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

NCT ID: NCT05069883

Last Updated: 2021-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2021-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Recurrence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Oral Steroid

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

Group Type EXPERIMENTAL

Steroid Drug

Intervention Type DRUG

In this group Oral steroid medication after Direct Vision Internal Urethrotomy

No Oral Steroids

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

Group Type PLACEBO_COMPARATOR

No steroid

Intervention Type DRUG

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

Interventions

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Steroid Drug

In this group Oral steroid medication after Direct Vision Internal Urethrotomy

Intervention Type DRUG

No steroid

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

Intervention Type DRUG

Other Intervention Names

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Oral steroid medication Placebo Medication

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Armed Forces Institute of Urology, Rawalpindi

OTHER

Sponsor Role collaborator

Services Hospital, Lahore

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. SamiUllah

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barza Afzal, MBBS, FCPS

Role: STUDY_DIRECTOR

[email protected]

Locations

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Armed Force Institute of Urology

Rawalpindi, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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AF1

Identifier Type: -

Identifier Source: org_study_id

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