Condition: Overactive Bladder (OAB) · Sponsor: INOPASE Pty Ltd
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.
This description comes directly from the study's public registry record.
Christopher Ong · +61411256603 · chris.ong@wonderlandmedical.com
Always discuss trial participation with your own doctor first.
| St George Private Hospital | Kogarah, New South Wales, Australia | Recruiting |
| St George Urology | Kogarah, New South Wales, Australia | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07193407