Randomized Study Of Novel Enuresis Alarm vs Standard Bedwetting Alarm

Description

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

Study Overview

Study Details

Study overview

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

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

Randomized Study Of Novel Enuresis Alarm vs Standard Bedwetting Alarm

Condition
Bedwetting
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale New Haven Health, New Haven, Connecticut, United States, 06520

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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. -
  • 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.

Ages Eligible for Study

6 Years to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Yale University,

Israel Franco, MD, PRINCIPAL_INVESTIGATOR, Dept of Urology, Yale School of Medicine

Study Record Dates

2025-01