BedwettingNCT02747849
Hand & Foot Nocturnal Enuresis TENS Study
A study testing TENS in people with Bedwetting, run by Rajeev Chaudhry at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Bedwetting
- What is being tested?
- TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children ages 5 to 18 years old without any specific neurological disorder or urinary tract infection, clinically diagnosed as having nocturnal enuresis AT LEAST 4 episodes per month by history, nocturnal enuresis is a DSM V diagnosable medical condition
- Currently having no daytime overactive bladder symptoms, i.e. urinary frequency, urgency, or daytime incontinence
- Having been assessed for and treated if applicable for behavioral etiologies of nocturnal enuresis - consuming excess fluids or specific bladder irritants
- Having been assessed for and treated if applicable for constipation
Who cannot join
- Children with known neurological disorders which may be contributing to nocturnal enuresis episodes
- Children found through history to have significant behavioral causes of nocturnal enuresis including consumption of excessive fluids or known bladder irritants
- Children with chronic constipation who are non-compliant with previous pharmacologic efforts to treat.
- Children who are not adequately potty trained
- Children with significant daytime symptoms of overactive bladder including frequency, urgency, and daytime incontinence
- Children who do not tolerate initial stimulation training session in the urology clinic upon enrollment
- Children with any implantable medical devices such as a pacemaker will be excluded from the study
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Pittsburgh og UPMC
Pittsburgh, Pennsylvania, 15224
About this study
Official title: Pilot Study: Hand & Foot Neuromodulation for Nocturnal Enuresis in Children
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.
Read the detailed description
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.
- Conditions
- Bedwetting
- Being tested
- TENS
- Medical subject headings
- Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Hand neuromodulation | Placebo comparator | 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. Receives: Device: TENS |
| Foot Neuromodulation | Active comparator | 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. Receives: Device: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Response to Treatment
Total number of participants that responded to treatment after stimulation with Hand or Foor unit.
Measured: An average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BedwettingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rajeev Chaudhry
- Sponsor type
- University, hospital or other
- Collaborators
- The Coulter Foundation
- Responsible party
- Sponsor-investigator, Rajeev Chaudhry, University of Pittsburgh
- Investigators
- Rajeev Chaudhry, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747849
- Sponsor's protocol ID
- Pro15120157
- Status last verified
- Mar 2023
- First submitted
- 5 Apr 2016
- Last updated
- 21 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Hand & Foot Neuromodulation for Nocturnal Enuresis in Children
- ClinicalTrials.gov ID
- NCT02747849
- Acronym / sponsor ID
- Pro15120157
- Conditions
- Bedwetting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Rajeev ChaudhryUniversity, hospital or other
- Collaborators
- The Coulter Foundation
- Study start
- Apr 2016
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Posted 21 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand neuromodulation | Placebo comparator | Device: TENSThe 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. |
| Foot Neuromodulation | Active comparator | Device: TENSThe 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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Children ages 5 to 18 years old without any specific neurological disorder or urinary tract infection, clinically diagnosed as having nocturnal enuresis AT LEAST 4 episodes per month by history, nocturnal enuresis is a DSM V diagnosable medical condition
- Currently having no daytime overactive bladder symptoms, i.e. urinary frequency, urgency, or daytime incontinence
- Having been assessed for and treated if applicable for behavioral etiologies of nocturnal enuresis - consuming excess fluids or specific bladder irritants
- Having been assessed for and treated if applicable for constipation
Key exclusion criteria (8 listed)
- Children with known neurological disorders which may be contributing to nocturnal enuresis episodes
- Children found through history to have significant behavioral causes of nocturnal enuresis including consumption of excessive fluids or known bladder irritants
- Children with chronic constipation who are non-compliant with previous pharmacologic efforts to treat.
- Children who are not adequately potty trained
- Children with significant daytime symptoms of overactive bladder including frequency, urgency, and daytime incontinence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TENSPlacebo 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. | Device | Foot Neuromodulation, Hand neuromodulation |
Primary outcome
Change in Number of Nights Wet Per 2 Weeks
Time frame: 6 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
Response to Treatment
Time frame: An average of 6 weeks
Total number of participants that responded to treatment after stimulation with Hand or Foor unit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajeev Chaudhry, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS in people with Bedwetting, run by Rajeev Chaudhry at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Number of Nights Wet Per 2 Weeks (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.