Overactive Bladder (OAB)NCT07193407
INOPASE - Performance and Safety Study of a Personalised SNM System
A study testing Sacral Neuromodulation System in people with Overactive Bladder (OAB), run by INOPASE Pty Ltd at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder (OAB)
- What is being tested?
- Sacral Neuromodulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesAustralia
- Study dates
- 27 Feb 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 2 recruiting
- Recruiting
St George Private Hospital
Kogarah, New South Wales, 2217
Tracy Liaw, +61295985022, LiawT@ramsayhealth.com.au
- Recruiting
St George Urology
Kogarah, New South Wales, 2217
William Lynch, +642 9553 7110, lynch@sgu.com.au
William Lynch
About this study
Official title: Feasibility and Safety Study to Evaluate the Sensing and Stimulation Performance of a Personalised Sacral Neuromodulation (SNM) System for Refractory Overactive Bladder
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:
Read more
- 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
- Overactive Bladder (OAB)
- Being tested
- Sacral Neuromodulation System
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacral Neuromodulation SystemDevice
INOPASE Sacral Neuromodulation System (INO-SNM-01) for treatment of overactive bladder.
| Study group | Role | What they receive |
|---|---|---|
| INOPASE Sacral Neuromodulation System 01 (INO-SNM-01) | Experimental | Participants are implanted with the Trial Lead and undergo 2 days of monitoring in hospital with the INO-SNM-01 System. Receives: Device: Sacral Neuromodulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between bladder afferent nerve activity measured by the INO-SNM-01 and patient reported urgency sensation (Feeling Indicator measure)
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.
Measured: From device implantation to the end of treatment 2 days
Secondary outcomes (6)
Evaluation of whether timely stimulation by the INO-SNM-01 device correlates with 'Loss of desire to urinate' as measured by the Feeling Indicator
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.
Measured: From device implantation to the end of treatment 2 days
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
Measured: From device implantation to the end of treatment 2 days
Evaluation of whether timely stimulation by the INO-SNM-01 shows a reduction in bladder pressure (cm H2O) measured by a urodynamics monitor
Measured: From device implantation to the end of treatment 2 days
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.
Measured: From device implantation to the end of treatment 2 days
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 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.
Measured: From device implantation to the end of treatment 2 days
Incidence of Adverse Events
Evaluation of device safety profile through adverse event reporting during device implantation, testing or explantation.
Measured: From device implantation to the end of treatment 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start27 Feb 2026
- Primary completion2 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder (OAB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- INOPASE Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wiliam Lynch, Principal investigator, St George Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193407
- Sponsor's protocol ID
- PoC-01
- Status last verified
- Feb 2026
- First submitted
- 10 Sep 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to publish paper outside of initial research group.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety Study to Evaluate the Sensing and Stimulation Performance of a Personalised Sacral Neuromodulation (SNM) System for Refractory Overactive Bladder
- ClinicalTrials.gov ID
- NCT07193407
- Acronym / sponsor ID
- PoC-01
- Conditions
- Overactive Bladder (OAB)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- INOPASE Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2026 (actual)
- Primary completion
- 2 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INOPASE Sacral Neuromodulation System 01 (INO-SNM-01) | Experimental | Device: Sacral Neuromodulation SystemParticipants are implanted with the Trial Lead and undergo 2 days of monitoring in hospital with the INO-SNM-01 System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacral Neuromodulation SystemINOPASE Sacral Neuromodulation System (INO-SNM-01) for treatment of overactive bladder. | Device | INOPASE Sacral Neuromodulation System 01 (INO-SNM-01) |
Primary outcome
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.
6 secondary outcomes
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
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
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
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
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
Incidence of Adverse Events
Time frame: From device implantation to the end of treatment 2 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No. No plans to publish paper outside of initial research group.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wiliam Lynch principal investigator
St George Urology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacral Neuromodulation System in people with Overactive Bladder (OAB), run by INOPASE Pty Ltd at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Ong (+61411256603, chris.ong@wonderlandmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.