Cindy Amundsen, MD, shares 2-year data on the Revi System for UUI

In this video, Cindy L. Amundsen, MD, shares updated 2-year data from the OASIS trial (NCT03596671), which is evaluating the Revi System in patients with urgency urinary incontinence (UUI). The findings were shared by Amundsen, who is a urogynecologist at Duke University in Durham, North Carolina, at Pelvic Floor Disorders Week 2024 in Washington, DC.

In total, 151 patients were initially enrolled in the trial, of whom 97 completed the 24-month assessment. Data showed that 79% of patients experienced a response to therapy, and 56% achieved at least a 75% reduction in UUI episodes. Regarding safety, no serious device- or procedure-related adverse events were observed at 24 months.¹

Video Transcript:

The great thing about this study is that although we looked at the outcomes at 6 months as a primary outcome for their first paper, we also then followed patients for 12 months, and I'll be presenting the 24-month outcomes. Again, all [patients who] were recruited were women who mainly suffer from urgency incontinence, though the devices is also FDA approved for men.

The outcomes were looking at safety. When you have a new device, especially placed in an area that urogynecologists and urologists are not operating in, which is the ankle, we want the device to be safe, and, of course, the therapy effective[ness]. I think that's the great thing that we found out by this device. The explantation rates were extremely low at 2%, and they were explanted not because of device or procedure-related [reasons]. Because this particular Revi System is anchored to the fascia, we did not see any migrations of this device in the ankle, and no long-term pain or any problems with patients able to return to their regular activities. So, that was all very good. All adverse events were mild and moderate and were around the time of implant, which is typical, [and requires a] need for maybe some antibiotics or anti-inflammatory medication. These side effects or adverse events were resolved.

And then, of course, the other thing we want to know about the device is its efficacy. The good thing about it is it rivals other neuromodulation devices that are already on the market. This is a more minimally invasive option for individuals, and the rates were sustained throughout the whole 2-year period of time. Over 80% of the patients are greater than 50% improved, and 50% [had] over [a] 75% reduction in UUI episodes. [These were] very exciting results that were sustainable, and also adverse events very low.

This transcription was AI generated and edited by human editors for clarity.

Reference

1. Amundsen C, Heesakkers J, Toozs-Hobson P, et al. 2 year results: Revi therapy, implanted neuromodulator for urgency incontinence. Presented at: Pelvic Floor Disorders Week 2024. October 22-25, 2024. Washington, DC