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临床试验/CTRI/2025/03/082748
CTRI/2025/03/082748尚未招募不适用

To compare the outcomes of visual internal urethrotomy for short segment anterior urethral stricture using thulium laser versus cold knife A Prospective Exploratory Study

AIIMS RISHIKESH1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年5月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
To compare the change in peak flow rate,post void residual and IPSS Score of Thulium laser visual internal urethrotomy with that of cold knife visual internal urethrotomy for short segment upto 1 cm anterior urethral stricture in adult males at 1 and 3 months after intervention

研究概览

简要总结

This study is a non randomised,open label, parallel group,single centre trial comparing the outcomes of Thulium laser visual internal urethrotomy with that of cold knife visual internal urethrotomy for short segment upto 1 cm anterior urethral stricture in adult males at  1 and 3 months after intervention.This will be conducted in department of Urology, AIIMS RISHIKESH.The primary outcome measure will be change in peak flow rate, post void residual and IPSS Score at 1 and 3 months post intervention.The Secondary outcome measure will be Recurrence rates, change in IPSS Score, post op complications rate and change in IIEF Score at 1 and 3 months post intervention.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
Male

入选标准

  • Short Segment Anterior Urethral stricture upto 1 cm Newly diagnosed Cases and failure following a single previous Visual internal urethrotomy.

排除标准

  • Long segment urethral stricture greater than 1 cm Multiple Strictures Recurrent Urethral stricture after 2 attempts of internal urethrotomy Obliterative Urethral stricture even guidewire could not be passed Patient not providing informed consent Active UTI.

结局指标

主要结局

To compare the change in peak flow rate,post void residual and IPSS Score of Thulium laser visual internal urethrotomy with that of cold knife visual internal urethrotomy for short segment upto 1 cm anterior urethral stricture in adult males at 1 and 3 months after intervention

时间窗: 3 months

次要结局

  • To compare the recurrence rates at 1 and 3 Months of follow up in either procedures
  • To compare the patient reported outcome measures at 1 and 3 months of follow up in either procedures(3 months)
  • To compare the incidence of Complications in either procedures at 1 and 3 months follow up(3 months)
  • To compare the change in sexual function in either procedures at 1 and 3 months follow up(3 months)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Abinash Paul

AIIMS RISHIKESH

研究点 (1)

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