Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2025-12-27 @ 10:15 PM
Study NCT ID:
NCT07153861
Status:
RECRUITING
Last Update Posted:
2025-09-04
First Post:
2025-08-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Mucosal Graft Versus Labial Graft in Female Urethroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-30', 'studyFirstSubmitDate': '2025-08-24', 'studyFirstSubmitQcDate': '2025-08-30', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urine flow rate', 'timeFrame': '6 months post-procedure', 'description': 'Urine flow rate will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oral Mucosal Graft', 'Labial Graft', 'Female', 'Urethroplasty']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the oral versus labial graft in female urethroplasty in female urethral stricture.', 'detailedDescription': 'Female urethral stricture is an uncommon condition with an estimated prevalence of 4%-13% in women with bladder outlet obstruction.\n\nUrethral reconstruction may become the treatment of choice in stricture recurrence following the failure of minimally invasive procedures. and the use of flaps and grafts has all been proposed. Different materials (e.g., vaginal and genital mucosal graft or flap, bladder mucosal flap, and oral mucosal graft) have been reported for augmentation urethroplasty.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female undergoing urethroplasty', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients with urethral stricture.\n* Female patients with non-traumatic urethral stricture.\n\nExclusion Criteria:\n\n* Female patients with traumatic urethral stricture.\n* Female patients with systemic contraindications of surgery like bleeding disorders.'}, 'identificationModule': {'nctId': 'NCT07153861', 'briefTitle': 'Oral Mucosal Graft Versus Labial Graft in Female Urethroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Oral Mucosal Graft Versus Labial Graft in Female Urethroplasty: A Prospective Comparative Study', 'orgStudyIdInfo': {'id': '36264PR1113/2/25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Patients will be admitted for the surgical management by the oral mucosal graft urethroplasty with the anterior onlay technique.', 'interventionNames': ['Procedure: Oral mucosal graft']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Patients will be admitted for the surgical management by the labial graft urethroplasty with the anterior onlay technique.', 'interventionNames': ['Procedure: Labial graft']}], 'interventions': [{'name': 'Oral mucosal graft', 'type': 'PROCEDURE', 'description': 'Patients will be admitted for the surgical management by the oral mucosal graft urethroplasty with the anterior onlay technique.', 'armGroupLabels': ['Group 1']}, {'name': 'Labial graft', 'type': 'PROCEDURE', 'description': 'Patients will be admitted for the surgical management by the labial graft urethroplasty with the anterior onlay technique.', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed I Elmaadawy, MD', 'role': 'CONTACT', 'email': 'Mohamed.elmaadawy@med.tanta.edu.eg', 'phone': '00201060245430'}], 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Elmaadawy I Elmaadawy, MD', 'role': 'CONTACT', 'email': 'Mohamed.elmaadawy@med.tanta.edu.eg', 'phone': '00201060245430'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Urology, Faculty of Medicine, Tanta University, Tanta, Egypt.', 'investigatorFullName': 'Mohamed Ibrahim Ahmed Elmaadawy', 'investigatorAffiliation': 'Tanta University'}}}}