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

NCT07020325 | Not Yet Recruiting DMC

• 1 other identifier: 2/2025 Urol
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Enucleation Efficiency (g/min) 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/min 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

Secondary Outcomes (6)

• Perioperative Safety: Incidence of Adverse Events (Clavien-Dindo Classification)

  Time Frame: Intraoperative and up to 30 days postoperative

• Change in International Prostate Symptom Score (IPSS)

  Time Frame: Preoperative baseline, and at 6 weeks, 3 months, and 6 months postoperative

• Change in Maximum Flow Rate (Qmax)

  Time Frame: Preoperative baseline, 6 weeks, 3 months, and 6 months postoperative

• Change in Post-Void Residual Volume (PVR)

  Time Frame: Preoperative baseline, 6 weeks, 3 months, and 6 months postoperative

• Learning Curve Assessment Based on Enucleation Time Over Consecutive Cases

  During 12-month recruitment/study period

Study Arms (4)

Bipolar Enucleation Using Electrode A (Company X)

EXPERIMENTAL

Participants will undergo prostate enucleation using Electrode A for BPH treatment.

Procedure: Bipolar Enucleation of the Prostate; Device: Bipolar electrode From Wolf company

Bipolar Enucleation Using Electrode B (Company Y)

EXPERIMENTAL

Participants will undergo prostate enucleation using Electrode B for BPH treatment.

Procedure: Bipolar Enucleation of the Prostate; Device: Bipolar electrode From Storz company

Bipolar Enucleation Using Electrode C (Company W)

EXPERIMENTAL

Bipolar Enucleation Using Electrode C (Company W)

Procedure: Bipolar Enucleation of the Prostate; Device: Bipolar electrode From Olympus company

Bipolar Enucleation Using Electrode D (Company Z)

EXPERIMENTAL

Bipolar Enucleation Using Electrode D (Company Z)

Procedure: Bipolar Enucleation of the Prostate; Device: Bipolar electrode From Lamidey company

Interventions

Bipolar Enucleation of the Prostate PROCEDURE

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

Bipolar Enucleation Using Electrode A (Company X); Bipolar Enucleation Using Electrode B (Company Y); Bipolar Enucleation Using Electrode C (Company W); Bipolar Enucleation Using Electrode D (Company Z)

Bipolar electrode From Wolf company DEVICE

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.

Bipolar Enucleation Using Electrode A (Company X)

Bipolar electrode From Storz company DEVICE

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.

Bipolar Enucleation Using Electrode B (Company Y)

Bipolar electrode From Olympus company DEVICE

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.

Bipolar Enucleation Using Electrode C (Company W)

Bipolar electrode From Lamidey company DEVICE

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.

Bipolar Enucleation Using Electrode D (Company Z)

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Prostate cancer.
• Urethral stricture disease.
• Patients with severe cardiac comorbidities or bleeding disorders.
• Patients on anticoagulation therapy.

Sponsors & Collaborators

• Menoufia University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Urology in Menoufia University

Model Details: 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.

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: June 13, 2025
• Study Start: July 1, 2025
• Primary Completion: February 10, 2026
• Study Completion: March 10, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-06