In March, 2011, the FDA provided good news for millions of Americans. After reviewing data from years of trials, the agency approved marketing of the InterStim® Therapy System, a surgically implanted device used to help a patient reduce the number of bowel accidents.
It’s not something that people like to talk about, even though an estimated 18 million Americans have to deal with it. Fecal incontinence (FI), commonly referred to as “bowel problems,” is the inability to hold a bowel movement in until reaching a bathroom. It may also involve accidental leakage of solid or liquid stool.
As of this Spring, however, it’s definitely in the interest of people with FI to speak up to their physicians. FDA approval of the InterStim® Therapy System for use in fecal incontinence has finally provided an effective means of controlling, or even stopping, FI in a large proportion of sufferers.
“We see a number of patients with fecal incontinence,” says Dr. Sunil Khurana of Premier Medical Group’s GI Division. “Most are elderly, but not all, and it is a serious quality of life issue for anyone with the condition. They’re afraid to go out to a restaurant or shopping because they don’t know when it will happen. Their lives revolve around it.”
In the past, there was no good modality to treat fecal incontinence. Physicians prescribed dietary changes, special exercises and bulk agents like Metamucil. Only rarely did these approaches help, but there was little else to offer. “Most of the time,” Khurana says, “patients would get resigned to the condition, think of it as a way of life, and stop complaining.”
Sacral nerve stimulation has changed the picture. “Now we have something significant to offer our patients,” says Khurana. “The studies tell us that, a year after treatment, close to 50 percent of patients have a complete response. Another 30 percent experience a significant diminution in episodes.
Being able to help up to 80 percent of patients with the condition is a remarkable achievement.”
How it works
The implantable InterStim® system acts like a pacemaker. It delivers mild electrical pulses to the sacral nerves to influence the behavior of the pelvic floor muscles, bowel and anal sphincter. Mandated by the FDA and insurance companies, treatment with sacral nerve stimulation is a two-step process.
It begins with a test of whether a patient will be responsive to the stimulation. In a 20-minute office procedure, a thin wire is positioned near the sacral nerves and attached to an exterior power source. If, over a period of two weeks, the patient experiences greater than 50 percent improvement in incontinence episodes, he or she is considered to be a candidate for implantation of the InterStim® device. The temporary wire is replaced with a permanent lead and the stimulator is implanted under the skin on the upper buttock.
“I’m a big proponent of sacral nerve stimulation,” says Dr. Dan Katz of Premier Medical Group’s Urology Division. “I’ve been using it for years as an adjunct in the treatment of overactive bladder symptoms and have done hundreds of procedures—on patients as old as eighty, as young as 18—with great success.
The procedure is simple, it’s easy to do and easy for the patients to tolerate. It’s minimally invasive and done under mild sedation, less even than for a colonoscopy.
I’ve had patients who were going 50 times a day who now are down to 15 times; you can imagine the effect on their lifestyles.”