ClinicalTrials.gg
CompletedNCT03389412DRYCHILDUpdated Aug 2, 2023

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

A Phase 4 interventional study of Desmopressin and Conditional alarm in Enuresis, Nocturnal, sponsored by University of Aarhus. Completed at 6 sites in 4 countries. Open to participants aged 6 Years to 14 Years. Per ClinicalTrials.gov, last updated 2023-08-02.

Sponsored by University of Aarhus · Phase 4, Interventional, and Treatment

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Phase
Phase 4
Study type
Interventional
Enrollment
324
Allocation
Randomized
Ages
6 Years to 14 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 17 studies testing Deamino Arginine Vasopressin in Nocturnal Enuresis — 2 open to participants now, 2 under way, none of them phase 3. Deamino Arginine Vasopressin · Nocturnal Enuresis.

Enrollment
2nd of 17
324 · median 80
Started
2017
the only one that year
Phase 4
6 of 17
none open now
Registered
9th of 17
by date
Lead sponsor
2 of 17
University of Aarhus

Among the 17 studies testing Deamino Arginine Vasopressin in Nocturnal Enuresis, this one is the 2nd largest by enrollment, is the only one that started in 2017, is one of 6 in phase 4, and was the 9th registered.

Nocturnal Enuresis

105 studies on the registry are indexed under Nocturnal Enuresis; 22 are open to participants now.

Browse Nocturnal Enuresis studies →

Open to participants now

2 of the 17 studies testing Deamino Arginine Vasopressin in Nocturnal Enuresis are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

About Deamino Arginine Vasopressin

Deamino Arginine Vasopressin: first FDA approval 1978 (DDAVP (NEEDS NO REFRIGERATION)). What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 14 Nocturnal Enuresis studies recruiting now, 5 (36%) set no upper age limit and 9 (64%) stop at 75 or younger; 8 take children under 18; 2 take healthy volunteers.

This study: 6 Years to 14 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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.

Read the detailed description

This is a randomized, controlled study.

This study will be performed at Aarhus University Hospital (Denmark), Ghent University Hospital (Belgium) and Hospital of Zhengzhou University (China) following the same protocol.

According to the initial randomization, children will be allocated to treatment without (group A) or with (group B) prior clinical characterization based on home recordings.

Group A: The children will be randomized to either an enuresis alarm or desmopressin without evaluating the home recordings.

Group B: The home recordings will be evaluated and treatment will be based on the recordings. Desmopressin will be administered to the children with nocturnal polyuria and the conditional alarm to the children with reduced bladder capacity. Children with nocturnal polyuria and reduced bladder capacity will be treated with both desmopressin and conditional alarm. Children with neither nocturnal polyuria nor reduced bladder capacity will again be randomized to either desmopressin or alarm treatment.

03

Conditions studied

  • Enuresis, Nocturnal

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04

Who can participate

Ages eligible
6 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 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.
  • for the use of desmopressin: habitual or psychogenic polydipsia, use of diuretics, renal insufficiency, hyponatremia or SIADH.
  • / allergy to substances in the tablets.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
324 participants (actual)

Study arms

  • Experimental
    Treatment without evaluating the home recordings, medicin.

    Children will receive desmopressin without evaluating the home recordings.

    Drug: Desmopressin

  • Experimental
    Treatment without evaluating the home recordings, alarm.

    Children will receive conditional alarm without evaluating the home recordings.

    Device: Conditional alarm

  • Active comparator
    Treatment based on home recordings, polyuria.

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

    Drug: 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.

    Device: 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.

    Drug: Desmopressin · Device: 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.

    Drug: Desmopressin · Device: Conditional alarm

Interventions

  • 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

  • DeviceConditional alarm

    Eight weeks of treatment.

06

What researchers measure

Primary outcomes

  1. The number of children who responded to the treatment

    Evaluated by home recordings

    Time frame: Eight weeks

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

    Evaluated by home recordings

    Time frame: Eight weeks

Secondary outcomes

  1. Change in wet nights

    Evaluated by home recordings

    Time frame: Eight weeks

07

Study locations

6 sites
  • Algemeen Ziekenhuis Sint-Jan Brugge
    Brugge, 8000, Belgium
  • Ghent University Hospital
    Ghent, 9000, Belgium
  • First Affiliated Hospital of Zhengzhou University
    Zhengzhou, Henan, China
  • Aalborg University Hospital
    Aalborg, Jylland 9000, Denmark
  • Aarhus University Hospital
    Aarhus, Jylland 8200, Denmark
  • University Clinical Centre in Gdańsk
    Gdańsk, 80-952, Poland
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2017 to primary completion in Jan 2023, 63 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 27, 2017
First posted
Jan 3, 2018
StartActual
Oct 1, 2017
Primary completionActual
Jan 3, 2023
CompletionActual
Jan 3, 2023
Last update
Aug 2, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03389412
Collaborators
University Ghent, First Affiliated Hospital of Zhengzhou University, China, University Clinical Centre in Gdansk, Poland
Responsible party
Sponsor
First posted
Jan 3, 2018
Start date
Oct 1, 2017
Primary completion
Jan 3, 2023
Completion
Jan 3, 2023
Last update
Aug 2, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Deamino Arginine Vasopressin

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