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A comparison between the effectiveness of the body-worn alarm system and a bell-and-pad alarm system for the management of bed wetting in children.

Validity of a body-worn alarm system for the effective management of enuresis in children: A study in Western Victoria

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000354189
Enrollment
250
Registered
2019-03-06
Start date
2019-04-01
Completion date
2020-04-01
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Bedwetting is a major issue for children in Australia. Currently the most widely used system for managing this issue is the bell-pad alarm system. This alarm is expensive and children often have to wait for long periods before they can get access. However, there is an alternative device that is cheaper and therefore more readily accessible for children and families. This project will consider how well this alternative device compares to the bell-pad for treating bedwetting in children. Enuresis is the most common chronic condition in children between 6-7 years of age, with approximately 1 in 5 children in Australia experiencing bed-wetting. Currently the most widely used system for managing enuresis in childhood is the traditional bell-pad alarm system. However, this system represents a significant expense that impacts upon the capacity of a health service to make these devices readily available to children and families, resulting in prolonged waiting periods for the afflicted (upwards of 6 months). It is widely appreciated by paediatric health professionals, that optimal clinical outcomes in overcoming nocturnal enuresis are achieved if therapy is commenced as soon as a child is psychologically ready to begin. This poses therefore an unfortunate conundrum for the stakeholders in paediatric healthcare and one that warrants research efforts. At a comparative cost ratio of 1:17, per/unit the body-worn alarm system offers a potential alternative. Therefore, this pilot-project will compare agreement between an alternative body-worn alarm system and the bell-pad system. The findings may have important implications for the practice of treating children with enuresis in Western Victoria and beyond. If good levels of agreement can be achieved, the body-worn alarm system would warrant further examination as a first line option for treatment that aligns with a child-focused ‘window of opportunity’ for optimal treatment.

Interventions

Once consented/recruited, each child and family is randomly allocated to an intervention group. Body-Worn Group (Intervention/Experimental Group) The body-worn group will be provided with the device and instructions on its specific use. The body-worn device includes a sensor that connects to the underwear of the child which is also attached to an alarm unit that will sound when the sensor becomes wet. The alarm device is 53x50x17 mm in size and has a clip that attaches to the child underwear. A

Once consented/recruited, each child and family is randomly allocated to an intervention group. Body-Worn Group (Intervention/Experimental Group) The body-worn group will be provided with the device and instructions on its specific use. The body-worn device includes a sensor that connects to the underwear of the child which is also attached to an alarm unit that will sound when the sensor becomes wet. The alarm device is 53x50x17 mm in size and has a clip that attaches to the child underwear. A sensor 25x20x3 mm is placed within the underwear to make contact with the urine once the child begins to wet. The sensor has 8 alarm tones that sound when the device sensor is wet. The device is encouraged to be used every night for a period of uptown 16 weeks or at the point at which the child is dry for 14 consecutive dry nights. Participants are asked to maintain a bedwetting diary. Parents of the child will be asked to complete the diary to the best of their ability on a daily basis. The intervention takes place in the child's normal place of sleep. An advantage of the body-worn device is the ability to take the alarm to different sites if required i.e. holidays, family homes etc.

Sponsors

Federation University Australia
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
6 Years to 16 Years
Healthy volunteers
No

Inclusion criteria

Developmentally healthy children (male and female) who are between the ages of 6 and 15 years and 11 months old and who have presented to the Grampians Regional Continence Service with bedwetting and have subsequently been diagnosed with enuresis.

Exclusion criteria

Children younger than 6 or older than 16 years of age Children who have been identified as having significant medical history (e.g. spina bifida or cerebral palsy).

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 27, 2026