Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:23 PM
Study NCT ID:
NCT06056856
Status:
UNKNOWN
Last Update Posted:
2023-09-28
First Post:
2023-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anatomical and Functional Outcome of PSG Vs BMG for Urethral Substitution in Long Segment Anterior Urethral Strictures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014525', 'term': 'Urethral Stricture'}], 'ancestors': [{'id': 'D014524', 'term': 'Urethral Obstruction'}, {'id': 'D014522', 'term': 'Urethral Diseases'}, {'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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-30', 'size': 371771, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-09-23T07:33', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-arm parallel assignment. The first arm will be operated using penile skin grafts, The second arm will be operated using buccal mucosal grafts.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-26', 'studyFirstSubmitDate': '2023-08-11', 'studyFirstSubmitQcDate': '2023-09-26', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The degree of urethral lumen patency.', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'Patent urethra as evidenced by uroflowmetry and retrograde urethrography +/- urethroscopy'}], 'secondaryOutcomes': [{'measure': 'Lower urinary tract symptoms improvement', 'timeFrame': '6 months', 'description': 'lower urinary tract symptoms as assessed by the international prostate symptom score, ranging from 0 to 35, where scores from 0-7 are mild, from 8-19 are moderate, from 20-35 are severe symptoms.'}, {'measure': 'Erectile function assessment', 'timeFrame': '6 months', 'description': 'sexual function as assessed by the international index of erectile function-5 questionnaire, ranging from 5-25, where 22-25 is normal, 17-21 is mild ED, 12-16 is mild to moderate ED, 8-11 is moderate ED, and 5-7 is severe ED.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['urethral stricture', 'urethroplasty', 'BMG', 'PSG', 'penile skin'], 'conditions': ['Anterior Urethral Stricture, Male']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the penile skin graft and buccal mucosal graft for substitution of long anterior urethral strictures using one-sided dorsal perineal approach.', 'detailedDescription': 'Since previous studies were:\n\n* Retrospective and very few were prospective randomized studies\n* Some studies were done on lichen sclerosis cases that have an adverse effect on the PSG outcome.\n* The follow-up duration was longer for PSG patients.\n* Stricture length was usually longer for PSG cases.\n\nThis study aims to compare the PSG and BMG for substitution of long anterior urethral strictures using one-sided dorsal perineal approach.\n\nThe investigators hypothesize that:\n\n❶ Conducting a well-designed prospective, randomized study can help identify which technique is better than the other.\n\n❷ Using the one-side dorsal approach can improve the outcomes of both techniques and identify their advantages and disadvantages.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study will include patients with long segment anterior urethral stricture (\\>2 cm).\n\nExclusion Criteria:\n\n* Urethro-cutaneous fistula, urethral abscess or diverticulum.\n* A scarred and unsalvageable urethral plate or scarred perineum.\n* Lichen sclerosis (Balanitis xerotica obliterans).\n* Unhealthy/unavailable buccal mucosa.'}, 'identificationModule': {'nctId': 'NCT06056856', 'briefTitle': 'Anatomical and Functional Outcome of PSG Vs BMG for Urethral Substitution in Long Segment Anterior Urethral Strictures', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Anatomical and Functional Outcome of Penile Skin Graft Versus Buccal Mucosal Graft for Urethral Substitution in Long Segment Anterior Urethral Strictures', 'orgStudyIdInfo': {'id': '773'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PSG group', 'description': 'The group of patients who will undergo penile skin graft substitituion of long anterior urethral stricture', 'interventionNames': ['Procedure: Penile skin graft substituttion urethroplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BMG group', 'description': 'The group of patients who will undergo buccal mucosal graft substitituion of long anterior urethral stricture', 'interventionNames': ['Procedure: Buccal Mucosal Graft substitution urethroplasty']}], 'interventions': [{'name': 'Penile skin graft substituttion urethroplasty', 'type': 'PROCEDURE', 'description': 'substitution of long anterior urethral strictures using one-sided dorsal perineal approach', 'armGroupLabels': ['PSG group']}, {'name': 'Buccal Mucosal Graft substitution urethroplasty', 'type': 'PROCEDURE', 'description': 'substitution of long anterior urethral strictures using one-sided dorsal perineal approach', 'armGroupLabels': ['BMG group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11511', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Malakah Mohamed, secretary', 'role': 'CONTACT', 'email': 'urologydepartment@azhar.edu.eg', 'phone': '+20225107222'}, {'name': 'Samah Adel, secretary', 'role': 'CONTACT', 'phone': '00201007561116'}], 'facility': 'Al-Azhar urology department, Al-Azhar university hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mohamed Anwar, A. lecturer', 'role': 'CONTACT', 'email': 'm0anwar2005@gmail.com', 'phone': '00201155678282'}, {'name': 'Ahmed Alrefaey, lecturer', 'role': 'CONTACT', 'email': 'urologydepartment@azhar.edu.eg', 'phone': '00201149394121'}], 'overallOfficials': [{'name': 'Ahmed Fahim, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Urology department, Al-Azhar university, Cairo, Egypt'}, {'name': 'Mostafa Ezzeldein, professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Urology department, Al-Azhar university, Cairo, Egypt'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'The data will be available after 1 year, and for 2 years.', 'ipdSharing': 'YES', 'description': "Patients' data sheet, patient consent forms through my E-mail: m0anwar2005@gmail.com", 'accessCriteria': 'My e-mail: m0anwar2005@gmail.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Mohamed Ahmed Anwar', 'investigatorAffiliation': 'Al-Azhar University'}}}}