Clinical trial NCT06769854: Defining the Safety and Efficacy of POSterIor Tibial NeRve StimulatiON in Children
Official title: Defining the Safety and Efficacy of POSterIor Tibial NeRve StimulatiON in Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
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
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Duke Clinical Research Institute
name: The Emmes Company, LLC
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2025-01-10
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multi-center, single-arm cohort study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The frequency of select safety Events of Special Interest.
timeFrame: Weekly, Week 1 through Week 16
measure: Change in maximum voided volume on the Bladder Diary
timeFrame: Week 1, Week 12
Secondary outcomes:
measure: Proportion of children who experienced complete response, no response, or partial response on the Vancouver Dysfunctional Elimination Survey (VDES)
timeFrame: Screening, Weekly (Week 1 through Week 12)
measure: Change in OAB symptoms (Urgency, Frequency and Daytime Incontinence) reported on the VDES
timeFrame: Screening, Weekly (Week 1 through Week 12), Week 16, Week 36
measure: Proportion of children who develop a febrile UTI
timeFrame: Weekly, Week 1 through Week 12
measure: The change of Pediatric Incontinence Quality of Life (PINQ) score
timeFrame: Week 1, Week 6, Week 12, Week 16, and Week 36
measure: The percent of study visits attended within the protocol specified window from baseline through Week 12
timeFrame: Screening, Weekly (week 1 through week 12)
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Chi Hornik
role: PRINCIPAL_INVESTIGATOR
References: