Urinary IncontinenceU-PROTECTNCT05275257
Can the Use of Uricap Female Device Lead to Better Care for Women > 75+Years?
A study testing Use of Uricap Female, a New Urine Collecting Device in people with Urinary Incontinence and Urinary Tract Infections, run by Region Örebro County at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 75 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Urinary Tract Infections, Incontinence-associated Dermatitis
- What is being tested?
- Use of Uricap Female, a New Urine Collecting Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2022to Apr 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- UI that requires incontinence aids
- Suitable anatomy (outer labia cover and protect the Uricap Female cup).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Urinary Incontinence, Urinary Tract Infections, Incontinence-associated Dermatitis, Cognition Disorders in Old Age, Behavioral and Psychiatric Symptoms of Dementia
- Being tested
- Use of Uricap Female, a New Urine Collecting Device
- Keywords
- Long-Term Nursing Homes, BPSD, Urinary incontinence, Urinary Tract Infections, Cognitive decline/dementia
- Medical subject headings
- Urinary Incontinence, Urinary Tract Infections, Behavior, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Uricap Female, a New Urine Collecting DeviceDevice
The uridome is changed daily by trained staff
| Study group | Role | What they receive |
|---|---|---|
| Uricap group | Experimental | the new incontinence device Receives: Device: Use of Uricap Female, a New Urine Collecting Device |
| Control group | No intervention | the usual incontinence care |
What is being measured
The primary outcome is the main question the study is designed to answer.
UTIs
Frequency of incontinence-associated urinary tract infections (UTIs)
Measured: 12 weeks
Secondary outcomes (7)
Inflammation
Grade of inflammation in the urinary tract tissues (inflammation levels assessed by measuring cytokines in urine)
Measured: Baseline, week 6, week 12
Genital skin status
Asessed using GLOBIAD (plus M) classification tool, grade of incontinence-associated dermatitis (IAD).
Measured: 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.
Measured: 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.
Measured: Baseline, week 12
Health economics
Nursing time required for incontinence care (minutes per day)
Measured: 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.
Measured: 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.
Measured: Baseline, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study startApr 2022 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2028 (estimated)
Why it stopped: The study never started due to lack of mutual agreements.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- Örebro kommun, Kumla kommun
- Responsible party
- Sponsor
- Investigators
- Yvonne Freund-Levi, MD, PhD, Principal investigator, Region Örebro County/Örebro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275257
- Sponsor's protocol ID
- 274847
- Acronym
- U-PROTECT
- Status last verified
- Sep 2023
- First submitted
- 31 Jan 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Use of Uricap Female, a New Urine Collecting Device, Lead to Better Care for Women > 75+Years With Urinary Incontinence?
- ClinicalTrials.gov ID
- NCT05275257
- Acronym / sponsor ID
- U-PROTECT / 274847
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study never started due to lack of mutual agreements.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- Örebro kommun, Kumla kommun
- Study start
- Apr 2022 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The uridome is changed daily in the intervention group, while the control group will continue to receive the usual incontinence treatment.
| Arm | Type | Receives |
|---|---|---|
| Uricap group | Experimental | Device: Use of Uricap Female, a New Urine Collecting Devicethe new incontinence device |
| Control group | No intervention | –the usual incontinence care |
Who may qualify
- Ages
- 75 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- UI that requires incontinence aids
- Suitable anatomy (outer labia cover and protect the Uricap Female cup).
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of Uricap Female, a New Urine Collecting DeviceThe uridome is changed daily by trained staff | Device | Uricap group |
Primary outcome
UTIs
Time frame: 12 weeks
Frequency of incontinence-associated urinary tract infections (UTIs)
7 secondary outcomes
Inflammation
Time frame: Baseline, week 6, week 12
Genital skin status
Time frame: Baseline, week12
Cognitive status
Time frame: Baseline, week 12
QoL
Time frame: Baseline, week 12
Health economics
Time frame: baseline, week 11-12
Behavioural and psychological symptoms
Time frame: Baseline, week 12
Neuropsychiatric symptoms in dementia
Time frame: Baseline, week 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Urinary Incontinence
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne Freund-Levi, MD, PhD principal investigator
Region Örebro County/Örebro University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Uricap Female, a New Urine Collecting Device in people with Urinary Incontinence and Urinary Tract Infections, run by Region Örebro County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UTIs (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.