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Enuresis Alarm

Novel Enuresis Alarm vs Standard Alarm for Bedwetting

N/A
Recruiting
Led By Israel Franco, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female, aged 6 to 21 years
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 month period
Awards & highlights

Study Summary

This trial looks at the dry night rate for patients using the GoGoband® device vs a standard bedwetting alarm.

Who is the study for?
This trial is for boys and girls aged 6 to 21 who are generally healthy but struggle with bedwetting (MNE). They must be able to follow the study's procedures, have not used any bedwetting treatments in the last six months, and cannot be on certain medications like ADHD drugs or antidepressants. Those with conditions such as autism, developmental disabilities, diabetes, severe kidney issues or a history of low sodium levels can't join.Check my eligibility
What is being tested?
The study is testing how effective a new device called GoGoband® is compared to a standard Pflaundler alarm in helping patients achieve dry nights. Participants will use one of these two alarms at random to see which one works better for stopping bedwetting.See study design
What are the potential side effects?
Since this trial involves non-invasive devices aimed at reducing bedwetting incidents rather than medication, side effects may include discomfort from wearing the device overnight or potential sleep disturbances due to alarm activation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 6 and 21 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 month period
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 month period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of wet nights

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: gogoband alarmExperimental Treatment1 Intervention
patients will be assigned to the novel bedwetting alarm
Group II: standard nocturnal enuresis alarm (SNEA) groupActive Control1 Intervention
this is the standard bedwetting alarm that is presently available through out the world

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Who is running the clinical trial?

Food and Drug Administration (FDA)FED
174 Previous Clinical Trials
1,333,592 Total Patients Enrolled
Southwest pediatric Device ConsortiumUNKNOWN
Yale UniversityLead Sponsor
1,863 Previous Clinical Trials
2,742,481 Total Patients Enrolled

Media Library

GoGoband® Nocturnal Enuresis Device (Enuresis Alarm) Clinical Trial Eligibility Overview. Trial Name: NCT05214131 — N/A
Bedwetting Research Study Groups: gogoband alarm, standard nocturnal enuresis alarm (SNEA) group
Bedwetting Clinical Trial 2023: GoGoband® Nocturnal Enuresis Device Highlights & Side Effects. Trial Name: NCT05214131 — N/A
GoGoband® Nocturnal Enuresis Device (Enuresis Alarm) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05214131 — N/A
Bedwetting Patient Testimony for trial: Trial Name: NCT05214131 — N/A
~22 spots leftby Jan 2025
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