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

Last updated: May 6, 2025
Sponsor: Essity Hygiene and Health AB
Overall Status: Completed

Phase

N/A

Condition

Urinary Incontinence

Enuresis

Treatment

TENA SmartCare Change Indicator

Clinical Study ID

NCT05247047
WHEELS-ONE
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject has urinary incontinence managed with incontinence products with tapes,belted or pull up incontinence product type (products for moderate to heavyincontinence).

  2. Subject is a permanent (intended length of stay four months or longer) resident ofthe nursing home.

  3. Subject is unable to consistently communicate toileting needs.

  4. Subject is unable to successfully toilet and change the pad without assistance.

  5. Subject is using or is willing to use TENA Slip (Stretch) TENA Flex (Belted) andTENA Pants (Underwear) absorbing products for the study.

  6. Subject has a waist size appropriate to the available sizes of incontinenceproducts.

  7. Subject is willing and able to provide informed consent to participate or if unableto provide consent have a legal representative who is willing and able to provideinformed consent on behalf of the subject.

  8. Subject is part of a continence care regimen, defined as "check and change", usingany method.

  9. If applicable, subject is to be on a stable regimen of medications for urinaryincontinence

  10. Subject is over 18 years of age.

Exclusion

Exclusion Criteria:

  1. Subject has frequent (daily) faecal incontinence in the pad or having severeproblems with faecal incontinence as determined by the investigator.

  2. Subject has severe incontinence product related skin problems, as defined by theGLOBIAD categorization 2B (skin loss & infection).

  3. Subject has any type of indwelling or external urinary catheter(s).

  4. Subject is anuric.

  5. Subject is managed using another automated or digital health technology incontinencemanagement device.

  6. Subject has responsive behaviors of sufficient severity, in the opinion of the carestaff, to make participation impractical.

  7. Subject has any other condition that makes participation in the clinicalinvestigation inappropriate, as judged by investigator.

  8. Subject has a life expectancy of fewer than 3 months or be receiving palliative orterminal care.

  9. Subject has participated in an investigational study of a drug, biologic, or devicewithin 30 days prior to entering the clinical investigation or planned during theclinical investigation.

  10. Subject is dependent on either alcohol or recreational drugs.

Study Design

Total Participants: 108
Treatment Group(s): 1
Primary Treatment: TENA SmartCare Change Indicator
Phase:
Study Start date:
October 07, 2022
Estimated Completion Date:
January 30, 2024

Study 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 TENA SmartCare Change Indicator is an accessory to TENA absorbing incontinence products. This clinical investigation is intended to demonstrate that use of TENA SmartCare Change Indicator has the ability to increase continence care efficiency at the nursing home by reducing the time needed in daily handling of absorbing incontinence products. Furthermore, this reduction in needed care does not have a detrimental effect on skin health. Secondarily, the investigation have multiple outcomes regarding number of checks, changes and leaks and also quality of life for subjects and qualitative measures for caregivers. Furthermore, the safety will continuously be monitored through analyzing device-related adverse events reported during the investigation.

Connect with a study center

  • University of Alberta

    Edmonton, Alberta T6G 2P4
    Canada

    Site Not Available

  • Hochschule Niederrhein University of Applied Sciences

    Krefeld, 47805
    Germany

    Site Not Available

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