Randomized Study Of Novel Enuresis Alarm vs Standard Bedwetting Alarm

NCT05214131 | Terminated Results FDA Device

• 1 other identifier: 2000031281
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bedwetting; Nocturnal Enuresis; Urinary Incontinence

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Wet Nights

  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 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. If patient numbers are less than 10 per group no statistical analysis will be performed.

  3 month period

Study Arms (2)

gogoband alarm

EXPERIMENTAL

patients will be assigned to the novel bedwetting alarm

Device: gogoband

standard nocturnal enuresis alarm (SNEA) group

ACTIVE COMPARATOR

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

Device: SNEA group

Interventions

gogoband DEVICE

use of biometric alarm to wake patient prior to wetting

gogoband alarm

SNEA group DEVICE

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

Also known as: standard bedwetting alarm

standard nocturnal enuresis alarm (SNEA) group

Eligibility Criteria

• Age: 6 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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. -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• Southwest pediatric Device Consortium: collaborator
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

Yale New Haven Health

New Haven, Connecticut, 06520, United States

Location

Related Links

• website for the gogoband device

MeSH Terms

Conditions

Nocturnal Enuresis; Urinary Incontinence; Enuresis

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study was terminated because of lack of enrollment and patients not returning the data sheets. patients would enroll in the study and once randomized to the standard bedwetting alarm they would not participate in the study and would not return calls or return data sheets. once it became clear that there was no way we would be able to achieve enrollment goals we decided to terminate the study

Results Point of Contact

• Title: Israel Franco MD
• Organization: Yale School of Medicine

Israel.franco@yale.edu

423 778 5910

Study Officials

• Israel Franco, MD

  Dept of Urology, Yale School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: January 28, 2022
• Study Start: April 29, 2022
• Primary Completion: June 13, 2025
• Study Completion: June 13, 2025
• Last Updated: March 9, 2026
• Results First Posted: March 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)