Background: To assess vibegron for the treatment of overactive bladder (OAB) in a real-world setting, the COMPOSUR study is evaluating patient treatment satisfaction, tolerability, and safety. Results from a 3-month analysis were previously presented. We report results of a protocol-defined interim analysis of selected endpoints conducted when most patients completed the 6-month questionnaire and >100 patients completed the study. Methods: COMPOSUR (NCT05067478) is a 12-month, phase 4 study of vibegron enrolling patients ≥18 years old with OAB with/without urge urinary incontinence who were starting a new course of vibegron and who had previous exposure to anticholinergics (Cohort A) or mirabegron with/without anticholinergics (Cohort B). Enrollment criteria follow the vibegron US product label. The primary endpoint is patient satisfaction assessed as a composite of the OAB Satisfaction with Treatment Questionnaire (OAB-SAT-q) questions 1‒3 (6-point Likert scale; normalized score range: 0 [extremely dissatisfied] to 100 [extremely satisfied]), completed monthly. Safety is assessed by adverse events (AEs). Results: As of the 6-month interim analysis, enrollment has completed (Cohort A, n=134; Cohort B, n=266); 124 patients (31%) have discontinued (n=40; n=84, respectively), most commonly due to withdrawal of consent (n=10; n=23). Mean (SD) age was 56.0 (12.5) years; 71.0% were female. A total of 202 patients completed the 6-month OAB-SAT-q, and 96 completed the 12-month OAB-SAT-q. Mean (SD) OAB-SAT-q satisfaction scale score was 70.3 (21.9) at month 6 and 71.2 (22.8) at month 12; 80.2% and 78.1% of patients, respectively, were consistently satisfied with treatment (ie, selected satisfied or better on OAB-SAT-q questions 1-3). Of patients reporting a preference for an oral pharmacotherapy at month 6, 84.8% (151/178) stated they preferred vibegron vs the treatment they received before entering the study (ie, selected slightly or definitely preferred on OAB-SAT-q question 8); at month 12, 85.2% (75/88) stated they preferred vibegron. Overall, 30.5% of patients experienced a treatment-emergent AE; 6 patients (1.5%) experienced a serious AE. The only AEs reported in ≥2% of patients overall were urinary tract infection (3.8%), headache (2.8%), and dizziness (2.3%). Conclusions: As of the 6-month interim analysis of the COMPOSUR trial, most patients receiving vibegron were satisfied with treatment. Treatment with vibegron was generally safe and well tolerated. Data are preliminary, and the study remains ongoing.
