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

Essity

Status: Completed

Conditions: Urinary Incontinence

Treatments: Device: TENA SmartCare Change Indicator

Study type: Interventional

Funder types: Industry

Identifiers

NCT04071301

FUEL_CIP_Ver.B_19-Jul-2019

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Investigational Device

Experimental group

Description:

TENA SmartCare Change Indicator

Treatment:

Device: TENA SmartCare Change Indicator