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

Primary Purpose

Treatment of Patients Suffering From Overactive Bladder (OAB)

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
RENOVA iStim™ System
Sponsored by
BlueWind Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment of Patients Suffering From Overactive Bladder (OAB)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of California IrvineRecruiting
  • Kaiser PermanenteRecruiting
  • Norwalk Urology
  • Florida Urology Partners
  • Comprehensive Urologic CareRecruiting
  • Regional Urology, LLCRecruiting
  • Chesapeake Urology - HanoverRecruiting
  • Chesapeake Urology - Owing MillsRecruiting
  • Minnesota UrologyRecruiting
  • Adult Pediatric Urology & UrogynecologyRecruiting
  • Duke UrogynecologyRecruiting
  • Southern Urogynocology
  • Sanford Health
  • University of WashingtonRecruiting
  • University Hospital Antwerp
  • UZ Leuven
  • Rijnstate Hospital
  • Academic Hospital Maastricht
  • Radboud University Medical Center
  • UMC Utrecht
  • Isala
  • Birmingham Women's and Children's NHS Foundation Trust
  • Imperial College, St. Mary's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment arm

Arm Description

RENOVA iStim™ System implanted patients

Outcomes

Primary Outcome Measures

Improvement in urinary urgency incontinence (UUI) episodes based on patient voiding diary
Safety - incidence of adverse events

Secondary Outcome Measures

Full Information

First Posted
July 1, 2018
Last Updated
September 7, 2023
Sponsor
BlueWind Medical
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1. Study Identification

Unique Protocol Identification Number
NCT03596671
Brief Title
BlueWind RENOVA iStim™ System for the Treatment of OAB
Acronym
OASIS
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 12, 2019 (Actual)
Primary Completion Date
October 28, 2022 (Actual)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BlueWind Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment of Patients Suffering From Overactive Bladder (OAB)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment arm
Arm Type
Experimental
Arm Description
RENOVA iStim™ System implanted patients
Intervention Type
Device
Intervention Name(s)
RENOVA iStim™ System
Intervention Description
Tibial implantable neuromodulation device
Primary Outcome Measure Information:
Title
Improvement in urinary urgency incontinence (UUI) episodes based on patient voiding diary
Time Frame
6 months
Title
Safety - incidence of adverse events
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roni Diaz
Phone
(469) 423 -2015
Email
roni.diaz@bluewindmedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Heesakkers, MD
Organizational Affiliation
Maastricht University Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linh Huynh
Phone
714-456-6155
Email
plhuynh@hs.uci.edu
First Name & Middle Initial & Last Name & Degree
Felicia Lane, MD
Facility Name
Kaiser Permanente
City
San Diego
State/Province
California
ZIP/Postal Code
92110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gisselle Zazueta
Phone
619-821-5717
Email
gisselle.zazueta-damian@kp.org
First Name & Middle Initial & Last Name & Degree
Linda Mackinnon
Phone
619-821-6009
Email
linda.m.mackinnon@kp.org
First Name & Middle Initial & Last Name & Degree
Kimberly Ferrante, MD
First Name & Middle Initial & Last Name & Degree
Shawn Menefee, MD
Facility Name
Norwalk Urology
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06850
Country
United States
Individual Site Status
Completed
Facility Name
Florida Urology Partners
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Individual Site Status
Completed
Facility Name
Comprehensive Urologic Care
City
Lake Barrington
State/Province
Illinois
ZIP/Postal Code
60010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Knutson
Phone
847-852-4306
Email
jknutson@compurocare.com
First Name & Middle Initial & Last Name & Degree
Ning Z Wu, MD
Facility Name
Regional Urology, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leah Renfro
Phone
318-683-0411
Ext
125
Email
lrenfro@regionalurology.com
First Name & Middle Initial & Last Name & Degree
Kayla Telano
Email
ktelano@regionalurology.com
First Name & Middle Initial & Last Name & Degree
Kevin Cline, MD
First Name & Middle Initial & Last Name & Degree
Ashley Baker, MD
Facility Name
Chesapeake Urology - Hanover
City
Hanover
State/Province
Maryland
ZIP/Postal Code
21076
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Kyei
Phone
443-231-1313
Email
bkyei@chesuro.com
First Name & Middle Initial & Last Name & Degree
Kaiser Robertson, MD
Facility Name
Chesapeake Urology - Owing Mills
City
Owings Mills
State/Province
Maryland
ZIP/Postal Code
21117
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rayna Bennett
Phone
443-231-1203
Email
rbennett@chesuro.com
First Name & Middle Initial & Last Name & Degree
Laura Giusto, MD
Facility Name
Minnesota Urology
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shirley Eke-ejee
Phone
651-999-7033
Email
sekeejee@mnurology.com
First Name & Middle Initial & Last Name & Degree
Diane Kachel
Phone
612-819-0533
Email
dkachel@mnurology.com
First Name & Middle Initial & Last Name & Degree
Michael Ehlert, MD
Facility Name
Adult Pediatric Urology & Urogynecology
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amber Howard, RN
Phone
402-399-7894
Email
ahoward@adultpediatricuro.com
First Name & Middle Initial & Last Name & Degree
Rebecca McCrery, MD
Facility Name
Duke Urogynecology
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27707
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasmeen Bruton
Phone
919-401-1015
Email
yasmeen.bruton@duke.edu
First Name & Middle Initial & Last Name & Degree
Cindy Amundsen, M.D.
Facility Name
Southern Urogynocology
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Individual Site Status
Completed
Facility Name
Sanford Health
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Individual Site Status
Completed
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Wick
Phone
206-356-0240
Email
Kwick11@uw.edu
First Name & Middle Initial & Last Name & Degree
Suzette Sutherland, MD
Facility Name
University Hospital Antwerp
City
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Completed
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Completed
Facility Name
Rijnstate Hospital
City
Arnhem
Country
Netherlands
Individual Site Status
Completed
Facility Name
Academic Hospital Maastricht
City
Maastricht
Country
Netherlands
Individual Site Status
Completed
Facility Name
Radboud University Medical Center
City
Nijmegen
Country
Netherlands
Individual Site Status
Completed
Facility Name
UMC Utrecht
City
Utrecht
Country
Netherlands
Individual Site Status
Completed
Facility Name
Isala
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Individual Site Status
Completed
Facility Name
Birmingham Women's and Children's NHS Foundation Trust
City
Birmingham
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Imperial College, St. Mary's Hospital
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Individual Site Status
Completed

12. IPD Sharing Statement

Learn more about this trial

BlueWind RENOVA iStim™ System for the Treatment of OAB

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