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

Urovant Sciences GmbH403 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

403

Conditions

Overactive Bladder

Interventions

VibegronDRUG

Vibegron to be administered.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (64)

Outcomes

Primary Outcomes

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.

Time frame: Month 3

Mean Satisfaction Domain Score as Assessed by the OAB-SAT-q

Time frame: Month 6

Mean Satisfaction Domain Score as Assessed by the OAB-SAT-q

Time frame: Month 12

Secondary Outcomes

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

Data from ClinicalTrials.gov

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