Investigation of the Ability of the TENA SmartCare Change Indicator to Reduce the Number of Manual Checks Between Changes of Absorbing Incontinence Products

  • STATUS
    Recruiting
  • End date
    Nov 15, 2021
  • participants needed
    35
  • sponsor
    Essity Hygiene and Health AB
Updated on 27 April 2021

Summary

The purpose of this post market clinical investigation is to demonstrate the performance and safety of the TENA SmartCare Change Indicator.

Description

The TENA SmartCare Change Indicator is intended for use on individuals, dependent end user (DEU), suffering from Urinary Incontinence (UI) who are cared for in a home environment, by one or more caregivers (CGR). 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 reduce the number of manual checks between daily changes of absorbing incontinence products. Secondarily, the investigation will evaluate number of leakages, skin redness, usability and fecal incidence. Furthermore, the safety will continuously be monitored through analyzing device-related adverse events reported during the investigation.

Details
Condition Urinary Incontinence
Treatment TENA SmartCare Change Indicator
Clinical Study IdentifierNCT04846270
SponsorEssity Hygiene and Health AB
Last Modified on27 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

DEU is diagnosed with urinary incontinence managed with a tape-style incontinence product
DEU is unable to sufficiently communicate the need for an incontinence product to be changed
DEU is being cared for in a home environment and most of the care is provided by a main CGR
DEU is willing and able to provide informed consent and to participate in the clinical investigation or has a legally designated representative willing to provide informed consent on behalf of the DEU. Note, the legally designated representative and main CGR cannot be the same person
CGR is willing and able to provide informed consent to participate in the clinical investigation
The CGR frequently checks the saturation level of the incontinence product, manually and/or by a touch-feel process
If incontinence is managed by pharmaceuticals, the dose regime is stable
DEU and CGR 18 years of age

Exclusion Criteria

DEU is cared for in a professional establishment or is institutionalized
DEU has 4 fecal "incidences" per week
DEU has severe incontinence product related skin problems, as judged by the investigator
DEU has any type of urinary catheter(s) resulting in improved/treated urinary incontinence
The incontinence product is changed on a routine based on time (schedule) or device alert, without manual checks
Any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator
CGR is incapable or unwilling to use the required smartphone application and/or the diary registration webpage required for the clinical investigation
Participation in an investigational study of a drug, biologic, or device within 30 days prior to entering the clinical investigation or planned during the course of the clinical investigation
DEU is pregnant or nursing
CGR or DEU with an alcohol or drug addiction
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