NCT07753304

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2026

Completed
Last Updated

August 7, 2026

Status Verified

August 1, 2024

Enrollment Period

6 months

First QC Date

August 4, 2026

Last Update Submit

August 4, 2026

Conditions

Keywords

Nocturnal EnuresisEmpowerment; Mothers; Nocturnal Enuresis; Knowledge; Practices; Quality of Life.

Outcome Measures

Primary Outcomes (2)

  • Maternal self-reported practices regarding nocturnal enuresis

    Maternal practices will be assessed using the Mothers' Self-Reported Practices Checklist regarding nocturnal enuresis. Higher scores indicate better implementation of recommended caregiving practices for managing nocturnal enuresis.

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

  • Maternal knowledge regarding nocturnal enuresis

    Maternal knowledge will be assessed using the Nocturnal Enuresis Structured Knowledge Questionnaire. Higher scores indicate greater knowledge regarding nocturnal enuresis, including its definition, causes, risk factors, complications, and management.

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

Study Arms (2)

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).

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.

Interventions

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
Empowerment Program

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsmothers only.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of nursing Cairo university

Cairo, Egypt

Location

Related Publications (4)

  • Tsuji S, Kaneko K. Management of treatment-resistant nocturnal enuresis. Pediatr Int. 2023 Jan-Dec;65(1):e15573. doi: 10.1111/ped.15573.

    PMID: 37428825BACKGROUND
  • 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.

    PMID: 34238464BACKGROUND
  • 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.

    PMID: 39964278BACKGROUND
  • Guzman JA, Palmer LS. Nocturnal Enuresis. Pediatr Rev. 2024 Aug 1;45(8):479-481. doi: 10.1542/pir.2023-006166. No abstract available.

    PMID: 39085181BACKGROUND

MeSH Terms

Conditions

Nocturnal EnuresisEmpowerment

Condition Hierarchy (Ancestors)

EnuresisUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBehavioral SymptomsBehaviorElimination DisordersMental DisordersSocial Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 4, 2026

First Posted

August 7, 2026

Study Start

September 25, 2024

Primary Completion

March 27, 2025

Study Completion

June 29, 2025

Last Updated

August 7, 2026

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations