Use of isotonic contrast solution in the artificial urinary sphincter does not impact device longevity

The artificial urinary sphincter (AUS), the gold standard for treatment of male stress urinary incontinence, can be filled with normal saline (NS) or isotonic contrast solution. Surgeons have voiced concerns about the impact on device malfunction and longevity, but no studies address this issue. We used industry data to identify differences in outcomes between NS and contrast-filled AUS.

Our analysis included all men patients in the industry who maintained the AUS database (Boston Scientific) from 2001 to 2016. Patients were divided into two groups: AUS filled with NS or contrast. Patient demographics and device characteristics were compared. Device survival was defined as time to the need for reoperation. We compared device survival between AUS filled with NS versus contrast using a Kaplan-Meier curve adjusted for age, cuff size, and pressure regulating balloon (PRB) size.

A total of 39,363 patients were included. 34,674 (88.1%) devices were filled with NS. The reoperation rate overall was 24.5%, with no difference between groups. The mean time to reoperation overall was 3 years (±3.0). After adjustment for age, cuff size, and PRB size, Kaplan-Meier analysis demonstrated a similar time to reoperation between the two groups.

The use of contrast in the AUS does not appear to change rates of the device malfunction, fluid loss, or need for reoperation. Since filling the device with contrast does not appear inferior to saline in terms of longevity, we feel this should be considered a safe tool for the implanting surgeon.