The TENA SmartCare Change Indicator is a medical device accessory intended to aid caregivers in deciding when to change an absorbing incontinence product. The aim of this interventional, post-market clinical trial was to demonstrate the performance and safety of this device in a home environment with a family caregiver. The primary objective of the trial was to demonstrate that use of the device can reduce the number of manual checks needed in incontinence care.

Typically, an absorbing incontinence product is changed several times per day. 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. To provide quality care and reassure that the incontinent individual is comfortable, a family caregiver checks the saturation status of each pad on average 2-3 times between changes, a manual process involving touch-feel, looking, and/or asking that not only implies worry for the caregiver and hygienic consequences but also is an invasion of the privacy of the incontinent individual being cared for. The device is a system that consists of a reusable electronic sensor and a smart phone app. The device estimates the saturation level of the absorbing incontinence product and informs the caregiver about the urine saturation level via the app. This information support decisions in incontinence care, complementing a manual check routine.

The POWER clinical trial was conducted in Poland and designed to be open, prospective, interventional and single arm. The trial population consisted of 35 subjects suffering from urinary incontinence, cared for in a home environment with most of the care provided by a main caregiver, and confirmed eligible for participation according to the inclusion and exclusion criteria. The trial duration was three weeks. 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 was 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 were 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 at the investigational week compared to the baseline week. There were also multiple secondary endpoints regarding safety, number of product leakages, fecal incidents, skin irritation and device usability. In the trial the subjects act as their own control and data from the investigational week is compared to that from the baseline week. 
Descriptive statistics was given for each variable in the trial. The level of significance was set to 0.05 for all variables. Paired t-test or Wilcoxon signed-rank test was used for analyzing the variables. The primary variable was the percentage change of 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 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 urinary incontinence and were current users of TENA absorbing 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 (Figure 1). 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 (figure 2), 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 incidences was shown in the investigation. Only two subjects showed signs of skin redness and irritation at the end of 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. After 2 weeks of use, 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 wellbeing 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. For the safety endpoint, a total of 5 adverse events were reported in the clinical investigation. None of them were considered related to the investigational device or procedure and none of them were serious. No subjects withdrew from the trial.

The results indicate that the use of the device reduces the number of manual checks needed in-between changes of absorbing incontinence products. Furthermore, the number of daily leakages is reduced. 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 appear well tolerated.

The trial results suggest that the device helps caregivers decide when incontinence products need to be changed, as demonstrated by a reduction both in the number of manual checks needed between changes and in the number of leakages. Additionally, the device appears to be safe to use in its intended setting and in a home environment. Overall usability aspects of TENA SmartCare Change Indicator handling were reported to be satisfactory, and caregivers believe the device is easy to use and give benefit to them and also to the comfort of the subjects.

Continence 2S2 (2022) 100198
DOI: 10.1016/j.cont.2022.100198