Status:
NOT_YET_RECRUITING
INOPASE - Performance and Safety Study of a Personalised SNM System
Lead Sponsor:
INOPASE Pty Ltd
Conditions:
Overactive Bladder (OAB)
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn whether a new sacral neuromodulation (SNM) system (INO-SNM-01) can safely and effectively sense bladder nerve activity and provide stimulation to help manag...
Eligibility Criteria
Inclusion
- Adult female participants between 18 and 70 years of age
- Diagnosed with refractory overactive bladder that is resistant to behavioural therapy and/or pharmacotherapy, for at least 12 weeks
- Experience at least 3 urgency episodes within a 24-hour period from the past 3 consecutive days (reported in a bladder diary)
- Baseline of greater than 7 on the Overactive Bladder Symptom Score (OABSS)
- Baseline score of greater than 12 on the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS)
- Willing to receive SNM therapy
- Willing to provide free and Informed consent to participate in the clinical investigation
- Able to understand all study instructions, willing to attend all study visits, and likely to comply with all study procedures
Exclusion
- Participants who are diagnosed with stress urinary incontinence
- Received tibial nerve stimulation therapy within the past 3 months
- Received treatment of urinary symptoms with botulinum toxin in the past 9 months or any plan to have botulinum toxin treatment during the study
- Have neurological conditions such as dementia, multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury
- Participants who presently have, or are at high risk of urinary tract infection
- Have uncontrolled systemic disease or comorbidities which may affect bladder function (for example diabetes, hypertension, cancer)
- Implanted with a neurostimulator, pacemaker, or defibrillator
- Participation in another interventional drug or device clinical trial concurrently or concluding within 30 days of screening
- Women who are pregnant
- Participants with known history of allergies to materials in contact with tissue for this study (i.e. adhesive dressing patch, silicone)
- Have implanted devices that contain metallic components
- Any other clinical or social reason that, in the opinion of the investigator could restrict a participant's ability to successfully meet the study objectives
Key Trial Info
Start Date :
December 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 28 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07193407
Start Date
December 15 2025
End Date
June 28 2026
Last Update
November 17 2025
Active Locations (2)
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1
St George Private Hospital
Kogarah, New South Wales, Australia, 2217
2
St George Urology
Kogarah, New South Wales, Australia, 2217