[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594506":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":34,"centralContacts":34,"locations":34,"responsibleParty":49,"collaborators":34,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":34,"eligibilityCriteria":58,"healthyVolunteers":55,"sex":59,"minAge":60,"maxAge":34,"enrollmentInfo":61,"targetDuration":34,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":34,"overallStatus":69,"whyStopped":34,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":34},{"fullName":5,"class":6},"Menoufia University","OTHER",[8,15,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Bipolar Enucleation Using Electrode A (Company X)","EXPERIMENTAL","Participants will undergo prostate enucleation using Electrode A for BPH treatment.",[13,14],"Procedure: Bipolar Enucleation of the Prostate","Device: Bipolar electrode From Wolf company",{"label":16,"type":10,"description":17,"interventionNames":18},"Bipolar Enucleation Using Electrode B (Company Y)","Participants will undergo prostate enucleation using Electrode B for BPH treatment.",[13,19],"Device: Bipolar electrode From Storz company",{"label":21,"type":10,"description":21,"interventionNames":22},"Bipolar Enucleation Using Electrode C (Company W)",[13,23],"Device: Bipolar electrode From Olympus company",{"label":25,"type":10,"description":25,"interventionNames":26},"Bipolar Enucleation Using Electrode D (Company Z)",[13,27],"Device: Bipolar electrode From Lamidey company",[29,35,40,43,46],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"PROCEDURE","Bipolar Enucleation of the Prostate","Bipolar enucleation of the prostate involves the removal of prostate tissue using a bipolar electrode. This procedure is performed for patients with benign prostatic hyperplasia (BPH), with different electrode types used for comparison in this study",[9,16,21,25],null,{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":34},"DEVICE","Bipolar electrode From Wolf company","This study involves bipolar transurethral resection of the prostate (TURP) using four different bipolar electrosurgical systems, each provided by a distinct manufacturer. The aim is to evaluate and compare the efficacy, safety, and clinical outcomes associated with each system.",[9],{"type":36,"name":41,"description":38,"armGroupLabels":42,"otherNames":34},"Bipolar electrode From Storz company",[16],{"type":36,"name":44,"description":38,"armGroupLabels":45,"otherNames":34},"Bipolar electrode From Olympus company",[21],{"type":36,"name":47,"description":38,"armGroupLabels":48,"otherNames":34},"Bipolar electrode From Lamidey company",[25],{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Mohamed Kamal Omar","Clinical Professor of Urology in Menoufia University","100594506","comparative-analysis-of-bipolar-enucleation-of-the-prostate-using-different-commercial-types-of-electrodes-100594506",false,"NCT07020325","Comparative Analysis of Bipolar Enucleation of the Prostate Using Different Commercial Types of Electrodes","Inclusion Criteria:\n\n* Age ≥50 years\n* Diagnosed with moderate to severe LUTS due to BPH.\n* Prostate size ≥40 g based on transrectal ultrasound (TRUS) or MRI.\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Prostate cancer.\n* Urethral stricture disease.\n* Patients with severe cardiac comorbidities or bleeding disorders.\n* Patients on anticoagulation therapy.","MALE","50 Years",{"count":62,"type":63},100,"ESTIMATED","INTERVENTIONAL",[66],"NA","The goal of this randomized, prospective, multicenter clinical trial is to compare the enucleation efficacy of prostate enucleation using different commercial bipolar electrodes in male patients aged ≥50 years diagnosed with benign prostatic hyperplasia (BPH). The main questions it aims to answer are:\n\nWhich bipolar electrode provides the most effective enucleation?\n\nWhat are the safety and postoperative outcomes of different bipolar electrodes?\n\nWhat are the intraoperative and postoperative complication rates for each electrode type?\n\nHow does the learning curve differ among different electrode types?\n\nWhat is the cost-effectiveness of each electrode?\n\nResearchers will compare four groups, each assigned a different commercial bipolar electrode (Electrode A, B, C, or D), to determine differences in efficacy, safety, and cost-effectiveness.\n\nParticipants will:\n\nUndergo bipolar enucleation of the prostate performed by experienced surgeons.\n\nBe randomized into one of four groups based on the electrode used.\n\nFollow a standardized surgical technique across all centres.\n\nBe monitored for intraoperative and postoperative outcomes over a 6-month follow-up period.\n\nData collection and analysis will be conducted by blinded investigators to ensure unbiased results.",[31],"NOT_YET_RECRUITING","2025-06-04",{"date":72,"type":73},"2025-06-13","ACTUAL",{"date":75,"type":63},"2025-07-01",{"date":77,"type":63},"2026-03-10",{"name":5,"class":6}]