NCT03389412

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
324

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2017

Longer than P75 for phase_4

Geographic Reach
4 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 3, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2023

Completed
Last Updated

August 2, 2023

Status Verified

July 1, 2023

Enrollment Period

5.3 years

First QC Date

December 27, 2017

Last Update Submit

July 31, 2023

Conditions

Enuresis, Nocturnal

Outcome Measures

Primary Outcomes (2)

  • The number of children who responded to the treatment

    Evaluated by home recordings

    Eight weeks

  • The number of children achieving complete dryness (complete responders)

    Evaluated by home recordings

    Eight weeks

Secondary Outcomes (1)

  • Change in wet nights

    Eight weeks

Study Arms (6)

Treatment without evaluating the home recordings, medicin.

EXPERIMENTAL

Children will receive desmopressin without evaluating the home recordings.

Drug: Desmopressin

Treatment without evaluating the home recordings, alarm.

EXPERIMENTAL

Children will receive conditional alarm without evaluating the home recordings.

Device: Conditional alarm

Treatment based on home recordings, polyuria.

ACTIVE COMPARATOR

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

Drug: Desmopressin

Treatment based on home recordings, reduced bladder capacity.

ACTIVE COMPARATOR

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

Device: Conditional alarm

Treatment based on home recordings, both.

ACTIVE COMPARATOR

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

Drug: DesmopressinDevice: Conditional alarm

Treatment based on home recordings, none.

ACTIVE COMPARATOR

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.

Drug: DesmopressinDevice: Conditional alarm

Interventions

DesmopressinDRUG

The children will be treated with 120 microgram/day the first two weeks. If the child is not completely dry, the dose will be increased to 240 microgram/day the rest of the study period (maximum eight weeks of treatment).

Also known as: Minirin, melt
Treatment based on home recordings, both.Treatment based on home recordings, none.Treatment based on home recordings, polyuria.Treatment without evaluating the home recordings, medicin.
Conditional alarmDEVICE

Eight weeks of treatment.

Treatment based on home recordings, both.Treatment based on home recordings, none.Treatment based on home recordings, reduced bladder capacity.Treatment without evaluating the home recordings, alarm.

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 6-14 years.
  • Three or more wet nights per week regarding the home registrations.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Algemeen Ziekenhuis Sint-Jan Brugge

Bruges, 8000, Belgium

Location

Ghent University Hospital

Ghent, 9000, Belgium

Location

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Aalborg University Hospital

Aalborg, Jylland, 9000, Denmark

Location

Aarhus University Hospital

Aarhus, Jylland, 8200, Denmark

Location

University Clinical Centre in Gdańsk

Gdansk, 80-952, Poland

Location

Related Publications (2)

  • Hahn 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: 40728007DERIVED

  • Jorgensen 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: 38950376DERIVED

MeSH Terms

Conditions

Nocturnal Enuresis

Interventions

Deamino Arginine VasopressinFreezing

Condition Hierarchy (Ancestors)

EnuresisUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBehavioral SymptomsBehaviorElimination DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Arginine VasopressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsPhase TransitionPhysical PhenomenaCold TemperatureTemperatureThermodynamicsChemical Phenomena

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The children and the parents will not know, if there treatment is based on home recordings or not.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, controlled study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2017

First Posted

January 3, 2018

Study Start

October 1, 2017

Primary Completion

January 3, 2023

Study Completion

January 3, 2023

Last Updated

August 2, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

Locations

DK(2)CN(1)PL(1)BE(2)