Dr. Rogers discusses FDA approval of InterStim X system

The UUI responder rate was 71.8% among those who received SNM and 71.3% among those who received iTNM.

“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.

At 1 month, the mean decrease in the OAB-Q symptom severity subscale score was -31.2 in the 1-injection cohort vs -39.5 in the 10-injection cohort.

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

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.