CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 282 enrolled
Drug / intervention
RENOVA iStim™ Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03596671
NCT03596671N/ACompleted

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)

BlueWind Medical·interventional·Posted Jul 24, 2018·Updated Sep 16, 2025

In Brief

A clinical study evaluating RENOVA iStim™ System for Treatment of Patients Suffering From Overactive Bladder (OAB). Completed, enrolled 282 participants across 23 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Netherlands, United Kingdom, United States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJul 24, 2018
Enrollment StartJun 12, 2019
Primary CompletionOct 28, 2022
Study CompletionJan 24, 2025
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 7.9 years ago

Interventions

RENOVA iStim™ Systemdevice

Tibial implantable neuromodulation device