Nocturnal EnuresisEMNENCT07753304
Empowering Mothers of Children With Nocturnal Enuresis to Improve Knowledge, Practices, and Quality of Life
A study testing Mother Empowerment Program for Nocturnal Enuresis in people with Nocturnal Enuresis, run by Cairo University at 1 site in Egypt.
Trial summary
This study aimed to evaluate the effect of the empowerment program on the knowledge, practices, and quality of life of mothers of children with nocturnal enuresis in a two-arm randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Nocturnal Enuresis
- What is being tested?
- Mother Empowerment Program for Nocturnal Enuresis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Sep 2024to 29 Jun 2025
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria Mothers aged 18 years or older. Mothers of school-age children diagnosed with nocturnal enuresis. Child aged 6-12 years attending the outpatient urinary incontinence clinic at the Centre for Social and Preventive Medicine, Cairo University.
Able to communicate in Arabic. Willing to participate and provide written informed consent. Available to complete baseline, post-intervention (4 weeks), and 3-month follow-up assessments.
Exclusion Criteria Mothers of children with secondary nocturnal enuresis caused by serious neurological, endocrine, or structural urinary tract disorders.
Mothers whose children have severe cognitive impairment or medical conditions preventing participation in the educational program.
Mothers currently participating in another structured educational or behavioral intervention related to nocturnal enuresis.
Mothers unwilling or unable to provide informed consent or complete study assessments.
Mothers planning to relocate or unlikely to complete follow-up evaluations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Empowering Mothers of Children With Nocturnal Enuresis on Knowledge, Practices and Quality of Life
This study aimed to evaluate the effect of the empowerment program on the knowledge, practices, and quality of life of mothers of children with nocturnal enuresis in a two-arm randomized controlled trial.
Read the detailed description
Nocturnal enuresis is a common pediatric condition that adversely affects children's physical, psychological, and social well-being, as well as the quality of life of their families. Mothers play a central role in the day-to-day management of children with nocturnal enuresis; however, insufficient knowledge and inappropriate management practices may reduce the effectiveness of treatment and increase the family burden.
Objective: This randomized controlled trial aimed to evaluate the effectiveness of an empowerment program for mothers of children with nocturnal enuresis in improving their knowledge, self-reported practices, and quality of life.
Methods: A two-arm parallel randomized controlled trial was conducted at the Outpatient Urinary Incontinence Clinic, Centre for Social and Preventive Medicine, Cairo University, Egypt. A total of 200 eligible mothers were randomly allocated to either an intervention group that received the structured empowerment program or a wait-list control group that received routine care during the study period. Outcomes were assessed at baseline (T0), four weeks after the intervention (T1), and three months after the intervention (T2).
- Conditions
- Nocturnal Enuresis
- Being tested
- Mother Empowerment Program for Nocturnal Enuresis
- Keywords
- Empowerment; Mothers; Nocturnal Enuresis; Knowledge; Practices; Quality of Life.
- Medical subject headings
- Nocturnal Enuresis, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mother Empowerment Program for Nocturnal EnuresisBehavioural
Also called Structured Educational Empowerment Program, Family Empowerment Program
The intervention is a structured nurse-led behavioral empowerment program designed for mothers of school-age children with nocturnal enuresis. The program is delivered in Arabic through 30-minute small-group sessions (3-5 mothers per group) using interactive teaching, discussion, and an educational booklet developed by the research team. The educational content includes the definition and types of nocturnal enuresis, causes and risk factors, diagnostic evaluation, complications, behavioral management strategies, fluid management, bladder training, reward systems, alarm therapy, medication adherence, hygiene measures, and family support strategies. Mothers receive the educational booklet at the completion of the sessions for continued home reference. The intervention aims to improve maternal knowledge, caregiving practices, and family quality of life. Participants are evaluated at baseline (T0), 4 weeks after the intervention (T1), and 3 months after the intervention
| Study group | Role | What they receive |
|---|---|---|
| Empowerment Program | Experimental | Mothers assigned to this arm receive a structured empowerment program for managing children with nocturnal enuresis. The program consists of 30-minute small-group educational sessions (3-5 mothers per group) delivered in Arabic using lectures, discussions, and an educational booklet developed by the researchers. The program covers the definition, types, risk factors, diagnosis, complications, and evidence-based management of nocturnal enuresis, with the aim of improving maternal knowledge, caregiving practices, and quality of life. Participants are assessed at baseline (T0), 4 weeks (T1), and 3 months (T2). Receives: Behavioral: Mother Empowerment Program for Nocturnal Enuresis |
| Usual Care (Waitlist Control) | No intervention | Mothers assigned to this arm receive the routine care provided at the outpatient urinary incontinence clinic during the study period without the structured empowerment program. Participants complete the same outcome assessments at baseline (T0), 4 weeks (T1), and 3 months (T2). After completion of the T2 assessment, mothers in the waitlist control group receive the full empowerment program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mothers' Knowledge Regarding Nocturnal Enuresis
Mothers' knowledge regarding nocturnal enuresis will be assessed using the researcher-developed Nocturnal Enuresis Structured Knowledge Questionnaire (15 items).
Knowledge scoring system: "Two" scores were given for a completely correct answer, "one" score for an incomplete correct answer, and "zero" for an incorrect or unknown answer. The higher scores reflect higher levels of knowledge about nocturnal enuresis. The total knowledge scores are categorized into three levels: unsatisfactory knowledge (less than 50%), partially satisfactory knowledge (50%-75%), and satisfactory knowledge (more than 75%).
Measured: Baseline (T0), 4 weeks after intervention (T1), and 3 months after intervention (T2)
Secondary outcomes (2)
Mothers' Self-Reported Practices Regarding Nocturnal Enuresis
Mothers' self-reported practices will be assessed using a researcher-developed 15-item checklist covering behavioral management practices, including fluid management, bladder training, reward systems, alarm therapy, hygiene, and follow-up care. Each performed practice is scored as 1 and each non-performed practice as 0. Higher scores indicate better practice.
Self-reported practices scoring system: Each item was given one score if performed, and a score of zero for actions not performed. Total scores were classified as follows: poor practices (less than 50%), fair practices (50%-75%), and good practices (more than 75%).
Measured: Baseline (T0), 4 weeks after intervention (T1), and 3 months after intervention (T2)
Mothers' Quality of Life
Mothers' quality of life will be measured using the Modified Pediatric Enuresis Module on Quality of Life-Short Form (PEMQOL-SF). The instrument consists of 16 items evaluating the impact of nocturnal enuresis on the child and family. Scores are transformed to a 0-100 scale according to the instrument scoring guidelines.
The PEMQOL-Short Form is made up of 16 questions: 7 questions concerning the impact on the child's well-being (child impact scale) and 9 questions concerning its impact on the family's emotional and social well-being (family impact scale). Response options for both scales have five levels each: A lot, Quite a bit, Some, A little bit, and Not at all. For ease of interpretation, the raw scale scores are converted to a 0-100 continuum using a standard mathematical formula. A score of more than 50 is considered a significant effect on psychological well-being.
Measured: Baseline (T0), 4 weeks after intervention (T1), and 3 months after intervention (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start25 Sep 2024
- Primary completion27 Mar 2025
- Study completion29 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nocturnal EnuresisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized controlled trial aims to evaluate the effectiveness of a structured educational empowerment program delivered to mothers of children diagnosed with nocturnal enuresis. Eligible participants will be randomly assigned to either the intervention group or the control group. Mothers in the intervention group will receive a comprehensive educational program that includes information about nocturnal enuresis, behavioral management techniques, lifestyle modifications, bladder training, fluid management, positive reinforcement strategies, and psychological support. Participants in the control group will receive routine care provided by the study setting. Outcomes will be measured before the intervention and after completion of the educational program using validated questionnaires assessing knowledge, caregiving practices, and quality of life.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manal Mohamed Elsawy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753304
- Sponsor's protocol ID
- 05-10-2024
- Acronym
- EMNE
- Status last verified
- Aug 2024
- First submitted
- 4 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tsuji S, Kaneko K. Management of treatment-resistant nocturnal enuresis. Pediatr Int. 2023 Jan-Dec;65(1):e15573. doi: 10.1111/ped.15573.
PubMed 37428825Kamperis K. Nocturnal enuresis in children: The role of arginine-vasopressin. Handb Clin Neurol. 2021;181:289-297. doi: 10.1016/B978-0-12-820683-6.00021-X.
PubMed 34238464Cammisa I, Zona M, Ferrara P. Management of nocturnal enuresis in children. Minerva Pediatr (Torino). 2025 Aug;77(4):360-371. doi: 10.23736/S2724-5276.25.07812-7. Epub 2025 Feb 18.
PubMed 39964278Guzman JA, Palmer LS. Nocturnal Enuresis. Pediatr Rev. 2024 Aug 1;45(8):479-481. doi: 10.1542/pir.2023-006166. No abstract available.
PubMed 39085181Elsawy MM, Shokr EA, Atress MS, Al Ali MF, Zabin LM, Mousa KM. Effect of empowering mothers of children with nocturnal enuresis on knowledge, practices and quality of life. J Pediatr Nurs. 2026 Oct 30;92:96-104. doi: 10.1016/j.pedn.2026.10.035. Online ahead of print.
PubMed 42962350
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Empowering Mothers of Children With Nocturnal Enuresis on Knowledge, Practices and Quality of Life
- ClinicalTrials.gov ID
- NCT07753304
- Acronym / sponsor ID
- EMNE / 05-10-2024
- Conditions
- Nocturnal Enuresis
- Keywords
- Empowerment; Mothers; Nocturnal Enuresis; Knowledge; Practices; Quality of Life.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 27 Mar 2025 (actual)
- Study completion
- 29 Jun 2025 (actual)
- First posted
- 7 Aug 2026 (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.
This study aimed to evaluate the effect of the empowerment program on the knowledge, practices, and quality of life of mothers of children with nocturnal enuresis in a two-arm randomized controlled trial.
Detailed description
Nocturnal enuresis is a common pediatric condition that adversely affects children's physical, psychological, and social well-being, as well as the quality of life of their families. Mothers play a central role in the day-to-day management of children with nocturnal enuresis; however, insufficient knowledge and inappropriate management practices may reduce the effectiveness of treatment and increase the family burden.
Objective: This randomized controlled trial aimed to evaluate the effectiveness of an empowerment program for mothers of children with nocturnal enuresis in improving their knowledge, self-reported practices, and quality of life.
Methods: A two-arm parallel randomized controlled trial was conducted at the Outpatient Urinary Incontinence Clinic, Centre for Social and Preventive Medicine, Cairo University, Egypt. A total of 200 eligible mothers were randomly allocated to either an intervention group that received the structured empowerment program or a wait-list control group that received routine care during the study period. Outcomes were assessed at baseline (T0), four weeks after the intervention (T1), and three months after the intervention (T2).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This randomized controlled trial aims to evaluate the effectiveness of a structured educational empowerment program delivered to mothers of children diagnosed with nocturnal enuresis. Eligible participants will be randomly assigned to either the intervention group or the control group. Mothers in the intervention group will receive a comprehensive educational program that includes information about nocturnal enuresis, behavioral management techniques, lifestyle modifications, bladder training, fluid management, positive reinforcement strategies, and psychological support. Participants in the control group will receive routine care provided by the study setting. Outcomes will be measured before the intervention and after completion of the educational program using validated questionnaires assessing knowledge, caregiving practices, and quality of life.
| Arm | Type | Receives |
|---|---|---|
| Empowerment Program | Experimental | Behavioral: Mother Empowerment Program for Nocturnal EnuresisMothers assigned to this arm receive a structured empowerment program for managing children with nocturnal enuresis. The program consists of 30-minute small-group educational sessions (3-5 mothers per group) delivered in Arabic using lectures, discussions, and an educational booklet developed by the researchers. The program covers the definition, types, risk factors, diagnosis, complications, and evidence-based management of nocturnal enuresis, with the aim of improving maternal knowledge, caregiving practices, and quality of life. Participants are assessed at baseline (T0), 4 weeks (T1), and 3 months (T2). |
| Usual Care (Waitlist Control) | No intervention | –Mothers assigned to this arm receive the routine care provided at the outpatient urinary incontinence clinic during the study period without the structured empowerment program. Participants complete the same outcome assessments at baseline (T0), 4 weeks (T1), and 3 months (T2). After completion of the T2 assessment, mothers in the waitlist control group receive the full empowerment program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Mother Empowerment Program for Nocturnal EnuresisAlso: Structured Educational Empowerment Program, Family Empowerment ProgramThe intervention is a structured nurse-led behavioral empowerment program designed for mothers of school-age children with nocturnal enuresis. The program is delivered in Arabic through 30-minute small-group sessions (3-5 mothers per group) using interactive teaching, discussion, and an educational booklet developed by the research team. The educational content includes the definition and types of nocturnal enuresis, causes and risk factors, diagnostic evaluation, complications, behavioral management strategies, fluid management, bladder training, reward systems, alarm therapy, medication adherence, hygiene measures, and family support strategies. Mothers receive the educational booklet at the completion of the sessions for continued home reference. The intervention aims to improve maternal knowledge, caregiving practices, and family quality of life. Participants are evaluated at baseline (T0), 4 weeks after the intervention (T1), and 3 months after the intervention | Behavioural | Empowerment Program |
Primary outcome
Mothers' Knowledge Regarding Nocturnal Enuresis
Time frame: Baseline (T0), 4 weeks after intervention (T1), and 3 months after intervention (T2)
Mothers' knowledge regarding nocturnal enuresis will be assessed using the researcher-developed Nocturnal Enuresis Structured Knowledge Questionnaire (15 items). Knowledge scoring system: "Two" scores were given for a completely correct answer, "one" score for an incomplete correct answer, and "zero" for an incorrect or unknown answer. The higher scores reflect higher levels of knowledge about nocturnal enuresis. The total knowledge scores are categorized into three levels: unsatisfactory knowledge (less than 50%), partially satisfactory knowledge (50%-75%), and satisfactory knowledge (more than 75%).
2 secondary outcomes
Mothers' Self-Reported Practices Regarding Nocturnal Enuresis
Time frame: Baseline (T0), 4 weeks after intervention (T1), and 3 months after intervention (T2)
Mothers' Quality of Life
Time frame: Baseline (T0), 4 weeks after intervention (T1), and 3 months after intervention (T2)
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 11 Aug 2026.
- Background: PubMed 37428825Tsuji S, Kaneko K. Management of treatment-resistant nocturnal enuresis. Pediatr Int. 2023 Jan-Dec;65(1):e15573. doi: 10.1111/ped.15573.
- Background: PubMed 34238464Kamperis K. Nocturnal enuresis in children: The role of arginine-vasopressin. Handb Clin Neurol. 2021;181:289-297. doi: 10.1016/B978-0-12-820683-6.00021-X.
- Background: PubMed 39964278Cammisa I, Zona M, Ferrara P. Management of nocturnal enuresis in children. Minerva Pediatr (Torino). 2025 Aug;77(4):360-371. doi: 10.23736/S2724-5276.25.07812-7. Epub 2025 Feb 18.
- Background: PubMed 39085181Guzman JA, Palmer LS. Nocturnal Enuresis. Pediatr Rev. 2024 Aug 1;45(8):479-481. doi: 10.1542/pir.2023-006166. No abstract available.
- Derived from this study: PubMed 42962350Elsawy MM, Shokr EA, Atress MS, Al Ali MF, Zabin LM, Mousa KM. Effect of empowering mothers of children with nocturnal enuresis on knowledge, practices and quality of life. J Pediatr Nurs. 2026 Oct 30;92:96-104. doi: 10.1016/j.pedn.2026.10.035. Online ahead of print.
- Individual participant dataSharing planned: No
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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 Mother Empowerment Program for Nocturnal Enuresis in people with Nocturnal Enuresis, run by Cairo University 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?
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 11 Aug 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. 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?
Mothers' Knowledge Regarding Nocturnal Enuresis (time frame: Baseline (T0), 4 weeks after intervention (T1), and 3 months after intervention (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07753304, which also lists 5 linked publications.
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 11 Aug 2026.