INOPASE - Performance and Safety Study of a Personalised SNM System

NCT07193407 | Recruiting

• 1 other identifier: PoC-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Overactive Bladder (OAB)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Evaluation of whether timely stimulation by the INO-SNM-01 device correlates with 'Loss of desire to urinate' as measured by the Feeling Indicator

  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

  From device implantation to the end of treatment 2 days

Study Arms (1)

INOPASE Sacral Neuromodulation System 01 (INO-SNM-01)

EXPERIMENTAL

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

Interventions

Sacral Neuromodulation System DEVICE

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

INOPASE Sacral Neuromodulation System 01 (INO-SNM-01)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• INOPASE Pty Ltd: lead

Study Sites (2)

St George Private Hospital

Kogarah, New South Wales, 2217, Australia

RECRUITING

St George Urology

Kogarah, New South Wales, 2217, Australia

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wiliam Lynch

  St George Urology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Ong

CONTACT

+61411256603; chris.ong@wonderlandmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 25, 2025
• Study Start: February 27, 2026
• Primary Completion (Estimated): October 2, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)