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OASIS: BlueWind RENOVA iStim™ System for the Treatment of OAB

Sponsor
BlueWind Medical (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03596671
Collaborator
(none)
150
Enrollment
23
Locations
1
Arm
41.7
Anticipated Duration (Months)
6.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: RENOVA iStim™ System
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Jun 12, 2019
Actual Primary Completion Date :
Jun 15, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment arm

RENOVA iStim™ System implanted patients

Device: RENOVA iStim™ System
Tibial implantable neuromodulation device

Outcome Measures

Primary Outcome Measures

  1. Improvement in urinary urgency incontinence (UUI) episodes based on patient voiding diary [6 months]

  2. Safety - incidence of adverse events [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California Irvine Orange California United States 92868
2 Kaiser Permanente San Diego California United States 92110
3 Norwalk Urology Norwalk Connecticut United States 06850
4 Florida Urology Partners Tampa Florida United States 33615
5 Comprehensive Urologic Care Lake Barrington Illinois United States 60010
6 Regional Urology, LLC Shreveport Louisiana United States 71106
7 Chesapeake Urology - Hanover Hanover Maryland United States 21076
8 Chesapeake Urology - Owing Mills Owings Mills Maryland United States 21117
9 Minnesota Urology Woodbury Minnesota United States 55125
10 Adult Pediatric Urology & Urogynecology Omaha Nebraska United States 68114
11 Duke Urogynecology Durham North Carolina United States 27707
12 Southern Urogynocology West Columbia South Carolina United States 29169
13 Sanford Health Sioux Falls South Dakota United States 57105
14 University of Washington Seattle Washington United States 98195
15 University Hospital Antwerp Antwerp Belgium 2650
16 UZ Leuven Leuven Belgium 3000
17 Rijnstate Hospital Arnhem Netherlands
18 Academic Hospital Maastricht Maastricht Netherlands
19 Radboud University Medical Center Nijmegen Netherlands
20 UMC Utrecht Utrecht Netherlands
21 Isala Zwolle Netherlands 8025 AB
22 Birmingham Women's and Children's NHS Foundation Trust Birmingham United Kingdom
23 Imperial College, St. Mary's Hospital London United Kingdom W2 1NY

Sponsors and Collaborators

  • BlueWind Medical

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
BlueWind Medical
ClinicalTrials.gov Identifier:
NCT03596671
Other Study ID Numbers:
  • G02-CLP-0002
First Posted:
Jul 24, 2018
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Urinary Bladder, Overactive

Study Results

No Results Posted as of Aug 22, 2022