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Overactive BladderPhase 2NCT02240459

A Study of Fesoterodine and Oxybutynin on Cognitive Function in Mild Cognitive Impairment

A Phase 2 study testing fesoterodine 4mg, Oxybutynin and fesoterodine 8mg in people with Overactive Bladder and Mild Cognitive Impairment, run by University of Alberta at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the effects of fesoterodine at 4mg and 8mg doses versus a placebo and oxybutynin 5mg bid versus placebo on cognitive abilities in older people with overactive bladder and mild cognitive impairment. Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Overactive Bladder, Mild Cognitive Impairment
What is being tested?
fesoterodine 4mg, Oxybutynin and fesoterodine 8mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
47 participants
Where
1 siteCanada
Study dates
Aug 2016to 31 Jan 2020
Phase
Phase 2
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 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • The subject is either male or female and ≥ 75 years of age.
  • The subject has OAB as determined by ICS criteria
  • The subject has mild cognitive impairment as determined by NIA criteria
  • The subject is competent to give informed consent and perform the tasks associated with the study
  • The subject has a body mass index (BMI) between 18.0 to 30.0 kg/m2 inclusive.
  • Written informed consent has been obtained.
  • The subject is available to complete the study.
  • At training visits (visit 2): the subject has performed at or above the minimum level on at least one occasion for each individual task measure in cognitive function test training.

Who cannot join

  • The subject does not have OAB.
  • The subject has either dementia or moderate to severe cognitive impairment at screening.
  • The subject has probable clinical depression as determined by Geriatric Depression Scale (GDS) short form >5 at screening.
  • Subjects taking any cognitive enhancers (cholinesterase inhibitors or memantine).
  • The subject has a history of allergy to the study drug(s), to any component of the dosage form or any other allergy, which, in the opinion of the Investigator, contraindicates their participation.
  • The subject has any clinically significant abnormal heart rate or blood pressure measurements, at the screening visit, which, in the opinion of the Investigator, prevent safe participation in the study. (dBP< 60mmHg or > 90mmHg, sBP < 95mmHg or > 160mmHg or HR < 40bpm or > 100bpm).
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  • Subjects with known history of urinary retention, severe gastrointestinal obstruction (including paralytic ileus or intestinal atony) or severe gastrointestinal conditions (including toxic megacolon or ulcerative colitis), myasthenia gravis, uncontrolled narrow angle glaucoma or shallow interior chamber or subjects deemed to be at risk for these conditions.
  • Subjects undergoing haemodialysis or who have severe renal impairment.
  • Subjects with severe hepatic impairment, defined as Child-Pugh grade IV.
  • Subjects taking potent CYP 3A4 inhibitors which would, under normal circumstances, require adjustment of the dose of the test drugs.
  • Subject has taken prescribed medication within 14 days prior to the first study day or over-the-counter medicine (including vitamins and herbal remedies) within 48 hours prior to the first study day, which in the opinion of the Investigator, will interfere with the study procedures or compromise safety.
  • Subject has an average weekly alcohol intake of greater than 21 units (male) or 14 units (female) within the 90 days prior to the study. 1 unit is 270cc of beer, 40cc of spirits or 125cc of wine.
  • History of smoking more than 10 cigarettes (or the equivalent amount of tobacco) per day within the 90 days prior to the study.
  • Subject has participated in any clinical study within the last 90 days.
  • Any clinically significant abnormality following Investigator review of the pre study physical examination.
  • Any clinical condition, which, in the opinion of the Investigator, would not allow safe completion of the study.
  • Any subjects who, in the opinion of the investigator, may find it difficult to adhere to the provisions of treatment and observation specified in the protocol.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp

    Edmonton, Alberta, T6G 2P4

Other trials in Canada

About this study

Official title: A Double Blind, Randomized Four Way Cross Over Study to Compare the Effect of Fesoterodine 4mg and 8mg Once Daily and Oxybutynin 5mg Twice Daily After Steady State Dosing Versus Placebo on Cognitive Function in Subjects With Overactive Bladder, Over the Age of 75 Years With Mild Cognitive Impairment

The purpose of this study is to assess the effects of fesoterodine at 4mg and 8mg doses versus a placebo and oxybutynin 5mg bid versus placebo on cognitive abilities in older people with overactive bladder and mild cognitive impairment.

Read the detailed description

This is a randomized placebo controlled, blinded four way cross over trial of the effect of medications used to treat overactive bladder on the cognition of older men and women with mild cognitive impairment. Each treatment phase is a week, with a weeks washout period before starting the next treatment. Cognitive testing is by way of a validated computer assisted battery of tests

Being tested
fesoterodine 4mg, Oxybutynin, placebo, fesoterodine 8mg
Keywords
crossover study, placebo controlled, double blind, overactive bladder
Medical subject headings
Urinary Bladder, Overactive, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fesoterodine 4mgDrug

    Also called Toviaz

    7 days therapy followed by seven days washout. Each 4mg tablet is taken in the morning

  • OxybutyninDrug

    Also called ditropan

    5mg IR oxybutynin taken bid, encapsulated into a form indistinguishable from placebo

  • placeboDrug

    Also called placebo capsule

    placebo capsule, one twice daily, and 2 placebo fesoterodine tablets taken each morning for masking and comparator purposes

  • fesoterodine 8mgDrug

    Also called Toviaz 8mg

    2, 4mg fesoterodine capsules taken together in the morning

Study groups in NCT02240459
Study groupRoleWhat they receive
Fesoterodine 4mg dailyExperimentalfesoterodine 4mg oral
Receives: Drug: fesoterodine 4mg; Drug: Oxybutynin; Drug: placebo; Drug: fesoterodine 8mg
Fesoterodine 8mgExperimentalFesoterodine 8mg in form of 2, 4mg tablets
Receives: Drug: fesoterodine 4mg; Drug: Oxybutynin; Drug: placebo; Drug: fesoterodine 8mg
oxybutyninActive comparatoroxybutynin immediate release, encapsulated 2, 5mg capsules daily
Receives: Drug: fesoterodine 4mg; Drug: Oxybutynin; Drug: placebo; Drug: fesoterodine 8mg
placebo capsulePlacebo comparatorplacebo capsule, 2 per day
Receives: Drug: fesoterodine 4mg; Drug: Oxybutynin; Drug: placebo; Drug: fesoterodine 8mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. continuity of attention

    Continuity of Attention:

    Accuracy of responding in Choice Reaction Time task Percent Target Detection in Digit Vigilance task False Alarms in Digit Vigilance task

    Measured: 1 and 4h post dose

Secondary outcomes (1)

  1. cognitive function

    includes the following domains of cognition

    • power of attention,
    • quality of working memory,
    • quality of episodic secondary memory,
    • speed of memory
    • Montreal Cognitive assessment score

    Measured: 1 and 4h post last dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2014 (estimated)
  2. Study startAug 2016
  3. Primary completion31 Jan 2020
  4. Study completion31 Jan 2020

Resources

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
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02240459
Sponsor's protocol ID
FES-COG 1808
Status last verified
Feb 2020
First submitted
11 Sep 2014
Last updated
19 Feb 2020
Results posted
No
Data monitoring committee
No

Publications

  • Wagg A, Dale M, Tretter R, Stow B, Compion G. Randomised, multicentre, placebo-controlled, double-blind crossover study investigating the effect of solifenacin and oxybutynin in elderly people with mild cognitive impairment: the SENIOR study. Eur Urol. 2013 Jul;64(1):74-81. doi: 10.1016/j.eururo.2013.01.002. Epub 2013 Jan 11.

    PubMed 23332882

  • Wesnes KA, Edgar C, Tretter RN, Bolodeoku J. Exploratory pilot study assessing the risk of cognitive impairment or sedation in the elderly following single doses of solifenacin 10 mg. Expert Opin Drug Saf. 2009 Nov;8(6):615-26. doi: 10.1517/14740330903260790.

    PubMed 19747069

  • Rajabali S, Asaana P, Nazari S, Wagg A. A Double-blind, Randomised Four-way Crossover Study to Compare the Effects of Fesoterodine 4 and 8 mg Once Daily and Qxybutynin 5 mg Twice Daily After Steady-state Dosing Versus Placebo on Cognitive Function in Overactive Bladder-wet Patients over the Age of 75 Years with Mild Cognitive Impairment. Eur Urol Focus. 2024 Mar;10(2):325-331. doi: 10.1016/j.euf.2024.02.005. Epub 2024 Feb 23.

    PubMed 38402104

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing fesoterodine 4mg, Oxybutynin and fesoterodine 8mg in people with Overactive Bladder and Mild Cognitive Impairment, run by University of Alberta 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 8 inclusion and 17 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: finished, as of the sponsor's last update on 19 Feb 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

continuity of attention (time frame: 1 and 4h post dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02240459, which also lists 3 linked publications.

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 19 Feb 2020.

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