A Prospective Multicenter Randomized Study Comparing Photoselective Vaporization of the Prostate With the GreenLight XPS™ Laser System and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Hyperplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 291
- 试验地点
- 37
- 主要终点
- International Prostate Symptom Score (IPSS)
研究概览
简要总结
The study compares procedural and post procedural outcomes for photoselective vaporization of the prostate (PVP) and transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction. The study requires use of the CE marked GreenLight XPS™ Laser System (GreenLight XPS) or a CE marked monopolar or bipolar loop TURP system for the treatment of benign prostatic hyperplasia (BPH).
详细描述
The study will compare procedural and post procedural outcomes for photoselective vaporization of the prostate (PVP) and transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction. The study requires use of the CE marked GreenLight XPS™ Laser System (GreenLight XPS) or a CE marked monopolar or bipolar loop TURP system for the treatment of benign prostatic hyperplasia (BPH). The purpose of the study is to demonstrate that PVP is not inferior to TURP.
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
International Prostate Symptom Score (IPSS)
时间窗: 6 months
The IPSS is a patient-administered 7-question instrument used to classify severity of benign prostatic hyperplasia symptoms (BPH). Total scores can range from 0 to 35 (asymptomatic to very symptomatic).
次要结局
- Prostate Volume(6 months)
- Freedom From Complications(180 days)
- Immediate Post Treatment Outcomes of PVP and TURP(3 weeks)
- Tolerability of PVP and TURP Assessed Using International Index of Erectile Function (IIEF-5) and International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)(Baseline, 12-months, and 24-months)
- Maximum Urinary Flow Rate (Qmax)(6 months)
- Post Treatment Outcomes of PVP and TURP(3 weeks post treatment)
- Health Status of PVP and TURP(Baseline and 24-months)
- Rate of Retreatment of PVP and TURP(2 Years)
- Subject Satisfaction of PVP and TURP(3-weeks, 3-months, 6-months, 12-months, and 24-months)