Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT05475093
Status:
COMPLETED
Last Update Posted:
2024-04-08
First Post:
2022-07-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact Evaluation of Different Micturition Modes on Patients With Medullar Injury of Quality of Life and Their Occupations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014555', 'term': 'Urination Disorders'}], 'ancestors': [{'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-05', 'studyFirstSubmitDate': '2022-07-22', 'studyFirstSubmitQcDate': '2022-07-22', 'lastUpdatePostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life by QUALIVEEN-30', 'timeFrame': 'at baseline', 'description': "The questionnaire QUALIVEEN-30 will be used to evaluate the quality of life. It's a reliable tool specially for patients with medullar injury and recommended by the European Association of Urology as Guideline since 2008. The french version is validated."}, {'measure': 'Model of human occupation', 'timeFrame': 'at baseline', 'description': 'Questionnaire MCREO (french version) will be used to evaluate patients in the occupational aspect.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Medullary Injury', 'Micturition modes', 'Quality of life', 'Human occupation'], 'conditions': ['Medullary Injury', 'Micturition Disorder']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to analysis the personal determination factors (age, sex, stage of injury, pain, urinary continence and durations of spinal cord injury) and environmental determination factors (need for medical devices, nurse care and adaptation of accommodations) which affect the quality of life and their occupations on patients with medullar injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with medular injury who have their follow-up care in the neuro-urology unit in raymond poincaré hospital, live at home or in long-term care facility definitively.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with spinal cord injury;\n* Live at home or in long-term care facility definitively;\n* Have one of the following urination modes:\n\n 1. urine with indwelling catheter in place\n 2. catheter in suprapubic area\n 3. intermittent catheterization by urethra\n 4. intermittent catheterization by incontinent cystostomy\n 5. sphincterotomy\n 6. incontinent stomia (Bricker)\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT05475093', 'acronym': 'URO-ActSCi', 'briefTitle': 'Impact Evaluation of Different Micturition Modes on Patients With Medullar Injury of Quality of Life and Their Occupations', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Evaluation of Impact of Different Micturition Modes on Patients With Medullar Injury of Their Quality of Life and Their Occupations', 'orgStudyIdInfo': {'id': 'APHP220265'}, 'secondaryIdInfos': [{'id': '2021-A02637-34', 'type': 'REGISTRY', 'domain': 'IDRCB'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garches', 'country': 'France', 'facility': 'Neuro-Urology Unit, Physical Medicine and Rehabilitation Department, Raymond Poincaré Hospital, APHP', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}], 'overallOfficials': [{'name': 'Alexia EVEN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Neuro-Urology Unit, Physical Medicine and Rehabilitation Department, Raymond Poincaré Hospital, APHP'}, {'name': 'Aurélie -Anna DUBOIS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Neuro-Urology Unit, Physical Medicine and Rehabilitation Department, Raymond Poincaré Hospital, APHP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}