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

Primary Purpose

Enuresis, Nocturnal, Enuresis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
MyPad
Sponsored by
Lancashire Teaching Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Enuresis, Nocturnal

Eligibility Criteria

7 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Lancashire Teaching Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Participants will wear the device for the specified test period (3 months)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Comfort
Comfort, design and tolerability of device using validated comfort tool

Full Information

First Posted
February 5, 2020
Last Updated
November 9, 2022
Sponsor
Lancashire Teaching Hospitals NHS Foundation Trust
Collaborators
University of Central Lancashire
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1. Study Identification

Unique Protocol Identification Number
NCT04280887
Brief Title
MyPad - Intelligent Bladder Pre-void Alerting System
Acronym
MyPad
Official Title
MyPad - Intelligent Bladder Pre-void Alerting System
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 3, 2018 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lancashire Teaching Hospitals NHS Foundation Trust
Collaborators
University of Central Lancashire

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enuresis, Nocturnal, Enuresis

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Cohort
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants will wear the device for the specified test period (3 months)
Intervention Type
Device
Intervention Name(s)
MyPad
Intervention Description
Ultrasound bed wetting alarm
Primary Outcome Measure Information:
Title
Bladder expansion
Description
Bladder size measurements, device is able to provide consistent readings
Time Frame
3 months
Title
Reduction in adverse events
Description
Number of adverse events measured over the three months - reduction over time
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Comfort
Description
Comfort, design and tolerability of device using validated comfort tool
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Lancashire Teaching Hospitals NHS Foundation Trust
City
Preston
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

MyPad - Intelligent Bladder Pre-void Alerting System

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