Trial Outcomes & Findings for Hand & Foot Nocturnal Enuresis TENS Study (NCT NCT02747849)
NCT ID: NCT02747849
Last Updated: 2023-04-21
Results Overview
The subject/parents will be instructed to record a night-time voiding log specifying the change in number of nights wet per 2 weeks. This log is included in the IRB application. Subjects/parents will fill out the log for a two week period prior to foot stimulation to determine a baseline average of nocturnal enuresis episodes, during week 3 and 4 of the study the subjects will stimulate either their foot or hand to measure any acute effect on nocturnal enuresis episodes and finally during week 5 and 6 of the study, after stimulation subjects will keep a log to evaluate any post-stimulation residual benefit
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
6 weeks
Results posted on
2023-04-21
Participant Flow
Participant milestones
| Measure |
Hand Neuromodulation
The stimulation characteristics for this arm include a continuous frequency of 5 Hz, pulsewidth 0.2 ms, and intensity 2-4 times the threshold voltage required for finger twitching - or the intensity that the subject feels comfortable with. Subjects will be asked to use the stimulator for a minimum of 60 minutes prior to bedtime for two weeks, or longer if they can tolerate it, have the time, and accurately record the total duration. Stimulation will be performed during the first, second, and third weeks of the study.
TENS: Placebo had stimulator placed on hand. Active comparator had stimulator placed on foot. Amount of time, intensity, threshold voltage, pulsewidth and frequency remained the same for both arms.
|
Foot Neuromodulation
The stimulation characteristics include a continuous frequency of 5 Hz, pulsewidth 0.2 ms, and intensity 2-4 times the threshold voltage required for inducing toe twitching - or the intensity that the subject feels comfortable with. The subjects will be asked to wear socks on their foot to prevent the electrodes from detachment and to stop the stimulation during walking or in any non-resting situation. Subjects will be asked to use the stimulator for a minimum of 60 minutes prior to bedtime for two weeks, or longer if they can tolerate it, have the time, and accurately record the total duration. Stimulation will be performed during the first, second, and third weeks of the study.
TENS: Placebo had stimulator placed on hand. Active comparator had stimulator placed on foot. Amount of time, intensity, threshold voltage, pulsewidth and frequency remained the same for both arms.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
14
|
|
Overall Study
COMPLETED
|
12
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Hand Neuromodulation
n=12 Participants
The stimulation characteristics for this arm include a continuous frequency of 5 Hz, pulsewidth 0.2 ms, and intensity 2-4 times the threshold voltage required for finger twitching - or the intensity that the subject feels comfortable with. Subjects will be asked to use the stimulator for a minimum of 60 minutes prior to bedtime for two weeks, or longer if they can tolerate it, have the time, and accurately record the total duration. Stimulation will be performed during the first, second, and third weeks of the study.
TENS: Placebo had stimulator placed on hand. Active comparator had stimulator placed on foot. Amount of time, intensity, threshold voltage, pulsewidth and frequency remained the same for both arms.
|
Foot Neuromodulation
n=14 Participants
The stimulation characteristics include a continuous frequency of 5 Hz, pulsewidth 0.2 ms, and intensity 2-4 times the threshold voltage required for inducing toe twitching - or the intensity that the subject feels comfortable with. The subjects will be asked to wear socks on their foot to prevent the electrodes from detachment and to stop the stimulation during walking or in any non-resting situation. Subjects will be asked to use the stimulator for a minimum of 60 minutes prior to bedtime for two weeks, or longer if they can tolerate it, have the time, and accurately record the total duration. Stimulation will be performed during the first, second, and third weeks of the study.
TENS: Placebo had stimulator placed on hand. Active comparator had stimulator placed on foot. Amount of time, intensity, threshold voltage, pulsewidth and frequency remained the same for both arms.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
12 Participants
n=12 Participants
|
14 Participants
n=14 Participants
|
26 Participants
n=26 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=12 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=26 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=12 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=26 Participants
|
|
Age, Continuous
|
12 years
n=12 Participants
|
12.1 years
n=14 Participants
|
12 years
n=26 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
9 Participants
n=12 Participants
|
9 Participants
n=14 Participants
|
18 Participants
n=26 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
3 Participants
n=12 Participants
|
4 Participants
n=14 Participants
|
7 Participants
n=26 Participants
|
|
Sex/Gender, Customized
Gender · Did not identify
|
0 Participants
n=12 Participants
|
1 Participants
n=14 Participants
|
1 Participants
n=26 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
12 participants
n=12 Participants
|
14 participants
n=14 Participants
|
26 participants
n=26 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Patients with primary nocturnal enuresis.
The subject/parents will be instructed to record a night-time voiding log specifying the change in number of nights wet per 2 weeks. This log is included in the IRB application. Subjects/parents will fill out the log for a two week period prior to foot stimulation to determine a baseline average of nocturnal enuresis episodes, during week 3 and 4 of the study the subjects will stimulate either their foot or hand to measure any acute effect on nocturnal enuresis episodes and finally during week 5 and 6 of the study, after stimulation subjects will keep a log to evaluate any post-stimulation residual benefit
Outcome measures
| Measure |
Hand Neuromodulation
n=12 Participants
The stimulation characteristics for this arm include a continuous frequency of 5 Hz, pulsewidth 0.2 ms, and intensity 2-4 times the threshold voltage required for finger twitching - or the intensity that the subject feels comfortable with. Subjects will be asked to use the stimulator for a minimum of 60 minutes prior to bedtime for two weeks, or longer if they can tolerate it, have the time, and accurately record the total duration. Stimulation will be performed during the first, second, and third weeks of the study.
TENS: Placebo had stimulator placed on hand. Active comparator had stimulator placed on foot. Amount of time, intensity, threshold voltage, pulsewidth and frequency remained the same for both arms.
|
Foot Neuromodulation
n=14 Participants
The stimulation characteristics include a continuous frequency of 5 Hz, pulsewidth 0.2 ms, and intensity 2-4 times the threshold voltage required for inducing toe twitching - or the intensity that the subject feels comfortable with. The subjects will be asked to wear socks on their foot to prevent the electrodes from detachment and to stop the stimulation during walking or in any non-resting situation. Subjects will be asked to use the stimulator for a minimum of 60 minutes prior to bedtime for two weeks, or longer if they can tolerate it, have the time, and accurately record the total duration. Stimulation will be performed during the first, second, and third weeks of the study.
TENS: Placebo had stimulator placed on hand. Active comparator had stimulator placed on foot. Amount of time, intensity, threshold voltage, pulsewidth and frequency remained the same for both arms.
|
|---|---|---|
|
Change in Number of Nights Wet Per 2 Weeks
# nights wet before stimulation over 2 weeks
|
11 # nights wet over 2 weeks
Standard Deviation 3.46
|
8.78 # nights wet over 2 weeks
Standard Deviation 4.12
|
|
Change in Number of Nights Wet Per 2 Weeks
# nights wet during stimulation over 2 weeks
|
8.75 # nights wet over 2 weeks
Standard Deviation 3.99
|
6.22 # nights wet over 2 weeks
Standard Deviation 4.21
|
|
Change in Number of Nights Wet Per 2 Weeks
# nights wet after stimulation over 2 weeks
|
9.5 # nights wet over 2 weeks
Standard Deviation 3.82
|
6.78 # nights wet over 2 weeks
Standard Deviation 5.19
|
PRIMARY outcome
Timeframe: An average of 6 weeksPopulation: Patients
Total number of participants that responded to treatment after stimulation with Hand or Foor unit.
Outcome measures
| Measure |
Hand Neuromodulation
n=12 Participants
The stimulation characteristics for this arm include a continuous frequency of 5 Hz, pulsewidth 0.2 ms, and intensity 2-4 times the threshold voltage required for finger twitching - or the intensity that the subject feels comfortable with. Subjects will be asked to use the stimulator for a minimum of 60 minutes prior to bedtime for two weeks, or longer if they can tolerate it, have the time, and accurately record the total duration. Stimulation will be performed during the first, second, and third weeks of the study.
TENS: Placebo had stimulator placed on hand. Active comparator had stimulator placed on foot. Amount of time, intensity, threshold voltage, pulsewidth and frequency remained the same for both arms.
|
Foot Neuromodulation
n=14 Participants
The stimulation characteristics include a continuous frequency of 5 Hz, pulsewidth 0.2 ms, and intensity 2-4 times the threshold voltage required for inducing toe twitching - or the intensity that the subject feels comfortable with. The subjects will be asked to wear socks on their foot to prevent the electrodes from detachment and to stop the stimulation during walking or in any non-resting situation. Subjects will be asked to use the stimulator for a minimum of 60 minutes prior to bedtime for two weeks, or longer if they can tolerate it, have the time, and accurately record the total duration. Stimulation will be performed during the first, second, and third weeks of the study.
TENS: Placebo had stimulator placed on hand. Active comparator had stimulator placed on foot. Amount of time, intensity, threshold voltage, pulsewidth and frequency remained the same for both arms.
|
|---|---|---|
|
Response to Treatment
|
8 Participants
|
9 Participants
|
Adverse Events
Hand Neuromodulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Foot Neuromodulation
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