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

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

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

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

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

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

⁶Medical Department, Eli Lilly and Company, Taiwan

⁷Lilly Research Laboratories, Indianapolis, IN, USA

author email corresponding author email

BMC Urology 2008, 8:2doi: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