Trials / Completed
CompletedNCT03596671
BlueWind RENOVA iStim™ System for the Treatment of OAB
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)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 282 (actual)
- Sponsor
- BlueWind Medical · Industry
- Sex
- Female
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | RENOVA iStim™ System | Tibial implantable neuromodulation device |
Timeline
- Start date
- 2019-06-12
- Primary completion
- 2022-10-28
- Completion
- 2025-01-24
- First posted
- 2018-07-24
- Last updated
- 2025-09-16
- Results posted
- 2025-09-16
Locations
23 sites across 4 countries: United States, Belgium, Netherlands, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03596671. Inclusion in this directory is not an endorsement.