Randomized Clinical Trial Comparing Low Power (50W) Holmium Laser Enucleation of the Prostate (HoLEP) Versus High Power (100W) HoLEP
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Operative time (minutes)
研究概览
简要总结
HoLEP (Holmium laser enucleation of the prostate) entails dissection of the whole median and lateral prostatic lobes off the surgical capsule via a retrograde approach starting at the apex. The enucleated lobes were pushed to the bladder followed by hemostasis of the prostate bed then intravesical morcellation of the enucleated adenoma.
The investigators are going to compare safety and efficacy of low power; LP-HoLEP vs. high power; HP-HoLEP in treatment of infra-vesical obstruction secondary to BPH (Benign prostate Hyperplasia).
详细描述
Introduction
Benign prostatic hyperplasia (BPH) is a pathologic process that contributes to, but is not the sole cause of, lower urinary tract symptoms (LUTS) in aging men.
The decision to intervene is frequently used as an end point after failure of different medical therapies. These medications are able to delay this point. Failed medical treatment either due to refractory LUTS or in patients who are not willing to make a lifetime commitment to medical therapy represents one indication to intervene.
Urine retention secondary to BPH with failed voiding trial without catheter is an indication for intervention in healthy individuals as well as recurrent hematuria, secondary vesical stones and recurrent urinary tract infection. Renal deterioration secondary to BPH is an indication of intervention after proper evaluation of the bladder function.
For years, surgical treatment for BPH was transurethral resection of the prostate (TURP) for small to moderate sized prostate and open prostatectomy (OP) for markedly enlarged one.
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
- Double (Participant, 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
- 否
入选标准
- •Patients' age ≥50 years
- •ASA (American society of anesthesiologists) score ≤
- •TRUS (transrectal ultrasound) estimated weight ≥40 grams.
排除标准
- •Patients who have any of the following were excluded:
- •Patient with neurological disorder which might affect bladder function as cerebrovascular stroke or Parkinson disease.
- •Active urinary tract infection.
- •Presence of bladder cancer (within the last 2 years).
- •Prostate cancer patients.
- •Patients with bleeding tendency, ongoing anticoagulants or antiplatelet medications
- •Previous prostate surgery
研究组 & 干预措施
LP-HoLEP
Low power Holmium laser enucleation of the prostate
干预措施: Low power Holmium laser enucleation of the prostate (Procedure)
HP-HoLEP
High power Holmium laser enucleation of the prostate
干预措施: High power Holmium laser enucleation of the prostate (Procedure)
结局指标
主要结局
Operative time (minutes)
时间窗: one day
Which is the time from insertion of the resectoscope till the time of catheterization
Operative efficacy (gm/minute)
时间窗: one day
Which is the number or grams of the resected prostate tissue weight divided by operative time
Enucleation efficacy (gm/minute)
时间窗: one day
Which is the number of grams of the resected prostate tissue divided by enucleation time
次要结局
- dysuria score(4 weeks)
- Maximum urine flow rate (ml/sec)(3 months)