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May 21, 2002


Nerve Stimulation Procedure Is Promising Option for Treating Bladder Control Problems

Urinary urge incontinence patients who have not responded favorably to traditional therapy options have an option for an alternative treatment that is proving to be effective in patients treated at Emory University. An implanted stopwatch-sized device acts as a 'pacemaker' by determining the rate of firing of the muscles in the pelvic floor and can change the way the bladder and bowel behaves.

The InterStim® Therapy, developed by Medtronic, Inc., is a sacral nerve stimulation device that sends mild electrical pulses to the sacral nerves in the lower back that control the bladder, sphincter and pelvic floor muscles.. The neurostimulator is placed under the skin of the abdomen and generates mild impulses via a thin wire.

"With the InterStim® implant, our incontinence patients are experiencing a significant reduction in leaking episodes and in some cases, complete relief from leaking episodes," says Dr. Niall Galloway, FRCS, associate professor of urology and medical director of the Emory Continence Center.

According to Dr. Galloway, individuals carry a lot of guilt, shame and embarrassment with problems below the belt and are reluctant to seek help. "In the United States, patients wait an average of 7-8 years with moderate or severe incontinence before they seek help. The prevalence is far higher than people understand. There are more people with moderate or severe incontinence in the Unites States than all people with cancer and all with diabetes combined." Interested urge incontinence patients are pre-screened to determine their eligibility for the procedure. Most have undergone previous medical treatment such as medication, pelvic floor exercises or other surgeries that proved to be ineffective in alleviating their condition.

The InterStim® procedure is a two-stage process. First, the physician internally places electrodes in the patient's lower back, using X-rays for precise placement. The electrodes are then tested to confirm perfect position before they are attached to an external device. The patient wears the test stimulator for approximately one week.

"This allows us to predict whether or not the final implant will work for patient," says Dr. Galloway, who has performed almost twenty InterStim¨ implants. "Consequently, every time you do an operation it is a success because you've selected out only those patients who will do well."

If the patient's symptoms have resolved in the presence of electrical stimulus, the electrodes are attached to an implanted neurostiumulator. A hand-held electromagnetic device allows the patient or doctor to non-invasively control and adjust the strength of the stimulation, described by most people as a slight pulling sensation in the pelvic area; in the scrotum area for men and in the vagina for women.

"Without this sort of simple technology, we would have to do major reconstruction surgical operations for patients with severe incontinence that might create new problems for them," Dr. Galloway says.

InterStim® Therapy is completely reversible and can be discontinued at any time with no permanent damage to the nerves.

The U.S. Food and Drug Administration (FDA) approved InterStim® for use with urge incontinence patients in September 1997 and later for urgency-frequency and urinary retention patients in April 1999. Currently, almost 6,000 implants have been performed worldwide.

More than 13 million people in the United States experience urinary incontinence, including urinary urge incontinence, urinary retention, and symptoms of urgency-frequency. Individuals with urge incontinence or urgency-frequency experience involuntary bladder contractions that cause urine leakage or the sudden urge to urinate. Individuals with urinary retention have problems emptying their bladders completely.

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