Mirabegron [amount hidden] for Treatment of Primary Nocturnal Enuresis

What Was Tested

The trial (not phased) is built around Desmopressin.

It had three arms (groups): patients with primary nocturnal enuresis will be followed up with behavioral therapy alone. (placebo comparator), one (active comparator) and one (active comparator).

The registry classes the interventions as behavioral and drug.

More on the Plan

No doubt that nocturnal enuresis is one of the commonest types of urinary incontinence which affect children and always run in family .

Nocturnal enuresis occurs at the age of 5 years with leakage of urine involuntarily during sleep for two times or more per week in three consecutive months not due to congenital or acquired cause.

Nocturnal enuresis can be categorized into primary or secondary depending on occurrence of bed dryness for more than six months or not .

The International Children's Continence Society (ICCS) recommended combination therapy for treatment of primary nocturnal enuresis after failure of first line therapy with desmopressin or enuresis alarms .

Who Took Part

Enrollment: 150 planned participants were the target.

It was open to people of any sex aged from 5 years up to 15 years.

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

Examples of who could join: Primary nocturnal enuresis,. Negligible daytime wetting,. Wet at least 4 times over 4 weeks. Normal clinical examination with no neurological or urological cause for the enuresis.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: secondary enuresis, polysymptomatic; neurologic bladder, neurological disorders,; urinary incontinence disorders.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

Everyone knew when Desmopressin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2022-11-23 with completion listed for 2023-09.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example side effects of drugs used.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Desmopressin in 150 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.