Korean J Urol.  2006 May;47(5):527-535. 10.4111/kju.2006.47.5.527.

Duloxetine versus Placebo for the Treatment of Korean Women with Stress Predominant Urinary Incontinence

• Mah SY
• Lee KS
• Choo MS
• Seo JT
• Lee JZ
• Park WH
• Kim JC
• Lee SY
• Zhao YD
• Beyrer J
• Wulster-Radcliffe M
• Levine L
• Viktrup L

• KMID: 2294140
• DOI: http://doi.org/10.4111/kju.2006.47.5.527

Abstract

PURPOSE
To compare duloxetine with placebo for the treatment of Korean women with stress urinary incontinence (SUI).
MATERIALS AND METHODS
This was a phase 3, double-blind, stratified, randomized, parallel, placebo-controlled, multi-center study investigating efficacy and safety of a of duloxetine compared with placebo in the treatment of SUI. After a 2-week no-drug screening period, women ages 29-69 were randomly assigned to placebo (n=60) or duloxetine (n=61) as 40mg twice daily for 8 weeks followed by a 2 week no-drug period. Women were seen at 4-week intervals. The primary efficacy variable was percent change in incontinence episodes frequency (IEF)/week. Secondary variables included percent change in, changes in Incontinence Quality of Life (I-QoL) total and 3 sub-scale scores, and Patient Global Impression of Improvement (PGI-I) ratings. Safety was evaluated by treatment emergent adverse events (TEAE), discontinuations due to adverse events, vital signs measurements, and clinical laboratory tests.
RESULTS
There were statistically significant improvements with duloxetine compared with placebo in IEF (duloxetine baseline 16.4IEF/wk, endpoint 7.7IEF/wk, median percent reduction=50.0% vs placebo baseline 13.3IEF/ wk, endpoint 8.8IEF/wk, median percent reduction=37.1%, p=0.033), and avoidance and limiting behavior subscale (p=0.006) in I-QoL. TEAEs were reported significantly more often in the duloxetine group compared with the placebo group (82.0% vs 31.7%; p<0.001); common AEs (>or=5% in duloxetine-treated subjects and p<0.05) were nausea, dizziness, anorexia, fatigue, lethargy, abdominal discomfort, and constipation. Discontinuation rates because of AEs were 34.4% for duloxetine and 8.3% for placebo.
CONCLUSIONS
These data provide evidence for the safety and efficacy of duloxetine for the treatment for Korean women with SUI.

Keyword

Urinary incontinence; stress; Duloxetine

MeSH Terms

Anorexia
Constipation
Dizziness
Fatigue
Female
Humans
Lethargy
Mass Screening
Nausea
Quality of Life
Urinary Incontinence*
Vital Signs
Duloxetine Hydrochloride

Figure

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  Fig. 1. Study design and the timing of acquiring the urinary diaries and reports on the quality of life measurements. I-QoL: Incontinence Quality of Life questionnaire, PGI-I: Patient Global Inpression of Improvement.

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