Randomized Study Of Novel Enuresis Alarm vs Standard Bedwetting Alarm

NCT ID: NCT05214131

Last Updated: 2023-12-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-29
• Study Completion Date: 2025-01-31

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.

Conditions

Bedwetting; Nocturnal Enuresis; Urinary Incontinence

Keywords

bedwetting; biometric; artificial intelligence; machine learning; heart rate variability; nocturnal enuresis; enuresis; urinary incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

gogoband alarm

patients will be assigned to the novel bedwetting alarm

Group Type: EXPERIMENTAL

gogoband

Intervention Type: DEVICE

use of biometric alarm to wake patient prior to wetting

standard nocturnal enuresis alarm (SNEA) group

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

Group Type: ACTIVE_COMPARATOR

SNEA group

Intervention Type: DEVICE

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

Interventions

gogoband

use of biometric alarm to wake patient prior to wetting

Intervention Type: DEVICE

SNEA group

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

Intervention Type: DEVICE

Other Intervention Names

standard bedwetting alarm

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Southwest pediatric Device Consortium

UNKNOWN

Sponsor Role: collaborator

Food and Drug Administration (FDA)

FED

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Israel Franco, MD

Role: PRINCIPAL_INVESTIGATOR

Dept of Urology, Yale School of Medicine

Locations

Yale New Haven Health

New Haven, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Israel Franco, MD

Role: CONTACT

Phone: 2037857671

Email: israel.franco@yale.edu

Angela Gold

Role: CONTACT

Phone: 2037857671

Email: angela.gold@yale.edu

Facility Contacts

Yale Care Center

Role: primary

Angela Gold

Role: backup

Related Links

http://mygogoband.com

website for the gogoband device

Other Identifiers

2000031281

Identifier Type: -

Identifier Source: org_study_id