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Bedtime Device Restriction and Desmopressin in PMNE.

Plain-language guide to NCT07776977: not phased randomized trial of Desmopressin, 140 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07776977
Phase
not phased
Status
recruiting participants
Start
2026-08-20
Completion (planned or actual)
2027-05
Participants
140 (estimated)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Primary Monosymptomatic Nocturnal Enuresis
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Desmopressin.

Participants will receive desmopressin for 8 weeks and will be assigned to either bedtime device restriction or usual screen habits.

It had two arms (groups): Desmopressin plus bedtime device restriction (experimental) and Desmopressin only (active comparator).

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.

Participants will receive oral desmopressin at bedtime for 8 weeks and will continue their usual bedtime digital-device habits without restriction.

The registry classes the interventions as behavioral and drug.

More on the Plan

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.

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.

Who Took Part

The registry lists 140 planned participants were the target.

It was open to people of any sex aged from 6 years up to 14 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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).

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Desmopressin group and the comparison group should start out alike.

The Desmopressin group and the comparison group ran side by side rather than switching.

Being open-label, the Desmopressin study did not mask who received what.

It started in 2026-08-20 with completion listed for 2027-05.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Full Response Rate (time frame: Week 8, based on the final 2 weeks of treatment).

It also tracked 5 secondary outcomes, for example Change in Wet Nights per Week, Relapse Rate After Treatment, Adherence to Bedtime Device Restriction, Desmopressin Adherence and Adverse Effects of Desmopressin.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Desmopressin in 140 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Desmopressin compound page, all human trials.

Our Notes on the Compound

Desmopressin: A synthetic vasopressin analog (DDAVP) used for bedwetting, diabetes insipidus and some bleeding disorders.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.