Bedtime Device Restriction and Desmopressin in PMNE.

Effect of Bedtime Digital-Device Restriction on the Therapeutic Response to Desmopressin in Children With Primary Monosymptomatic Nocturnal Enuresis: A Randomized Controlled Trial

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.

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.

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.