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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07149103




Registration number
NCT07149103
Ethics application status
Date submitted
21/08/2025
Date registered
29/08/2025
Date last updated
29/08/2025

Titles & IDs
Public title
Stimulating Percutaneous Array for Urinary Reflex Control (SPARC)
Scientific 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
Secondary ID [1] 0 0
CP-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Over Active Bladder 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Percutaneous Tibial Nerve Stimulation
Other interventions - Placebo

Experimental: Treatment Arm - The treatment arm will undergo the experimental treatment

Placebo comparator: SHAM ARM - The sham arm will undergo the same procedure as the treatment group but the therapy will not be switched on


Other interventions: Percutaneous Tibial Nerve Stimulation
By wearing the Confidanz Smart Patch, the Tibial Nerve will be stimulated

Other interventions: Placebo
No active stimulation will be provided
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Up to 12 weeks
Secondary outcome [1] 0 0
Change from baseline in average voids per day at 6- and 12-weeks.
Timepoint [1] 0 0
Up to 12 weeks

Eligibility
Key inclusion criteria
1. Willing and able to give informed consent for participation in the investigation
2. Is aged 18 years or older
3. Has been diagnosed with idiopathic overactive bladder (OAB) by a qualified urologist (FRACS) or gynaecologist (FRANZCOG)
4. 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
5. Clinically acceptable laboratory results within 30 days of enrolment Urinalysis: Dipstick (Leukocytes & Nitrites)
6. In the Investigator's opinion, participant is able and willing to comply with all trial requirements
7. Willing to allow their general practitioner and/or other specialists to be aware of their participation in the trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Presence of urinary tract infection based on a positive dipstick AND positive mid-stream urine (MSU) test within 4 weeks prior to therapy commencement.
2. Female participant who is pregnant, lactating or planning pregnancy during the trial.
3. History of bladder augmentation/cystoplasty
4. Morbid obesity (BMI greater than 35)
5. Poorly controlled diabetes mellitus (HbA1c > 7.5% (based on diabetic study)
6. Intravesical injection of botulinum toxin within 12 months of study enrolment.
7. Patients who have failed intravesical Botox therapy.
8. Patients with neurogenic lower urinary tract dysfunction or relevant neurological disease
9. A treatment within the previous year of neuromodulation (TNS or sacral neuromodulation) for OAB.
10. Participant with pacemakers or implantable defibrillators, or other active implantable devices (e.g., spinal cord stimulators, bladder neurostimulators)
11. Participant who have participated in another research trial involving an investigational product in the past 12 weeks.
12. Participant on medication therapy for OAB who have not gone through a two-week washout period during which time medications were discontinued.
13. Participant is in the investigators opinion, unable to comply with trial requirements.
14. Participant has inflamed, infected or otherwise compromised skin in the treatment area.
15. Participant with a bleeding disorder e.g., haemophilia

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
29/08/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/01/2026
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Vincent Tse Pty Ltd - Chatswood
Recruitment hospital [2] 0 0
AndroUrology Centre - Spring Hill
Recruitment postcode(s) [1] 0 0
2067 - Chatswood
Recruitment postcode(s) [2] 0 0
4001 - Spring Hill

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Australis Scientific PTY LTD
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Nigel D'Silva
Address 0 0
Country 0 0
Phone 0 0
+61466411877
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will not be shared with other researchers.


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07149103