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Trial · Interventional

CompletedPhase 4Registry data

The Effect of Selecting Treatment With Desmopressin or Alarm to Children With Enuresis Based on Home Recordings.

Short name DRYCHILD

NCTNCT03389412 (opens ClinicalTrials.gov in a new tab)Other idDRYCHILD
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
324 participants (actual)
Sponsor
University of Aarhus · Other
Design
Randomized · Single masking
Countries
4 countries

Belgium, China, Denmark, Poland

Start
1 Oct 2017
Primary completion
3 Jan 2023
Completion
3 Jan 2023
First posted
3 Jan 2018
Last update posted
2 Aug 2023
Conditions
Enuresis, Nocturnal

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2018202020222024
  1. Ph 4

    DRYCHILD

    NCT03389412

    1 Oct 2017 to 3 Jan 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The aim of this study is to investigate the importance of clinical characterization of children with monosymptomatic nocturnal enuresis (MNE) in order to improve treatment efficacy. The hypothesis is that clinical characterization by measurement of nocturnal urine production and maximal voided volumes in children with MNE and subsequent treatment tailoring improves the response to first-line treatment approach.

Interventions

  • DesmopressinDrug
  • Conditional alarmDevice

Arms6

  • Experimental

    Treatment without evaluating the home recordings, medicin.

    Children will receive desmopressin without evaluating the home recordings.

  • Experimental

    Treatment without evaluating the home recordings, alarm.

    Children will receive conditional alarm without evaluating the home recordings.

  • Active comparator

    Treatment based on home recordings, polyuria.

    Children with polyuria based on the home recordings will receive desmopressin.

  • Active comparator

    Treatment based on home recordings, reduced bladder capacity.

    Children with reduced bladder capacity based on the home recordings will receive the conditional alarm.

  • Active comparator

    Treatment based on home recordings, both.

    Children with polyuria and reduced bladder capacity based on the home recordings will receive desmopressin and the conditional alarm.

  • Active comparator

    Treatment based on home recordings, none.

    Children with neither nocturnal polyuria nor reduced bladder capacity based on the home recordings will be randomized to either desmopressin or alarm treatment. If there is no effect of the treatment, the treatment can be switched.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. The number of children who responded to the treatment

    Time frame · Eight weeks

    Registry description

    Evaluated by home recordings

  2. The number of children achieving complete dryness (complete responders)

    Time frame · Eight weeks

    Registry description

    Evaluated by home recordings

Secondary outcomes(1)

  1. Change in wet nights

    Time frame · Eight weeks

    Registry description

    Evaluated by home recordings

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedHahn D, Stewart F, Raman G. Desmopressin for nocturnal enuresis in children. Cochrane Database Syst Rev. 2025 Jul 29;7(7):CD002112. doi: 10.1002/14651858.CD002112.pub2. PMID 40728007
  • DerivedJorgensen CS, Dossche L, Zhai R, Maternik M, Kamperis K, Breinbjerg AS, Karamaria S, Thorsteinsson K, Borg B, Wang Y, Li S, Raes A, Wei L, Zurowska A, Hagstrom S, Walle JV, Guo WJ, Rittig S. Development of a Novel Prediction Tool for Response to First-Line Treatments of Monosymptomatic Nocturnal Enuresis: A Randomized, Controlled, International, Multicenter Study (DRYCHILD). J Urol. 2024 Oct;212(4):539-549. doi: 10.1097/JU.0000000000004129. Epub 2024 Jul 1. PMID 38950376

Eligibility

Who could join, as posted.

Sex
All
Age
from 6 Years up to 14 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Age 6-14 years. * Three or more wet nights per week regarding the home registrations. Exclusion Criteria: * Ongoing constipation and/or faecal incontinence. * Daytime symptoms such as urgency, frequency or incontinence. * Recurrent urinary tract infections. * Anamnestic, clinical or laboratory findings that can be related to diseases or conditions that might affect the parameters investigated. * Neurological and/or known clinically significant anatomical abnormalities of the urinary tract. * Former operations in the urinary tract. * Prior or ongoing treatment with alarm, desmopressin or anticholinergics. * Ongoing medication that may interfere with the parameters tested. * Pregnant or lactating girl. * Contra-indications for the use of desmopressin: habitual or psychogenic polydipsia, use of diuretics, renal insufficiency, hyponatremia or SIADH. * Hypersensitivity / allergy to substances in the tablets.

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