MyPad – Intelligent Bladder Pre-void Alerting System
Research type
Research Study
Full title
MyPad – Intelligent Bladder Pre-void Alerting System
IRAS ID
247101
Contact name
Christian De Goede
Contact email
Sponsor organisation
Lancashrie Teaching Hospitals NHS Trust
Duration of Study in the UK
1 years, 6 months, 31 days
Research summary
Research Summary
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 children to have dry nights 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.Summary of Research
Aims and Objectives The aim of this study was to develop a ‘dry alarm’ that can help children and adolescents stay dry at night. The alarm sounds when the bladder is full, before the child passes urine. The main objective of the device is to enable children and young people to gain control over the bladder and consistently have dry nights.
Background
Bedwetting is a common problem which can be very distressing for a child and their family. Most alarms work by detecting wetness and sounding the alarm when the child starts to pass urine. While over time they learn to control their bladder, this can take 2 to 4 months. During this time, they still wet the bed from time to time, disrupting sleep with the need to change pyjamas and bed sheets. The initial request for innovation in this area originated from clinicians, parents and children who were unsatisfied with the performance of traditional moisture alarms to treat bed wetting.Methods
A device has been developed, consisting of a small box worn over the abdomen using an undergarment tailored for the device and the child using it. Children who wet the bed wear it overnight. The box contains a mini ultrasound machine, which measures how much urine is in the bladder. Using artificial intelligence, the device triggers an alarm when the bladder is full, specific to the individual child. It is linked to an alarm which sounds once the bladder is getting full just before the child passes urine, waking the child up to go to the toilet.The development of the device was carried out with the public involvement, including children who have experienced bed wetting. The shape, comfort, ease of use and method of alarm of the device has been improved along the way of the design process with input from the established patient and public groups with the expertise of stakeholders such as ERIC (The children’s bowel and bladder charity).
Key findings and next steps
We have developed a prototype device that can detect the size of the bladder using ultrasound sensors. The components of the MyPad device have been tested with healthy children. We have shown that it can determine the point where the bladder is nearly full, which will be the trigger point for the alarm. Our next steps are to reduce the size of the device and to make it more comfortable and easier to wear. This will then be developed into a commercially available product, that will need further testing in children who wet the bed.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
18/NW/0435
Date of REC Opinion
25 Jun 2018
REC opinion
Favourable Opinion