Status:
NOT_YET_RECRUITING
Stimulating Percutaneous Array for Urinary Reflex Control (SPARC)
Lead Sponsor:
Australis Scientific PTY LTD
Conditions:
Over Active Bladder
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 clinic...
Eligibility Criteria
Inclusion
- 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
- 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)
- Poorly controlled diabetes mellitus (HbA1c \> 7.5% (based on diabetic study)
- Intravesical injection of botulinum toxin within 12 months of study enrolment.
- Patients who have failed intravesical Botox therapy.
- Patients with neurogenic lower urinary tract dysfunction or relevant neurological disease
- A treatment within the previous year of neuromodulation (TNS or sacral neuromodulation) for OAB.
- Participant with pacemakers or implantable defibrillators, or other active implantable devices (e.g., spinal cord stimulators, bladder neurostimulators)
- Participant who have participated in another research trial involving an investigational product in the past 12 weeks.
- Participant on medication therapy for OAB who have not gone through a two-week washout period during which time medications were discontinued.
- Participant is in the investigators opinion, unable to comply with trial requirements.
- Participant has inflamed, infected or otherwise compromised skin in the treatment area.
- Participant with a bleeding disorder e.g., haemophilia
Key Trial Info
Start Date :
August 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07149103
Start Date
August 29 2025
End Date
January 30 2026
Last Update
August 29 2025
Active Locations (2)
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1
Vincent Tse Pty Ltd
Chatswood, New South Wales, Australia, 2067
2
AndroUrology Centre
Spring Hill, Queensland, Australia, 4001