What is the mechanism of action of this treatment?

Behavioral conditioning devices, such as the GoGoband® nocturnal enuresis device, use vibration or sound to wake the patient when wetness is detected. This method conditions the brain to recognize the sensation of a full bladder and wake up before urination occurs, thereby helping to develop bladder control and reduce bedwetting episodes. This approach is crucial for bedwetting patients as it promotes long-term improvement in bladder awareness and control. Other common treatments include medications like desmopressin, which reduces urine production at night, and lifestyle changes such as limiting fluid intake before bedtime.

What side effects are associated with this type of intervention?

Behavioral conditioning devices for bedwetting, such as the GoGoband® nocturnal enuresis device, generally have minimal side effects. The most common issues reported include sleep disturbances due to the alarm waking the patient, which can lead to temporary sleep deprivation or fatigue. Some users may also experience anxiety or stress related to the alarm. Overall, these devices are considered safe with no serious adverse effects.

What prior FDA approvals exist?

The GoGoband® nocturnal enuresis device, which uses behavioral conditioning through vibration or sound to wake the patient when wetness is detected, is similar to standard bedwetting alarms. These alarms have been shown to be effective in achieving dryness in children with nocturnal enuresis. While the context does not provide specific FDA approval details for these devices, it does highlight their effectiveness compared to pharmacological treatments like desmopressin. Bedwetting alarms are generally preferred due to their lower relapse rates and superior long-term outcomes in well-motivated children.

What other types of research exist?

Promising alternatives to the GoGoband® nocturnal enuresis device include: 1) Standard bedwetting alarms, which use sound or vibration to wake the patient when wetness is detected. 2) Pharmacological treatments such as desmopressin, which reduces urine production at night. 3) Combination therapy involving behavioral interventions and medications. 4) Newer wearable technologies and smart textiles that integrate moisture sensors with mobile apps for real-time monitoring and feedback. 5) Cognitive-behavioral therapy (CBT) to address underlying psychological factors contributing to bedwetting.

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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

Must not have

No patient with known Chronic renal disease with moderate to severe renal impairment (defined as a creatinine clearance below 50mL/min)

Presence of Autistic Spectrum disorder, ADHD, genetic syndrome associated with developmental or learning disabilities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 month period

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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

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I am between 6 and 21 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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I am currently taking medication for ADHD, depression, or psychosis.

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I have diabetes.

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I do not have, nor have I had, low sodium levels in my blood.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 month period

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of wet nights

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Behavioral conditioning devices, such as the GoGoband® nocturnal enuresis device, use vibration or sound to wake the patient when wetness is detected. This method conditions the brain to recognize the sensation of a full bladder and wake up before urination occurs, thereby helping to develop bladder control and reduce bedwetting episodes. This approach is crucial for bedwetting patients as it promotes long-term improvement in bladder awareness and control. Other common treatments include medications like desmopressin, which reduces urine production at night, and lifestyle changes such as limiting fluid intake before bedtime.