Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt

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