NCT00877669已完成2 期
The Comparison of Efficacy Between Holmium Laser Enucleation of the Prostate (HoLEP) and Transurethral Resection of the Prostate (TURP) on the Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostate Hyperplasia (BPH)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 313
- 试验地点
- 1
- 主要终点
- The changes of International Prostatic Symptom Scores (IPSS) from baseline to 6 months after operation
研究概览
简要总结
The purpose of this study is to compare of Efficacy and Safety Between Holmium Laser Enucleation of the Prostate (HoLEP) and Transurethral Resection of the Prostate (TURP) on the Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostate 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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •50 yrs or greater
- •International prostatic symptom score >= 12
- •Bladder outlet obstruction confirmed by pressure-flow study (BOOI > 20)
- •Able to give fully informed consent
排除标准
- •Patients with urologic malignancies such as prostate cancer and bladder cancer
- •Patients underwent urethral, prostate surgery
- •Patients with urethral stricture or bladder diverticulum or bladder neck contracture
- •Patients with histories of bacterial prostatitis within 1 year
- •seems not to be appropriate to this study by the decision of investigators because of any other reasons
研究组 & 干预措施
Transurethral resection of the prostate
Active Comparator
TURP group
干预措施: Transurethral resection of the prostate (Procedure)
Holmium Laser Enucleation of Prostate
Experimental
HoLEP group
干预措施: Holmium Laser Enucleation of the Prostate (Procedure)
结局指标
主要结局
The changes of International Prostatic Symptom Scores (IPSS) from baseline to 6 months after operation
时间窗: 6 months
次要结局
- The changes of IPSS and QoL parameters(1 month and 3months after operation)
- Operative time and Resected tissue weight(0 day after operation)
- The changes of Patient perception of treatment benefit questionnaire (PPTB) parameters(3 and 6 months after operation)
- Ejaculation parameter(6 months after operation)
- The changes of the hemoglobin and the serum sodium(0 and 1 day after operation)
- The changes of Quality of Life (QoL) parameters(6 months)
- The changes of Uroflowmetry (UFM) and Postvoid residual urine(PVR) parameters(2 weeks and 3 and 6 months after operation)
- The changes of voiding frequencies and urgency parameters in Frequency volume chart(3 and 6 months after operation)
- The changes of ICS male questionnaire (short form) parameters(3 and 6 months after operation)
- The changes of international index of erectile function (IIEF)-15 parameters(6 months after operation)
- Postoperative hospital stay days and postoperative catheterization days(immediate postoperative period)
- Complications(During all study periods)
研究者
KYU-SUNG LEE
Urology, Professor
Samsung Medical Center
研究点 (1)
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