Skip to main content
OpenTrials
Completed

NCT Number: NCT05078788

Holmium Laser Uretherotomy in Combination With Intralesional Steroids in Bulbar Uretheral Stricture

the purpose is to evaluate the outcome of visual internal uretherotomy with Holmium laser along with intralesional steroid injection.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urethral Stricture Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urethral Diseases Urethral Obstruction Urogenital Diseases Urologic Diseases

Age range

26 year–69 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams university

Cairo, Egypt

About this study

In this study, the investigator evaluates the efficacy of Holmium laser in combination with intra lesional steroid injection in the treatment of bulbar urethral strictures

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presence of obstructive symptoms,
  • Short segment strictures (stricture length <2 cm) as evident on radiological studies, i.e. retrograde urethrography and micturating cystourethrography.
  • Peak flow rate on uroflowmetry less than 15 ml/s

Exclusion criteria

  • Complete obliteration of lumen of urethra on urethroscopy,
  • Balanitis Xerotica Obliterans,
  • Age less than 18 years,
  • Multiple strictures,
  • Active urinary tract infection,
  • Recurrent Strictures.
  • Prior internal uretherotomy
  • Prior urethroplasty
  • Pan-anterior urethral strictures
  • Posterior stenosis
  • Those who lost to follow up

Treatment and study plan

Laser uretherotomy

Procedure

Holmium YAG Laser with pulse energy from 1-2 Joule, frequency from 10-15 Hertz and total power from 3.0 to 30.0 Watt were set up, respectively, based on the extent of the lesions. Scar tissue was incised at the position of 12-o'clock under the guidance of guidewire or ureteric catheter till fresh mucosa appeared.

Laser uretherotomy with triamcinolone

Procedure

After laser urethrotomy, 80 mg of triamcinolone (diluted with normal saline to 10 ml) will be injected by using an injection needle (5 F size and 23 G needle size) at 10 sites, 1 ml each, along the site of urethrotomy and circumferentially.

Primary outcomes

  1. the maximum flow rate (Qmax) is >15 ml/s at 3 and 6 months after procedure

    Time frame: 3 and 6 months

    The procedure will be accepted as successful when the maximum flow rate (Qmax) is >15 ml/s.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Efficacy of Holmium Laser Uretherotomy in Combination With Intralesional Steroids in the Treatment of Bulbar Uretheral Stricture

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 15, 2021
Registry last updated
Oct 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.