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InterStim Therapy for Bowel Control

This month, a University of Rochester Medical Center (URMC) surgeon became the first in the nation to implant a pacemaker-like device since the April 2011 FDA approval of this new treatment, which could help millions of Americans with fecal incontinence regain bowel control and live more normal lives.

Colorectal surgeon Jenny R. Speranza, M.D. implanted the device in a patient on June 14 at URMC affiliate Highland Hospital.

Speranza is director of the Colorectal Physiology Center, the only center of its kind within 450 miles to offer a wide array of diagnostic procedures and non-surgical and surgical treatments for fecal incontinence. Speranza’s patient sought treatment at the center after an unsuccessful surgery in 2006 to repair a prolapsed rectum caused frequent incontinence issues.

Aging, injury from giving birth and other medical issues cause bowel incontinence for an estimated 18 million Americans, and it can be challenging to treat.

“Loss of bowel control can be devastating, in many cases significantly disrupting daily life,” said Speranza, an associate professor of both Colorectal Surgery and Oncology at URMC. “Some people stop travelling or going to the gym; others withdraw socially, avoiding family and friends for fear of having an accident. We’re excited to be at the forefront in treating this disorder, offering a new option for so many men and women who are suffering in silence.”

The InterStim Therapy for Bowel Control system uses an implantable, stopwatch-size device that emits a continuous, mild electrical pulse through a wire to stimulate sacral nerves, which strengthen the pelvic floor muscles and sphincter complex.

Before implanting the InterStim device, patients participate in a 14-day trial of a wearable, external version to see if the nerve stimulation works for them. If the stimulation is successful over the course of the trial period, a surgeon implants a permanent device under the skin in the lower back. The patient then can adjust the intensity of electrical pulses – within physician-set limits – via a remote-control.

“Until now, therapy for this troubling disorder has focused on dietary modification, fiber intake adjustments, or medications – or in some cases, more invasive surgical options to repair the sphincter muscles, but these approaches don’t help every patient,” Speranza said. “This new device offers a revolutionary alternative – a minimally invasive, reversible option for many of our patients who have not received benefit from conservative therapies and have continued poor quality of life due to their incontinence.”

This new therapy that has delivered very promising results in clinical trials. In a study published last year in the Annals of Surgery, which tracked 120 patients with the device for one year, 83 percent of participants experienced a 50 percent or more reduction in bowel incontinence episodes. More impressively, in a randomized, controlled trial comparing InterStim Therapy to non-surgical treatments (results published in the Diseases of the Colon and Rectum), 47 percent of the 60 InterStim patients had regained total control, experiencing no incontinence episodes at all 12 months post-implant.

Before its FDA approval as a bowel incontinence therapy, the system has been a go-to treatment for urinary incontinence and overactive bladder since 1997. To date, the device has helped more than 95,000 men and women in Europe, Australia, Canada and the U.S.