Defining the Safety and Efficacy of POSterIor Tibial NeRve StimulatiON in Children (NCT06769854) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Defining the Safety and Efficacy of POSterIor Tibial NeRve StimulatiON in Children
50 participantsStarted 2027-04-01
Plain-language 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.
Who can participate
Age range5 Years – 21 Years
SexALL
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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
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
What they're measuring
1
The frequency of select safety Events of Special Interest.
Timeframe: Weekly, Week 1 through Week 16
2
Change in maximum voided volume on the Bladder Diary