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

Urethral Stricture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05078788
• Other study ID #: M D 98/ 2020
• Status: Completed
• Phase: N/A
• Start date: June 2, 2020
• Est. completion date: September 10, 2021

Study information

• Verified date: September 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: September 10, 2021
• Est. primary completion date: February 2, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 26 Years to 69 Years

Eligibility

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:

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Urethral Stricture

Intervention

Procedure:
• Laser 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.
• Laser 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.

Locations

Country	Name	City	State
Egypt	Ain Shams university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 and 6 months