Summary

Eligibility
for females ages 18-80 (full criteria)
Location
at UC Irvine
Dates
study started
estimated completion
Principal Investigator
by Felicia Lane, MD (uci)

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) Urinary Bladder, Overactive 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 University of California Health

  • Felicia Lane, MD (uci)
    Health Sciences Professor, Obstetrics and Gynecology. Authored (or co-authored) 32 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
Last Updated