Laser Enucleation of Prostate (LEP) Versus Transurethral Resection of Prostate (TURP): a Prospective Study Comparing Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Change in Urinary Flow Rate
研究概览
简要总结
Benign prostatic hyperplasia (BPH) refers to the proliferation of smooth muscle and epithelial cells of the prostate gland. The enlarged gland has the potential to result in lower urinary tract symptoms (LUTS) secondary to either bladder outlet obstruction or increased muscle tone and resistance, or both.
For decades transurethral resection of the prostate (TURP) has been the gold standard for treatment of symptomatic BPH that is refractory to nonoperative management. This is a surgical intervention aimed to reduce the size of the prostate gland. However, over the past fifteen years, many alternative therapies have been introduced including laser enucleation of the prostate (LEP). LEP has numerous advantages including decreased blood loss and length of hospital stay as well as increased effectiveness and safety for large prostate gland sizes (>80g).
详细描述
The purpose of this study is to compare the effectiveness of TURP to LEP using the ProTouch laser technology. While TURP has historically been the gold standard, LEP has become more widespread and is arguably a safer and more effective therapy for the patient. TURP is still widely performed because it is a traditional therapy with decades of data to support its efficacy, despite higher volume of blood loss and risk for TUR syndrome. In comparison, there is some data demonstrating that Holmium Laser Enucleation of the Prostate can have similar efficacy but may have longer operative times. The ProTouch laser is comparable to the Holmium laser but additionally provides improved hemostasis and tissue vaporization. There is little to no data comparing LEP with the ProTouch laser to TURP. This study will directly compare the efficacy of these two treatment methods by enrolling eligible subjects and comparing outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age > 50-80 years
- •Prostate gland size 50-100g
- •Failure of nonoperative therapy
- •FR <15ml/s
- •PVR <250
- •If PVR is 250-400 then pre-operative urodynamics will be indicated
- •Language: English, Spanish, Haitian Creole, French, Portuguese
- •Willing to randomize
排除标准
- •Neurogenic bladder
- •PVR >400ml
- •FR >15ml/Indwelling catheter
- •History of prostate cancer
- •History of urethral stricture or vesicourethral anastomotic stricture
- •Unable to be placed in lithotomy position
- •Unable to undergo general or spinal anesthesia
- •Unable to consent
- •Untreated or uncorrected coagulopathy
结局指标
主要结局
Change in Urinary Flow Rate
时间窗: From time of randomization and ultimately at 24 months
Velocity (in cc/sec) of the urine flow
次要结局
- Quality of Life score(From time of randomization and ultimately at 24 months)
- Blood loss(During surgery (full length of operative time))
- Sexual Health Inventory for Men (SHIM)(From time of randomization and ultimately at 24 months)
- Catheter time(From time of surgery to up to 3 weeks after surgery.)
- Post void residual(From time of randomization and ultimately at 24 months)