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

Study Overview
=================
Brief Summary
-----------------
The purpose of this post market clinical investigation is to demonstrate the performance and safety of the TENA SmartCare Change Indicator.

Detailed 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.

Official Title
-----------------
An Open, Single-arm, Post-market Clinical Investigation to Verify the Ability of TENA SmartCare Change Indicator to Reduce the Number of Manual Checks Between Changes of Absorbing Incontinence Products in a Home Environment.

Conditions
-----------------
Urinary Incontinence

Intervention / Treatment
-----------------
* Device: TENA SmartCare Change Indicator


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Device<br>TENA SmartCare Change Indicator | Device: TENA SmartCare Change Indicator<br>* Each participating subject will be provided with TENA SmartCare Change Indicator and incontinence products for the duration of the investigation. Each participating subject will be allocated to the incontinence type(s) that are considered most suitable.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the number of manual checks | A comparison between investigational week (week 3) and baseline week (week 1) in the average number of manual checks in-between the daily changes of the absorbing incontinence product. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AE), adverse device effects (ADE), serious adverse events (SAE), serious adverse device effects (SADE), and device deficiency (DD) during learning week (week 2) and investigational week (week 3). | Number of incidents during the investigation | 2 weeks | 
| Change in the number of leakages into the clothes and/or bed linen | A comparison between investigational week (week 3) and baseline week (week 1) in the number of leakages into the clothes and/or bed linen. | 3 weeks | 
| Assessment of skin redness and irritation (GLOBIAD scoring) | A comparison between investigational (week 3) week and baseline week (week 1). GlOBIAD is a 4 point scale from minimum 1A to maximum 2B (with 1A being better outcome). | 3 weeks | 
| Usability questionnaire: Overall usability assessed via caregiver-reported questions with a qualitative scale and Y/N questions at the end of learning week (week 2) and investigational week (week 3). | Percentage of caregivers selecting a given answer is presented. The scare is 5-point, from minimum 1 to maximum 5 (with 5 being the better outcome). | At the end of learning week (week 2) and investigational week (week 3). | 
| Number of fecal incidences. | Presented in listing. No formal endpoint. Will only be used for assessing reliable primary endpoint measurements. | 3 weeks |