ICS 2022: An Open, Single-Arm, Post-Market Clinical Trial Using The Tena Smartcare Change Indicator™ In A Home Environment.

(UroToday.com) An incontinence absorbent product is changed several times per day, but changing too early leads to unutilized products being discarded, and changing too late implies a risk of urine leakages, as well as, risk of moisture-associated skin damage. Caregivers must check the product for saturation status many times a day, which can be a burdensome manual process. This presentation was on the TENA SmartCare Change Indicator, a medical device accessory intended to aid caregivers in deciding when to change an incontinence product. 

The device is a system that consists of a reusable electronic sensor and a smartphone app. The device estimates the saturation level of the product and informs the caregiver about the urine saturation level via the app.

The aim of this post-market 3-week clinical trial (POWER) was to demonstrate the performance and safety of this device in a home environment with a family caregiver and to demonstrate that use of the device can reduce the number of manual checks needed for incontinence care. The trial population consisted of 35 subjects suffering from UI, cared for in a home environment with most of the care provided by a primary caregiver. A diary was used during the trial for the caregiver to enter information about manual checks, product changes, and leakages. During the first week (baseline week), TENA incontinence products were to be used without the addition of the device. During the second week (learning week), the device was introduced, and the caregiver learned how to set up and use it as intended by the manufacturer. During the third week (investigational week), the caregiver was to use the device as intended. In the trial, there were five mandatory, and three optional visits planned for each subject. At the final visit, a questionnaire was supplied to the caregiver to assess usability of the device. The primary endpoint was the change in the number of manual checks in-between the daily changes of the absorbing incontinence product during the investigational week compared to the baseline week.

There were also multiple secondary endpoints regarding safety, number of product leakages, fecal accidents, skin irritation, and device usability. In the trial, the subjects acted as their own control, and data from the investigational week is compared to that from the baseline week. Descriptive statistics were given for each variable in the trial. The primary variable was the percentage change in the mean number of checks/day between week 1 (baseline) and week 3 (investigational) of the trial. Secondary variables were analyzed in a similar fashion except for the safety, skin, and usability variables which were covered by descriptive and summary statistics. Furthermore, the skin redness/irritation variable was evaluated using the Ghent Global IAD Categorization Tool (GLOBIAD) 15. The analysis was to determine if there is a significant difference in scoring between the time points 35 subjects completed the trial. The subjects consisted of 28 females and 7 males with a mean age of 74 years. The family caregivers consisted of 30 females and 5 males with a mean age of 54 years. All subjects suffered from UI and were current users of TENA incontinence products. For the primary endpoint, the change in the number of manual checks performed by the caregiver saw an average reduction of 0.8 ±1.7 checks/day from baseline week to investigational week.

This reduction was statistically significant (p = 0.0006). This corresponds to a reduction in daily checks by 16%. For the secondary endpoints, the number of daily leakages saw a reduction of 0.13 ± 0.29 leakages/day from baseline week to investigational week or a 40% reduction in the number of daily leaks. This reduction was statistically significant (p=0.0051). No statistically significant reduction in the number of fecal accidents was shown in the investigation. Only two subjects showed signs of skin redness and irritation at the end of the baseline week and after the investigational week, no subjects suffered from skin redness. The questionnaires filled out by the caregiver regarding the use of the device generally showed very positive results for the device as more than 80% of caregivers rated the ease of use as “very easy to use”. More than 70% of the caregivers assessed that the use of the device facilitated their decision on product changes and reduced their worries about subject comfort. 60% of caregivers also perceived that the well-being of the subject was improved by using the system. 89% of the caregivers rated the overall usefulness of the system as “good” or “very good” and a majority would continue to use the system.

The results indicated that the use of the device reduces the number of manual checks needed in-between changes of absorbing incontinence products. Using the device could therefore reduce the amount of work and worry associated with incontinence care in the home without affecting the skin negativity. Additionally, the device raises few safety concerns and appears well tolerated.

Presented by: Piotr Radziszewski, MD, PhD, Medical Concierge, Warsaw, Poland

Written by: Diane Newman, DNP, CRNP, FAAN, BCB-PMD, Urologic Nurse Practitioner, Adjunct Professor of Urology in Surgery, Senior Research Investigator, Perelman School of Medicine, University of Pennsylvania during the International Continence Society Annual Meeting, September 7-10, 2022, Vienna, Austria.