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

Inclusion Criteria:

1. Has a Body Mass Index (BMI) between 18 and 40.

2. Has a diagnosis of UUI for greater than or equal to 6 months prior to the screeningbaseline visit date.

3. Has failed or was not a candidate for more conservative treatment (e.g. pelvic floortraining, biofeedback, behavioral modification).

4. Has failed or could not tolerate (stopped taking medication due to lack of efficacyor intolerable side effects) or not a good candidate for (as determined by treatingphysician) at least one (1) antimuscarinic or β3 adrenoceptor agonist medication.

5. Has a diagnosis of UUI with at least 4 UUI episodes on a 72-hour diary, and minimumof one (1) UUI episode per 24-hour period.

Exclusion Criteria:

1. Has a hemoglobin A1c of greater than 8 percent, or has diabetes mellitus withglucosuria.

2. Has diabetic neuropathy.

3. Has interstitial cystitis or bladder pain syndrome as defined by either AmericanUrological 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 baselinevisit 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 componentpredominates or has been treated surgically for stress urinary incontinence within 6months prior to the screening baseline visit date.

9. Has received tibial nerve stimulation (TNS) in the past 3 months for the treatmentof overactive bladder or unwilling to stay off TNS therapy for 12-month periodfollowing implant.