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NCT Number: NCT07776977

Bedtime Device Restriction and Desmopressin in PMNE.

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.

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Key information

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University

Cairo, Egypt

Location status: Recruiting

Location contact

Abul-fotouh Ahmed

CONTACT

[email protected]

+201001066756

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Full Response Rate

    Time frame: 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 outcomes

  1. Change in Wet Nights per Week

    Time frame: Baseline to Week 8

    Change from baseline in the average number of wet nights per week, calculated from the participant's wet-night diary.

  2. Relapse Rate After Treatment

    Time frame: 4 weeks after treatment discontinuation.

    Proportion of participants with recurrence of at least 2 wet nights per week after stopping treatment.

  3. Adherence to Bedtime Device Restriction

    Time frame: 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.

  4. Desmopressin Adherence

    Time frame: 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.

  5. Adverse Effects of Desmopressin

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Abul-fotouh Ahmed

CONTACT

[email protected]

+201001066756

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 20, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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