Urinary IncontinenceNCT05247047
The Effect of the TENA SmartCare Change Indicator on Care Efficiency and Skin Health in Long Term Care Facilities
A study testing TENA SmartCare Change Indicator in people with Urinary Incontinence, run by Essity Hygiene and Health AB at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- TENA SmartCare Change Indicator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 7 Oct 2022to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- If applicable, subject is to be on a stable regimen of medications for urinary incontinence
- Subject is over 18 years of age.
Who cannot join
- Subject has frequent (daily) faecal incontinence in the pad or having severe problems with faecal incontinence as determined by the investigator.
- Subject has severe incontinence product related skin problems, as defined by the GLOBIAD 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 incontinence management device.
- Subject has responsive behaviors of sufficient severity, in the opinion of the care staff, to make participation impractical.
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- Subject has any other condition that makes participation in the clinical investigation inappropriate, as judged by investigator.
- Subject has a life expectancy of fewer than 3 months or be receiving palliative or terminal care.
- Subject has 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.
- Subject is dependent on either alcohol or recreational drugs.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Hochschule Niederrhein University of Applied Sciences
Krefeld, 47805
About this study
Official title: A Post-market Cluster Randomized Controlled Trial of the Effect of the TENA SmartCare Change Indicator on Continence Care Efficiency and Skin Health in Long Term Care Facilities
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.
Read the detailed description
The TENA SmartCare Change Indicator is intended for use on individuals suffering from Urinary Incontinence who are cared for in a nursing home environment, by one or more professional caregivers. The TENA SmartCare Change Indicator is an accessory to TENA absorbing incontinence products. This clinical investigation is intended to demonstrate that use of TENA SmartCare Change Indicator has the ability to increase continence care efficiency at the nursing home by reducing the time needed in daily handling of absorbing incontinence products. Furthermore, this reduction in needed care does not have a detrimental effect on skin health. Secondarily, the investigation have multiple outcomes regarding number of checks, changes and leaks and also quality of life for subjects and qualitative measures for caregivers. Furthermore, the safety will continuously be monitored through analyzing device-related adverse events reported during the investigation.
- Conditions
- Urinary Incontinence
- Being tested
- TENA SmartCare Change Indicator
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENA SmartCare Change IndicatorDevice
The intervention is a medical device system that consists of a reusable electronic sensor and an application installed on one or more smart phones. The device estimates the saturation level of an absorbing incontinence product used by a study subject. The device is non-invasive and does not have any effect on the function of the absorbing incontinence product.
| Study group | Role | What they receive |
|---|---|---|
| Device | Experimental | Clusters in this arm will start using the device and use it for 6 weeks. Receives: Device: TENA SmartCare Change Indicator |
| Control | No intervention | Clusters in this arm will not receive the device it will continue with usual care with no changes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Care Efficiency score
Care efficiency is the weighted sum of the pre-defined care events divided by the number of recorded diary days of the subject in question. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared. Data is presented as average daily care efficiency score (min/day). Data is collected daily via the study diary.
Measured: 10 weeks.
Daily Skin Health score
Skin health score is based on skin health grades (from 0, no skin problems to 4, very seveer skin problems) that have been reported by the caregiver in the study diary. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared. Data is presented as average daily skin health score.
Measured: 10 weeks.
Secondary outcomes (18)
Number of continence care product checks
From the study diary the number of checks of absorbing incontinence products is retrieved. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared. Data is presented as average daily number of checks.
Measured: 10 weeks.
Number of continence care product changes
From the study diary the number of changes of absorbing incontinence products is retrieved. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared. Data is presented as average daily number of changes.
Measured: 10 weeks.
Number of continence care toilet visits
From the study diary the number of toilet visits is retrieved. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared. Data is presented as average daily number of toilet visits.
Measured: 10 weeks.
Number of continence care clothing changes
From the study diary the number of clothing changes due to leakages is retrieved. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared. Data is presented as average daily number of clothing changes.
Measured: 10 weeks.
Number of continence care bed linen changes
From the study diary the number of bed linen changes due to leakages is retrieved. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared. Data is presented as average daily number of linen changes.
Measured: 10 weeks.
The time spent on continence care episodes
From the study diary the total time spent on continence care is retrieved. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared. Data is presented as average daily time spent on continence care.
Measured: 10 weeks.
Skin health score
Measured by the skin health assessment tool at study completion visit and compared to the end of baseline visit.
Measured: 10 weeks.
Quality of life and level of utility
Measured using the EQ-5D-5L questionnaire at study completion visit and compared to the end of baseline visit.
Measured: 10 weeks.
Quality of life according to the QoL-AD
Measured and scored at completion visit and compared to the end of baseline visit.
Measured: 10 weeks.
Level of agitation and responsive behavior.
Measured via interRAI Aggressive Behavior Scale at study completion visit and compared to the end of baseline visit.
Measured: 10 weeks.
Number of sleep interruptions due to continence care
From the study diary the number of sleep interruptions are retrieved. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared. Data is presented as average daily number of interruptions.
Measured: 10 weeks.
Total absorption value
From the study diary the type, number and absorption value of the incontinence care product is retrieved. This data is used to create a total absorption measure. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared.
Measured: 10 weeks.
Caregiver work engagement
Using the UWES questionnaire the work engagement of caregivers are measured at a cluster's end-of-trial visit and compared to the end of baseline visit.
Measured: 10 weeks.
Caregiver work conditions
Measured using the organizational headroom questionnaire at a cluster's end-of-trial visit and compared to the end of baseline visit.
Measured: 10 weeks.
Time spent in a saturated continence care product
Data from study diary used to retrieve the total hours that occur between an observed fully saturated product and the change of the saturated product. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared. Data is presented as average daily time spent in the saturated product.
Measured: 10 weeks
Number of unnecessary checks.
Data from study diary used to retrieve the number of unnecessary checks/changes. An unnecessary check/change is defined as, an activity line where a product check was performed but no product change occurred or an activity line where a product change occurred but neither a fully nor partially saturated product was indicated. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared. Data is presented as average daily number of checks/changes.
Measured: 10 weeks
Qualitative data on implementation, uptake, opportunities and barriers to use.
Response to interviews with caregivers, coded by the investigator and collated into trends and themes. Conducted after completion of study for subjects.
Measured: 10 weeks.
Safety data for the device.
Incidence of adverse events (AE), adverse device effects (ADE), serious adverse events (SAE), serious adverse device effects (SADE), and device deficiency (DD).
Measured: 10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start7 Oct 2022
- Primary completion15 Dec 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essity Hygiene and Health AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adrian Wagg, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247047
- Sponsor's protocol ID
- WHEELS-ONE
- Status last verified
- Aug 2025
- First submitted
- 9 Feb 2022
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market Cluster Randomized Controlled Trial of the Effect of the TENA SmartCare Change Indicator on Continence Care Efficiency and Skin Health in Long Term Care Facilities
- ClinicalTrials.gov ID
- NCT05247047
- Acronym / sponsor ID
- WHEELS-ONE
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Essity Hygiene and Health ABIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The TENA SmartCare Change Indicator is intended for use on individuals suffering from Urinary Incontinence who are cared for in a nursing home environment, by one or more professional caregivers. The TENA SmartCare Change Indicator is an accessory to TENA absorbing incontinence products. This clinical investigation is intended to demonstrate that use of TENA SmartCare Change Indicator has the ability to increase continence care efficiency at the nursing home by reducing the time needed in daily handling of absorbing incontinence products. Furthermore, this reduction in needed care does not have a detrimental effect on skin health. Secondarily, the investigation have multiple outcomes regarding number of checks, changes and leaks and also quality of life for subjects and qualitative measures for caregivers. Furthermore, the safety will continuously be monitored through analyzing device-related adverse events reported during the investigation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster
| Arm | Type | Receives |
|---|---|---|
| Device | Experimental | Device: TENA SmartCare Change IndicatorClusters in this arm will start using the device and use it for 6 weeks. |
| Control | No intervention | –Clusters in this arm will not receive the device it will continue with usual care with no changes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (10 listed)
- Subject has frequent (daily) faecal incontinence in the pad or having severe problems with faecal incontinence as determined by the investigator.
- Subject has severe incontinence product related skin problems, as defined by the GLOBIAD 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 incontinence management device.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TENA SmartCare Change IndicatorThe intervention is a medical device system that consists of a reusable electronic sensor and an application installed on one or more smart phones. The device estimates the saturation level of an absorbing incontinence product used by a study subject. The device is non-invasive and does not have any effect on the function of the absorbing incontinence product. | Device | Device |
Primary outcome
Care Efficiency score
Time frame: 10 weeks.
Care efficiency is the weighted sum of the pre-defined care events divided by the number of recorded diary days of the subject in question. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared. Data is presented as average daily care efficiency score (min/day). Data is collected daily via the study diary.
Daily Skin Health score
Time frame: 10 weeks.
Skin health score is based on skin health grades (from 0, no skin problems to 4, very seveer skin problems) that have been reported by the caregiver in the study diary. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared. Data is presented as average daily skin health score.
18 secondary outcomes
Number of continence care product checks
Time frame: 10 weeks.
Number of continence care product changes
Time frame: 10 weeks.
Number of continence care toilet visits
Time frame: 10 weeks.
Number of continence care clothing changes
Time frame: 10 weeks.
Number of continence care bed linen changes
Time frame: 10 weeks.
The time spent on continence care episodes
Time frame: 10 weeks.
Skin health score
Time frame: 10 weeks.
Quality of life and level of utility
Time frame: 10 weeks.
Quality of life according to the QoL-AD
Time frame: 10 weeks.
Level of agitation and responsive behavior.
Time frame: 10 weeks.
Number of sleep interruptions due to continence care
Time frame: 10 weeks.
Total absorption value
Time frame: 10 weeks.
Caregiver work engagement
Time frame: 10 weeks.
Caregiver work conditions
Time frame: 10 weeks.
Time spent in a saturated continence care product
Time frame: 10 weeks
Number of unnecessary checks.
Time frame: 10 weeks
Qualitative data on implementation, uptake, opportunities and barriers to use.
Time frame: 10 weeks.
Safety data for the device.
Time frame: 10 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Wagg, MD principal investigator
University of Alberta
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENA SmartCare Change Indicator in people with Urinary Incontinence, run by Essity Hygiene and Health AB at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Care Efficiency score (time frame: 10 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.