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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03596671
Recruitment Status : Recruiting
First Posted : July 24, 2018
Last Update Posted : January 3, 2024
Sponsor:
Information provided by (Responsible Party):
BlueWind Medical

Study Description
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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
Treatment of Patients Suffering From Overactive Bladder (OAB) Device: RENOVA iStim™ System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 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 : June 12, 2019
Actual Primary Completion Date : October 28, 2022
Estimated Study Completion Date : January 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment arm
RENOVA iStim™ System implanted patients
 Device: RENOVA iStim™ System
Tibial implantable neuromodulation device


Outcome Measures
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Primary Outcome Measures :
  1. Improvement in urinary urgency incontinence (UUI) episodes based on patient voiding diary [ Time Frame: 6 months ]
  2. Safety - incidence of adverse events [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03596671


Contacts
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Contact: Roni Diaz (469) 423 -2015 roni.diaz@bluewindmedical.com

Locations
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Sponsors and Collaborators
BlueWind Medical
Investigators
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Principal Investigator: John Heesakkers, MD Maastricht University Medical Centre
More Information
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Responsible Party: BlueWind Medical
ClinicalTrials.gov Identifier: NCT03596671    
Other Study ID Numbers: G02-CLP-0002
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: January 3, 2024
Last Verified: December 2023

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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
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Male Urogenital Diseases
Lower Urinary Tract Symptoms
Urological Manifestations