Stimulating Percutaneous Array for Urinary Reflex Control (SPARC)
NCT ID: NCT07149103
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2025-08-29
2026-01-30
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment Arm
The treatment arm will undergo the experimental treatment
Percutaneous Tibial Nerve Stimulation
By wearing the Confidanz Smart Patch, the Tibial Nerve will be stimulated
SHAM ARM
The sham arm will undergo the same procedure as the treatment group but the therapy will not be switched on
Placebo
No active stimulation will be provided
Interventions
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Percutaneous Tibial Nerve Stimulation
By wearing the Confidanz Smart Patch, the Tibial Nerve will be stimulated
Placebo
No active stimulation will be provided
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Australis Scientific PTY LTD
INDUSTRY
Responsible Party
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Locations
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Vincent Tse Pty Ltd
Chatswood, New South Wales, Australia
AndroUrology Centre
Spring Hill, Queensland, Australia
Countries
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Central Contacts
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Facility Contacts
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Wing Ming Vincent TSE, PROFESSOR
Role: primary
Eric Chung, PROFESSOR
Role: primary
Other Identifiers
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CP-001
Identifier Type: -
Identifier Source: org_study_id