Solifenacin for overactive bladder: secondary analysis of data from VENUS based on baseline continence status.

INTRODUCTION AND HYPOTHESIS

VENUS evaluated the efficacy of solifenacin on urgency in patients with overactive bladder (OAB). We hypothesized that solifenacin would be comparably efficacious in continent and incontinent patients.

METHODS

VENUS was a 12-week, placebo-controlled trial in patients with OAB. Treatment efficacy was assessed using bladder diaries and patient-reported outcome measures. The primary endpoint was the change in daily urgency episodes. Exploratory subgroup analyses were conducted using baseline continence status.

RESULTS

Solifenacin reduced urgency episodes versus placebo in continent (-3.4 vs. -2.3) and incontinent patients (-4.2 vs. -2.9) and incontinence episodes (-2.1 vs. -1.2) in that subgroup; 58% versus 42% of incontinent patients receiving solifenacin versus placebo were continent at study end. In both cohorts, solifenacin- versus placebo-treated patients showed greater improvements in perceptions of urgency severity, symptom bother, and health-related quality of life.

CONCLUSION

This post hoc analysis demonstrates the efficacy of solifenacin regardless of baseline continence status.