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Stimulating Percutaneous Array for Urinary Reflex Control (SPARC)

NCT07149103 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-08-29

No results posted yet for this study

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.

Conditions

  • Over Active Bladder

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

Sponsors & Collaborators

  • Australis Scientific PTY LTD

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-29
Primary Completion
2026-01-30
Completion
2026-01-30

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07149103 on ClinicalTrials.gov