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

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.

Study Overview

• Status: Recruiting
• Conditions: Overactive Bladder (OAB)
• Intervention / Treatment: Device: Sacral Neuromodulation System

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christopher Ong; Phone Number: +61411256603; Email: chris.ong@wonderlandmedical.com

Study Locations

• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Recruiting
      • St George Private Hospital
      • Contact: Tracy Liaw; Phone Number: +61295985022; Email: LiawT@ramsayhealth.com.au
    • Kogarah, New South Wales, Australia, 2217
      • Recruiting
      • St George Urology
      • Contact: William Lynch; Phone Number: +642 9553 7110; Email: lynch@sgu.com.au
      • Principal Investigator: William Lynch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult female participants 18 years of age or older
2. Diagnosed with refractory overactive bladder that is resistant to behavioural therapy and/or pharmacotherapy, for at least 12 weeks
3. Experience at least 3 urgency episodes within a 24-hour period from the past 3 consecutive days (reported in a bladder diary)
4. Baseline of greater than 7 on the Overactive Bladder Symptom Score (OABSS)
5. Baseline score of greater than 12 on the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS)
6. Willing to receive SNM therapy
7. Willing to provide free and Informed consent to participate in the clinical investigation
8. Able to understand all study instructions, willing to attend all study visits, and likely to comply with all study procedures

Exclusion Criteria:

1. Participants who are diagnosed with stress urinary incontinence
2. Received tibial nerve stimulation therapy within the past 3 months
3. Received treatment of urinary symptoms with botulinum toxin in the past 9 months or any plan to have botulinum toxin treatment during the study
4. Have neurological conditions such as dementia, multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury
5. Participants who presently have, or are at high risk of urinary tract infection
6. Have uncontrolled systemic disease or comorbidities which may affect bladder function (for example diabetes, hypertension, cancer)
7. Implanted with a neurostimulator, pacemaker, or defibrillator
8. Participation in another interventional drug or device clinical trial concurrently or concluding within 30 days of screening
9. Women who are pregnant
10. Participants with known history of allergies to materials in contact with tissue for this study (i.e. adhesive dressing patch, silicone)
11. Have implanted devices that contain metallic components within 2cm of the implanted lead location
12. Any other clinical or social reason that, in the opinion of the investigator could restrict a participant's ability to successfully meet the study objectives

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INOPASE Sacral Neuromodulation System 01 (INO-SNM-01); Participants are implanted with the Trial Lead and undergo 2 days of monitoring in hospital with the INO-SNM-01 System.	Device: Sacral Neuromodulation System; INOPASE Sacral Neuromodulation System (INO-SNM-01) for treatment of overactive bladder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between bladder afferent nerve activity measured by the INO-SNM-01 and patient reported urgency sensation (Feeling Indicator measure)	Success is defined as the ability of the INO-SNM-01 device to detect an increase in nerve activity (mV) as measured by the INO-SNM-01 when the participant reports 'Urgency' on the wireless input Feeling Indicator device. The Feeling Indicator allows patients to record their urgency sensations as 'Desire to urinate', 'Loss of desire to urinate', 'Urgency' or 'Urination' in real-time throughout the test period.	From device implantation to the end of treatment 2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of whether timely stimulation by the INO-SNM-01 device correlates with 'Loss of desire to urinate' as measured by the Feeling Indicator	The Feeling Indicator device allows patients to record their urgency sensations as 'Desire to urinate', 'Loss of desire to urinate', 'Urgency' or 'Urination' in real-time throughout the test period.	From device implantation to the end of treatment 2 days
Evaluation of whether timely stimulation by the INO-SNM-01 device shows a reduction in bladder afferent nerve activity response when providing stimulation compared to no stimulation		From device implantation to the end of treatment 2 days
Evaluation of whether timely stimulation by the INO-SNM-01 shows a reduction in bladder pressure (cm H2O) measured by a urodynamics monitor		From device implantation to the end of treatment 2 days
Evaluation of whether timely stimulation by the INO-SNM-01 device shows an increase in urinary volume (mL) during each urination cycle as measure by a urodynamics monitor.		From device implantation to the end of treatment 2 days
Evaluation of whether timely stimulation using the INO-SNM-01 device shows an increase in time between urination cycles (minutes) as reported by the Feeling Indicator	Time of urination is recorded when the participant reports the 'Urination' state on the Feeling Indicator during testing. Time between urination cycles is calculated as the difference between 2 consecutive urination times.	From device implantation to the end of treatment 2 days
Incidence of Adverse Events	Evaluation of device safety profile through adverse event reporting during device implantation, testing or explantation.	From device implantation to the end of treatment 2 days

Collaborators and Investigators

• Sponsor: INOPASE Pty Ltd
• Investigators: Principal Investigator: Wiliam Lynch, St George Urology

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2026
• Primary Completion (Estimated): October 2, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 10, 2025
• First Submitted That Met QC Criteria: September 18, 2025
• First Posted (Actual): September 25, 2025

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Bladder, Overactive
• Other Study ID Numbers: PoC-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plans to publish paper outside of initial research group.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No