跳至主要内容
临床试验/NCT01073241
NCT01073241Unknown不适用

Transurethral Ventral Wall of Urethra-preserving Enucleation of Prostate

Southwest Hospital, China2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2010年3月1日最近更新:
适应症

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

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

研究者

发起方
Southwest Hospital, China
申办方类型
Other

研究点 (2)

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