NCT05069883

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
Last Updated

October 6, 2021

Status Verified

March 1, 2021

Enrollment Period

3.2 years

First QC Date

September 26, 2021

Last Update Submit

September 26, 2021

Conditions

Recurrence

Outcome Measures

Primary Outcomes (1)

  • Recurrence of Urethral Stricture

    Number of patients presenting with recurrence of urethral stricture after direct vision internal urethrotomy

    6 months post-operatively

Study Arms (2)

Oral Steroid

EXPERIMENTAL

In this group oral steroids were given after Direct vision internal urethrotomy

Drug: Steroid Drug

No Oral Steroids

PLACEBO COMPARATOR

In this group no oral steroids were given after Direct vision internal urethrotomy

Drug: No steroid

Interventions

Steroid DrugDRUG

In this group Oral steroid medication after Direct Vision Internal Urethrotomy

Also known as: Oral steroid medication
Oral Steroid
No steroidDRUG

In this group no Oral steroid medication (palcebo medication) after Direct Vision Internal Urethrotomy

Also known as: Placebo Medication
No Oral Steroids

Eligibility Criteria

Age20 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Armed Force Institute of Urology

Rawalpindi, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Barza Afzal, MBBS, FCPS

    barza_afzal@hotmail.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 26, 2021

First Posted

October 6, 2021

Study Start

January 1, 2018

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

October 6, 2021

Record last verified: 2021-03

Locations

PA(1)