Status:
COMPLETED
Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence
Lead Sponsor:
MedtronicNeuro
Conditions:
Fecal Incontinence
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
285 Patients enrolled
Trial Details
Trial ID
NCT00200057
Start Date
January 1 2002
End Date
September 1 2011
Last Update
January 24 2013
Active Locations (13)
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1
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Los Angeles, California, United States
2
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San Francisco, California, United States
3
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Washington D.C., District of Columbia, United States
4
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Weston, Florida, United States