NCT04471155已完成不适用
Comparison of Holmium Laser Enucleation Prostatectomy and Open Transvesical Prostatectomy in Large Prostate More Than 80 Grams in Egyptian Men
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- efficacy in american urological association symptom score
研究概览
简要总结
comparison of holmium laser enucleation prostatectomy and open prostatectomy regarding safety and efficacy in men with prostate larger than 80 grams
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •American Urological Association Symptom Score of eight or higher,
- •Maximum urinary flow rate of 10ml/s or less,
- •Post void residual urine volume of 50 ml or more,
- •And a total prostate volume of 80 ml or more in transrectal ultrasound (TRUS).
排除标准
- •A previous prostate or urethral surgery
- •And non-BPH related voiding disorders
- •Prostate cancer patients
结局指标
主要结局
efficacy in american urological association symptom score
时间窗: 1 year
change of american urological association symptom score pre and post operative by scale from 1 to 35
efficacy by measuring maximum urinary flow rate in millilitre per second
时间窗: 1 year
change of maximum urinary flow rate in mililiter per second pre and post opeartive
efficacy of evacuation by measuring post-voiding residual urine volume in millilitre
时间窗: 1 year
change of post-voiding residual urine volume in millilitre
次要结局
- safety by doing blood picture to asses hemoglobin drop(immediate post-operative)
研究者
mohamed alnoomani
mohamed nabil alnoomani, assistant lecturer of urology
Ain Shams University
研究点 (1)
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