June 9, 1998 DALLAS, Texas, June 5, 1998--Urologists at UT Southwestern Medical Center at Dallas soon will test whether severe incontinence can be improved by applying electrical stimulation to a spot near the ankle to stimulate the nerves that affect bladder control.
Patients with urinary frequency, urgency, pelvic pain and uncontrollable urination, called urge incontinence, are needed for the study, which involves a series of outpatient procedures designed to relieve the debilitating symptoms.
"We have identified a point approximately three finger breadths above the ankle bone where nerves affecting bladder behavior can be modulated with this new technology," said Dr. Scott Litwiller, assistant professor of urology and leader of the Dallas study. "By stimulating the peripheral sacral nerve near the ankle, we can override some of the bladder stimulation that causes urgent and frequent urination and related pelvic pain. We hope patients will experience significant improvement."
UT Southwestern is one of four medical centers in the country that will test the "needle stimulation" therapy developed at the University of California, San Francisco, School of Medicine, where more than 90 patients have been treated successfully.
Patients in the UT Southwestern study will make weekly visits to the James W. Aston Ambulatory Care Center, where Litwiller will insert a fine needle about 2 inches above the patient's ankle. The needle will be used to electrically stimulate nerves using the battery-operated device called a percutaneous sacral nerve stimulator. The treatment session lasts 20 to 30 minutes and is performed once a week for 12 weeks. Patients then are tapered off the device over the following 20 weeks.
"There may be some tingling during the treatment," Litwiller said. "But it's easily tolerated and relatively pain free." For most patients with severe incontinence, the needle stimulation therapy is expected to be a significant improvement over an implant approved by the Food and Drug Administration (FDA) last fall that also electrically stimulates the nerves to improve bladder control. It requires permanent implantation of wires in the patient's back and a control box beneath the skin. "We are very excited about this new technology," Litwiller said.
Therapy to stimulate the sacral nerves is just one of the proven and experimental treatments for incontinence offered at the UT Southwestern Clinical Center for Bladder and Incontinence Treatment.
This month the center became one of 50 in the United States and the only in Dallas to participate in a new study for post-menopausal women who suffer from incontinence. The study is testing the efficacy of combining two therapies approved by the FDA: Estring, a vaginal ring that releases a low, continuous dose of estrogen, and tolterodine tartrate tablets, which received FDA approval in March as the first new medication in 20 years for bladder-control problems.
"We want to know whether these two therapies in combination are better than one alone," said Litwiller, who is conducting the study with Dr. Joseph Schaffer, assistant professor of obstetrics and gynecology.
For more information on incontinence studies at UT Southwestern, please call (214) 648-4868.
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