Clinical Trial

Stimulating Percutaneous Array for Urinary Reflex Control (SPARC)

Not Yet Recruiting
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Record status
This record was last updated August 29, 2025 (before its estimated January 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
The Confidanz Smart Patch System consists of a Smart Patch containing one transcutaneous gel electrode and one percutaneous microneedle array electrode that sits directly superficial to the posterior tibial nerve. An applicator is used by the patient to deploy the microneedles into the skin. A Capital Stimulation Unit (CSU) is magnetically aligned with the Smart Patch and generates biphasic current wave form to the posterior tibial nerve through the patch. The CSU is connected to a mobile application via Bluetooth, allowing control over the stimulation intensity parameters. Primary Objective: To investigate the safety of the Confidanz Smart Patch System for adults diagnosed with idiopathic overactive bladder. Secondary Objective: To measure the reduction from baseline in average incontinence events (IE) per day at 6- and 12-weeks. Primary Hypothesis: The use of the Confidanz Smart Patch System is safe for use in adults with idiopathic overactive bladder.
Trial Details
NCT Number NCT07149103
Lead Sponsor Australis Scientific PTY LTD
Conditions Over Active Bladder
Enrollment 40 participants
Start Date 2025-08-29
Primary Completion 2026-01-30 (estimated)
Study Completion 2026-01-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-29