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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of alarms to address bedwetting: an experimental device called the GoGoband® Nocturnal Enuresis Device and a standard bedwetting alarm. The aim is to determine which alarm helps children and young adults achieve more dry nights. It is suitable for individuals aged 6 to 21 who have been diagnosed with bedwetting (nocturnal enuresis) and have not received treatment for it in the past six months. Participants must be in good health and not currently taking certain medications or have specific health issues such as diabetes or kidney problems. As an unphased trial, this study provides a unique opportunity to explore new solutions for bedwetting without the constraints of traditional clinical trial phases.

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 prior data suggests that the GoGoband® nocturnal enuresis device is safe for treating bedwetting?

Research has shown that the GoGoband® device for bedwetting is generally easy to use and effective. Studies have found that it can significantly reduce the number of wet nights. In one study, users who consistently used the device experienced dry nights 93% of the time, equating to about 1 or 2 wet nights per month. This suggests the device is effective without causing major issues for users.

While detailed information on negative side effects or issues with the GoGoband® is limited, high satisfaction rates among users suggest that the device is safe and does not cause significant discomfort. This makes it a promising option for those considering participation in a clinical trial for bedwetting. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GoGoband® Nocturnal Enuresis Device because it offers a novel approach to tackling bedwetting, a common condition where kids struggle to stay dry at night. Unlike standard bedwetting alarms that simply alert when wetness is detected, GoGoband® is designed to engage users more interactively, potentially increasing adherence and effectiveness. This innovative device could mean a more engaging and responsive experience for children, which might improve outcomes and foster a more positive approach to managing nocturnal enuresis.

What evidence suggests that these alarms are effective for bedwetting?

Research has shown that the GoGoband® device for bedwetting yields promising results. In earlier studies, 85% of users experienced 14 consecutive dry nights, suggesting it could help reduce bedwetting. This trial will assign participants to either the GoGoband® alarm or a standard bedwetting alarm. Although regular bedwetting alarms are common, early findings suggest the GoGoband® might be more effective. Users may achieve better results with GoGoband® compared to traditional alarms. ^{2 3 6 7 8}

Who Is on the Research Team?

Israel Franco, MD

Principal Investigator

Dept of Urology, Yale School of Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37217414/

Initial outcomes using a novel bedwetting alarm ... The ability to achieve 14 days straight of dry nights was 85%. Our findings indicate that GOGOband® provides a significant benefit to all its users reducing ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1477513123001535

Initial outcomes using a novel bedwetting alarm ... The ability to achieve 14 days straight of dry nights was 85%. Our findings indicate that GOGOband® provides a significant benefit to all its ...

3. jpurol.com jpurol.com/article/S1477-5131(23)00153-5/pdf

Initial outcomes using a novel bedwetting alarm (Gogoband The ability to achieve 14 days straight of dry nights was 85%. Our findings indicate that GOGOband provides a significant benefit to all its ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05214131?cond=%22bedwetting%22&aggFilters=status:not%20rec&rank=3

Randomized Study Of Novel Enuresis Alarm vs Standard ... Identify the dry night rate in patients using the GoGoband® nocturnal enuresis device vs a standard Pflaundler bedwetting alarm. Detailed Description.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05214131/randomized-study-of-novel-enuresis-alarm-vs-standard-bedwetting-alarm

Randomized Study Of Novel Enuresis Alarm vs Standard ... Identify the dry night rate in patients using the GoGoband® nocturnal enuresis device vs a standard Pflaundler bedwetting alarm.

6. researchgate.net researchgate.net/publication/370405816_Initial_Outcomes_Using_a_Novel_Bedwetting_Alarm_GogobandR_That_Utilizes_Real_Time_Artificial_Intelligence_to_Wake_Users_Prior_To_Wetting

Initial Outcomes Using a Novel Bedwetting Alarm (Gogoband® ... Overall ability to achieve 14 dry nights in a row was 66.7% (36/54) with some achieving a median of 16 14-day periods of dryness (IQR 0-35.75). Conclusions: We ...

7. i-jmr.org i-jmr.org/2023/1/e43194

Identifying Targets for Innovation in Amazon Reviews of ... This study aimed to determine areas of satisfaction versus dissatisfaction reported by the parents and caregivers of children using current bedwetting alarms.

8. ctv.veeva.com ctv.veeva.com/study/randomized-study-of-novel-enuresis-alarm-vs-standard-bedwetting-alarm

Randomized Study Of Novel Enuresis Alarm vs Standard ... Identify the dry night rate in patients using the GoGoband® nocturnal enuresis device vs a standard Pflaundler bedwetting alarm.