FOR IMMEDIATE RELEASE
September 30, 1997
Contact: Sarah Ellis, (303) 315-5571
Surgical Implant to Treat Incontinence Gains FDA Approval
A revolutionary treatment for some sufferers of chronic urinary incontinence has been approved by the U.S. Food and Drug Administration (FDA). The Interstim(r) Continence Control Therapy, manufactured by Medtronic, Inc., is the first implantable treatment to use electrical stimulation of the sacral nerves, located at the base of the spine, to manage urinary urge incontinence.
The device was envisioned and developed two decades ago by Richard Schmidt, MD, professor of urology and surgery at the University of Colorado Health Sciences Center, as a way to help some of his patients who suffered the pelvic pain, discomfort and embarrassment of chronic urge incontinence. The implantable device has been offered by Dr. Schmidt through FDA-approved trials since 1980.
An estimated 13 million Americans, about 85 percent of whom are women between the ages of 30 and 59, suffer from urinary incontinence. Annual health care costs to treat incontinence is estimated at $11.2 billion. Of incontinence sufferers, about 40 percent suffer from urinary frequency and urge incontinence -- strong, sudden urges to urinate followed by involuntary losses of urine. This form of incontinence is particularly distressing for people because of the unpredictability of the frequency and severity of these episodes.
"Urinary incontinence is a serious medical condition that can be emotionally crushing and can prevent people from performing basic daily activities, including work and sleep," Dr. Schmidt said. "With this device, some people can see real improvement in their quality of life, regaining control not only of their bodily functions, but also of their self-esteem and confidence."
The device is implanted in the abdomen, and two wires are threaded through the tailbone to stimulate nerves around the bladder, acting as "electrical massage therapy," relaxing the muscles so they are more responsive and easier to control.
"This therapy is proven to be highly effective, with nearly half of the patients in the clinical trial reporting dryness after receiving the implant," Dr. Schmidt said. "Further, three out of four trial participants experienced at least a 50 percent reduction in leakage episodes and severity of leaks."
The most recent FDA trial included about 86 patients in 10 centers worldwide over the last three years. The treatment is currently being used by physicians in Europe, Africa, Australia and the Middle East.
The therapy is a reversible treatment that does not preclude other medical interventions. Depending on the patient, it can be used instead of or in conjunction with more conservative therapies, such as physical therapy, drug therapy and biofeedback.
The device, while it has shown dramatic success for some patients, is not a cure for everyone who suffers urinary incontinence, Dr. Schmidt cautioned. He and his colleagues screen each patient to determine the best course of treatment, from lifestyle changes to medication to surgery.
Urinary and bowel dysfunction have long been thought of as anatomical problems. Dr. Schmidt treats them from a behavioral standpoint. "We are given a neural network which doesn't always work as it should," he said. "With the Medtronic Interstim Continence Control Therapy, we can access the nerves to retrain the pelvic muscles to work more efficiently." For more information on incontinence treatment, call (303) 315-6038.
Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, specializing in implantable and interventional therapies. For more information about the Interstim implantable device, call (800) 664-5111, ext. 3000.
University Hospital is the Rocky Mountain region's only academic tertiary care and referral center. Located in Denver, Colo., the hospital is part of the University of Colorado Health Sciences Center campus, one of four campuses in the University of Colorado system.
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