Satisfaction and persistence with vibegron in the first 6 months of overactive bladder treatment: interim results of the phase 4, real-world COMPOSUR study
Abstract
Background: The COMPOSUR study is evaluating vibegron for the treatment of overactive bladder (OAB) in a real-world setting. We report results of a prespecified 6-month interim analysis, assessing patient-reported treatment satisfaction, persistence, safety, and tolerability over the first 6 months after receiving a new prescription for vibegron.
Methods: COMPOSUR (NCT05067478) is a 12-month, phase 4 study of vibegron. Patients were enrolled if they were ≥ 18 years of age with OAB, initiating vibegron after previously receiving anticholinergics (Cohort A) or mirabegron with/without anticholinergics (Cohort B). Satisfaction was assessed via the OAB Satisfaction With Treatment Questionnaire (OAB-SAT-q; domain scores on 0-100 scale, higher scores denoting greater satisfaction). The primary endpoint is the OAB-SAT-q satisfaction domain score. The key secondary endpoints are the percentage of positive responses to OAB-SAT-q questions 1-3 and 11. Additional secondary endpoints include OAB-SAT-q scores for side effects, endorsement, preference, and convenience. Persistence was assessed as an exploratory endpoint. Safety was assessed via adverse events (AEs).
Results: A total of 403 patients were enrolled and initiated treatment with vibegron; 104 patients discontinued the study before month 6, most commonly owing to withdrawal of consent (n = 32) and AEs (n = 8). Mean (SD) patient age was 56.1 (12.5) years, and 29% were male. Overall, at 6 months, mean (SD) OAB-SAT-q domain scores…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 403 participants or records.
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