Can the Use of Uricap Female Device Lead to Better Care for Women > 75+Years?

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Can the Use of Uricap Female, a New Urine Collecting Device, Lead to Better Care for Women > 75+Years With Urinary Incontinence?

Conditions
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Urinary Incontinence, Urinary Tract Infections, Incontinence-associated Dermatitis, Cognition Disorders in Old Age, Behavioral and Psychiatric Symptoms of Dementia

Intervention / Treatment
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* Device: Use of Uricap Female, a New Urine Collecting Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: UI that requires incontinence aids Suitable anatomy (outer labia cover and protect the Uricap Female cup). Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The uridome is changed daily in the intervention group, while the control group will continue to receive the usual incontinence treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Uricap group<br>the new incontinence device | Device: Use of Uricap Female, a New Urine Collecting Device<br>* The uridome is changed daily by trained staff<br>|
| No Intervention: Control group<br>the usual incontinence care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UTIs | Frequency of incontinence-associated urinary tract infections (UTIs) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation | Grade of inflammation in the urinary tract tissues (inflammation levels assessed by measuring cytokines in urine) | Baseline, week 6, week 12 | 
| Genital skin status | Asessed using GLOBIAD (plus M) classification tool, grade of incontinence-associated dermatitis (IAD). | Baseline, week12 | 
| Cognitive status | The patients' cognitive status and neuropsychiatric symptoms for patients with dementia using Mini Mental State Examination Svensk Revidering (MMSE-SR) scale. MMSE-SR is assessed on a scale with the minimum and maximum values: 0-30, where a score >25 are seen as normal cognitive status. Lower scores mean a worse outcome. | Baseline, week 12 | 
| QoL | The quality of life using analog EQ-5D-5L with VAS scale. EQ VAS registers the patient's self-rated health in a analog scale with the minimum and maximum values: 0-100 where the endpoints are marked: 100 -The best health you can imagine and 0 - The worst health you can imagine. Lower scores mean a worse outcome. The quality of life using EQ-5D-5L. EQ-5D assesses the current state of health in five dimensions related to well-being and function; mobility, personal care, regular activities, pain/discomfort and anxiety/depression. Each dimension has five levels from No problems to extreme problems. This results in a single-digit number (from 1 to 5) that expresses the level selected for that dimension. Higher digits/scores mean en worse uotcome. | Baseline, week 12 | 
| Health economics | Nursing time required for incontinence care (minutes per day) | baseline, week 11-12 | 
| Behavioural and psychological symptoms | Neuropsychiatric Inventory (NPI) scale. NPI is a scale developed to measure behavioral symptoms in various dementia diseases. NPI is assessed on a scale with the minimum and maximum values: 12-144. Higher scores mean a worse outcome/more severe symptoms. | Baseline, week 12 | 
| Neuropsychiatric symptoms in dementia | Cohen Mansfield Agitation Inventory (CMAI) scale CMAI is a scale developed to assess behaviors of older adults living in long-term nursing homes. CMAI is assessed on a scale with the minimum and maximum values: 29-203. Higher scores mean a worse outcome. | Baseline, week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Long-Term Nursing Homes, BPSD, Urinary incontinence, Urinary Tract Infections, Cognitive decline/dementia