Back to resultsHolmium Laser Uretherotomy in Combination With Intralesional Steroids in Bulbar Uretheral Stricture
Primary Purpose
Urethral Stricture
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laser uretherotomy
Laser uretherotomy with triamcinolone
Sponsored by
About this trial
This is an interventional treatment trial for Urethral Stricture
Eligibility Criteria
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
Sites / Locations
- Ain Shams university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Laser uretherotomy
Laser uretherotomy with intralesional steroids
Arm Description
Using Holmium laser uretherotomy only in the treatment of bulbar uretheral stricture
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05078788
First Posted
September 21, 2021
Last Updated
October 1, 2021
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT05078788
Brief Title
Holmium Laser Uretherotomy in Combination With Intralesional Steroids in Bulbar Uretheral Stricture
Official Title
Efficacy of Holmium Laser Uretherotomy in Combination With Intralesional Steroids in the Treatment of Bulbar Uretheral Stricture
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 2, 2020 (Actual)
Primary Completion Date
February 2, 2021 (Actual)
Study Completion Date
September 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
the purpose is to evaluate the outcome of visual internal uretherotomy with Holmium laser along with intralesional steroid injection.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urethral Stricture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laser uretherotomy
Arm Type
Experimental
Arm Description
Using Holmium laser uretherotomy only in the treatment of bulbar uretheral stricture
Arm Title
Laser uretherotomy with intralesional steroids
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Laser uretherotomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Laser uretherotomy with triamcinolone
Intervention Description
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 Outcome Measure Information:
Title
the maximum flow rate (Qmax) is >15 ml/s at 3 and 6 months after procedure
Description
The procedure will be accepted as successful when the maximum flow rate (Qmax) is >15 ml/s.
Time Frame
3 and 6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
26 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ain Shams university
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Holmium Laser Uretherotomy in Combination With Intralesional Steroids in Bulbar Uretheral Stricture
We'll reach out to this number within 24 hrs