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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05067478
Recruitment Status : Recruiting
First Posted : October 5, 2021
Last Update Posted : June 10, 2022
Sponsor:
Information provided by (Responsible Party):
Urovant Sciences GmbH

Study Description
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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
Overactive Bladder Drug: Vibegron

Study Design
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Study Type : Observational
Estimated 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 : October 28, 2021
Estimated Primary Completion Date : July 29, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Vibegron

Groups and Cohorts
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Group/Cohort 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 Name: 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 Name: GEMTESA


Outcome Measures
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Primary Outcome Measures :
  1. Mean Satisfaction Domain Score as Assessed by the Overactive Bladder Satisfaction with Treatment Questionnaire (OAB-SAT-q) [ Time Frame: 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 [ Time Frame: Month 3 ]
  3. Percentage of Positive Responders to Individual Treatment Satisfaction Questions 1-3 and 11 as Assessed by the OAB-SAT-q [ Time Frame: Month 6 ]
  4. Percentage of Positive Responders to Individual Treatment Satisfaction Questions 1-3 and 11 as Assessed by the OAB-SAT-q [ Time Frame: Month 12 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) [ Time Frame: Up to Month 12 ]
  3. Mean Duration of Vibegron Treatment [ Time Frame: Month 3, Month 6 and Month 12 ]
  4. Number of Participants Discontinuing Vibegron Treatment for the Indicated Reasons [ Time Frame: Month 3, Month 6 and Month 12 ]
  5. Percentage of Participants Discontinuing Vibegron Treatment for the Indicated Reasons [ Time Frame: Month 3, Month 6 and Month 12 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05067478


Contacts
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Contact: Urovant Call Center 833-876-8268 clinicaltrials@urovant.com

Locations
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Sponsors and Collaborators
Urovant Sciences GmbH
Investigators
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Study Director: Study Director Urovant Sciences
More Information
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Responsible Party: Urovant Sciences GmbH
ClinicalTrials.gov Identifier: NCT05067478    
Other Study ID Numbers: URO-901-4001
First Posted: October 5, 2021    Key Record Dates
Last Update Posted: June 10, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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.
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).

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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:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations