Sacral Nerve Stimulation for Anal Incontinence and Bowel Control

Phase 4

Completed

• Conditions: Fecal Incontinence and Constipation

• Registration Number: NCT00200005
• Lead Sponsor: MedtronicNeuro

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1998-11
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2006-12
• Study Completion: 2012-09
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-09
• Last Update Posted: 2014-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (9)

Danube Hospital/SMZ-Ost; 🇦🇹 Vienna, Austria

Herlev Hospital; 🇩🇰 Copenhagen, Denmark

University Hospital Erlangen; 🇩🇪 Erlangen, Germany

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Hospital Mutua de Terrassa; 🇪🇸 Terrassa, Spain

Maastricht University Hospital; 🇳🇱 Maastricht, Netherlands

Danderyd Hospital; 🇸🇪 Stockholm, Sweden

St. Mark's Hospital; 🇬🇧 London, United Kingdom

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark