Omegapres Versus Solifenacin and Mirabegron Combination Therapy in Treatment of Primary MNE

What Was Tested

In this phase 3 trial, researchers set out to test Desmopressin.

The goal of this clinical trial is to compare combination of Solifenacin and MIrabegron in treatment of primary mono-symptomatic nocturnal enuresis in children.

It will also learn about the safety of that combination.

The main questions it aims to answer are: Does combination of Solifenacin and MIrabegron lower the number of wet nights?

It had two arms (groups): ADH analougue monotherapy (sham comparator) and Anticholinergic and b3 agonist combination (experimental).

Desmopressin.

Solifenacin and Mirabegron.

The registry classes the interventions as drug.

More on the Plan

Nocturnal enuresis (NE) is defined as intermittent incontinence during sleep in a child aged 5 years or more in the absence of congenital anomalies of the urinary tract or congenital or acquired defects of the central nervous system.

Patients with mono-symptomatic nocturnal enuresis (MNE) do not have any other symptoms of lower urinary tract dysfunction.

The standard view of NE pathogenesis as being the result of either nocturnal polyuria or nocturnal detrusal overactivity with high arousal thresholds has become well-established, but further research now complicates the picture.

First, Psychological/psychiatric problems are overrepresented in enuresis and might in a minority of cases have a causal or aggravating role.

Who Took Part

120 planned participants were the target.

It was open to people of any sex aged from 6 years up to 18 years.

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

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

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.

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 2024-12-01 with completion listed for 2025-12-01.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Number of patients who experienced side effects in response to each treatment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Desmopressin in 120 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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