Comparison of Pasmakinetic Enucleation of the Prostate With Bipolar Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Hypertrophy Patients With Large Prostate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- time of catheterization
研究概览
简要总结
The goal of this study is to compare the perioperative and postoperative characters of plasmakinetic enucleation of the prostate(PkEP) with bipolar TURP(B-TURP) for BPH patients with large prostate.
详细描述
Despite the availability of numerous minimally invasive alternatives, monopolar transurethral resection of the prostate (TURP) remains the most frequently performed operation for benign prostatic hypertrophy (BPH) with small to moderate size prostates. Nevertheless, TURP for large prostates is associated with various complications and unsatisfactory long-term results. B-TURP and PkEP have both been proved to have more favorable postoperative outcomes than monopolar TURP. But whether B-TURP or PkEP is better remain controversial. We aim to compare the perioperative and postoperative characters of PkEP with B-TURP for BPH patients with large prostate. Moreover, we evaluate the long-term results of both approaches.
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 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Qmax < 10 mL/s, IPSS >19
- •Age between 50 and 70 years
- •Prostate volume between 70 and 200 mL, as determined by TRUS, and medical therapy failure.
排除标准
- •Patients with neurogenic bladder
- •Urethral stricture
- •Bladder tumor
- •Prostate cancer and previous prostate bladder neck
- •Urethral surgery
- •PSA>4ng/ml, or receiving prostate biopsy within 3 months
结局指标
主要结局
time of catheterization
At the end of both procedures, a 22F three-way Folley catheter was inserted and continuous bladder irrigation was performed. Irrigation was discontinued when the catheter drainage became clear, and the catheter was removed 6 h later.Two experienced urologists who were unaware of the surgical modality used decided bladder irrigation and catheter removal for all cases.
次要结局
- changes in serum haemoglobin as a measure of one of the complications
- Operation time
- resected adenoma weight as a measure of treatment efficacy
- postoperative International Prostate Symptom Score as a measure of treatment efficacy and durability(5 years)
- postoperative Qmax as a masure of treatment efficacy and durability(5 years)
- re-operation rate as a measure of durability(5 years)