May 22, 2002
SAN FRANCISCO (Reuters Health)
Fecal incontinence among scleroderma patients may be aided by sacral nerve stimulation delivered by an implanted neurostimulator, researchers reported Tuesday at Digestive Disease Week and the 103rd annual meting of the American Gastroenterological Association meeting that is underway here.
"These early results are encouraging," said lead author Dr. Michael A. Kamm, a professor of gastroenterology at St. Marks Hospital in Harrow, England, and a consultant for the device's manufacturer, Minneapolis-based Medtronic, Inc. "It's a very effective therapy for incontinence."
Medtronic's InterStim device is currently approved worldwide for urinary incontinence and in Europe for fecal incontinence. A multicenter clinical trial testing the device for efficacy on fecal incontinence is currently underway in the United States to gain FDA approval.
The device delivers a consistent low-level of stimulation to the nerves of the sacral plexus, which alters the functioning of the lower bowel and pelvic floor.
In this study, the researchers tested the stimulatory device on five women diagnosed with scleroderma who had had reported at least 5 years of fecal incontinence and had failed transitional antidiarrheal agents and behavioral therapies, such as pelvic muscle exercises. The average age of the women was 61 years, and each had experienced an average of two episodes of incontinence per week.
Four of the five women reported improvement from temporary stimulation. One woman failed to show improvement from temporary stimulation and did not receive the implant. At follow-up a median of 2 years later, all four patients with implants were continent, better able to delay defecation, and reported an improved quality of life.
Episodes of weekly incontinence went from an average of 13 pre-implantation to 0. Pre-implantation, the patients were able to delay bowel movement less than 1 minute on average, while afterwards, they could delay an average of 12.5 minutes. The researchers also found significant improvements in anal squeeze pressure, resting pressure and rectal sensation.
No major complications were reported. The product will cost an estimated
$20,000 and is expected to last from 8 to 10 years, according to a Metronic
© 2002 Reuters Ltd