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

Essity

Status

Completed

Conditions

Urinary Incontinence

Treatments

Device: TENA SmartCare Change Indicator

Study type

Interventional

Funder types

Industry

Identifiers

NCT06092099

GASOLINA

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 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.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.