NCT07015320

The Behavioral Therapy for Primary Monosymptomatic Nocturnal Enuresis

Completed Last updated 11 June 2025

What this trial tests

trial testing urotherapy in Enuresis, Nocturnal in 120 participants. Completed in 30 December 2024.

Timeline

15 January 2023

Primary endpoint
30 December 2024

30 December 2024

Quick facts

Lead sponsor	Cairo University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	120
Start date	15 January 2023
Primary completion	30 December 2024
Estimated completion	30 December 2024
Sites	1 location across Egypt

Drugs / interventions tested

• urotherapy
• no intervention

Conditions studied

• Enuresis, Nocturnal — all drugs for Enuresis, Nocturnal →

Sponsor

Cairo University

Who can join

Adults 4 to 5, any sex, with Enuresis, Nocturnal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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 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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.