Clinical trial NCT06092099: Collecting Real-life Data for the Updated TENA SmartCare Change Indicator.
Official title: A Clinical Investigation to Collect Real-life Measurement Data to Allow Development of Mathematical Algorithms for the Updated TENA SmartCare Change Indicator.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: Essity Hygiene and Health AB
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects in the study will use the device
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Urine weight
timeFrame: 15 days
Secondary outcomes:
measure: Number of safety related events
timeFrame: 15 days
measure: Caregiver assessment on urine saturation
timeFrame: 15 days
measure: Caregiver usability for sensor
timeFrame: 15 days
measure: Resident satisfaction with sensor
timeFrame: 15 days
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Tre Stiftelser Änggårdsbacken
Study officials:
affiliation: VIP Hälsan Väst
name: Roland Frösing, MD
role: PRINCIPAL_INVESTIGATOR
References: