BlueWind RENOVA iStim™ System for the Treatment of OAB (OASIS)

August 27, 2025 updated by: BlueWind Medical

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

282

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2650
        • University Hospital Antwerp
      • Leuven, Belgium, 3000
        • UZ Leuven
  • Netherlands
      • Arnhem, Netherlands
        • Rijnstate Hospital
      • Maastricht, Netherlands
        • Academic Hospital Maastricht
      • Nijmegen, Netherlands
        • Radboud University Medical Center
      • Utrecht, Netherlands
        • UMC Utrecht
      • Zwolle, Netherlands, 8025 AB
        • Isala
  • United Kingdom
      • Birmingham, United Kingdom
        • Birmingham Women's and Children's NHS Foundation Trust
      • London, United Kingdom, W2 1NY
        • Imperial College, St. Mary's Hospital
  • United States
    • California
      • Orange, California, United States, 92868
        • University of California Irvine
      • San Diego, California, United States, 92110
        • Kaiser Permanente
    • Connecticut
      • Norwalk, Connecticut, United States, 06850
        • Norwalk Urology
    • Florida
      • Tampa, Florida, United States, 33615
        • Florida Urology Partners
    • Illinois
      • Lake Barrington, Illinois, United States, 60010
        • Comprehensive Urologic Care
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Regional Urology, LLC
    • Maryland
      • Hanover, Maryland, United States, 21076
        • Chesapeake Urology - Hanover
      • Owings Mills, Maryland, United States, 21117
        • Chesapeake Urology - Owing Mills
    • Minnesota
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Urology
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Adult Pediatric Urology & Urogynecology
    • North Carolina
      • Durham, North Carolina, United States, 27707
        • Duke Urogynecology
    • South Carolina
      • West Columbia, South Carolina, United States, 29169
        • Southern Urogynocology
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Sanford Health
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment arm
RENOVA iStim™ System implanted patients
Device: RENOVA iStim™ System
Tibial implantable neuromodulation device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
≥50% Decrease in Mean Urinary Urgency Incontinence (UUI) Episodes
Time Frame: 6 months
Proportion of responders at 6 months post system activation as demonstrated by ≥50% improvement in average number of urgency related incontinence episodes, measured by 7-day Patient Voiding Diary.
6 months
Safety - Number of Participants With Adverse Events
Time Frame: 12 months
The primary safety endpoint was to assess adverse events from implantation to 12-months post-activation (Treatment Emergent Adverse Events).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BlueWind Medical

Investigators

  • Principal Investigator: John Heesakkers, MD, Maastricht University Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2019

Primary Completion (Actual)

October 28, 2022

Study Completion (Actual)

January 24, 2025

Study Registration Dates

First Submitted

July 1, 2018

First Submitted That Met QC Criteria

July 12, 2018

First Posted (Actual)

July 24, 2018

Study Record Updates

Last Update Posted (Estimated)

September 16, 2025

Last Update Submitted That Met QC Criteria

August 27, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G02-CLP-0002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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