Comparative Analysis of Bipolar Enucleation of the Prostate Using Different Commercial Types of Electrodes
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bipolar Enucleation of the Prostate, Bipolar electrode From Wolf company, Bipolar electrode From Storz company, Bipolar electrode From Olympus company.
- Who it may be relevant to
- Registry conditions: Bipolar Enucleation of the Prostate. Basic parameters: from 50 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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: Which bipolar electrode provides the most effective enucleation? What are the safety and postoperative outcomes of different bipolar electrodes? What are the intraoperative and postoperative complication rates for each electrode type? How does the learning curve differ among different electrode types? What is the cost-effectiveness of each electrode? Researchers 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. Participants will: Undergo bipolar enucleation of the prostate performed by experienced surgeons. Be randomized into one of four groups based on the electrode used. Follow a standardized surgical technique across all centres. Be monitored for intraoperative and postoperative outcomes over a 6-month follow-up period. Data collection and analysis will be conducted by blinded investigators to ensure unbiased results.
Interventions
- 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 - 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. - Device Bipolar electrode From Storz 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. - Device Bipolar electrode From Olympus 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. - Device Bipolar electrode From Lamidey 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.
Primary outcome measures
- Enucleation Efficiency (g/min) of Different Bipolar Electrodes [Time frame: Time Frame: Intraoperative]
Secondary outcome measures (6)
- Perioperative Safety: Incidence of Adverse Events (Clavien-Dindo Classification) [Time frame: Time Frame: Intraoperative and up to 30 days postoperative]
- Change in International Prostate Symptom Score (IPSS) [Time frame: Time Frame: Preoperative baseline, and at 6 weeks, 3 months, and 6 months postoperative]
- Change in Maximum Flow Rate (Qmax) [Time frame: Time Frame: Preoperative baseline, 6 weeks, 3 months, and 6 months postoperative]
- Change in Post-Void Residual Volume (PVR) [Time frame: Time Frame: Preoperative baseline, 6 weeks, 3 months, and 6 months postoperative]
- Learning Curve Assessment Based on Enucleation Time Over Consecutive Cases [Time frame: During 12-month recruitment/study period]
- Cost-Effectiveness: Total Procedure and Postoperative Cost per Patient [Time frame: Time Frame: From procedure day to end of 6-month follow-up]
Eligibility criteria
Inclusion criteria
- Age ≥50 years
- Diagnosed with moderate to severe LUTS due to BPH.
- Prostate size ≥40 g based on transrectal ultrasound (TRUS) or MRI.
- Ability to provide informed consent.
Exclusion criteria
- Prostate cancer.
- Urethral stricture disease.
- Patients with severe cardiac comorbidities or bleeding disorders.
- Patients on anticoagulation therapy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07020325 · 2/2025 Urol