Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-01 @ 6:19 PM
Study NCT ID:
NCT02361450
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2015-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrograde Colonic Irrigation to Manage Spina Bifida Functional Digestive Sequelae: a Multicenter, Prospective, Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016135', 'term': 'Spinal Dysraphism'}, {'id': 'D004688', 'term': 'Encopresis'}, {'id': 'D003248', 'term': 'Constipation'}, {'id': 'D008591', 'term': 'Meningomyelocele'}], 'ancestors': [{'id': 'D009436', 'term': 'Neural Tube Defects'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019960', 'term': 'Elimination Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-22', 'studyFirstSubmitDate': '2015-02-02', 'studyFirstSubmitQcDate': '2015-02-06', 'lastUpdatePostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurogenic Bowel Dysfunction (NBD) score', 'timeFrame': 'Ten weeks after inclusion'}], 'secondaryOutcomes': [{'measure': 'Questionnaire data of incontinence and constipation (Cleveland scores)', 'timeFrame': 'Ten weeks after inclusion'}, {'measure': 'Questionnaire data of incontinence and constipation (Cleveland scores)', 'timeFrame': 'Twenty-four weeks after inclusion'}, {'measure': 'Quality of life', 'timeFrame': 'Ten weeks after inclusion', 'description': 'Quality of life will be assess by semi-quantified scales'}, {'measure': 'Quality of life', 'timeFrame': 'Twenty-four weeks after inclusion', 'description': 'Quality of life will be assess by semi-quantified scales'}, {'measure': 'Self esteem (Rosenberg scale)', 'timeFrame': 'Ten weeks after inclusion'}, {'measure': 'Functional digestive score (NBD)', 'timeFrame': 'Twenty-four weeks after inclusion'}, {'measure': 'Cumulative time spent using restrooms', 'timeFrame': 'Ten weeks after inclusion', 'description': 'Cumulative time spent using restrooms will be collected with a patient reported outcome questionnaire'}, {'measure': 'Cumulative time spent using restrooms', 'timeFrame': 'Twenty-four weeks after inclusion', 'description': 'Cumulative time spent using restrooms will be collected with a patient reported outcome questionnaire'}, {'measure': 'Number of accidents of incontinence', 'timeFrame': 'Ten weeks after inclusion', 'description': 'Number of accidents of incontinence will be collected with a patient reported outcome questionnaire'}, {'measure': 'Number of accidents of incontinence', 'timeFrame': 'Twenty-four weeks after inclusion', 'description': 'Number of accidents of incontinence will be collected with a patient reported outcome questionnaire'}, {'measure': 'Number of incontinence guards used', 'timeFrame': 'Ten weeks after inclusion', 'description': 'Number of incontinence guards used will be collected with a patient reported outcome questionnaire'}, {'measure': 'Number of incontinence guards used', 'timeFrame': 'Twenty-four weeks after inclusion', 'description': 'Number of incontinence guards used will be collected with a patient reported outcome questionnaire'}, {'measure': 'Type of incontinence guards used', 'timeFrame': 'Ten weeks after inclusion', 'description': 'Type of incontinence guards (panty liner, pad, nappy) used will be collected with a patient reported outcome questionnaire'}, {'measure': 'Type of incontinence guards used', 'timeFrame': 'Twenty-four weeks after inclusion', 'description': 'Type of incontinence guards (panty liner, pad, nappy) used will be collected with a patient reported outcome questionnaire'}, {'measure': 'Number of stools', 'timeFrame': 'Ten weeks after inclusion', 'description': 'Number of stools will be collected with a patient reported outcome questionnaire'}, {'measure': 'Number of stools', 'timeFrame': 'Twenty-four weeks after inclusion', 'description': 'Number of stools will be collected with a patient reported outcome questionnaire'}, {'measure': 'Stools consistency', 'timeFrame': 'Ten weeks after inclusion', 'description': 'Stools consistency will be collected with a patient reported outcome questionnaire'}, {'measure': 'Stools consistency', 'timeFrame': 'Twenty-four weeks after inclusion', 'description': 'Stools consistency will be collected with a patient reported outcome questionnaire'}, {'measure': 'Symptoms experienced during defecation', 'timeFrame': 'Ten weeks after inclusion', 'description': 'Symptoms experienced during defecation will be collected with a patient reported outcome questionnaire'}, {'measure': 'Symptoms experienced during defecation', 'timeFrame': 'Twenty-four weeks after inclusion', 'description': 'Symptoms experienced during defecation will be collected with a patient reported outcome questionnaire'}, {'measure': 'Frequency of digital help during defecation', 'timeFrame': 'Ten weeks after inclusion', 'description': 'The frequency of digital stimulation will be collected with a patient reported outcome questionnaire'}, {'measure': 'Frequency of digital help during defecation', 'timeFrame': 'Twenty-four weeks after inclusion', 'description': 'The frequency of digital stimulation will be collected with a patient reported outcome questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Faecal incontinence', 'Spina Bifida', 'Enema', 'Constipation', 'Myelomeningocele', 'Human'], 'conditions': ['Spina Bifida']}, 'referencesModule': {'references': [{'pmid': '36799340', 'type': 'RESULT', 'citation': 'Brochard C, Jezequel M, Blanchard-Dauphin A, Kerdraon J, Perrouin-Verbe B, Leroi AM, Reymann JM, Peyronnet B, Morcet J, Siproudhis L. Transanal irrigation is a better choice for bowel dysfunction in adults with Spina bifida: A randomised controlled trial. Colorectal Dis. 2023 Jun;25(6):1267-1276. doi: 10.1111/codi.16518. Epub 2023 Mar 11.'}]}, 'descriptionModule': {'briefSummary': 'Spina Bifida is a developmental congenital disorder caused by the incomplete closing of the embryonic neural tube, leading to serious malformations of the nervous system. Caudal neuropore malformations almost always lead to sensory-motor deficits (including complete paraplegia) with orthopedic deformations, pressure sores, and pelvic/perineal neurological dysfunctions (affecting the bladder-sphincter, anorectal, and genital sphere).\n\nThe purpose of the study is to assess the efficacy of retrograde colonic irrigation associated with usual care (medical treatments, patient education) on anorectal dysfunction (incontinence and/or constipation), compared to usual care only.', 'detailedDescription': "Sphincter dysfunctions impair the quality of life and patients' self-esteem. However, defecation disorders are important issues the Spina Bifida National Reference Center has to deal with. Indeed, more than half of patients are concerned. These disorders are mainly due to fecal stasis. Treatments include laxatives and hygiene recommendations. Colonic irrigation can also be useful, especially to achieve colonic vacuity and improve continence. The use of intra-rectal balloon inflation probes and the control of instillation flow improved retrograde colonic irrigation efficacy. Nevertheless, this technique is currently not evaluated in young adults suffering from Spina Bifida functional digestive sequelae, who are mainly concerned by Malone enema.\n\nThe purpose of the study is to assess the efficacy of retrograde colonic irrigation associated with usual care (medical treatments, patient education) on anorectal dysfunction (incontinence and/or constipation), compared to usual care only."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aging at least 15 years old with Spina Bifida neurological pelvi-perineal sequelae, objected by neurologic exam , functional urinary and/or anorectal and/or neurophysiological data,\n* Patients with NBD score above 9,\n* Written and informed consent (Minor children may be included with the consent of the two parents).\n\nExclusion Criteria:\n\n* Patients with psychiatric disorders, cognitive or intellectual disabilities compromising the assessment of primary outcome measure,\n* Patients using currently irrigation colonic technique,\n* Patients with functional colostomy, known anal or colorectal stenosis, colorectal cancer, acute or chronic inflammatory disease, recent anal or colorectal surgery for less than 3 months, polyp removal for less than 4 weeks, ischemic colitis.\n* Patients with urinary trophic or orthopedic disease with planned surgery during inclusion or follow-up periods,\n* Patients with progressive anal disease (suppuration, hemorrhoid or rectal prolapse)\n* Patient with a hard follow-up ( judged by the investigator)\n* Person involved in another clinical trial\n* Pregnant women\n* Person with a measure of legal protection (guardianship)'}, 'identificationModule': {'nctId': 'NCT02361450', 'acronym': 'IRRICO', 'briefTitle': 'Retrograde Colonic Irrigation to Manage Spina Bifida Functional Digestive Sequelae: a Multicenter, Prospective, Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Retrograde Colonic Irrigation to Manage Spina Bifida Functional Digestive Sequelae: a Multicenter, Prospective, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2013-A01520-45'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Retrograde Colonic Irrigation with usual care', 'description': 'In the experimental group, retrograde colonic irrigation sessions will be scheduled in addition to conventional treatment according to a progressive volume program.', 'interventionNames': ['Device: Retrograde Colonic Irrigation', 'Other: Usual Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': 'In the comparator group, patients will receive conventional care, according to each clinical center habits.', 'interventionNames': ['Other: Usual Care']}], 'interventions': [{'name': 'Retrograde Colonic Irrigation', 'type': 'DEVICE', 'armGroupLabels': ['Retrograde Colonic Irrigation with usual care']}, {'name': 'Usual Care', 'type': 'OTHER', 'armGroupLabels': ['Retrograde Colonic Irrigation with usual care', 'Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'CHRU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '56275', 'city': 'Ploemeur', 'country': 'France', 'facility': 'CMRRF de Kerpape', 'geoPoint': {'lat': 47.73512, 'lon': -3.42952}}, {'zip': '35000', 'city': 'Rennes', 'country': 'France', 'facility': 'Rennes University Hospital', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'CHU de Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'CHRU de Nancy-Brabois', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'overallOfficials': [{'name': 'Laurent Siproudhis, Md, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rennes University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}