Phase
Condition
Urinary Incontinence
Enuresis
Treatment
TENA SmartCare Change Indicator
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject has urinary incontinence managed with incontinence products with tapes,belted or pull up incontinence product type (products for moderate to heavyincontinence).
Subject is a permanent (intended length of stay four months or longer) resident ofthe nursing home.
Subject is unable to consistently communicate toileting needs.
Subject is unable to successfully toilet and change the pad without assistance.
Subject is using or is willing to use TENA Slip (Stretch) TENA Flex (Belted) andTENA Pants (Underwear) absorbing products for the study.
Subject has a waist size appropriate to the available sizes of incontinenceproducts.
Subject is willing and able to provide informed consent to participate or if unableto provide consent have a legal representative who is willing and able to provideinformed consent on behalf of the subject.
Subject is part of a continence care regimen, defined as "check and change", usingany method.
If applicable, subject is to be on a stable regimen of medications for urinaryincontinence
Subject is over 18 years of age.
Exclusion
Exclusion Criteria:
Subject has frequent (daily) faecal incontinence in the pad or having severeproblems with faecal incontinence as determined by the investigator.
Subject has severe incontinence product related skin problems, as defined by theGLOBIAD categorization 2B (skin loss & infection).
Subject has any type of indwelling or external urinary catheter(s).
Subject is anuric.
Subject is managed using another automated or digital health technology incontinencemanagement device.
Subject has responsive behaviors of sufficient severity, in the opinion of the carestaff, to make participation impractical.
Subject has any other condition that makes participation in the clinicalinvestigation inappropriate, as judged by investigator.
Subject has a life expectancy of fewer than 3 months or be receiving palliative orterminal care.
Subject has participated in an investigational study of a drug, biologic, or devicewithin 30 days prior to entering the clinical investigation or planned during theclinical investigation.
Subject is dependent on either alcohol or recreational drugs.
Study Design
Study Description
Connect with a study center
University of Alberta
Edmonton, Alberta T6G 2P4
CanadaSite Not Available
Hochschule Niederrhein University of Applied Sciences
Krefeld, 47805
GermanySite Not Available
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