Role of Oral Steroids in Reducing Recurrence of Urethral Stricture After Direct Vision Internal Urethrotomy

September 26, 2021 updated by: Dr. SamiUllah, Services Hospital, Lahore
It was a randomized controlled trial conducted at department of Urology, Armed Forces Institute of Urology, Rawalpindi from 1st January, 2018 July 2019 to 31st March 2021 to determine the role of oral steroids after Direct Vision Internal Urethrotomy to reduce the recurrence rate of urethral strictures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

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

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 54000
        • Armed Force Institute of Urology

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

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Patients with urethral stricture with restricted urine flow of < 15 ml/min on uroflowmetry

Exclusion Criteria:

  • Patients presenting with post-anastomotic urethroplasty strictures (assessed on history and medical record),
  • Patients with post-TURP strictures
  • Patients with neurogenic bladder
  • Patients with prior history of steroid use
  • Patients with extravasation during optical internal urethrotomy

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral Steroid
In this group oral steroids were given after Direct vision internal urethrotomy
Drug: Steroid Drug
In this group Oral steroid medication after Direct Vision Internal Urethrotomy
Other Names:
  • Oral steroid medication
Placebo Comparator: No Oral Steroids
In this group no oral steroids were given after Direct vision internal urethrotomy
Drug: No steroid
In this group no Oral steroid medication (palcebo medication) after Direct Vision Internal Urethrotomy
Other Names:
  • Placebo Medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of Urethral Stricture
Time Frame: 6 months post-operatively
Number of patients presenting with recurrence of urethral stricture after direct vision internal urethrotomy
6 months post-operatively

Collaborators and Investigators

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

Sponsor

Services Hospital, Lahore

Collaborators

Armed Forces Institute of Urology, Rawalpindi

Investigators

  • Study Director: Barza Afzal, MBBS, FCPS, barza_afzal@hotmail.com

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)

January 1, 2018

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

March 31, 2021

Study Registration Dates

First Submitted

September 26, 2021

First Submitted That Met QC Criteria

September 26, 2021

First Posted (Actual)

October 6, 2021

Study Record Updates

Last Update Posted (Actual)

October 6, 2021

Last Update Submitted That Met QC Criteria

September 26, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AF1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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