Comparative Analysis of Bipolar Enucleation of the Prostate Using Different Commercial Types of Electrodes

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.

NCT Number	NCT07020325
Lead Sponsor	Menoufia University
Conditions	Bipolar Enucleation of the Prostate
Enrollment	100 participants
Start Date	2025-07-01
Primary Completion	2026-02-10 (estimated)
Study Completion	2026-03-10 (estimated)
Updated on ClinicalTrials.gov	2025-06-13