Can the Use of Uricap Female Device Lead to Better Care for Women > 75+Years? (U-PROTECT)

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

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.

Study Overview

• Status: Withdrawn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

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Örebro, Sweden
    • Department of Geriatrics, University Hospital Örebro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Region Örebro County
• Collaborators: Örebro kommun; Kumla kommun
• Investigators: Principal Investigator: Yvonne Freund-Levi, MD, PhD, Region Örebro County/Örebro University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2022
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: March 1, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Urinary incontinence; Urinary Tract Infections; BPSD; Long-Term Nursing Homes; Cognitive decline/dementia
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Infections; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Neurocognitive Disorders; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Dementia; Dermatitis; Urinary Tract Infections; Cognition Disorders; Enuresis
• Other Study ID Numbers: 274847

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No