Can the Use of Uricap Female Device Lead to Better Care for Women > 75+Years? (U-PROTECT)
Primary Purpose
Urinary Incontinence, Urinary Tract Infections, Incontinence-associated Dermatitis
Status
Withdrawn
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Use of Uricap Female, a New Urine Collecting Device
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring Long-Term Nursing Homes, BPSD, Urinary incontinence, Urinary Tract Infections, Cognitive decline/dementia
Eligibility Criteria
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
Sites / Locations
- Department of Geriatrics, University Hospital Örebro
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Uricap group
Control group
Arm Description
the new incontinence device
the usual incontinence care
Outcomes
Primary Outcome Measures
UTIs
Frequency of incontinence-associated urinary tract infections (UTIs)
Secondary Outcome Measures
Inflammation
Grade of inflammation in the urinary tract tissues (inflammation levels assessed by measuring cytokines in urine)
Genital skin status
Asessed using GLOBIAD (plus M) classification tool, grade of incontinence-associated dermatitis (IAD).
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.
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.
Health economics
Nursing time required for incontinence care (minutes per day)
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.
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.
Full Information
NCT ID
NCT05275257
First Posted
January 31, 2022
Last Updated
September 11, 2023
Sponsor
Region Örebro County
Collaborators
Örebro kommun, Kumla kommun
1. Study Identification
Unique Protocol Identification Number
NCT05275257
Brief Title
Can the Use of Uricap Female Device Lead to Better Care for Women > 75+Years?
Acronym
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?
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Withdrawn
Why Stopped
The study never started due to lack of mutual agreements.
Study Start Date
April 2022 (Anticipated)
Primary Completion Date
April 2026 (Anticipated)
Study Completion Date
April 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Örebro County
Collaborators
Örebro kommun, Kumla kommun
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Urinary Tract Infections, Incontinence-associated Dermatitis, Cognition Disorders in Old Age, Behavioral and Psychiatric Symptoms of Dementia
Keywords
Long-Term Nursing Homes, BPSD, Urinary incontinence, Urinary Tract Infections, Cognitive decline/dementia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Uricap group
Arm Type
Experimental
Arm Description
the new incontinence device
Arm Title
Control group
Arm Type
No Intervention
Arm Description
the usual incontinence care
Intervention Type
Device
Intervention Name(s)
Use of Uricap Female, a New Urine Collecting Device
Intervention Description
The uridome is changed daily by trained staff
Primary Outcome Measure Information:
Title
UTIs
Description
Frequency of incontinence-associated urinary tract infections (UTIs)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Inflammation
Description
Grade of inflammation in the urinary tract tissues (inflammation levels assessed by measuring cytokines in urine)
Time Frame
Baseline, week 6, week 12
Title
Genital skin status
Description
Asessed using GLOBIAD (plus M) classification tool, grade of incontinence-associated dermatitis (IAD).
Time Frame
Baseline, week12
Title
Cognitive status
Description
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.
Time Frame
Baseline, week 12
Title
QoL
Description
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.
Time Frame
Baseline, week 12
Title
Health economics
Description
Nursing time required for incontinence care (minutes per day)
Time Frame
baseline, week 11-12
Title
Behavioural and psychological symptoms
Description
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.
Time Frame
Baseline, week 12
Title
Neuropsychiatric symptoms in dementia
Description
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.
Time Frame
Baseline, week 12
Other Pre-specified Outcome Measures:
Title
Staff interviews
Description
Is Uricap Female easy to use and how do the nursing staff assess the new treatment method compared to the usual treatment?
Time Frame
Baseline, week 12
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvonne Freund-Levi, MD, PhD
Organizational Affiliation
Region Örebro County/Örebro University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Geriatrics, University Hospital Örebro
City
Örebro
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
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Can the Use of Uricap Female Device Lead to Better Care for Women > 75+Years?
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