Study Results
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View full resultsBasic Information
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COMPLETED
NA
282 participants
INTERVENTIONAL
2019-06-12
2025-01-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment arm
RENOVA iStim™ System implanted patients
RENOVA iStim™ System
Tibial implantable neuromodulation device
Interventions
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RENOVA iStim™ System
Tibial implantable neuromodulation device
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
FEMALE
No
Sponsors
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BlueWind Medical
INDUSTRY
Responsible Party
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Principal Investigators
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John Heesakkers, MD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Centre
Locations
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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
Countries
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References
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Heesakkers JPFA, Toozs-Hobson P, Sutherland SE, Digesu A, Amundsen CL, McCrery RJ, De Wachter S, Kean ER, Martens F, Benson K, Ferrante KL, Cline KJ, Padron OF, Giusto L, Lane FL, Witte LPW, Dmochowski RR. Two-Year Efficacy and Safety Outcomes of the Pivotal OASIS Study Using the Revi System for Treatment of Urgency Urinary Incontinence. J Urol. 2025 Mar;213(3):323-332. doi: 10.1097/JU.0000000000004328. Epub 2024 Nov 25.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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G02-CLP-0002
Identifier Type: -
Identifier Source: org_study_id
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