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

NCT ID: NCT04290403

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2024-07-22

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.

Conditions

Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Pull ups

Pull-up continence products

Group Type: EXPERIMENTAL

Pull Ups

Intervention Type: DEVICE

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

Styled briefs with tapes

Styled briefs with tapes

Group Type: EXPERIMENTAL

Styled Briefs with tapes

Intervention Type: DEVICE

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

Interventions

Pull Ups

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

Intervention Type: DEVICE

Styled Briefs with tapes

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Essity Hygiene and Health AB

INDUSTRY

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Edmonton, Alberta, Canada

Countries

Canada

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

CUPID-CDMW-1019

Identifier Type: -

Identifier Source: org_study_id