Primary Monosymptomatic Nocturnal Enuresis
Conditions
Brief summary
This randomized controlled trial will evaluate whether restricting bedtime digital-device use improves the response to desmopressin in children with primary monosymptomatic nocturnal enuresis. Participants will receive desmopressin for 8 weeks and will be assigned to either bedtime device restriction or usual screen habits.
Detailed description
This is a prospective, parallel-group, open-label randomized controlled trial conducted at Al-Hussein and Sayed Galal Hospitals, Al-Azhar University, Cairo, Egypt. Children aged 6-14 years with primary monosymptomatic nocturnal enuresis will be enrolled and randomized 1:1 to receive desmopressin plus bedtime digital-device restriction or desmopressin with no restriction. The intervention group will avoid digital devices, including smartphones, tablets, televisions, computers, and video games, for at least 60 minutes before habitual bedtime. The control group will continue the usual screen habits. All participants will receive oral desmopressin at bedtime for 8 weeks, with dose adjustment allowed according to clinical response. The primary outcome is the proportion of participants achieving full response, defined as no more than 1 wet night during the last 2 weeks of treatment. Secondary outcomes include reduction in wet nights per week, partial response rate, sleep quality, adherence, and relapse 4 weeks after treatment discontinuation. Baseline demographic, clinical, and sleep-related data will also be collected to explore predictors of treatment response.
Interventions
DRUGDesmopressin
Oral desmopressin administered at bedtime for 8 weeks for treatment of primary monosymptomatic nocturnal enuresis.
BEHAVIORALBedtime digital-device restriction
Restriction of digital-device use, including smartphones, tablets, televisions, computers, and video games, for at least 60 minutes before habitual bedtime during the 8-week treatment period.
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Age 6-14 years. * Diagnosis of PMNE (≥2 wet nights/week for ≥6 months, no daytime symptoms, no prior sustained dryness \>6 months). * Willingness to take oral desmopressin nightly for 8 weeks. * Parent/guardian able to monitor and report screen time and wet nights. * Written informed consent from parent/guardian and assent from child (if age-appropriate).
Exclusion criteria
* Secondary enuresis or non-monosymptomatic enuresis (daytime incontinence, urgency, frequency). * Known organic causes (e.g., diabetes mellitus, urinary tract anomalies, neurological disorders). * Current use of other enuresis treatments (alarms, anticholinergics, imipramine) within 4 weeks prior to enrollment. * Severe sleep disorders (e.g., obstructive sleep apnea) or psychiatric conditions affecting compliance. * Inability to comply with study procedures or follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Full Response Rate | Week 8, based on the final 2 weeks of treatment | Proportion of participants achieving full response, defined as no more than 1 wet night during the last 2 weeks of the 8-week treatment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Wet Nights per Week | Baseline to Week 8 | Change from baseline in the average number of wet nights per week, calculated from the participant's wet-night diary. |
| Relapse Rate After Treatment | 4 weeks after treatment discontinuation. | Proportion of participants with recurrence of at least 2 wet nights per week after stopping treatment. |
| Adherence to Bedtime Device Restriction | During the 8-week treatment period | Proportion of nights in which participants in the intervention group avoided digital-device use for at least 60 minutes before bedtime, based on parental log. |
| Desmopressin Adherence | During the 8-week treatment period. | Proportion of prescribed desmopressin doses taken during the 8-week treatment period, based on parental report and pill count. |
| Adverse Effects of Desmopressin | During the 8-week treatment period and 4 weeks after treatment discontinuation | Proportion of participants experiencing adverse effects related to desmopressin, including headache, nausea, vomiting, hyponatremia symptoms, excessive thirst, fluid retention, or any other treatment-emergent adverse event. |
Countries
Egypt
Contacts
CONTACTAbul-fotouh Ahmed
PRINCIPAL_INVESTIGATORAbul-fotouh Ahmed
Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
Outcome results
None listed