BlueWind RENOVA iStim™ System for the Treatment of OAB

Launched by BLUEWIND MEDICAL · Jul 12, 2018

Keywords

ClinConnect Summary

The OASIS study is looking into a new treatment option for women who suffer from Overactive Bladder (OAB), a condition that causes frequent and sudden urges to urinate. The trial is testing the BlueWind RENOVA iStim™ System, which is a small device implanted to help manage these symptoms. This study is currently recruiting participants, specifically women aged 18 and older who have had urinary urgency for at least six months. It's important that participants are mentally capable of understanding the study and following its guidelines.

Women who are pregnant, breastfeeding, or have certain other medical conditions may not be eligible to join. If you participate, you can expect to receive the implant and be monitored for its effectiveness and safety. This is a chance to potentially improve your quality of life if you struggle with OAB. If you meet the criteria and are interested, you could play a key role in helping researchers learn more about this treatment.

Gender

FEMALE

Eligibility criteria

• 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