Clinically proven to be the key to treating UUI
Of patients who completed the study* (124/130) were satisfied with the treatment at 12 months
High patient satisfaction
Following treatment with BlueWind Revi™, patients in the OASIS pivotal study reported high levels of satisfaction and saw some or much benefit in their treatment at 12 months. In addition, 85% of patients implanted with Revi experienced a ≥ 10 point improvement, a clinically meaningful benefit, in their Health-Related Quality of Life (HRQL) score at 12 months.
Proven efficacy, proven results
In the OASIS pivotal study, Revi demonstrated significant reductions in UUI episodes after 6 months of treatment in the ITT population (P<.0001). In the Completers analysis* (N=139) at 12 months, Revi demonstrated:1
82%
of patients had ≥ 50% reduction in UUI episodes.
67%
of patients had ≥ 75% reduction in UUI episodes.
50%
of patients were dry on 3 consecutive days.
Favorable safety profile
Revi’s leadless implant design with activation by a rechargeable external wearable, combined with its reproducible surgical technique, has resulted in an exceptional safety profile that underscores its transformative benefits. Of the patients implanted with Revi at 12 months:1,2
- No device or procedure-related serious adverse events (SAEs)
- No surgical revision/reintervention related to migration
- No unanticipated adverse events
Patient-centric programming improves outcomes over time
With the ability to individually tailor and optimize treatment parameters, Revi demonstrates a reduction in UUI episodes over time, particularly in those seeing a ≥ 75% improvement. By 12 months, an impressive 66.9% of patients who completed this study saw a ≥ 75% improvement in their UUI due to patient-centric programming.1
The OASIS pivotal trial is a prospective, single-arm, open-label study conducted to evaluate the safety and efficacy of the Revi System for treating patients with urge urinary incontinence (UUI).
The OASIS trial consisted of:
- 23 leading medical centers across the U.S., U.K., and Europe.
- 151 women enrolled.
- 9+ UUI episodes during a 7-day diary were required for inclusion.
- ≥ 50% reduction in UUI episodes compared to baseline was the primary endpoint.
Highly regarded OASIS oversight
OASIS’ Data Safety Monitoring Board and Clinical Events Committee are comprised of some of the most highly regarded physicians in academia, ensuring the highest level of scientific rigor and ethical oversight. Their objective and independent perspective is invaluable in helping to ensure that the study results are valid, reliable, and relevant.
Data & Safety Monitoring Board (DSMB)
Clinical Event Committee (CEC)
Pilot study demonstrated durable efficacy at 3 years
At 36 months in a prospective, interventional, multi-center, single-arm study, the results were durable with a 75% success rate in the intention-to-treat (ITT) analysis (n=20). In addition, 80% of the ITT analysis had a greater than 50% reduction in the number of large volume leaks at 36 months, the most debilitating type of leaks.3
*Completers analysis represents the patients with available data at 12 months.
For further information on the OASIS study and other on-going clinical studies, please visit clinicaltrials.gov (OASIS NCT03596671)
References
1. Heesakkers, J.et al. (2023, April 30). Pivotal Study of a Novel Wirelessly Powered, Patient Tailored Programmed, Tibial Neurostimulator for the Treatment of Patients with Overactive Bladder. AUA 2023.
2. Sutherland, S et. al. OASIS Pivotal Trail to Evaluate the Safety and Efficacy of the Renova iStim System and for the Treatment of Women with OAB. Jurol. 2022; 207(S5):e1043.
3. Dorsthorst MJ, Digesu GA, Tailor V, Gore M, van Kerrebroeck PE, van Breda HMK, Elneil S, Heesakkers J. 3-year follow-up of a new implantable tibial nerve stimulator for the treatment of Overactive Bladder Syndrome. Jurol Vol. 204, 545-550, September 202. https://doi.org/10.1097/JU.0000000000001024