Background

Artificial urinary sphincters (AUS) are the gold standard treatment for patients with stress urinary incontinence. However, risk factors for implant infection, complication, or re-intervention (removal, repair, replacement) are incompletely understood. We sought to understand the impact of various patient factors on the risk of device failure by leveraging a large, multi-national research database.

Methods

We queried the TriNetX database for all adult patients undergoing AUS. We evaluated the impact of age, body mass index, race, ethnicity, diabetes (DM), smoking history, history of radiation therapy (RT), history of radical prostatectomy (RP) and history of urethroplasty on select clinical outcomes. Our primary outcome was the need for re-intervention defined by current procedural terminology (CPT) codes. Secondary outcomes included overall device complication rate and infection rate defined by international classification of diseases (ICD) codes. Analytics were performed on TriNetX which calculated risk ratios (RR) and Kaplan-Meier (KM) survival. We evaluated our outcomes first on the entire population and then repeated analyses for each individual comparison cohort using the remaining demographic variables to perform propensity score matching (PSM).

Results

The overall rates of AUS re-intervention, complication and infection were 23.4%, 24.1% and 6.4%, respectively. KM analysis showed median AUS survival (no need for re-intervention) at 10.6 years and projected 20-year survival probability at 31.3%. Patients with a history of smoking or urethroplasty were at higher risk of AUS complication and re-intervention. Patients with DM or a history of RT were at higher risk of AUS infection. Patients with a history of RT were at higher risk of AUS complication. All risk factors besides race showed a difference in device removal itself.

Conclusions

To our knowledge, this represents the largest series to follow patients with an AUS. About one-quarter of AUS patients needed re-intervention. Multiple demographics place patients at increased risk of re-intervention, infection, or complication. These results can help guide patient selection and counseling with the goal of reducing complications.