Collecting Real-life Data for the Updated TENA SmartCare Change Indicator.

Study Overview
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Brief Summary
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This study is an explorative, open, single-arm clinical investigation to collect real-life measurement data in order to assess the mathematical algorithms involved in TENA SmartCare Change Indicator.

Detailed Description
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The purpose of this exploratory clinical investigation is to evaluate safety and to collect real-life measurement data using the updated TENA SmartCare Change Indicator. The collected data will be used to assess and develop the device related algorithms. These algorithms have been tested in a laboratory setting but real-life measurement data are to be collected to the aid in further product development.

Official Title
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A Clinical Investigation to Collect Real-life Measurement Data to Allow Development of Mathematical Algorithms for the Updated TENA SmartCare Change Indicator.

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Device: TENA SmartCare Change Indicator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be willing and able to provide informed consent to participate or, if unable to provide such consent, have a legal representative who is willing and able to provide informed consent on behalf of the resident. Be 18 years of age of older. Be cared for at the investigation site. Suffer from urinary incontinence. Be current user of TENA Slip, Flex, Pants or Comfort incontinence products or during the course of the study be willing to become user of TENA Slip Flex, Pants or Comfort incontinence products. If applicable, be on a stable regimen of medications for urinary incontinence. Exclusion Criteria: Have frequent (daily) faecal incontinence in the pad or having severe problems with faecal incontinence as determined by the investigator. Have severe incontinence product related skin problems, as defined by the GLOBIAD categorization 2B (skin loss & infection). Have any type of indwelling or external urinary catheter(s). Be anuric. Be of childbearing potential as determined by the investigator. Be managed using another automated or digital health technology incontinence management device. Have responsive behaviors of sufficient severity, in the opinion of the care staff, to make participation impractical. Have any other condition that makes participation in the clinical investigation Have a life expectancy of less than 90 days or be in receipt of palliative/terminal care. Have 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. Be dependent on either alcohol or recreational drugs.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: All subjects in the study will use the device
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Subjects wear the sensor part of the Change indicator system during a 15-day period. | Device: TENA SmartCare Change Indicator<br>* The TENA SmartCare Change Indicator is an accessory to absorbent incontinence products, intended for use on individual(s) with urinary incontinence who are dependent on one or more caregivers to change the absorbent incontinence product. The TENA SmartCare Change Indicator estimates the degree of urine saturation in the absorbent incontinence product and notifies the caregivers. This facilitates the caregiver's decision regarding when to change the absorbent incontinence product. As the current study is needed to validate the updated device, the full system will not be used, only the sensor part.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine weight | Absorbing hygiene products used by the subjects are collected in the investigation and the urine weight is determined. The urine weight is then matched with the data measured by the sensor to obtain connect sensor raw data with a specific urine content of an absorbing hygiene products | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of safety related events | Reported adverse events and device deficiencies are collected during the study. | 15 days | 
| Caregiver assessment on urine saturation | At the collection of the used absorbing hygiene products the caregiver assess the urine content of the product. This is done by indicating on a 3-point scale if the product change was 1. early, 2. in time or 3. late. | 15 days | 
| Caregiver usability for sensor | Using a questionnaire at the end of the study data on the caregivers user experience with the sensor is collected using a 5-grade Likert scale were 1 is minimum and 5 maximum and 5 represents the better outcome. | 15 days | 
| Resident satisfaction with sensor | Using a questionnaire at the end of the study data on the residents satisfaction with the sensor is collected using a 5-grade Likert scale were 1 is minimum and 5 maximum and 5 represents the better outcome. | 15 days |