Personalised sacral neuromodulation (INO-SNM-01) for overactive bladder

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

This will test whether a personalised sacral neuromodulation device (INO-SNM-01) can detect bladder nerve signals and deliver targeted stimulation to reduce symptoms in adult women whose overactive bladder has not responded to standard treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: INOPASE Pty Ltd (Industry-sponsored)
• Locations: 2 sites (Kogarah, New South Wales and 1 other locations)
• Trial ID: NCT07193407 on ClinicalTrials.gov

What this trial studies

This is a small, non-randomised interventional study enrolling up to 10 adult women with refractory overactive bladder to test the sensing and stimulation capabilities of the INO-SNM-01 system. Participants will have a temporary trial lead implanted near the sacral nerve and remain in hospital for monitoring and testing for up to two days to record bladder nerve activity and patient-reported urgency. The study will look for correlations between nerve signals and urgency sensations and will deliver stimulation based on sensed activity to see if symptoms are reduced. Safety and device performance will be monitored throughout, with no comparison group used in this initial feasibility work.

Who should consider this trial

Good fit: Adult women aged 18–70 with refractory overactive bladder who have had at least three urgency episodes per day, OABSS >7 and ICIQ-FLUTS >12, and who are willing to undergo a temporary implant and follow-up visits.

Not a fit: People who have stress urinary incontinence, recent tibial nerve stimulation, men, or those unwilling to undergo a temporary implant or travel to the study site are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, the device could reduce urgency and other overactive bladder symptoms by delivering stimulation only when bladder nerve activity indicates it is needed.

How similar studies have performed: Conventional sacral neuromodulation is an established therapy for refractory OAB, but personalised closed-loop systems that sense bladder nerve signals are relatively novel with only limited early feasibility data.

Eligibility criteria

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

Where this trial is running

Kogarah, New South Wales and 1 other locations

• St George Private Hospital — Kogarah, New South Wales, Australia (Recruiting)
• St George Urology — Kogarah, New South Wales, Australia (Recruiting)

Study contacts

• Principal investigator: Wiliam Lynch — St George Urology
• Study coordinator: Christopher Ong

Conditions Overactive Bladder