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

January 9, 2014 updated by: MedtronicNeuro
Multicenter European study to evaluate efficacy and safety of sacral nerve stimulation with InterStim Therapy to treat fecal incontinence or constipation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • Danube Hospital/SMZ-Ost
  • Denmark
      • Aarhus, Denmark
        • Aarhus University Hospital
      • Copenhagen, Denmark
        • Herlev Hospital
  • Germany
      • Erlangen, Germany
        • University Hospital Erlangen
  • Netherlands
      • Maastricht, Netherlands
        • Maastricht University Hospital
  • Spain
      • Terrassa, Spain
        • Hospital Mutua de Terrassa
  • Sweden
      • Stockholm, Sweden
        • Danderyd Hospital
  • United Kingdom
      • London, United Kingdom
        • St. Mark's Hospital
  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: Annually
Annually

Secondary Outcome Measures

Outcome Measure
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.
Time Frame: Annually
Annually

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1998

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

January 10, 2014

Last Update Submitted That Met QC Criteria

January 9, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mdt-301 November 03,1998
  • Mdt-301 (Nov 03, 98),
  • Amendment I (Dec 14, 99),
  • Amendment II (Jan 31, 02)
  • Amendment III (Jul 01, 2009)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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