INOPASE - Performance and Safety Study of a Personalised SNM System
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
| Condition(s) | Overactive Bladder (OAB) |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 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 t |
| Who can participate | Inclusion Criteria: 1. Adult female participants 18 years of age or older 2. Diagnosed with refractory overactive bladder that is resistant to behavioural therapy and/or pharmacotherapy, for at least 12 weeks 3. Experience at least 3 urgency episodes within a 24-hour period from the past 3 consecutive days (reported in a bladder diary) 4. Baseline of greater than 7 on the Overactive Bladder Symptom Score (OABSS) 5. Baseline score of greater than 12 on the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) 6. Willing to receive SNM therapy 7. Willing to provide free and Informed consent to participate in the clinical investigation 8. Able to understand all study instructions, willing to attend all study visits, and likely to com |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | INOPASE Pty Ltd |
| Locations | Kogarah, New South Wales, Australia; Kogarah, New South Wales, Australia |
| Start date | 2026-02-27 |
| NCT ID | NCT07193407 |
| Official listing | https://clinicaltrials.gov/study/NCT07193407 |