Defining the Safety and Efficacy of POSterIor Tibial NeRve StimulatiON in Children

Exclusion Criteria

• •1. Known or apparent untreated anatomical abnormality of the lower urinary tract (e.g., untreated ureterocele)
• •2. Known neurogenic bladder (e.g., spina bifida, history of spinal cord injury, tethered cord)
• •3. Presence of local skin lesions (e.g., rash, skin infections) on the medial surfaces of both ankles at the time of consent
• •4. Metal implants in the medial ankle area
• •5. Pacemakers or implantable defibrillators
• •6. History of excessive bleeding
• •7. Nerve damage that may impact the percutaneous tibial nerve or pelvic floor function
• •8. History of chemodenervation of the bladder (e.g., via intravesical instillation or intradetrusor injection of botulinum toxin)
• •9. Known current, untreated UTI
• •10. Current or previous pregnancy at screening or planned pregnancy during the duration of the study, for females of childbearing potential
• •11. Any condition that, in the judgment of the investigator or treating clinician, precludes participation because it could affect participant safety
• •12. Previous treatment with this device or participation in this study or in any other study for the treatment of OAB
• •13. High-grade vesicoureteral reflux (grades 4-5)
• •14. Diagnosed diabetes insipidus (pituitary, nephrogenic, or acquired)
• •15. Stage 4-5 chronic kidney disease (CKD) (since device may further disrupt or exacerbate abnormal urine flow)
• •16. Significant post-void residual defined as \>60 mL
• •17. Initiation of or change of OAB treatment during screening or the duration of the study.