Back to resultsRole of Oral Steroids in Reducing Recurrence of Urethral Stricture After Direct Vision Internal Urethrotomy
Primary Purpose
Recurrence
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Steroid Drug
No steroid
Sponsored by
About this trial
This is an interventional prevention trial for Recurrence
Eligibility Criteria
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
Sites / Locations
- Armed Force Institute of Urology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Oral Steroid
No Oral Steroids
Arm Description
In this group oral steroids were given after Direct vision internal urethrotomy
In this group no oral steroids were given after Direct vision internal urethrotomy
Outcomes
Primary Outcome Measures
Recurrence of Urethral Stricture
Number of patients presenting with recurrence of urethral stricture after direct vision internal urethrotomy
Secondary Outcome Measures
Full Information
NCT ID
NCT05069883
First Posted
September 26, 2021
Last Updated
September 26, 2021
Sponsor
Services Hospital, Lahore
Collaborators
Armed Forces Institute of Urology, Rawalpindi
1. Study Identification
Unique Protocol Identification Number
NCT05069883
Brief Title
Role of Oral Steroids in Reducing Recurrence of Urethral Stricture After Direct Vision Internal Urethrotomy
Official Title
Role of Oral Steroids in Reducing Recurrence of Urethral Stricture After Direct Vision Internal Urethrotomy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Services Hospital, Lahore
Collaborators
Armed Forces Institute of Urology, Rawalpindi
4. Oversight
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
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrence
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral Steroid
Arm Type
Experimental
Arm Description
In this group oral steroids were given after Direct vision internal urethrotomy
Arm Title
No Oral Steroids
Arm Type
Placebo Comparator
Arm Description
In this group no oral steroids were given after Direct vision internal urethrotomy
Intervention Type
Drug
Intervention Name(s)
Steroid Drug
Other Intervention Name(s)
Oral steroid medication
Intervention Description
In this group Oral steroid medication after Direct Vision Internal Urethrotomy
Intervention Type
Drug
Intervention Name(s)
No steroid
Other Intervention Name(s)
Placebo Medication
Intervention Description
In this group no Oral steroid medication (palcebo medication) after Direct Vision Internal Urethrotomy
Primary Outcome Measure Information:
Title
Recurrence of Urethral Stricture
Description
Number of patients presenting with recurrence of urethral stricture after direct vision internal urethrotomy
Time Frame
6 months post-operatively
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barza Afzal, MBBS, FCPS
Organizational Affiliation
barza_afzal@hotmail.com
Official's Role
Study Director
Facility Information:
Facility Name
Armed Force Institute of Urology
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Role of Oral Steroids in Reducing Recurrence of Urethral Stricture After Direct Vision Internal Urethrotomy
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