Steroid Treatment for Meatal Stenosis

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

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.

Study Overview

• Status: Completed
• Conditions: Meatal Stenosis
• Intervention / Treatment: Drug: Betamethasone Cream; Procedure: meatotomy

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Turkey
  • Sancaktepe
    • Istanbul, Sancaktepe, Turkey, 34000
      • Sancaktepe Ilhan Varank Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study included patients who were treated for meatal stenosis.

Description

Inclusion Criteria:

• Presence of meatal stenosis

Exclusion Criteria:

• Presence of any anatomical problem or history of surgery

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Topical steroid	Drug: Betamethasone Cream; Betamethasone 0.1% cream was administered to the external meatus twice per day for a duration of 21 days.
Meatotomy	Procedure: meatotomy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	2 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): May 15, 2025

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): February 19, 2025

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Respiratory System Agents; Anti-Asthmatic Agents; Betamethasone
• Other Study ID Numbers: 2024/243

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No