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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

Find a Location

Who is running the clinical trial?

Food and Drug Administration (FDA)FED
171 Previous Clinical Trials
1,331,506 Total Patients Enrolled
Southwest pediatric Device ConsortiumUNKNOWN
Yale UniversityLead Sponsor
1,848 Previous Clinical Trials
2,737,718 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being enrolled in this clinical endeavor presently?

"Affirmative. Clinicaltrials.gov confirms that this study is presently recruiting patients, with the first listing being published on April 29th 2022 and last edited on November 28th 2022. The trial is searching for a total of 100 participants from 1 location to be involved in the research."

Answered by AI

Does this research accept persons aged 40 or older as participants?

"According to the eligibility requirements, individuals between 6 and 21 years old are suitable for involvement in this clinical study."

Answered by AI

What is the maximum number of participants for this research endeavor?

"Affirmative. The records stored on clinicaltrials.gov suggest that this medical trial is actively recruiting individuals; it was first announced on April 29th 2022 and has been updated most recently on November 28th 2022. This study seeks 100 volunteers from a single site to complete the research."

Answered by AI

To whom is this research endeavor best suited?

"This clinical trial seeks 100 participants, aged 6 to 21 that suffer from nocturnal enuresis. All volunteers must present a signed and dated consent form as well as being males or females in good physical health with the capacity and willingness to adhere to the prescribed treatment plan for the entirety of this study's duration."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
What site did they apply to?
Yale New Haven Health
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

We would like to try a drug free solution to bed wetting.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How often would travel to New Haven be required?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Randomized Study Of Novel Enuresis Alarm vs Standard Bedwetting Alarm
2022. "Randomized Study Of Novel Enuresis Alarm vs Standard Bedwetting Alarm". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05214131.
All > Urinary Incontinence
~25 spots leftby Jan 2025
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