Enuresis Clinical Trial
— MyPadOfficial title:
MyPad - Intelligent Bladder Pre-void Alerting System
Verified date | November 2022 |
Source | Lancashire Teaching Hospitals NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Development a 'dry alarm' that can help children and adolescents become dry at night.
Status | Completed |
Enrollment | 18 |
Est. completion date | June 30, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years to 12 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Lancashire Teaching Hospitals NHS Foundation Trust | Preston |
Lead Sponsor | Collaborator |
---|---|
Lancashire Teaching Hospitals NHS Foundation Trust | University of Central Lancashire |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bladder expansion | Bladder size measurements, device is able to provide consistent readings | 3 months | |
Primary | Reduction in adverse events | Number of adverse events measured over the three months - reduction over time | 3 months | |
Secondary | Comfort | Comfort, design and tolerability of device using validated comfort tool | 3 months |
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