Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-24 @ 4:18 PM
Study NCT ID:
NCT06758466
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-03
First Post:
2024-12-27
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bipolar TURP Versus Bipolar Enucleation for BPH Management
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': 180}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2028-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-02', 'studyFirstSubmitDate': '2024-12-27', 'studyFirstSubmitQcDate': '2025-01-02', 'lastUpdatePostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'International Prostate Symptom Score (IPSS)', 'timeFrame': '12 months'}, {'measure': 'Qmax', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'PVR', 'timeFrame': '12 months'}, {'measure': 'Complications', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BPH - Bipolar- TURP - Enucleation'], 'conditions': ['Benign Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'To compare the surgical outcomes at 12 months post-surgery between Bipolar TURP and BipoLEP in men with BPH and prostate volumes between 30-80 grams.', 'detailedDescription': "Create a research protocol in a prospective study to compare bipolar transurethral resection of prostate vs bipolar enucleation of prostate between 30 and 80 gm in management of BPH\n\nOkay, here's a detailed research protocol for a prospective study comparing Bipolar Transurethral Resection of the Prostate (TURP) and Bipolar Enucleation of the Prostate (BipoLEP) for BPH, specifically focusing on prostates between 30-80 grams:\n\nStudy Title: A Prospective Randomized Controlled Trial Comparing Bipolar TURP and Bipolar Enucleation of the Prostate for Benign Prostatic Hyperplasia (BPH) with Prostate Volumes between 30-80 grams\n\n1\\. Introduction\n\nBackground: Briefly introduce Benign Prostatic Hyperplasia (BPH), its prevalence, and the associated lower urinary tract symptoms (LUTS). Highlight the common surgical interventions: TURP and, more recently, enucleation techniques.\n\nProblem Statement: State that while both bipolar TURP and BipoLEP are established treatments, there's a need for a direct comparison, especially for moderate-sized prostates (30-80g). There's an ongoing debate regarding which approach offers superior outcomes and a better balance of efficacy and safety.\n\nRationale: Explain why this study is necessary. This can be because there is limited direct\n\nPrimary Objective: To compare the International Prostate Symptom Score (IPSS) at 12 months post-surgery between Bipolar TURP and BipoLEP in men with BPH and prostate volumes between 30-80 grams.\n\nSecondary Objectives:\n\nTo compare perioperative outcomes including:\n\nOperative time (minutes)\n\nCatheterization time (days)\n\nLength of hospital stay (days)\n\nBlood loss (change in hemoglobin)\n\nRequirement of blood transfusion\n\nIncidence of perioperative complications (e.g., TUR syndrome, bleeding, infection, clot retention)\n\nTo compare postoperative functional outcomes including:\n\nPeak urinary flow rate (Qmax) at 3, 6, and 12 months\n\nPost-void residual (PVR) volume at 3, 6, and 12 months\n\nQuality of life (QoL) using a validated questionnaire at 3, 6, and 12 months\n\nTo compare the incidence of postoperative complications including:\n\nUrinary tract infection (UTI)\n\nUrinary incontinence (UI)\n\nUrethral stricture\n\nBladder neck contracture\n\nNeed for re-operation within 12 months.\n\nTo compare overall patient satisfaction using a visual analog scale (VAS) at 3, 6, and 12 months"}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'genderBased': True, 'genderDescription': 'BPH', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male patients aged 45-80 years diagnosed with symptomatic BPH.\n* Prostate volume between 30-80 grams as determined by transrectal ultrasound (TRUS) performed within 4 weeks before randomization.\n* Moderate to severe LUTS with an IPSS of ≥ 8.\n* Failure of medical management.\n* Patients able to provide written informed consent.\n\nExclusion Criteria:\n\n* History of prostate cancer.\n* History of previous prostate surgery (including any procedure for BPH or prostate cancer).\n* History of urethral stricture or bladder neck contracture.\n* Neurogenic bladder dysfunction.\n* Significant coagulopathy.\n* Uncontrolled urinary tract infection.\n* Patient on anticoagulant medication.'}, 'identificationModule': {'nctId': 'NCT06758466', 'briefTitle': 'Bipolar TURP Versus Bipolar Enucleation for BPH Management', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'A Prospective Randomized Controlled Trial Comparing Bipolar TURP and Bipolar Enucleation of the Prostate for Benign Prostatic Hyperplasia (BPH) With Prostate Volumes Between 30-80 Grams', 'orgStudyIdInfo': {'id': 'Kasr Alainy- Cairo University'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bipolar enucleation', 'interventionNames': ['Procedure: Prostate surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bipolar resection', 'interventionNames': ['Procedure: Prostate surgery']}], 'interventions': [{'name': 'Prostate surgery', 'type': 'PROCEDURE', 'description': 'Prostate removal', 'armGroupLabels': ['Bipolar enucleation', 'Bipolar resection']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Samer Morsy', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}