Novel Enuresis Alarm vs Standard Alarm for Bedwetting

Overseen By Angela Gold

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: ADHD medications, Tricyclics, SSRIs, NRIs

Disqualifiers: Autism, ADHD, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares two bedwetting devices, GoGoband® and another device, in children who wet the bed but do not have ADHD. Both devices work by waking the child when they start to wet the bed, helping them learn to stay dry. The body-worn alarm has been shown to be as effective as other methods and superior in terms of rapidity of response and consumer appeal.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications like ADHD medications, Tricyclics, SSRIs, NRIs, or any antipsychotic medications to participate in this trial.

What data supports the effectiveness of the GoGoband® Nocturnal Enuresis Device for bedwetting treatment?

Research shows that enuresis alarms, like the GoGoband® device, have a success rate of about 75% in reducing bedwetting, with a low chance of relapse. Body-worn alarms, similar to GoGoband®, are effective and preferred due to their quick response and user satisfaction. ^{1 2 3 4 5}

How is the GoGoband® Nocturnal Enuresis Device different from other bedwetting treatments?

The GoGoband® Nocturnal Enuresis Device is unique because it is a novel enuresis alarm that may offer a different approach compared to standard alarms, potentially involving advanced technology or design features. Unlike traditional alarms that activate after bedwetting occurs, this device might incorporate innovative elements to improve user experience and effectiveness. ^{2 3 5 6 7}

Research Team

Israel Franco, MD

Principal Investigator

Dept of Urology, Yale School of Medicine

Eligibility Criteria

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.

Inclusion Criteria

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

You are generally healthy and have been diagnosed with MNE.

Exclusion Criteria

My kidneys work well (creatinine clearance above 50mL/min).

I have been diagnosed with autism, ADHD, or a genetic condition affecting my learning.

I haven't received any treatment for bedwetting in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Evaluation and Treatment

Standard evaluation and initial treatment for nocturnal enuresis, including assessment of bowel habits and voiding dysfunction questionnaire

2 weeks

1 visit (in-person)

Treatment

Participants receive either the GoGoband® or SNEA alarm for 3 months, with weekly monitoring and data collection

12 weeks

Weekly data review (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• GoGoband® Nocturnal Enuresis Device
• Standard Bedwetting Alarm

Trial Overview 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.

Participant Groups

Group I: gogoband alarm Experimental Treatment 1 Intervention

patients will be assigned to the novel bedwetting alarm

Group II: standard nocturnal enuresis alarm (SNEA) group Active Control 1 Intervention

this is the standard bedwetting alarm that is presently available through out the world

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Food and Drug Administration (FDA)

Collaborator

Trials

184

Recruited

1,553,000+

Southwest pediatric Device Consortium

Collaborator

Trials

1

Recruited

100+

References

1. England pubmed.ncbi.nlm.nih.gov

Long-term follow-up of enuretic alarm treatment in enuresis nocturna. [2013]

2. England pubmed.ncbi.nlm.nih.gov

Prognostic factors for alarm treatment. [2009]

3. England pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of a code-word enuresis alarm. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

The treatment of nocturnal enuresis: a controlled comparison of two models of urine alarm. [2006]

5. England pubmed.ncbi.nlm.nih.gov

The body-worn alarm in the treatment of childhood enuresis. [2006]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Patient Engagement in Medical Device Design: Refining the Essential Attributes of a Wearable, Pre-Void, Ultrasound Alarm for Nocturnal Enuresis. [2021]

7. Sweden pubmed.ncbi.nlm.nih.gov

[Alarm defends its position. Comments to meta-analysis of alarm treatment of nocturnal enuresis]. [2018]