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.