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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-05

Study Completion Date

2019-11-27

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.

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RECRUITING

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.

Conditions

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Urinary Incontinence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Investigational Device

TENA SmartCare Change Indicator

Group Type EXPERIMENTAL

TENA SmartCare Change Indicator

Intervention Type DEVICE

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.

Interventions

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TENA SmartCare Change Indicator

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. The subject is willing and able to provide informed consent and to participate in the clinical investigation.
2. The subject is ≥18 years of age.
3. The subject is diagnosed with urinary incontinence.
4. The subject is being cared for at Tre Stiftelser.

Exclusion Criteria

1. The subject has ≥ 4 fecal "incidences" per week.
2. The subject has severe absorbent product related skin problems, as judged by the investigator.
3. The subject is hyper sensitive related to allergic reaction to any of the included materials, as judged by the investigator.
4. The subject has ≥ 2 intermittent urinary catheters per day.
5. The subject has a pacemaker or an implantable cardioverter-defibrillator.
6. The subject removes the incontinence product.
7. The subject demonstrates responsive behavior towards sensors.
8. The subject has any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator.
9. The subject is not cared for at Tre Stiftelser.
10. The subject is pregnant or lactating.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No