MyPad - Intelligent Bladder Pre-void Alerting System

Status Completed

Clinical Trial Summary

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04280887
Study type	Interventional
Source	Lancashire Teaching Hospitals NHS Foundation Trust
Contact
Status	Completed
Phase	N/A
Start date	August 3, 2018
Completion date	June 30, 2022

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See also
Status	Clinical Trial	Phase
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Completed	`NCT02369445` - Investigation of Teacher-Mediated Toilet Training Using a Manualized Moisture Alarm Intervention	N/A
Completed	`NCT01978210` - Development of a Manualized Wireless Moisture Pager Intervention for Teaching Toileting in Children With Autism	N/A
Recruiting	`NCT06070675` - Comparison of a Paper and Automated Bladder Diary in Pediatric Patients	N/A
Completed	`NCT01747343` - Toilet Training Toddlers and Preschoolers	N/A
Recruiting	`NCT00437528` - Safety and Applicability Study of a Novel Heat Flow Sensor Unit for Measuring Urinary Bladder Capacity	Phase 1
Recruiting	`NCT02699528` - The Effect of Methylphenidate on Primary Enuresis in Children With Attention Deficit Hyperactivity Disorder	N/A
Withdrawn	`NCT01861145` - Intranasal Steroids for the Treatment of Nocturnal Enuresis With Associated Obstructive Sleep Apnea	Phase 4
Completed	`NCT04260646` - Alarm Treatment for Combined Enuresis and Daytime Urinary Incontinence in Children	N/A
Completed	`NCT00270621` - Family Help Program: Nighttime Enuresis Treatment Program	Phase 2
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Completed	`NCT00226122` - The Effect of Indomethacin in Monosymptomatic Enuresis Nocturnal	Phase 4
Completed	`NCT05190601` - Uroflowmetry in Children With Enuresis Nocturnal
Withdrawn	`NCT03478813` - Voiding School as a Treatment of Children's Day-time Incontinence or Enuresis	N/A
Recruiting	`NCT03399877` - A Study on Accuracy Improvement of Repeated Measure Uroflowmetry- Electromyography	N/A
Completed	`NCT01036841` - Influence of Food-intake on Desmopressin Oral Tablets and MELT-formulation	Phase 4
Active, not recruiting	`NCT06185361` - Selective Serotonin Reuptake Inhibitors, Fluoxetine Versus the Standard Oral Desmopressin for Management of Mono-symptomatic Nocturnal Enuresis.	N/A
Completed	`NCT00240812` - A Study to Determine if Ibuprofen in Combination With Pseudoephedrine HCl is More Effective Than Each Drug Alone in the Treatment of Nighttime Bedwetting	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

MyPad - Intelligent Bladder Pre-void Alerting System — MyPad

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms