Effectiveness and Complications of the AMS AdVance™ Male Sling System for the Treatment of Stress Urinary Incontinence: A Prospective Multicenter Study.

ABSTRACT

OBJECTIVE: To evaluate the effectiveness and tolerance of the AdVance Male Sling System for the treatment of male stress urinary incontinence in patients after prostatic surgery. METHODS: An international, observational, prospective, multicenter study was conducted on male patients with urinary incontinence after prostatic surgery. Patients underwent a 24-hour pad test with a threshold at 250 g. All patients were operated with the same AdVance implant procedure. They were seen 6 weeks later, and examined again at 3, 6, 12, and 24 months. Incontinence was measured using 1-hour and 24-hour pad tests, the number of protective pads used, ICIQ-SF and IQoL questionnaires. Success was defined as no urinary leakage and no pad use. Patient improvement was defined as a reduction of more than 50% in leakage and no more than one pad used per day. Any perioperative and late complications were documented. RESULTS: From January 2007 to November 2012, 113 patients were successfully operated on. At 24 months after surgery, the mean weight of the 1-hour pad test had decreased from 48.7 g to 6.6 g (P < 0.001) while that of the 24-hour pad test decreased to 45.0 g from 113.9 g (P < 0.001). Success and improvement occurred in 22.6% and 58.0% of the patients, respectively. Seventy-five patients (80.6%) used none or one protective pad daily, and the IQoL and ICIQ-SF scores were both significantly improved. Fourteen patients (12.4%) required a second intervention. Three patients (2.7%) had a Clavien IIIb complication. CONCLUSION: The AdVance Male Sling System is an effective treatment for mild to moderate male stress urinary incontinence. Complications from its use are rare and 24-month results are satisfactory.