Investigation of the Superiority Effect of Desmopressin to Placebo in Terms of Night Voids Reduction in Nocturia Adult Female Patients

What Was Tested

This registered phase 3 trial tested Desmopressin.

It had two arms (groups): one (experimental) and Placebo (placebo comparator).

Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.

The registry classes the interventions as drug.

Who Took Part

The registry lists 268 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

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

Examples of who could join: Written informed consent prior to performance of any trial-related activity. Female sex 18 years of age or older. At least 2 voids every night in a consecutive 3-day period during the screening period.

The full record lists 3 inclusion and 26 exclusion criteria; among the exclusions: evidence of severe daytime voiding dysfunction defined as:; urge urinary incontinence (more than 1 episode/day in the 3-day diary period); urgency (more than 1 episode/day in the 3-day diary period).

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.

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

Blinding on both sides kept the participants and researchers unaware of who received Desmopressin.

Those kept unaware of assignments: participant and investigator.

It started in 2010-11 with completion listed for 2011-11.

It ran at 45 sites in United States (41) and Canada (4).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period (time frame: Day 1 (Baseline); Week 1, Months 1, 2, 3 (3-month treatment period)).

It also tracked 7 secondary outcomes, for example Change From Baseline in Mean Number of Nocturnal Voids at Month 3, Change From Baseline in Mean Time to First Nocturnal Void at Month 3, Change From Baseline in Nocturnal Urine Volume at Month 3, Change From Baseline in 24-Hour Urine Volume at Month 3, Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) and Minimum Post-Treatment Serum Sodium Levels.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Desmopressin in 268 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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