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.
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.
Prostate cancer.
Urethral stricture disease.
Patients with severe cardiac comorbidities or bleeding disorders.
Patients on anticoagulation therapy.
Parallel
Bipolar Enucleation of the Prostate
Procedure/SurgeryBipolar 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 electrode From Wolf company
DeviceThis 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 electrode From Storz company
DeviceThis 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 electrode From Olympus company
DeviceThis 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 electrode From Lamidey company
DeviceThis 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.
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.
Perioperative Safety: Incidence of Adverse Events (Clavien-Dindo Classification)
Complications will be recorded and graded according to the Clavien-Dindo classification system. Events include, but are not limited to, bleeding requiring transfusion, urinary retention, infection, bladder injury, and incontinence. The frequency and severity of complications will be analyzed and compared between devices. Unit of Measure: Number of adverse events per Clavien-Dindo grade.
Change in International Prostate Symptom Score (IPSS)
Description: Change from baseline in patient-reported urinary symptoms as measured by the International Prostate Symptom Score (IPSS) to evaluate symptom improvement after bipolar enucleation. Unit of Measure: IPSS score (0-35)
Change in Maximum Flow Rate (Qmax)
Description: Change from baseline in maximum urinary flow rate to assess improvement in urinary flow after bipolar enucleation. Unit of Measure: mL/second
Change in Post-Void Residual Volume (PVR)
Description: Change from baseline in post-void residual urine volume to evaluate bladder emptying efficiency after bipolar enucleation. Unit of Measure: milliliters (mL)
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