NocturiaPhase 2/3DEFENDNCT02262936
Comparison Between Desmopressin and Fesoterodine for Treatment of Night Time Voiding in Women Aged 65 and Older
A Phase 2/3 study testing Desmopressin and Fesoterodine in people with Nocturia, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Nocturia
- What is being tested?
- Desmopressin and Fesoterodine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to Feb 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Nocturia
- Being tested
- Desmopressin, Fesoterodine
- Keywords
- Aged, Deamino Arginine Vasopressin, Fesoterodine, Randomized Controlled Trial
- Medical subject headings
- Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesmopressinDrug
FesoterodineDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Fesoterodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (4)
Adverse event profile
Type and number of adverse events will be collected and compared between the two treatment groups.
Measured: 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.
Measured: 18 months
Nocturnal voided volume
The total volume of urine voided at night will be compared between the two treatment groups.
Measured: 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startJul 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NocturiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Baycrest, The Physicians' Services Incorporated Foundation
- Responsible party
- Sponsor
- Investigators
- Harold P Drutz, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262936
- Sponsor's protocol ID
- 14-0188-A
- Other IDs
- 14-56, 14-16
- Acronym
- DEFEND
- Status last verified
- Nov 2016
- First submitted
- 8 Oct 2014
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02262936
- Acronym / sponsor ID
- DEFEND / 14-0188-A
- Conditions
- Nocturia
- Keywords
- Aged, Deamino Arginine Vasopressin, Fesoterodine, Randomized Controlled Trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- Baycrest, The Physicians' Services Incorporated Foundation
- Study start
- Jul 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 13 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desmopressin | Active comparator | Drug: DesmopressinPatients 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. |
| Fesoterodine | Active comparator | Drug: FesoterodinePatients 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Desmopressin | Drug | Desmopressin |
| Fesoterodine | Drug | Fesoterodine |
Primary outcome
Number of night time voids
Time frame: 18 months
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.
4 secondary outcomes
Adverse event profile
Time frame: 18 months
Quality of life
Time frame: 18 months
Nocturnal voided volume
Time frame: 18 months
Time to first nocturnal void
Time frame: 18 months
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harold P Drutz, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Desmopressin and Fesoterodine in people with Nocturia, run by Mount Sinai Hospital, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of night time voids (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.