Enuresis, NocturnalMyPadNCT04280887
MyPad - Intelligent Bladder Pre-void Alerting System
A study testing MyPad in people with Enuresis, Nocturnal and Enuresis, run by Lancashire Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Development a 'dry alarm' that can help children and adolescents become dry at night. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Enuresis, Nocturnal, Enuresis
- What is being tested?
- MyPad
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Aug 2018to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Lancashire Teaching Hospitals NHS Foundation Trust
Preston
About this study
Development a 'dry alarm' that can help children and adolescents become dry at night.
Read the 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
- Conditions
- Enuresis, Nocturnal, Enuresis
- Being tested
- MyPad
- Medical subject headings
- Nocturnal Enuresis, Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyPadDevice
Ultrasound bed wetting alarm
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will wear the device for the specified test period (3 months) Receives: Device: MyPad |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder expansion
Bladder size measurements, device is able to provide consistent readings
Measured: 3 months
Reduction in adverse events
Number of adverse events measured over the three months - reduction over time
Measured: 3 months
Secondary outcomes (1)
Comfort
Comfort, design and tolerability of device using validated comfort tool
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start3 Aug 2018
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enuresis, NocturnalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cohort
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lancashire Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Central Lancashire
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280887
- Sponsor's protocol ID
- My Pad Protocol version 1
- Acronym
- MyPad
- Status last verified
- Nov 2022
- First submitted
- 5 Feb 2020
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyPad - Intelligent Bladder Pre-void Alerting System
- ClinicalTrials.gov ID
- NCT04280887
- Acronym / sponsor ID
- MyPad / My Pad Protocol version 1
- Conditions
- Enuresis, Nocturnal, Enuresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Lancashire Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Central Lancashire
- Study start
- 3 Aug 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohort
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: MyPadParticipants will wear the device for the specified test period (3 months) |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyPadUltrasound bed wetting alarm | Device | Intervention |
Primary outcome
Bladder expansion
Time frame: 3 months
Bladder size measurements, device is able to provide consistent readings
Reduction in adverse events
Time frame: 3 months
Number of adverse events measured over the three months - reduction over time
1 secondary outcome
Comfort
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Enuresis, Nocturnal
Recruiting
Effectiveness of Individualized Pelvic Floor Muscle Rehabilitation in Addition to Standard Urotherapy and Alarm Therapy in Children With Primary Monosymptomatic Nocturnal Enuresis
Primary Monosymptomatic Nocturnal Enuresis
Active, not recruitingPhase 3
Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence
Stress Urinary Incontinence
Not yet recruiting
Potential Adjuvant Therapies for Children With Primary Nocturnal Enuresis
Nocturnal Enuresis in Children, Primary Nocturnal Enuresis
Active, not recruitingPhase 3
Efficacy of Mirabegron for Treatment of Non-monosymptomatic Nocturnal Enuresis in Children
Treatment of Non-monosymptomatic Nocturnal Enuresis
Recruiting
Adjustable Continence Therapy (ACT) for the Treatment of Female SUI
Urinary Incontinence, Urinary Incontinence,Stress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyPad in people with Enuresis, Nocturnal and Enuresis, run by Lancashire Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder expansion (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.