Two-Year Efficacy and Safety Outcomes of the Pivotal OASIS Study Using the Revi System for Treatment of Urgency Urinary Incontinence.

ABSTRACT:

Purpose

The BlueWind Medical Device, Revi, is a novel implantable tibial neuromodulation system powered by an external, battery-operated wearable that facilitates individually tailored stimulation to provide treatment for urgency urinary incontinence (ie, overactive bladder wet). The Revi System is the first Food and Drug Administration-cleared implantable neuromodulation device which can be used without prior failure with more conservative treatment options. Two-year follow-up results of the OASIS (Overactive Bladder Stimulation System) study are presented.

Materials and methods

The Revi System was implanted in 151 female participants. The primary efficacy and safety end points were assessed at 6 and 12 months, after which participants either consented to extend follow-up f

SUBMITTER: Heesakkers JPFA 

PROVIDER: S-EPMC12708047 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature