Study Investigating the Impact Burden of Nocturia Using the Nocturia Impact Diary

What Was Tested

The trial (phase 3) is built around Desmopressin.

The purpose of this study is to assess psychometric properties (reliability and validity) of the Nocturia Impact (NI) diary.

To assess which NI diary items account for the main difference in change in total NI score in treatment versus placebo.

It had four arms (groups): one (experimental), Female - Placebo (placebo comparator), one (experimental) and Male - Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 56 actual participants took part.

It was open to people of any sex 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 study-related activity. 18 years of age (at the time of written consent) or older.

The full record lists 4 inclusion and 22 exclusion criteria; among the exclusions: chronic prostatitis (males)/chronic pelvic pain syndrome (cpps); surgical treatment, including transurethral resection, for boo or benign prostatic hyperplasia (males) within the past six months; central or nephrogenic diabetes insipidus.

How the Study Was Run

The set-up was randomized, parallel-group and triple-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.

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

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2012-03 with completion listed for 2012-05.

It ran at 10 sites in United States (10).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The Pearson Correlation Coefficient Between Change From Baseline to Month 1 in Number of Nocturnal Voids and Change From Baseline to Month 1 in Nocturia Impact (NI) Diary Total Score (time frame: Day 1 (Baseline), Month 1). Difference in Mean Change From Baseline to Month 1 in Nocturia Impact (NI) Total Scores and Overall Impact Question for Responders and Non-Responders (time frame: Day 1 (Baseline), Month 1). Cohen's D Effect Size in Responsiveness in the Nocturia Impact (NI) Total Scores and Overall Impact Question as Measured From Baseline (Day 1) to Month 1 (time frame: Day 1 (Baseline), Month 1).

It also tracked 5 secondary outcomes, for example Internal Consistency of the Nocturia Impact (NI) Total Score for Each Day NI Diaries Were Completed Assessed as Cronbach's Alpha Values, Change From Baseline to Month 1 on Nocturia Impact (NI) Total Score, Minimum Post-Treatment Serum Sodium Levels and Summary of Participants With Treatment-Emergent Adverse Events (TEAEs).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Desmopressin in 56 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.