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Posterior Tibial Nerve Stimulation Vs Desmopressin In Children With Primary Monosymptomatic Nocturnal Enuresis

Plain-language guide to NCT04545931: phase 4 randomized trial of Desmopressin, 80 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04545931
Phase
phase 4
Status
status unknown
Start
2020-03-15
Completion (planned or actual)
2020-11-15
Participants
80 (estimated)
Design
randomized, double-blind, treatment
Conditions studied
Primary Monosymptomatic Nocturnal Enuresis
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 4 trial tested Desmopressin.

Nocturnal enuresis is a worldwide health problem frequently encountered in childhood .

It had two arms (groups): Posterior tibial nerve stimulation (experimental) and Desmopressin (experimental).

First arm will undergo posterior tibial nerve stimulation ( one session per week for 12 weeks ).

The registry classes the interventions as device and drug.

More on the Plan

Both groups are constructed to be adherent to behavioral therapy.

The two groups were statistically evaluated regarding the frequency of nocturnal enuresis before, after treatment, and after one month of follow up.

The researchers should tailor the treatment according to the child and caregiver's condition.

Who Took Part

80 planned participants were the target.

It was open to people of any sex aged from 5 years up to 12 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Experiencing more than two wetting episodes per week . Normal urinalysis results . Unremarkable urinary tract ultrasaound . Normal physical examination.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: diurnal enuresis ; faecal soiling ; cardiovascular disease .

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this Desmopressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Desmopressin group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Desmopressin.

Those kept unaware of assignments: participant and investigator.

It started in 2020-03-15 with completion listed for 2020-11-15.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Posterior tibial nerve stimulation Vs desmopressin In children with primary monosymptomatic Nocturnal enuresis (time frame: 4 months).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Desmopressin in 80 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compound

Desmopressin: A synthetic vasopressin analog (DDAVP) used for bedwetting, diabetes insipidus and some bleeding disorders.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.