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

Starting soon · Phase 4

Conditions studied: Overactive Bladder, Overactive Bladder Syndrome

In brief

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.

Key facts

Study ID

NCT06769854

Run by

Chi Dang Hornik

People needed

50

Starts

2027-04-01

Expected to finish

2029-10-31

Last updated by the study team

2026-06-17

Who can join

Age: 5 and older, up to 21. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• Has previously tried and failed standard urotherapy and at least one anticholinergic or beta-3 adrenergic agonist
• Adequate fluid intake for age as reported by participant or parent/legal guardian/LAR
• Micturition frequency of at least 8 times (mean)/day for at least 4 weeks prior to enrollment
• At least 1 daytime incontinence episode (mean)/day for at least 4 weeks prior to enrollment
• 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

You may not qualify if…

• 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
• Pacemakers or implantable defibrillators
• History of excessive bleeding
• Nerve damage that may impact the percutaneous tibial nerve or pelvic floor function
• History of chemodenervation of the bladder (e.g., via intravesical instillation or intradetrusor injection of botulinum toxin)
• Known current, untreated UTI
• Current or previous pregnancy at screening or planned pregnancy during the duration of the study, for females of childbearing potential
• Any condition that, in the judgment of the investigator or treating clinician, precludes participation because it could affect participant safety
• Previous treatment with this device or participation in this study or in any other study for the treatment of OAB
• High-grade vesicoureteral reflux (grades 4-5)
• Diagnosed diabetes insipidus (pituitary, nephrogenic, or acquired)
• Stage 4-5 chronic kidney disease (CKD) (since device may further disrupt or exacerbate abnormal urine flow)
• Significant post-void residual defined as >60 mL
• Initiation of or change of OAB treatment during screening or the duration of the study.

Full record on ClinicalTrials.gov

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