The virtue sling--a new quadratic sling for postprostatectomy incontinence--results of a multinational clinical trial.

OBJECTIVE: To successfully perform male sling surgery, and the surgery must achieve proximal urethral relocation and/or bulbar urethral compression. The Virtue quadratic sling is a novel device that incorporates both mechanisms of action. We report the 1-year results of the Virtue sling with fixation and compare it with the results of the initial "unfixed" sling trial.

METHODS: A prospective trial was performed to assess the efficacy and safety of the Virtue sling. Objective success was predefined as >50% decrease in 24-hour pad weight and subjective success as a score of "much" or "very much" better on the Patient Global Impression of Improvement. Subgroups were analyzed by baseline incontinence: mild (<100 g), moderate (100-400 g), and severe (>400 g). After analysis of the 1-year data, a second clinical trial incorporating a novel "fixation" technique was performed, with similar outcome measures.

RESULTS: In the initial cohort, subjective and objective successes were achieved in 41.9% at 12 months. Median pad weight reduction was 51.1% at 12 months and varied with the degree of baseline leakage. In the fixation cohort, subjective and objective successes were 70.9% and 79.2%, median pad weight reduction was 88.3% at 12 months, and efficacy was similar regardless of baseline incontinence. There were no cases of prolonged retention and no severe adverse events.

CONCLUSION: The Virtue sling with fixation is a safe and efficacious treatment for postprostatectomy incontinence. Superior 12-month results compared with the unfixed device demonstrate that fixation prevents early sling loosening.