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

NCT05078788 | Completed

• 1 other identifier: M D 98/ 2020
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Urethral Stricture

Outcome Measures

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.

  3 and 6 months

Study Arms (2)

Laser uretherotomy

EXPERIMENTAL

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

Procedure: Laser uretherotomy

Laser uretherotomy with intralesional steroids

EXPERIMENTAL

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

Laser uretherotomy PROCEDURE

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

Laser uretherotomy with triamcinolone PROCEDURE

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.

Laser uretherotomy with intralesional steroids

Eligibility Criteria

• Age: 26 Years - 69 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams university

Cairo, Egypt

Location

MeSH Terms

Conditions

Urethral Stricture

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: October 15, 2021
• Study Start: June 2, 2020
• Primary Completion: February 2, 2021
• Study Completion: September 10, 2021
• Last Updated: October 15, 2021

Record last verified: 2021-09

Locations

EG (1)