The Behavioral Therapy for Primary Monosymptomatic Nocturnal Enuresis

The Behavioral and Alarm Therapy for Primary Monosymptomatic Nocturnal Enuresis , a Prospective Randomized Control Trial.

A prospective randomized clinical study was conducted at Urology departments, faculties of medicine, Fayoum and Cairo Universities. All children either boys or girls between 4-4.5 years old presented with bedtime wetting despite good daytime urine control were included in the study. The children who were older than 4.5 years, had daytime voiding dysfunction, had !، behavioural disorders like attention deficient and hyperactivity disorder (ADHD) or other comorbidities like diabetes mellitus (DM) or congenital abnormalities were excluded from the study. In addition, those children whom parents refused to sign the consent of participation were also excluded. 120 children with primary monosymptomatic nocturnal enuresis (PMNE) were initially included in this study and randomized into two groups according to computer generated randomization. Group A (early therapy) included initially 60 child who had done behavioural and alarm therapy from the start of the study regularly till the age of 5.5 years and Group B (deferred therapy) included 60 child who waited without therapy till age of 5 years, then they started the behavioural and alarm therapy regularly for 6 months. They were interviewed at urology clinics in Fayoum and Cairo Universities in Egypt. The behavioural therapy was in the form of prompted and scheduled voiding, regular sleep timing, fluid and caffeine restriction and avoiding the cellular phones 2 hours before bedtime. If the child had constipation, it should be treated. In addition, alarm therapy was performed in the form of awaking the child every night by his parents after 1-2 hours from deep sleep to void then continue the sleep. The parents should be informed about the importance of their psychological support I to their child by avoiding any punishment or embarrassment. Furthermore, the parents were asked to monitor their child's response by documenting the number of wet nights within the last 4 month. All children were then evaluated at the age of 5 and 5.5 years using the following outcomes through the last month before the visit: complete response (0 wet nights), > 80 % stoppage of bedwetting (< 6 wet nights), 50-80 % stoppage of bedwetting (6-15 wet nights) and < 50 % stoppage of bedwetting (> 15 wet nights).

Study Overview

• Status: Completed
• Conditions: Enuresis, Nocturnal
• Intervention / Treatment: Behavioral: no intervention; Behavioral: urotherapy

Detailed Description

A prospective randomized clinical study was conducted at Urology departments, faculties of medicine, Fayoum and Cairo Universities. All children either boys or girls between 4-4.5 years old presented with bedtime wetting despite good daytime urine control were included in the study. The children who were older than 4.5 years, had daytime voiding dysfunction, had behavioural disorders like attention deficient and hyperactivity disorder (ADHD) or other comorbidities like diabetes mellitus (DM) or congenital abnormalities were excluded from the study. In addition, those children whom parents refused to sign the consent of participation were also excluded. 120 children with primary monosymptomatic nocturnal enuresis (PMNE) were initially included in this study. They were randomized into two groups according to computer generated randomization. Group A (early therapy) included initially 60 child who had done behavioural and alarm therapy from the start of the study regularly till the age of 5.5 years and Group B (deferred therapy) included 60 child who waited without therapy till age of 5 years, then they started the behavioural and alarm therapy regularly for 6 months. They were interviewed at urology clinics in Fayoum and Cairo Universities in Egypt. The behavioural therapy was in the form of prompted and scheduled voiding, regular sleep timing, fluid and caffeine restriction and avoiding the cellular phones 2 hours before bedtime. If the child had constipation, it should be treated. In addition, alarm therapy was performed in the form of awaking the child every night by his parents after 1-2 hours from deep sleep to void then continue the sleep. The parents should be informed about the importance of their psychological support to their child by avoiding any punishment or embarrassment. Furthermore, the parents were asked to monitor their child's response by documenting the number of wet nights within the last 4 month. All children were then evaluated at the age of 5 and 5.5 years using the following outcomes through the last month before the visit: complete response (0 wet nights), > 80 % stoppage of bedwetting (< 6 wet nights), 50-80 % stoppage of bedwetting (6-15 wet nights) and < 50 % stoppage of bedwetting (> 15 wet nights).

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

PMNE

Description

Inclusion Criteria:

• PMNE

Exclusion Criteria:

• neurogenic bladder

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
control	Behavioral: no intervention; no intervention
urotherapy	Behavioral: urotherapy; prompted and scheduled voiding, regular sleep timing, fluid and caffeine restriction and avoiding the cellular phones 2 hours before bedtime. If the child had constipation, it should be treated. In addition, alarm therapy was performed in the form of awaking the child every night by his parents after 1-2 hours from deep sleep to void then continue the sleep. The parents should be informed about the importance of their psychological support to their child by avoiding any punishment or embarrassment. Furthermore, the parents were asked to monitor their child's response by documenting the number of wet nights within the last month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bed wetting	complete response (0 wet nights), > 80 % stoppage of bedwetting (< 6 wet nights), 50-80 % stoppage of bedwetting (6-15 wet nights) and < 50 % stoppage of bedwetting (> 15 wet nights).	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2023
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: May 30, 2025
• First Submitted That Met QC Criteria: June 7, 2025
• First Posted (Actual): June 11, 2025

Study Record Updates

• Last Update Posted (Actual): June 11, 2025
• Last Update Submitted That Met QC Criteria: June 7, 2025
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: urotherapy; behavioural therapy; nocturnal enuresis
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Urinary Incontinence; Enuresis; Nocturnal Enuresis
• Other Study ID Numbers: R408

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No