Comparing a new bedwetting alarm to a standard one
Randomized Study Of Novel Enuresis Alarm (GoGoband® )Vs Standard Nocturnal Enuresis Alarm (SNEA)
This study is testing a new bedwetting alarm to see if it helps children stay dry at night better than a standard alarm.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 6 Years to 21 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT05214131 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of the GoGoband® nocturnal enuresis device against a standard bedwetting alarm, the Pflaundler alarm, in achieving dry nights for children diagnosed with monosymptomatic nocturnal enuresis. The research will involve a randomized approach where participants will be monitored over a three-month period to assess the dry night rates between the two devices. The study seeks to provide clearer data on the efficacy of the GoGoband® compared to traditional methods, addressing previous inconsistencies in outcome measures from earlier studies.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 21 years diagnosed with monosymptomatic nocturnal enuresis who are in good general health.
Not a fit: Patients with underlying conditions such as ADHD, autism spectrum disorder, or those who have received treatment for nocturnal enuresis in the past six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for children suffering from bedwetting.
How similar studies have performed: While there have been studies on bedwetting treatments, this specific comparison of the GoGoband® to a standard alarm is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New Haven, Connecticut
- Yale New Haven Health — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Israel Franco, MD — Dept of Urology, Yale School of Medicine
- Study coordinator: Israel Franco, MD
- Email: israel.franco@yale.edu
- Phone: 2037857671
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.