Slim Sheath 22F Holmium Laser Enucleation of the Prostate (HoLEP) Technique vs 26 F Sheath HoLEP for Treatment of Benign Prostatic Hyperplasia (BPH): A Randomized Prospective Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Comparison of Operating Time
研究概览
简要总结
Holmium laser enucleation of the prostate (HoLEP) is routinely performed with 24F, 26F, and 28F laser scopes. Proponents of larger caliber scopes suggest that the larger scope size allows for improved visualization, hemostasis, and operative efficiencies. Proponents of a smaller scope diameter suggest that by eliminating the need for pre-HoLEP urethral dilation to accommodate a larger scope. It has also been proposed that a smaller caliber scope is less traumatic to the urethra resulting in lower rates of bladder neck contracture and urethral stricture disease. Currently, to our knowledge, there are no level one evaluation examining scope size 22F versus 26F sheath in laser enucleation outcomes. The aim of our study is to determine if a smaller diameter scope is associated with improved laser enucleation time, post-operative recovery, rates of same-day discharge, or increasing intra-operative or postoperative complication rates
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 secondary to BPH
- •Failed medical (non-surgical) treatment
- •Prostate size on preoperative TRUS of > 80 ml
- •IPSS >15, 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
结局指标
主要结局
Comparison of Operating Time
时间窗: Intra-op
Operating time as measured during the procedure measured in minutes.
次要结局
- Quality of Life (QOL) as scored on the International Prostate Symptom Score (IPSS)(One year post-procedure)
- Length of Hospital Stay(Within 6 hours of procedure completion)
- Time to Catheter Removal(Within 6 hours of procedure completion)
- Continence status(One year post-procedure)
- International Prostate Symptom Score(One year post-procedure)
- Rate of Complications(One year post-procedure)
- Peak flow rate(One year post-procedure)
- Post-void residual(One year post-procedure)