BlueWind RENOVA iStim™ System for the Treatment of OAB

a study on Overactive Bladder

Summary

Eligibility
for females ages 18-80 (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Felicia Lane, MD

Description

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.

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)

Keywords

Treatment of Patients Suffering From Overactive Bladder (OAB), Overactive Urinary Bladder, RENOVA iStim™ System

Eligibility

You can join if…

Open to females ages 18-80

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California Irvine accepting new patients
    Orange California 92868 United States
  • Kaiser Permanente accepting new patients
    San Diego California 92110 United States

Lead Scientist at UC Irvine

  • Felicia Lane, MD
    Health Sciences Professor, Obstetrics and Gynecology, School of Medicine. Authored (or co-authored) 35 research publications. Research interests: Urinary Incontinence · Fecal Incontinence · Pelvic Organ Prolapse · Reconstructive Pelvic Surgery

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
BlueWind Medical
ID
NCT03596671
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated
Contact us about this trial