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The trial is taking place at:
S

Sanford Health | Clinical Research Department

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

B

BlueWind Medical

Status

Enrolling

Conditions

Treatment of Patients Suffering From Overactive Bladder (OAB)

Treatments

Device: RENOVA iStim™ System

Study type

Interventional

Funder types

Industry

Identifiers

NCT03596671
G02-CLP-0002

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

200 participants in 1 patient group

Treatment arm
Experimental group
Description:
RENOVA iStim™ System implanted patients
Treatment:
Device: RENOVA iStim™ System

Trial contacts and locations

23

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Central trial contact

Roni Diaz

Data sourced from clinicaltrials.gov

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