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Improved overactive bladder is a side benefit of new incontinence Tx. (Investigational Drug).

SAN FRANCISCO -- Treatment with the investigational drug duloxetine not only improved stress urinary incontinence, compared with placebo, in 683 women but decreased overactive bladder symptoms in those who had them, Dr. Peggy A. Norton said.

Stress urinary incontinence and overactive bladder usually are thought of as two separate conditions that may coexist, a paradigm that is beginning to be examined more closely, she said at the annual meeting of the American Urogynecologic Society.

These results from a secondary analysis of data from the phase III trial support previous findings from a phase II study. This earlier study suggested that overactive bladder symptoms occur in women with more severe and more frequent stress urinary incontinence and that overactive bladder symptoms tend to resolve as stress incontinence improves.

Both trials focused on women with predominant stress urinary incontinence. Of the 683 patients in the phase III trial, 33% had pure stress urinary incontinence, 20% had stress urinary incontinence plus an overactive bladder, and 47% had stress urinary incontinence and met some but not all criteria for overactive bladder.

The median number of incontinence episodes per week decreased by 53% in patients with pure stress incontinence treated with duloxetine, compared with a 36% decrease in patients with pure incontinence on placebo. Duloxetine at 80 mg/day produced similar benefits in patients with mixed stress urinary incontinence and overactive bladder: a 58% decrease in the median number of incontinence episodes per week, compared with a 38% decrease in patients on placebo.

The study was funded by Eli Lilly & Co., which is developing duloxetine, a serotonin-norepinephrine reuptake inhibitor. It is being investigated for the treatment of stress urinary incontinence and also as an antidepressant.

"This is a drug that's supposedly only working in patients with stress urinary incontinence [without affecting other bladder problems]. We don't really know what this means...Unexpectedly, duloxetine seemed equally effective for those with pure and those with mixed symptoms, said Dr. Norton, chief of urogynecology and pelvic reconstructive surgery at the University of Utah, Salt Lake City.

After treatment, more than half of patients with mixed symptoms at baseline reverted to having only stress urinary incontinence. In those whose mixed symptoms persisted, stress unnary incontinence was more frequent and more severe as measured by the Incontinence Quality of Life Questionnaire and the Patient Global Impression of Severity Scale.
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Publication:OB GYN News
Date:Feb 1, 2003
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