Clinical trial NCT04290403: Briefs With Tapes Versus Pull Ups for Urinary Incontinence in Older People With Mild to Moderate Dementia (CUPID)
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urinary Incontinence
Keywords: Urinary Incontinence
Dementia
Randomised Cross Over Trial
continence products
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Essity Hygiene and Health AB
First posted: 2020-02-28
Enrollment: 15
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover trial of briefs with tapes versus pull ups for the containment of urinary incontinence
Primary purpose: OTHER

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Successful Toileting Episodes
timeFrame: 56 days
Secondary outcomes:
measure: Number of continence products used
timeFrame: 56 days
measure: Number of unintentional leakage
timeFrame: 56 days
measure: Number of episodes leading to unintentionally soiled or wet clothing
timeFrame: 56 days
measure: Number of laundry episodes
timeFrame: 56 days
measure: Number of hours of care partner time
timeFrame: 56 days
measure: Cost of care partner time
timeFrame: 56 days
measure: Quality of life at baseline and end of study
timeFrame: 56 days
measure: Zarit burden index
timeFrame: 56 days
measure: Number of Care Partners satisfied with treatment
timeFrame: 56 days
measure: Number of PLWD satisfied with treatment
timeFrame: 56 days
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp
state: Alberta
Study officials:
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