Collection of Real-life Measurement Data for TENA SmartCare Change Indicator in Subjects With Urinary Incontinence

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 TENA SmartCare Change Indicator. The collected data will be used to assess the device related algorithms. These algorithms have been established and verified in a laboratory environment. However, due to possible differences in parameters, real-life measurement data are to be collected to aid in further product development.

Official Title
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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.

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: The subject is willing and able to provide informed consent and to participate in the clinical investigation. The subject is ≥18 years of age. The subject is diagnosed with urinary incontinence. The subject is being cared for at Tre Stiftelser. Exclusion Criteria: The subject has ≥ 4 fecal incidences per week. The subject has severe absorbent product related skin problems, as judged by the investigator. The subject is hyper sensitive related to allergic reaction to any of the included materials, as judged by the investigator. The subject has ≥ 2 intermittent urinary catheters per day. The subject has a pacemaker or an implantable cardioverter-defibrillator. The subject removes the incontinence product. The subject demonstrates responsive behavior towards sensors. The subject has any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator. The subject is not cared for at Tre Stiftelser. The subject is pregnant or lactating.

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: Device Feasibility
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 a Change Indicator and absorbent products for the duration of the investigation. Nine types of absorbent products will be used to collect real-life measurement data in order to assess the mathematical algorithms involved in the TENA SmartCare Change Indicator. Each participating subject will be allocated to the type(s) that are considered most suitable. Gateways will be placed in the resident's rooms as well as in common areas, this to enable full measurement registration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine Volume Quantification and Impedance Measurements | Descriptive statistics were used to summarize any individual differences between the predicted urine volume from the Change Indicator and the true urine volume (by measuring absorbent product weight). A measure of mean difference for the predicted volume minus true volume is assessed. A combination of these values were used to assess the mathematical algorithms for the TENA SmartCare Change Indicator. | 11 weeks |