Expired Study
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Minneapolis, Minnesota


Purpose:

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


Criteria:

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.


NCT ID:

NCT00200005


Primary Contact:

Principal Investigator
Klaus Matzel, MD
University Hospital Erlangen- Erlangen, Germany


Backup Contact:

N/A


Location Contact:

Minneapolis, Minnesota
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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