N/A
N=282
BlueWind RENOVA iStim™ System for the Treatment of OAB
Treatment of Patients Suffering From Overactive Bladder (OAB)
Bottom Line
View on ClinicalTrials.gov: NCT03596671 ↗Enrolled (actual)
282
Serious AEs
8.6%
Results posted
Sep 2025
Primary outcome: Primary: ≥50% Decrease in Mean Urinary Urgency Incontinence (UUI) Episodes — 76.4 Percentage of Responders
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RENOVA iStim™ System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- BlueWind Medical
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ≥50% Decrease in Mean Urinary Urgency Incontinence (UUI) Episodes |
76.4 | — |
| PRIMARY Safety - Number of Participants With Adverse Events |
117; 16; 6; 10; 13 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03596671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.