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NCT Number: NCT07193407

INOPASE - Performance and Safety Study of a Personalised SNM System

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.

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Key information

Conditions

Overactive Bladder (OAB) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St George Private Hospital, Kogarah, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Sacral Neuromodulation System

Device

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

Primary outcomes

  1. Correlation between bladder afferent nerve activity measured by the INO-SNM-01 and patient reported urgency sensation (Feeling Indicator measure)

    Time frame: From device implantation to the end of treatment 2 days

    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.

Secondary outcomes

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

    Time frame: From device implantation to the end of treatment 2 days

    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.

  2. 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

    Time frame: From device implantation to the end of treatment 2 days

  3. Evaluation of whether timely stimulation by the INO-SNM-01 shows a reduction in bladder pressure (cm H2O) measured by a urodynamics monitor

    Time frame: From device implantation to the end of treatment 2 days

  4. 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.

    Time frame: From device implantation to the end of treatment 2 days

  5. 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 frame: From device implantation to the end of treatment 2 days

    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.

  6. Incidence of Adverse Events

    Time frame: From device implantation to the end of treatment 2 days

    Evaluation of device safety profile through adverse event reporting during device implantation, testing or explantation.

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Ong

CONTACT

[email protected]

+61411256603

Sponsors and collaborators

Lead sponsor

INOPASE Pty Ltd

Industry

Registry information

Official study title

Feasibility and Safety Study to Evaluate the Sensing and Stimulation Performance of a Personalised Sacral Neuromodulation (SNM) System for Refractory Overactive Bladder

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2025
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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