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

Launched by ESSITY HYGIENE AND HEALTH AB · Aug 26, 2019

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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.