CompletedNot Applicable

The Effect of the TENA SmartCare Change Indicator on Care Efficiency and Skin Health in Long Term Care Facilities

Canada, Germany108 participantsStarted 2022-10-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Care Efficiency score

Timeframe: 10 weeks.

Daily Skin Health score

Timeframe: 10 weeks.

Trial details

NCT IDNCT05247047

SponsorEssity Hygiene and Health AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-15

View on ClinicalTrials.gov More Urinary Incontinence trials