Duloxetine Controls Symptoms of Stress Urinary Incontinence

Laurie Barclay, MD

July 22, 2002

July 23, 2002 -- Duloxetine, a selective reuptake inhibitor of the neurotransmitters serotonin and norepinephrine (SNRI), was safe and somewhat effective in controlling the symptoms of stress urinary incontinence, according to the results of a double-blind, placebo-controlled trial reported in the July issue of the American Journal of Obstetrics and Gynecology. Duloxetine is awaiting U.S. Food and Drug Administration (FDA) approval.

"Current treatment options are limited to surgery, devices and pelvic muscle strengthening exercises," lead author Peggy A. Norton, MD, of the University of Utah in Salt Lake City, says in a news release. "If eventually approved, duloxetine could be the first drug therapy indicated for the treatment of stress urinary incontinence, offering a new treatment option for millions of women with the condition."

In this study, 553 women aged 18 to 65 years with a predominant symptom of stress urinary incontinence were randomized to treatment with placebo or duloxetine 20 mg/day, 40 mg/day, or 80 mg/day.

Duloxetine was associated with significant and dose-dependent decreases in frequency of incontinence episodes, correlated with improvements on the Patient Global Impression of Improvement scale and the Incontinence Quality of Life questionnaire. Median decrease in frequency of incontinence episodes was 41% for placebo, 54% for duloxetine 20 mg daily (P=.06), 59% for duloxetine 40 mg daily (P=.002), and 64% for duloxetine 80 mg daily (P<.001).

Of subjects taking 80 mg per day, half had at least a 64% reduction in incontinence episode frequency (P<.001) and 67% had at least a 50% reduction compared with placebo (P=.001). Dose-dependent increases in the average voiding interval in the duloxetine groups compared with the placebo group did not affect this reduction in frequency of incontinence.

In a subgroup of 163 subjects with more severe stress urinary incontinence who had at least 14 episodes per week, reduction in incontinence episode frequency in the duloxetine groups was 49% to 64%, compared with 30% in the placebo group.

Discontinuation rates for adverse events, most commonly nausea, were 5% for placebo, 9% for duloxetine 20 mg daily, 12% for 40 mg daily, and 15% for 80 mg daily (P=.04).

"These data are very encouraging for women and physicians alike and provide evidence for the potential of duloxetine as a future pharmaceutical treatment for stress urinary incontinence," Norton says.

Large multinational trials are ongoing. Lilly, which supported this study, is also investigating duloxetine in the treatment of depression. The company filed a New Drug Application with the FDA for this indication in late 2001.

Am J Obstet Gynecol. 2002;187:40-48

Reviewed by Gary D. Vogin, MD

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