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

NCT06769854 | Not Yet Recruiting Phase 4 DMC FDA Device

• 2 other identifiers: Pro00114395HHSN275201800003I
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Overactive Bladder; Overactive Bladder Syndrome

Keywords

PTNS; Overactive Bladder; percutaneous tibial nerve stimulation; Urgent PC; urinary urgency; urinary incontinence; urinary frequency; OAB; urinary urge; Urinary Bladder; Urinary Bladder Diseases; Urologic Diseases; Pediatrics

Outcome Measures

Primary Outcomes (2)

• The frequency of select safety Events of Special Interest.

  1. Electrode site reaction (bruising, bleeding, hematoma, or persistent erythema at the electrode site) 2. Electrode site infection 3. Repeated post-void residual \>60 mL (at ≥ 2 consecutive visits) 4. Urinary tract infection 5. Urinary retention/obstruction 6. Toe numbness 7. Stomach and leg cramps

  Weekly, Week 1 through Week 16

• Change in maximum voided volume on the Bladder Diary

  The Bladder Diary is a paper diary recommended by the International Children's Continence Society that will be completed by the parent/guardian/LAR or participant. The Bladder Diary includes the following variables: fluid intake, number of voids, volume of voids, degree of urgency, number of incontinent episodes.

  Week 1, Week 12

Secondary Outcomes (5)

• Proportion of children who experienced complete response, no response, or partial response on the Vancouver Dysfunctional Elimination Survey (VDES)

  Screening, Weekly (Week 1 through Week 12)

• Change in OAB symptoms (Urgency, Frequency and Daytime Incontinence) reported on the VDES

  Screening, Weekly (Week 1 through Week 12), Week 16, Week 36

• Proportion of children who develop a febrile UTI

  Weekly, Week 1 through Week 12

• The change of Pediatric Incontinence Quality of Life (PINQ) score

  Week 1, Week 6, Week 12, Week 16, and Week 36

• The percent of study visits attended within the protocol specified window from baseline through Week 12

  Screening, Weekly (week 1 through week 12)

Study Arms (1)

Single-Arm Cohort

EXPERIMENTAL

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

Device: Urgent PC

Interventions

Urgent PC 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.

Also known as: Non-drug, non-surgical treatment for overactive bladder, PRC 26348 - V1.00

Single-Arm Cohort

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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)

Sponsors & Collaborators

• Chi Dang Hornik: lead
• Duke Clinical Research Institute: collaborator
• The Emmes Company, LLC: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence; Urinary Bladder Diseases; Urologic Diseases

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders

Study Officials

• Chi Hornik

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Davy A Andersen, MHA

CONTACT

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

Sharon Settles

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Model Details: Prospective, multi-center, single-arm cohort study

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 10, 2025
• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): October 31, 2029
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be uploaded to the repository within 2 years of study completion. It will be maintained in the repository indefinitely.
• Access Criteria: In order to have access, researchers have to complete a Data access request. NICHD will review the request and either approve or deny it. IRB approval must be obtained by the researcher to access the data. https://dash.nichd.nih.gov/Resource/DataRequestChecklist