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Urinary IncontinenceCUPIDNCT04290403

Briefs With Tapes Versus Pull Ups for Urinary Incontinence in Older People With Mild to Moderate Dementia (CUPID)

A study testing Pull Ups and Styled Briefs with tapes in people with Urinary Incontinence, run by University of Alberta at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Urinary incontinence is a common health problem that significantly affects the quality of life of older people. The risk of urinary incontinence is increased in people living with dementia. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Urinary Incontinence
What is being tested?
Pull Ups and Styled Briefs with tapes
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteCanada
Study dates
1 Aug 2021to 22 Jul 2024
Phase
Interventional
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
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Able to toilet independently or independently following prompting or instruction to do so.
  • Independently mobile, with or without walking aids
  • Use of any type of continence produce, for the management of moderate incontinence.
  • Moderate incontinence severity as measured by Incontinence Severity (Sandvik) index.
  • Availability of care partner willing to co-operate and participate in trail procedures

Who cannot join

  • Need for daily help with dexterity to apply any continence product
  • Waist size or body shape which renders any size of either investigational product inapplicable
  • PLWD unable to indicate the need to toilet
  • PLWD with significant faecal incontinence
  • Permanent residence in nursing home or expected to enter nursing home within two months of trail entry
  • Presence of any other condition, which, in the opinion of the investigator makes PLWD unable to participate in the necessary trail procedures.

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 Randomised Cross Over Trial of Briefs With Tapes Versus Pull Ups for the Containment of Urinary Incontinence in Community Dwelling Older People Living With Mild to Moderate Dementia (CUPID)

Urinary incontinence is a common health problem that significantly affects the quality of life of older people. The risk of urinary incontinence is increased in people living with dementia. Many products aid the management of urinary incontinence, with many people choosing to manage incontinence with containment products. The purpose of this study is to examine and compare two containment products - pull ups and style briefs with tapes, in self-management of urinary incontinence in people living with dementia.

Read the detailed description

Urinary incontinence is common in later life and the risk of incontinence is increased in people living with dementia (PLWD). For many, incontinence is managed with toileting assistance containment products, regardless of other potential treatments. As toileting becomes more difficult and incontinence more likely, a containment product which mimics normal underwear, which is familiar to the PLWD may be an attractive option to preserve successful toileting and self management of continence with containment products and toileting for as long as possible. This study is designed to explore the relative benefits or disadvantages of containment with either briefs with tapes or pull ups in the self management of continence by containment products and toileting in PLWD.

Primary objective

To examine the benefits and disadvantages of self-management of urinary incontinence by pulls compared to style briefs with tapes in PLWD.

Research Method/Procedures

This study will comprise a three-phase design

A small sample, exploratory study to ascertain the feasibility of recruitment, trial design and conduct and to enable calculation of an effect size for the trial primary outcome including care partner interviews and exploration of qualitative factors in use not captured elsewhere, economic variables and costs.

A crossover study with an interval washout (pre-trial care) period. Each participant will undergo a 3-day assessment of incontinence severity to ensure eligibility and then, in random order, a four-week period of use of one investigational product, a two week return to their usual care (the care methods undertaken prior to trial commencement) and then a four-week period of use of the comparative investigational product.

A post-treatment phase, qualitative semi-structured interview with PLWD and their care partners to discuss the impressions of the use of each investigational product.

Being tested
Pull Ups, Styled Briefs with tapes
Keywords
Urinary Incontinence, Dementia, Randomised Cross Over Trial, continence products
Medical subject headings
Urinary Incontinence, Dementia

What participants receive

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

  • Pull UpsDevice

    Participants will be asked to wear pull-ups continence products for the duration of four weeks

  • Styled Briefs with tapesDevice

    Participants will be asked to wear styled briefs with tapes for the duration of four weeks

Study groups in NCT04290403
Study groupRoleWhat they receive
Pull upsExperimentalPull-up continence products
Receives: Device: Pull Ups
Styled briefs with tapesExperimentalStyled briefs with tapes
Receives: Device: Styled Briefs with tapes

What is being measured

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

  1. Number of Successful Toileting Episodes

    Between group change in the proportion of "successful toileting episodes", defined as episodes of independent toileting with pad use and reapplication without leakage, misapplication or failure, between baseline measurement and end of study investigational product.

    Measured: 56 days

Secondary outcomes (10)

  1. Number of continence products used

    Number of products used in excess of those deemed necessary [2/24h] according to degree of incontinence.

    Measured: 56 days

  2. Number of unintentional leakage

    Number of unintentionally leaking products due to misapplication, average per 24h over the duration of the study

    Measured: 56 days

  3. Number of episodes leading to unintentionally soiled or wet clothing

    Difference in number of episodes leading to wet or unintentionally soiled clothing, between investigational products over the duration of the study.

    Measured: 56 days

  4. Number of laundry episodes

    Differences in number of laundry episodes(either clothes or bed linen) between investigational products over the duration of the study

    Measured: 56 days

  5. Number of hours of care partner time

    Difference in care partner time in maintaining continence with investigational products and toileting over the duration of the study

    Measured: 56 days

  6. Cost of care partner time

    Difference in care partner cost (costed at minimum wage per hour) in maintaining continence with investigational products and toileting over the duration of the study

    Measured: 56 days

  7. Quality of life at baseline and end of study

    Change in quality of life measures between baseline assessment and end of study using Quality of Life Alzheimer Disease (ADQoL) validated questionnaire.

    The ADQoL scores can be calculated based on patient and caregiver reports and can be combined into a single score, with total scores range from 13 to 52, with higher scores indicating better QoL

    Measured: 56 days

  8. Zarit burden index

    Comparison of change in Zarit burden index between baseline and end of investigational product use compared between products. Zarit burden index consists of 22 items used to calculate a total score that can range between 0 and 88 (88 = more burden)

    Measured: 56 days

  9. Number of Care Partners satisfied with treatment

    Persons living with dementia and care partner assessment of satisfaction with each investigational product and its use, assessed at the end of each testing period

    Measured: 56 days

  10. Number of PLWD satisfied with treatment

    Impressions of ease of use and user satisfaction on the part of persons living with dementia and care partner, at the end of each period of investigational product use, assessed by semi-structured interview

    Measured: 56 days

Timeline

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

  1. First posted28 Feb 2020
  2. Study start1 Aug 2021
  3. Primary completion22 Jul 2024
  4. Study completion22 Jul 2024

Why it stopped: Recruitment difficulties

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 N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
Crossover trial of briefs with tapes versus pull ups for the containment of urinary incontinence
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04290403
Sponsor's protocol ID
CUPID-CDMW-1019
Acronym
CUPID
Status last verified
May 2025
First submitted
5 Dec 2019
Last updated
11 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

    PubMed 1202204

  • Hilmer SN, Perera V, Mitchell S, Murnion BP, Dent J, Bajorek B, Matthews S, Rolfson DB. The assessment of frailty in older people in acute care. Australas J Ageing. 2009 Dec;28(4):182-8. doi: 10.1111/j.1741-6612.2009.00367.x.

    PubMed 19951339

  • Logsdon, R.G., , Gibbons, L.E., McCurry, S.M., Teri, L., Quality of life in Alzheimer's disease: patient and caregiver reports. Journal of mental health and ageing, 1999. 5: p. 21-25.

  • Volz-Sidiropoulou E, Rings T, Wagg AS, Leistner N, Gauggel S, Kirschner-Hermanns R. Development and initial psychometric properties of the 'ICIQ-Cog': a new assessment tool to measure the disease-related impact and care effort associated with incontinence in cognitively impaired adults. BJU Int. 2018 Aug;122(2):309-316. doi: 10.1111/bju.14186. Epub 2018 Apr 10.

    PubMed 29509292

  • Baker PS, Bodner EV, Allman RM. Measuring life-space mobility in community-dwelling older adults. J Am Geriatr Soc. 2003 Nov;51(11):1610-4. doi: 10.1046/j.1532-5415.2003.51512.x.

    PubMed 14687391

  • Gotoh M, Matsukawa Y, Yoshikawa Y, Funahashi Y, Kato M, Hattori R. Impact of urinary incontinence on the psychological burden of family caregivers. Neurourol Urodyn. 2009;28(6):492-6. doi: 10.1002/nau.20675.

    PubMed 19090589

  • Hérbert, R., Bravo, G., & Préville, M., Reliability, validity, and reference values of the Zarit Burden Interview for assessing informal caregivers of community-dwelling older persons with dementia. Canadian Journal on Aging, 2000. 19: p. 494-507.

  • Lesen E, Bjorholt I, Ingelgard A, Olson FJ. EXPLORATION AND PREFERENTIAL RANKING OF PATIENT BENEFITS OF MEDICAL DEVICES: A NEW AND GENERIC INSTRUMENT FOR HEALTH ECONOMIC ASSESSMENTS. Int J Technol Assess Health Care. 2017 Jan;33(4):463-471. doi: 10.1017/S0266462317000848. Epub 2017 Oct 25.

    PubMed 29065937

Questions about this trial

What is this clinical trial studying?

A study testing Pull Ups and Styled Briefs with tapes in people with Urinary Incontinence, 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 5 inclusion and 6 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 11 May 2025. 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.

Are results available for this study?

The study was stopped early (reason given: Recruitment difficulties). 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 Successful Toileting Episodes (time frame: 56 days). 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 NCT04290403, which also lists 8 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 11 May 2025.

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