BlueWind RENOVA iStim™ System for the Treatment of OAB

Last updated: December 29, 2023
Sponsor: BlueWind Medical
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

RENOVA iStim™ System

Clinical Study ID

NCT03596671
G02-CLP-0002
  • Ages 18-80
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 therequirements of the study

Exclusion

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 eitherAmerican Urological Association (AUA) or European Association of Urology (EAU)guidelines

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: RENOVA iStim™ System
Phase:
Study Start date:
June 12, 2019
Estimated Completion Date:
January 31, 2025

Connect with a study center

  • University Hospital Antwerp

    Antwerp, 2650
    Belgium

    Completed

  • UZ Leuven

    Leuven, 3000
    Belgium

    Completed

  • Heilig Hart Lier

    Lier, 2500
    Belgium

    Site Not Available

  • Isar Kliniken GmbH

    München,
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen

    Tübingen,
    Germany

    Site Not Available

  • "Rabin" Medical Center - "Belinson" Campus

    Petah tikva, 49100
    Israel

    Site Not Available

  • Rijnstate Hospital

    Arnhem,
    Netherlands

    Completed

  • Academic Hospital Maastricht

    Maastricht,
    Netherlands

    Completed

  • Radboud University Medical Center

    Nijmegen,
    Netherlands

    Completed

  • UMC Utrecht

    Utrecht,
    Netherlands

    Completed

  • Isala

    Zwolle, 8025 AB
    Netherlands

    Completed

  • Birmingham Women's and Children's NHS Foundation Trust

    Birmingham,
    United Kingdom

    Completed

  • Imperial College, St. Mary's Hospital

    London, W2 1NY
    United Kingdom

    Completed

  • University of California Irvine

    Orange, California 92868
    United States

    Site Not Available

  • Kaiser Permanente

    San Diego, California 92110
    United States

    Active - Recruiting

  • Colorado Pelvic Floor Consultants

    Denver, Colorado 80220
    United States

    Site Not Available

  • Norwalk Urology

    Norwalk, Connecticut 06850
    United States

    Completed

  • Florida Urology Partners

    Tampa, Florida 33615
    United States

    Completed

  • Comprehensive Urologic Care

    Lake Barrington, Illinois 60010
    United States

    Active - Recruiting

  • NorthShore University HealthSystem

    Skokie, Illinois 60076
    United States

    Site Not Available

  • Regional Urology, LLC

    Shreveport, Louisiana 71106
    United States

    Site Not Available

  • Chesapeake Urology - Hanover

    Hanover, Maryland 21076
    United States

    Site Not Available

  • Chesapeake Urology - Owing Mills

    Owings Mills, Maryland 21117
    United States

    Site Not Available

  • Minnesota Urology

    Woodbury, Minnesota 55125
    United States

    Site Not Available

  • Adult Pediatric Urology & Urogynecology

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Duke Urogynecology

    Durham, North Carolina 27707
    United States

    Site Not Available

  • Albert Einstein Healthcare Network

    Plymouth Meeting, Pennsylvania 19462
    United States

    Site Not Available

  • Southern Urogynocology

    West Columbia, South Carolina 29169
    United States

    Completed

  • Sanford Health

    Sioux Falls, South Dakota 57105
    United States

    Completed

  • Inova Fairfax Medical Campus

    Falls Church, Virginia 22042
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98195
    United States

    Active - Recruiting

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