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CompletedNCT05078788Updated Oct 15, 2021

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

An interventional study of Laser uretherotomy and Laser uretherotomy with triamcinolone in Urethral Stricture, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to male participants aged 26 Years to 69 Years. Per ClinicalTrials.gov, last updated 2021-10-15.

Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Jun 2020, registered Sep 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
26 Years to 69 Years
Sex
Male
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Study summary

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

Read the detailed description

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

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Conditions studied

  • Urethral Stricture
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In context

Urethral Stricture

68 studies on the registry are indexed under Urethral Stricture; 23 are open to participants now.

This study's enrollment of 124 is above the median of 60 across 53 interventional studies indexed under Urethral Stricture.

Browse Urethral Stricture studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
26 Years to 69 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Complete obliteration of lumen of urethra on urethroscopy,
  2. Balanitis Xerotica Obliterans,
  3. Age less than 18 years,
  4. Multiple strictures,
  5. Active urinary tract infection,
  6. Recurrent Strictures.
  7. Prior internal uretherotomy
  8. Prior urethroplasty
  9. Pan-anterior urethral strictures
  10. Posterior stenosis
  11. Those who lost to follow up
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
124 participants (actual)

Study arms

  • Experimental
    Laser uretherotomy

    Using Holmium laser uretherotomy only in the treatment of bulbar uretheral stricture

    Procedure: Laser uretherotomy

  • Experimental
    Laser uretherotomy with intralesional steroids

    Using holmium laser uretherotomy with injection of 80 mg of triamcinolone (diluted with normal saline to 10 ml) in the treatment of bulbar uretheral stricture

    Procedure: Laser uretherotomy with triamcinolone

Interventions

  • ProcedureLaser uretherotomy

    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.

  • ProcedureLaser uretherotomy with triamcinolone

    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.

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What researchers measure

Primary outcomes

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

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

    Time frame: 3 and 6 months

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Study locations

1 site
  • Ain Shams university
    Cairo, Egypt
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05078788
Lead sponsor
Ain Shams University
Responsible party
Sponsor
First posted
Oct 15, 2021
Start date
Jun 2, 2020
Primary completion
Feb 2, 2021
Completion
Sep 10, 2021
Last update
Oct 15, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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