Status:
TERMINATED
Comparison Between Desmopressin and Fesoterodine for Treatment of Night Time Voiding in Women Aged 65 and Older
Lead Sponsor:
Mount Sinai Hospital, Canada
Collaborating Sponsors:
Baycrest
The Physicians' Services Incorporated Foundation
Conditions:
Nocturia
Eligibility:
FEMALE
65+ years
Phase:
PHASE2
PHASE3
Brief 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 sodiu...
Detailed Description
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 comp...
Eligibility Criteria
Inclusion
- 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
- Patients capable of understanding and having signed the consent form after full discussion of the research, nature of the treatment, its risks and benefits
Exclusion
- Urinary tract infection or chronic inflammation such as interstitial cystitis and bladder stones
- Urinary and gastric retention
- Narrow-angle glaucoma
- von Willebrand's disease
- Chronic severe constipation or history of gastrointestinal obstructive disease
- Untreated congestive heart failure and venous insufficiency
- Untreated hypertension or tachycardia
- Untreated renal or liver disease
- Untreated diabetes mellitus or insipidus
- Unexplained and untreated electrolyte disturbances
- Any clinical condition which in the opinion of the investigator would not allow safe completion of the study
- Current use of diuretics with untreated electrolyte disturbances
- Patients taking drugs known to be strong CYP3A4 inhibitors (protease inhibitors, ketoconazole, clarithromycin) or strong CYP3A4 inducers (carbamazepine, phenytoin, St. John's Wort) used on a regular basis
- Patients taking anticholinergic or antispasmodic medications who did not comply with a minimum 14 days washout period
- Previous failed therapy with Fesoterodine or Desmopressin
- Hypersensitivity or intolerance to Fesoterodine or Desmopressin
- Hypersensitivity to soya, peanuts or lactose
- Clinically significant outlet obstruction as determined by the investigator
- Patients with Post Void Residual (PVR) \> 100 ml
- Patients with Mini-Mental State Exam (MMSE) \<24
Key Trial Info
Start Date :
July 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT02262936
Start Date
July 1 2015
End Date
February 1 2016
Last Update
November 15 2016
Active Locations (1)
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1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5