Defining the Safety and Efficacy of POSterIor Tibial NeRve StimulatiON in Children (POSITRON-C)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Overactive Bladder; Overactive Bladder Syndrome
• Intervention / Treatment: Device: Urgent PC

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Davy A Andersen, MHA; Phone Number: 919-338-6429; Email: davy.andersen@duke.edu
• Study Contact Backup: Name: Sharon Settles; Phone Number: 919-691-4593; Email: sharon.settles@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The frequency of select safety Events of Special Interest.	Electrode site reaction (bruising, bleeding, hematoma, or persistent erythema at the electrode site); Electrode site infection; Repeated post-void residual >60 mL (at ≥ 2 consecutive visits); Urinary tract infection; Urinary retention/obstruction; Toe numbness; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of children who experienced complete response, no response, or partial response on the Vancouver Dysfunctional Elimination Survey (VDES)	The VDES is a validated questionnaire that was developed for diagnosing dysfunctional elimination syndrome. The survey uses a five-point Likert scale to score symptoms of bladder dysfunction. Each question is scored on a scale of 0-4, with 0 indicating no complaints and 4 indicating severe symptoms. The total score ranges from 0-52, with higher scores indicating more severe symptoms. The question about voiding frequency is scored differently from the other questions. A neutral choice of five to six urination per day is scored as 0. A urinary frequency of one to two times or more than eight times a day is scored as 4. A urinary frequency of three or four and seven or eight times a day is scored as 2. A cutoff score of 11 is used for patients and 9 for parents to diagnose dysfunctional voiding. The VDES is completed by the parent/legal guardian if participants are < 9 years old and by participants if they are ≥ 9 years old.	Screening, Weekly (Week 1 through Week 12)
Change in OAB symptoms (Urgency, Frequency and Daytime Incontinence) reported on the VDES	Change in OAB symptoms will be evaluated from the symptom questions on the VDES survey assessing Urgency, Frequency and Daytime Incontinence. The survey uses a five-point Likert scale to score symptoms of bladder dysfunction. Each question is scored on a scale of 0-4, with 0 indicating no complaints and 4 indicating severe symptoms. The total score ranges from 0-52, with higher scores indicating more severe symptoms. The question about voiding frequency is scored differently from the other questions. A neutral choice of five to six urination per day is scored as 0. A urinary frequency of one to two times or more than eight times a day is scored as 4. A urinary frequency of three or four and seven or eight times a day is scored as 2. A cutoff score of 11 is used for patients and 9 for parents to diagnose dysfunctional voiding. The VDES is completed by the parent/legal guardian if participants are < 9 years old and by participants if they are ≥ 9 years old.	Screening, Weekly (Week 1 through Week 12), Week 16, Week 36
Proportion of children who develop a febrile UTI	Febrile UTI occurrence, defined as: • Fever > 101.5°F (> 38.6°C); and >50,000 colony forming units (CFU)/mL of 1 or more speciated organisms; and 10 white blood cells per higher power field (WBC/HPF) on urine microscopy and/or leucocyte esterase > 2+ on dipstick; and At least 1 of the following symptoms: Gross hematuria (defined as pink or red urine, not a spot of blood on a catheter) OR Abdominal, suprapubic, or flank pain or tenderness OR New or worsening incontinence OR New or worsening urinary urgency, frequency, or hesitancy OR Nausea/vomiting OR Pain with urination OR Malodorous/cloudy urine.	Weekly, Week 1 through Week 12
The change of Pediatric Incontinence Quality of Life (PINQ) score	The Pediatric Incontinence Quality of Life (PINQ) is a 20-item, self-reported questionnaire that evaluates the QoL of children who have urinary incontinence. Each item is scored on a 5-point Likert scale, with 1 being "no" and 5 being "always". The total score ranges from 20 to 100 points. A higher score indicates a better QoL that is less affected by urinary symptoms. The PINQ is validated for use in children 6-17 years old and has been used in studies of participants up to 30 years old.21,25 The PINQ will be completed by the parent/legal guardian/LAR if participants are < 9 years old and by participants if they are ≥ 9 years old.	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	The percent of study visits attended within the protocol specified window from baseline through Week 12	Screening, Weekly (week 1 through week 12)

Collaborators and Investigators

• Sponsor: Chi Dang Hornik
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Duke Clinical Research Institute; The Emmes Company, LLC
• Investigators: Principal Investigator: Chi Hornik, Duke University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): October 31, 2029

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: January 7, 2025
• First Posted (Actual): January 10, 2025

Study Record Updates

• Last Update Posted (Actual): June 3, 2025
• Last Update Submitted That Met QC Criteria: May 29, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Pediatrics; Overactive Bladder; Urologic Diseases; OAB; urinary incontinence; Urinary Bladder; urinary urge; urinary frequency; urinary urgency; PTNS; Urinary Bladder Diseases; Urgent PC; percutaneous tibial nerve stimulation
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder Diseases; Urinary Bladder, Overactive
• Other Study ID Numbers: Pro00114395; HHSN275201800003I (Other Grant/Funding Number: National Institute of Child Health and Human Development)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data collected is uploaded into the National Institute of Health Data Repository (DASH) at the end of the study (de-identified).
• IPD Sharing Time Frame: Data will be uploaded to the repository within 2 years of study completion. It will be maintained in the repository indefinitely.
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No