NCT02072499已完成4 期
The Effect of KTP (Potassium-titanyl-phosphate) Green Light Prostatectomy (180W) Compared With Open Prostatectomy When Treating Benign Prostatic Hyperplasia, a Prospective Randomized Study
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- IPSS (International Prostate Symptom Score)
研究概览
简要总结
The purpose of this study is to compare safety and efficacy of Green Light PVP (Photoselective Vaporisation of the Prostate) compared to open prostatectomy when treating benign prostatic hyperplasia (BPH).
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 95 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men undergoing surgery for BPH with prostate size more than 100cc
排除标准
- •Previous prostate surgery
- •Carcinoma of the prostate
- •Neurogenic bladder
- •Bladder carcinoma
研究组 & 干预措施
KTP Green Light Prostatectomy
Experimental
Device
干预措施: KTP Green Light Prostatectomy (Procedure)
KTP Green Light Prostatectomy
Experimental
Device
干预措施: Green Light (Device)
Open prostatectomy
Active Comparator
Surgical procedure
干预措施: Open prostatectomy (Procedure)
结局指标
主要结局
IPSS (International Prostate Symptom Score)
时间窗: 12 months
symptom score
次要结局
- Rate of unscheduled hospital contacts(12 months)
- IIEF (International Index of Erectile Function questionnaire)(0,12 months)
- Perioperative bleeding(Time of operation)
- IPSS (International Prostate Symptom Score)(0, 3 and 6 months)
- Residual urine(0, 3, 6 and 12 months)
- Prostate volume measured with TRUS (transrectal ultrasound)(0, 12 moths)
- DAN-PSS (Danish Prostate Symptom Score)(0, 3, 6 and 12 months)
- Maximum flow rate (Qmax)(0, 3, 6 and 12 months)
- Length of catheterization(Participants will be followed for the duration of hospital stay, an expected maximum of two weeks)
- Length of hospital stay(Participants will be followed for the duration of hospital stay, an expected maximum of two weeks)
研究者
Hannu Koistinen
MD
University of Helsinki
研究点 (2)
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