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INOPASE - Performance and Safety Study of a Personalised SNM System | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT07193407•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.

Eligibility

Age

18 - 70 years

Sex

FEMALE

Healthy Volunteers

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)
+2 more criteria

Locations (2)

St George Private Hospital

Kogarah, New South Wales, Australia

St George Urology

Kogarah, New South Wales, Australia

Key Dates

Start Date

February 27, 2026

Primary Completion Date

March 2, 2026

Completion Date

December 31, 2026

Last Updated

February 13, 2026

Enrollment

ESTIMATED participants

Conditions

Overactive Bladder (OAB)

Interventions

Sacral Neuromodulation System

DEVICE

Contacts

Christopher Ong

CONTACT

+61411256603 chris.ong@wonderlandmedical.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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INOPASE - Performance and Safety Study of a Personalised SNM System

Inclusion Criteria

Exclusion Criteria

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