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

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.

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.