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

Menoufia University

Status: Begins enrollment this month

Conditions: Bipolar Enucleation of the Prostate

Treatments: Device: Bipolar electrode From Olympus company; Device: Bipolar electrode From Storz company; Device: Bipolar electrode From Lamidey company; Device: Bipolar electrode From Wolf company; Procedure: Bipolar Enucleation of the Prostate

Study type: Interventional

Funder types: Other

Identifiers

NCT07020325

2/2025 Urol

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 4 patient groups

Bipolar Enucleation Using Electrode A (Company X)

Experimental group

Description:

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

Treatment:

Procedure: Bipolar Enucleation of the Prostate

Device: Bipolar electrode From Wolf company

Bipolar Enucleation Using Electrode B (Company Y)

Experimental group

Description:

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

Treatment:

Procedure: Bipolar Enucleation of the Prostate

Device: Bipolar electrode From Storz company

Bipolar Enucleation Using Electrode C (Company W)

Experimental group

Description:

Bipolar Enucleation Using Electrode C (Company W)

Treatment:

Procedure: Bipolar Enucleation of the Prostate

Device: Bipolar electrode From Olympus company

Bipolar Enucleation Using Electrode D (Company Z)

Experimental group

Description:

Bipolar Enucleation Using Electrode D (Company Z)

Treatment:

Procedure: Bipolar Enucleation of the Prostate

Device: Bipolar electrode From Lamidey company