INTRODUCTION: 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/m PATIENTS & METHODS: 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). RESULTS: 30 adults (female/male: 67%/33%
median age: 53 years (Interquartile range (IQR) 32-61 years)
median BMI of 22.6 kg/m CONCLUSION: 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. TRIAL REGISTRATION: Registration number is NL81246.000.22.