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Clinical Trials/CTRI/2025/03/082748
CTRI/2025/03/082748
Not yet recruiting
Not Applicable

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 site in 1 country40 target enrollmentStarted: May 1, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
40
Locations
1
Primary Endpoint
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

Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 99.00 Year(s) (—)
Sex
Male

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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

Time Frame: 3 months

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Abinash Paul

AIIMS RISHIKESH

Study Sites (1)

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