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Stimulating Percutaneous Array for Urinary Reflex Control (SPARC)
Sponsor: Australis Scientific PTY LTD
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.
Official title: A Pilot Sham-Controlled Study to Evaluate the Safety and Efficacy of a Wearable Microneedle Percutaneous Neuromodulation System for Idiopathic Overactive Bladder and Urinary Incontinence
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-08-29
Completion Date
2026-01-30
Last Updated
2025-08-29
Healthy Volunteers
No
Conditions
Interventions
Percutaneous Tibial Nerve Stimulation
By wearing the Confidanz Smart Patch, the Tibial Nerve will be stimulated
Placebo
No active stimulation will be provided
Locations (2)
Vincent Tse Pty Ltd
Chatswood, New South Wales, Australia
AndroUrology Centre
Spring Hill, Queensland, Australia