NCT Number: NCT07020325
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.
Trial opening soon.
Get Notified50 year and older
Male
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Menoufia University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
