Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2026-01-01 @ 12:20 PM
Study NCT ID:
NCT06922968
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-11
First Post:
2025-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-Time (TRUS) Guidance in Endoscopic Treatment of BPH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 114}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2025-03-17', 'studyFirstSubmitQcDate': '2025-04-09', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'efficacy of endoscopic treatment of BPH', 'timeFrame': 'At 12 weeks after the procedure', 'description': 'Intervention efficacy will be evaluated by comparing the Peak flow rate in ml/second.(measured by uroflowmetry) between the two groups'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['BPH (Benign Prostatic Hyperplasia)']}, 'descriptionModule': {'briefSummary': 'The study aims to evaluate the role of TRUS in improving the efficacy and safety of endoscopic enucleation of prostate and TURP.', 'detailedDescription': 'Standard TURP is an established procedure for managing BPH but has limitations, including the risk of incomplete adenoma removal and complications such as bleeding. Research on transurethral enucleation techniques has demonstrated potential for improved outcomes, especially in larger prostates. However, challenges persist in achieving precise resection boundaries and minimizing intraoperative risks.\n\nTRUS, widely utilized for prostate biopsy and volume assessment, has recently gained attention for its intraoperative applications. Studies show that real-time TRUS provides accurate imaging of prostate anatomy and resection planes, helping surgeons better differentiate adenomatous tissue from surrounding structures. This enhances surgical precision, reduces intraoperative bleeding, and minimizes residual tissue, leading to better outcomes in procedures like TURP and enucleation.\n\nCurrent TURP and enucleation approaches depend heavily on endoscopic visual guidance, which, despite significant advancements, can lead to residual tissue, excessive bleeding, and prolonged recovery. While enucleation techniques have addressed some of these challenges, they remain less accessible due to high costs and steep learning curves, making them unsuitable for all healthcare settings.\n\nIntegrating TRUS into TURP or enucleation offers the potential to address these limitations by enhancing tissue differentiation and guiding precise resection. This study aims to evaluate the efficacy of TRUS in reducing complications, achieving complete tissue removal, and improving patient recovery outcomes, potentially paving the way for its routine adoption in BPH surgery.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male patients aged 50-80 years\n* Diagnosed with benign prostatic hyperplasia (BPH) and scheduled for TURP or prostatic adenoma enucleation.\n* The patients have clear indication for endoscopic surgery (according to the guidelines).\n* Clinically fit patients for surgery.\n* Signed an informed consent.\n\nExclusion Criteria:\n\n* • Prostate cancer\n\n * Previous urethral or prostate surgery\n * Neurogenic bladder\n * Urethral stricture'}, 'identificationModule': {'nctId': 'NCT06922968', 'briefTitle': 'Real-Time (TRUS) Guidance in Endoscopic Treatment of BPH', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Standard Versus Transrectal Ultrasound (TRUS)-Guided Endoscopic Treatment of Benign Prostatic Hyperplasia: A Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'TRUS with TURP and enucleation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control group', 'description': 'Control cases under went TURP and enucleation', 'interventionNames': ['Procedure: Standard TURP and enucleation']}, {'type': 'EXPERIMENTAL', 'label': 'TRUS Guided group', 'description': 'TRUS guided group during TURP and enucleation', 'interventionNames': ['Procedure: TRUS-Guided TURP and enucleation']}], 'interventions': [{'name': 'TRUS-Guided TURP and enucleation', 'type': 'PROCEDURE', 'description': 'realtime TRUS guidance during the procedure (TURP and enucleation)', 'armGroupLabels': ['TRUS Guided group']}, {'name': 'Standard TURP and enucleation', 'type': 'PROCEDURE', 'description': 'No TRUS guidance during the procedure (TURP and enucleation)', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Mohamed mostafa Elsharkawy, assistant lecturer of Urology', 'role': 'CONTACT', 'email': 'mhmdsharkawy@aun.edu.eg', 'phone': '+201065811880'}, {'name': 'Mahmoud Farouk Hassan, lecturer Of Urology', 'role': 'CONTACT', 'email': 'Mahmoud12@aun.edu.eg', 'phone': '+201009152070'}], 'overallOfficials': [{'name': 'Ahmed Mohamed Abdel-Moniem Hassanein, professor of Urology', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'to put protect privacy of participants'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohamed ElSharkawy', 'investigatorAffiliation': 'Assiut University'}}}}