- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07424651
Hidden Link Between Meatal Stenosis and Primary Nocturnal Enuresis in Children
Investigating the Hidden Link Between Meatal Stenosis and Primary Nocturnal Enuresis in Children
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Cairo Governorate
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New Valley, Cairo Governorate, Egypt, 72511
- New Valley University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Study group
Patients who underwent meatoplasty.
|
Patients diagnosed with primary nocturnal enuresis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 years from collecting the data from the database
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resolution of primary nocturnal enuresis post-meatoplasty
Time Frame: 3 years from collecting the data from the database
|
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.
|
3 years from collecting the data from the database
|
|
Need for Revision Meatoplasty
Time Frame: 3 years from collecting the data from the database
|
Need for Revision Meatoplasty was assessed in patients due to persistent or recurrent meatal stenosis after the initial surgery.
|
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
|
Prevalence of Meatal Stenosis in primary nocturnal enuresis patients was assessed among children diagnosed with primary nocturnal enuresis within the study period (2021-2024).
|
3 years from collecting the data from the database
|
|
Incidence of complications
Time Frame: 3 years from collecting the data from the database
|
Any complications or adverse events following meatoplasty, including infection, scarring, or urinary retention were recorded.
|
3 years from collecting the data from the database
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025130002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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