Clinical trial NCT05214131: Randomized Study Of Novel Enuresis Alarm vs Standard Bedwetting Alarm
Official title: Randomized Study Of Novel Enuresis Alarm (GoGoband® )Vs Standard Nocturnal Enuresis Alarm (SNEA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bedwetting
Nocturnal Enuresis
Urinary Incontinence
Keywords: bedwetting
biometric
artificial intelligence
machine learning
heart rate variability
nocturnal enuresis
enuresis
urinary incontinence
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Southwest pediatric Device Consortium
name: Food and Drug Administration (FDA)
First posted: 2022-01-28
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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:

  1. 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.
  2. On return visit bedwetters and parents will be given the option of using medication , no further treatment, or alarm therapy.
  3. If patients choose alarm therapy, they will be asked if they wish to participate in the Randomized study comparing GoGoband® vs SNEA.
  4. Alarms will be provided to the patients free of cost to participants
  5. Patients in the alarm group will be treated for 3 months continuously.
  6. Patients in the SNEA group will record nightly if they wet their clothes and the report will be recorded and reviewed weekly
  7. GoGoband® patients' data will be automatically saved on the HIPPA Compliant servers and subsequently reviewed at the end of the week.

Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 6 to 21 years
4. In good general health as evidenced by medical history and diagnosed with MNE
5. Ability to and be willing to adhere to the treatment regimen. -

Exclusion Criteria:

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

Primary outcomes:
measure: Number of wet nights
timeFrame: 3 month period
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Health
state: Connecticut
Study officials:
affiliation: Dept of Urology, Yale School of Medicine
name: Israel Franco, MD
role: PRINCIPAL_INVESTIGATOR
References: