Continuous Temperature and Humidity Monitoring Using Sensors Within an External Male Incontinence Device over 12 Hours of Wear-time

Abstract

<h3>Background</h3> Skin maceration and tissue breakdown, with subsequent infection, have been long-standing challenges in hospital and long-term care environments. In this regard, we sought to devise a trial that accurately measures temperature and humidity within the skin-exposed environment of a male anatomy urine collection device. <h3>Methods</h3> A device was engineered to allow air flow and yet allow for male anatomy urine collection without a catheter in order to mitigate skin exposure risks and a novel study design using state-of-the-art sensors within the device generated robust data for 24 adult males continuously over 12 hours period in a simulated clinical setting. Weight, height, age, ingested food and liquids, along with type, frequency and volume of liquid intake, frequency of urination, and volume of urine were all documented. The sensors precisely logged temperature and humidity data from within the skin-exposed environment of the device. <h3>Results</h3> The data yielded a mean temperature of 31.09°C (88°F) [Standard Error-of-the-Mean (SEM) = 0.01; SD = 1.90; range: minimum = 23.80°C and maximum = 35.40°C] and a mean relative humidity of 54.79% [SEM = 0.13; SD = 23.31; range: minimum = 24.70% and maximum = 100.00%]. Mean temperature and relative humidity within the system stabilizes over a12-hour period to produce a skin-exposed environment for male anatomy with a mean temperature of 31.09°C (88°F) and a mean relative humidity of 54.79%. <h3>Conclusions</h3> Study findings demonstrate that an external urine management system designed for male anatomy, after 12-hours of continuous wear, was able to predictably provide a skin-exposed environment for temperature and relative humidity within the device. Since the device is designed to mitigate the risk for tissue maceration and skin breakdown in a relatively enclosed environment, this novel methodology yields evidence to support continuous wear-time in the clinical setting.