Actively Recruiting
INOPASE - Performance and Safety Study of a Personalised SNM System
Led by INOPASE Pty Ltd · Updated on 2026-05-06
10
Participants Needed
2
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
INOPASE - Performance and Safety Study of a Personalised SNM System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult female participants 18 years of age or older
- Diagnosed with refractory overactive bladder resistant to behavioral therapy and/or pharmacotherapy for at least 12 weeks
- Experience at least 3 urgency episodes within a 24-hour period for 3 consecutive days as reported in a bladder diary
- Baseline Overactive Bladder Symptom Score (OABSS) greater than 7
- Baseline International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) score greater than 12
- Willing to receive sacral neuromodulation therapy
- Willing to provide free and informed consent to participate
- Able to understand study instructions, attend all visits, and comply with study procedures
You will not qualify if you...
- Diagnosed with stress urinary incontinence
- Received tibial nerve stimulation therapy within the past 3 months
- Received botulinum toxin treatment for urinary symptoms in the past 9 months or planning to have it during the study
- Have neurological conditions such as dementia, multiple sclerosis, significant peripheral neuropathy, or spinal cord injury
- Currently have or are at high risk for urinary tract infection
- Have uncontrolled systemic diseases or comorbidities affecting bladder function (e.g., diabetes, hypertension, cancer)
- Implanted with a neurostimulator, pacemaker, or defibrillator
- Participating in another interventional drug or device clinical trial currently or within 30 days before screening
- Pregnant women
- Known allergies to materials contacting tissue in this study (e.g., adhesive patches, silicone)
- Have implanted devices with metallic parts within 2cm of the implanted lead site
- Any other clinical or social reason that may prevent successful study participation according to the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
St George Private Hospital
Kogarah, New South Wales, Australia, 2217
Actively Recruiting
2
St George Urology
Kogarah, New South Wales, Australia, 2217
Actively Recruiting
Research Team
C
Christopher Ong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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