Bipolar Enucleation of the Prostate
Conditions
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.
Interventions
PROCEDUREBipolar Enucleation of the Prostate
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
DEVICEBipolar electrode From Wolf company
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.
DEVICEBipolar electrode From Storz company
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.
DEVICEBipolar electrode From Olympus company
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.
DEVICEBipolar electrode From Lamidey company
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.
Sponsors
Menoufia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
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.
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enucleation Efficiency (g/min) of Different Bipolar Electrodes | Time Frame: Intraoperative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in International Prostate Symptom Score (IPSS) | Time Frame: Preoperative baseline, and at 6 weeks, 3 months, and 6 months postoperative | 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) | Time Frame: Preoperative baseline, 6 weeks, 3 months, and 6 months postoperative | Description: Change from baseline in maximum urinary flow rate to assess improvement in urinary flow after bipolar enucleation. Unit of Measure: mL/second |
| Perioperative Safety: Incidence of Adverse Events (Clavien-Dindo Classification) | Time Frame: Intraoperative and up to 30 days postoperative | 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. |
| Learning Curve Assessment Based on Enucleation Time Over Consecutive Cases | During 12-month recruitment/study period | Surgeon learning curve will be assessed by measuring enucleation time (in minutes) across consecutive cases for each bipolar system. The trend in time reduction will be analyzed to evaluate the learning trajectory. Unit of Measure: Enucleation time in minutes per case |
| Cost-Effectiveness: Total Procedure and Postoperative Cost per Patient | Time Frame: From procedure day to end of 6-month follow-up | Total cost per patient will be calculated by summing surgical device costs, operating room time, length of hospital stay, and postoperative care costs (including catheter duration, readmissions, and complication-related expenses). Unit of Measure: Cost in local currency (e.g., Euros or USD) |
| Change in Post-Void Residual Volume (PVR) | Time Frame: Preoperative baseline, 6 weeks, 3 months, and 6 months postoperative | Description: Change from baseline in post-void residual urine volume to evaluate bladder emptying efficiency after bipolar enucleation. Unit of Measure: milliliters (mL) |
Outcome results
None listed