General Obstetrics and Gynecology: GynecologyDuloxetine versus placebo in the treatment of stress urinary incontinence☆,☆☆,★
Section snippets
Material and methods
Incontinent female outpatients aged 18 to 65 years who had a clinical diagnosis of SUI for at least 3 months in duration were invited to participate in this double-blind, placebo controlled, randomized clinical trial. To enroll, subjects must have reported a predominant symptom of SUI with ≥4 incontinent episodes per week, where an episode was defined as an easily noticeable leakage of urine that wets a pad or clothing and occurs with a physical stress such as coughing, sneezing, or exercising.
Results
Originally 1124 female subjects were screened for eligibility; 553 women met entry criteria and were randomized to either duloxetine 20 mg/day (n = 138 women), duloxetine 40 mg/day (n = 137 women), duloxetine 80 mg/day (n = 140 women), or placebo (n = 138 women). Ninety-six percent of the women (132/138) receiving placebo, 96% of the women (132/138) receiving duloxetine 20 mg/day, 94% of the women (129/137) receiving duloxetine 40 mg/day, and 93% of the women (130/140) receiving duloxetine 80
Comment
The results of this study provide evidence for the efficacy of duloxetine as a pharmacologic agent for the treatment of SUI, with significant improvements in both IEF and quality of life. The subgroup analysis of the more severely incontinent subjects (IEF ≥14 at baseline) indicated that improvements that were observed with duloxetine treatment were maintained, despite increased baseline incontinence severity.
The significant dose-dependent response to duloxetine in the current trial differs
Acknowledgements
We thank Stephanie C. Koke, MS, for her assistance in the preparation of this manuscript.
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Supported by Eli Lilly and Company.
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The members of the Duloxetine Urinary Incontinence Study Group are listed in the Appendix.
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Reprint requests: Richard C. Bump, MD, Eli Lilly and Company Corporate Center, DC 2200, Indianapolis, IN 46285. E-mail: bump_richard@ lilly.com