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临床试验/NCT07837167
NCT07837167已完成3 期

The Effect of Platelet Rich Plasma Injection on Post Internal Urethrotomy Stricture Recurrence

Benha University1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2024年2月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
156
试验地点
1
主要终点
Post-voiding residual urine volume (PVR)

研究概览

简要总结

The effect of platelet rich plasma injection on post internal urethrotomy stricture recurrence

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
20 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •patients with symptomatic bulbar urethral stricture (diagnosed by retrograde urethrography) aged between 20 and 50 years.

排除标准

  • •History or medical evidence of symptomatic benign prostatic enlargement.
  • •documented or suspicious prostate cancer.
  • •history of hypospadias, neurogenic disorders.
  • •previous internal urethrotomy or urethral reconstruction.
  • •strictures longer than 1.5 cm.
  • •multiple strictures.

研究组 & 干预措施

PRP in stricture urethra

Active Comparator

干预措施: PRP injection (Drug)

viu in stricture urethra

Placebo Comparator

干预措施: VIU (Procedure)

结局指标

主要结局

Post-voiding residual urine volume (PVR)

时间窗: 2 weeks

Post-voiding residual urine volume will be measured by ultrasonography , Unit of Measure : ml .

Maximum urinary flow rate (Qmax)

时间窗: 2 weeks

Maximum urinary flow rate will be assessed by uroflowmetry , Unit of Measure : ml/second

次要结局

  • recurrence of stricture urethra(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mostafa Ali Mahmoud

urology lecturer , urology department ,principal investigator ,benha university

Benha University

研究点 (1)

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