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

Not Applicable

Completed

• Conditions: Urethral Stricture
• Interventions: Procedure: Laser uretherotomy with triamcinolone; Procedure: Laser uretherotomy

• Registration Number: NCT05078788
• Lead Sponsor: Ain Shams University

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

Study Timeline

• Study Start: 2020-06-02
• Primary Completion: 2021-02-02
• Status Verified: 2021-09
• Study Completion: 2021-09-10
• Study First Submitted: 2021-09-21
• Study First Submitted QC: 2021-10-01
• Last Update Submitted: 2021-10-01
• Study First Posted: 2021-10-15
• Last Update Posted: 2021-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 124

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

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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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser uretherotomy with intralesional steroids	Laser uretherotomy with triamcinolone	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
Laser uretherotomy	Laser uretherotomy	Using Holmium laser uretherotomy only in the treatment of bulbar uretheral stricture

Primary Outcome Measures

Name	Time	Method
the maximum flow rate (Qmax) is >15 ml/s at 3 and 6 months after procedure	3 and 6 months	The procedure will be accepted as successful when the maximum flow rate (Qmax) is \>15 ml/s.

Trial Locations

Locations (1)

Ain Shams university; 🇪🇬 Cairo, Egypt