NCT02075736Unknown不适用
The Effect of KTP (Potassium-titanyl-phosphate) Green Light Prostatectomy (120W) Compared With TUR-P When Treating Benign Prostatic Hyperplasia in High Risk Patients, A Prospective Randomized Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Re-bleeding rate requiring hospitalization
研究概览
简要总结
The purpose of this study is to compare safety and efficacy of Green Light PVP (Photoselective Vaporization of the Prostate) compared to TUR-P in high risk patients
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
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men with anticoagulant medication undergoing surgery for BPH
排除标准
- •Previous prostate surgery
- •Carcinoma of the prostate
- •Neurogenic bladder
- •Bladder carcinoma
研究组 & 干预措施
TUR-P
Active Comparator
device
干预措施: TUR-P (Procedure)
KTP laser
Experimental
device
干预措施: KTP laser (Procedure)
结局指标
主要结局
Re-bleeding rate requiring hospitalization
时间窗: two months postoperatively
次要结局
- Length of catheterization(Participants will be followed for the duration of hospital stay, an expected maximum of one week)
- Residual urine(0, 3, 6 and 12 months)
- Length of hospital stay(Participants will be followed for the duration of hospital stay, an expected maximum of one week)
- Perioperative bleeding(Time of operation)
- IPSS (International Prostate Symptom Score)(0, 3, 6 and 12 months)
- Maximum flow rate (Qmax)(0, 3, 6 and 12 months)
- DAN-PSS (Danish Prostate Symptom Score)(0, 3, 6 and 12 months)
- IIEF (International Index of Erectile Function) questionnaire(0,12 months)
- TRUS (transrectal ultrasound)(0, 12 months)
研究者
Hannu Koistinen
MD
University of Helsinki
研究点 (1)
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