Back to resultsSacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence
Primary Purpose
Fecal Incontinence
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
InterStim Sacral Nerve Stimulation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Fecal Incontinence focused on measuring Fecal Incontinence, InterStim
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.
Sites / Locations
- Contact Medtronic for specific site information
- Contact Medtronic for specific site information
- Contact Medtronic for specific site information
- Contact Medtronic for specific site information
- Contact Medtronic for specific site information
- Contact Medtronic for specific site information
- Contact Medtronic for specific site information
- Contact Medtronic for specific site information
- Contact Medtronic for specific site information
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- Contact Medtronic for specific site information
- Contact Medtronic for specific site information
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Outcomes
Primary Outcome Measures
Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Episodes Per Week
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
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
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
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00200057
Brief Title
Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence
Official Title
Medtronic InterStim® Sacral Nerve Stimulation Therapy for Bowel Control: Fecal Incontinence Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
MedtronicNeuro
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence
Keywords
Fecal Incontinence, InterStim
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
285 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
InterStim Sacral Nerve Stimulation Therapy
Intervention Description
Open label study. All subjects that qualify for the study will be implanted.
Primary Outcome Measure Information:
Title
Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Episodes Per Week
Description
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.
Time Frame
Baseline and 12 months
Secondary Outcome Measure Information:
Title
Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Days Per Week
Description
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.
Time Frame
Baseline and 12 months
Title
Change in Quality of Life From Baseline to 12 Months: Scale 1 - Lifestyle
Description
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.
Time Frame
Baseline and 12 months
Title
Change in Quality of Life From Baseline to 12 Months: Scale 2 - Coping/Behavior
Description
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.
Time Frame
Baseline and 12 Months
Title
Change in Quality of Life From Baseline to 12 Months: Scale 3 - Depression/Self-Perception
Description
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.
Time Frame
Baseline and 12 Months
Title
Change in Quality of Life From Baseline to 12 Months: Scale 4 - Embarrassment
Description
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.
Time Frame
Baseline and 12 Months
Title
Proportion of Subjects With at Least 50% Reduction in Number of Urgent Incontinent Episodes Per Week
Description
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.
Time Frame
Baseline and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sudha Iyer, PhD
Organizational Affiliation
Medtronic
Official's Role
Study Director
Facility Information:
Facility Name
Contact Medtronic for specific site information
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Contact Medtronic for specific site information
City
San Francisco
State/Province
California
Country
United States
Facility Name
Contact Medtronic for specific site information
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Contact Medtronic for specific site information
City
Weston
State/Province
Florida
Country
United States
Facility Name
Contact Medtronic for specific site information
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Contact Medtronic for specific site information
City
Kansas City
State/Province
Kansas
Country
United States
Facility Name
Contact Medtronic for specific site information
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Contact Medtronic for specific site information
City
Burlington
State/Province
Massachusetts
Country
United States
Facility Name
Contact Medtronic for specific site information
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Contact Medtronic for specific site information
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Contact Medtronic for specific site information
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Contact Medtronic for specific site information
City
Fort Worth
State/Province
Texas
Country
United States
Facility Name
Contact Medtronic for specific site information
City
Fleurimont
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
20160636
Citation
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.
Results Reference
result
PubMed Identifier
20354809
Citation
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.
Results Reference
result
Learn more about this trial
Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence
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