Comparison Between Desmopressin and Fesoterodine for Treatment of Night Time Voiding in Women Aged 65 and Older

What Was Tested

This registered phase 2, phase 3 trial tested Desmopressin.

Nocturia, or voiding at night, is an extremely troublesome symptom which is highly prevalent in the elderly.

Desmopressin is a treatment for nocturia but it can result in hyponatremia (low blood sodium), particularly in those aged 65 and older.

Fesoterodine is used for the treatment of overactive bladder (OAB).

It had two arms (groups): Desmopressin (active comparator) and Fesoterodine (active comparator).

The registry classes the interventions as drug.

More on the Plan

It will be a 12 week prospective, randomized double-blind trial comparing treatment of nocturia using Fesoterodine and Desmopressin.

This decision will be made by the patient and physician together.

All patients and investigators will be blinded to the treatment group.

Patients will be followed for 12 weeks, with visits at 4 and 12 weeks.

Who Took Part

The registry lists 4 actual participants took part.

It was open to women only aged from 65 years with no upper age limit.

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

Examples of who could join: Menopausal female patients aged 65 years and older. Patients with severe nocturia, defined as waking to void 3 or more times at night due to an urge to void.

The full record lists 3 inclusion and 20 exclusion criteria; among the exclusions: urinary tract infection or chronic inflammation such as interstitial cystitis and bladder stones; urinary and gastric retention; narrow-angle glaucoma.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Desmopressin group and the comparison group should start out alike.

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, care provider, investigator and outcomes assessor.

It started in 2015-07 with completion listed for 2016-02.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of night time voids (time frame: 18 months).

It also tracked 4 secondary outcomes, for example Adverse event profile, Quality of life, Nocturnal voided volume and Time to first nocturnal void.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Desmopressin in 4 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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