An interventional study of Desmopressin and Bedtime digital-device restriction in Primary Monosymptomatic Nocturnal Enuresis, sponsored by Al-Azhar University. Recruiting at 1 site in Egypt. Open to participants aged 6 Years to 14 Years. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment
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.
104 studies on the registry are indexed under Nocturnal Enuresis; 22 are open to participants now.
This study's planned enrollment of 140 is above the median of 68 across 76 interventional studies indexed under Nocturnal Enuresis.
Browse Nocturnal Enuresis studies →Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive oral desmopressin at bedtime for 8 weeks and will avoid digital-device use, including smartphones, tablets, televisions, computers, and video games, for at least 60 minutes before habitual bedtime.
Drug: Desmopressin · Behavioral: Bedtime digital-device restriction
Participants will receive oral desmopressin at bedtime for 8 weeks and will continue their usual bedtime digital-device habits without restriction.
Drug: Desmopressin
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.
Full 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
Started Aug 2026 (actual). Primary completion is estimated for May 2027, 9 months after the start.
Of 40 interventional studies with no phase under Nocturnal Enuresis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 49. This study's planned 9 months is below that.
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