Hidden Link Between Meatal Stenosis and Primary Nocturnal... | NCT07424651

Studies
Hidden Link Between Meatal Stenosis and Primary Nocturnal Enuresis in Children

NCT07424651

Sponsor

New Valley University

Status

Completed

Last Update Posted

Feb 20, 2026Actual

Enrollment

400Actual

Phase

Not provided

Conditions

Meatal Stenosis
Primary Nocturnal Enuresis
Children

Interventions

Meatoplasty Primary nocturnal enuresis.

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 31, 2021Actual

Primary Completion Date

Mar 10, 2025Actual

Completion Date

Mar 10, 2025Actual

First Submitted Date

Feb 14, 2026

First Submission Date that Met QC Criteria

Feb 14, 2026

First Posted Date

Feb 20, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2026

Last Update Posted Date

Feb 20, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Waheed Fawzy Abdelrasol, Lecturer of Urology, Faculty of medicine, New Vally University, New Vally, Egypt, New Valley UniversityPrincipal Investigator

Lead Sponsor

New Valley UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group		Patients who underwent meatoplasty.	Procedure: Meatoplasty Primary nocturnal enuresis.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Meatoplasty Primary nocturnal enuresis.	Procedure	Patients diagnosed with primary nocturnal enuresis.	Study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	3 years from collecting the data from the database

Secondary Outcomes

Measure	Description	Time Frame
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.	3 years from collecting the data from the database
Need for Revision Meatoplasty

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Males diagnosed with primary nocturnal enuresis

Minimum Age

7 Years

Maximum Age

12 Years

Standard Ages

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New Valley University		New Valley	Cairo Governorate	72511	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Types

Study Protocol

Time Frame

The data will be available upon a reasonable request from the corresponding author.

Access Criteria

After the end of study for one year.

URL

Not provided