Contrast Use in Artificial Urinary Sphincter Does Not Affect Device Survival

AUS can be filled with normal saline (NS) or isotonic contrast solution. However, surgeons have voiced concerns about the impact on device malfunction and longevity, but no studies address this issue. Therefore, researchers of the Duke University Medical Center, USA, conducted a study to identify differences in outcomes between NS and contrast-filled AUS.

For this analysis, the researchers included a total of 39,363 patients in the industry who maintained the AUS database (Boston Scientific) from 2001 to 2016. They divided the patients into two groups: AUS filled with NS or contrast. They compared the patient demographics and device characteristics. The device survival was determined as time to the need for reoperation. They also 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.

Key findings of the study were:

• Among 39,363 patients, 34,674 (88.1%) devices were filled with NS.
• The researchers noted that the overall reoperation rate was 24.5%, with no difference between groups with a mean time to the operation of 3 years.
• After adjustment for age, cuff size, and PRB size using Kaplan–Meier analysis, they found a similar time to reoperation between the two groups.

The authors concluded, "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."

For further information:

https://onlinelibrary.wiley.com/doi/10.1002/nau.24668