Thulium Fiber Laser Compared to Holmium:YAG Laser With Moses Technology for Enucleation of the Prostate: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare the hospital stay between the thulium fiber laser enucleation of the prostate (TFLEP) and the holmium:YAG laser enucleation of the prostate with Moses technology (m-HoLEP).
研究概览
简要总结
Enucleation of the prostate equips technology (usually laser) to effectively treat lower urinary tract symptoms associated with benign prostate hyperplasia (BPH). The holmium: yttrium-aluminum-garnet (Ho: YAG) laser is considered the gold standard laser used to perform enucleation of the prostate. Holmium laser enucleation of the prostate (HoLEP) reduces hospital stay and hemoglobin drop while improving International Prostate Symptom Score (IPSS) and quality of life, as well as other postoperative outcomes. HoLEP has been found to have a better enucleation efficiency rate and may have better hemostatic properties when combined with the modulated pulsed laser energy featured associated with Moses technology (m-HoLEP).
A novel laser technology called thulium fiber laser (TFL) delivers a pulsed laser at a more optimal wavelength and a shallower depth of tissue penetration leading to better hemostatic properties. However, the differences in clinical outcomes between TFL enucleation of the prostate (TFLEP) and m-HoLEP have yet to be described. This prospective study aims to compare the safety profile and clinical outcomes, peri-operatively up to one year post-operatively, between m-HoLEP and TFLEP with BPH and evidence of bladder obstruction.
详细描述
Enucleation of the prostate equips technology (usually laser) to effectively treat lower urinary tract symptoms associated with benign prostate hyperplasia (BPH). The holmium: yttrium-aluminum-garnet (Ho: YAG) laser is the longest running and most studied laser used to perform this minimally invasive procedure.
Holmium laser enucleation of the prostate (HoLEP) reduces hospital stay and hemoglobin drop while improving IPSS and quality of life, as well as other positive postoperative outcomes. HoLEP has been found to have a better enucleation efficiency rate and may have better hemostatic properties when combined with the modulated pulsed laser energy featured associated with Moses technology (m-HoLEP).
A novel laser technology called thulium fiber laser (TFL) delivers a pulsed laser at a more optimal wavelength and a shallower depth of tissue penetration leading to better hemostatic properties. However, the differences in clinical outcomes between TFL enucleation of the prostate (TFLEP) and m-HoLEP, to our knowledge, have yet to be described.
This prospective study aims to compare the safety profile and clinical outcomes, peri-operatively up to one year post-operatively, between m-HoLEP and TFLEP with BPH and evidence of bladder obstruction. Variables of particular interest include the length of hospital stay and the need for blood transfusion, which are benefits of both techniques compared to transurethral resection of the prostate, the current gold standard of BPH treatment according to American Urological Association (AUA) guidelines. The results of this study will guide urologists in selecting the most appropriate procedure from the growing armamentarium of treatments for BPH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Patients with symptomatic benign prostate hyperplasia : urinary retention, acute renal failure (post-renal), refractory hematuria, repeated urinary tract infections, refractory symptoms.
- •Prostates between 50-300 grams,
- •IPSS ≥ 8,
- •Inadequate response to previous medical treatments,
- •Qmax < 15 ml/sec and
- •Providing informed consent
排除标准
- •History of prostatic surgery,
- •History of prostate or bladder cancer,
- •Neurogenic bladder,
- •Urethral stricture,
- •Anticoagulant therapy (aspirin permitted), not ceased during surgery
- •Patients unfit for surgery
结局指标
主要结局
To compare the hospital stay between the thulium fiber laser enucleation of the prostate (TFLEP) and the holmium:YAG laser enucleation of the prostate with Moses technology (m-HoLEP).
时间窗: 1 day post-operatively
Length of hospital stay following surgery, measured in hours and minutes.
次要结局
- To compare intraoperative adverse events between cohorts(During surgery)
- To compare catheterization time between cohorts(Up to 7-days post-operatively)
- To compare drop in International Prostate Symptom Score (I-PSS) between cohorts(Up to 1-year post-operatively)
- To compare post-void residual urine volume (PVR) between cohorts(Up to 1-year post-operatively)
- To compare peak urine flow rates (Qmax) between cohorts(Up to 1-year post-operatively)
- To compare postoperative complications levels between cohorts(Up to 1-year post-operatively)
- To compare enucleation and morcellation time between cohorts(During surgery)
- To compare enucleation rate of instrumentation between cohorts(During surgery)
- To compare operative time between cohorts(During surgery)
- To measure increase of Quality of life (QoL) between cohorts(Up to 1-year post-operatively)
- To compare change in erectile function (IIEF) between cohorts(Up to 1-year post-operatively)
- To compare prostate-specific antigen (PSA) levels between cohorts(Up to 1-year post-operatively)
- To compare the impact of incontinence (ICIQ-short form) between cohorts(Up to 1-year post-operatively)