NCT04280887

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

November 10, 2022

Status Verified

November 1, 2022

Enrollment Period

3.9 years

First QC Date

February 5, 2020

Last Update Submit

November 9, 2022

Conditions

Enuresis, NocturnalEnuresis

Outcome Measures

Primary Outcomes (2)

  • Bladder expansion

    Bladder size measurements, device is able to provide consistent readings

    3 months

  • Reduction in adverse events

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

    3 months

Secondary Outcomes (1)

  • Comfort

    3 months

Study Arms (1)

Intervention

EXPERIMENTAL

Participants will wear the device for the specified test period (3 months)

Device: MyPad

Interventions

MyPadDEVICE

Ultrasound bed wetting alarm

Intervention

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lancashire Teaching Hospitals NHS Foundation Trust

Preston, United Kingdom

Location

MeSH Terms

Conditions

Nocturnal EnuresisEnuresis

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBehavioral SymptomsBehaviorElimination DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Model Details: Cohort
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2020

First Posted

February 21, 2020

Study Start

August 3, 2018

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

November 10, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)