Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP): Short-Term Efficacy and Safety Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Change from Baseline Qmax at 1,3 and 6 months
研究概览
简要总结
The aim of our study is to estimate the efficacy, safety and postoperative complications of the thulium fiber laser enucleation of the prostate (ThuFLEP) with Urolase system (NTO IRE-POLUS, Russia).
详细描述
In all patients, IPSS, Qmax, QoL, prostate volume, and IIEF-5 are measured prior to surgery.
For ThuFLEP, we use the Urolase system (NTO IRE-POLUS, Russia) and a 600 mcm fiber. The thulium fiber laser is set with a mean output power of 60 W and energy of 1.5 J. Tissue morcellation is completed with the Piranha Morcellator (Richard Wolf, Germany).
At the end of the procedure a 22 French three-way Foley catheter is placed. IPSS, Qmax, QoL, prostate volume are recorded at 1, 3 and 6 months after surgery. IIEF-5 are recorded at 3 and 6 months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged 18 or older
- •Infravesical obstruction due to prostatic hyperplasia (IPSS > 20 or Qmax <10)
排除标准
- •Participation in another clinical study
- •Prostate cancer (pathology confirmed)
- •Urinary tract infection
- •Neurogenic bladder
结局指标
主要结局
Change from Baseline Qmax at 1,3 and 6 months
时间窗: baseline and at 1,3 and 6 months
Maximal urinary flow rate
Change from Baseline IPSS at 1,3 and 6 months
时间窗: baseline and at 1,3 and 6 months
International Prostate Symptom Score
次要结局
- Change from Baseline Prostate Volume at 1,3 and 6 months(baseline and at 1,3 and 6 months)
- Change from Baseline QoL at 1,3 and 6 months(baseline and at 1,3 and 6 months)
- Change from Baseline IIEF-5 at 3 and 6 months(baseline and at 3 and 6 months)
研究者
Dmitry Enikeev, MD, PhD
Deputy Director for Science
I.M. Sechenov First Moscow State Medical University