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

NCT ID: NCT06769854

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2027-04-01
• Study Completion Date: 2029-10-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single-Arm Cohort

Single Arm Cohort: (n=50) PTNS treatment weekly over 30 minutes for a total of 12 weekly sessions.

Group Type: EXPERIMENTAL

Urgent PC

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Non-drug, non-surgical treatment for overactive bladder; PRC 26348 - V1.00

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke Clinical Research Institute

OTHER

Sponsor Role: collaborator

The Emmes Company, LLC

INDUSTRY

Sponsor Role: collaborator

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

NIH

Sponsor Role: collaborator

Chi Dang Hornik

OTHER

Sponsor Role: lead

Responsible Party

Chi Dang Hornik

Associate Professor of Pediatrics

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Chi Hornik

Role: PRINCIPAL_INVESTIGATOR

Duke University

Central Contacts

Davy A Andersen, MHA

Role: CONTACT

davy.andersen@duke.edu

919-338-6429

Sharon Settles

Role: CONTACT

sharon.settles@duke.edu

919-691-4593

Other Identifiers

HHSN275201800003I

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pro00114395

Identifier Type: -

Identifier Source: org_study_id