INOPASE - Performance and Safety Study of a Personalised SNM System (NCT07193407) | Clinical Trial Compass
RecruitingNot Applicable
INOPASE - Performance and Safety Study of a Personalised SNM System
Australia10 participantsStarted 2026-02-27
Plain-language 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 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.
Who can participate
Age range18 Years – 70 Years
SexFEMALE
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Inclusion criteria
✓. 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
Exclusion criteria
✕
What they're measuring
1
Correlation between bladder afferent nerve activity measured by the INO-SNM-01 and patient reported urgency sensation (Feeling Indicator measure)
Timeframe: From device implantation to the end of treatment 2 days