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
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 22 studies in Nocturnal Enuresis with a site in United States — 3 open to participants now, 4 under way, 1 of them phase 3. Nocturnal Enuresis · United States.
Among the 22 studies in Nocturnal Enuresis with a site in United States, this one is the 13th largest by enrollment of the 20 interventional ones that give a count, is one of 3 that started in 2016, is one of 17 with no phase, and was the 6th registered.
105 studies on the registry are indexed under Nocturnal Enuresis; 22 are open to participants now.
Browse Nocturnal Enuresis studies →3 of the 22 studies in Nocturnal Enuresis with a site in United States are open now. Recruiting first, the newest first:
Albany Medical College · Sites in United States
Ages 5–17
Uromedica · Sites in United States, France
Ages 22+ · Women only
Children's Hospital Los Angeles · Sites in United States
Ages 6–17
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 14 Nocturnal Enuresis studies recruiting now, 5 (36%) set no upper age limit and 9 (64%) stop at 75 or younger; 8 take children under 18; 2 take healthy volunteers.
This study: 5 Years to 18 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
22 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 3 started in 2016.
This study's enrollment of 27 is below the median of 66 across 77 interventional studies indexed under Nocturnal Enuresis.
Median enrollment 48 across the 20 interventional studies, 132 across the 2 observational. Of the 16 that completed or were terminated, 10 (63%) have results posted.
This tab as a report to print or save as PDF → With an account.
7 of 22 have an industry lead sponsor. The 10 most frequent:
Rajeev Chaudhry is the lead sponsor of 3 studies on the registry; none are open to participants now.
Rajeev Chaudhry has 1 study filed under Nocturnal Enuresis — fewer than ten, so there is no comparison to draw.
2 of the studies in Nocturnal Enuresis with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06135311Albany Medical CollegeOptimal Pulse Width Used in Transcutaneous Electrical Nerve Stimulation for Treating Nocturnal Enuresis in Children | 2026-12-31 |
| NCT04248283UromedicaAdjustable Continence Therapy (ACT) for the Treatment of Female SUI | 2027-05-31 |
Add all 2 to your calendar (.ics) → With an account.
Among the 22 studies in Nocturnal Enuresis with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
The record gives a start of Apr 2016, a primary completion of Dec 2021 and a completion of Dec 2021. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2023, 1 year 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.