Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-02-24 @ 3:13 PM
Study NCT ID:
NCT07149103
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-29
First Post:
2025-08-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stimulating Percutaneous Array for Urinary Reflex Control (SPARC)
Sponsor:
Australis Scientific PTY LTD
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
The Clinical Trial is a Randomised, single-blinded, sham-controlled study designed to assess the safety and performance of the Confidanz Smart Patch System for home-based intermittent use under clinical supervision, in patients with overactive bladder systems. Participant screening will occur at least 3-days prior to the baseline visit in the clinic. Participants who meet all the inclusion criteria and none of the exclusion criteria will be enrolled. Up to 40 participants will be enrolled in this clinical investigation. A computer-generated sequence will be created using a block randomisation method, participants will be randomised in a 3:1 fashion.
At the baseline visit, the investigator or study staff member will train the participant on the correct use of the device. At-home weekly treatments will be conducted for 12 weeks, here the patient will apply the Smart Patch and initiate a 30-minute stimulation session through the mobile application. The treatment arm will receive stimulation, whereas the control arm will not. Symptom tracking and adverse events will be recorded.
A maximum total of 12 weekly treatments will be conducted. At baseline, 6 and 12 weeks, a 3-day bladder diary, International Consultation on Incontinence Questionnaire (ICIQ), the Overactive Bladder Symptom Score (OABSS), Short Form Survey SF-12, Patient Global Impression of Change (PGI-C), VAS pain scale, and participant decision-making and feedback questionnaire will be administered in the clinic.
At the baseline visit, the investigator or study staff member will train the participant on the correct use of the device. At-home weekly treatments will be conducted for 12 weeks, here the patient will apply the Smart Patch and initiate a 30-minute stimulation session through the mobile application. The treatment arm will receive stimulation, whereas the control arm will not. Symptom tracking and adverse events will be recorded.
A maximum total of 12 weekly treatments will be conducted. At baseline, 6 and 12 weeks, a 3-day bladder diary, International Consultation on Incontinence Questionnaire (ICIQ), the Overactive Bladder Symptom Score (OABSS), Short Form Survey SF-12, Patient Global Impression of Change (PGI-C), VAS pain scale, and participant decision-making and feedback questionnaire will be administered in the clinic.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: