Meatal StenosisNCT06834698
Steroid Treatment for Meatal Stenosis
An observational study of Meatal Stenosis, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 16 years, men only
- Conditions the study is for
- Meatal Stenosis
- What is being tested?
- Betamethasone Cream and meatotomy
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 15 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- Men only
- No healthy volunteers
- Child
Study population: The study included patients who were treated for meatal stenosis.
Who may be able to join
- Presence of meatal stenosis
Who cannot join
- Presence of any anatomical problem or history of surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sancaktepe Ilhan Varank Training and Research Hospital
Istanbul, Sancaktepe, 34000
About this study
Official title: 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.
- Conditions
- Meatal Stenosis
- Being tested
- Betamethasone Cream, meatotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betamethasone CreamDrug
Betamethasone 0.1% cream was administered to the external meatus twice per day for a duration of 21 days.
meatotomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Topical steroid | Not described Receives: Drug: Betamethasone Cream | |
| Meatotomy | Not described Receives: Procedure: meatotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start1 Sep 2022
- Primary completion30 Dec 2024
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meatal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834698
- Sponsor's protocol ID
- 2024/243
- Status last verified
- Jun 2025
- First submitted
- 7 Feb 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Steroid Treatment for Meatal Stenosis: Clinical Outcomes and Uroflowmetry Assessment of Treatment Success
- ClinicalTrials.gov ID
- NCT06834698
- Acronym / sponsor ID
- 2024/243
- Conditions
- Meatal Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical steroid | – | Drug: Betamethasone Cream |
| Meatotomy | – | Procedure: meatotomy |
Who may qualify
- Ages
- Up to 16 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study included patients who were treated for meatal stenosis.
Key inclusion criteria (1 listed)
- Presence of meatal stenosis
Key exclusion criteria (1 listed)
- Presence of any anatomical problem or history of surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Betamethasone CreamBetamethasone 0.1% cream was administered to the external meatus twice per day for a duration of 21 days. | Drug | Topical steroid |
| meatotomyIn 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. | Procedure or surgery | Meatotomy |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meatal Stenosis, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients who showed significant clinical improvement over the course of the study (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.