Back to resultsSacral Nerve Stimulation for Anal Incontinence and Bowel Control (MDT-301)
Primary Purpose
Fecal Incontinence and Constipation
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Type: Implantable neurostimulator; InterStim
Sponsored by
About this trial
This is an interventional treatment trial for Fecal Incontinence and Constipation focused on measuring Slow transit constipation, Fecal incontinence, Constipation, Idiopathic slow transit constipation, Chronic constipation
Eligibility 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.
Sites / Locations
- University of Minnesota
- Danube Hospital/SMZ-Ost
- Aarhus University Hospital
- Herlev Hospital
- University Hospital Erlangen
- Maastricht University Hospital
- Hospital Mutua de Terrassa
- Danderyd Hospital
- St. Mark's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
InterStim therapy
Arm Description
Patients being treated with sacral neuromodulation with InterStim therapy.
Outcomes
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00200005
Brief Title
Sacral Nerve Stimulation for Anal Incontinence and Bowel Control
Acronym
MDT-301
Official Title
Sacral Nerve Stimulation for Anal Incontinence and Bowel Control
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
November 1998 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedtronicNeuro
4. Oversight
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence and Constipation
Keywords
Slow transit constipation, Fecal incontinence, Constipation, Idiopathic slow transit constipation, Chronic constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
InterStim therapy
Arm Type
Experimental
Arm Description
Patients being treated with sacral neuromodulation with InterStim therapy.
Intervention Type
Device
Intervention Name(s)
Type: Implantable neurostimulator; InterStim
Other Intervention Name(s)
InterStim Model 3023, InterStim Model 3058
Intervention Description
Treatment with InterStim Therapy: all patients meeting inclusion/exclusion criteria undergo test screening and those who have successful outcomes receive a permanent implant.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Matzel, MD
Organizational Affiliation
University Hospital Erlangen- Erlangen, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael A Kamm, MD
Organizational Affiliation
St. Vincent's Hospital- Melbourne, Australia. Former: St. Mark's Hospital, London, U.K.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cor Baeten, MD
Organizational Affiliation
Maastricht University Hospital- The Netherlands
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Christiansen, MD
Organizational Affiliation
Herlev Hospital- Copenhagen, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anders Mellgren, MD
Organizational Affiliation
Danderyd Hospital- Stockholm, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Harald Rosen, MD
Organizational Affiliation
Danube Hospital/SMZ-Ost- Vienna, Austria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Albert Navarro, MD
Organizational Affiliation
Hospital Mutua de Terrassa- Terrassa, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Madoff, MD
Organizational Affiliation
University of Minnesota- Minneapolis, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carolynne Vaizey, MD
Organizational Affiliation
St. Mark's Hospital- London, UK
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Claes Johansson, MD
Organizational Affiliation
Danderyd Hospital- Stockholm, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Soren Laurberg, MD
Organizational Affiliation
Aarhus University Hospital, Aarhus, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Danube Hospital/SMZ-Ost
City
Vienna
Country
Austria
Facility Name
Aarhus University Hospital
City
Aarhus
Country
Denmark
Facility Name
Herlev Hospital
City
Copenhagen
Country
Denmark
Facility Name
University Hospital Erlangen
City
Erlangen
Country
Germany
Facility Name
Maastricht University Hospital
City
Maastricht
Country
Netherlands
Facility Name
Hospital Mutua de Terrassa
City
Terrassa
Country
Spain
Facility Name
Danderyd Hospital
City
Stockholm
Country
Sweden
Facility Name
St. Mark's Hospital
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
7475602
Citation
Matzel KE, Stadelmaier U, Hohenfellner M, Gall FP. Electrical stimulation of sacral spinal nerves for treatment of faecal incontinence. Lancet. 1995 Oct 28;346(8983):1124-7. doi: 10.1016/s0140-6736(95)91799-3.
Results Reference
background
PubMed Identifier
15094271
Citation
Matzel KE, Kamm MA, Stosser M, Baeten CG, Christiansen J, Madoff R, Mellgren A, Nicholls RJ, Rius J, Rosen H. Sacral spinal nerve stimulation for faecal incontinence: multicentre study. Lancet. 2004 Apr 17;363(9417):1270-6. doi: 10.1016/S0140-6736(04)15999-0.
Results Reference
result
PubMed Identifier
15793647
Citation
Jarrett ME, Matzel KE, Stosser M, Baeten CG, Kamm MA. Sacral nerve stimulation for fecal incontinence following surgery for rectal prolapse repair: a multicenter study. Dis Colon Rectum. 2005 Jun;48(6):1243-8. doi: 10.1007/s10350-004-0919-y.
Results Reference
result
PubMed Identifier
15838899
Citation
Jarrett ME, Matzel KE, Christiansen J, Baeten CG, Rosen H, Bittorf B, Stosser M, Madoff R, Kamm MA. Sacral nerve stimulation for faecal incontinence in patients with previous partial spinal injury including disc prolapse. Br J Surg. 2005 Jun;92(6):734-9. doi: 10.1002/bjs.4859.
Results Reference
result
PubMed Identifier
15843939
Citation
Jarrett ME, Matzel KE, Stosser M, Christiansen J, Rosen H, Kamm MA. Sacral nerve stimulation for faecal incontinence following a rectosigmoid resection for colorectal cancer. Int J Colorectal Dis. 2005 Sep;20(5):446-51. doi: 10.1007/s00384-004-0729-7. Epub 2005 Apr 21.
Results Reference
result
PubMed Identifier
20207638
Citation
Kamm MA, Dudding TC, Melenhorst J, Jarrett M, Wang Z, Buntzen S, Johansson C, Laurberg S, Rosen H, Vaizey CJ, Matzel K, Baeten C. Sacral nerve stimulation for intractable constipation. Gut. 2010 Mar;59(3):333-40. doi: 10.1136/gut.2009.187989.
Results Reference
result
Learn more about this trial
Sacral Nerve Stimulation for Anal Incontinence and Bowel Control
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