Collecting Real-life Data for the Updated TENA SmartCare Change Indicator. (NCT06092099) | Clinical Trial Compass
CompletedNot Applicable
Collecting Real-life Data for the Updated TENA SmartCare Change Indicator.
Sweden13 participantsStarted 2023-11-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 dru…