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

Primary Purpose

Nocturia

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Desmopressin
Fesoterodine
Sponsored by
Mount Sinai Hospital, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nocturia focused on measuring Aged, Deamino Arginine Vasopressin, Fesoterodine, Randomized Controlled Trial

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Desmopressin

Fesoterodine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adverse event profile
Type and number of adverse events will be collected and compared between the two treatment groups.
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.
Nocturnal voided volume
The total volume of urine voided at night will be compared between the two treatment groups.
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.

Full Information

First Posted
October 8, 2014
Last Updated
November 11, 2016
Sponsor
Mount Sinai Hospital, Canada
Collaborators
Baycrest, The Physicians' Services Incorporated Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02262936
Brief Title
Comparison Between Desmopressin and Fesoterodine for Treatment of Night Time Voiding in Women Aged 65 and Older
Acronym
DEFEND
Official Title
A Randomized Double-blinded Trial Comparing DEsmopressin to FEsoterodine in the Treatment of Severe Nocturia in Women Aged 65 and olDer: The DEFEND Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
Poor recruitment
Study Start Date
July 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mount Sinai Hospital, Canada
Collaborators
Baycrest, The Physicians' Services Incorporated Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturia
Keywords
Aged, Deamino Arginine Vasopressin, Fesoterodine, Randomized Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Desmopressin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Fesoterodine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Desmopressin
Intervention Type
Drug
Intervention Name(s)
Fesoterodine
Primary Outcome Measure Information:
Title
Number of night time voids
Description
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
Secondary Outcome Measure Information:
Title
Adverse event profile
Description
Type and number of adverse events will be collected and compared between the two treatment groups.
Time Frame
18 months
Title
Quality of life
Description
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
Title
Nocturnal voided volume
Description
The total volume of urine voided at night will be compared between the two treatment groups.
Time Frame
18 months
Title
Time to first nocturnal void
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harold P Drutz, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X5
Country
Canada

12. IPD Sharing Statement

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

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