Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence

Medtronic InterStim® Sacral Nerve Stimulation Therapy for Bowel Control: Fecal Incontinence Study

Fecal incontinence (FI) is a difficulty in storing gas, liquid stool or solid stool (bowel movement) in order to expel it at a proper time and place. Patients who suffer from FI may experience passive FI (difficulty in sensing stool in the rectum) or urgency (able to sense a bowel movement but cannot hold the stool until an acceptable time and place). FI is not a life-threatening disease, but it is often profoundly distressing and socially incapacitating.

If a patient is suffering with symptoms of chronic FI despite trying oral medications, biofeedback and/or other more conservative treatments, a patient may be eligible to participate in a clinical research study to evaluate the safety and effectiveness of sacral nerve stimulation for the treatment of chronic fecal incontinence. One hundred-twenty (120) patients will be implanted with medical devices and followed closely for twelve months, and then once a year after that until the study closes. There are up to 20 centers in the United States.

Inclusion Criteria:

• Signed and dated informed consent.
• 18 years of age or older.
• Patient is diagnosed with chronic fecal incontinence of a duration greater than 6 months (>12 months post-vaginal childbirth) and defined as > 2 incontinent episodes on average per week of more than staining recorded during the baseline diary period.
• Failed or are not candidates for more conservative treatments.
• Willing and competent to completely and accurately fill out bowel diaries and questionnaires throughout the study.

Exclusion Criteria:

• Congenital anorectal malformations.
• Active participation in another bowel disorder investigational study.
• Present rectal prolapse.
• Previous rectal surgery (such as rectopexy or resection) or sphincteroplasty done < 12 months prior to study enrollment (24 months for cancer).
• Neurological diseases such as clinically significant peripheral neuropathy or complete spinal cord injury (i.e. paraplegia).
• Grade III hemorrhoids.
• Known or suspected organic disorders of the bowel (i.e. Inflammatory bowel disease such as Crohn's or ulcerative colitis).
• Chronic watery diarrhea, unmanageable by drugs or diet, as primary cause of fecal incontinence. (Incontinent episodes with a Bristol stool consistency of > 6 for > 4 days during the baseline diary period will be exclusionary, unless the investigator determines that the diary is not indicative of chronic watery diarrhea.)
• Pregnancy or planned pregnancy.
• Patients for whom patient materials are not available in a language understood by the patient.
• Life expectancy of less than one year.
• Patient characteristics indicating a poor understanding of the study or poor compliance with the study protocol (i.e., patients unable to adequately operate equipment, patients unwilling or unable to return for scheduled follow-up visits).
• Patients with a history of pelvic irradiation who present with visible or functional effects of irradiation.
• Patients with active anal abscesses or fistulas.
• Patients with anatomical limitations that would prevent the successful placement of an electrode.
• Patients with knowledge of planned MRIs, diathermy, microwave, or RF energy.
• Patients with other implantable neurostimulators, pacemakers or defibrillators.
• Defect of external anal sphincter of >60 degrees or amenable to surgical repair.