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

What Was Tested

In this phase 4 trial, researchers set out to test Desmopressin.

It had six arms (groups): Treatment without evaluating the home recordings, medicin. (experimental), Treatment without evaluating the home recordings, alarm. (experimental), Treatment based on home recordings, polyuria. (active comparator), one (active comparator) and Treatment based on home recordings, both. (active comparator).

Children will receive desmopressin without evaluating the home recordings.

Children will receive conditional alarm without evaluating the home recordings.

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

The registry classes the interventions as device and drug.

More on the Plan

This is a randomized, controlled study.

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.

Who Took Part

324 actual participants took part.

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. Three or more wet nights per week regarding the home registrations.

The full record lists 2 inclusion and 11 exclusion criteria; among the exclusions: ongoing constipation and/or faecal incontinence; daytime symptoms such as urgency, frequency or incontinence; recurrent urinary tract infections.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

In this single-blind Desmopressin study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2017-10-01 with completion listed for 2023-01-03.

It ran at 6 sites in Belgium (2), Denmark (2), China (1) and Poland (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The number of children who responded to the treatment (time frame: Eight weeks). The number of children achieving complete dryness (complete responders) (time frame: Eight weeks).

It also tracked 1 secondary outcome, for example Change in wet nights.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Desmopressin in 324 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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