Using Tele-rehabilitation on Management of Pediatric Nocturnal Enuresis

NCT07108062 | Active Not Recruiting DMC

• 1 other identifier: KFSIRB200-671
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence; Enuresis Nocturnal

Keywords

Enuresis; Bedwetting; Urinary Incontinence; Nocturnal

Outcome Measures

Primary Outcomes (2)

• number of wet nights/week

  The number of bedwetting episodes recorded by the caregiver during one week.

  Baseline and 4 weeks after completion of telerehabilitation intervention

• Pediatric Quality of Life scores

  Child 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.

  Baseline and 4 weeks after completion of telerehabilitation intervention

Study Arms (2)

Study Group

EXPERIMENTAL

Receives Tele-rehabilitation (lifestyle + dietary advice)

Other: Experimental

Control Group

PLACEBO COMPARATOR

Does not receive tele-rehabilitation

Other: Placebo

Interventions

Experimental OTHER

(lifestyle + dietary advice)

Study Group

Placebo OTHER

No intervention

Control Group

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hungarian University of Sports Science: lead
• Kafrelsheikh University: collaborator

Study Sites (1)

Faculty of physical therapy kfs university

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511, Egypt

Location

MeSH Terms

Conditions

Nocturnal Enuresis; Urinary Incontinence; Enuresis

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Model Details: 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.

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 6, 2025
• Study Start: June 29, 2025
• Primary Completion: March 29, 2026
• Study Completion: March 29, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The individual participant data (IPD) and supporting documentation will be made available on Zenodo beginning 6 months after publication of the study results. The data will remain publicly accessible for a minimum of 5 years from the upload date.
• Access Criteria: De-identified IPD, the study protocol, and data dictionary will be openly available to the public via Zenodo. Anyone may access and download the dataset under a Creative Commons license (e.g., CC BY 4.0). Users must agree to use the data for research or educational purposes only, with proper citation of the dataset and original publication.

Locations

EG (1)