Using Tele-rehabilitation on Management of Pediatric Nocturnal Enuresis

NCT ID: NCT07108062

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-29
• Study Completion Date: 2026-03-29

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

Conditions

Enuresis Nocturnal; Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study Group

Receives Tele-rehabilitation (lifestyle + dietary advice)

Group Type: EXPERIMENTAL

Experimental

Intervention Type: OTHER

(lifestyle + dietary advice)

Control Group

Does not receive tele-rehabilitation

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

No intervention

Interventions

Experimental

(lifestyle + dietary advice)

Intervention Type: OTHER

Placebo

No intervention

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: collaborator

Hungarian University of Sports Science

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Abdelaziz Emam

Lecturer assistant at of Basic Sciences Department , Faculty of Physical Therapy, Kafrelsheikh Univerisity, Kafrelsheikh 33511, Egypt | PhD Researcher Hungarian University of Sports science, Budapest, Hungary

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of physical therapy kfs university

Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt

Countries

Egypt

Other Identifiers

KFSIRB200-671

Identifier Type: -

Identifier Source: org_study_id