NCT00908427已完成不适用
Impact of 80 Watt KTP Photoselective Laser Vaporization Prostatectomy on Severity of Obstruction in Benign Prostatic Hyperplasia: 6-Month Results of a Nonrandomized Prospective Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- The changes of bladder outlet obstruction index (BOOI)
研究概览
简要总结
The purpose of this study is to compared the efficacy of 80W KTP photoselective laser vaporization prostatectomy (PVP) and transurethral resection of the prostate (TURP) in reducing the volume of prostate and relieving the obstruction in men with benign prostatic hyperplasia (BPH) on non-randomized controlled design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Symptomatic BPH
- •International Score Prostate Symptom (IPSS) of 13 or greater
- •prostate volume of 30 to 100 ML
- •Peak urinary flow rate (Qmax) less than 15 mL/s with a voided volume of >125 mL and a PVR <350mL
- •Able to give fully informed consent
排除标准
- •Subjects with histological diagnosis of prostate cancer
- •Subjects with history of chronic urinary retention
- •Subjects with urethral stricture,
- •Subjects with bladder neck contracture
- •Subjects with urinary tract infection
- •Subjects with prostate volume on TRUS of >100 mL
- •Subjects with suspected neurogenic bladder dysfunction
- •Subjects who, in the opinion of investigator, are not likely to complete the study for whatever reason
结局指标
主要结局
The changes of bladder outlet obstruction index (BOOI)
时间窗: 6months
次要结局
- The changes of Quality of Life (QoL) parameters(6, 12 months)
- The changes of Uroflowmetry (UFM) and Postvoid residual urine(PVR)(6, 12 months)
- The changes of detrusor pressure at maximum flow rate (PdetQmax)parameters(6months)
- The changes of International Prostatic Symptom Scores (IPSS)(6, 12 months)
- The changes of Schafer obstruction grade parameters(6months)
- The changes of prostate volume(6, 12 months)
- postoperative catheterization days(immediate postoperative period)
- Complications(During all study periods)
- The changes of the hemoglobin and the serum sodium and the serum PSA(immediate postoperative period)
- The change of IIEF score(6, 12 months)
研究者
研究点 (1)
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