Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-27 @ 11:22 PM
Study NCT ID:
NCT04940494
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2021-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anal Incontinence After Obstetrical Anal Sphincter Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004688', 'term': 'Encopresis'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 227}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2021-06-17', 'studyFirstSubmitQcDate': '2021-06-17', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anal incontinence', 'timeFrame': 'from the childbirth to the day of survey (2 to 16 years after childbirth)', 'description': 'loss of stool or gas ≥1/week during ≥1 month'}], 'secondaryOutcomes': [{'measure': 'Incidence of anal incontinence', 'timeFrame': 'Incidence of anal incontinence the date of the survey (2 to 16 years after childbirth)', 'description': 'AI graded by the St Mark Score'}, {'measure': 'cinetic of AI occurence', 'timeFrame': 'from the childbirth to the date of the survey (2 to 16 years after childbirth)', 'description': 'all the resolutive episodes of occurence of anal incontinence are reported'}, {'measure': 'Quality of life with fecal incontinence quality of life score', 'timeFrame': 'the date of the survey (2 to 16 years after childbirth)', 'description': 'fecal incontinence quality of life score'}, {'measure': 'Expectation of the women in term of information', 'timeFrame': 'the date of the survey (2 to 16 years after childbirth)', 'description': '2 questions on the expectation of the women in term of information towards the Obstetrical Anal Sphincter Injury'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstetric Trauma', 'Anal Sphincter Injury', 'Anal Incontinence']}, 'referencesModule': {'references': [{'pmid': '38368278', 'type': 'DERIVED', 'citation': 'Rebmann E, Hamel JF, Helbert C, Lemasson F, Legendre G, Venara A. Anal incontinence after obstetrical anal sphincter injury significantly impacts quality of life for women: a cohort study. Langenbecks Arch Surg. 2024 Feb 17;409(1):67. doi: 10.1007/s00423-024-03257-4.'}]}, 'descriptionModule': {'briefSummary': 'Obstetrical Anal Sphincter Injury is an identified risk factor for anal incontinence. The mechanisms and the risk factors for anal incontinence in Obstetrical Anal Sphincter Injury women are not well known.\n\nAnal incontinence in such women is not well documented and probably underestimated. Cohort studies estimated that up to 53% of Obstetrical Anal Sphincter Injury women are incontinent but that most of them does not complain their doctor.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All women that gave birth between 2005 January 1st and 2019 December 31th and that accept to respond to the survey', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Childbirth between 2005 January 1st and 2019 December 31th\n* Obstetrical Anal Sphincter Injury -≥ 18 y\n\nExclusion Criteria:\n\n* Patients' refusal\n* lost of view or deceased\n* anal incontinence before the Obstetrical Anal Sphincter Injury"}, 'identificationModule': {'nctId': 'NCT04940494', 'acronym': 'INCONT-LOSA', 'briefTitle': 'Anal Incontinence After Obstetrical Anal Sphincter Injury', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Incidence and Risk Factors for Anal Incontinence After Obstetrical Anal Sphincter Injury', 'orgStudyIdInfo': {'id': '2021-A01128-33'}}, 'armsInterventionsModule': {'interventions': [{'name': 'collection of data', 'type': 'OTHER', 'description': 'collection of data for all Obstetrical Anal Sphincter Injury women (score of quality of life, experimenting anal incontinence...)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'overallOfficials': [{'name': 'Aurélien VENARA, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Angers'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}