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.

Study Overview

• Status: Recruiting
• Conditions: Primary Monosymptomatic Nocturnal Enuresis
• Intervention / Treatment: Drug: Desmopressin; Behavioral: Bedtime digital-device restriction

Detailed Description

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
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abul-fotouh Ahmed; Phone Number: +201001066756; Email: abulfotouhahmed@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
    • Contact: Abul-fotouh Ahmed; Phone Number: +201001066756; Email: abulfotouhahmed@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Desmopressin plus bedtime device restriction; 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; Oral desmopressin administered at bedtime for 8 weeks for treatment of primary monosymptomatic nocturnal enuresis.; Behavioral: Bedtime digital-device restriction; 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.
Active Comparator: Desmopressin only; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 8, based on the final 2 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to Week 8
Relapse Rate After Treatment	Proportion of participants with recurrence of at least 2 wet nights per week after stopping treatment.	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.	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.	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.	During the 8-week treatment period and 4 weeks after treatment discontinuation

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Principal Investigator: Abul-fotouh Ahmed, Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: August 18, 2026
• First Submitted That Met QC Criteria: August 18, 2026
• First Posted (Actual): August 20, 2026

Study Record Updates

• Last Update Posted (Actual): August 24, 2026
• Last Update Submitted That Met QC Criteria: August 21, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Pituitary Hormones, Posterior; Pituitary Hormones; Arginine Vasopressin; Vasopressins; Deamino Arginine Vasopressin
• Other Study ID Numbers: UroAzhar_10_026

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No