An interventional study of TENS in Bedwetting, sponsored by Rajeev Chaudhry. Completed at 1 site in United States. Open to participants aged 5 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-21.
Sponsored by Rajeev Chaudhry · Not applicable, Interventional, and Treatment
The investigators believe in order to strengthen the evidence in support of transcutaneous foot stimulation in this population the investigators need to move forward with a randomized comparison study using the TENS device on the hand and foot as a control.
Nocturnal enuresis is a common problem in children which can have a dramatic psychological and social impact on quality of life. Neuromodulation by transcutaneous foot stimulation of peripheral tibial nerve branches has been shown to produce a prolonged inhibition of micturition reflex contractions and significantly increase bladder capacity. The investigators primary goal was to evaluate the effect of foot stimulation on the frequency of nocturnal enuresis episodes in children.
Exclusion Criteria:
Note: Any patient currently taking medication such as an anti-muscarinic or a tricyclic antidepressant for overactive bladder at time of enrollment will be eligible to participate and will be continued on their usual medication and dosage throughout the study.
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.
Device: TENS
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.
Device: 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
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
Time frame: 6 weeks
Response to Treatment
Total number of participants that responded to treatment after stimulation with Hand or Foor unit.
Time frame: An average of 6 weeks
| Milestone | Hand Neuromodulation | Foot Neuromodulation |
|---|---|---|
| Started | 13 | 14 |
| Completed | 12 | 14 |
| Not completed | 1 | 0 |
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
| # nights wet over 2 weeks | Hand Neuromodulation | Foot Neuromodulation |
|---|---|---|
| # nights wet before stimulation over 2 weeks | 11 ± 3.46 | 8.78 ± 4.12 |
| # nights wet during stimulation over 2 weeks | 8.75 ± 3.99 | 6.22 ± 4.21 |
| # nights wet after stimulation over 2 weeks | 9.5 ± 3.82 | 6.78 ± 5.19 |
Total number of participants that responded to treatment after stimulation with Hand or Foor unit.
| Participants | Hand | Foot |
|---|---|---|
| Response to Treatment | 8 | 9 |
Collected over 6 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hand Neuromodulation | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Foot Neuromodulation | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Age, Categorical(Participants) | Hand Neuromodulation | Foot Neuromodulation | Total |
|---|---|---|---|
| <=18 years | 12 | 14 | 26 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Hand Neuromodulation | Foot Neuromodulation | Total |
|---|---|---|---|
| Mean | 12 (8 to 17) | 12.1 (8 to 17) | 12 (8 to 17) |
| Sex/Gender, Customized(Participants) | Hand Neuromodulation | Foot Neuromodulation | Total |
|---|---|---|---|
| Gender — Male | 9 | 9 | 18 |
| Gender — Female | 3 | 4 | 7 |
| Gender — Did not identify | 0 | 1 | 1 |
| Race and Ethnicity Not Collected(Participants) | Hand Neuromodulation | Foot Neuromodulation | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Hand Neuromodulation | Foot Neuromodulation | Total |
|---|---|---|---|
| United States | 12 | 14 | 26 |
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