Sacral Nerve Stimulation for Anal Incontinence and Bowel Control
NCT ID: NCT00200005
Last Updated: 2014-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
140 participants
INTERVENTIONAL
1998-11-30
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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InterStim therapy
Patients being treated with sacral neuromodulation with InterStim therapy.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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:
* 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.
18 Years
75 Years
ALL
No
Sponsors
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MedtronicNeuro
INDUSTRY
Responsible Party
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Principal Investigators
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Klaus Matzel, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Erlangen- Erlangen, Germany
Michael A Kamm, MD
Role: PRINCIPAL_INVESTIGATOR
St. Vincent's Hospital- Melbourne, Australia. Former: St. Mark's Hospital, London, U.K.
Cor Baeten, MD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Hospital- The Netherlands
John Christiansen, MD
Role: PRINCIPAL_INVESTIGATOR
Herlev Hospital- Copenhagen, Denmark
Anders Mellgren, MD
Role: PRINCIPAL_INVESTIGATOR
Danderyd Hospital- Stockholm, Sweden
Harald Rosen, MD
Role: PRINCIPAL_INVESTIGATOR
Danube Hospital/SMZ-Ost- Vienna, Austria
Albert Navarro, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Mutua de Terrassa- Terrassa, Spain
Robert Madoff, MD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota- Minneapolis, USA
Carolynne Vaizey, MD
Role: PRINCIPAL_INVESTIGATOR
St. Mark's Hospital- London, UK
Claes Johansson, MD
Role: PRINCIPAL_INVESTIGATOR
Danderyd Hospital- Stockholm, Sweden
Soren Laurberg, MD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Danube Hospital/SMZ-Ost
Vienna, , Austria
Aarhus University Hospital
Aarhus, , Denmark
Herlev Hospital
Copenhagen, , Denmark
University Hospital Erlangen
Erlangen, , Germany
Maastricht University Hospital
Maastricht, , Netherlands
Hospital Mutua de Terrassa
Terrassa, , Spain
Danderyd Hospital
Stockholm, , Sweden
St. Mark's Hospital
London, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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Mdt-301 (Nov 03, 98),
Identifier Type: -
Identifier Source: secondary_id
Amendment I (Dec 14, 99),
Identifier Type: -
Identifier Source: secondary_id
Amendment II (Jan 31, 02)
Identifier Type: -
Identifier Source: secondary_id
Amendment III (Jul 01, 2009)
Identifier Type: -
Identifier Source: secondary_id
Mdt-301 November 03,1998
Identifier Type: -
Identifier Source: org_study_id
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