Thulium Fiber Laser (TFL) Versus Holmium MOSES Laser Enucleation of the Prostate for Treatment of Benign Prostatic Hyperplasia (BPH): A Randomized Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Length of stay in the hospital
研究概览
简要总结
Benign prostatic hyperplasia (BPH), the non-cancerous enlargement of the prostate, places pressure on the urethra and causes urination and bladder problems. Transurethral Resection of the Prostate (TURP) remains the gold standard treatment in most centres for BPH. However, morbidity after TURP is high, especially bleeding requiring blood transfusion and late postoperative bleeding.
Holmium laser enucleation of the prostate (HoLEP) is a safe and effective procedure which has demonstrated comparable results to TURP. HOLEP also offers patients the alternative of being treated endoscopically with minimal blood loss, short catheterization time, and decreased hospital stay. The main reason HoLEP has yet to become the new standard for treatment of symptomatic BPH is due the complexity of this procedure as compared to TURP. Furthermore, the HoLEP can be used with the MOSESTM system, a system that allows for more efficiency and ease of use of the HoLEP.
Thulium fiber laser (TFL) enucleation of the prostate is an emerging technology for endoscopic prostate enucleation that is notable for its high wavelength and pulsed mode of action. Recent studies have shown TFL enucleation of the prostate to be a safe and highly efficacious treatment modality for the management of large volume (> 80 cm3) glands in BPH. Due to its novelty, further studies are needed to broaden the investigators' understanding of the TFL and comprehend the full implications and benefits of this new technology, as well its limitations.
The aim of this study is to whether Thulium Fiber laser enucleation of the prostate (ThuFLEP) and Holmium laser enucleation using MOSES™ (M-HoLEP) have comparable length of hospital stay, as well as intraoperative and postoperative outcomes.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males over 50 years of age at the time of enrollment
- •Referred to urology for refractory LUTS or urinary retention secondary to BPH
- •Failed medical (non-surgical) treatment
- •Prostate size on preoperative TRUS of≥80 ml
- •IPSS >15 and QOL score ≥3 and Qmax <15 ml/sec
- •Written informed consent to participate in the study
- •Ability to comply with the requirements of the study procedures
排除标准
- •Previous surgical treatment for BPH
- •History of prostate cancer
- •Prostate size < 80 mL
- •History of urethral stenosis or its management
- •Known or suspected neurogenic bladder
- •Participants with active urinary tract infection until appropriately treated
- •Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study
- •Participants who lack the capacity, or cannot speak English, in order to provide free and informed written consent
结局指标
主要结局
Length of stay in the hospital
时间窗: within 6 hours
次要结局
- Change in size(6 months)
- Operative time(Intra-Op)
- Incidence of bleeding(Intra-Op)
- Quality of Life (QOL) as scored on the International Prostate Symptom Score (IPSS)(1,3,6,12 months post-op)
- Peak flow rate(1,3,6,12 months post-op)
- Incidence of blood transfusion(Intra-Op)
- International Prostate Symptom Score(1,3,6,12 months post-op)
- Post-void residual(1,3,6,12 months post-op)
- Prostate specific antigen(1,3,6,12 months post-op)
- Time to Catheter Removal(within 4 hours)
研究者
Hazem Elmansy
Urologist
Thunder Bay Regional Health Research Institute