MDT-301: Sacral Nerve Stimulation for Anal Incontinence and Bowel Control

Sponsor

MedtronicNeuro (Industry)

Overall Status

Completed

CT.gov ID

NCT00200005

Collaborator

(none)

140

Enrollment

Locations

Arm

166

Duration (Months)

15.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Fecal Incontinence and Constipation	Device: Type: Implantable neurostimulator; InterStim	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Sacral Nerve Stimulation for Anal Incontinence and Bowel Control

Study Start Date :

Nov 1, 1998

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: InterStim therapy Patients being treated with sacral neuromodulation with InterStim therapy.	Device: Type: Implantable neurostimulator; InterStim Treatment with InterStim Therapy: all patients meeting inclusion/exclusion criteria undergo test screening and those who have successful outcomes receive a permanent implant. Other Names: InterStim Model 3023 InterStim Model 3058

Arm

Intervention/Treatment

Experimental: InterStim therapy

Patients being treated with sacral neuromodulation with InterStim therapy.

Device: Type: Implantable neurostimulator; InterStim

Treatment with InterStim Therapy: all patients meeting inclusion/exclusion criteria undergo test screening and those who have successful outcomes receive a permanent implant.

Other Names:

InterStim Model 3023

InterStim Model 3058

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	University of Minnesota	Minneapolis	Minnesota	United States
2	Danube Hospital/SMZ-Ost	Vienna		Austria
3	Aarhus University Hospital	Aarhus		Denmark
4	Herlev Hospital	Copenhagen		Denmark
5	University Hospital Erlangen	Erlangen		Germany
6	Maastricht University Hospital	Maastricht		Netherlands
7	Hospital Mutua de Terrassa	Terrassa		Spain
8	Danderyd Hospital	Stockholm		Sweden
9	St. Mark's Hospital	London		United Kingdom

Sponsors and Collaborators

MedtronicNeuro

Investigators

Principal Investigator: Klaus Matzel, MD, University Hospital Erlangen- Erlangen, Germany
Principal Investigator: Michael A Kamm, MD, St. Vincent's Hospital- Melbourne, Australia. Former: St. Mark's Hospital, London, U.K.
Principal Investigator: Cor Baeten, MD, Maastricht University Hospital- The Netherlands
Principal Investigator: John Christiansen, MD, Herlev Hospital- Copenhagen, Denmark
Principal Investigator: Anders Mellgren, MD, Danderyd Hospital- Stockholm, Sweden
Principal Investigator: Harald Rosen, MD, Danube Hospital/SMZ-Ost- Vienna, Austria
Principal Investigator: Albert Navarro, MD, Hospital Mutua de Terrassa- Terrassa, Spain
Principal Investigator: Robert Madoff, MD, University of Minnesota- Minneapolis, USA
Principal Investigator: Carolynne Vaizey, MD, St. Mark's Hospital- London, UK
Principal Investigator: Claes Johansson, MD, Danderyd Hospital- Stockholm, Sweden
Principal Investigator: Soren Laurberg, MD, Aarhus University Hospital, Aarhus, Denmark