Randomized Study Of Novel Enuresis Alarm vs Standard Bedwetting Alarm

Launched by YALE UNIVERSITY · Jan 27, 2022

Keywords

ClinConnect Summary

This clinical trial is examining the effectiveness of a new device called the GoGoband® for treating bedwetting, also known as nocturnal enuresis, compared to a standard bedwetting alarm. The goal is to see if patients using the GoGoband® experience more dry nights than those using the traditional alarm. The study is currently looking for participants aged 6 to 21 years who are in good health and have been diagnosed with bedwetting.

To join the study, participants will need to agree to follow the study procedures and provide written consent. However, there are some important exclusions: those who have recently used bedwetting treatments, certain medications, or have specific health conditions like diabetes or chronic kidney disease will not be eligible. If you qualify and decide to participate, you can expect to use the device as part of the study and help researchers learn more about effective treatments for bedwetting.

Gender

ALL

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.