Meatal StenosisNCT07424651
Hidden Link Between Meatal Stenosis and Primary Nocturnal Enuresis in Children
An observational study of Meatal Stenosis and Primary Nocturnal Enuresis, run by New Valley University at 1 site in Egypt.
Trial summary
This study aimed to investigate the association between meatal stenosis and primary nocturnal enuresis severity, and evaluated therapeutic outcomes following surgical correction. Read more about this study
- Who is it for?
- Ages 7 to 12 years, men only
- Conditions the study is for
- Meatal Stenosis, Primary Nocturnal Enuresis, Children
- What is being tested?
- Meatoplasty Primary nocturnal enuresis.
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Jan 2021to 10 Mar 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 7 to 12 years
- Men only
- No healthy volunteers
- Child
Study population: This retrospective study population includes male children aged 7-12 years who presented with primary nocturnal enuresis at a pediatric urology clinic between October 2022 and December 2024.
Who may be able to join
- Male children aged 7-12 years.
- Diagnosed with primary nocturnal enuresis.
- Evaluated and treated at the study center between January 2021 and December 2024.
- Confirmed diagnosis of meatal stenosis based on clinical examination and uroflowmetry when indicated.
- Patients who underwent meatoplasty and completed the prescribed follow-up period.
Who cannot join
- Secondary enuresis (previously dry for ≥ 6 months before recurrence of bedwetting).
- Known neurological disorders (e.g., spina bifida, cerebral palsy) or developmental delays.
- Structural anomalies of the urinary tract other than meatal stenosis (e.g., posterior urethral valves, vesicoureteral reflux).
- Children who did not complete the follow-up or had incomplete clinical records.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Hidden Link Between Meatal Stenosis and Primary Nocturnal Enuresis in Children
This study aimed to investigate the association between meatal stenosis and primary nocturnal enuresis severity, and evaluated therapeutic outcomes following surgical correction.
Read the detailed description
Primary nocturnal enuresis (PNE) is a prevalent pediatric condition characterized by involuntary urination during sleep in children aged five years or older who have never achieved consistent nighttime dryness. The prevalence of PNE decreases with age, affecting approximately 15% of five-year-old and decreasing to 1-2% by adolescence.
Meatal stenosis, defined as the pathological narrowing of the urethral meatus, is an underexplored potential factor. This condition is known to cause obstructed urinary flow, incomplete bladder emptying, and increased bladder pressure, all of which may contribute to enuresis.
The incidence of meatal stenosis is higher in circumcised males but can also occur in uncircumcised males and females due to inflammation, trauma, or infection
- Conditions
- Meatal Stenosis, Primary Nocturnal Enuresis, Children
- Being tested
- Meatoplasty Primary nocturnal enuresis.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meatoplasty Primary nocturnal enuresis.Procedure or surgery
Patients diagnosed with primary nocturnal enuresis.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients who underwent meatoplasty. Receives: Procedure: Meatoplasty Primary nocturnal enuresis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between Meatal Stenosis and primary nocturnal enuresis
Association between Meatal Stenosis and primary nocturnal enuresis was assessed to determine whether there is a significant relationship between the presence of meatal stenosis and the occurrence of primary nocturnal enuresis in male children aged 7-12 years.
Measured: 3 years from collecting the data from the database
Secondary outcomes (4)
Resolution of primary nocturnal enuresis post-meatoplasty
Resolution of primary nocturnal enuresis post-meatoplasty was assessed to assess the effectiveness of meatoplasty in resolving primary nocturnal enuresis in children with meatal stenosis.
Measured: 3 years from collecting the data from the database
Need for Revision Meatoplasty
Need for Revision Meatoplasty was assessed in patients due to persistent or recurrent meatal stenosis after the initial surgery.
Measured: 3 years from collecting the data from the database
Prevalence of Meatal Stenosis in primary nocturnal enuresis patients
Prevalence of Meatal Stenosis in primary nocturnal enuresis patients was assessed among children diagnosed with primary nocturnal enuresis within the study period (2021-2024).
Measured: 3 years from collecting the data from the database
Incidence of complications
Any complications or adverse events following meatoplasty, including infection, scarring, or urinary retention were recorded.
Measured: 3 years from collecting the data from the database
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start31 Jan 2021
- Primary completion10 Mar 2025
- Study completion10 Mar 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waheed Fawzy Abdelrasol, New Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424651
- Sponsor's protocol ID
- 2025130002
- Status last verified
- Feb 2026
- First submitted
- 14 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Hidden Link Between Meatal Stenosis and Primary Nocturnal Enuresis in Children
- ClinicalTrials.gov ID
- NCT07424651
- Acronym / sponsor ID
- 2025130002
- Conditions
- Meatal Stenosis, Primary Nocturnal Enuresis, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- New Valley UniversityUniversity, hospital or other
- Study start
- 31 Jan 2021 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 20 Feb 2026 (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.
This study aimed to investigate the association between meatal stenosis and primary nocturnal enuresis severity, and evaluated therapeutic outcomes following surgical correction.
Detailed description
Primary nocturnal enuresis (PNE) is a prevalent pediatric condition characterized by involuntary urination during sleep in children aged five years or older who have never achieved consistent nighttime dryness. The prevalence of PNE decreases with age, affecting approximately 15% of five-year-old and decreasing to 1-2% by adolescence.
Meatal stenosis, defined as the pathological narrowing of the urethral meatus, is an underexplored potential factor. This condition is known to cause obstructed urinary flow, incomplete bladder emptying, and increased bladder pressure, all of which may contribute to enuresis.
The incidence of meatal stenosis is higher in circumcised males but can also occur in uncircumcised males and females due to inflammation, trauma, or infection
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Procedure: Meatoplasty Primary nocturnal enuresis.Patients who underwent meatoplasty. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This retrospective study population includes male children aged 7-12 years who presented with primary nocturnal enuresis at a pediatric urology clinic between October 2022 and December 2024.
Key inclusion criteria (5 listed)
- Male children aged 7-12 years.
- Diagnosed with primary nocturnal enuresis.
- Evaluated and treated at the study center between January 2021 and December 2024.
- Confirmed diagnosis of meatal stenosis based on clinical examination and uroflowmetry when indicated.
- Patients who underwent meatoplasty and completed the prescribed follow-up period.
Key exclusion criteria (4 listed)
- Secondary enuresis (previously dry for ≥ 6 months before recurrence of bedwetting).
- Known neurological disorders (e.g., spina bifida, cerebral palsy) or developmental delays.
- Structural anomalies of the urinary tract other than meatal stenosis (e.g., posterior urethral valves, vesicoureteral reflux).
- Children who did not complete the follow-up or had incomplete clinical records.
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 |
|---|---|---|
| Meatoplasty Primary nocturnal enuresis.Patients diagnosed with primary nocturnal enuresis. | Procedure or surgery | Study group |
Primary outcome
Association between Meatal Stenosis and primary nocturnal enuresis
Time frame: 3 years from collecting the data from the database
Association between Meatal Stenosis and primary nocturnal enuresis was assessed to determine whether there is a significant relationship between the presence of meatal stenosis and the occurrence of primary nocturnal enuresis in male children aged 7-12 years.
4 secondary outcomes
Resolution of primary nocturnal enuresis post-meatoplasty
Time frame: 3 years from collecting the data from the database
Need for Revision Meatoplasty
Time frame: 3 years from collecting the data from the database
Prevalence of Meatal Stenosis in primary nocturnal enuresis patients
Time frame: 3 years from collecting the data from the database
Incidence of complications
Time frame: 3 years from collecting the data from the database
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 20 Feb 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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 and Primary Nocturnal Enuresis, run by New Valley University at 1 site in Egypt.
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 5 inclusion and 4 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 20 Feb 2026. 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 Egypt. 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?
Association between Meatal Stenosis and primary nocturnal enuresis (time frame: 3 years from collecting the data from the database). 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 20 Feb 2026.