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)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of Successful Toileting Episodes
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Number of Successful Toileting Episodes
时间窗: 56 days
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.
次要结局
- Number of PLWD satisfied with treatment(56 days)
- Number of unintentional leakage(56 days)
- Quality of life at baseline and end of study(56 days)
- Zarit burden index(56 days)
- Number of continence products used(56 days)
- Number of episodes leading to unintentionally soiled or wet clothing(56 days)
- Number of hours of care partner time(56 days)
- Number of laundry episodes(56 days)
- Cost of care partner time(56 days)
- Number of Care Partners satisfied with treatment(56 days)