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

Region Örebro County

Status: Withdrawn

Conditions: Urinary Tract Infections; Incontinence-associated Dermatitis; Cognition Disorders in Old Age; Behavioral and Psychiatric Symptoms of Dementia; Urinary Incontinence

Treatments: Device: Use of Uricap Female, a New Urine Collecting Device

Study type: Interventional

Funder types: Other

Identifiers

NCT05275257

274847

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Uricap group

Experimental group

Description:

the new incontinence device

Treatment:

Device: Use of Uricap Female, a New Urine Collecting Device

Control group

No Intervention group

Description:

the usual incontinence care