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

Launched by CHI DANG HORNIK · Jan 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for children and young adults aged 5 to 21 who have overactive bladder (OAB), a condition that causes frequent and sometimes uncontrollable urges to urinate. The treatment being tested is called percutaneous tibial nerve stimulation (PTNS), which involves a small device that sends gentle electrical signals through a thin needle to a nerve near the ankle. This stimulation aims to improve bladder control and reduce symptoms of OAB.

To participate in the trial, individuals must meet certain criteria, such as having tried other treatments for their OAB without success and experiencing a high number of urination episodes each day. Participants will receive the PTNS treatment and will be monitored for its safety and effectiveness. It's important to note that some individuals, like those with certain medical conditions or who have had specific bladder treatments before, may not be eligible for this study. Overall, the trial aims to explore a new approach to help manage OAB in children and young adults.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 5-21 years old (inclusive)
• • 2. 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)
• • 3. Minor participant is willing and able to provide assent (as applicable)
• • 4. 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
• • 5. Has previously tried and failed standard urotherapy and at least one anticholinergic or beta-3 adrenergic agonist
• • 6. Adequate fluid intake for age as reported by participant or parent/legal guardian/LAR
• • 7. Micturition frequency of at least 8 times (mean)/day for at least 4 weeks prior to enrollment
• • 8. At least 1 daytime incontinence episode (mean)/day for at least 4 weeks prior to enrollment
• • 9. If on allowed treatment for OAB, stable dose for at least 30 days prior to screening and willingness to continue that dose for the duration of the study
• 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.