Comparative Analysis of the Efficacy and Safety of Thulium-fiber Laser Enucleation, Ho:YAG Laser Enucleation and Monopolar Enucleation in Management of BPH
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 主要终点
- IPSS
研究概览
简要总结
Today, endoscopic enucleation of the prostate (EEP) has been recognized a method of choice for treatment of benign prostatic hyperplasia (BPH) of any size, including large-sized glands (>80 cc). The goal of our study was to compare perioperative efficacy, functional outcomes and safety of different techniques of endoscopic enucleation of the prostate (monopolar enucleation, holmium laser enucleation, thulium laser enucleation) in a single center.
详细描述
HoLEP and ThuLEP or EEP have been approved by the current guidelines of the European Association of Urology for use in men with substantially enlarged prostates (>80 ml) as first-line therapy [1]. This type of operation can be performed by means of several sources of energy.
To our knowledge, there were no studies comparing efficacy and complications of these three treatment modalities.
In this study the investigators have evaluated efficacy of Thulium-fiber laser enucleation (120 W thulium fiber laser Urolase, IPG IRE-POLUS, Russia with wavelength of 1940 nm) and monopolar enuclation in comparision with HoLEP (VersaPulse Powersuite 100, Lumenis, USA/Israel) in reduction of LUTS secondary to BPH in a prospective randomized trial.
All peri-operative parameters, urinary flow parameters, prostate size changes, erectile function and complications associated with the procedures were compared.
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 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •IPSS>20;
- •maximum urinary flow rate< 10ml\s (Qmax);
- •ineffective alfa-blockers therapy.
排除标准
- •histologically verified prostate cancer;
- •history of prostatic surgery;
- •urethral strictures;
- •bladder stones;
- •chronic urinary retention and cystostomy.
结局指标
主要结局
IPSS
时间窗: Six months
International Prostate Symptom Score
次要结局
- PVR(Six months)
- QoL(Six months)
- Qmax(Six months)
- IIEF-5(Six months)
研究者
Dmitry Enikeev, MD, PhD
Deputy Director for Sсience, Dept. of Urology, I.M. Sechenov Moscow State Medical University
I.M. Sechenov First Moscow State Medical University