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临床试验/NCT04280887
NCT04280887已完成不适用

MyPad - Intelligent Bladder Pre-void Alerting System

Lancashire Teaching Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2018年8月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
1
主要终点
Bladder expansion

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Bladder expansion

时间窗: 3 months

Bladder size measurements, device is able to provide consistent readings

Reduction in adverse events

时间窗: 3 months

Number of adverse events measured over the three months - reduction over time

次要结局

  • Comfort(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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