INOPASE - Performance and Safety Study of a Personalised SNM System
Recruiting now · Not applicable
Conditions studied: Overactive Bladder (OAB)
In brief
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 manage symptoms of refractory overactive bladder in adult women aged 18-70 who have not responded to standard treatments. The main questions it aims to answer are: * Is there a clear relationship between bladder nerve activity and patient-reported urgency sensations? * Can targeted stimulation based on bladder nerve activity reduce overactive bladder symptoms? * Is the INO-SNM-01 System safe to use? Researchers will not use a comparison group in this study. Instead, all participants will receive the investigational device to see if it works as intended. Participants will undergo surgery to have a temporary trial lead implanted near the sacral nerve and spend up to 2 days in hospital for monitoring and testing to assess the device sensing and stimulation capabilities. Up to 10 participants will take part in this first-in-human feasibility study at a single site in Australia.
Key facts
- Study ID
- NCT07193407
- Run by
- INOPASE Pty Ltd
- People needed
- 10
- Starts
- 2026-02-27
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-05-18
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Adult female participants 18 years of age or older
- 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
You may not qualify if…
- 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 within 2cm of the implanted lead location
- 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
Where it is running
- St George Private Hospital — Kogarah, New South Wales, Australia (enrolling)
- St George Urology — Kogarah, New South Wales, Australia (enrolling)
Full record on ClinicalTrials.gov
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