Dr. Howard Kaufman, director of HMRI’s Colorectal Research Program, is one of the initial 16 doctors across the nation approved to perform the new InterStim® bowel control therapy, offered by Medtronic, Inc., of Minneapolis, MN.
Dr. Kaufman was a co-investigator in a multinational multicenter clinical study into whether the InterStim Therapy for urinary incontinence, for which Medtronic won FDA approval in 1997, could be successfully applied to bowel incontinence.
“The study in which Dr. Kaufman participated to evaluate the Medtronic InterStim system as a remedy for bowel incontinence fits well with the history of HMRI’s Neural Engineering Program for developing and evaluating clinical applications of nerve stimulations,” said Dr. Douglas McCreery, Neural Engineering director.
The HMRI Neural Engineering researchers have a long history of developing electrodes for activating nerves. The Huntington Helix array was licensed to Cyberonics, Inc. and subsequently has been implanted into more than 40,000 persons with epilepsy and with depression. Other version of our nerve electrodes have been evaluated by clinicians at the Cleveland Clinic for treating swallowing difficulties following cerebral stroke and at Washington University in St. Louis for treating urge incontinence.
This latest InterStim study’s success earned FDA approval in March.
Chronic involuntary loss of bowel control is a humiliating, life-changing condition. According to a National Institutes of Health (NIH)-funded study, more than 18 million Americans have fecal incontinence. Among older persons, the infirmity is the single most frequent factor for admittance to nursing homes because families have difficulty dealing with its demands.
Caused by a variety of factors, it is most common among adults, predominately women who experience nerve and muscular trauma in the anus, rectum, and pelvic floor during childbirth.
Eileen Brophy Williams was Dr. Kaufman’s first patient to participate in the clinical study. The former Newport Beach resident’s bowel incontinence resulted from an unsuccessful sphincteroplasty repair of an episiotomy following the birth of her first child 13 years ago. Her colorectal surgeon, Dr. Babak Rad, heard of the clinical study and referred her to Dr. Kaufman.
She thought her incontinence was due to digestion problems because she was a new mother nervous about her child or possibly related to an old back injury. She simply had no feeling or sensation when she had incontinent episodes that occurred almost every day.
Her life was severely limited to her household, and she wasn’t able to participate in her children’s school projects and so much more.
Brophy Williams was a perfect candidate for the clinical trial because she had gone through various other treatment options. Dr. Kaufman explained those therapies included bowel habit modification through diet (increasing fiber, prescribing anti-diarrheal medications, etc.), sphincter muscle surgery, as well as biofeedback and physical therapy.
InterStim Therapy is the only bowel control treatment option that allows patients and physicians to determine probable success of the therapy through a test stimulation procedure prior to committing to long-term therapy.
Brophy Williams went through InterStim’s two-step outpatient implant process in March 2005. During the first visit, an electrode connects sacral nerves to an external test stimulator that can be adjusted for the correct amperage to stimulate nerves.
“Patients will then walk around with the InterStim on a belt that’s programmed with the help of a Medtronic technician,” Dr. Kaufman explained. “If they pass the test of a reduction of incontinence of more than 50 percent for two weeks, they will qualify for a permanent implant.”
Brophy Williams said that during those two weeks, she experienced the sensation for a bowel movement that she hadn’t experienced in years. She became a candidate for permanent implant.
The InterStim Therapy uses an implantable system consisting of a thin wire lead and a neurostimulator, or pacemaker-like device about the size of a quarter, to stimulate the sacral nerve to control bowel function. The neurostimulator is implanted on the upper part of the buttock above the pelvis.
“I was involved with the industry and thought this would be a technology to offer patients who had been unsuccessful with available therapies,” Dr. Kaufman said. “I was fortunate to have the patient population and the relationship already with Medtronic and other companies so we could stratify patients based on their anatomy and physiology.”
“We implanted the device in 120 patients who met the inclusion criteria with various degrees of fecal incontinence,” Dr. Kaufman said. The study ran from 2002-2008, and “showed that at 12 months, 83 percent achieved ‘therapeutic’ success (with 41 percent of those subjects reaching 100 percent continence). While our paper reported on sustained success through two years, most patients have had continued success through their continued length of follow-up.”
Additionally incontinent episodes decreased from a mean of 9.4 per week to 1.9/week at 12 months and 2.9/week at two years.
“When I had this surgery within two weeks time, I was able to get involved with my kids in school,” Brophy Williams said. “It gave me back my life. I had stopped myself from having a life.”
“There are women who are going through this who don’t even know they have this. I had no idea I was as injured as I was. I was told there wasn’t any help for me.”
“Dr. Rad and Dr. Kaufman never gave up on me,” she recalled. “I owe them my life and my life with my kids and family.”
Now, Dr. Kaufman is the first physician authorized to perform the InterStim implant for patients in the Southwest, including Southern California, Nevada, Arizona and New Mexico. After he has completed 20 implants, Dr. Kaufman will train other colorectal surgeons in the two-step, out-patient procedure.
In an unrelated project funded by the National Institutes of Health, HMRI’s Neural Engineering Program researchers have been working to develop a neuroprosthetic device to artificially control urination for spinal cord injured patients. HMRI NEP scientists are also studying mechanisms of stroke-induced overactive bladder and a possible treatment by intraspinal microstimulation.