Pressure Regulating Balloon Herniation: A Correctable Cause of Artificial Urinary Sphincter Malfunction

Objective: To report our experience with isolated pressure regulating balloon (PRB) replacement for artificial urinary sphincter (AUS) malfunction in the setting of PRB herniation. Methods: A retrospective review of our large single-surgeon male AUS database was completed. We analyzed men with herniated PRBs palpable in the groin within an otherwise intact system. Patients with evidence of AUS fluid loss were excluded. PRBs were replaced in a submuscular location through a lower abdominal incision. Continence was defined as requiring ≤1 pad per day. Cystoscopic improvement of sphincter coaptation was confirmed intraoperatively. Results: Of the 725 patients who underwent AUS surgery between 2011 and 2019, we identified 23 (3.2%) with PRB herniation and persistent or bothersome stress urinary incontinence who underwent isolated PRB replacement (median age 72 years, interquartile range 66-80). Four of the 23 patients were excluded from the analysis for subsequent explant unrelated to PRB replacement. At a mean follow-up of 21.7 months (range 2-99 months), 94.7% of patients (18/19) noted significant improvement in their stress urinary incontinence, and 78.9% of patients (15/19) achieved continence. Median time between AUS placement and PRB revision was 13 months (interquartile range 6-34 months). Conclusion: PRB replacement appears to be a safe and effective salvage therapy for AUS patients with PRB herniation and persistent incontinence without mechanical failure. Intraoperative cystoscopic confirmation of enhanced sphincter coaptation appears to be a reliable predictor of treatment success.