New medication is effective in half of study patients.(urinary stress incontinence)(Brief Article)

2002 JUL 18 - (NewsRx.com & NewsRx.net) -- by Lynn Yoffee, senior medical writer - Researchers unveiled for the first time phase III data for a new treatment for stress urinary incontinence in a Late-Breaking Podium Session at the 97th annual scientific meeting of the American Urological Association (AUA) in Orlando, Florida.

Stress urinary incontinence - a common condition among women - occurs when any kind of pressure is put on the bladder, from sneezing to exercising. Childbirth and weight gain are two common causes of incontinence because they stretch the pelvic floor muscles. When the pelvic floor muscles are stretched, the neck of the bladder drops and pushes against the vagina wall, preventing the sphincter muscles that force the urethra shut from tightening as well as they should. The result is urine leaks during physical stress. Stress incontinence also can occur when the sphincter muscles themselves weaken.

Roger Dmochowski, urologist, Vanderbilt University, Department of Urology, Nashville, Tennessee, introduced data from a phase III trial of Duloxetine, a selective serotonin and norepinephrine reuptake inhibitor that increases rhabdosphincter contractility via stimulation of pudendal motor neuron alpha-1 adrenergic and 5HT-2 receptors. The aim of this first phase III 3 study was to assess the efficacy and safety of duloxetine in women with SUI.

"This first phase III data confirms what was seen in the phase II trial," Dmochowski said. "Fifty-one percent of patients had improvement."

The study enrolled 683 North American women ages 22 to 84. The case definition was a predominant symptom of SUI with a weekly incontinence episode frequency (IEF) 7, the absence of predominant urge symptoms, normal diurnal and nocturnal frequencies, a bladder capacity 400 mL, and positive cough stress and stress pad tests.

After a 2-week placebo lead in, subjects were randomly assigned to receive placebo (n=339) or duloxetine 80 mg/day (n=344; 40 mg bid) for 12 weeks.

There was a significant decrease in IEF with duloxetine compared with placebo with comparable significant ...