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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Percutaneous Tibial Nerve Stimulation
Other intervention
By wearing the Confidanz Smart Patch, the Tibial Nerve will be stimulated
Placebo
Other intervention
No active stimulation will be provided

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Treatment ArmExperimental treatment 1 intervention

Group B: SHAM ARMPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Number of AEs and SAEs occurring throughout the study

Time frame

Up to 12 weeks

Secondary outcomes

Change from baseline in average voids per day at 6- and 12-weeks.

To measure and compare average incontinence events (IE) per day at 6- and 12-weeks from baseline

Time frame

Up to 12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Australis Scientific PTY LTD

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: