Trial Outcomes & Findings for Randomized Study Of Novel Enuresis Alarm vs Standard Bedwetting Alarm (NCT NCT05214131)
NCT ID: NCT05214131
Last Updated: 2026-03-09
Results Overview
Comparison of alarms are to determine whether the GoGoband®\] is as effective or more effective in comparison to children who use SNEA in a population of MNE patients with no underlying ADHD. The number of wet nights in each group will be compared to each other providing a comparison of the data. The data will be compared using either a T test or Kruskal Wallis or anova depending on the number of comparisons performed and the data distribution is normal or not. If patient numbers are less than 10 per group no statistical analysis will be performed.
TERMINATED
NA
16 participants
3 month period
2026-03-09
Participant Flow
patients with NE were asked to participate in a study without compensation to evaluate different bedwetting alarms
patients were assigned randomly to gogoband group and standard alarm therapy
Participant milestones
| Measure |
Gogoband Alarm
patients will be assigned to the novel bedwetting alarm
gogoband: use of biometric alarm to wake patient prior to wetting
|
Standard Nocturnal Enuresis Alarm (SNEA) Group
this is the standard bedwetting alarm that is presently available through out the world
SNEA group: standard bedwetting alarm is used to treat patients, alarm sounds after wetting accident has occurred
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
Reasons for withdrawal
| Measure |
Gogoband Alarm
patients will be assigned to the novel bedwetting alarm
gogoband: use of biometric alarm to wake patient prior to wetting
|
Standard Nocturnal Enuresis Alarm (SNEA) Group
this is the standard bedwetting alarm that is presently available through out the world
SNEA group: standard bedwetting alarm is used to treat patients, alarm sounds after wetting accident has occurred
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
5
|
Baseline Characteristics
Randomized Study Of Novel Enuresis Alarm vs Standard Bedwetting Alarm
Baseline characteristics by cohort
| Measure |
Gogoband Alarm
n=8 Participants
patients will be assigned to the novel bedwetting alarm
gogoband: use of biometric alarm to wake patient prior to wetting
|
Standard Nocturnal Enuresis Alarm (SNEA) Group
n=8 Participants
this is the standard bedwetting alarm that is presently available through out the world
SNEA group: standard bedwetting alarm is used to treat patients, alarm sounds after wetting accident has occurred
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.5 years
STANDARD_DEVIATION 2.4 • n=68 Participants
|
9.8 years
STANDARD_DEVIATION 2.6 • n=69 Participants
|
9.65 years
STANDARD_DEVIATION 2.5 • n=137 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=68 Participants
|
3 Participants
n=69 Participants
|
5 Participants
n=137 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=68 Participants
|
5 Participants
n=69 Participants
|
11 Participants
n=137 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=68 Participants
|
1 Participants
n=69 Participants
|
2 Participants
n=137 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=68 Participants
|
7 Participants
n=69 Participants
|
13 Participants
n=137 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
1 Participants
n=137 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=68 Participants
|
1 Participants
n=69 Participants
|
1 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=68 Participants
|
1 Participants
n=69 Participants
|
1 Participants
n=137 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=68 Participants
|
5 Participants
n=69 Participants
|
12 Participants
n=137 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=68 Participants
|
1 Participants
n=69 Participants
|
2 Participants
n=137 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=68 Participants
|
8 participants
n=69 Participants
|
16 participants
n=137 Participants
|
PRIMARY outcome
Timeframe: 3 month periodPopulation: 8 patients in the SNEA group were enrolled and given alarms but only 3 returned their monthly data sheets for analysis.
Comparison of alarms are to determine whether the GoGoband®\] is as effective or more effective in comparison to children who use SNEA in a population of MNE patients with no underlying ADHD. The number of wet nights in each group will be compared to each other providing a comparison of the data. The data will be compared using either a T test or Kruskal Wallis or anova depending on the number of comparisons performed and the data distribution is normal or not. If patient numbers are less than 10 per group no statistical analysis will be performed.
Outcome measures
| Measure |
Gogoband Alarm
n=8 Participants
patients will be assigned to the novel bedwetting alarm
gogoband: use of biometric alarm to wake patient prior to wetting
|
Standard Nocturnal Enuresis Alarm (SNEA) Group
n=3 Participants
this is the standard bedwetting alarm that is presently available through out the world
SNEA group: standard bedwetting alarm is used to treat patients, alarm sounds after wetting accident has occurred
|
|---|---|---|
|
Number of Wet Nights
pretreatment
|
3.33 wet nights/week
Standard Deviation 2.045
|
4.33 wet nights/week
Standard Deviation 2.35
|
|
Number of Wet Nights
post treatment
|
0.8 wet nights/week
Standard Deviation 1.16
|
1 wet nights/week
Standard Deviation 1.4
|
Adverse Events
Gogoband Alarm
Standard Nocturnal Enuresis Alarm (SNEA) Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place