sacral nerve stimulation therapy for the treatment of chronic fecal incontinence

Conditions: Fecal Incontinence

Summary: 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.


Eligibility criteria:
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.

Keywords: fecal incontinence interstim