Health Trials

Bedtime Device Restriction and Desmopressin in PMNE.

ConditionPrimary Monosymptomatic Nocturnal Enuresis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-14
SponsorAl-Azhar University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Desmopressin

    Drug

    Oral desmopressin administered at bedtime for 8 weeks for treatment of primary monosymptomatic nocturnal enuresis.

  • Bedtime digital-device restriction

    Behavioral

    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.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Desmopressin plus bedtime device restrictionExperimental treatment 2 interventions
Group B: Desmopressin onlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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.
3

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
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Al-Azhar University

Lead sponsor

Source ClinicalTrials.gov
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