Introduction: Artificial urinary sphincter (AUS) is the gold standard for treatment of male stress urinary incontinence. The device can be filled with normal saline (NS) or isotonic contrast solution. Contrast can be useful for trouble shooting an AUS failure, to assess for fluid leak or sub-cuff atrophy. Many surgeons are hesitant to use contrast in the device due to concerns about the impact on device malfunction and longevity, but no studies have addressed this issue. We used industry data to identify differences in outcomes between NS and contrast-filled AUS.
Methods: Each AUS placement requires the submission of a patient information form that is sent to the manufacturer in order to track outcomes. This includes details of device preparation and the filling fluid. All patients in the industry database (Boston Scientific) from 2001 to 2016 were included. Groups were divided into AUS filled with NS and AUS filled with contrast. Patient demographics were recorded. Longevity of the device was defined as time to the need for reoperation (device removal, revision, or replacement). The groups were compared using t-test and chi-square test. A Kaplan Meier curve was created to compare device survival between AUS with filled NS versus contrast.
Results: A total of 39,591 patients were included in the cohort, of which 39,363 (99.5%) were male. 34,920 (88.2%) devices were filled with NS while 4,671 (11.8%) were filled with contrast. The reoperation rate overall was 16.1%, with no difference between groups (15.8% NS versus 18.1% contrast). The rate of fluid loss and device malfunction precipitating device removal did not differ between the groups (3.3% NS vs 4.1% contrast; 0.8% NS vs 0.9% contrast). The infection rate was similar between groups (1.9% NS vs 2.7% contrast). The mean time to reoperation overall was 3.9 years (± 3.4), and was significantly longer in the contrast filled cohort (3.8 ± 3.3 years NS vs 5.1 ± 3.9 years contrast, p<0.01). On Kaplan Meier analysis, the time to reoperation was longer in the contrast filled cohort (Figure 1).
Conclusions: The use of contrast in the AUS did not change rates of device malfunction or fluid loss, and devices filled with contrast lasted longer than those filled with NS. We find that contrast in the device is useful for troubleshooting when a patient returns with recurrent incontinence, and should be considered by AUS implanters since this practice does not impact outcomes. Source of
