Treatment of Patients Suffering From Overactive Bladder (OAB) Clinical Trial
— OASISOfficial title:
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.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | January 2025 |
| Est. primary completion date | October 28, 2022 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 80 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | University Hospital Antwerp | Antwerp | |
| Belgium | UZ Leuven | Leuven | |
| Netherlands | Rijnstate Hospital | Arnhem | |
| Netherlands | Academic Hospital Maastricht | Maastricht | |
| Netherlands | Radboud University Medical Center | Nijmegen | |
| Netherlands | UMC Utrecht | Utrecht | |
| Netherlands | Isala | Zwolle | |
| United Kingdom | Birmingham Women's and Children's NHS Foundation Trust | Birmingham | |
| United Kingdom | Imperial College, St. Mary's Hospital | London | |
| United States | Duke Urogynecology | Durham | North Carolina |
| United States | Chesapeake Urology - Hanover | Hanover | Maryland |
| United States | Comprehensive Urologic Care | Lake Barrington | Illinois |
| United States | Norwalk Urology | Norwalk | Connecticut |
| United States | Adult Pediatric Urology & Urogynecology | Omaha | Nebraska |
| United States | University of California Irvine | Orange | California |
| United States | Chesapeake Urology - Owing Mills | Owings Mills | Maryland |
| United States | Kaiser Permanente | San Diego | California |
| United States | University of Washington | Seattle | Washington |
| United States | Regional Urology, LLC | Shreveport | Louisiana |
| United States | Sanford Health | Sioux Falls | South Dakota |
| United States | Florida Urology Partners | Tampa | Florida |
| United States | Southern Urogynocology | West Columbia | South Carolina |
| United States | Minnesota Urology | Woodbury | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| BlueWind Medical |
United States, Belgium, Netherlands, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Improvement in urinary urgency incontinence (UUI) episodes based on patient voiding diary | 6 months | ||
| Primary | Safety - incidence of adverse events | 12 months |