Transurethral Bipolar Enucleation and Resection of the Prostate Versus Open Prostatectomy for the Treatment of Benign Prostatic Hyperplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- operative time
研究概览
简要总结
Benign prostatic hyperplasia (BPH) is a frequent disease in aging men accompanied by bladder outlet obstruction (BOO). Open prostatectomy (OP) is still considered the first-line treatment for more than 80 ml prostate size. In this study, a mixed technique called transurethral bipolar enucleation and resection of the prostate (TBERP) was compared to the standard open prostatectomy.
详细描述
Benign prostatic hyperplasia (BPH) is a frequent disease in aging men accompanied by bladder outlet obstruction (BOO). Open prostatectomy (OP) is still considered the first-line treatment for more than 80 ml prostate size. In this study, a mixed technique called transurethral bipolar enucleation and resection of the prostate (TBERP) was compared to the standard open prostatectomy.
This is a Comparative, Prospective Study conducted on men over 50 years.The patients were randomly distributed into two groups treated by TBERP and OP. Patients were evaluated preoperatively and at 1-week post catheter removal and 1-3-months postoperatively in terms of blood loss, operation time, the weight of resected prostatic tissues, post-operative catheterisation period, hospital stay, IPSS, PVR, prostate volume, early complications (recatheterization, urine retention, UTI and irritative symptoms) and late complications (urinary incontinence, urethral stricture and bladder neck contracture).
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
- •Male patients
- •Age more than 50 years
- •Prostate size of more than 80 ml
- •IPSS ≥ 8, and maximum urinary flow rate (Qmax) ≤ 15 mL/s
- •Indications for surgery
- •Refractory retention (failed ≥1 trial of voiding).
- •Associated bladder Stones.
- •Associated recurrent gross Hematuria.
- •Associated with recurrent Infections.
- •Associated renal insufficiency.
- •Bother symptoms refractory to medical treatment.
排除标准
- •Uncorrectable coagulopathy.
- •Patient with active UTI.
- •Prostate less than 80 ml.
- •Severe associated comorbidities.
- •Previous urethral, prostate, and bladder surgeries,
- •Patients diagnosed with neurogenic bladder.
- •Patients diagnosed with prostate cancer.
结局指标
主要结局
operative time
时间窗: Three months
To measure the difference between the two procedure regarding operative time measured in minutes.
recovery outcome
时间窗: Three months
To measure the difference between the two procedure regarding mean hospital stays measured in days and catheterization period measured in days
次要结局
- peri-operative complication(Three months)
- post-operative International Prostate Symptom Score (IPSS) score.(Three months)
- weight of resected prostatic tissues(Three months)
研究者
Mohamed Fawzy Hassan Mahdy Elsyaad
Principal Investigator
Helwan University