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NOT YET RECRUITING
NCT07149103
NA

Stimulating Percutaneous Array for Urinary Reflex Control (SPARC)

Sponsor: Australis Scientific PTY LTD

View on ClinicalTrials.gov

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

Interventions

OTHER

Percutaneous Tibial Nerve Stimulation

By wearing the Confidanz Smart Patch, the Tibial Nerve will be stimulated

OTHER

Placebo

No active stimulation will be provided

Locations (2)

Vincent Tse Pty Ltd

Chatswood, New South Wales, Australia

AndroUrology Centre

Spring Hill, Queensland, Australia