NCT07193407

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: INOPASE Pty Ltd · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Overactive Bladder (OAB)

Interventions

Type	Name	Description
DEVICE	Sacral Neuromodulation System	INOPASE Sacral Neuromodulation System (INO-SNM-01) for treatment of overactive bladder.

Timeline

• Start date: 2026-02-27
• Primary completion: 2026-03-02
• Completion: 2026-12-31
• First posted: 2025-09-25
• Last updated: 2026-02-13

Locations

2 sites across 1 country: Australia