BlueWind RENOVA iStim™ System for the Treatment of OAB

A Prospective Study to Assess the Efficacy and Safety of the BlueWind RENOVA iStim™ System in the Treatment of Patients Diagnosed With Overactive Bladder (OASIS - OverActive Bladder StImulation System Study)

The OASIS study is prospective, interventional, multi-center study to evaluate the safety and efficacy of the BlueWind RENOVA iStim™ implantable tibial neuromodulation System for the treatment of patients diagnosed with overactive bladder.

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 the requirements 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 either American Urological Association (AUA) or European Association of Urology (EAU) guidelines