Overactive BladderPhase 4POSITRON-CNCT06769854
Defining the Safety and Efficacy of POSterIor Tibial NeRve StimulatiON in Children
A Phase 4 study testing Urgent PC in people with Overactive Bladder and Overactive Bladder Syndrome, run by Chi Dang Hornik.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder, Overactive Bladder Syndrome
- What is being tested?
- Urgent PC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2027to 31 Oct 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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
- Being tested
- Urgent PC
- 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
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urinary Bladder Diseases, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urgent PCDevice
Also called Non-drug, non-surgical treatment for overactive bladder, PRC 26348 - V1.00
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.
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm Cohort | Experimental | Single Arm Cohort: (n=50) PTNS treatment weekly over 30 minutes for a total of 12 weekly sessions. Receives: Device: Urgent PC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Screening, Weekly (week 1 through week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start1 Apr 2027 (estimated)
- Primary completion31 May 2029 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multi-center, single-arm cohort study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chi Dang Hornik
- Sponsor type
- University, hospital or other
- Collaborators
- Duke Clinical Research Institute, The Emmes Company, LLC, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor-investigator, Chi Dang Hornik, Duke University
- Investigators
- Chi Hornik, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769854
- Sponsor's protocol ID
- Pro00114395
- Other IDs
- HHSN275201800003I
- Acronym
- POSITRON-C
- Status last verified
- Jun 2026
- First submitted
- 7 Jan 2025
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All data collected is uploaded into the National Institute of Health Data Repository (DASH) at the end of the study (de-identified).
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Safety and Efficacy of POSterIor Tibial NeRve StimulatiON in Children
- ClinicalTrials.gov ID
- NCT06769854
- Acronym / sponsor ID
- POSITRON-C / Pro00114395
- Conditions
- Overactive Bladder, Overactive Bladder Syndrome
- Keywords
- PTNS, Overactive Bladder, percutaneous tibial nerve stimulation, Urgent PC, urinary urgency, urinary incontinence, urinary frequency, OAB
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chi Dang HornikUniversity, hospital or other
- Collaborators
- Duke Clinical Research Institute, The Emmes Company, LLC, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multi-center, single-arm cohort study
| Arm | Type | Receives |
|---|---|---|
| Single-Arm Cohort | Experimental | Device: Urgent PCSingle Arm Cohort: (n=50) PTNS treatment weekly over 30 minutes for a total of 12 weekly sessions. |
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urgent PCAlso: Non-drug, non-surgical treatment for overactive bladder, PRC 26348 - V1.00PTNS 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. | Device | Single-Arm Cohort |
Primary outcome
The frequency of select safety Events of Special Interest.
Time frame: Weekly, Week 1 through Week 16
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
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.
5 secondary outcomes
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)
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
Proportion of children who develop a febrile UTI
Time frame: Weekly, Week 1 through Week 12
The change of Pediatric Incontinence Quality of Life (PINQ) score
Time frame: 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
Time frame: Screening, Weekly (week 1 through week 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: Yes. All data collected is uploaded into the National Institute of Health Data Repository (DASH) at the end of the study (de-identified).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chi Hornik principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Urgent PC in people with Overactive Bladder and Overactive Bladder Syndrome, run by Chi Dang Hornik.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Davy A Andersen, MHA (919-338-6429, davy.andersen@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of select safety Events of Special Interest. (time frame: Weekly, Week 1 through Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.