitesUnited States
- Study dates
- 28 Oct 2021to 26 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be recruited from primary care settings such as Family Practice, Urogynecology, and Urology practices
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
64 sites in 1 country.
64 sites in 1 country
United States64 sites
Institute for Female Pelvic Medicine
Allentown, Pennsylvania, 18103
Urology Partners
Arlington, Texas, 76017
American Health Network of Indiana, LLC
Avon, Indiana, 46123
Golden Gate Urology
Berkley, California, 94705
New Jersey Urology Cancer Treatment Center
Bloomfield, New Jersey, 07003
Circuit Clinical
Buffalo, New York, 14203
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
Georgia Urology
Cartersville, Georgia, 30120
Medicus Alliance Clinical Research Organization Inc.
Cedar Park, Texas, 78613
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
Atrium Health Infectious Diseases Kenilworth
Charlotte, North Carolina, 28207
Obstetrics and Gynecology Associates, Inc.
Cincinnati, Ohio, 45014
TriHealth
Cincinnati, Ohio, 45211-6301
University of Cincinnati Physicians Obstetrics & Gynecology
Cincinnati, Ohio, 45267
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
Urology Clinics of North Texas
Dallas, Texas, 75246
AccuMed Research Associates, Inc.
Garden City, New York, 11530
Alliance Urology Specialists
Greensboro, North Carolina, 27403
FirstHealth Urogynecology
Hamlet, North Carolina, 28345
Urological Research Network
Hialeah, Florida, 33016-1815
Urology Centers of Alabama
Homewood, Alabama, 35209-5603
University of Florida Health Jacksonville Facility Clinic
Jacksonville, Florida, 32209
The University of Kansas Health System
Kansas City, Kansas, 66160
Center for Urogynecology and Pelvic Health
King of Prussia, Pennsylvania, 19406
SVG Clinical
Las Vegas, Nevada, 89128
Lawrence OB-GYN Associates, P.C.
Lawrenceville, New Jersey, 08648
Arkansas Urology Associates, PA
Little Rock, Arkansas, 72211
Loyola University Medical Center
Maywood, Illinois, 60153-3328
Idaho Urologic Institute
Meridian, Idaho, 83642
University of Miami Miller School of Medicine
Miami, Florida, 33136
South Florida Research Phase I-IV, Inc.
Miami Springs, Florida, 33166
Clinical Research Solutions
Middleburg Heights, Ohio, 44130
Regents of the University of Minnesota
Minneapolis, Minnesota, 55455
West Virginia University
Morgantown, West Virginia, 26506-9186
Rutgers - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
DelRicht Research
New Orleans, Louisiana, 70115
Manhattan Medical Research Practice, PLLC
New York, New York, 10016
NYU Grossman School of Medicine
New York, New York, 10017
Weill Cornell Medical College
New York, New York, 10065
Urology Associates of Norwalk
Norwalk, Connecticut, 06850
Advanced Research Institute
Ogden, Utah, 84405
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Chesapeake Urology Research Associates
Owings Mills, Maryland, 21117
University of Pennsylvania
Philadelphia, Pennsylvania, 19014
43rd Medical Associates
Phoenix, Arizona, 85051
Premier Medical Group of the Hudson Valley, PC
Poughkeepsie, New York, 12603
Associated Urologists of North Carolina
Raleigh, North Carolina, 27612
North Austin Urology
Round Rock, Texas, 78681
Valley OB-GYN Clinic, PC
Saginaw, Michigan, 48602
WR-Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, 30328
Adult & Pediatric Urology
Sartell, Minnesota, 56377
Regional Urology, LLC
Shreveport, Louisiana, 71106
Medicus Alliance Clinical Research Organization Inc.
Sugar Land, Texas, 77479
AMP Urology
Syracuse, New York, 13210
Tampa Urology Partners LLP
Tampa, Florida, 33606
Florida Urology Partners
Tampa, Florida, 33615
Fiel Family and Sports Medicine, PC
Tempe, Arizona, 85283
Carle Foundation Hospital
Urbana, Illinois, 61801
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, 02472
Southern Urogynecology
West Columbia, South Carolina, 29169
Ardmore Family Practice, PA
Winston-Salem, North Carolina, 27103
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27103
Clinical Research of Central Florida - Winter Haven
Winter Haven, Florida, 33880
About this study
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
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.
- Conditions
- Overactive Bladder
- Being tested
- Vibegron
- Keywords
- Vibegron, Urinary bladder, overactive, Beta-3 adrenergic receptor (β3-AR) agonists, Urge urinary incontinence, OAB
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VibegronDrug
Also called GEMTESA
Vibegron to be administered.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A Vibegron | Participants with previous anticholinergic therapy experience will receive vibegron as per the United States (U.S.) label. Receives: Drug: Vibegron | |
| 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. Receives: Drug: Vibegron |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Month 12
Secondary outcomes (6)
Percentage of Positive Responders to Individual Treatment Satisfaction Questions 1-3 and 11 as Assessed by the OAB-SAT-q
Measured: Month 3, Month 6 and Month 12
Mean Scores on the Side Effects, Endorsement, Convenience, and Preference Domains as Assessed by the OAB-SAT-q
Measured: Month 3, Month 6 and Month 12
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Measured: Up to Month 12
Mean Duration of Vibegron Treatment
Measured: Month 3, Month 6 and Month 12
Number of Participants Discontinuing Vibegron Treatment for the Indicated Reasons
Measured: Month 3, Month 6 and Month 12
Percentage of Participants Discontinuing Vibegron Treatment for the Indicated Reasons
Measured: Month 3, Month 6 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start28 Oct 2021
- Primary completion22 Jul 2024
- Study completion26 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Urovant Sciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Urovant Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067478
- Sponsor's protocol ID
- URO-901-4001
- Status last verified
- Dec 2024
- First submitted
- 14 Sep 2021
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Dmochowski RR, Rovner ES, Kennelly MJ, Newman DK, Xavier K, Thomas E, Snyder D, Abedinzadeh L. Satisfaction and persistence with vibegron in the first 6 months of overactive bladder treatment: interim results of the phase 4, real-world COMPOSUR study. BMC Urol. 2025 Apr 2;25(1):66. doi: 10.1186/s12894-025-01742-6.
PubMed 40176006Dmochowski RR, Rovner ES, Kennelly MJ, Newman DK, Abedinzadeh L, Snyder D, Thomas E, Haag-Molkenteller C, Rosenberg MT. Study design of a phase 4, real-world study (COMPOSUR) to evaluate vibegron in patients with overactive bladder. BMC Urol. 2023 Apr 24;23(1):64. doi: 10.1186/s12894-023-01240-7.
PubMed 37095473
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05067478
- Acronym / sponsor ID
- URO-901-4001
- Conditions
- Overactive Bladder
- Keywords
- Vibegron, Urinary bladder, overactive, Beta-3 adrenergic receptor (β3-AR) agonists, Urge urinary incontinence, OAB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Urovant Sciences GmbHIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- 22 Jul 2024 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 5 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A Vibegron | – | Drug: VibegronParticipants with previous anticholinergic therapy experience will receive vibegron as per the United States (U.S.) label. |
| Cohort B Vibegron | – | Drug: VibegronParticipants with previous mirabegron monotherapy or mirabegron plus solifenacin or combination therapy experience will receive vibegron as per the U.S. label. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be recruited from primary care settings such as Family Practice, Urogynecology, and Urology practices
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VibegronAlso: GEMTESAVibegron to be administered. | Drug | Cohort A Vibegron, Cohort B Vibegron |
Primary outcome
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.
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.
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.
6 secondary outcomes
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
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
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: Up to Month 12
Mean Duration of Vibegron Treatment
Time frame: 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
Percentage of Participants Discontinuing Vibegron Treatment for the Indicated Reasons
Time frame: Month 3, Month 6 and Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Derived from this study: PubMed 40176006Dmochowski RR, Rovner ES, Kennelly MJ, Newman DK, Xavier K, Thomas E, Snyder D, Abedinzadeh L. Satisfaction and persistence with vibegron in the first 6 months of overactive bladder treatment: interim results of the phase 4, real-world COMPOSUR study. BMC Urol. 2025 Apr 2;25(1):66. doi: 10.1186/s12894-025-01742-6.
- Derived from this study: PubMed 37095473Dmochowski RR, Rovner ES, Kennelly MJ, Newman DK, Abedinzadeh L, Snyder D, Thomas E, Haag-Molkenteller C, Rosenberg MT. Study design of a phase 4, real-world study (COMPOSUR) to evaluate vibegron in patients with overactive bladder. BMC Urol. 2023 Apr 24;23(1):64. doi: 10.1186/s12894-023-01240-7.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Urovant Sciences
64 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder, run by Urovant Sciences GmbH at 64 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Satisfaction Domain Score as Assessed by the Overactive Bladder Satisfaction with Treatment Questionnaire (OAB-SAT-q) (time frame: Month 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05067478, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.