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Using Tele-rehabilitation on Management of Pediatric Nocturnal Enuresis

Using Tele-rehabilitation on Management of Pediatric Nocturnal Enuresis: Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07108062
Acronym
UTMPNE
Enrollment
69
Registered
2025-08-06
Start date
2025-06-29
Completion date
2026-01-29
Last updated
2026-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enuresis Nocturnal, Urinary Incontinence

Keywords

Enuresis, Bedwetting, Urinary Incontinence, Nocturnal

Brief summary

Objective: To evaluate the effectiveness of telerehabilitation (via lifestyle and dietary advice) in managing primary nocturnal enuresis (bedwetting) in children aged 5-10 years. Background: Nocturnal enuresis is common in children and can be influenced by genetic, hormonal, and bladder-related factors. Treatment includes behavioral, pharmacological, and psychological approaches. Telerehabilitation-remote delivery of care-emerged during the COVID-19 pandemic as a promising tool for maintaining continuity of care. Methodology: Design: Randomized Controlled Trial Participants: Children aged 5-10 with primary NE (wetting ≥4 nights/week), recruited online. Exclusion: Children with secondary NE due to medical conditions or those on medication. Groups: Study group: Received telerehabilitation (lifestyle + dietary guidance). Control group: No telerehabilitation. Duration: 3 weeks (1 week baseline, 1 week intervention, 1 week follow-up) Assessment: Number of wet nights per week (using ICCS classification: responders, partial responders, non-responders) Pediatric quality of life Intervention Details: Telerehabilitation involved dietary recommendations (e.g., reducing evening fluid intake, avoiding caffeine/chocolate), lifestyle tips, and motivational counseling delivered remotely to caregivers. Data Analysis: Pre- and post-intervention outcomes compared using paired t-tests. Demographics and clinical characteristics recorded.

Detailed description

Introduction & Background: Nocturnal Enuresis (NE) is the involuntary urination during sleep in children over 5 years of age, commonly known as bedwetting. It often causes psychological and social distress. Several contributing factors include: Genetics - Children with a family history are at higher risk. Bladder dysfunction - Overactive or underactive bladders can contribute. Hormonal imbalances - Especially a deficiency in antidiuretic hormone (ADH), which leads to excessive nighttime urine production. NE is classified as: Primary NE: The child has never achieved nighttime dryness. Secondary NE: The child had achieved dryness but started wetting again. It can also be: Mono-symptomatic (nighttime only) Non-mono-symptomatic (includes daytime symptoms) Current Treatments: Behavioral: Bedwetting alarms, bladder training Pharmacological: Desmopressin (synthetic ADH), oxybutynin Psychological: Counseling and emotional support Role of Telerehabilitation: Telerehabilitation is a branch of telehealth offering remote rehabilitation services via communication technologies. Benefits include: Useful where direct provider access is limited Cost-effective and time-saving Increases access to care in underserved or rural areas Particularly valuable during public health emergencies (e.g., COVID-19) Reduces waiting times for therapy Study Aim: To assess the effectiveness of telerehabilitation-specifically lifestyle and dietary advice delivered remotely-in reducing the frequency of bedwetting in children with primary NE. Methodology: Design: Randomized Controlled Trial (RCT) Participants: Inclusion Criteria: Children aged 5-10 years Diagnosed with primary NE Bedwetting occurs more than 4 nights per week Exclusion Criteria: Secondary NE due to neurological/musculoskeletal/congenital conditions On pharmacological treatment for NE Recruitment: Online via social media Parents filled out a screening form Informed consent obtained from caregivers Sample size calculated using G-Power software Group Allocation: Study Group: Received telerehabilitation (lifestyle + dietary advice) Control Group: Did not receive any intervention Intervention Details (Telerehabilitation): Duration: 1 week of intervention, following a 1-week baseline, with 1-week post-treatment follow-up Components: Lifestyle and Motivational Counseling (based on Hjalmas et al., 2004): Reassurance ("You WILL become dry!") Regular voiding and fluid intake routines Encourage calm bedtime routines Educate parents and child about normal bladder function Dietary Advice (based on Pietro Ferrara et al., 2015): Recommended Foods: Vegetables, cereals, eggs, yogurt, fruits (pineapple, banana), fish Avoid at Evening: Milk, cheese, salty foods Avoid Completely: Chocolate, caffeine, carbonated drinks, citrus juices Outcome Measures: Reduction in Wet Nights (per ICCS classification): Non-responder: \<50% reduction Partial responder: 50-99% reduction Full responder: 100% dry nights Pediatric Quality of Life: Measured pre- and post-treatment Assessment Procedure: Week 1: Baseline recording of wet nights Week 2: Intervention period (study group only) Week 3: Follow-up assessment for both groups Data Collection & Analysis: Demographics: Age, sex, weight, family history of NE Clinical data: Frequency of wet nights Descriptive stats: Means ± SEM for quantitative data; percentages for qualitative Paired t-test: To compare outcomes before and after telerehabilitation Expected Outcomes: Reduction in bedwetting frequency in the study group receiving telerehabilitation Improvement in quality of life metrics Demonstrated feasibility and benefit of remote intervention in pediatric NE management

Interventions

OTHERExperimental

(lifestyle + dietary advice)

OTHERPlacebo

No intervention

Sponsors

Hungarian University of Sports Science
Lead SponsorOTHER
Kafrelsheikh University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

participants are randomly assigned to one of two groups, and each group receives a different intervention Study Group: Receives telerehabilitation (lifestyle + dietary advice) Control Group: Does not receive telerehabilitation Participants in each group are treated simultaneously but independently, which is the hallmark of a parallel design.

Eligibility

Sex/Gender
ALL
Age
5 Years to 10 Years
Healthy volunteers
No

Inclusion criteria

* Children aged 5 to 10 years. * Diagnosed with primary nocturnal enuresis. * Experience more than 4 wet nights per week. * No prior pharmacological treatment for enuresis. * Caregiver is willing to provide informed consent and participate in remote sessions.

Exclusion criteria

Diagnosis of secondary nocturnal enuresis due to: * Neurological disorders * Musculoskeletal problems * Congenital abnormalities * Currently receiving or recently received pharmacological treatment for nocturnal enuresis. * Inability to participate in telehealth or remote intervention sessions. * Caregiver does not consent to participation.

Design outcomes

Primary

MeasureTime frameDescription
number of wet nights/weekBaseline and 4 weeks after completion of telerehabilitation interventionThe number of bedwetting episodes recorded by the caregiver during one week.
Pediatric Quality of Life scoresBaseline and 4 weeks after completion of telerehabilitation interventionChild and parent-reported outcomes using the Pediatric Quality of Life Inventory (PedsQL 4.0 Generic Core Scales). This validated tool measures physical, emotional, social, and school functioning. Total score ranges from 0 to 100, where higher scores indicate better quality of life.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026