Status:
UNKNOWN
Randomized Study Of Novel Enuresis Alarm vs Standard Bedwetting Alarm
Lead Sponsor:
Yale University
Collaborating Sponsors:
Southwest pediatric Device Consortium
Food and Drug Administration (FDA)
Conditions:
Bedwetting
Nocturnal Enuresis
Eligibility:
All Genders
6-21 years
Phase:
NA
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 make...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05214131
Start Date
April 29 2022
End Date
January 1 2025
Last Update
December 12 2023
Active Locations (1)
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1
Yale New Haven Health
New Haven, Connecticut, United States, 06520