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

Recurrence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05069883
• Other study ID #: AF1
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: March 31, 2021

Study information

• Verified date: March 2021
• Source: Services Hospital, Lahore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Recurrence
• Urethral Stricture

Intervention

Drug:
• Steroid Drug
In this group Oral steroid medication after Direct Vision Internal Urethrotomy
• No steroid
In this group no Oral steroid medication (palcebo medication) after Direct Vision Internal Urethrotomy

Locations

Country	Name	City	State
Pakistan	Armed Force Institute of Urology	Rawalpindi	Punjab

Sponsors (2)

Lead Sponsor	Collaborator
Services Hospital, Lahore	Armed Forces Institute of Urology, Rawalpindi

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of Urethral Stricture	Number of patients presenting with recurrence of urethral stricture after direct vision internal urethrotomy	6 months post-operatively