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

Urinary Incontinence Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04290403
• Other study ID #: CUPID-CDMW-1019
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: University of Alberta
• Contact: Adrian S Wagg, MD
• Phone: 780-492-5338
• Email: adrian.wagg[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia
• Enuresis
• Urinary Incontinence

Intervention

Device:
• Pull Ups
Participants will be asked to wear pull-ups continence products for the duration of four weeks
• Styled Briefs with tapes
Participants will be asked to wear styled briefs with tapes for the duration of four weeks

Locations

Country	Name	City	State
Canada	Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Essity Hygiene and Health AB

Country where clinical trial is conducted

Canada, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of continence products used	Number of products used in excess of those deemed necessary [2/24h] according to degree of incontinence.	56 days
Secondary	Number of unintentional leakage	Number of unintentionally leaking products due to misapplication, average per 24h over the duration of the study	56 days
Secondary	Number of episodes leading to unintentionally soiled or wet clothing	Difference in number of episodes leading to wet or unintentionally soiled clothing, between investigational products over the duration of the study.	56 days
Secondary	Number of laundry episodes	Differences in number of laundry episodes(either clothes or bed linen) between investigational products over the duration of the study	56 days
Secondary	Number of hours of care partner time	Difference in care partner time in maintaining continence with investigational products and toileting over the duration of the study	56 days
Secondary	Cost of care partner time	Difference in care partner cost (costed at minimum wage per hour) in maintaining continence with investigational products and toileting over the duration of the study	56 days
Secondary	Quality of life at baseline and end of study	Change in quality of life measures between baseline assessment and end of study using Quality of Life Alzheimer Disease (ADQoL) validated questionnaire.; The ADQoL scores can be calculated based on patient and caregiver reports and can be combined into a single score, with total scores range from 13 to 52, with higher scores indicating better QoL	56 days
Secondary	Zarit burden index	Comparison of change in Zarit burden index between baseline and end of investigational product use compared between products. Zarit burden index consists of 22 items used to calculate a total score that can range between 0 and 88 (88 = more burden)	56 days
Secondary	Number of Care Partners satisfied with treatment	Persons living with dementia and care partner assessment of satisfaction with each investigational product and its use, assessed at the end of each testing period	56 days
Secondary	Number of PLWD satisfied with treatment	Impressions of ease of use and user satisfaction on the part of persons living with dementia and care partner, at the end of each period of investigational product use, assessed by semi-structured interview	56 days