Defining the Safety and Efficacy of POSterIor Tibial NeRve StimulatiON in Children
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age5-21
SponsorChi Dang Hornik
About this trial
The purpose of this study is to find out if overactive bladder (OAB) can be safely treated by stimulating a nerve near the ankle. This procedure is called percutaneous tibial nerve stimulation (PTNS). It will be done by a device called the Urgent PC. The Urgent PC works by sending weak electrical signals through a thin needle to the nerve near the ankle. Stimulating this nerve may change bladder control.
Eligibility criteria
Qualifiers
Age 5-21 years old (inclusive)
Obtained legally effective informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization from the participant or the participant's parent/legal guardian/legally authorized representative (LAR)
Minor participant is willing and able to provide assent (as applicable)
History of primary or secondary non-neurogenic OAB as defined by a VDES score of ≥11 and a positive modified bother score within 30 days of consent
Disqualifiers
Known or apparent untreated anatomical abnormality of the lower urinary tract (e.g., untreated ureterocele)
Known neurogenic bladder (e.g., spina bifida, history of spinal cord injury, tethered cord)
Presence of local skin lesions (e.g., rash, skin infections) on the medial surfaces of both ankles at the time of consent
Metal implants in the medial ankle area
Trial design
Treatments tested in this trial
- Urgent PC
Treatment groups
50 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Chi Dang Hornik
Lead sponsor
Duke University
Sponsor institution
Duke Clinical Research Institute
Collaborator
The Emmes Company, LLC
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov