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

NCT04290403 | Terminated DMC

• 1 other identifier: CUPID-CDMW-1019
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Keywords

Urinary Incontinence; Dementia; Randomised Cross Over Trial; continence products

Outcome Measures

Primary Outcomes (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.

  56 days

Secondary Outcomes (10)

• Number of continence products used

  56 days

• Number of unintentional leakage

  56 days

• Number of episodes leading to unintentionally soiled or wet clothing

  56 days

• Number of laundry episodes

  56 days

• Number of hours of care partner time

  56 days

Study Arms (2)

Pull ups

EXPERIMENTAL

Pull-up continence products

Device: Pull Ups

Styled briefs with tapes

EXPERIMENTAL

Styled briefs with tapes

Device: Styled Briefs with tapes

Interventions

Pull Ups DEVICE

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

Pull ups

Styled Briefs with tapes DEVICE

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

Styled briefs with tapes

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead
• Essity Hygiene and Health AB: collaborator

Study Sites (1)

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

Edmonton, Alberta, T6G 2P4, Canada

Location

Related Publications (8)

• 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.

  PMID: 1202204 BACKGROUND

• 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.

  PMID: 19951339 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 29509292 BACKGROUND

• 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.

  PMID: 14687391 BACKGROUND

• 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.

  PMID: 19090589 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 29065937 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence; Dementia

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Crossover trial of briefs with tapes versus pull ups for the containment of urinary incontinence

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: February 28, 2020
• Study Start: August 1, 2021
• Primary Completion: July 22, 2024
• Study Completion: July 22, 2024
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)