A Phase 2/3 interventional study of Desmopressin and Fesoterodine in Nocturia, sponsored by Mount Sinai Hospital, Canada. Terminated at 1 site in Canada. Open to female participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2016-11-15.
Sponsored by Mount Sinai Hospital, Canada · Phase 2/3, Interventional, and Treatment
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 study will include female patients 65 years and older from the Urogynecology Units at Mount Sinai Hospital (MSH) and Baycrest. It will be a 12 week prospective, randomized double-blind trial comparing treatment of nocturia using Fesoterodine and Desmopressin. Patients who agree to participate in the study will receive a starting dose of either Fesoterodine 4mg tablet at bedtime or Desmopressin 0.1mg tablet at bedtime. After 4 weeks, if patients have had minimal improvement in their symptoms and are not significantly affected by side effects, patients will have the option of increasing the dose of their medication to 8mg of Fesoterodine or 0.2mg of Desmopressin. This decision will be made by the patient and physician together.
Patients will undergo block randomization by pharmacy. 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. Patients will also have urine cultures and uroflowmetry with measurement of post-void residuals at these visits, as per clinic standard of care. Venipuncture to monitor electrolyte levels will be done at baseline, 1 week after randomization and then monthly until the end of the study. If patients choose to increase their dose at the 4 week visit, electrolyte levels will be repeated one week after the dose adjustment and then monthly until the end of the study. The last follow up is at 12 weeks, when a 3 day voiding diary and the NNES-Q will be collected.
124 studies on the registry are indexed under Nocturia; 24 are open to participants now.
This study's enrollment of 4 is below the median of 67 across 94 interventional studies indexed under Nocturia.
Browse Nocturia studies →Mount Sinai Hospital, Canada is the lead sponsor of 157 studies on the registry; 33 are open to participants now.
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Exclusion Criteria:
Patients randomized to receive Desmopressin will be given 0.1mg daily by mouth at bedtime. After 4 weeks, patients will have the option to increase their dose to 0.2mg daily by mouth at bedtime. Total time of drug administration will be 12 weeks.
Drug: Desmopressin
Patients randomized to receive Fesoterodine will be given 4mg daily by mouth at bedtime. After 4 weeks, patients will have the option to increase their dose to 8mg daily by mouth at bedtime. Total time of drug administration will be 12 weeks.
Drug: Fesoterodine
Number of night time voids
Patients will complete a 3-day voiding diary at baseline and after 12 weeks of treatment. The number of night time voids will be compared before and after treatment. The anticipated reduction in night time voids between the two treatment groups will be compared.
Time frame: 18 months
Adverse event profile
Type and number of adverse events will be collected and compared between the two treatment groups.
Time frame: 18 months
Quality of life
Quality of life, as measured by the Nocturia, Nocturnal Enuresis and Sleep-interruptions Questionnaire (NNES-Q) will be compared between the two treatment groups.
Time frame: 18 months
Nocturnal voided volume
The total volume of urine voided at night will be compared between the two treatment groups.
Time frame: 18 months
Time to first nocturnal void
The number of minutes of sleep prior to first waking at night to void will be compared between the two treatment groups.
Time frame: 18 months
This study is terminated, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Mount Sinai Hospital, Canada