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Open Access Research article

Duloxetine versus placebo for the treatment of women with stress predominant urinary incontinence in Taiwan: a double-blind, randomized, placebo-controlled trial

Alex Tong-Long Lin1, Mou-Jong Sun2, Hui-Lung Tai3, Yao Chi Chuang4, Shih-Tsung Huang5, Nick Wang6, Yan Daniel Zhao7, Julie Beyrer7, Meghan Wulster-Radcliffe7, Louise Levine7, Curtis Chang6 and Lars Viktrup7*

Author Affiliations

1 Division of Urology, Department of Surgery, Taipei Veterans General Hospital, Taipei, Taiwan

2 Division of Urogynecology and Pelvic Reconstructive, Department of Obstetric and Gynecology, Changhua Christian Hospital, Changhua, Taiwan

3 Division of Urology, Department of Surgery, Changhua Christian Hospital, Changhua, Taiwan

4 Division of Urology, Department of Surgery, Chang Gung Memorial Hospital, Kaohsiung, Taiwan

5 Division of Urology, Department of Surgery, Chang Gung Memorial Hospital, Lin-Kou, Taiwan

6 Medical Department, Eli Lilly and Company, Taiwan

7 Lilly Research Laboratories, Indianapolis, IN, USA

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BMC Urology 2008, 8:2  doi:10.1186/1471-2490-8-2

Published: 25 January 2008

Abstract

Background

This manuscript compares the efficacy and safety of duloxetine with placebo in Taiwanese women with SUI.

Methods

Taiwanese women with SUI were were randomly assigned to placebo (n = 61) or duloxetine 80 mg/day (n = 60) in this double-blind, 8-week, placebo-controlled study. Outcome variables included: incontinence episode frequency (IEF), Incontinence Quality of Life questionnaire (I-QOL) scores, and Patient Global Impression of Improvement rating (PGI-I).

Results

Decrease in IEF was significantly greater in duloxetine-treated than placebo-treated women (69.98% vs 42.56%, P < .001). No treatment differences in I-QOL scores were significant. There were significant differences in PGI-I rating. Treatment-emergent adverse events (TEAEs) were experienced by more duloxetine-treated than placebo-treated women (80.0% vs 44.3%; P < .001). Discontinuations due to adverse events were significantly greater for duloxetine-treated than placebo-treated women (26.7% vs 6.6%; P = .003).

Conclusion

Data provide evidence for the safety and efficacy of duloxetine for the treatment for Taiwanese women with SUI.

Trial Registration

ClinicalTrials.gov Identifier: NCT00475358