Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-02-22 @ 5:24 PM
Study NCT ID:
NCT04676568
Status:
COMPLETED
Last Update Posted:
2020-12-21
First Post:
2020-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Analysis of Outcome Between Extravesical and Transvesical Repair for Vesico-vaginal Fistula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014719', 'term': 'Vesicovaginal Fistula'}], 'ancestors': [{'id': 'D014624', 'term': 'Vaginal Fistula'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001747', 'term': 'Urinary Bladder Fistula'}, {'id': 'D014548', 'term': 'Urinary Fistula'}, {'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-16', 'studyFirstSubmitDate': '2020-12-16', 'studyFirstSubmitQcDate': '2020-12-16', 'lastUpdatePostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'operative time', 'timeFrame': '3 months', 'description': 'total time taken for surgery'}, {'measure': 'complications', 'timeFrame': '3 months', 'description': 'bladder spasms, bleeding'}, {'measure': 'recurrence', 'timeFrame': '3 months', 'description': 'patients who have recurrenec of symptoms'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vesico Vaginal Fistula']}, 'descriptionModule': {'briefSummary': 'In patients with vesicovaginal fistula, transvesical and extravesical repair will be compared in terms of operative time, complications and recurrence rates.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients with Vesicovaginal fistula\n\nExclusion Criteria:\n\n* uretrovaginal fistula'}, 'identificationModule': {'nctId': 'NCT04676568', 'briefTitle': 'Comparative Analysis of Outcome Between Extravesical and Transvesical Repair for Vesico-vaginal Fistula', 'organization': {'class': 'OTHER', 'fullName': 'Armed Forces Institute of Urology, Rawalpindi'}, 'officialTitle': 'A One Year Interventional Study in Patients With Vesicovaginal Fistula', 'orgStudyIdInfo': {'id': 'AFIU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'extravesical VVF repair', 'interventionNames': ['Procedure: Extravesical VVF repair']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Transvesical VVF repair', 'interventionNames': ['Procedure: Extravesical VVF repair']}], 'interventions': [{'name': 'Extravesical VVF repair', 'type': 'PROCEDURE', 'otherNames': ['Transvesical VVF repair'], 'description': 'Both standard transvesical and extravesical approach for VVF repair will be utilised', 'armGroupLabels': ['Transvesical VVF repair', 'extravesical VVF repair']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46000', 'city': 'Rawalpindi', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Armed Forces Institute of Urology', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Armed Forces Institute of Urology, Rawalpindi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Surgeon', 'investigatorFullName': 'Adnan Ali', 'investigatorAffiliation': 'Armed Forces Institute of Urology, Rawalpindi'}}}}