CompletedNot Applicable

The Effect of the TENA SmartCare Change Indicator on Care Efficiency and Skin Health in Long Term Care Facilities

Canada, Germany108 participantsStarted 2022-10-07

Plain-language summary

The purpose of this post market clinical investigation is to demonstrate the performance and safety of the TENA SmartCare Change Indicator when used in a nursing home setting.

Who can participate

Age range

18 Years

Sex

ALL

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

. Subject has urinary incontinence managed with incontinence products with tapes, belted or pull up incontinence product type (products for moderate to heavy incontinence).
. Subject is a permanent (intended length of stay four months or longer) resident of the 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) and TENA Pants (Underwear) absorbing products for the study.
. Subject has a waist size appropriate to the available sizes of incontinence products.
. Subject is willing and able to provide informed consent to participate or if unable to provide consent have a legal representative who is willing and able to provide informed consent on behalf of the subject.
. Subject is part of a continence care regimen, defined as "check and change", using any method.

Exclusion criteria

. Subject has frequent (daily) faecal incontinence in the pad or having severe problems with faecal incontinence as determined by the investigator.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Care Efficiency score

Timeframe: 10 weeks.

Daily Skin Health score

Timeframe: 10 weeks.

Trial details

NCT IDNCT05247047

SponsorEssity Hygiene and Health AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-15

View on ClinicalTrials.gov More Urinary Incontinence trials