Transurethral Ventral Wall of Urethra-preserving Enucleation of Prostate
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- urodynamic study
研究概览
简要总结
In this study, the investigators designed a randomized and double-blind prospective trial to evaluate the efficiency and safety of the investigators new approach-transurethral ventral wall of urethra-preserving enucleation of prostate in comparison with TURP for the hyperplasia weighing more than 45 g.
详细描述
Although in recent dozen of years, laser operation and other safer minimally invasive surgeries have been well-developed, transurethral resection of the prostate (TURP) is still the gold standard for the surgical treatment of benign prostatic hyperplasia, despite of its various complications, and not suitable for the hyperplasia over 80 g which should be resected under open surgery. In this study, we design a randomized and double-blind prospective trial to evaluate the efficiency and safety of our new approach-transurethral ventral wall of urethra-preserving enucleation of prostate in comparison with TURP for the hyperplasia weighing more than 45 g.Urodynamic examination [maximum flow rate (QMax), detrusor pressure, and so on], transrectal color Doppler ultrasonography for the prostate, blood routine, blood electrolyte, prostate specific antigen (PSA), International Prostate Symptom Score (IPSS), the quality of life (Qol), blood loss during operation, and the weight of resected prostate were studied before and after the operation.
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
- 45 Years 至 90 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •BPH was diagnosed by DRE, Ultrasonography, CT or MR
- •IPSS:>15
- •Qmax:≤10ml/s and volume of bladder >200ml
- •The weight of prostate >45g
排除标准
- •Patient with other aggravating malignant tumor
- •Total-PSA>20ng/ml, or 4<total-PSA<20ng/ml but the value of Free-PSA/total-PSA<0.16
- •The maximum press of detrusor muscle <15cmH2O
- •Patient with urethral stricture
- •Patient with urinary infection
- •Patient with Nervous System Disease
- •Patient with surgical contraindication, such as severe cardiac or lung disease, diaphragmatic hernias, and so on
结局指标
主要结局
urodynamic study
时间窗: before operation and the third month, 6th month after operation
次要结局
未报告次要终点
