BlueWind RENOVA iStim™ System for the Treatment of OAB
- Conditions
- Treatment of Patients Suffering From Overactive Bladder (OAB)
- Registration Number
- NCT03596671
- Lead Sponsor
- BlueWind Medical
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Improvement in urinary urgency incontinence (UUI) episodes based on patient voiding diary 6 months Safety - incidence of adverse events 12 months
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (23)
University of California Irvine
🇺🇸Orange, California, United States
Kaiser Permanente
🇺🇸San Diego, California, United States
Norwalk Urology
🇺🇸Norwalk, Connecticut, United States
Florida Urology Partners
🇺🇸Tampa, Florida, United States
Comprehensive Urologic Care
🇺🇸Lake Barrington, Illinois, United States
Regional Urology, LLC
🇺🇸Shreveport, Louisiana, United States
Chesapeake Urology - Hanover
🇺🇸Hanover, Maryland, United States
Chesapeake Urology - Owing Mills
🇺🇸Owings Mills, Maryland, United States
Minnesota Urology
🇺🇸Woodbury, Minnesota, United States
Adult Pediatric Urology & Urogynecology
🇺🇸Omaha, Nebraska, United States
Scroll for more (13 remaining)University of California Irvine🇺🇸Orange, California, United States