Status:
COMPLETED
The Effect of the TENA SmartCare Change Indicator on Care Efficiency and Skin Health in Long Term Care Facilities
Lead Sponsor:
Essity Hygiene and Health AB
Conditions:
Urinary Incontinence
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this post market clinical investigation is to demonstrate the performance and safety of the TENA SmartCare Change Indicator when used in a nursing home setting.
Detailed Description
The TENA SmartCare Change Indicator is intended for use on individuals suffering from Urinary Incontinence who are cared for in a nursing home environment, by one or more professional caregivers. The ...
Eligibility Criteria
Inclusion
- Subject has urinary incontinence managed with incontinence products with tapes, belted or pull up incontinence product type (products for moderate to heavy incontinence).
- Subject is a permanent (intended length of stay four months or longer) resident of the nursing home.
- Subject is unable to consistently communicate toileting needs.
- Subject is unable to successfully toilet and change the pad without assistance.
- Subject is using or is willing to use TENA Slip (Stretch) TENA Flex (Belted) and TENA Pants (Underwear) absorbing products for the study.
- Subject has a waist size appropriate to the available sizes of incontinence products.
- Subject is willing and able to provide informed consent to participate or if unable to provide consent have a legal representative who is willing and able to provide informed consent on behalf of the subject.
- Subject is part of a continence care regimen, defined as "check and change", using any method.
- If applicable, subject is to be on a stable regimen of medications for urinary incontinence
- Subject is over 18 years of age.
Exclusion
- Subject has frequent (daily) faecal incontinence in the pad or having severe problems with faecal incontinence as determined by the investigator.
- Subject has severe incontinence product related skin problems, as defined by the GLOBIAD categorization 2B (skin loss \& infection).
- Subject has any type of indwelling or external urinary catheter(s).
- Subject is anuric.
- Subject is managed using another automated or digital health technology incontinence management device.
- Subject has responsive behaviors of sufficient severity, in the opinion of the care staff, to make participation impractical.
- Subject has any other condition that makes participation in the clinical investigation inappropriate, as judged by investigator.
- Subject has a life expectancy of fewer than 3 months or be receiving palliative or terminal care.
- Subject has participated in an investigational study of a drug, biologic, or device within 30 days prior to entering the clinical investigation or planned during the clinical investigation.
- Subject is dependent on either alcohol or recreational drugs.
Key Trial Info
Start Date :
October 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2024
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT05247047
Start Date
October 7 2022
End Date
January 30 2024
Last Update
August 11 2025
Active Locations (2)
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1
University of Alberta
Edmonton, Alberta, Canada, T6G 2P4
2
Hochschule Niederrhein University of Applied Sciences
Krefeld, Germany, 47805