BlueWind RENOVA iStim™ System for the Treatment of OAB
Completed · Not applicable
Conditions studied: Treatment of Patients Suffering From Overactive Bladder (OAB)
In brief
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.
Key facts
- Study ID
- NCT03596671
- Run by
- BlueWind Medical
- People needed
- 282
- Starts
- 2019-06-12
- Expected to finish
- 2025-01-24
- Last updated by the study team
- 2025-09-16
Who can join
Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
- Duke Urogynecology — Durham, North Carolina, United States
- Southern Urogynocology — West Columbia, South Carolina, United States
- Sanford Health — Sioux Falls, South Dakota, United States
- University of Washington — Seattle, Washington, United States
- University Hospital Antwerp — Antwerp, Belgium
- UZ Leuven — Leuven, Belgium
- Rijnstate Hospital — Arnhem, Netherlands
- Academic Hospital Maastricht — Maastricht, Netherlands
- Radboud University Medical Center — Nijmegen, Netherlands
- UMC Utrecht — Utrecht, Netherlands
- Isala — Zwolle, Netherlands
- Birmingham Women's and Children's NHS Foundation Trust — Birmingham, United Kingdom
- Imperial College, St. Mary's Hospital — London, United Kingdom
Full record on ClinicalTrials.gov
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