Comparative Analysis of Bipolar Enucleation of the Prostate Using Different Commercial Types of Electrodes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Enucleation Efficiency (g/min) of Different Bipolar Electrodes
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Prostate cancer.
- •Urethral stricture disease.
- •Patients with severe cardiac comorbidities or bleeding disorders.
- •Patients on anticoagulation therapy.
研究组 & 干预措施
Bipolar Enucleation Using Electrode A (Company X)
Participants will undergo prostate enucleation using Electrode A for BPH treatment.
干预措施: Bipolar Enucleation of the Prostate (Procedure)
Bipolar Enucleation Using Electrode A (Company X)
Participants will undergo prostate enucleation using Electrode A for BPH treatment.
干预措施: Bipolar electrode From Wolf company (Device)
Bipolar Enucleation Using Electrode B (Company Y)
Participants will undergo prostate enucleation using Electrode B for BPH treatment.
干预措施: Bipolar Enucleation of the Prostate (Procedure)
Bipolar Enucleation Using Electrode B (Company Y)
Participants will undergo prostate enucleation using Electrode B for BPH treatment.
干预措施: Bipolar electrode From Storz company (Device)
Bipolar Enucleation Using Electrode C (Company W)
Bipolar Enucleation Using Electrode C (Company W)
干预措施: Bipolar Enucleation of the Prostate (Procedure)
Bipolar Enucleation Using Electrode C (Company W)
Bipolar Enucleation Using Electrode C (Company W)
干预措施: Bipolar electrode From Olympus company (Device)
Bipolar Enucleation Using Electrode D (Company Z)
Bipolar Enucleation Using Electrode D (Company Z)
干预措施: Bipolar Enucleation of the Prostate (Procedure)
Bipolar Enucleation Using Electrode D (Company Z)
Bipolar Enucleation Using Electrode D (Company Z)
干预措施: Bipolar electrode From Lamidey company (Device)
结局指标
主要结局
Enucleation Efficiency (g/min) of Different Bipolar Electrodes
时间窗: 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.
次要结局
- Change in International Prostate Symptom Score (IPSS)(Time Frame: Preoperative baseline, and at 6 weeks, 3 months, and 6 months postoperative)
- Change in Maximum Flow Rate (Qmax)(Time Frame: Preoperative baseline, 6 weeks, 3 months, and 6 months postoperative)
- Perioperative Safety: Incidence of Adverse Events (Clavien-Dindo Classification)(Time Frame: Intraoperative and up to 30 days postoperative)
- Change in Post-Void Residual Volume (PVR)(Time Frame: Preoperative baseline, 6 weeks, 3 months, and 6 months postoperative)
- Learning Curve Assessment Based on Enucleation Time Over Consecutive Cases(During 12-month recruitment/study period)
- Cost-Effectiveness: Total Procedure and Postoperative Cost per Patient(Time Frame: From procedure day to end of 6-month follow-up)
研究者
Mohamed Kamal Omar
Clinical Professor of Urology in Menoufia University
Menoufia University