NCT05678452招募中不适用
Comparative Study Between Safety and Efficacy of High Versus Low Power HOLEP in Enucleation of the Prostate; Prospective Randomized Double Blind Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Enucleation Efficiency
研究概览
简要总结
Holmium laser enucleation (HOLEP) has became a standard of treatment of large prostates that indicates surgery. HOLEP is widely used nowadays. Many settings are used but no optimal setting was world wide adopted. The aim of this trial is to assess the Low-power Holmium laser enucleation of the prostate (LP-HoLEP)and compare to high-power (HP-HoLEP) for enucleation efficiency pertaining to the advantages of lower cost and minimal postoperative dysuria, storage symptoms, and negative sexual impact.
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
- None
盲法说明
double blind
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •large prostate indicated for surgical intervention.
排除标准
- •prostate cancer
- •recurrent adenomas
- •associated neurologic factors that may affect outcomes (e.g., neurogenic bladder)
结局指标
主要结局
Enucleation Efficiency
时间窗: 3 hours
Enucleated weight/min will be evaluated.
次要结局
- The complications of both techniques(3 months)
- Dysuria will be assessed by dysuria visual analog scale(2 weeks)
研究者
Mohamed Fawzy Abd Elfattah Salman
Director
Al-Azhar University
研究点 (1)
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