INOPASE - Performance and Safety Study of a Personalised SNM System

Exclusion Criteria

• •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)
• •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
• •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