Can the Use of Uricap Female Device Lead to Better Care for Women > 75+Years?

NCT05275257 | Withdrawn

• 1 other identifier: 274847
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• UTIs

  Frequency of incontinence-associated urinary tract infections (UTIs)

  12 weeks

Secondary Outcomes (7)

• Inflammation

  Baseline, week 6, week 12

• Genital skin status

  Baseline, week12

• Cognitive status

  Baseline, week 12

• QoL

  Baseline, week 12

• Health economics

  baseline, week 11-12

Other Outcomes (1)

• Staff interviews

  Baseline, week 12

Study Arms (2)

Uricap group

EXPERIMENTAL

the new incontinence device

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

Control group

NO INTERVENTION

the usual incontinence care

Interventions

Use of Uricap Female, a New Urine Collecting Device DEVICE

The uridome is changed daily by trained staff

Uricap group

Eligibility Criteria

• Age: 75 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• UI that requires incontinence aids
• Suitable anatomy (outer labia cover and protect the Uricap Female cup).

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Örebro County: lead
• Örebro kommun: collaborator
• Kumla kommun: collaborator

Study Sites (1)

Department of Geriatrics, University Hospital Örebro

Örebro, Sweden

Location

MeSH Terms

Conditions

Urinary Incontinence; Urinary Tract Infections; Behavior; Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Yvonne Freund-Levi, MD, PhD

  Region Örebro County/Örebro University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The uridome is changed daily in the intervention group, while the control group will continue to receive the usual incontinence treatment.

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: March 11, 2022
• Study Start: April 1, 2022
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2028
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)