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

Urinary Incontinence Clinical Trial

— U-PROTECT  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05275257
• Other study ID #: 274847
• Status: Withdrawn
• Phase: N/A
• Start date: April 2022
• Est. completion date: April 2028

Study information

• Verified date: September 2023
• Source: Region Örebro County
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2028
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Use of Uricap Female, a New Urine Collecting Device
The uridome is changed daily by trained staff

Locations

Country	Name	City	State
Sweden	Department of Geriatrics, University Hospital Örebro	Örebro

Sponsors (3)

Lead Sponsor	Collaborator
Region Örebro County	Kumla kommun, Örebro kommun

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Staff interviews	Is Uricap Female easy to use and how do the nursing staff assess the new treatment method compared to the usual treatment?	Baseline, week 12
Primary	UTIs	Frequency of incontinence-associated urinary tract infections (UTIs)	12 weeks
Secondary	Inflammation	Grade of inflammation in the urinary tract tissues (inflammation levels assessed by measuring cytokines in urine)	Baseline, week 6, week 12
Secondary	Genital skin status	Asessed using GLOBIAD (plus M) classification tool, grade of incontinence-associated dermatitis (IAD).	Baseline, week12
Secondary	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
Secondary	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
Secondary	Health economics	Nursing time required for incontinence care (minutes per day)	baseline, week 11-12
Secondary	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
Secondary	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