ClinicalTrials.gg
CompletedNCT07753304EMNEUpdated Aug 11, 2026

Empowering Mothers of Children With Nocturnal Enuresis to Improve Knowledge, Practices, and Quality of Life

An interventional study of Mother Empowerment Program for Nocturnal Enuresis in Nocturnal Enuresis, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by Cairo University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Sep 2024, registered Aug 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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 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).

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Conditions studied

  • Nocturnal Enuresis

Keywords

  • Empowerment; Mothers; Nocturnal Enuresis; Knowledge; Practices; Quality of Life.
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In context

Nocturnal Enuresis

104 studies on the registry are indexed under Nocturnal Enuresis; 22 are open to participants now.

This study's enrollment of 200 is above the median of 68 across 76 interventional studies indexed under Nocturnal Enuresis.

Browse Nocturnal Enuresis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

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 . 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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    Empowerment Program

    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).

    Behavioral: Mother Empowerment Program for Nocturnal Enuresis

  • No intervention
    Usual Care (Waitlist Control)

    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.

Interventions

  • BehavioralMother Empowerment Program for Nocturnal Enuresis

    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

    Also known as: Structured Educational Empowerment Program, Family Empowerment Program

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What researchers measure

Primary outcomes

  1. 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%).

    Time frame: Baseline (T0), 4 weeks after intervention (T1), and 3 months after intervention (T2)

Secondary outcomes

  1. 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%).

    Time frame: Baseline (T0), 4 weeks after intervention (T1), and 3 months after intervention (T2)

  2. 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.

    Time frame: Baseline (T0), 4 weeks after intervention (T1), and 3 months after intervention (T2)

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Study locations

1 site
  • Faculty of nursing Cairo University
    Cairo, Egypt
08

References and documents

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 37428825 ↗
  • Kamperis 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 34238464 ↗
  • Cammisa 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 39964278 ↗
  • Guzman JA, Palmer LS. Nocturnal Enuresis. Pediatr Rev. 2024 Aug 1;45(8):479-481. doi: 10.1542/pir.2023-006166. No abstract available. PubMed 39085181 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07753304
Lead sponsor
Cairo University
Responsible party
Manal Mohamed Elsawy (Assistant professor, Cairo University) — Principal investigator
First posted
Aug 7, 2026
Start date
Sep 25, 2024
Primary completion
Mar 27, 2025
Completion
Jun 29, 2025
Last update
Aug 11, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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