Comparison Between Desmopressin and Fesoterodine for Treatment of Night Time Voiding in Women Aged 65 and Older
Status:
Terminated
Trial end date:
2016-02-01
Target enrollment:
Participant gender:
Summary
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). Recent trials showed Fesoterodine was effective in
reducing nocturia. This study aims to answer the following: In women 65 and older with severe
nocturia, is Fesoterodine more effective than Desmopressin in reducing the number of night
time voids? Does Fesoterodine have a better side effect profile compared to Desmopressin?
The study design is a 12 week randomized double-blinded trial of Fesoterodine and
Desmopressin in the treatment of severe nocturia in women aged 65 and older. This will be
conducted at the Urogynecology Unit at Mount Sinai Hospital (MSH) and Baycrest. A 3 day
voiding diary and Nocturia, Nocturnal Enuresis and Sleep-interruption Questionnaire (NNES-Q)
will be completed at baseline and at week 12. The primary outcome will be the number of night
time voids in the Fesoterodine group compared to the Desmopressin group, 12 weeks after
starting treatment. Secondary outcomes include changes in the NNES-Q scores and the safety of
each medication.
This study is expected to show that, in women 65 and older with severe nocturia, Fesoterodine
will be more effective in reducing the number of night time voids, reducing the volume of
voided urine, increasing the duration of sleep prior to first nocturnal void and improving
quality of life relative to Desmopressin. Fesoterodine will also be better tolerated, with
fewer significant adverse events, relative to Desmopressin.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Mount Sinai Hospital, Canada
Collaborators:
Baycrest The Physicians' Services Incorporated Foundation