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Data from phase 2 of the SANS-UUI trial are expected to support an application to the FDA for approval of the device in patients with urge urinary incontinence.

“This technique is feasible, it is very well tolerated, and there’s not much of a complication rate, so it appears to be very safe,” says Amy D. Dobberfuhl, MD, MS.

"We believe the collective findings are unique in urogynecology and offer strong evidence that first-line incontinence treatment is effective, and women can access it using the Leva System,” says Evelyn Hall, MD.

“We need to improve the fact that 75% of these patients are untreated [or] unmanaged and frustrated,” says Alexandra Rogers, MD.

“We think artificial intelligence has a wide variety of applications that will benefit urologists both in and out of training,” says Mubashir S. Billah, MD.

The decision is supported by findings from the phase 3 EMPOWUR trial and the phase 3 EMPOWUR extension study.