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Release: Feb. 23, 2000

FDA approves new UI treatment for urinary incontinence

IOWA CITY, Iowa -- Technology studied by University of Iowa Health Care specialists in the UI Department of Urology for the treatment of urinary incontinence has received approval for use in the United States by the Food and Drug Administration.

The technology represents a new approach to the treatment of incontinence. It's called the Percutaneous Stoller Afferent Nerve Stimulation System, or PerQ SANS. The SANS technology stimulates the sacral nerves, which affect bladder control. The simple and safe SANS therapy can be performed in a physician's office.

Urinary incontinence affects an estimated 13 to 15 million Americans, with an annual cost of treatment in the United States alone exceeding $15 billion. About one half of people diagnosed with urinary incontinence are affected by urge incontinence, characterized by a sudden, possibly frequent, urge to pass urine. The disorder is caused by a malfunction of the nerves that control the bladder.

"Causes of urge incontinence include an overactive bladder muscle, abnormalities of the nervous system or stroke," said Karl Kreder, M.D., UI professor of urology. Kreder helped lead the research of the SANS technique. "Urinary incontinence can occur following pregnancy and childbirth, pelvic or spinal injuries, hormonal changes during menopause, prostate surgery and from the normal aging process."

Previously, treatment for urinary incontinence focused on palliative measures, such as absorbent pads, exercise or medications. Those approaches were not always effective, and the medications can cause side effects. Surgery or implants are also possible treatment options, but they can result in complications such as infection or increased pain levels.

SANS involves inserting a fine gauge needle into the posterior tibial nerve just above the ankle. The tibial nerve then carries an electrical stimulation up the leg to the lower spine. Initially, 12 weekly treatments are performed, each lasting 30 minutes. The results are then assessed and the frequency of ongoing treatment sessions is tailored to the needs of each individual patient.

Study results showed that SANS therapy is up to 80 percent effective in treating urinary urgency, frequency and pelvic pain.

"The results are promising," Kreder said. "Patients need to be evaluated by an urologist to see if they are good candidates for SANS, but it has great potential to help relieve symptoms in selected patients."

The SANS technology was developed by Urosurge, a firm based in Coralville, Iowa, that was established to develop treatments for medical problems of the genito-urinary tract. For more information about SANS therapy in the treatment or urge incontinence, contact the UI Department of Urology in the UI Hospitals and Clinics at (319) 356-2421.

University of Iowa Health Care describes the partnership between the UI College of Medicine and the UI Hospitals and Clinics and the patient care, medical education and research programs and services they provide.