RecruitingNot ApplicableNCT07193407

INOPASE - Performance and Safety Study of a Personalised SNM System

Feasibility and Safety Study to Evaluate the Sensing and Stimulation Performance of a Personalised Sacral Neuromodulation (SNM) System for Refractory Overactive Bladder

Sponsor

INOPASE Pty Ltd

Enrollment

10 participants

Start Date

Feb 27, 2026

Study Type

INTERVENTIONAL

Conditions

Overactive Bladder (OAB)

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalised sacral nerve stimulation (SNM) device — a small implant that sends gentle electrical signals to nerves controlling the bladder — in women with overactive bladder that has not responded to other treatments. **You may be eligible if...** - You are a woman between 18 and 70 years old - You have been diagnosed with refractory overactive bladder (urgency to urinate that hasn't improved with behavioral therapy or medication for at least 12 weeks) - You experience at least 3 urgent urge episodes per day - Your symptom scores meet the study's minimum thresholds - You are willing to receive the SNM implant and attend all study visits **You may NOT be eligible if...** - You are male - Your overactive bladder has responded to prior behavioral or medication treatments - You have fewer than 3 urgency episodes per day - Your symptom scores are below the required thresholds - You are unwilling to undergo the implant procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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