Clinical trial NCT07020325: Comparative Analysis of Bipolar Enucleation of the Prostate Using Different Commercial Types of Electrodes
Official title: Comparative Analysis of Bipolar Enucleation of the Prostate Using Different Commercial Types of Electrodes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bipolar Enucleation of the Prostate
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 100
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Enucleation Efficiency (g/min) of Different Bipolar Electrodes
timeFrame: Time Frame: Intraoperative
Secondary outcomes:
measure: Perioperative Safety: Incidence of Adverse Events (Clavien-Dindo Classification)
timeFrame: Time Frame: Intraoperative and up to 30 days postoperative
measure: Change in International Prostate Symptom Score (IPSS)
timeFrame: Time Frame: Preoperative baseline, and at 6 weeks, 3 months, and 6 months postoperative
measure: Change in Maximum Flow Rate (Qmax)
timeFrame: Time Frame: Preoperative baseline, 6 weeks, 3 months, and 6 months postoperative
measure: Change in Post-Void Residual Volume (PVR)
timeFrame: Time Frame: Preoperative baseline, 6 weeks, 3 months, and 6 months postoperative
measure: Learning Curve Assessment Based on Enucleation Time Over Consecutive Cases
timeFrame: During 12-month recruitment/study period
measure: Cost-Effectiveness: Total Procedure and Postoperative Cost per Patient
timeFrame: Time Frame: From procedure day to end of 6-month follow-up
Other outcomes:
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