Stimulating Percutaneous Array for Urinary Reflex Control (SPARC) (NCT07149103) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Stimulating Percutaneous Array for Urinary Reflex Control (SPARC)
Australia40 participantsStarted 2025-08-29
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Willing and able to give informed consent for participation in the investigation
✓. Is aged 18 years or older
✓. Has been diagnosed with idiopathic overactive bladder (OAB) by a qualified urologist (FRACS) or gynaecologist (FRANZCOG)
✓. Eligibility is based on meeting the criteria for an OAB, defined by the International Continence Society as an average urinary frequency: ≥8 voids and ≥1 urgency episode (with or without incontinence) per 24 hours
✓. Clinically acceptable laboratory results within 30 days of enrolment Urinalysis: Dipstick (Leukocytes \& Nitrites)
✓. In the Investigator's opinion, participant is able and willing to comply with all trial requirements
✓. Willing to allow their general practitioner and/or other specialists to be aware of their participation in the trial.
Exclusion criteria
✕. Presence of urinary tract infection based on a positive dipstick AND positive mid-stream urine (MSU) test within 4 weeks prior to therapy commencement.
What they're measuring
1
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)