NEW YORK (Reuters Health) - Results of a large, multicenter trial show that the experimental antidepressant duloxetine can be an effective treatment for stress urinary incontinence in women, according to a report in the October issue of the Journal of Urology.

Duloxetine (Cymbalta; Eli Lilly) is a serotonin and norepinephrine reuptake inhibitor, which in a prior phase II study reduced the frequency of stress incontinence (see Reuters Health report, July 29, 2002).

Dr. Richard C. Bump, with Lilly Research Laboratories in Indianapolis, and members of the Duloxetine Urinary Incontinence Study Group recruited 683 women, ages 22 to 84 years old, who experienced seven or more episodes of incontinence per week. About two-thirds reported "moderately or severely abnormal" urinary tract function.

The authors randomly assigned 344 subjects to 40 mg duloxetine b.i.d., and 339 to placebo. During the 12-week trial, median absolute decrease in frequency of incontinence episodes was 7 per week in the active treatment group and 3 per week in the control group. Frequency declined by at least half in 51.4% and 33.5%, respectively (p < 0.001).

Incontinence quality-of-life scores, which included measures of avoidance/limiting behavior, psychosocial impact, and social embarrassment, also improved significantly more after treatment with duloxetine (p < 0.001).

More subjects in the duloxetine group withdrew from the trial because of adverse events, 24.1% versus 4.1%. Nausea, the most frequent problem, resolved within 1 to 4 weeks. Changes in blood pressure, electrocardiogram, and laboratory tests did not differ between groups.

"Within 4 weeks, a patient with incontinence and her physician should be able to assess the adequacy of the response to duloxetine by comparing improvement with any residual side effects," Dr. Bump's group advises.

Cymbalta is likely to be approved soon by the U.S. Food and Drug Administration for the treatment of depression. Approval for a urinary incontinence indication is dependent on further drug interaction studies. (See Reuters Health report, October 1, 2003.)

Urology 2003;170:1259-1263.

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