TerminatedNot Applicable

Randomized Study Of Novel Enuresis Alarm vs Standard Bedwetting Alarm

Stopped: low enrollment, patients did not want to be randomized into the regular alarm group, poor compliance with standard alarm

United States16 participantsStarted 2022-04-29

Plain-language summary

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

Age range6 Years – 21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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. -

✕. 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.

Number of Wet Nights

Timeframe: 3 month period

NCT IDNCT05214131

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-13

Results submitted2026-01-26