Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence

Study Overview
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Brief Summary
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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.

Official Title
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Medtronic InterStim® Sacral Nerve Stimulation Therapy for Bowel Control: Fecal Incontinence Study

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Device: InterStim Sacral Nerve Stimulation Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: InterStim Sacral Nerve Stimulation Therapy|Open label study. All subjects that qualify for the study will be implanted.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 12 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. | Baseline and 12 months | 
| 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. | Baseline and 12 Months | 
| 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. | Baseline and 12 Months | 
| 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. | Baseline and 12 Months | 
| 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. | Baseline and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fecal Incontinence, InterStim