Change Indicator for Urinary Incontinence

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

108 Participants Needed

Trial Summary

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.

Is the TENA SmartCare Change Indicator safe for humans?

The safety of urinary incontinence products, like the TENA SmartCare Change Indicator, is generally well-established. These products have been assessed for safety, particularly in terms of skin compatibility, and are considered safe for use. ^{1 2 3 4 5}

How does the TENA SmartCare Change Indicator treatment for urinary incontinence differ from other treatments?

The TENA SmartCare Change Indicator is unique because it is a device that estimates urine saturation and alerts caregivers when it's the best time to change continence products, improving care efficiency and skin health, unlike traditional methods that rely on manual checks. ^{2 6 7 8 9}

What is the purpose of this trial?

This trial aims to show that the TENA SmartCare Change Indicator can make caring for people with urinary incontinence in nursing homes more efficient. The device alerts caregivers when a diaper needs changing, reducing the time spent on manual checks. The study will also monitor if this efficiency improvement affects skin health and overall quality of life.

Research Team

Adrian Wagg, MD

Principal Investigator

University of Alberta

Eligibility Criteria

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

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

Treatment Details

Interventions

• TENA SmartCare Change Indicator

Participant Groups

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+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Support of adult urinary incontinence products: recommendations to assure safety and regulatory compliance through application of a risk assessment framework. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A new pelvic muscle trainer for the treatment of urinary incontinence. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Content validation of the patient-reported outcomes measurement information system (PROMIS) framework in women with urinary incontinence. [2021]

4. Canada pubmed.ncbi.nlm.nih.gov

User Experience of an App-Based Treatment for Stress Urinary Incontinence: Qualitative Interview Study. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Long-term results of the FemSoft urethral insert for the management of female stress urinary incontinence. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Paper towel test as independently self-administered to quantify cough-related urine loss: Compliance and comparisons with survey-only data in SWAN. [2022]

7. England pubmed.ncbi.nlm.nih.gov

A post-market cluster randomized controlled trial of the effect of the TENA SmartCare Change Indicator™ on urinary continence care efficiency and skin health in older nursing home residents. [2023]

8. Spain pubmed.ncbi.nlm.nih.gov

[Do the incontinent patients improve their equality of life using a humidity detector device?]. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Serial incontinence assessment in elderly inpatient men. [2019]