Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-02-20 @ 1:44 AM
Study NCT ID:
NCT01786304
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2013-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Sacral Nerve Stimulation on Enteric Nervous System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005242', 'term': 'Fecal Incontinence'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'colonic biopsies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-06', 'studyFirstSubmitDate': '2013-02-05', 'studyFirstSubmitQcDate': '2013-02-06', 'lastUpdatePostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fecal incontinence score', 'timeFrame': '6 months', 'description': 'Measured using the Cleveland Clinic score'}, {'measure': 'Quality of life', 'timeFrame': '6 months', 'description': 'measured using the FIQL score that has been validated in french'}], 'primaryOutcomes': [{'measure': 'Number of neurons producing vasoactive intestinal peptide (VIP)', 'timeFrame': '6 months', 'description': 'Number of neurons producing vasoactive intestinal peptide (VIP) by immunochemistry'}], 'secondaryOutcomes': [{'measure': 'Number of cholinergic neurons', 'timeFrame': '6 months', 'description': 'Number of cholinergic neurons by immunochemistry'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fecal incontinence, sacral nerve stimulation'], 'conditions': ['Fecal Incontinence']}, 'descriptionModule': {'briefSummary': 'Sacral nerve stimulation (SNS) is a new therapeutic option to treat fecal incontinence, although its mecanims of action remains poorly understood. The investigators hypothtized that SNS could act on enteric nervous system (ENS). To verify this hypothesis, the investigators will collect biopsy samples from patients implanted for SNS, and assess whether SNS induces changes in ENS.', 'detailedDescription': 'Sacral nerve stimulation (SNS) is a new therapeutic option to treat fecal incontinence. Its efficacy yields 80% approximately, but its mecanims of action remains poorly understood. In particular, SNS does not restore anal squeezing contraction nor it increase anal tone. Recently, using a porcine model, it was shown that SNS changed colonic permeability, suggesting that SNS may activate the enteric nervous system (ENS).\n\nThe investigators hypothtized therefore that SNS could act on enteric nervous system (ENS).\n\nTo verify this hypothesis, the investigators will collect biopsy samples from patients before and after implantation for SNS. The investigators will assess whether SNS induces changes in ENS, and if this is correlated to SNS efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with fecal incontience refractory to standard medical treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fecal incotinence\n* refractory to medial treatment\n* Eligible to a treatment with sacral nerve stimulation\n\nExclusion Criteria:\n\n* age \\< 18 yo\n* age \\< 75 yo\n* anal defect \\> 120°\n* bilateral interruption of the bulbo-cavernous reflex\n* patient not able to speack and understand the French Language\n* patient not affilated to the French healthcare system\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01786304', 'acronym': 'ENS-3', 'briefTitle': 'Effect of Sacral Nerve Stimulation on Enteric Nervous System', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'Effect of Sacral Nerve Stimulation on Enteric Nervous System', 'orgStudyIdInfo': {'id': '2012/091/HP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fecal incontinence', 'description': 'Patient with fecal incontinence and referred for a treatment with sacral nerve stimulation', 'interventionNames': ['Procedure: Sacral nerve stimulation']}], 'interventions': [{'name': 'Sacral nerve stimulation', 'type': 'PROCEDURE', 'description': 'implantation of a stimulation electrode in one of the S2-S3-S4 sacral hole then connected to a subcutaneous stimulator for permanent stimulation of the sacral nerve', 'armGroupLabels': ['Fecal incontinence']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76000', 'city': 'Rouen', 'state': 'Normandy', 'country': 'France', 'facility': 'Rouen University Hospital', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '44000', 'city': 'Nantes', 'state': 'Pays de Loire', 'country': 'France', 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'overallOfficials': [{'name': 'Guillaume Gourcerol, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rouen University Hospital, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nantes University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}