Overactive Bladder (OAB)
Conditions
Brief 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.
Interventions
DEVICESacral Neuromodulation System
INOPASE Sacral Neuromodulation System (INO-SNM-01) for treatment of overactive bladder.
Sponsors
INOPASE Pty Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between bladder afferent nerve activity measured by the INO-SNM-01 and patient reported urgency sensation (Feeling Indicator measure) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From device implantation to the end of treatment 2 days | 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. |
| Incidence of Adverse Events | From device implantation to the end of treatment 2 days | Evaluation of device safety profile through adverse event reporting during device implantation, testing or explantation. |
| 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. | From device implantation to the end of treatment 2 days | — |
| Evaluation of whether timely stimulation by the INO-SNM-01 device correlates with 'Loss of desire to urinate' as measured by the Feeling Indicator | From device implantation to the end of treatment 2 days | 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. |
| 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 | 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 | From device implantation to the end of treatment 2 days | — |
Countries
Australia
Contacts
CONTACTChristopher Ong
PRINCIPAL_INVESTIGATORWiliam Lynch
St George Urology
Outcome results
None listed