Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence - Full Text View

Purpose

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.

Condition	Intervention
Fecal Incontinence	Device: InterStim Sacral Nerve Stimulation Therapy

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Medtronic InterStim® Sacral Nerve Stimulation Therapy for Bowel Control: Fecal Incontinence Study

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement

U.S. FDA Resources

Further study details as provided by MedtronicNeuro:

Primary Outcome Measures:

Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Episodes Per Week [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
The primary efficacy objective was to demonstrate that at least 50% of subjects will achieve at least 50% reduction in the number of fecal incontinent episodes per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of fecal incontinent episodes per week at 12 months post-implant compared to baseline are considered "successes."

The observed therapeutic success rate is calculated as the proportion of implanted subjects who achieve at least 50% reduction in the number of incontinent episodes per week from baseline to twelve months.

Secondary Outcome Measures:

Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Days Per Week [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
This secondary objective was to demonstrate that at least 50% of subjects achieved at least 50% reduction in the number of incontinent days per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of fecal incontinent days per week at 12 months post-implant compared to baseline are considered "successes."

The observed therapeutic success rate is calculated as the proportion of implanted subjects who achieve at least 50% reduction in the number of incontinent days per week from baseline to twelve months.
Change in Quality of Life From Baseline to 12 Months: Scale 1 - Lifestyle [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.
Change in Quality of Life From Baseline to 12 Months: Scale 2 - Coping/Behavior [ Time Frame: Baseline and 12 Months ] [ Designated as safety issue: No ]
This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.
Change in Quality of Life From Baseline to 12 Months: Scale 3 - Depression/Self-Perception [ Time Frame: Baseline and 12 Months ] [ Designated as safety issue: No ]
This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.
Change in Quality of Life From Baseline to 12 Months: Scale 4 - Embarrassment [ Time Frame: Baseline and 12 Months ] [ Designated as safety issue: No ]
This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.
Proportion of Subjects With at Least 50% Reduction in Number of Urgent Incontinent Episodes Per Week [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
This secondary objective was to demonstrate that at least 50% of subjects achieved at least 50% reduction in the number of urgent incontinent episodes per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of urgent fecal incontinent episodes per week at 12 months post-implant compared to baseline are considered "successes."

The observed therapeutic success rate is calculated as the proportion of implanted subjects who achieve at least 50% reduction in the number of urgent incontinent episodes per week from baseline to 12 months.

Enrollment:	285
Study Start Date:	January 2002
Study Completion Date:	September 2011
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Open label study. All subjects that qualify for the study will be implanted.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200057

Locations

United States, California
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Los Angeles, California, United States
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San Francisco, California, United States
United States, District of Columbia
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Washington, District of Columbia, United States
United States, Florida
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Weston, Florida, United States
United States, Illinois
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Chicago, Illinois, United States
United States, Kansas
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Kansas City, Kansas, United States
United States, Louisiana
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New Orleans, Louisiana, United States
United States, Massachusetts
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Burlington, Massachusetts, United States
United States, Minnesota
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Minneapolis, Minnesota, United States
United States, Ohio
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Cleveland, Ohio, United States
United States, Oklahoma
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Oklahoma City, Oklahoma, United States
United States, Texas
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Fort Worth, Texas, United States
Canada, Quebec
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Fleurimont, Quebec, Canada

Sponsors and Collaborators

MedtronicNeuro

Investigators

Study Director:

Sudha Iyer, PhD

Medtronic

More Information

Publications:

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.

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. Epub 2010 Mar 31.

Responsible Party:	Sudha Iyer, Clinical Research Manager, Medtronic
ClinicalTrials.gov Identifier:	NCT00200057 History of Changes
Other Study ID Numbers:	G010206
Study First Received:	September 12, 2005
Results First Received:	April 13, 2011
Last Updated:	January 17, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by MedtronicNeuro:

Fecal Incontinence
InterStim

Additional relevant MeSH terms:

Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013