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

Recruiting in Palo Alto (17 mi)

+89 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Urovant Sciences GmbH

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Study Director

Principal Investigator

Urovant Sciences

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

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Treatment Details

Interventions

Vibegron (Beta-3 Adrenergic Agonist)

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Cohort B VibegronExperimental Treatment1 Intervention

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

Group II: Cohort A VibegronExperimental Treatment1 Intervention

Participants with previous anticholinergic therapy experience will receive vibegron as per the United States (U.S.) label.

Vibegron is already approved in Japan for the following indications: