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The Behavioral Therapy for Primary Monosymptomatic Nocturnal Enuresis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07015320
Enrollment
120
Registered
2025-06-11
Start date
2023-01-15
Completion date
2024-12-30
Last updated
2025-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enuresis, Nocturnal

Keywords

nocturnal enuresis, behavioural therapy, urotherapy

Brief summary

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).

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).

Interventions

BEHAVIORALurotherapy

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

BEHAVIORALno intervention

no intervention

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 5 Years
Healthy volunteers
No

Inclusion criteria

* PMNE

Exclusion criteria

* neurogenic bladder

Design outcomes

Primary

MeasureTime frameDescription
bed wetting6 monthscomplete 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).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026