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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fecal Incontinence and Constipation | Device: Type: Implantable neurostimulator; InterStim | Phase 4 |
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 |
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:
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- 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 ]
- 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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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
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 |
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 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 |