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

NCT06769854 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-06-03

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Duke Clinical Research Institute

    collaborator OTHER

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Chi Dang Hornik

    lead OTHER

Principal Investigators

  • Chi Hornik · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2027-04-01
Primary Completion
2029-05-31
Completion
2029-10-31
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06769854 on ClinicalTrials.gov