Over Active BladderNCT07149103
Stimulating Percutaneous Array for Urinary Reflex Control (SPARC)
A study testing Percutaneous Tibial Nerve Stimulation in people with Over Active Bladder, run by Australis Scientific PTY LTD at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Over Active Bladder
- What is being tested?
- Percutaneous Tibial Nerve Stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesAustralia
- Study dates
- 29 Aug 2025to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites
Vincent Tse Pty Ltd
Chatswood, New South Wales, 2067
Wing Ming Vincent TSE, PROFESSOR, 61 410 482 838, vwmtse@gmail.com
AndroUrology Centre
Spring Hill, Queensland, 4001
Eric Chung, PROFESSOR, 61 (07) 38321168, ericchg@hotmail.com
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Over Active Bladder
- Being tested
- Percutaneous Tibial Nerve Stimulation, Placebo
- Keywords
- Over active bladder, Incontinence, Ideopathic Over active bladder, Percutaneous Tibial Nerve Stimulation (PTNS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Tibial Nerve StimulationOther
By wearing the Confidanz Smart Patch, the Tibial Nerve will be stimulated
PlaceboOther
No active stimulation will be provided
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | The treatment arm will undergo the experimental treatment Receives: Other: Percutaneous Tibial Nerve Stimulation |
| SHAM ARM | Placebo comparator | The sham arm will undergo the same procedure as the treatment group but the therapy will not be switched on Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of AEs and SAEs occurring throughout the study
Measured: Up to 12 weeks
Secondary outcomes (1)
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
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start29 Aug 2025 (estimated)
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Over Active BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Australis Scientific PTY LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149103
- Sponsor's protocol ID
- CP-001
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07149103
- Acronym / sponsor ID
- CP-001
- Conditions
- Over Active Bladder
- Keywords
- Over active bladder, Incontinence, Ideopathic Over active bladder, Percutaneous Tibial Nerve Stimulation (PTNS)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Australis Scientific PTY LTDIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2025 (estimated)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Other: Percutaneous Tibial Nerve StimulationThe treatment arm will undergo the experimental treatment |
| SHAM ARM | Placebo comparator | Other: PlaceboThe sham arm will undergo the same procedure as the treatment group but the therapy will not be switched on |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Tibial Nerve StimulationBy wearing the Confidanz Smart Patch, the Tibial Nerve will be stimulated | Other | Treatment Arm |
| PlaceboNo active stimulation will be provided | Other | SHAM ARM |
Primary outcome
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 12 weeks
Number of AEs and SAEs occurring throughout the study
1 secondary outcome
Change from baseline in average voids per day at 6- and 12-weeks.
Time frame: Up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers.
Related trials for Over Active Bladder
Enrolling by invitationObservational study
Autologous Platelet Concentrate Bladder Injection for Refractory Overactive Bladder
Over Active Bladder
Recruiting
Electroacupuncture as a Treatment for Refractory Overactive Bladder
Over Active Bladder, Urinary Incontinence (UI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Tibial Nerve Stimulation in people with Over Active Bladder, run by Australis Scientific PTY LTD at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nigel D'Silva (+61466411877, nigel.dsilva@australisscientific.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.