A Bladder Sensor for Adults With Urinary Incontinence

Urinary incontinence (UI) is a very common hygiene and health problem in adults which has an enormous impact on quality of life (QoL). Noninvasive treatment options are the first line of treatment. It would be beneficial to know when the bladder reaches its maximum capacity, to enable to prompt going to the bathroom on time and thereby potentially prevent an UI event. Recently, a wearable bladder sensor was developed, the TENA SmartCare Bladder Sensor (Bladder Sensor), which is intended to support children ( ≥ 6 years) and adults (BMI ≤ 25 kg/m²). The Bladder Sensor tracks the bladder filling status and notifies the user when it is time to go to the bathroom by a vibration of the device and/or a notification in an app on a mobile device (e.g., smartphone and/or Apple Watch®). The primary objective of this first pivotal study was to demonstrate that the Bladder Sensor can detect the bladder before urination among adult intended users. The secondary objectives were to collect real-life data to evaluate performance, safety, usability, and subject satisfaction with the device as well as impact on QoL. The primary hypothesis was to evaluate if the median bladder detection rate in the evaluated population is greater than the threshold of 85% (H0: ≤ 0.85, H1: > 0.85, p-value < 0.05).

Adults ( ≥ 18 years) suffering from UI during day and/or night tested the Bladder Sensor independently at home for 1 week. Device performance, safety, usability, user satisfaction and self-reported disease specific information, and QoL were assessed at pre-defined times. Intra-individual results were compared. Any episodes of urination and/or urine loss were documented by subjects in a paper diary. Raw data of the Bladder Sensor was analyzed to evaluate the bladder detection rate and full bladder notification rate(s).

30 adults (female/male: 67%/33%; median age: 53 years (Interquartile range (IQR) 32-61 years); median BMI of 22.6 kg/m² (IQR 20.7-23.8 kg/m²)) completed the study testing the Bladder Sensor at home for 6.9 days on average. The median bladder detection rate was 89.8% (IQR 82.6-95.3%) in a sample without statistically and clinically identified outliers (n = 28). The null hypothesis was rejected among those (z = 69, p < 0.05). The median actual full bladder notification rate was 63.1% (IQR 50.0-71.4%), and the median perceived full bladder notification rate was 94.4% (IQR 87.0-105.6%). The device showed to have a positive effect on subjects' UI problems (e.g., 67% reduced number of unwanted leakages) and QoL.

It was demonstrated that the Bladder Sensor can detect the bladder under real-life conditions among its intended users and can support in the prevention of UI. This seemed dependent on anatomical limitations (e.g., BMI and body shape), bladder volume (low bladder detection rate < 100 mL), and/or proper fixation. The device had a positive effect on the subject's urinary incontinence, their Qo,L and overall well-being while testing it for 1 week. It is assumed that this effect will be strengthened when users incorporate the use of the device into their daily life. Long-term benefits of the Bladder Sensor as an adjunct tool in continence care management needs to be investigated.

Registration number is NL81246.000.22.