View clinical trials related to Nocturia.
Filter by:Observation of safety and efficacy of Minirin Melt® in adult patients with nocturia
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.
This trial will investigate the relationship of sleep, daytime performance and nocturia in patients treated with Desmopressin or placebo. Male and Female patients will be administered Desmopressin or Placebo every day for 3 months.
The purpose of the study is to evaluate the efficacy of desmopressin on symptoms of nocturia in patients with Obstructive Sleep Apnoea (OSA). The improvement of sleep quality and the quality of life will be measured.