Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-03-02 @ 8:05 AM
Study NCT ID:
NCT02294760
Status:
COMPLETED
Last Update Posted:
2018-05-17
First Post:
2014-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Sacral Nerve Stimulation for Irritable Bowel Syndrome.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-16', 'studyFirstSubmitDate': '2014-11-10', 'studyFirstSubmitQcDate': '2014-11-14', 'lastUpdatePostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome version', 'timeFrame': 'Change in the IBS-specific symptom score between the subsensory and the OFF period in the crossover study', 'description': 'The questionnaire is filled in every week of the 12 week study period'}], 'secondaryOutcomes': [{'measure': 'Irritable Bowel Syndrome - Impact Scale questionnaire', 'timeFrame': 'Change in the IBS-specific quality of life score between the subsensory and the OFF period in the crossover study', 'description': 'The questionnaire is filled in every week of the 12 week study period'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Irritable Bowel Syndrome', 'Sacral Nerve Stimulation', 'Symptoms', 'Quality of Life'], 'conditions': ['Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'A recent randomised, controlled, crossover study has shown that sacral nerve stimulation (SNS) significantly reduces symptoms and improves quality of life of highly selected patients with irritable bowel syndrome (IBS). Relief of IBS symptoms during SNS is associated with consistent changes in rectal sensitivity and biomechanical wall properties.\n\nThe aim of the present study is to evaluate long-term efficacy of sacral nerve stimulation on symptoms and quality of life in patients with IBS in a randomised, placebo-controlled, crossover study.', 'detailedDescription': 'Twenty two patients with IBS-D or IBS-M according to the ROME III criteria, will be enrolled by invitation in the study.\n\nHaving meet inclusion criteria, the patients are first set subsensory for 4 weeks and then randomised to receive either OFF-subsensory or subsensory-OFF stimulation in a 4+4-week period.\n\nDuring the PNE test the effect of the stimulation is evaluated by specific IBS symptom and quality of life questionnaires (GSRS-IBS and IBS-IS) and bowel habit diaries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are psychologically stable and suitable for intervention and able to provide informed consent\n* Patients who are diagnosed with IBS according to the Rome III criteria and characterised with IBS-D or IBS-M.\n* Patients who have been treated with sacral nerve stimulation for a minimum of 3 years.\n\nExclusion Criteria:\n\n* Other bowel diseases including inflammatory bowel disease\n* Pregnant or breast feeding\n* Patients who are considered unable to follow the planned programme of the study, including mentally illness or physiological instability\n* Patients who are on medication with known influence on gastrointestinal motility including those for thyroid disease, diabetes mellitus, celiac disease and neurological diseases.'}, 'identificationModule': {'nctId': 'NCT02294760', 'briefTitle': 'Long-term Sacral Nerve Stimulation for Irritable Bowel Syndrome.', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Long-term Efficacy of Sacral Nerve Stimulation for Irritable Bowel Syndrome. A Randomised Controlled Crossover Study', 'orgStudyIdInfo': {'id': '44418'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Subsensory, OFF, subsensory', 'description': 'The stimulator is set subsensory for the first 4 weeks (90% of sensory threshold), then turned OFF for the next 4 weeks and finally set subsensory for the last 4 weeks.', 'interventionNames': ['Device: Subsensory', 'Device: OFF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Subsensory, subsensory, OFF', 'description': 'The stimulator is set subsensory for the first 4 weeks (90% of sensory threshold), then set subsensory for another 4 weeks and finally turned OFF for the last 4 weeks.', 'interventionNames': ['Device: Subsensory', 'Device: OFF']}], 'interventions': [{'name': 'Subsensory', 'type': 'DEVICE', 'otherNames': ['Device: External pacemaker, model 3625, Medtronic Inc.'], 'description': 'The stimulation is set to 90% of the sensory threshold.', 'armGroupLabels': ['Subsensory, OFF, subsensory', 'Subsensory, subsensory, OFF']}, {'name': 'OFF', 'type': 'DEVICE', 'otherNames': ['Device: External pacemaker, model 3625, Medtronic Inc.'], 'description': 'The stimulation is turned OFF.', 'armGroupLabels': ['Subsensory, OFF, subsensory', 'Subsensory, subsensory, OFF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Surgical Research Unit, Department of Surgery P, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Janne Fassov, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Surgical Research Unit, Department of Surgery P, Aarhus University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}