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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05078788
Other study ID # M D 98/ 2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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