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Recruitment difficulties
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| Name | Class |
|---|---|
| Essity Hygiene and Health AB | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pull ups | Experimental | Pull-up continence products |
|
| Styled briefs with tapes | Experimental | Styled briefs with tapes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pull Ups | Device | Participants will be asked to wear pull-ups continence products for the duration of four weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of continence products used | Number of products used in excess of those deemed necessary [2/24h] according to degree of incontinence. | 56 days |
| Number of unintentional leakage | Number of unintentionally leaking products due to misapplication, average per 24h over the duration of the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp | Edmonton | Alberta | T6G 2P4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1202204 | Background | 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. | |
| 19951339 | 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. |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Crossover trial of briefs with tapes versus pull ups for the containment of urinary incontinence
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| Styled Briefs with tapes | Device | Participants will be asked to wear styled briefs with tapes for the duration of four weeks |
|
| 56 days |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| 29509292 | 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. |
| 14687391 | 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. |
| 19090589 | 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. |
| 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. |
| 29065937 | 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. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |