Sacral Nerve Stimulation for Anal Incontinence and Bowel Control

Study Overview
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Brief Summary
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Multicenter European study to evaluate efficacy and safety of sacral nerve stimulation with InterStim Therapy to treat fecal incontinence or constipation

Official Title
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Sacral Nerve Stimulation for Anal Incontinence and Bowel Control

Conditions
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Fecal Incontinence and Constipation

Intervention / Treatment
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* Device: Type: Implantable neurostimulator; InterStim


Participation Criteria
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Eligibility Criteria
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140 patients (7 study groups, up to 20 implanted patients per study group) Fecal Incontinence groups: Main Inclusion Criteria: Fecal incontinence (defined as incontinence to solid or liquid stool > 1 / week); Failed biofeedback or medical therapy; Groups 1 - 5 patients with: Group 1) Circumferentially intact external anal sphincter, no previous surgery; Group 2) Circumferentially intact external anal sphincter after surgical repair; Group 3) Rectal prolapse repaired with a rectopexy; Group 4) Spinal injury including disc prolapse; Group 5) Sigmoid or partial rectal resection with colorectal or coloanal anastomosis Constipation groups: Main Inclusion Criteria: Chronic constipation (defined as </= 2 weekly bowel movements; and/or >25% of bowel movements required straining; and/or >25% of bowel movements patient did not feel empty afterwards) with symptoms more than 1 year Failed biofeedback or medical therapy; Groups 6 - 7 patients with: Group 6) Idiopathic slow transit constipation as proven on colonic transit studies; Group 7) Normal colonic transit studies but chronic constipation due to either pelvic floor dysfunction or disordered defecation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: InterStim therapy<br>Patients being treated with sacral neuromodulation with InterStim therapy. | Device: Type: Implantable neurostimulator; InterStim<br>* Treatment with InterStim Therapy: all patients meeting inclusion/exclusion criteria undergo test screening and those who have successful outcomes receive a permanent implant.<br>* Other names: InterStim Model 3058;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FI - number of FI episodes per week and/or number of days with FI per week. Constipation - number of bowel movements per week; &/or decrease defecations requiring straining; &/or decrease defecations where there was incomplete emptying |  | Annually | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FI-number of days with staining/week;urgency with continent bowel movements; Improvement in QOL;* Improvement in anal canal pressure. Constipation - Improvement in Wexner constipation score; QOL. |  | Annually | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Slow transit constipation, Fecal incontinence, Constipation, Idiopathic slow transit constipation, Chronic constipation