Stimulating Percutaneous Array for Urinary Reflex Control (SPARC)
ConditionOver Active Bladder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAustralis Scientific PTY LTD
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Presence of urinary tract infection based on a positive dipstick AND positive mid-stream urine (MSU) test within 4 weeks prior to therapy commencement.
Female participant who is pregnant, lactating or planning pregnancy during the trial.
History of bladder augmentation/cystoplasty
Morbid obesity (BMI greater than 35)
Trial design
Treatments tested in this trial
- Percutaneous Tibial Nerve Stimulation
- Placebo
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov