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INOPASE - Performance and Safety Study of a Personalised SNM System

NCT07193407 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-05-18

No results posted yet for this study

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

DEVICE

Sacral Neuromodulation System

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

Sponsors & Collaborators

  • INOPASE Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Wiliam Lynch · St George Urology

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-27
Primary Completion
2026-10-02
Completion
2026-12-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07193407 on ClinicalTrials.gov