Briefs vs Pull-Ups for Urinary Incontinence in Dementia

(CUPID Trial)

Overseen By Saima Rajabali, MBBS

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Faecal incontinence, Nursing home, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two products, pull-ups and briefs with tapes, for managing urinary incontinence in people with dementia. The goal is to determine which product better aids daily life and comfort. Suitable participants are those who can use the bathroom independently or with assistance, have moderate incontinence, and can still move around independently. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance daily living for many.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing incontinence products, so you may not need to change your medications, but it's best to confirm with the trial organizers.

What prior data suggests that these containment products are safe for managing urinary incontinence in people with dementia?

Research shows that people with dementia often prefer pull-ups over other incontinence products. They find pull-ups more acceptable and comfortable, making them easier to use. No specific safety concerns have been reported with pull-ups, indicating they are generally well-tolerated.

Styled briefs with tapes offer another option for managing urinary incontinence. They can be effective, but regular changes are important. If not changed often, they can keep the skin wet, leading to irritation or discomfort. This requires more attention to prevent skin issues.

Both pull-ups and styled briefs are designed to manage urinary incontinence safely. Research does not highlight major safety concerns for either option. However, it is always important to monitor for any skin reactions and follow the recommended usage instructions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing pull-up continence products and styled briefs with tapes for managing urinary incontinence in dementia patients because these options could offer significant improvements in comfort, dignity, and ease of use over traditional incontinence pads and briefs. Pull-ups are designed to be more like regular underwear, which may help maintain a sense of normalcy for users. Styled briefs with tapes provide secure fit and adjustability, potentially reducing leaks and enhancing skin health by minimizing prolonged wetness. These features could lead to better overall quality of life for those affected by dementia-related incontinence.

What evidence suggests that this trial's treatments could be effective for urinary incontinence in dementia?

This trial compares pull-up style products with styled briefs with tapes for managing urinary incontinence in people with dementia. Research has shown that pull-up style products are often more acceptable for people with dementia due to their ease of use. One study found that people were very satisfied with pull-ups, suggesting they are a good option for managing urinary incontinence in this population.

Styled briefs with tapes, another option in this trial, also show promise. They have proven effective for older adults with mild to moderate dementia. A study in care facilities found that high-quality incontinence products, like these briefs, can be effective when combined with proper education.

Both pull-ups and briefs with tapes offer different benefits and are being evaluated in this trial to help manage urinary incontinence in people with dementia. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for older individuals with mild to moderate dementia who can use the toilet on their own or with a reminder, move around (with aids if needed), and are currently using products for moderate urinary incontinence. They must have a caregiver willing to help with the study. People who need daily help applying these products, don't fit the product sizes, can't signal when they need to go, have severe bowel incontinence, live in nursing homes or might enter one soon cannot join.

Inclusion Criteria

You use any type of product to manage moderate incontinence.

You have a moderate level of urine leakage as measured by the Incontinence Severity (Sandvik) index.

Able to toilet independently or independently following prompting or instruction to do so

Exclusion Criteria

Need for daily help with dexterity to apply any continence product

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Pre-trial Care

Participants undergo a 3-day assessment of incontinence severity to ensure eligibility

1 week

1 visit (in-person)

Crossover Treatment

Participants use one investigational product for four weeks, followed by a two-week washout period, and then use the comparative product for another four weeks

10 weeks

Regular monitoring visits

Post-treatment

Qualitative semi-structured interviews with PLWD and their care partners to discuss impressions of the investigational products

1 week

1 visit (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pull Ups
• Styled Briefs with tapes

Trial Overview The CUPID trial is comparing two types of incontinence products: styled briefs with tapes versus pull ups. The goal is to see which one better helps manage urinary incontinence for people living with dementia. Participants will be randomly assigned to use either styled briefs with tapes or pull ups and their effectiveness will be evaluated.

How Is the Trial Designed?

Group I: Styled briefs with tapes Experimental Treatment 1 Intervention

Styled briefs with tapes

Group II: Pull ups Experimental Treatment 1 Intervention

Pull-up continence products

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Essity Hygiene and Health AB

Industry Sponsor

Trials

16

Recruited

900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9135215/

A qualitative study of continence service provision for ... Incontinence is a major problem for people with dementia (PWD) and their family/friend caregivers, often causing substantial harm, including ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9292568/

A research agenda for promoting continence for people ... 'Pull‐ups' are often more acceptable than insertable incontinence pads for PLWD (Drennan et al., 2011, 2017).

3. tena-images.essity.com tena-images.essity.com/images-c5/121/329121/original/essity-dmu-study.pdf

An exploration of the experience of using the TENA Pants ... Findings: Overall, high satisfaction levels with the product were recorded suggesting this to be a suitable continence product for people with dementia residing ...

4. alzheimers.org.uk alzheimers.org.uk/dementia-together-magazine/aug-sept-2018/your-answers-continence-products

Your answers: Continence products This saves a wet nightie (or sheets) when there's a leak. I've found the urine incontinence one of the hardest things to manage with Mum's dementia, especially ...

5. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-07031-z

A post-market cluster randomized controlled trial of the effect ... This study will seek to examine the effect of the TENA SmartCare Change Indicator on urinary continence care efficiency and skin health, in comparison to usual ...

6. systematicreviewsjournal.biomedcentral.com systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-021-01743-0

Understanding how to facilitate continence for people with ... People living with dementia (PLWD) are at significant risk of developing urinary and/or faecal incontinence and are also at risk of ...

7. racgp.org.au racgp.org.au/getattachment/93153a34-3930-4947-b576-7fa319c4f5ef/200604yap.pdf

Urinary incontinence in dementia Pull up pants can be an alternative here. Otherwise, applying absorbent pads on the undergarments can be attempted. The person with dementia may not always be.

8. researchgate.net researchgate.net/publication/346332147_Problems_facing_people_living_at_home_with_dementia_and_incontinence_causes_consequences_and_potential_solutions

Problems facing people living at home with dementia and ... Background: many people living at home with dementia (PLWD) also have poorly managed toilet-use or incontinence problems with damaging consequences for both ...