BlueWind RENOVA iStim System for the Treatment of OAB

  • STATUS
    Recruiting
  • End date
    Dec 11, 2022
  • participants needed
    200
  • sponsor
    BlueWind Medical
Updated on 11 November 2020
Investigator
Roni Diaz
Primary Contact
Chesapeake Urology - Owing Mills (0.5 mi away) Contact
+11 other location

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.

Details
Treatment RENOVA iStim™ System
Clinical Study IdentifierNCT03596671
SponsorBlueWind Medical
Last Modified on11 November 2020

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Eligibility

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Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Are you female?
Do you have Treatment of Patients Suffering From Overactive Bladder (OAB)?
Do you have any of these conditions: Do you have Treatment of Patients Suffering From Overactive Bladder (OAB)??
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
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Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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