Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-01-04 @ 4:13 PM
Study NCT ID:
NCT02139956
Status:
UNKNOWN
Last Update Posted:
2014-05-16
First Post:
2014-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Internal Urethral Sphincter and the Vagina by Three Dimensional Ultrasound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}, 'targetDuration': '2 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'lastUpdateSubmitDate': '2014-05-15', 'studyFirstSubmitDate': '2014-05-06', 'studyFirstSubmitQcDate': '2014-05-15', 'lastUpdatePostDateStruct': {'date': '2014-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evaluation of the internal urethral sphincter and assesst the extend and degree of the torn internal urethral sphincter', 'timeFrame': '6 month', 'description': 'we are going to do 3d ultrasound by transvaginal probe to see the internal urethral sphincter if torn or not and evaluate the morphology of the urethra and pelvic floor structure'}]}, 'conditionsModule': {'conditions': ['Urinary Incontinence Due to Urethral Sphincter Incompetence']}, 'referencesModule': {'references': [{'pmid': '23436235', 'type': 'RESULT', 'citation': 'Kruger JA, Dietz HP, Budgett SC, Dumoulin CL. Comparison between transperineal ultrasound and digital detection of levator ani trauma. Can we improve the odds? Neurourol Urodyn. 2014 Mar;33(3):307-11. doi: 10.1002/nau.22386. Epub 2013 Feb 22.'}]}, 'descriptionModule': {'briefSummary': 'Continent women have an intact internal urethral sphincter that extends from the bladder neck down to the perineal membrane. The internal urethral sphincter is a strong collagen muscle tissue cylinder lined by urothelium. On ultrasound scanning tissue echo will be detected torn internal urethral sphincter will not stand sudden rise of abdominal pressure. Three dimensional ultrasound assessment of the internal urethral sphincter is very sensitive and specific for the diagnosis of stress urinary incontinence.', 'detailedDescription': "The internal urethral sphincter used to be said it's a muscular ring but the investigators will visualize by three dimensional ultrasound it's a cylinder in shape and it's the cause of stress urinary incontinence by being torn by stretching the vagina during normal delivery."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'out patient \\[clinics\\] and in patient', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signed an informed consent\n* patient with stress urinary incontinence\n* patient have done a vaginal delivery\n* patient with genital prolapse\n\nExclusion Criteria:\n\n* refusal to sign an informed consent\n* patient have urinary tract infection\n* patient with pregnancy\n* patient have vaginal infection\n* patient who has undiagnosed vaginal bleeding'}, 'identificationModule': {'nctId': 'NCT02139956', 'briefTitle': 'Assessment of the Internal Urethral Sphincter and the Vagina by Three Dimensional Ultrasound', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Ultrasonic Assessment of the Urethra and the Vagina in Normal Continent Women and Women Suffering From Stress Urinary Incontinence', 'orgStudyIdInfo': {'id': 'mekky'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'stress urinary incontinence', 'description': 'group 1 women with stress urinary incontinence by ultrasonography', 'interventionNames': ['Device: ultrasonography']}, {'label': 'continent group', 'description': 'group 2 women without stress urinary incontinence by ultrasonography', 'interventionNames': ['Device: ultrasonography']}], 'interventions': [{'name': 'ultrasonography', 'type': 'DEVICE', 'otherNames': ['vilson E6', 'transvaginal probe'], 'description': 'open', 'armGroupLabels': ['continent group', 'stress urinary incontinence']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00202', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'mekky', 'investigatorFullName': 'dr mervat ekky', 'investigatorAffiliation': 'Ain Shams University'}}}}