The 51-60 cm H2O Artificial Urinary Sphincter Pressure Regulating Balloon: Indications and Outcomes

OBJECTIVE:To describe the role and long-term outcomes of using the 51-60cm H2O pressure regulating balloon (PRB) in male patients with an artificial urinary sphincter (AUS). METHODS:From 2005-2021, 90 patients with a variety of urethral risk factors underwent AUS placement with use of the low-pressure 51-60 cm H2O PRB to treat stress incontinence. Patient demographics, indication for use of the 51-60 cm H2O PRB, perioperative data, and postoperative outcomes were examined and Pearson's chi squared test and Wilcoxon rank sum test were used to identify associations with future revisions, erosion, and mechanical failure. RESULTS:Ninety patients were included in the study. After median follow-up of 46.6months (range: 6-146months), 4 (4.44%) patients developed an erosion-related complication that required device removal, 4 developed an infection, and 3 underwent surgery for pump relocation. One patient had a reported mechanical failure of unknown source. Thirty patients underwent revision surgery to reduce incontinence. Of the 4 patients with erosion, 1 was due to iatrogenic catheterization. The remaining 3 had numerous urethral risk factors. Univariate analysis was performed to identify predictors of cuff erosion, infection, and revision in patients with a 51-60 cm H2O PRB. No significant associations were found including prior pelvic radiation, age at AUS placement, presence of inflatable penile prosthesis (IPP), prior AUS erosion, or previous urethroplasty. CONCLUSION:The low-pressure 51-60 cm H2O PRB can be used in high-risk male patients with urinary incontinence with low rates of complications including erosion, infection, and mechanical failure. While patients may choose to undergo future revisional surgery to improve continence, the 51-60 cm H2O PRB should be considered as the initial PRB in patients with urethral risk factors.