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.
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).
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 were 70.0 (21.9) for satisfaction, 84.7 (20.6) for convenience, 91.1 (16.4) for side effects, and 80.4 (20.6) for endorsement. At 6 months, 85.6% (95% CI, 81.1%-90.1%) of patients preferred vibegron to previous OAB treatment. Most patients responded positively to individual OAB-SAT-questions; outcomes were similar from months 1 to 6 and in Cohorts A and B. Persistence with vibegron treatment at 6 months was 73.9% (95% CI, 69.3%-78.0%). Overall, 33.5% of patients experienced a treatment-emergent AE, most commonly (≥ 2% overall) urinary tract infection (4.0%), headache (2.7%), and dizziness (2.2%).
As of the 6-month interim analysis of the COMPOSUR study, most patients receiving vibegron were satisfied with treatment; satisfaction generally persisted from month 1 to 6, regardless of prior OAB treatment received. Treatment with vibegron was generally safe and well tolerated.
ClinicalTrials.gov identifier: NCT05067478; registered: October 5, 2021.
BMC urology. 2025 Apr 02*** epublish ***
Roger R Dmochowski, Eric S Rovner, Michael J Kennelly, Diane K Newman, Keith Xavier, Elizabeth Thomas, Daniel Snyder, Laleh Abedinzadeh
Department of Urologic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA., Department of Urology, Medical University of South Carolina, Charleston, SC, USA., Carolinas Medical Center, Charlotte, NC, USA., Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA., Urology Partners of North Texas, Arlington, TX, USA., Medical Affairs, Sumitomo Pharma America, Inc., 84 Waterford Dr, Marlborough, MA, 01752, USA., Medical Affairs, Sumitomo Pharma America, Inc., 84 Waterford Dr, Marlborough, MA, 01752, USA. .