- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07508111
Causes and Types of Nocturnal Enuresis in Children
A Descriptive Study on the Causes and Types of Nocturnal Enuresis Among Children Attending Assiut University Children's Hospital
Nocturnal enuresis, commonly known as bedwetting, is a frequent condition that affects many children and can have a significant impact on their self-esteem, social life, and family stress. The causes of bedwetting can vary widely, ranging from deep sleep patterns and excess nighttime urine production to underlying medical conditions like constipation, urinary tract infections, or enlarged tonsils and adenoids (which can affect breathing during sleep).The main goal of this descriptive study is to understand the different types and the underlying causes of bedwetting among children attending the pediatric outpatient clinics at Assiut University Children's Hospital. By identifying these specific causes in the local population, healthcare providers can offer better, more targeted treatments and help reduce the stigma surrounding this condition.
During a single clinic visit, researchers will collect information through a structured interview with the parents and the child. The study involves a routine physical examination, including checking weight, height, and looking for physical signs of constipation or enlarged tonsils. Participants will also undergo standard tests to help pinpoint any medical causes, such as a urine test (urinalysis and culture), a basic ultrasound of the abdomen and pelvis, and potentially plain X-rays if issues like severe constipation or airway blockages are suspected.
The study aims to include at least 80 male and female children aged 5 years and older who have been experiencing bedwetting at least twice a week for three months or more.
Study Overview
Status
Detailed Description
This research is a descriptive, cross-sectional study conducted at the pediatric outpatient clinics of Assiut University Hospital. It assesses a single cohort of children presenting with nocturnal enuresis at a specific point in time to determine the prevalence, types, and associated causes of their condition, without longitudinal follow-up or comparison against a pre-defined control group.
Data collection utilizes a structured checklist derived from clinical guidelines, administered by the principal investigator during a single clinic visit for each subject. The assessment includes the following components:
- Comprehensive History Taking: A semi-structured interview will classify the enuresis as primary or secondary, and mono-symptomatic or poly-symptomatic. The history will systematically evaluate potential contributing factors, including constipation (utilizing the Bristol Stool Scale and Rome IV criteria), history of urinary tract infections (UTIs), symptoms of adenotonsillar hypertrophy (e.g., mouth breathing, snoring, observed sleep apnea), dietary habits (caffeine and fluid intake patterns), current medications, and family history.
- Physical Examination: Subjects will undergo a targeted physical examination, including anthropometric measurements (weight, height, BMI percentiles). An oral examination will grade tonsil and adenoid size using the Brodsky scale. Further screening includes an abdominal examination for fecal loading or palpable masses, a genitourinary inspection, and screening for spinal malformations (e.g., inspecting the sacral area for dimples or hair tufts indicative of spina bifida occulta).
- Routine Investigations: All participants will undergo same-day routine laboratory and imaging investigations, including urinalysis, urine culture and sensitivity, and an abdominal/pelvic ultrasound.
- Conditional/Advanced Investigations: Depending on clinical indications and the presence of "red flags," additional diagnostics may be ordered. These include plain X-rays (KUB for constipation/stones or lateral neck X-rays for adenoidal-nasopharyngeal ratio), MRI of the spine or brain for suspected neurological anomalies, urodynamics for suspected bladder dysfunction or outlet obstruction, and polysomnography for suspected obstructive sleep apnea.
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male and female children aged above 5 years.
- Presenting with nocturnal enuresis, defined as involuntary voiding during sleep for ≥2 nights/week for ≥3 months.
- Parents or caregivers providing informed consent, including child assent where applicable.
Exclusion Criteria:
- Children with known neurological disorders, such as epilepsy or cerebral palsy.
- Presence of an acute urinary tract infection (indicated by a positive urine culture requiring treatment).
- Children diagnosed with diabetes mellitus.
- Structural anomalies of the urinary system requiring immediate surgery, such as severe hypospadias.
- Families unwilling to participate or complete follow-up data collection.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Children with Nocturnal Enuresis
Male and female children over 5 years of age presenting with nocturnal enuresis (involuntary voiding during sleep ≥2 nights/week for ≥3 months) at the pediatric outpatient clinics at Assiut University Hospital.
This observational cohort will be evaluated via clinical history, physical examination, and routine laboratory and imaging investigations.
The purpose is to determine the prevalence, types (primary vs. secondary, mono vs. polysymptomatic), and associated causes (e.g., constipation, UTI, adenotonsillar hypertrophy, malformations) of their condition.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Participants with Identified Medical Causes for Nocturnal Enuresis
Time Frame: Up to 7 days from the initial clinic visit
|
The proportion of enrolled children diagnosed with underlying medical conditions contributing to nocturnal enuresis.
This is determined through structured clinical history, physical examinations, and diagnostic investigations.
Specific underlying factors evaluated include constipation (assessed using the Bristol Stool Scale and Rome IV criteria) , urinary tract infections (confirmed via urine culture) , and adenotonsillar hypertrophy (assessed using the Brodsky scale).
The outcome will be reported as the percentage of the study cohort presenting with one or more of these identified medical conditions.
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Up to 7 days from the initial clinic visit
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Mental Disorders
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urination Disorders
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Behavioral Symptoms
- Elimination Disorders
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Enuresis
- Urinary Incontinence
- Nocturnal Enuresis
Other Study ID Numbers
- Nocturnal Enuresis Causes
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