Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT00200005
Status:
COMPLETED
Last Update Posted:
2014-01-10
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sacral Nerve Stimulation for Anal Incontinence and Bowel Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Switzerland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D005242', 'term': 'Fecal Incontinence'}, {'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-09', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2014-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': 'Annually'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': 'Annually'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Slow transit constipation', 'Fecal incontinence', 'Constipation', 'Idiopathic slow transit constipation', 'Chronic constipation'], 'conditions': ['Fecal Incontinence and Constipation']}, 'referencesModule': {'references': [{'pmid': '7475602', 'type': 'BACKGROUND', '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.'}, {'pmid': '15094271', 'type': 'RESULT', '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.'}, {'pmid': '15793647', 'type': 'RESULT', '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.'}, {'pmid': '15838899', 'type': 'RESULT', '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.'}, {'pmid': '15843939', 'type': 'RESULT', '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.'}, {'pmid': '20207638', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': 'Multicenter European study to evaluate efficacy and safety of sacral nerve stimulation with InterStim Therapy to treat fecal incontinence or constipation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '140 patients (7 study groups, up to 20 implanted patients per study group)\n\nFecal Incontinence groups:\n\nMain Inclusion Criteria:\n\n* Fecal incontinence (defined as incontinence to solid or liquid stool \\> 1 / week);\n* Failed biofeedback or medical therapy;\n\nGroups 1 - 5 patients with:\n\n* Group 1) Circumferentially intact external anal sphincter, no previous surgery;\n* Group 2) Circumferentially intact external anal sphincter after surgical repair;\n* Group 3) Rectal prolapse repaired with a rectopexy;\n* Group 4) Spinal injury including disc prolapse;\n* Group 5) Sigmoid or partial rectal resection with colorectal or coloanal anastomosis\n\nConstipation groups:\n\nMain Inclusion Criteria:\n\n* 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\n* Failed biofeedback or medical therapy;\n\nGroups 6 - 7 patients with:\n\n* Group 6) Idiopathic slow transit constipation as proven on colonic transit studies;\n* Group 7) Normal colonic transit studies but chronic constipation due to either pelvic floor dysfunction or disordered defecation.'}, 'identificationModule': {'nctId': 'NCT00200005', 'acronym': 'MDT-301', 'briefTitle': 'Sacral Nerve Stimulation for Anal Incontinence and Bowel Control', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedtronicNeuro'}, 'officialTitle': 'Sacral Nerve Stimulation for Anal Incontinence and Bowel Control', 'orgStudyIdInfo': {'id': 'Mdt-301 November 03,1998'}, 'secondaryIdInfos': [{'id': 'Mdt-301 (Nov 03, 98),'}, {'id': 'Amendment I (Dec 14, 99),'}, {'id': 'Amendment II (Jan 31, 02)'}, {'id': 'Amendment III (Jul 01, 2009)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'InterStim therapy', 'description': 'Patients being treated with sacral neuromodulation with InterStim therapy.', 'interventionNames': ['Device: Type: Implantable neurostimulator; InterStim']}], 'interventions': [{'name': 'Type: Implantable neurostimulator; InterStim', 'type': 'DEVICE', 'otherNames': ['InterStim Model 3023', 'InterStim Model 3058'], 'description': 'Treatment with InterStim Therapy: all patients meeting inclusion/exclusion criteria undergo test screening and those who have successful outcomes receive a permanent implant.', 'armGroupLabels': ['InterStim therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'Danube Hospital/SMZ-Ost', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Erlangen', 'country': 'Germany', 'facility': 'University Hospital Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University Hospital', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Terrassa', 'country': 'Spain', 'facility': 'Hospital Mutua de Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Danderyd Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "St. Mark's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Klaus Matzel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Erlangen- Erlangen, Germany'}, {'name': 'Michael A Kamm, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Vincent's Hospital- Melbourne, Australia. Former: St. Mark's Hospital, London, U.K."}, {'name': 'Cor Baeten, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Hospital- The Netherlands'}, {'name': 'John Christiansen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herlev Hospital- Copenhagen, Denmark'}, {'name': 'Anders Mellgren, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Danderyd Hospital- Stockholm, Sweden'}, {'name': 'Harald Rosen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Danube Hospital/SMZ-Ost- Vienna, Austria'}, {'name': 'Albert Navarro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Mutua de Terrassa- Terrassa, Spain'}, {'name': 'Robert Madoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota- Minneapolis, USA'}, {'name': 'Carolynne Vaizey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Mark's Hospital- London, UK"}, {'name': 'Claes Johansson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Danderyd Hospital- Stockholm, Sweden'}, {'name': 'Soren Laurberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedtronicNeuro', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}