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临床试验/NCT03554070
NCT03554070Unknown不适用

Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP): Short-Term Efficacy and Safety Trial

I.M. Sechenov First Moscow State Medical University2 个研究点 分布在 2 个国家目标入组 500 人开始时间: 2018年3月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dmitry Enikeev, MD, PhD

Deputy Director for Science

I.M. Sechenov First Moscow State Medical University

研究点 (2)

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