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

October 1, 2021 updated by: Ain Shams University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laser uretherotomy
Using Holmium laser uretherotomy only in the treatment of bulbar uretheral stricture
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.
Experimental: Laser uretherotomy with intralesional steroids
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the maximum flow rate (Qmax) is >15 ml/s at 3 and 6 months after procedure
Time Frame: 3 and 6 months
The procedure will be accepted as successful when the maximum flow rate (Qmax) is >15 ml/s.
3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2020

Primary Completion (Actual)

February 2, 2021

Study Completion (Actual)

September 10, 2021

Study Registration Dates

First Submitted

September 21, 2021

First Submitted That Met QC Criteria

October 1, 2021

First Posted (Actual)

October 15, 2021

Study Record Updates

Last Update Posted (Actual)

October 15, 2021

Last Update Submitted That Met QC Criteria

October 1, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M D 98/ 2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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