Change Indicator for Urinary Incontinence

No longer recruiting at 1 trial location

Overseen By Fredrik Agholme, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Essity Hygiene and Health AB

Must be taking: Urinary incontinence medications

Disqualifiers: Faecal incontinence, Catheter use, Anuric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the TENA SmartCare Change Indicator, a device designed to help manage urinary incontinence in nursing homes. The goal is to evaluate the device's performance and ensure its safety. Participants in the experimental group will use the device for six weeks, while the control group will continue their usual care routine. Ideal candidates include nursing home residents with urinary incontinence who use specific incontinence products and need assistance with toileting. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance incontinence care for many.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on a stable regimen of medications for urinary incontinence, you should continue with them.

What prior data suggests that the TENA SmartCare Change Indicator is safe for use in a nursing home setting?

Research has shown that the TENA SmartCare Change Indicator is safe and easy to use. In a previous study, people used this device in nursing homes and at home without major problems. The device monitors urine levels in a product and sends a notification when a change is needed, simplifying incontinence management for caregivers without constant checking. So far, no significant negative effects have been reported, suggesting that the device is safe and integrates smoothly into daily routines. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TENA SmartCare Change Indicator because it offers a new approach to managing urinary incontinence. Unlike traditional methods that rely on caregivers manually checking for wetness, this device uses smart technology to provide real-time alerts when a change is needed. This innovative feature can improve care efficiency and reduce discomfort for individuals with incontinence. By providing timely notifications, it helps ensure that users are changed promptly, potentially enhancing their comfort and hygiene.

What evidence suggests that the TENA SmartCare Change Indicator is effective for urinary incontinence?

Research shows that the TENA SmartCare Change Indicator effectively manages urinary incontinence (UI) in nursing homes. In this trial, some participants will use the TENA SmartCare Change Indicator, which studies have found reduces the need for manual checks and prevents leaks. The device is safe, easy to use, and well-tolerated. It signals caregivers when a change is needed, improving care efficiency and skin health. Overall, the TENA SmartCare Change Indicator keeps residents more comfortable and dry. ^{2 6 7 8 9}

Who Is on the Research Team?

Adrian Wagg, MD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

Inclusion Criteria

Subject is a permanent (intended length of stay four months or longer) resident of the nursing home

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

Exclusion Criteria

You are using another automated or digital device to manage incontinence.

Subject has any type of indwelling or external urinary catheter(s)

You have frequent daily accidents with bowel movements or severe problems with controlling bowel movements as determined by the doctor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants undergo a 4-week baseline period to collect initial data on continence care and skin health

4 weeks

Daily data collection via study diary

Treatment

Clusters in the experimental arm use the TENA SmartCare Change Indicator for 6 weeks to assess its impact on care efficiency and skin health

6 weeks

Daily data collection via study diary

Follow-up

Participants are monitored for safety and effectiveness after the treatment phase

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TENA SmartCare Change Indicator

How Is the Trial Designed?

Group I: Device Experimental Treatment 1 Intervention

Clusters in this arm will start using the device and use it for 6 weeks.

Group II: Control Active Control 1 Intervention

Clusters in this arm will not receive the device it will continue with usual care with no changes.

Who Is Running the Clinical Trial?

Essity Hygiene and Health AB

Lead Sponsor

Trials

16

Recruited

900+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12365968/

A post-market, cluster randomised controlled trial of the effect ...

This study examined the efficacy and safety of the use of the TENA SmartCare Change Indicator (Change Indicator) device for nursing home ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2772973725007994

258 - A post-market, cluster randomized controlled trial of ...

This study examined the efficacy and safety of the use of the TENA Smart Care Change Indicator (Change Indicator) device for nursing home residents with UI who ...

3.

archivesofmedicalscience.com

archivesofmedicalscience.com/POWER-an-open-single-arm-post-market-clinical-trial-using-the-TENA-SmartCare-Change,158568,0,2.html

POWER: an open, single-arm, post-market clinical trial ...

Use of the device lead to a reduction in numbers of manual checks and leakages. The device appears to be safe, well-tolerated and easy to use.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04846270

Investigation of the Ability of the TENA SmartCare Change ...

The purpose of this post market clinical investigation is to demonstrate the performance and safety of the TENA SmartCare Change Indicator. Detailed Description.

5.

ctv.veeva.com

ctv.veeva.com/study/the-effect-of-the-tena-smartcare-change-indicator-on-care-efficiency-and-skin-health-in-long-term-ca

The Effect of the TENA SmartCare Change Indicator on Care ...

This clinical investigation is intended to demonstrate that use of TENA SmartCare Change Indicator has the ability to increase continence care ...

6.

tena.us

tena.us/caregiver/caregiver-support/using-our-products/tena-smartcare-change-indicator

The TENA SmartCare Change Indicator helps you ...

The TENA SmartCare Change Indicator detects and tracks urine levels in the product. When it's time to consider a change, you receive a discreet notification ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9897102/

POWER: an open, single-arm, post-market clinical trial ...

The TENA SmartCare Change Indicator appears to be safe and well tolerated in its intended setting and in a home environment.

8.

tena-images.essity.com

tena-images.essity.com/images-c5/777/299777/original/tena-smartcare-ifu-instructions-for-use-pro.pdf

TENA SmartCare Change Indicator™

The system provides information on urine saturation levels to help guide decision making regarding when TENA incontinence products should be changed. • TENA ...

9.

tena.us

tena.us/caregiver/caregiver-support/help/tena-smartcare-change-indicator-faq

TENA SmartCare Change Indicator FAQ

The Change Indicator tracks the amount of urine in TENA products. This information is then sent via the gateway and processed by Essity. Finally, a notification ...