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

Not Applicable

Withdrawn

• Conditions: Incontinence-associated Dermatitis; Urinary Tract Infections; Cognition Disorders in Old Age; Urinary Incontinence; Behavioral and Psychiatric Symptoms of Dementia
• Interventions: Device: Use of Uricap Female, a New Urine Collecting Device

• Registration Number: NCT05275257
• Lead Sponsor: Region Örebro County

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-01-31
• Study First Submitted QC: 2022-03-01
• Study First Posted: 2022-03-11
• Study Start: 2022-04
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13
• Primary Completion: 2026-04
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Uricap group	Use of Uricap Female, a New Urine Collecting Device	the new incontinence device

Primary Outcome Measures

Name	Time	Method
UTIs	12 weeks	Frequency of incontinence-associated urinary tract infections (UTIs)

Secondary Outcome Measures

Name	Time	Method
Inflammation	Baseline, week 6, week 12	Grade of inflammation in the urinary tract tissues (inflammation levels assessed by measuring cytokines in urine)
Behavioural and psychological symptoms	Baseline, week 12	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.
Cognitive status	Baseline, week 12	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.
Health economics	baseline, week 11-12	Nursing time required for incontinence care (minutes per day)
Genital skin status	Baseline, week12	Asessed using GLOBIAD (plus M) classification tool, grade of incontinence-associated dermatitis (IAD).
QoL	Baseline, week 12	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.
Neuropsychiatric symptoms in dementia	Baseline, week 12	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.

Trial Locations

Locations (1)

Department of Geriatrics, University Hospital Örebro; 🇸🇪 Örebro, Sweden