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

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

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.

Sponsors & Collaborators

• Menoufia University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-01

Primary Completion

2026-02-10

Completion

2026-03-10