Title: MyPad – Intelligent Bladder Pre-void Alerting System
Funder: Department of Health and Social Care

Abstract: Project Description: Iterative development of a comfortable, miniaturised, highly customisable, US-based device which is mounted ergonomically on a child s abdomen wall, to measure the distension of urinary bladder and consequently decides smartly whether to issue an alert to wake the patient (pre-void) during the night. Particularly, this project relates to methods and apparatuses for treating urinary incontinence, suitably by providing pre-void alerts. A patent has been published on our techniques, innovative US processing software and the design of the device [8]. Methodology: Several non-invasive low powered sensors detect changes in the pattern of ultrasound pulses reflected from multiple points of the bladder and related tissue around the bladder in intermittent manner using a skin-interfacing pad, and the acquired information in a data storage unit is transmitted into a processing/computing unit using wireless Bluetooth technology. The discriminant features (detailed in our patent [8]) extracted from this information based on the specific characteristics of urine in the bladder and the bladder itself are then processed by the smartphone computer-implemented Machine Learning (ML) techniques in a parallel software processing to determine the relative fluid level (to at least 50ml) in the bladder. Other sensors such as movement, temperature and moisture measurements are employed to enhance warning performance and self-customising features. Data Collection, Storage & Analysis: i) Acquiring and extracting information from bladder data: Upon collecting A-mode reflected signals obtained via a plurality of transducers interchangeably through skin-interfacing device, the echoes are stored and time stamped in memory and sent to a wireless computing device on real-time for further processing using Bluetooth technology. ii) Acquiring and extracting information from real-time event data: Our intelligent smartphone application where several ML algorithms are working in parallel processing extracts discriminant features from acquired data. iii) Correlating bladder data or information with a status: These features are mapped onto multiple classifiers that have previously been observed, and modulated using different levels of liquid encapsulated within the bladder. The mapping classifiers depicting level of liquid are obtained by applying several ML techniques on detected features, status data and similarities. iv) Triggering alerts: Final bladder status is determined by the weighted average/weighted majority of the plurality of classifiers, and accordingly an alarm type customised for the user is triggered if the level is depicting a trigger point. Design & Safety: The geometry, wearability, and usability and optimisation of the device will be iterated through a reference group comprising children with their families, by taking both sex and different morphology types into consideration throughout the project. For the prototype, software has been designed to decrease the intensity and ultrasound signal exposure time to the minimum. The sonar energy penetrated through the body in intermittent manner will cause no heating risk for the body in line with international guidelines and regulations of related international organisations [7]. Necessary permissions will be obtained from organisations such as NHS National Research Ethics Service (NRES) and National Patient Safety Agency (NPSA). Device Assessment: i) Trial assessments will be performed to verify the basic functionality of the device. When a first functional version of My-PAD is worn by healthy child volunteers over a 12h monitoring period and then, ii) a trial with healthy child volunteers will be performed to assess sensor performance and comfort at night. After obtaining successful results from previous phases, the device iii) will be tested on children with NE. Throughout there will be focused engagement with the trial participants in group sessions and through individual interviews to gain qualitative and quantitative data and iterate the device design and functionality through an EBCD process.

Lay abstract: Bedwetting is a common problem causing much emotional distress. Most children are dry by the age of 5 years, but a significant number of older children still wet their bed. This can be very distressing for child and family. There is also an associated cost due to extra laundary and impact of lost sleep. Programmes to help children become dry at night often include the use of a moisture alarm. The alarms sound when the child begins to wet the bed, waking them up to go to the toilet instead. Most alarms work by detecting wetness, sounding the alarm when the child starts to pass urine. As such, they still need to change pyjamas and bed sheets. Our aim is to develop a dry alarm that can help children and adolescents become dry at night. The alarm sounds when the bladder is full, before the child passes urine. This would avoid wet beds. We have developed the important parts for this alarm, but need to work on making it ready for use. This device will enable sufferers to reach stable dryness whilst learning bladder control. This study has several phases. The alarm will consist of a small box worn over the abdomen. First we aim to test this overnight, and adjust it for comfort and ease. The device uses a mini ultrasound machine, which measures how much urine is in the bladder. We will test if these measurements are correct, and if they can tell us when to trigger an alarm. Next, children with bed wetting will wear it overnight. It will be linked to an alarm which will sound once the bladder is full. This project will take approximately 2 years. After completion, we will work with industry to make this available to all children who need it.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: RENAL AND UROGENITAL