Comparative Analysis of Bipolar Enucleation of the Prostate Using Different Commercial Types of Electrodes

Обзор

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.

Вмешательства

• Процедура Bipolar 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
• Устройство Bipolar 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.
• Устройство Bipolar 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.
• Устройство Bipolar 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.
• Устройство Bipolar 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.

Первичные конечные точки

• Enucleation Efficiency (g/min) of Different Bipolar Electrodes [Срок оценки: Time Frame: Intraoperative]

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Prostate cancer.
• Urethral stricture disease.
• Patients with severe cardiac comorbidities or bleeding disorders.
• Patients on anticoagulation therapy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07020325 · 2/2025 Urol

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗