Dr. Samantha Pulliam describes the leva Pelvic Health System

In total, the prospective SOPHIA study enrolled 6 men with stress urinary incontinence who have reduced outlet resistance due to intrinsic sphincter deficiency.

“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.

The FDA's decision was based on results from the OASIS trial, in which the Revi tibial neurostimulator device demonstrated significant efficacy for treating urge urinary incontinence in women.

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

The UroActive device is currently being studied in the SOPHIA study, which published initial results earlier this year.

UroMonitor was developed in response to conventional urodynamics, which have several limitations.