Neuspera's Implantable Sacral Nerve Stimulation System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)

Exclusion Criteria

• •1. Has a hemoglobin A1c of greater than 8 percent, or has diabetes mellitus with glucosuria.
• •2. Has diabetic neuropathy.
• •3. Has interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines, chronic pelvic pain or recurrent symptomatic urinary tract infections.
• •4. Has neurogenic bladder dysfunction such as traumatic or atraumatic myelopathy, multiple sclerosis, Parkinsonism, or history of cerebrovascular accident.
• •5. Has documented urinary retention within 6 months prior to the screening baseline visit date.
• •6. Has clinically significant bladder outlet obstruction.
• •7. Is a subject with a mechanical obstruction such as benign prostatic hypertrophy, urethral stricture or cancer.
• •8. Has primary stress incontinence or mixed incontinence where the stress component predominates or has been treated surgically for stress urinary incontinence within 6 months prior to the screening baseline visit date.
• •9. Has received tibial nerve stimulation (TNS) in the past 3 months for the treatment of overactive bladder or unwilling to stay off TNS therapy for 12-month period following implant.