ABSTRACT
OBJECTIVE: : To evaluate the efficacy of solifenacin versus placebo by baseline continence status using post hoc analysis. METHODS: : Patients with overactive bladder (OAB) were randomized to solifenacin or placebo for 12 weeks; patient-reported outcome (PRO) measures and bladder diaries were completed at prespecified time points. VESIcare Investigation of Bother and Quality of Life in Subjects with OAB (VIBRANT) was not designed to show treatment differences within continence status subgroups. RESULTS: : In the full analysis set (n = 750), 73% of patients were incontinent (n = 545) at baseline. After 12 weeks, incontinent patients receiving solifenacin showed significant improvements versus placebo on PRO measures and most diary-based end points; continent patients (n = 205) showed smaller but similar treatment-related changes. Tolerability was similar in both subgroups and by treatment; most frequent adverse events were dry mouth and constipation. CONCLUSIONS: : In the VIBRANT study, solifenacin significantly improved OAB symptom bother, health-related quality of life, and most symptoms versus placebo in incontinent patients. Continent patients showed smaller but similar trends. Solifenacin was well tolerated in both subgroups.
