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

NCT02262936 | Terminated Phase 2

• 3 other identifiers: 14-0188-A14-5614-16
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Nocturia

Keywords

Aged; Deamino Arginine Vasopressin; Fesoterodine; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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.

  18 months

Secondary Outcomes (4)

• Adverse event profile

  18 months

• Quality of life

  18 months

• Nocturnal voided volume

  18 months

• Time to first nocturnal void

  18 months

Study Arms (2)

Desmopressin

ACTIVE COMPARATOR

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

Fesoterodine

ACTIVE COMPARATOR

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

Interventions

Desmopressin DRUG

Desmopressin

Fesoterodine DRUG

Fesoterodine

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• Baycrest: collaborator
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

MeSH Terms

Conditions

Nocturia

Interventions

Deamino Arginine Vasopressin; fesoterodine

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Harold P Drutz, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: October 13, 2014
• Study Start: July 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: November 15, 2016

Record last verified: 2016-11

Locations

CA (1)