Outcomes of single- vs double-cuff artificial urinary sphincter insertion in low- and high-risk profile male patients with severe stress urinary incontinence.

OBJECTIVES: To evaluate continence and complication rates of bulbar single and distal bulbar double cuff insertion according to low and high risk for unfavorable artificial urinary sphincter outcomes.

PATIENTS AND METHODS: 180 patients who underwent artificial urinary sphincter implantation between 2009 and 2013 were followed according to institutional standards. Patients with previous pelvic radiation therapy, open bulbar urethral or incontinence surgery ("high risk") underwent distal bulbar double cuff (n=123), all others ("low risk") proximal bulbar single cuff (n=57) placement. Primary and secondary endpoints consisted of continence and complication rates. Kaplan-Meier analysis determined explantation-free survival, Cox regression models assessed risk factors for persistent incontinence and explantation.

RESULTS: Median follow-up was 24 months. Whereas no significant difference in pad usage/objective continence was observed after single vs. double cuff insertion, superior rates of subjective/social continence and less persistent incontinence were reported by double cuff patients (all p≤0.02). Overall, device explantation (erosion, infection or mechanical failure) occured in 12.8%. While early (<6 weeks) complication rates compared to single cuff were similar (p>0.05), double cuff patients had a 5.7-fold higher risk of device explantation in the late follow-up (p=0.02) and significantly shorter explantation-free-suvival (log-rank: 0.003).

CONCLUSIONS: Distal bulbar double cuff insertion in patients with a "high risk" profile (previous pelvic radiation, urtehral surgery) leads to similar objective continence, but increased explantation rates when compared to "low risk" proximal bulbar single cuff. Randomized controlled trials comparing both devices will need to differ if higher explanations rates attribute to the double cuff device or risk factors. This article is protected by copyright. All rights reserved.