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

Toglia MR, Ostergard DR, Appell RA, Andoh M, Fakhoury A, Hussain IF

International urogynecology journal, 2010

Abstract

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.

How strong is the evidence?

Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.

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