BlueWind RENOVA iStim™ System for the Treatment of OAB

Inclusion Criteria:

• Female aged 18 or greater (21 in the US)

• More than or equal to 6 months history of UUI diagnosis

• Patient who is mentally competent with the ability to understand and comply with therequirements of the study

Exclusion Criteria:

• Any significant medical condition that is likely to interfere with study procedures

• Patients who are breastfeeding

• Predominant stress incontinence

• Have a life expectancy of less than 1 year

• Diagnosis of interstitial cystitis or bladder pain syndrome as defined by eitherAmerican Urological Association (AUA) or European Association of Urology (EAU)guidelines