Maturitas 60 (2008) 138–147 Available online at www.sciencedirect.com Efficacy and safety of duloxetine in elderly women with stress urinary incontinence or stress-predominant mixed urinary incontinence Jules H. Schagen van Leeuwen a,∗ , Rainer R. Lange b , Aino Fianu Jonasson c , Wei J. Chen d , Lars Viktrup d a Secretariaat Gynaecologie F1, Antonius Hospital, Koekoekslaan 1, 3435 CM Nieuwegein, The Netherlands b Alzey, Germany c Karolinska University Hospital, Huddinge, Stockholm, Sweden d Lilly Research Laboratories, Indianapolis, IN, USA Received 12 December 2007; received in revised form 22 April 2008; accepted 29 April 2008 Abstract Objectives: To evaluate the efficacy and safety of duloxetine in community-dwelling women ≥65 years with stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence (S-MUI) versus placebo. Methods: Patients were randomly assigned for 12 weeks to placebo (N = 134) or duloxetine (N = 131) (20 mg twice daily [BID] for 2 weeks and 40 mg BID for an additional 10 weeks), followed by a double-blind 4-week dose de-escalation/discontinuation phase. The primary efficacy variable was the percent change in incontinence episode frequency (IEF) from baseline to endpoint. Other variables included absolute IEF change, responder rate, changes in mean time between voids (MTBV), weekly continence pad usage, the impact of treatment on quality of life, patient’s global impression of improvement (PGI-I), and changes in depression and cognition. Results: Duloxetine-treated patients had a significantly greater decrease from baseline to endpoint in mean IEF/week than placebo-treated patients (-52.47% vs. -36.70%, P < 0.001). The IEF responder rate (≥50% reduction in IEF/week) was 57.1% in the duloxetine group and 35.2% in the placebo group (P < 0.001). Significant benefits of duloxetine were also demonstrated for weekly continence pad usage (P = 0.011), MTBV (P < 0.001), incontinence quality of life questionnaire (I-QOL) scores (P < 0.001), and PGI-I ratings (P < 0.001). Patients with depressive symptoms and cognitive impairments were few and changes were insignificant. The proportion of patients with ≥1 treatment-emergent adverse event (TEAE) was similar with both treatments, but dry mouth, fatigue, constipation, and hyperhidrosis were significantly more common in women taking duloxetine. Conclusions: Duloxetine is a safe and effective treatment for elderly women with symptoms of SUI or S-MUI. © 2008 Elsevier Ireland Ltd. All rights reserved. Keywords: Cognition; Duloxetine; Elderly women; Quality of life; Stress urinary incontinence ∗ Corresponding author. Tel.: +31 30 609 2172; fax: +31 306 605 1270. E-mail address: j.schagen@Antonius.net (J.H. Schagen van Leeuwen). 0378-5122/$ – see front matter © 2008 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.maturitas.2008.04.012