[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594506":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":37,"studyPopulation":37,"armGroups":48,"interventions":69,"overallOfficials":37,"centralContacts":37,"locations":37,"responsibleParty":89,"collaborators":37,"id":93,"slug":37,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":37,"eligibilityCriteria":97,"healthyVolunteers":94,"sex":98,"minAge":99,"maxAge":37,"enrollmentInfo":100,"targetDuration":37,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":37,"overallStatus":108,"whyStopped":37,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":37},{"fullName":5,"class":6},"Menoufia University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"Enucleation Efficiency (g\u002Fmin) of Different Bipolar Electrodes","Enucleation efficiency will be calculated by dividing the enucleated tissue weight (grams) by the total enucleation time (minutes), providing a g\u002Fmin value. This metric reflects the technical efficacy of the bipolar enucleation electrode in prostate tissue removal. Data will be compared across the four bipolar systems used in the study.","Time Frame: Intraoperative",[14,18,22,26,29,33],{"measure":15,"description":16,"timeFrame":17},"Perioperative Safety: Incidence of Adverse Events (Clavien-Dindo Classification)","Complications will be recorded and graded according to the Clavien-Dindo classification system. Events include, but are not limited to, bleeding requiring transfusion, urinary retention, infection, bladder injury, and incontinence. The frequency and severity of complications will be analyzed and compared between devices.\n\nUnit of Measure: Number of adverse events per Clavien-Dindo grade.","Time Frame: Intraoperative and up to 30 days postoperative",{"measure":19,"description":20,"timeFrame":21},"Change in International Prostate Symptom Score (IPSS)","Description: Change from baseline in patient-reported urinary symptoms as measured by the International Prostate Symptom Score (IPSS) to evaluate symptom improvement after bipolar enucleation.\n\nUnit of Measure: IPSS score (0-35)","Time Frame: Preoperative baseline, and at 6 weeks, 3 months, and 6 months postoperative",{"measure":23,"description":24,"timeFrame":25},"Change in Maximum Flow Rate (Qmax)","Description: Change from baseline in maximum urinary flow rate to assess improvement in urinary flow after bipolar enucleation.\n\nUnit of Measure: mL\u002Fsecond","Time Frame: Preoperative baseline, 6 weeks, 3 months, and 6 months postoperative",{"measure":27,"description":28,"timeFrame":25},"Change in Post-Void Residual Volume (PVR)","Description: Change from baseline in post-void residual urine volume to evaluate bladder emptying efficiency after bipolar enucleation.\n\nUnit of Measure: milliliters (mL)",{"measure":30,"description":31,"timeFrame":32},"Learning Curve Assessment Based on Enucleation Time Over Consecutive Cases","Surgeon learning curve will be assessed by measuring enucleation time (in minutes) across consecutive cases for each bipolar system. The trend in time reduction will be analyzed to evaluate the learning trajectory.\n\nUnit of Measure: Enucleation time in minutes per case","During 12-month recruitment\u002Fstudy period",{"measure":34,"description":35,"timeFrame":36},"Cost-Effectiveness: Total Procedure and Postoperative Cost per Patient","Total cost per patient will be calculated by summing surgical device costs, operating room time, length of hospital stay, and postoperative care costs (including catheter duration, readmissions, and complication-related expenses).\n\nUnit of Measure: Cost in local currency (e.g., Euros or USD)","Time Frame: From procedure day to end of 6-month follow-up",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":41,"primaryPurpose":42,"observationalModel":37,"timePerspective":37,"maskingInfo":43},"RANDOMIZED","PARALLEL","This study follows a parallel design, where participants are randomly assigned to one of four intervention groups. Each group receives treatment with a specific type of commercial bipolar electrode. The study aims to assess differences in efficacy, safety, learning curve, and cost-effectiveness across the four electrode types. The surgical technique is standardized across all centers to minimize variability, and data collection is blinded to ensure objective analysis.","TREATMENT",{"masking":44,"maskingDescription":45,"whoMasked":46},"SINGLE","Data collection and analysis will be conducted by blinded investigators to minimize bias. While surgeons performing the procedures will be aware of the electrode type used, the outcomes assessors evaluating postoperative results will remain blinded to ensure objective assessment of efficacy, safety, complications, and cost-effectiveness.",[47],"OUTCOMES_ASSESSOR",[49,56,61,65],{"label":50,"type":51,"description":52,"interventionNames":53},"Bipolar Enucleation Using Electrode A (Company X)","EXPERIMENTAL","Participants will undergo prostate enucleation using Electrode A for BPH treatment.",[54,55],"Procedure: Bipolar Enucleation of the Prostate","Device: Bipolar electrode From Wolf company",{"label":57,"type":51,"description":58,"interventionNames":59},"Bipolar Enucleation Using Electrode B (Company Y)","Participants will undergo prostate enucleation using Electrode B for BPH treatment.",[54,60],"Device: Bipolar electrode From Storz company",{"label":62,"type":51,"description":62,"interventionNames":63},"Bipolar Enucleation Using Electrode C (Company W)",[54,64],"Device: Bipolar electrode From Olympus company",{"label":66,"type":51,"description":66,"interventionNames":67},"Bipolar Enucleation Using Electrode D (Company Z)",[54,68],"Device: Bipolar electrode From Lamidey company",[70,75,80,83,86],{"type":71,"name":72,"description":73,"armGroupLabels":74,"otherNames":37},"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",[50,57,62,66],{"type":76,"name":77,"description":78,"armGroupLabels":79,"otherNames":37},"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.",[50],{"type":76,"name":81,"description":78,"armGroupLabels":82,"otherNames":37},"Bipolar electrode From Storz company",[57],{"type":76,"name":84,"description":78,"armGroupLabels":85,"otherNames":37},"Bipolar electrode From Olympus company",[62],{"type":76,"name":87,"description":78,"armGroupLabels":88,"otherNames":37},"Bipolar electrode From Lamidey company",[66],{"type":90,"investigatorFullName":91,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"PRINCIPAL_INVESTIGATOR","Mohamed Kamal Omar","Clinical Professor of Urology in Menoufia University","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":101,"type":102},100,"ESTIMATED","INTERVENTIONAL",[105],"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.",[72],"NOT_YET_RECRUITING","2025-06-04",{"date":111,"type":112},"2025-06-13","ACTUAL",{"date":114,"type":102},"2025-07-01",{"date":116,"type":102},"2026-03-10",{"name":5,"class":6}]