BlueWind RENOVA iStim™ System for the Treatment of OAB

Description

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.

Conditions

Treatment of Patients Suffering From Overactive Bladder (OAB)

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Study Overview

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Study Details

Study overview

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.

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)

BlueWind RENOVA iStim™ System for the Treatment of OAB

Condition
Treatment of Patients Suffering From Overactive Bladder (OAB)
Intervention / Treatment

-

Contacts and Locations

Orange

University of California Irvine, Orange, California, United States, 92868

San Diego

Kaiser Permanente, San Diego, California, United States, 92110

Norwalk

Norwalk Urology, Norwalk, Connecticut, United States, 06850

Tampa

Florida Urology Partners, Tampa, Florida, United States, 33615

Lake Barrington

Comprehensive Urologic Care, Lake Barrington, Illinois, United States, 60010

Shreveport

Regional Urology, LLC, Shreveport, Louisiana, United States, 71106

Hanover

Chesapeake Urology - Hanover, Hanover, Maryland, United States, 21076

Owings Mills

Chesapeake Urology - Owing Mills, Owings Mills, Maryland, United States, 21117

Woodbury

Minnesota Urology, Woodbury, Minnesota, United States, 55125

Omaha

Adult Pediatric Urology & Urogynecology, Omaha, Nebraska, United States, 68114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

BlueWind Medical,

John Heesakkers, MD, PRINCIPAL_INVESTIGATOR, Maastricht University Medical Centre

Study Record Dates

2025-01