search
Back to results

Pilot Study: Foot Neuromodulation for Nocturnal Enuresis in Children

Primary Purpose

Bedwetting

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NewTENS Design
Sponsored by
Heidi Stephany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bedwetting

Eligibility Criteria

5 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Children ages 5 to 16 years old without any specific nocturnal enuresisneurological, disorder or urinary tract infection.
  2. Currently having no daytime overactive bladder symptoms, i.e. urinary frequency, urgency, or daytime incontinence

Exclusion Criteria:

  1. Patients with nocturnal enuresis and day time symptoms will be excluded from this study.
  2. Children with known neurological disorders which may be contributing to nocturnal enuresis episodes
  3. Children who are not adequately potty trained
  4. Children with significant daytime symptoms of overactive bladder including frequency, urgency, and daytime incontinence
  5. Children who do not tolerate initial stimulation training session in the urology clinic upon enrollment
  6. Children with any implantable medical devices such as a pacemaker will be excluded from the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    New TENS design

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Night Time log
    Participants will complete a night time log to determine of the new design works at preventing night time wetting

    Full Information

    First Posted
    April 5, 2016
    Last Updated
    February 2, 2018
    Sponsor
    Heidi Stephany
    Collaborators
    CMI's Early-Stage Medical Technology Research and Development 2015 PILOT FUNDING PROGRAM
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02747810
    Brief Title
    Pilot Study: Foot Neuromodulation for Nocturnal Enuresis in Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    We have decided not to test the newly designed TENS device
    Study Start Date
    March 2016 (undefined)
    Primary Completion Date
    April 2017 (Actual)
    Study Completion Date
    April 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Heidi Stephany
    Collaborators
    CMI's Early-Stage Medical Technology Research and Development 2015 PILOT FUNDING PROGRAM

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bedwetting

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    New TENS design
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Device
    Intervention Name(s)
    NewTENS Design
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Questionnaire
    Description
    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.
    Time Frame
    2 weeks
    Secondary Outcome Measure Information:
    Title
    Night Time log
    Description
    Participants will complete a night time log to determine of the new design works at preventing night time wetting
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Heidi A Stephany, MD
    Organizational Affiliation
    University of Pittsburgh
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Pilot Study: Foot Neuromodulation for Nocturnal Enuresis in Children

    We'll reach out to this number within 24 hrs