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

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ClinicalTrials.gov Identifier: NCT00200005
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : January 10, 2014
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 1998
Actual Primary Completion Date : December 2006
Actual Study Completion Date : September 2012

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U.S. FDA Resources

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00200005


Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States
Austria
Danube Hospital/SMZ-Ost
Vienna, Austria
Denmark
Aarhus University Hospital
Aarhus, Denmark
Herlev Hospital
Copenhagen, Denmark
Germany
University Hospital Erlangen
Erlangen, Germany
Netherlands
Maastricht University Hospital
Maastricht, Netherlands
Spain
Hospital Mutua de Terrassa
Terrassa, Spain
Sweden
Danderyd Hospital
Stockholm, Sweden
United Kingdom
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Other Publications:

Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT00200005     History of Changes
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)
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: January 2014

Keywords provided by MedtronicNeuro:
Slow transit constipation
Fecal incontinence
Constipation
Idiopathic slow transit constipation
Chronic constipation

Additional relevant MeSH terms:
Constipation
Fecal Incontinence
Signs and Symptoms, Digestive
Signs and Symptoms
 Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases