Duloxetine versus placebo for the treatment of women with stress predominant urinary incontinence in Taiwan: a double-blind, randomized, placebo-controlled trial
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
BMC Urology 2008, 8:2 doi:10.1186/1471-2490-8-2Published: 25 January 2008
This manuscript compares the efficacy and safety of duloxetine with placebo in Taiwanese women with SUI.
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).
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).
Data provide evidence for the safety and efficacy of duloxetine for the treatment for Taiwanese women with SUI.
ClinicalTrials.gov Identifier: NCT00475358