MyPad - Intelligent Bladder Pre-void Alerting System (MyPad)

Development a 'dry alarm' that can help children and adolescents become dry at night.

Study Overview

• Status: Completed
• Conditions: Enuresis; Enuresis, Nocturnal
• Intervention / Treatment: Device: MyPad

Detailed Description

Enuresis / 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 laundry 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.

The investigators aim to develop a 'dry alarm' that can help children and adolescents become dry at night. The alarm will sound when the bladder is full, before the child passes urine. This would avoid wet beds. The investigators have engineered 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. The aim is 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. There will be a series of tests to calibrate the device compared to a clinical ultrasound device. Then children with enuresis/ bed wetting will wear it overnight. It will be linked to an alarm which will sound once the bladder is full.

This particular study will determine the feasibility of the product, to confirm the design and specifications, including a comfort trial, calibration and comparison with clinical scans, and operating process prior to a future clinical trial.

The total number of participants is 25 - however this will be split over the different phases of the trial.

Comfort Trial - 5 Calibration trial 3 month testing phase - 10

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Preston, United Kingdom
    • Lancashire Teaching Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 7 years to 12 years
• Bedwetting twice a week or more
• Good understanding of English language
• For the initial comfort trials and the calibration trial healthy volunteers may be invited to take part.

Exclusion Criteria:

• there is a medical cause for bedwetting
• they have significant learning difficulties
• they are obese (above 98th centile for Body Mass Index)
• they have severe hearing impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Participants will wear the device for the specified test period (3 months)	Device: MyPad; Ultrasound bed wetting alarm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bladder expansion	Bladder size measurements, device is able to provide consistent readings	3 months
Reduction in adverse events	Number of adverse events measured over the three months - reduction over time	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort	Comfort, design and tolerability of device using validated comfort tool	3 months

Collaborators and Investigators

• Sponsor: Lancashire Teaching Hospitals NHS Foundation Trust
• Collaborators: University of Central Lancashire

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2018
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Nocturnal Enuresis
• Other Study ID Numbers: My Pad Protocol version 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No