A New Check-list Method for Nocturnal Enuresis

What Was Tested

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

The parents with children who complain of bed-wetting 3 or more nights per week for at last 14 days, they was randomly divided into three groups.

The parents in Group I were instructed only a verbal behavioral therapy, the parents in Group II were instructed a behavioral therapy with a written formed check-list for parents to fulfill and the children in Group III will received desmopressin treatment plus verbal behavioral therapy.

It had three arms (groups): Verbal Behavioral Therapy (sham comparator), Check-list (experimental) and Desmopressin plus verbal therapy (active comparator).

All children and their parents were instructed only a verbal behavioral therapy.

All participants were instructed a behavioral therapy with a written formed check-list for parents to complete.

The registry classes the interventions as behavioral and drug.

More on the Plan

Monosymptomatic Nocturnal Enuresis (MNE) is defined as involuntarily nighttime bed-wetting after the age of 5 years without any other lower urinary tract symptoms and without a history of bladder dysfunction.

MNE can lead to developmental and psychosocial problems on child and negative impact of the family life.

It has been recommended that consisting of collaboration with children and their parents is very crucial point to tackle this disturbing condition.

The behavioral therapy is composed of a lot of verbal recommendations including urination before going to sleep at night, a monitorisation daily fluid intake, a restriction of fluid volume before bedtime, rewards for dry nights, etc.

Who Took Part

The registry lists 75 actual participants took part.

It was open to people of any sex aged from 6 years up to 15 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Monosymptomatic nocturnal enuresis. Bed-wetting frequency of 3 or more nights per week for at last 14 days.

The full record lists 2 inclusion and 8 exclusion criteria; among the exclusions: active urinary tract infection; non-monosymptomatic nocturnal enuresis; endocrinologic disease like diabetes mellitus or diabetes insipidus which can cause polyuria.

How the Study Was Run

Design: 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.

Only one side, usually the participants, was kept unaware of whether Desmopressin was given.

Those kept unaware of assignments: participant.

It started in 2015-01-01 with completion listed for 2017-12-31.

It ran at 1 site in Turkey (Türkiye).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): dry nights (time frame: 8 weeks).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Desmopressin in 75 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.