Evaluating the Clinical Efficacy of Thulio vs. Holmium Laser Enucleation of the Prostate
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Hemostasis time
研究概览
简要总结
Many consider laser enucleation of the prostate the new 'gold standard' for the surgical treatment of benign prostatic hyperplasia (BPH) due to its excellent outcomes, high success rates, and long-term efficacy. Holmium laser enucleation of the prostate (HoLEP) was the earliest form of prostate enucleation and is recommended by the American Urological Association (AUA), along with thulium laser enucleation of the prostate (ThuLEP), as size-independent techniques for the management of BPH with fewer complications than transurethral resection of the prostate (TURP). Further development of laser technology has additionally led to enucleation using pulsed-modulated (e.g. "Virtual Basket™" mode or MOSES™ mode) holmium lasers as well as the thulium fiber laser.
详细描述
Study Design This is a prospective randomized study to evaluate the differences in outcomes comparing the existing laser to a new laser among patients undergoing HoLEP. Patients will be evaluated prior to the procedure and at one follow-up time point. Patients will be randomized in equal numbers to each group. The primary outcome will be non-inferiority in hemostasis timing. Several secondary outcomes will be evaluated including enucleation time, active laser time, morcellation time, prostate volume, change in hemoglobin, applied total laser energy, enucleation efficacy (g/min), IPSS (International Prostate Symptom Score), QoL (Quality of Life), uroflowmetry, PVR (post-void residual), duration of catheterization.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Understand and voluntarily sign an informed consent form.
- •Patients must be males with a prostate, at least 18 years of age
- •No prior prostate surgery
排除标准
- •Unable/refuse to provide informed consent
- •Prior prostate surgery
- •Bladder stones that requiring lasering (small stone that can be removed whole is ok)
- •Unable to hold anticoagulants or antiplatelets per standard protocols for surgery and up to 1 week postop.
结局指标
主要结局
Hemostasis time
时间窗: During surgery
time required to get adequate hemostasis intraoperatively
次要结局
- Laser parameters(During surgery)
- Blood Loss(During surgery)
- Operative parameters(During surgery)
- Subjective laser performance(During surgery)
- Perioperative outcomes(30 days post op)
研究者
Smita De
Principal Investigator
The Cleveland Clinic