Can the Use of Uricap Female, a New Urine Collecting Device, Lead to Better Care for Women > 75+Years With Urinary Incontinence?
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- UTIs
研究概览
简要总结
The purpose of the study is to evaluate if Uricap Female, an uridome for women, can be used instead of traditional incontinence aids to treat urinary incontinence (UI) among women 75 years and older.
详细描述
The aim is to improve the care for female patients in long-term nursing homes who suffer from UI and to prevent recurrent urinary tract infections (UTIs).
The project organization consist of researchers within primary care, geriatrics and nursing sciences. The investigators will recruit study participants with UI from long-term nursing homes in Örebro County that will be randomized in an open randomised controlled trial to an intervention or a control group. The intervention will last for 3 months. The study participants will receive a structured medical assessment before and after the intervention, including assessment of the patient's cognitive functions, genital skin status, neuropsychiatric symptoms and quality of life (QoL).
The uridome is changed daily while the control group will receive usual incontinence treatment. The investigators will study the number of UTIs during the intervention period, analyze inflammatory cytokines in urine using OLINK proteomics and ELISA to study inflammation. Health economic analysis will be performed.
The investigators believe that treatment with Uricap Female will be more effective in preventing recurrent UTIs, improve genital skin status, cognitive status and neuropsychiatric symptoms and QoL for the women. This will directly lead to individualised care and less strain on primary care resources.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •UI that requires incontinence aids
- •Suitable anatomy (outer labia cover and protect the Uricap Female cup).
排除标准
- •active UTI
- •urinary retention (cannot empty the bladder on her own)
- •macroscopic hematuria
- •prolapse or similar gynecological disorders
- •allergy to silicone or latex (the material of Uricap Female)
- •short expected survival time
结局指标
主要结局
UTIs
时间窗: 12 weeks
Frequency of incontinence-associated urinary tract infections (UTIs)
次要结局
- Inflammation(Baseline, week 6, week 12)
- Behavioural and psychological symptoms(Baseline, week 12)
- Cognitive status(Baseline, week 12)
- Health economics(baseline, week 11-12)
- Genital skin status(Baseline, week12)
- QoL(Baseline, week 12)
- Neuropsychiatric symptoms in dementia(Baseline, week 12)