INOPASE - Performance and Safety Study of a Personalised SNM System

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