Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence

Completed · Not applicable

Conditions studied: Fecal Incontinence

In brief

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.

Key facts

Study ID: NCT00200057
Run by: MedtronicNeuro
People needed: 285
Starts: 2002-01-01
Expected to finish: 2011-09-01
Last updated by the study team: 2013-01-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Contact Medtronic for specific site information — Los Angeles, California, United States
Contact Medtronic for specific site information — San Francisco, California, United States
Contact Medtronic for specific site information — Washington D.C., District of Columbia, United States
Contact Medtronic for specific site information — Weston, Florida, United States
Contact Medtronic for specific site information — Chicago, Illinois, United States
Contact Medtronic for specific site information — Kansas City, Kansas, United States
Contact Medtronic for specific site information — New Orleans, Louisiana, United States
Contact Medtronic for specific site information — Burlington, Massachusetts, United States
Contact Medtronic for specific site information — Minneapolis, Minnesota, United States
Contact Medtronic for specific site information — Cleveland, Ohio, United States
Contact Medtronic for specific site information — Oklahoma City, Oklahoma, United States
Contact Medtronic for specific site information — Fort Worth, Texas, United States
Contact Medtronic for specific site information — Fleurimont, Quebec, Canada

Full record on ClinicalTrials.gov

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