INOPASE - Performance and Safety Study of a Personalised SNM System
NCT: NCT07193407 · RECRUITING
Brief 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.
Frequently Asked Questions
What is INOPASE - Performance and Safety Study of a Personalised SNM System?
INOPASE - Performance and Safety Study of a Personalised SNM System is a clinical trial registered under NCT07193407. Current status: RECRUITING.
What is the status of NCT07193407?
The current status of NCT07193407 (INOPASE - Performance and Safety Study of a Personalised SNM System) is: RECRUITING.
When did INOPASE - Performance and Safety Study of a Personalised SNM System start?
INOPASE - Performance and Safety Study of a Personalised SNM System started on 2026-02-27.
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.