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

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)

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200 participants in 1 patient group

Treatment arm

Experimental group

Description:

RENOVA iStim™ System implanted patients

Treatment:

Device: RENOVA iStim™ System