BedwettingNCT02747810
Pilot Study: Foot Neuromodulation for Nocturnal Enuresis in Children
A study testing NewTENS Design in people with Bedwetting, run by Heidi Stephany.
Trial summary
Background: Previous animal model studies at the University of Pittsburgh have shown a significant impact on inhibiting bladder over activity and increasing bladder capacity with neuromodulation techniques, specifically tibial nerve stimulation. Read more about this study
- Who is it for?
- Ages 5 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Bedwetting
- What is being tested?
- NewTENS Design
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children ages 5 to 16 years old without any specific nocturnal enuresisneurological, disorder or urinary tract infection.
- Currently having no daytime overactive bladder symptoms, i.e. urinary frequency, urgency, or daytime incontinence
Who cannot join
- Patients with nocturnal enuresis and day time symptoms will be excluded from this study.
- Children with known neurological disorders which may be contributing to nocturnal enuresis episodes
- 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
About this study
Background: Previous animal model studies at the University of Pittsburgh have shown a significant impact on inhibiting bladder over activity and increasing bladder capacity with neuromodulation techniques, specifically tibial nerve stimulation. This has been translated into adult clinical trials through the department of urology. Through the use of a commercially available subcutaneous nerve stimulator placed on the dorsum of the foot, researchers were able to demonstrate a significant increase in bladder capacity and the delay of voiding sensation for up to 5 hours after stimulation in eight healthy subjects. This prompted the clinical trial approved under IRB PRO13020474 which is currently enrolling patients.
The incidence of night-time overactive bladder leading to nocturnal enuresis (bed wetting) is very common in the pediatric and teenage population, particularly in patients without daytime bladder over activity symptoms. When behavioral modification (i.e. refraining from night-time fluid consumption and bladder irritants, and bed wetting alarms for timed voiding) fails which it often does there is a paucity of effective and safe treatment options. Medications can be tried, but generally these are from the tricyclic antidepressant family and carry significant side effects limiting the use.
Aim: Researchers aim to utilize the same technology currently being studied under IRB PRO14080250. Electrical stimulation will be applied to the foot via skin surface electrodes for a minimum of 1 hour before bed for 2 weeks to 5 normal subjects. Normal Subjects will be asked to complete a questionnaire about any skin irritation or experiences of toe twitching while wearing the newly designed TENS device, during a return visit with Dr. Stephany. The primary outcomes of this study are safety and functionality of the New TENS unit
Read the detailed description
Nocturnal Enuresis is a very common and difficult to treat problem in the pediatric population which can have significant negative impact on a child's quality of life. Apart from medications which can have significant side effects limiting the use, there is a lack of effective and safe treatment options for children with frequent nocturnal enuresis. If foot stimulation prior to bed does indeed improve the frequency of nocturnal enuresis, it may provide a safe and non-invasive therapeutic option.
To achieve the aims Dr. Tai will work closely with Dr. Sun and Dr. Jia to design and develop a small, inexpensive, and easy-to-use stimulator for foot neuromodulation, and test its safety and usability in 5 healthy subjects for a 2-week period. . The straps in the design have three functions: 1) making an electrical connection to electrode, 2) securing the insole and the electronic unit, and 3) facilitating observation and hand access to the top panel for adjusting the stimulation strength.
- Conditions
- Bedwetting
- Being tested
- NewTENS Design
- Medical subject headings
- Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NewTENS DesignDevice
This device functions the same as the FDA approved TENS unit, but provides a small, inexpensive unit that will be easy for a child to use. 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 also be instructed how to use the stimulator and where to attach the electrodes on the foot at the beginning of the study. The investigator will provide the stimulator and electrodes. The subjects will be asked to wear socks 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 in the evening prior to bedtime at home for two weeks. They will be encouraged to use the stimulator for more time than the minimum as long as they accurately record the total duration.
| Study group | Role | What they receive |
|---|---|---|
| New TENS design | Experimental | To determine the function and safety of the strap design by evaluating the electrical connection to electrode, 2) the security in the insole and the electronic unit, and 3) facilitating observation and hand access to the top panel for adjusting the stimulation strength. 4) to elicit toe twitching with stimulation of tribal nerve Receives: Device: NewTENS Design |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire
Subjects will be asked to record the intensity at which they see the big toe twitching and where they keep the intensity over the hour of stimulation. They will also record if any issues with the unit or any side effects, such as pain or foot irritation. They will document the time of starting and finishing stimulation.
Measured: 2 weeks
Secondary outcomes (1)
Night Time log
Participants will complete a night time log to determine of the new design works at preventing night time wetting
Measured: 2 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 startMar 2016
- Primary completionApr 2017
- Study completionApr 2017
Why it stopped: We have decided not to test the newly designed TENS device
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidi Stephany
- Sponsor type
- University, hospital or other
- Collaborators
- CMI's Early-Stage Medical Technology Research and Development 2015 PILOT FUNDING PROGRAM
- Responsible party
- Sponsor-investigator, Heidi Stephany, University of Pittsburgh
- Investigators
- Heidi A Stephany, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747810
- Sponsor's protocol ID
- PRO15070130
- Status last verified
- Feb 2018
- First submitted
- 5 Apr 2016
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Foot Neuromodulation for Nocturnal Enuresis in Children
- ClinicalTrials.gov ID
- NCT02747810
- Acronym / sponsor ID
- PRO15070130
- Conditions
- Bedwetting
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We have decided not to test the newly designed TENS device
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Heidi StephanyUniversity, hospital or other
- Collaborators
- CMI's Early-Stage Medical Technology Research and Development 2015 PILOT FUNDING PROGRAM
- Study start
- Mar 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Previous animal model studies at the University of Pittsburgh have shown a significant impact on inhibiting bladder over activity and increasing bladder capacity with neuromodulation techniques, specifically tibial nerve stimulation. This has been translated into adult clinical trials through the department of urology. Through the use of a commercially available subcutaneous nerve stimulator placed on the dorsum of the foot, researchers were able to demonstrate a significant increase in bladder capacity and the delay of voiding sensation for up to 5 hours after stimulation in eight healthy subjects. This prompted the clinical trial approved under IRB PRO13020474 which is currently enrolling patients.
The incidence of night-time overactive bladder leading to nocturnal enuresis (bed wetting) is very common in the pediatric and teenage population, particularly in patients without daytime bladder over activity symptoms. When behavioral modification (i.e. refraining from night-time fluid consumption and bladder irritants, and bed wetting alarms for timed voiding) fails which it often does there is a paucity of effective and safe treatment options. Medications can be tried, but generally these are from the tricyclic antidepressant family and carry significant side effects limiting the use.
Aim: Researchers aim to utilize the same technology currently being studied under IRB PRO14080250. Electrical stimulation will be applied to the foot via skin surface electrodes for a minimum of 1 hour before bed for 2 weeks to 5 normal subjects. Normal Subjects will be asked to complete a questionnaire about any skin irritation or experiences of toe twitching while wearing the newly designed TENS device, during a return visit with Dr. Stephany. The primary outcomes of this study are safety and functionality of the New TENS unit
Detailed description
Nocturnal Enuresis is a very common and difficult to treat problem in the pediatric population which can have significant negative impact on a child's quality of life. Apart from medications which can have significant side effects limiting the use, there is a lack of effective and safe treatment options for children with frequent nocturnal enuresis. If foot stimulation prior to bed does indeed improve the frequency of nocturnal enuresis, it may provide a safe and non-invasive therapeutic option.
To achieve the aims Dr. Tai will work closely with Dr. Sun and Dr. Jia to design and develop a small, inexpensive, and easy-to-use stimulator for foot neuromodulation, and test its safety and usability in 5 healthy subjects for a 2-week period. . The straps in the design have three functions: 1) making an electrical connection to electrode, 2) securing the insole and the electronic unit, and 3) facilitating observation and hand access to the top panel for adjusting the stimulation strength.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New TENS design | Experimental | Device: NewTENS DesignTo determine the function and safety of the strap design by evaluating the electrical connection to electrode, 2) the security in the insole and the electronic unit, and 3) facilitating observation and hand access to the top panel for adjusting the stimulation strength. 4) to elicit toe twitching with stimulation of tribal nerve |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children ages 5 to 16 years old without any specific nocturnal enuresisneurological, disorder or urinary tract infection.
- Currently having no daytime overactive bladder symptoms, i.e. urinary frequency, urgency, or daytime incontinence
Key exclusion criteria (6 listed)
- Patients with nocturnal enuresis and day time symptoms will be excluded from this study.
- Children with known neurological disorders which may be contributing to nocturnal enuresis episodes
- 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
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 |
|---|---|---|
| NewTENS DesignThis device functions the same as the FDA approved TENS unit, but provides a small, inexpensive unit that will be easy for a child to use. 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 also be instructed how to use the stimulator and where to attach the electrodes on the foot at the beginning of the study. The investigator will provide the stimulator and electrodes. The subjects will be asked to wear socks 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 in the evening prior to bedtime at home for two weeks. They will be encouraged to use the stimulator for more time than the minimum as long as they accurately record the total duration. | Device | New TENS design |
Primary outcome
Questionnaire
Time frame: 2 weeks
Subjects will be asked to record the intensity at which they see the big toe twitching and where they keep the intensity over the hour of stimulation. They will also record if any issues with the unit or any side effects, such as pain or foot irritation. They will document the time of starting and finishing stimulation.
1 secondary outcome
Night Time log
Time frame: 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
- 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.
Heidi A Stephany, MD principal investigator
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
A study testing NewTENS Design in people with Bedwetting, run by Heidi Stephany.
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 2 inclusion and 6 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: withdrawn, as of the sponsor's last update on 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Questionnaire (time frame: 2 weeks). 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 6 Feb 2018.