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

Chi Dang Hornik

Status and phase: Begins enrollment in a year or more; Phase 4

Conditions: Overactive Bladder Syndrome; Overactive Bladder

Treatments: Device: Urgent PC

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT06769854

HHSN275201800003I (Other Grant/Funding Number)

Pro00114395

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 5 to 21 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Single-Arm Cohort

Experimental group

Description:

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

Treatment:

Device: Urgent PC