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 Lin,Nick Wang,Louise Levine,Yan Daniel Zhao,Hui-Lung Tai,Meghan Wulster-Radcliffe,Curtis Chang,Yao Chi Chuang,Mou-Jong Sun,Julie Beyrer,Shih-Tsung Huang,Lars Viktrup

doi:10.1186/1471-2490-8-2

Abstract

BackgroundThis manuscript compares the efficacy and safety of duloxetine with placebo in Taiwanese women with SUI.MethodsTaiwanese 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).ResultsDecrease 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).ConclusionData provide evidence for the safety and efficacy of duloxetine for the treatment for Taiwanese women with SUI.Trial RegistrationClinicalTrials.gov Identifier: NCT00475358

Highlights

This manuscript compares the efficacy and safety of duloxetine with placebo in Taiwanese women with stress urinary incontinence (SUI)
In August 2004, duloxetine became the first medication approved for the treatment of women with moderate to severe SUI throughout Europe, portions of Central and South America, and the Middle East
There was a significant difference between treatment group in height, but there were no significant differences in body mass indices (BMI) (Table 1)

Summary

Introduction

This manuscript compares the efficacy and safety of duloxetine with placebo in Taiwanese women with SUI. Duloxetine is a dual serotonin and norepinephrine reuptake inhibitor (SNRI) with little or no affinity for cholinergic receptors. Serotonergic agonists suppress parasympathetic activity and enhance sympathetic and somatic activity in the lower urinary tract [3,4,5] promoting urine storage by relaxing the bladder and increasing outlet resistance. NE variably affects the lower urinary tract depending on interactions with appropriate adrenergic receptor subtypes [6,7,8,9,10] The dual actions of duloxetine have been shown in the cat model to increase bladder capacity and striated urethral sphincter activity presumably through central actions in the spinal cord[11].

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Discussion

Conclusion