Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence
NCT ID: NCT00200057
Last Updated: 2013-01-24
Study Results
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View full resultsBasic Information
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COMPLETED
NA
285 participants
INTERVENTIONAL
2002-01-31
2011-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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InterStim Sacral Nerve Stimulation Therapy
Open label study. All subjects that qualify for the study will be implanted.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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MedtronicNeuro
INDUSTRY
Responsible Party
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Medtronic
Principal Investigators
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Sudha Iyer, PhD
Role: STUDY_DIRECTOR
Medtronic
Locations
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Los Angeles, California, United States
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San Francisco, California, United States
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Washington D.C., District of Columbia, United States
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Weston, Florida, United States
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Chicago, Illinois, United States
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Kansas City, Kansas, United States
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New Orleans, Louisiana, United States
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Burlington, Massachusetts, United States
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Minneapolis, Minnesota, United States
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Cleveland, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Fort Worth, Texas, United States
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Fleurimont, Quebec, Canada
Countries
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References
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Wexner SD, Coller JA, Devroede G, Hull T, McCallum R, Chan M, Ayscue JM, Shobeiri AS, Margolin D, England M, Kaufman H, Snape WJ, Mutlu E, Chua H, Pettit P, Nagle D, Madoff RD, Lerew DR, Mellgren A. Sacral nerve stimulation for fecal incontinence: results of a 120-patient prospective multicenter study. Ann Surg. 2010 Mar;251(3):441-9. doi: 10.1097/SLA.0b013e3181cf8ed0.
Wexner SD, Hull T, Edden Y, Coller JA, Devroede G, McCallum R, Chan M, Ayscue JM, Shobeiri AS, Margolin D, England M, Kaufman H, Snape WJ, Mutlu E, Chua H, Pettit P, Nagle D, Madoff RD, Lerew DR, Mellgren A. Infection rates in a large investigational trial of sacral nerve stimulation for fecal incontinence. J Gastrointest Surg. 2010 Jul;14(7):1081-9. doi: 10.1007/s11605-010-1177-z. Epub 2010 Mar 31.
Other Identifiers
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G010206
Identifier Type: -
Identifier Source: org_study_id
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