Dr. Pulliam on future research for the leva Pelvic Health System

Over 12 weeks, the average reduction in total UI frequency was 2.3 episodes per day among those in the pelvic yoga program compared with 1.9 episodes per day among those in the general physical conditioning program.

“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.

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.

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

"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.

The phase 1b trial enrolled 51 female patients with OAB to assess the safety, tolerability, and preliminary efficacy of V117957.