Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-05 @ 9:04 PM
Study NCT ID:
NCT06759194
Status:
RECRUITING
Last Update Posted:
2025-07-24
First Post:
2024-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HoLEP vs BipolEP in Management of BPH Patients With Large Prostates
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': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 98}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2024-12-30', 'studyFirstSubmitQcDate': '2025-01-03', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in peak flow rate', 'timeFrame': 'At 6 months after the procedure (HoLEP or BipolEP)', 'description': 'Treatment efficacy will be evaluated by comparing the change in peak flow rate (Qmax) on uroflowmetry between the two groups'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': 'At 6 months after the procedure (HoLEP or BipolEP)', 'description': 'Treatment safety will be evaluated by collecting and analyzing any reported complication within the first 6 postoperative months. Complications will be reported using the modified Clavien-Dindo classification system.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Holmium Laser Enucleation of Prostate (HoLEP)', 'Benign Prostatic Hyperplasia (BPH)', 'Bipolar Enucleation of Prostate (BipolEP)'], 'conditions': ['Benign Prostatic Hyperplasia']}, 'referencesModule': {'references': [{'pmid': '29730838', 'type': 'BACKGROUND', 'citation': 'Becker B, Herrmann TRW, Gross AJ, Netsch C. Thulium vapoenucleation of the prostate versus holmium laser enucleation of the prostate for the treatment of large volume prostates: preliminary 6-month safety and efficacy results of a prospective randomized trial. World J Urol. 2018 Oct;36(10):1663-1671. doi: 10.1007/s00345-018-2321-8. Epub 2018 May 5.'}, {'pmid': '12100945', 'type': 'BACKGROUND', 'citation': 'Tan AH, Gilling PJ. Holmium laser prostatectomy: current techniques. Urology. 2002 Jul;60(1):152-6. doi: 10.1016/s0090-4295(02)01648-5.'}, {'pmid': '17095078', 'type': 'BACKGROUND', 'citation': 'Neill MG, Gilling PJ, Kennett KM, Frampton CM, Westenberg AM, Fraundorfer MR, Wilson LC. Randomized trial comparing holmium laser enucleation of prostate with plasmakinetic enucleation of prostate for treatment of benign prostatic hyperplasia. Urology. 2006 Nov;68(5):1020-4. doi: 10.1016/j.urology.2006.06.021. Epub 2006 Nov 7.'}, {'pmid': '37667842', 'type': 'BACKGROUND', 'citation': 'Shoma AM, Ghobrial FK, El-Tabey N, El-Hefnawy AS, El-Kappany HA. A randomized trial of holmium laser vs thulium laser vs bipolar enucleation of large prostate glands. BJU Int. 2023 Dec;132(6):686-695. doi: 10.1111/bju.16174. Epub 2023 Sep 28.'}]}, 'descriptionModule': {'briefSummary': 'This is a non-inferiority prospective randomized comparative clinical trial aiming to prove the non-inferiority of bipolar enucleation of the prostate in comparison to holmium laser enucleation of the prostate in management of benign prostatic hyperplasia patients with large prostates and in turn its feasibility as an alternative procedure in hospitals with limited resources', 'detailedDescription': 'Benign prostatic hyperplasia (BPH) is a prevalent condition among older men. It is characterized by non-cancerous enlargement of the prostate gland often leading to urinary obstruction and significant morbidity. In case of failure of medical treatment, surgical intervention is often required especially in patients with larger prostates. Surgical options in such cases include Holmium Laser Enucleation of the Prostate (HoLEP) and Bipolar Enucleation of the Prostate (BipolEP). These modalities have emerged as promising relatively minimally invasive treatment options in patients with large prostates. HoLEP, utilizing laser technology to enucleate prostatic tissue, has been associated with reduced intraoperative blood loss, shorter catheterization time, and quicker recovery in comparison to open prostatectomy. Likewise, BipolEP, utilizing bipolar energy for enucleation, offers the advantage of reduced bleeding and shorter operative time. Both HoLEP and BipolEP have demonstrated efficacy in improving lower urinary tract symptoms (LUTS) and alleviating obstruction in BPH patients with large prostates, but the comparative efficacy and safety of both techniques remains highly debated. This study aims to compare the efficacy and safety of these two surgical modalities aiming to provide valuable insights that can enhance clinical decision-making and patient care in BPH management.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>50 years\n* Prostate volume \\>80 ml\n* Failure of or noncompliance with medical treatment\n* IPSS \\>15\n* Qmax \\<15 ml/sec\n* Urinary retention and fixed catheters with poor results on trial of voiding without catheter\n\nExclusion Criteria:\n\n* Patients with active UTI\n* Prostate cancer\n* Bladder carcinoma\n* Urethral stricture\n* Neurogenic bladder disorders\n* Redo cases'}, 'identificationModule': {'nctId': 'NCT06759194', 'briefTitle': 'HoLEP vs BipolEP in Management of BPH Patients With Large Prostates', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Holmium Laser Versus Bipolar Enucleation of the Prostate in Management of Benign Prostatic Hyperplasia Patients With Large Prostates: A Non-inferiority Prospective Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'HoLEP vs BipolEP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Holmium Laser Enucleation of the Prostate (HoLEP)', 'description': 'Half of the BPH patients with large prostate admitted to the study will undergo Holmium Laser Enucleation of the Prostate (HoLEP)', 'interventionNames': ['Procedure: Holmium Laser Enucleation of the Prostate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bipolar Enucleation of the Prostate (BipolEP)', 'description': 'Half of the BPH patients with large prostate admitted to the study will undergo Bipolar Enucleation of the Prostate (BipolEP)', 'interventionNames': ['Procedure: Bipolar Enucleation of the Prostate']}], 'interventions': [{'name': 'Holmium Laser Enucleation of the Prostate', 'type': 'PROCEDURE', 'description': 'Enucleation of the prostate gland using holmium laser energy', 'armGroupLabels': ['Holmium Laser Enucleation of the Prostate (HoLEP)']}, {'name': 'Bipolar Enucleation of the Prostate', 'type': 'PROCEDURE', 'description': 'Enucleation of the prostate gland using bipolar energy', 'armGroupLabels': ['Bipolar Enucleation of the Prostate (BipolEP)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mostafa M Mostafa, M.D., M.Sc. Urology, Ph.D. Uro', 'role': 'CONTACT', 'email': 'mostafaabdelaziz91@gmail.com', 'phone': '1000740478', 'phoneExt': '20'}], 'facility': 'Assiut University Urology Hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Mostafa M. Mostafa, M.D.', 'role': 'CONTACT', 'email': 'mostafaabdelaziz91@gmail.com', 'phone': '+201000740478'}, {'name': 'Mohammad A. Abd ElMoneim, M.D.', 'role': 'CONTACT', 'email': 'mohamed.20134296@med.aun.edu.eg', 'phone': '+201028511082'}], 'overallOfficials': [{'name': 'Mostafa M. Mostafa, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be made available to protect privacy of patients'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Urology', 'investigatorFullName': 'Mostafa Mohamed Atef Abdelaziz Mostafa', 'investigatorAffiliation': 'Assiut University'}}}}