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

Phase 4

Not yet recruiting

• Conditions: Overactive Bladder; Overactive Bladder Syndrome

• Registration Number: NCT06769854
• Lead Sponsor: Chi Dang Hornik

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.

Study Timeline

• Study First Submitted: 2025-01-07
• Study First Submitted QC: 2025-01-07
• Study First Posted: 2025-01-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-29
• Last Update Posted: 2025-06-03
• Study Start: 2027-04-01
• Primary Completion: 2029-05-31
• Study Completion: 2029-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The frequency of select safety Events of Special Interest.	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	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 Outcome Measures

Name	Time	Method
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)	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.
Change in OAB symptoms (Urgency, Frequency and Daytime Incontinence) reported on the VDES	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.
Proportion of children who develop a febrile UTI	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.
The change of Pediatric Incontinence Quality of Life (PINQ) score	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.
The percent of study visits attended within the protocol specified window from baseline through Week 12	Screening, Weekly (week 1 through week 12)	The percent of study visits attended within the protocol specified window from baseline through Week 12