Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt

Primary Inclusion Criteria:

1. Diagnosis of UUI demonstrated on a 72-hour voiding diary defined as a minimum of four
(4) leaking episodes associated with urgency, at least 50% of all leaking episodes
associated with urgency, and at least one leaking episode each 24-hour period.

2. Greater than or equal to 6 months' history of UUI diagnosis

3. For male subjects only: Peak flow rate > 15 cc/s as verified by uroflowmetry within 6
months prior to enrollment; Residual bladder volume < 150 cc tested within 6 months
prior to enrollment

4. 21 years of age and older

5. Willing and capable of providing informed consent

6. Capable of participating in all testing associated with this clinical investigation

Primary Exclusion Criteria:

1. Stress incontinence or mixed incontinence.

2. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or
urethral stricture)

3. Interstitial cystitis or bladder pain syndrome as defined by either American
Urological Association (AUA) or European Association of Urology (EAU) guidelines

4. A female who is breastfeeding

5. A female with a positive urine pregnancy test