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临床试验/NCT04342533
NCT04342533Unknown不适用

Prospective Randomized Trial of Irritative Symptoms Severity Assessment After Holmium Laser Enucleation of the Prostate (HoLEP) Versus Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP).

I.M. Sechenov First Moscow State Medical University2 个研究点 分布在 2 个国家目标入组 140 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
140
试验地点
2
主要终点
severity of urinary incontinence

研究概览

简要总结

The investigators hypothesize that the functional outcomes of both techniques are comparable. However, ThuFLEP might increase speed recovery of postoperative irritation and early stress urinary incontinence according to the Questionnaire for Urinary Incontinence Diagnosis (QUID) because of minimal tissue penetration depth of TFL.

详细描述

Thulium fiber laser enucleation of the prostate (ThuFLEP) has already shown the outcomes comparable to OSP with better safety profile (lower blood loss compared to OSP) and shorter hospital stay. TFL has the efficacy and safety proven in comparative trials, being a promising rival for HoLEP. The main features of TFL distinguishing it from Ho:YAG is its wavelength of 1.94 µm (leading to about three-fold increase in water absorption and lesser penetration depth of <0.1 mm vs >0.2 mm in Ho:YAG). With identical average and peak powers of 100 W, the laser does not burst tissues, allowing for clean and precise cutting instead. Conversely, Ho:YAG's average power is about 100 W and its presumable peak power is around 10-15 kW. With such an outburst of energy, each pulse of Ho:YAG creates a large vapor bubble which ruptures the tissue. This may be a possible reason for increased irritative symptoms in early postoperative period after HoLEP comparing to ThuFLEP. But all in all, the probable causes for such postoperative symptoms remain unclear so far, despite the fact that absence of irritation and incontinence is ought to be one quality marker of "Pentafecta". According to the idea of high-power impact, probably, decreasing of HoLEP power will mitigate these problems. On the one hand, low-power HoLEP is feasible, safe and effective modality for symptomatic BPO. However, the results remain controversial and there is lack of LP-HoLEP application data nowadays. May be, with another option, for instance OSP or monopolar enucleation, it is possible to solve the issues. But the discussion of the past years demonstrates that the presence of early SUI is not only a problem of EEP, but also underreported in other approaches in relieving BPO secondary to 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
Single (Participant)

入排标准

性别
Male
接受健康志愿者

入选标准

  • LUTS presence, proven by:
  • IPSS questionnaire (Score >20);
  • OR uroflowmetry result (Qmax <10 ml/s);

排除标准

  • Prostate volume > 120 cc
  • Prostate cancer on pathology;
  • Urethral strictures;
  • Bladder calculi;
  • Prior prostate surgery;
  • Neurogenic bladder dysfunction.

结局指标

主要结局

severity of urinary incontinence

时间窗: change from 1 week to 6 months after surgery

Questionnaire for Urinary Incontinence Diagnosis (higher score means worse incontinence)

次要结局

  • catheter stay(1 week after surgery)
  • functional outcomes(change from 3 to 6 months after surgery)
  • surgery duration(during surgery)
  • hemoglobin drop(1 day after surgery)
  • hospitalization length(1 week after surgery)
  • rate of intra- and perioperative adverse events(6 months follow up)

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 research

I.M. Sechenov First Moscow State Medical University

研究点 (2)

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