NEW YORK (Reuters Health) - Results of a controlled trial suggest that women awaiting surgery to relieve severe stress urinary incontinence may find significant relief with the serotonin/norepinephrine reuptake inhibitor, duloxetine, leading some to reconsider surgery.

Duloxetine has previously been shown to be safe and effective in women with mild to moderate stress urinary incontinence (seven or more episodes per week). (See Reuters Health report October 29, 2003).

In the current double-blind study, Dr. Richard C. Bump, with Eli Lilly Research Laboratories in Indianapolis, and colleagues randomly assigned 109 women between 33 and 75 years of age to duloxetine 80 mg daily or placebo for 4 weeks, escalated to 120 mg daily for 4 weeks.

All of the women had pure urodynamic stress urinary incontinence, experienced 14 or more episodes of incontinence per week and were scheduled for continence surgery, investigators explain in the September issue of Obstetrics and Gynecology.

Compared with placebo, duloxetine significantly reduced the frequency of incontinence episodes (-60% vs -27%), decreased pad use (-34.5% vs -4.8%), and improved incontinence-related quality of life scores (+10.6 vs +2.4).

After 8 weeks of treatment, 20% of duloxetine-treated women decided to skip the surgery compared with none of the women given placebo.

Duloxetine's beneficial effects were observed within 2 weeks of initiation.

"Overall," Dr. Bump said, "the data mean that physicians and patients have an additional option besides surgery or pelvic floor muscle training for treating women with [severe urinary incontinence] and will know very quickly which of their patients will respond to treatment."

Side effects noted in the current trial were similar to those seen in previous trials of duloxetine and included transient mild to moderate nausea, constipation, headache and dry mouth.

Obstet Gynecol 2004;104:511-519

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