Interventional Clinical Trial in Patients in Overactive Bladder With Nocturia in Women

What Was Tested

The trial (phase 2) is built around Desmopressin.

It had two arms (groups): Combination (experimental) and Tolterodine (active comparator).

Tolterodine tartrate extended release capsules + Desmopressin orally disintegrating tablets.

Tolterodine tartrate extended release capsules + Placebo orally disintegrating tablets.

The registry classes the interventions as drug.

Who Took Part

106 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, at least 18 years of age (at the time of written consent). Nocturia and overactive bladder symptoms present for ≥6 months prior to trial entry (patient-reported).

The full record lists 4 inclusion and 22 exclusion criteria; among the exclusions: evidence of severe voiding dysfunction defined as:; symptoms of severe stress urinary incontinence in the opinion of the investigator; central or nephrogenic diabetes insipidus.

How the Study Was Run

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

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

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

It started in 2013-01 with completion listed for 2014-11.

It ran at 24 sites in United States (24).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Mean Number of Nocturnal Voids From Baseline (time frame: Baseline to 3 months of treatment).

It also tracked 5 secondary outcomes, for example Change in Mean Time to First Nocturnal Void From Baseline, Change in Mean Nocturnal Urine Volume From Baseline, Responder Status, Onset of Effect as Seen in Change in Mean Number of Nocturnal Voids From Baseline for Each Visit During Three Months of Treatment and Change in the Impact on Sleep as Measured by the Sleep Rating Scales From Baseline.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Desmopressin in 106 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.