About this trial
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
Qualifiers
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.
Disqualifiers
Prostate cancer.
Urethral stricture disease.
Patients with severe cardiac comorbidities or bleeding disorders.
Patients on anticoagulation therapy.
Trial design
Treatments tested in this trial
- Bipolar Enucleation of the Prostate
- Bipolar electrode From Wolf company
- Bipolar electrode From Storz company
- Bipolar electrode From Olympus company
- Bipolar electrode From Lamidey company