To identify patient and component specific factors that predispose patients to device-related complications when undergoing pressure-regulating balloon (PRB) exchange in men with an artificial urinary sphincter (AUS).

From 2009 to 2018, 55 patients underwent AUS revision with placement of a higher pressure 71-80 cm H₂O PRB to treat recurrent stress incontinence. Patient demographics, perioperative data, and postoperative outcomes were examined and multivariable logistic regression analyses performed to identify predictors of erosion and mechanical failure.

After a median follow-up of 26.4 months (range: 6-103.7 months), 21 of 55 (38.1%) patients developed a device-related complication that required operative repair or removal of the AUS. Four (7.3%) patients developed erosion after the PRB pressure increase and 5 patients showed evidence of impending erosion on follow-up and underwent successful revision surgery. Twelve patients developed mechanical failure (cuff leak, n = 7; pump malfunction, n =4; unidentified fluid loss, n = 1). Multivariable logistic regression analysis found that increasing body mass index was a predictor of mechanical failure. Hypertension and lower body mass index were found to increase the risk of cuff erosion whereas radiotherapy was not.

In the carefully selected patient, PRB exchange can be performed to treat recurrent incontinence in patients with an AUS, including those treated with pelvic radiotherapy. Our data suggest that this technique is susceptible to a high rate of revision surgery. As such, when revising a functional AUS system, meticulous preoperative screening, comprehensive informed consent, and follow-up protocols are essential in minimizing adverse events.