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.
Data from a real-world evidence study of the Leva System were recently published in JMIR Formative Research, supporting the safety and effectiveness of the program in the treatment of patients with urinary incontinence.
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 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.