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OpenTrials
Completed

NCT Number: NCT06834698

Steroid Treatment for Meatal Stenosis

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.

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Key information

Conditions

Age range

Up to 16 year

Sex eligibility

Male

Study type

Observational

Primary location

Sancaktepe Ilhan Varank Training and Research Hospital

Istanbul, Sancaktepe, 34000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presence of meatal stenosis

Exclusion criteria

  • Presence of any anatomical problem or history of surgery

Treatment and study plan

Betamethasone Cream

Drug

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

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.

Primary outcomes

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

    Time frame: 2 months

    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.

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

    Time frame: 2 months

    Uroflowmetry is a diagnostic test that evaluates the flow of urine during micturition (urination), providing valuable insights into bladder function and obstruction.

    The voiding curve pattern refers to the shape and flow characteristics of the urine stream during urination. A normal voiding pattern typically presents a bell shape, reflecting a steady and consistent flow of urine without interruptions. However, in certain conditions, such as urinary tract obstruction or bladder dysfunction, the voiding curve may become irregular, showing reduced flow or intermittent pauses. A plateau-shaped voiding curve is typically observed in conditions like meatal stenosis. Improvement in the voiding curve pattern following treatment indicates that urine flow has become more consistent and efficient.

    Maximal urine flow rate (Qmax) is the highest rate at which urine is expelled during micturition. This measurement is important for assessing bladder function and identifying potential urinary flow iss

Sponsors and collaborators

Lead sponsor

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Other

Registry information

Official study title

Topical Steroid Treatment for Meatal Stenosis: Clinical Outcomes and Uroflowmetry Assessment of Treatment Success

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Feb 19, 2025
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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