Comparative Trial to Investigate the Efficacy and Safety of Desmopressin for the Treatment of Nocturia in Adult Men

What Was Tested

This registered phase 2 trial tested Desmopressin.

It had three arms (groups): one (active comparator), one (active comparator) and C. Placebo (placebo comparator).

1 orally disintegrating tablet every night during study period.

1 orally disintegrating tablet every night during study period.

1 orally disintegrating tablet every night during study period.

The registry classes the interventions as drug.

Who Took Part

The registry lists 183 actual participants took part.

It was open to men only aged from 20 years with no upper age limit.

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

Examples of who could join: Has given written consent prior to any trial-related activity is performed. Male sex, aged 20 years or older. At least 2 nocturnal voids every night in a consecutive 3-day period as documented in the diary during the screening period. Has given agreement about contraception during the trial.

The full record lists 4 inclusion and 25 exclusion criteria; among the exclusions: A surgical treatment for bladder outlet obstruction or prostatic hyperplasia within the past 6 months; chronic prostatitis/chronic pelvic pain syndrome; psychogenic or habitual polydipsia.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Desmopressin and who got the comparison, which limits bias.

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

Neither the participants nor the staff measuring them knew who was on Desmopressin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2012-09 with completion listed for 2013-06.

It ran at 35 sites in Japan (35).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change from baseline in mean number of nocturnal voids (time frame: During 12 weeks).

It also tracked 10 secondary outcomes, for example Change from baseline in mean time to first void, Change from baseline in mean number of nocturnal voids, Change from baseline in mean time to first void, Change from baseline in mean nocturnal urine volume, Change from baseline in nocturnal polyuria index and Change from baseline in the effect on sleep disturbance.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Desmopressin in 183 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.