Enuresis NocturnalUTMPNENCT07108062
Using Tele-rehabilitation on Management of Pediatric Nocturnal Enuresis
A study testing Experimental in people with Enuresis Nocturnal and Urinary Incontinence, run by Hungarian University of Sports Science at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Enuresis Nocturnal, Urinary Incontinence
- What is being tested?
- Experimental
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Jun 2025to 29 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of physical therapy kfs university
Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511
About this study
Official title: Using Tele-rehabilitation on Management of Pediatric Nocturnal Enuresis: Randomized Controlled Trial
Objective:
To evaluate the effectiveness of telerehabilitation (via lifestyle and dietary advice) in managing primary nocturnal enuresis (bedwetting) in children aged 5-10 years.
Read more
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.
Read the 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
- Being tested
- Experimental, Placebo
- Keywords
- Enuresis, Bedwetting, Urinary Incontinence, Nocturnal
- Medical subject headings
- Nocturnal Enuresis, Urinary Incontinence, Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
(lifestyle + dietary advice)
PlaceboOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Receives Tele-rehabilitation (lifestyle + dietary advice) Receives: Other: Experimental |
| Control Group | Placebo comparator | Does not receive tele-rehabilitation Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of wet nights/week
The number of bedwetting episodes recorded by the caregiver during one week.
Measured: 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.
Measured: Baseline and 4 weeks after completion of telerehabilitation intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start29 Jun 2025
- Primary completion29 Jan 2026
- Study completion29 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enuresis NocturnalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hungarian University of Sports Science
- Sponsor type
- University, hospital or other
- Collaborators
- Kafrelsheikh University
- Responsible party
- Principal investigator, Mohamed Abdelaziz Emam, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108062
- Sponsor's protocol ID
- KFSIRB200-671
- Acronym
- UTMPNE
- Status last verified
- Jul 2025
- First submitted
- 29 Jul 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan Description: The following specific Individual Participant Data (IPD) will be shared: Demographic Data: Participant age Sex Weight Family history of nocturnal enuresis (in parents or siblings) Clinical Baseline Data: Number of wet nights per week at baseline Type of enuresis (primary mono-symptomatic) Intervention Details: Group allocation (study vs. control) Telerehabilitation session logs (adherence to advice) Outcome Data: Number of wet nights post-intervention Classification according to ICCS criteria (non-responder, partial responder, responder) Pediatric quality of life scores (pre- and post-intervention) Adverse Events (if any): Reports of negative outcomes or non-compliance issues during the intervention
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Tele-rehabilitation on Management of Pediatric Nocturnal Enuresis: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07108062
- Acronym / sponsor ID
- UTMPNE / KFSIRB200-671
- Conditions
- Enuresis Nocturnal, Urinary Incontinence
- Keywords
- Enuresis, Bedwetting, Urinary Incontinence, Nocturnal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Hungarian University of Sports ScienceUniversity, hospital or other
- Collaborators
- Kafrelsheikh University
- Study start
- 29 Jun 2025 (actual)
- Primary completion
- 29 Jan 2026 (actual)
- Study completion
- 29 Jan 2026 (actual)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: ExperimentalReceives Tele-rehabilitation (lifestyle + dietary advice) |
| Control Group | Placebo comparator | Other: PlaceboDoes not receive tele-rehabilitation |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental(lifestyle + dietary advice) | Other | Study Group |
| PlaceboNo intervention | Other | Control Group |
Primary outcome
number of wet nights/week
Time frame: Baseline and 4 weeks after completion of telerehabilitation intervention
The number of bedwetting episodes recorded by the caregiver during one week.
Pediatric Quality of Life scores
Time frame: Baseline and 4 weeks after completion of telerehabilitation intervention
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: Yes. Plan Description: The following specific Individual Participant Data (IPD) will be shared: Demographic Data: Participant age Sex Weight Family history of nocturnal enuresis (in parents or siblings) Clinical Baseline Data: Number of wet nights per week at baseline Type of enuresis (primary mono-symptomatic) Intervention Details: Group allocation (study vs. control) Telerehabilitation session logs (adherence to advice) Outcome Data: Number of wet nights post-intervention Classification according to ICCS criteria (non-responder, partial responder, responder) Pediatric quality of life scores (pre- and post-intervention) Adverse Events (if any): Reports of negative outcomes or non-compliance issues during the intervention
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Enuresis Nocturnal and Urinary Incontinence, run by Hungarian University of Sports Science at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of wet nights/week (time frame: Baseline and 4 weeks after completion of telerehabilitation intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.