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NCT Number: NCT06769854

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

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.

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Overactive Bladder Syndrome Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

5 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • Significant post-void residual defined as >60 mL
  • Initiation of or change of OAB treatment during screening or the duration of the study.

Treatment and study plan

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.

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

Primary outcomes

  1. The frequency of select safety Events of Special Interest.

    Time frame: Weekly, Week 1 through Week 16

    • 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

  2. Change in maximum voided volume on the Bladder Diary

    Time frame: Week 1, Week 12

    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.

Secondary outcomes

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

    Time frame: Screening, Weekly (Week 1 through Week 12)

    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.

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

    Time frame: Screening, Weekly (Week 1 through Week 12), Week 16, Week 36

    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.

  3. Proportion of children who develop a febrile UTI

    Time frame: Weekly, Week 1 through Week 12

    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.

  4. The change of Pediatric Incontinence Quality of Life (PINQ) score

    Time frame: Week 1, Week 6, Week 12, Week 16, and Week 36

    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.

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

    Time frame: Screening, Weekly (week 1 through week 12)

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

Study contacts

Contact information is provided by the study sponsor or research team.

Davy A Andersen, MHA

CONTACT

[email protected]

919-338-6429

Sharon Settles

CONTACT

[email protected]

919-691-4593

Sponsors and collaborators

Lead sponsor

Chi Dang Hornik

Other

Collaborators

  • Duke Clinical Research Institute
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • The Emmes Company, LLC

Registry information

Acronym: POSITRON-C

Important dates

Study start
2027
Primary completion
2029
Study completion
2029
First posted
Jan 10, 2025
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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