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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Oral desmopressin administered at bedtime for 8 weeks for treatment of primary monosymptomatic nocturnal enuresis.
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.
Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
Cairo, Egypt
RECRUITINGFull Response Rate
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.
Time frame: Week 8, based on the final 2 weeks of treatment
Change in Wet Nights per Week
Change from baseline in the average number of wet nights per week, calculated from the participant's wet-night diary.
Time frame: Baseline to Week 8
Relapse Rate After Treatment
Proportion of participants with recurrence of at least 2 wet nights per week after stopping treatment.
Time frame: 4 weeks after treatment discontinuation.
Adherence to Bedtime Device Restriction
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.
Time frame: During the 8-week treatment period
Desmopressin Adherence
Proportion of prescribed desmopressin doses taken during the 8-week treatment period, based on parental report and pill count.
Time frame: During the 8-week treatment period.
Adverse Effects of Desmopressin
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.
Time frame: During the 8-week treatment period and 4 weeks after treatment discontinuation
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