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

This study has been completed.
Information provided by (Responsible Party):
MedtronicNeuro Identifier:
First received: September 12, 2005
Last updated: January 9, 2014
Last verified: January 2014

September 12, 2005
January 9, 2014
November 1998
December 2006   (Final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00200005 on Archive Site
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 ]
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Sacral Nerve Stimulation for Anal Incontinence and Bowel Control
Sacral Nerve Stimulation for Anal Incontinence and Bowel Control
Multicenter European study to evaluate efficacy and safety of sacral nerve stimulation with InterStim Therapy to treat fecal incontinence or constipation
Not Provided
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Fecal Incontinence and Constipation
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
Experimental: InterStim therapy
Patients being treated with sacral neuromodulation with InterStim therapy.
Intervention: Device: Type: Implantable neurostimulator; InterStim

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2012
December 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Denmark,   Germany,   Netherlands,   Spain,   Sweden,   United Kingdom
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)
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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
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP