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RECRUITING

NCT07193407

INOPASE - Performance and Safety Study of a Personalised SNM System

Sponsor: INOPASE Pty Ltd

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-02-27

Completion Date

2026-12-31

Last Updated

2026-02-13

Healthy Volunteers

Conditions

Overactive Bladder (OAB)

Interventions

DEVICE

Sacral Neuromodulation System

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

Inclusion Criteria: * Adult female participants between 18 and 70 years of age * 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 * 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

Locations (2)

St George Private Hospital

Kogarah, New South Wales, Australia

St George Urology