NCT07020325

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Menoufia University · Academic / Other
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Bipolar Enucleation of the Prostate

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-02-10
• Completion: 2026-03-10
• First posted: 2025-06-13
• Last updated: 2025-06-13