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

What Was Tested

In this phase 2 trial, researchers set out to test Desmopressin.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 178 actual participants took part.

It was open to women 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. Female 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 23 exclusion criteria; among the exclusions: psychogenic or habitual polydipsia; A history of urologic malignancies or a history of cancer which has not been in remission for the last 5 years; genito-urinary tract pathology.

How the Study Was Run

Design: 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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Desmopressin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

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

It ran at 36 sites in Japan (36).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 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 178 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.