Evaluation of the TheraNova Neuromodulation System to Provide Durable Relief of Overactive Bladder Symptoms

Exclusion Criteria

• •Individual has recurrent UTI defined as ≥4 UTIs in the past 12 months
• •* Female of childbearing age (≤50 years old) who is pregnant as confirmed by urine pregnancy test, or who plans to become pregnant during the study period
• •* Individual has peripheral arterial disease
• •* Individual has the presence of a urinary fistula, bladder stone, or interstitial cystitis
• •* Individual has a diagnosis of prostate, urethral, or bladder cancer
• •* Individual has morbid obesity (BMI ≥ 40)
• •* Individual has clinically significant urethral stricture disease or bladder neck contracture
• •* Individual has a metallic implant that is exposed above the bone surface (e.g. a bone fracture fixation plate, but not an embedded bone screw) and is located under the skin on the bottom of the foot for either foot or under the skin on the anterior aspect of the mid-thigh for either leg.
• •* Individual has an implanted electrical and/or neurostimulator device (e.g. pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, sacral stimulator, bone growth stimulator, or cochlear implant)
• •* Individual has been treated with percutaneous tibial nerve stimulation or pelvic floor muscle stimulation
• •* Individual has been treated with onabotulinumtoxinA in the past 9 months
• •* Individual has a clinically significant peripheral neuropathy
• •* Individual has a history of pelvic pain as primary diagnosis in the past 12 months (VAS score of \>4 (scale of 0 to 10)) Individual has neurogenic bladder (i.e. Multiple Sclerosis, Parkinson's, Spinal Cord Injury)
• •* Individual has used an investigational drug, biologic, or medical device in the past 4 weeks
• •* Individual is deemed unsuitable for enrollment in the study by the investigator based on the subject's history or physical examination