Efficacy of Solifenacin on Overactive Bladder Symptoms, Symptom Bother, and Other Patient-Reported Outcomes in Subjects With or Without Incontinence: A Post Hoc Analysis of Data From VIBRANT.

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.

Efficacy of Solifenacin on Symptom Bother and Health-Related Quality of Life in Patients With Acute, Early Chronic, and Late Chronic Overactive Bladder: Secondary Analysis of Data From the VOLT Study.

OBJECTIVES: : In many clinical trials of pharmacotherapy for overactive bladder (OAB), the duration of symptoms is reported as a baseline characteristic; none has investigated this as a prognostic variable. We evaluated the efficacy of solifenacin by patient-reported OAB duration. METHODS: : In this post hoc analysis, patients from a 12-week, open-label study of solifenacin were grouped into 3 OAB duration categories: 3 months to 1 year, 1 to 5 years, and more than 5 years. Changes from baseline to end point on the Patient Perception of Bladder Condition (PPBC), Overactive Bladder Questionnaire (OAB-q), and visual analog scale (VAS) are summarized for each duration cohort. In addition, analysis of covariance was used to compare baseline characteristics and treatment-related changes from baseline among the 3 duration cohorts. RESULTS: : After 12 weeks, all 3 duration cohorts showed numeric improvements in the PPBC, VAS, and OAB-q. Approximately 75% of patients in each group showed improvement on the PPBC. All 3 cohorts showed a 36- to 45-point improvement in the level of bother on the symptom-specific VAS. The magnitude of score improvements (14-31 points) on the OAB-q exceeded the minimally important within group difference of 10 points in all 3 groups. Although results from the analysis of covariance model indicated statistically significant differences between the 3 cohorts for some end points, these differences were numerically small and may not be clinically relevant. Tolerability was similar among the cohorts and compared with the safety population. The most frequently reported adverse events were dry mouth, constipation, headache, and blurred vision. CONCLUSIONS: : These findings showed that irrespective of OAB symptom duration, patients who received 12 weeks of solifenacin perceived meaningful improvements in symptom-specific bother, health-related quality of life, and their overall bladder condition.