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


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


BACKGROUND
ClinicalTrials.gov Identifier: NCT00475358.
Lin
Alex Tong-Long
AT
Division of Urology, Department of Surgery, Taipei Veterans General Hospital, Taipei, Taiwan. lintl@vghtpe.gov.tw
Sun
Mou-Jong
MJ
Tai
Hui-Lung
HL
Chuang
Yao Chi
YC
Huang
Shih-Tsung
ST
Wang
Nick
N
Zhao
Yan Daniel
YD
Beyrer
Julie
J
Wulster-Radcliffe
Meghan
M
Levine
Louise
L
Chang
Curtis
C
Viktrup
Lars
L
D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D000068736:Duloxetine Hydrochloride; D005260:Female; D006801:Humans; D008875:Middle Aged; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D013624:Taiwan; D013876:Thiophenes / Q000627:therapeutic use*; D014550:Urinary Incontinence, Stress / Q000188:drug therapy*
D000068736:Duloxetine Hydrochloride; D017367:Selective Serotonin Reuptake Inhibitors; D013876:Thiophenes