Steroid Treatment for Meatal Stenosis

NCT06834698 | Completed DMC

• 1 other identifier: 2024/243
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the efficacy of topical steroid treatment for meatal stenosis. The main question it aims to answer is: Is steroid therapy effective for treatment of meatal stenosis? Participants already treated for meatal stenosis will be included.

Conditions

Meatal Stenosis

Outcome Measures

Primary Outcomes (1)

• The number of patients who showed significant clinical improvement over the course of the study

  The resolution of symptoms such as straining, hesitancy, interrupted voiding, thin urine stream, and storage symptoms (e.g., urgency, frequency, urge incontinence) along with improved urination were considered indicators of treatment success. All patients underwent assessment through physical examination and observation of the urinary stream during micturition.

  2 months

Secondary Outcomes (1)

• The number of participants who exhibited treatment-related improvements in voiding curve pattern and maximal urine flow rate, as assessed by uroflowmetry, which measures the free flow of urine during micturition

  2 months

Study Arms (2)

Topical steroid

Drug: Betamethasone Cream

Meatotomy

Procedure: meatotomy

Interventions

Betamethasone Cream DRUG

Betamethasone 0.1% cream was administered to the external meatus twice per day for a duration of 21 days.

Topical steroid

meatotomy PROCEDURE

In the event of steroid therapy failure, a meatotomy was performed under general anesthesia. The procedure involved squashing the ventral aspect of the pinpoint meatus for approximately 3-5 millimeters for 10 seconds and then incising it. The mucosal margins were sutured with absorbable sutures to avoid renarrowing. Urethral catheterization was not employed, and the procedure was performed on an outpatient basis. Patients were discharged following urination.

Meatotomy

Eligibility Criteria

• Age: Up to 16 Years
• Gender Eligibility Details: This study is about external urethral meatal stenosis, which is seen in boys.
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study included patients who were treated for meatal stenosis.

You may qualify if:

• Presence of meatal stenosis

You may not qualify if:

• Presence of any anatomical problem or history of surgery

Sponsors & Collaborators

• Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital: lead

Study Sites (1)

Sancaktepe Ilhan Varank Training and Research Hospital

Istanbul, Sancaktepe, 34000, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 19, 2025
• Study Start: September 1, 2022
• Primary Completion: December 30, 2024
• Study Completion: May 15, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

TU (1)