NCT06769854

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Chi Dang Hornik · Academic / Other
• Sex: All
• Age: 5 Years – 21 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This study is a single-arm, open label, prospective, multicenter study of 50 participants aged 5-21 years with OAB. Participants will undergo outpatient PTNS sessions per routine clinical care using Urgent PC once weekly for 12 weeks. Patients, parents and clinicians will not be blinded to treatment or assessments during the study.

Conditions

• Overactive Bladder
• Overactive Bladder Syndrome

Interventions

Type	Name	Description
DEVICE	Urgent PC	PTNS is a technique of electrical neuromodulation used primarily for treating OAB. The procedure for PTNS consists of the insertion of a fine needle above the medial malleolus near the posterior tibial nerve followed by the application of low-voltage electrical stimulation that produces sensory and motor responses.

Timeline

• Start date: 2027-04-01
• Primary completion: 2029-05-31
• Completion: 2029-10-31
• First posted: 2025-01-10
• Last updated: 2025-06-03

Regulatory

• FDA-regulated device study