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

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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+