Randomized Study Of Novel Enuresis Alarm vs Standard Bedwetting Alarm

Sponsor

Yale University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05214131

Collaborator

Southwest pediatric Device Consortium (Other), Food and Drug Administration (FDA) (U.S. Fed)

100

Enrollment

Location

Arms

33.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Identify the dry night rate in patients using the GoGoband® nocturnal enuresis device vs a standard Pflaundler bedwetting alarm.

Condition or Disease	Intervention/Treatment	Phase
Bedwetting Nocturnal Enuresis Urinary Incontinence	Device: gogoband Device: SNEA group	N/A

Detailed Description

3.1 Problem Statement At the present time, there are no side-by-side comparison studies of GoGoband® vs SNEA. Since many of the prior studies were conducted using variable outcome parameters that makes direct comparisons of studies difficult it would be beneficial to obtain comparable data from the 2 groups and compare dry night rates for the 2 devices.

3.2 Purpose of Study/Potential Impact Our preliminary quality improvement data indicates that the GoGoband® is more efficacious than both medication and SNEA in an uncontrolled environment when deidentified data was analyzed off our servers. Our present database does not allow us to discern if patients are monosymptomatic nocturnal enuresis (MNE) or non monosymptomatic nocturnal enuresis (NMNE). Without this ability as well as for controlling for behavioral and academic problems which are known to affect outcomes in nocturnal enuresis studies, the investigators are not able to compare our results definitively and accurately to other treatment modalities.

Hypothesis Our hypothesis is that the GoGoband® is more effective than SNEA and Desmopressin in the treatment of Nocturnal Enuresis Primary Objective The primary objective of this study is to determine whether the GoGoband®] is as effective or more effective in comparison to children who use SNEA in a population of MNE patients with no underlying Attention deficit hyperactivity disorder (ADHD) in a 3 month period.

Secondary Objectives

To ascertain if familial incidence of nocturnal enuresis has an effect on outcomes

5.1 General Design Description The investigators propose the following study in patients who have been evaluated for primary nocturnal enuresis in our Yale New Haven Clinics.

All patients to be evaluated for nocturnal enuresis will undergo standard evaluation and initial treatment for nocturnal enuresis which includes:
Assessment Of Bowel Habits,
Fill Out A Questionnaire To Evaluate For Voiding Dysfunction
Treatment with routine bedwetting protocol of:

Stopping drinks 1 HR before bedtime, meals at least 3 hrs before bedtime, eliminating milk and ice cream from dinner and on, making sure that bowel movements are occurring 4 times per week and treating appropriately if necessary.
On return visit bedwetters and parents will be given the option of using medication , no further treatment, or alarm therapy.
If patients choose alarm therapy, they will be asked if they wish to participate in the Randomized study comparing GoGoband® vs SNEA.
Alarms will be provided to the patients free of cost to participants
Patients in the alarm group will be treated for 3 months continuously.
Patients in the SNEA group will record nightly if they wet their clothes and the report will be recorded and reviewed weekly
GoGoband® patients' data will be automatically saved on the HIPPA Compliant servers and subsequently reviewed at the end of the week.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Randomized Study Of Novel Enuresis Alarm (GoGoband® )Vs Standard Nocturnal Enuresis Alarm (SNEA)

Actual Study Start Date :

Apr 29, 2022

Anticipated Primary Completion Date :

Jan 31, 2024

Anticipated Study Completion Date :

Jan 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: gogoband alarm patients will be assigned to the novel bedwetting alarm	Device: gogoband use of biometric alarm to wake patient prior to wetting
Active Comparator: standard nocturnal enuresis alarm (SNEA) group this is the standard bedwetting alarm that is presently available through out the world	Device: SNEA group standard bedwetting alarm is used to treat patients, alarm sounds after wetting accident has occurred Other Names: standard bedwetting alarm

Arm

Intervention/Treatment

Experimental: gogoband alarm

patients will be assigned to the novel bedwetting alarm

Device: gogoband

use of biometric alarm to wake patient prior to wetting

Active Comparator: standard nocturnal enuresis alarm (SNEA) group

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

Device: SNEA group

standard bedwetting alarm is used to treat patients, alarm sounds after wetting accident has occurred

Other Names:

standard bedwetting alarm

Outcome Measures

Primary Outcome Measures

Number of wet nights [3 month period]
Comparison of alarms are to determine whether the GoGoband®] is as effective or more effective in comparison to children who use SNEA in a population of MNE patients with no underlying ADHD. The number of wet nights in each group will be compared to each other providing a comparison of the data. The gogoband group will be broken into two sections, training data and predictive and weaning data to compare against the SNEA data. Since the training data closely matches SNEA data, the investigators will compare the set of data and then compare the Predictive and Weaning data as the experimental group, since it has an active predictive alarm like the SNEA. The data will be compared using either a T test or Kruskal Wallis or anova depending on the number of comparisons performed and the data distribution is normal or not.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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
Male or female, aged 6 to 21 years
In good general health as evidenced by medical history and diagnosed with MNE
Ability to and be willing to adhere to the treatment regimen. -

Exclusion Criteria:

No patient may have had treatment of MNE in the past 6 months whether with medications or alarms
Current use of on ADHD medications, Tricyclics, SSRI's, NRI's or any antipsychotic medications.
Presence of Autistic Spectrum disorder, ADHD, genetic syndrome associated with developmental or learning disabilities
Treatment with another investigational drug or other intervention within last 6 months
Any form of Diabetes Mellitus or Diabetes Insipidus
No patient with known Chronic renal disease with moderate to severe renal impairment (defined as a creatinine clearance below 50mL/min).
No patient with known hyponatremia or a history of hyponatremia.