Interstitial Cystitis Network : News Room : Medtronic InterStim Therapy for Urinary Control Shows Long-Term Benefit Among Severely Affected Patients

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Revised: May 4, 2000

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FOR IMMEDIATE RELEASE

Medtronic InterStim Therapy for Urinary Control Shows Long-Term Benefit Among Severely Affected Patients

ATLANTA, May 2, 2000 -- A study presented here today at the American Urological Association annual meeting suggests that sacral nerve stimulation should be considered earlier as a treatment option for patients suffering from the bladder control problems of urge incontinence, significant symptoms of urgency-frequency, and nonobstructive urinary retention.

Conducted by an international team of urologists, the three-year study concluded that Medtronic InterStim Therapy for Urinary Control provides long-term benefit to patients whose condition resists adequate improvement with drug therapy, pelvic floor exercises, biofeedback and surgery.

"Our study suggests that physicians should consider Medtronic InterStim Therapy for Urinary Control earlier in the treatment ladder for patients with severe bladder control problems in order to minimize the use of ineffective treatments and to deliver improved clinical outcomes for their patients," said David A. Rivas, M.D., of Thomas Jefferson University Hospital in Philadelphia.

According to Dr. Rivas, who reported the study findings, many refractory patients responded dramatically to sacral nerve stimulation therapy, resulting in a reduction in pharmacotherapeutic intervention and further surgeries unrelated to sacral nerve stimulation.

Of the 112 patients in the study, 41 suffered from urge incontinence, 42 from urgency-frequency and 29 from urinary retention. Before the start of the study, 93 percent of the patients had not experienced relief with drug therapy, 46 percent had not responded to behavioral therapy, and 58 percent had not been helped by surgery.

Urge incontinence is characterized by the sudden, strong urge to urinate, followed by the involuntary loss of urine, or leaking. Symptoms of urgency-frequency include the urgent need to urinate -- in severe cases, as many as 40 times per day. Urinary retention describes an inability to empty the bladder completely or at all.

After treatment with InterStim Therapy, all three patient groups in the study showed significant improvement in their symptoms.

Urge incontinence: The 41 patients with urge incontinence reduced the average number of leaking episodes per day by more than half, from 11.6 to 5.0 events; 24 (59 percent) of the urge-incontinent patients reduced leaking by 50 percent, and 46 percent were completely dry. In addition, heavy leaking episodes decreased from an average of 3.6 to 1.3 events per day, with 65 percent eliminating heavy leaking events altogether.

Urgency-frequency: The 29 patients with urgency-frequency reduced the number of voids, or urinating episodes, by 40 percent, from 17.7 to 10.6 voids per day. Voided volumes per void increased by nearly 70 percent, from 132.5 ml to 225 ml. Sixteen (56 percent) of the urgency-frequency patients showed a 50 percent reduction in the average number of voids per day, including 32 percent who returned to a normal range of 4-7 voids per day. In addition, 20 patients in this group (69 percent) showed improvement in the degree of urgency prior to voiding.

Urinary Retention: The 42 retention patients experienced a nearly 75 percent reduction in the volume of urine remaining in their bladder after voiding, from 343 ml to 91 ml. In addition, 58 percent of the group no longer required catheterization to empty the bladder. The Agency for Healthcare Research and Quality (formerly the Agency for Health Care Policy and Research) estimates that there are 13 million incontinent adults in the United States. Urge incontinence, urgency-frequency and urinary retention are among the most common and serious voiding dysfunctions. Five million Americans suffer from urge incontinence, more than 1.2 million from urgency-frequency and more than 1.7 million from urinary retention.

InterStim Therapy is a treatment option for consideration by people whose bladder control problems have not responded well to drug, diet, exercise or biofeedback therapies and who seek a less invasive treatment option than irreversible surgeries. It uses neurostimulation to send mild electrical pulses to the sacral nerves in the lower back that control bladder function. A stopwatch-sized neurostimulator, placed under the skin of the abdomen, generates mild pulses that are carried via a thin implanted lead, or wire, to the sacral nerves.

More information on InterStim Therapy can be found online at www.interstim.com. Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. Its Internet address is www.medtronic.com.

Any statements made about the company's anticipated financial results and regulatory approvals are forward-looking statements subject to risks and uncertainties such as those described in the company's Annual Report and Form 10-K for the year ended April 30, 1999. Actual results may differ materially from anticipated results.

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