Objective: Surgery and pelvic floor muscle training are established methods for treating stress urinary incontinence (SUI). A new serotonin and noradrenaline reuptake inhibitor, duloxetine, has been studied in multiple phase 3 trials as a form of medical management of this condition. This systematic review determined the effectiveness and acceptability of duloxetine in managing SUI.
Methods: We reviewed all randomised controlled trials comparing duloxetine with placebo or no treatment. The search included the Cochrane Incontinence Group specialised register, CENTRAL, MEDLINE, PREMEDLINE, dissertation abstracts, and the reference lists of relevant articles. The primary outcome was the number of participants whose symptoms were "cured" while on treatment. Secondary outcomes included subjective improvement, incontinent episodes, quality of life, adverse events, and discontinuation rates.
Results: Nine trials were included, totalling 3063 women with predominantly SUI, all randomised to receive duloxetine or placebo. Treatment duration was 3-36 wk. Subjective cure favoured duloxetine (from three trials, 10.8% vs. 7.7%; RR=1.42; 95%CI, 1.02-1.98, p=0.04). The limited data available to assess objective cure rates were consistent with this. Individual studies showed a significant reduction in the Incontinence Episode Frequency (IEF) by approximately 50% during treatment. Duloxetine groups had significantly better quality-of-life scores (weighted mean difference for Incontinence Quality of Life Index for participants on 80 mg daily: 4.5; 95%CI, 2.83-6.18; p<0.00001) and rates of symptom improvement. Adverse effects were common (71% vs. 59%) but are reported as not serious and were equivalent to about one in eight participants reporting adverse effects (most commonly nausea) directly related to duloxetine treatment. About one in eight stopped treatment as a consequence of taking duloxetine (17% vs. 4%).
Conclusions: Duloxetine can significantly improve the quality of life of patients with SUI, but it is unclear whether or not benefits are sustainable. Side-effects such as nausea are common.