Trial Outcomes & Findings for TENS Treatment for Bedwetting (NCT NCT04313192)
NCT ID: NCT04313192
Last Updated: 2026-04-15
Results Overview
%change in wet nights compared in each TENS arm and baseline wet nights
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
125 participants
Primary outcome timeframe
30 days
Results posted on
2026-04-15
Participant Flow
30 into arm 1 29 into arm 2 30 into arm 3
125 total pre-assignment
Participant milestones
| Measure |
Pulse Rate 2Hz
Pulse Rate 2Hz frequency
|
Pulse Rate 10Hz
Pulse Rate 10 Hz frequency
|
Pulse Rate 150Hz
Pulse Rate 150Hz frequency
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
29
|
30
|
|
Overall Study
COMPLETED
|
30
|
29
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Pulse Rate 2Hz
n=30 Participants
Pulse Rate 2Hz frequency
|
Pulse Rate 10Hz
n=29 Participants
Pulse Rate 10 Hz frequency
|
Pulse Rate 150Hz
n=30 Participants
Pulse Rate 150Hz frequency
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
30 Participants
n=30 Participants
|
29 Participants
n=29 Participants
|
30 Participants
n=30 Participants
|
89 Participants
n=89 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=30 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=89 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=30 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=89 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=30 Participants
|
9 Participants
n=29 Participants
|
7 Participants
n=30 Participants
|
29 Participants
n=89 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=30 Participants
|
20 Participants
n=29 Participants
|
23 Participants
n=30 Participants
|
60 Participants
n=89 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 30 days%change in wet nights compared in each TENS arm and baseline wet nights
Outcome measures
| Measure |
Pulse Rate 2Hz
n=30 Participants
Pulse Rate 2Hz frequency
|
Pulse Rate 10Hz
n=29 Participants
Pulse Rate 10 Hz frequency
|
Pulse Rate 150Hz
n=30 Participants
Pulse Rate 150Hz frequency
|
|---|---|---|---|
|
Percentage of Wet Nights
|
-0.104790479 %change wet nights
Standard Deviation 0.183305268
|
-0.099141959 %change wet nights
Standard Deviation 0.174013801
|
-0.111602158 %change wet nights
Standard Deviation 0.192153509
|
SECONDARY outcome
Timeframe: 30 daysMean score (0 dry to 3 soaked) of subjective severity of wetness each night during treatment month compared to baseline month
Outcome measures
| Measure |
Pulse Rate 2Hz
n=30 Participants
Pulse Rate 2Hz frequency
|
Pulse Rate 10Hz
n=29 Participants
Pulse Rate 10 Hz frequency
|
Pulse Rate 150Hz
n=30 Participants
Pulse Rate 150Hz frequency
|
|---|---|---|---|
|
Severity of Wet Nights
|
-0.422916667 scores on a scale (0-3)
Standard Deviation 0.556608356
|
-0.1484 scores on a scale (0-3)
Standard Deviation 0.49945537
|
-0.1935 scores on a scale (0-3)
Standard Deviation 0.517506929
|
SECONDARY outcome
Timeframe: 30 daysScores on a scale. Quality of life questionnaire score after treatment month compared to after baseline month. Score ranges from 0-80. Lower scores are better and higher scores are worse. Scores = mild \<20, moderate 21-50, and severe \>51.
Outcome measures
| Measure |
Pulse Rate 2Hz
n=30 Participants
Pulse Rate 2Hz frequency
|
Pulse Rate 10Hz
n=29 Participants
Pulse Rate 10 Hz frequency
|
Pulse Rate 150Hz
n=30 Participants
Pulse Rate 150Hz frequency
|
|---|---|---|---|
|
Pediatric Incontinence Questionnaire (PIN-Q)
|
0 mean PIN-Q score change
Standard Deviation 6.585107164
|
-0.538461538 mean PIN-Q score change
Standard Deviation 6.438824546
|
-2.541666667 mean PIN-Q score change
Standard Deviation 7.695165996
|
Adverse Events
Pulse Rate 2Hz
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pulse Rate 10Hz
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pulse Rate 150Hz
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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