Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence
Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence
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.