Prospective Study Comparing Convective Radio-frequency Water Vapor Energy With Trans-urethral Enucleation of Prostate for Management of Benign Prostatic Hyperplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
研究概览
简要总结
Convective RF water vapor energy was introduced as a minimally invasive, radio-frequency thermal energy-based treatment, designed to convectively deliver sterile water vapor, or steam for targeted ablation limited to the transition and central zones in men with clinical BPH. Thus. the aim of the study is to compare Convective RF water vapor energy (Rezum) with trans-urethral enucleation of the prostate (TUEP) regarding efficacy in terms of lower urinary tract symptoms (LUTS) improvement, international prostatic symptoms score (IPSS), improving of the maximum flow rate (Qmax), worsening of erectile and ejaculatory function, and safety regarding post operative complications & hospital stay.
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)
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
- •Male aged > 50 yrs.
- •International Prostate Symptom Score (IPSS) >12
- •Maximum flow rate ( Qmax ) < 15 ml/s for 125ml voided volume
- •Post-void residual volume <350 ml
- •Prostate volume 80-120 g
排除标准
- •Active urinary tract infection at time of treatment.
- •Prostate-specific antigen (PSA) more than 10 ng/l.
- •history of prostate or bladder cancer.
- •Anticoagulants within 3d of the index procedure
研究者
Hany Fathy Badawy, MD
Associate professor
Beni-Suef University