Loading clinical trials...

Defining the Safety and Efficacy of POSterIor Tibial NeRve StimulatiON in Children | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE4

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

NCT06769854•Chi Dang Hornik

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.

Eligibility

Age

5 - 21 years

Sex

ALL

Healthy Volunteers

Yes

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
+7 more criteria

Key Dates

Start Date

April 1, 2027

Primary Completion Date

May 31, 2029

Completion Date

October 31, 2029

Last Updated

June 3, 2025

Enrollment

ESTIMATED participants

Conditions

Overactive BladderOveractive Bladder Syndrome

Interventions

Urgent PC

DEVICE

Contacts

Davy A Andersen, MHA

CONTACT

919-338-6429 davy.andersen@duke.edu

Sharon Settles

CONTACT

919-691-4593 sharon.settles@duke.edu

TReating Incontinence for Underlying Mental and Physical Health

NCT05362292

Urinary Incontinence, UrgeUrinary Incontinence+4 more

View study

RECRUITINGNA

INOPASE - Performance and Safety Study of a Personalised SNM System

NCT07193407

Overactive Bladder (OAB)

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

TReating Incontinence for Underlying Mental and Physical Health

INOPASE - Performance and Safety Study of a Personalised SNM System

Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)

Home Versus Office Removal of Percutaneous Nerve Evaluation (PNE) Lead

BTL Emsella Chair Versus Sham for the Treatment of Overactive Bladder

Urinary Microbiome Changes Following Administration of 500 mg of NDS-446 in Women With Dry OAB at 12 Weeks