Selective Serotonin Reuptake Inhibitors, Fluoxetine Versus the Standard Oral Desmopressin for Management of Mono-symptomatic Nocturnal Enuresis.

What Was Tested

The trial (not phased) is built around Desmopressin.

To determine whether there is a role for the selective serotonin reuptake inhibitors fluoxetine versus desmopressin in the treatment of nocturnal enuresis in children who have not responded to standard nonpharmacological urotherapy, and whether there are side effects involved.

It had two arms (groups): fluoxetine (active comparator) and desmopressin (active comparator).

The registry classes the interventions as drug.

Who Took Part

60 actual participants took part.

It was open to people of any sex aged from 8 years up to 16 years.

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

Examples of who could join: Age ≥ 7 years.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: underlying renal, urologic, neurologic, endocrinologic, or cardiac conditions; patients with psychiatric disorders and behavioral disorders including depression, attention-deficit/hyperactivity disorder; untreated constipation.

How the Study Was Run

Design: randomized, single-group and single-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.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: participant.

It started in 2022-12-01 with completion listed for 2024-03-01.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The children will be non-responders, partial responders, or full responders to therapy (time frame: three months).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Desmopressin in 60 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.