Objectives: This systematic review determined whether the duloxetine can get more benefits versus placebo in managing women with stress urinary incontinence (SUI) all over the world.
Methods: We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing duloxetine with placebo in these patients. The eligible RCTs were identified from the following electronic databases: Cochrane CENTRAL, Medline and EMBASE. We treated the incontinence episode frequency (IEF) as the main outcome, and the secondary outcomes were cured, average voiding interval, incontinence quality of life (I-QOL), treatment-emergent adverse events (TEAEs) and discontinuation.
Results: The review contained ten trials including 5,738 women who were randomized to take duloxetine or placebo. All arms in individual trials were comparable for various baseline characteristics. Individual studies showed a significantly greater decrease in IEF than placebo group. The total IEF responders (defined as a woman who had at least a 50 % decrease in IEF with treatment) within the duloxetine-treated women were more than the placebo-treated women (52.5 vs. 33.7 %; RR = 1.56; 95 %CI, 1.46-1.66; p < 0.00001). TEAEs were commonly experienced by both two groups (62.7 vs. 45.3 %) though they were not critical.
Authors' conclusions: Our meta-analysis showed that significant efficacy can be found in women treated with a certain dose of duloxetine. The adverse events like nausea, constipation, dry mouth, fatigue etc. are common.