Clinical trial NCT05275257: Can the Use of Uricap Female Device Lead to Better Care for Women > 75+Years?
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
Overall status: WITHDRAWN
Phase: NA
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
Lead sponsor: Region Örebro County
Sponsor class: OTHER
Collaborators: name: Örebro kommun
name: Kumla kommun
First posted: 2022-03-11
Enrollment: 0
Sex: FEMALE
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The uridome is changed daily in the intervention group, while the control group will continue to receive the usual incontinence treatment.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: UTIs
timeFrame: 12 weeks
Secondary outcomes:
measure: Inflammation
timeFrame: Baseline, week 6, week 12
measure: Genital skin status
timeFrame: Baseline, week12
measure: Cognitive status
timeFrame: Baseline, week 12
measure: QoL
timeFrame: Baseline, week 12
measure: Health economics
timeFrame: baseline, week 11-12
measure: Behavioural and psychological symptoms
timeFrame: Baseline, week 12
measure: Neuropsychiatric symptoms in dementia
timeFrame: Baseline, week 12
Other outcomes:
measure: Staff interviews
timeFrame: Baseline, week 12
Locations:
city: Örebro
country: Sweden
facility: Department of Geriatrics, University Hospital Örebro
Study officials:
affiliation: Region Örebro County/Örebro University
name: Yvonne Freund-Levi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: