The Virtue quadratic male sling for postradical prostatectomy urinary incontinence: 3-Year outcome measurements and a predictive model of surgical outcome from a European prospective observational study.

AIMS: This prospective multicenter observational study evaluated postprostatectomy incontinence treatment outcomes with Virtue male sling at 12 and 36 months. METHODS: Objective assessment was based on a 24-h pad weight test with improvement defined by a decrease >50% and cure by less than 1.3 g. Subjective assessment was based on the patient global impression of improvement and International Consultation on Incontinence Questionnaire-urinary incontinence-short form (ICIQ-UI-SF) questionnaires. Subgroups were analyzed by baseline severity of incontinence on a 24-h-pad test, body mass index (BMI), and pads usage. Factors associated with treatment response were assessed using logistic regression at Months 36. Complications were reported. RESULTS: We analyzed data from 117 men. Objective and subjective improvement were achieved in 54% and 35% and 51% and 34% at 12 and 36 months, respectively. Twenty-one percent and 19% were considered cured, respectively, at 12 and 36 months. No differences per baseline incontinence severity, BMI and pads usage were found at 36 months. Mean ICIQ-UI-SF score decreased from 15 to 9. Predictive factors were BMI, postvoid residual urine, number of nighttime urination, and ICIQ total score. Seven Clavien-Dindo Grade III (5.1%) including four Virtue sling revisions were reported. The most frequent Grade II complications were overactive bladder symptoms and pain reported in 10.3% and 2.9%, respectively. No complications required explantation. CONCLUSIONS: Virtue male sling is safe and effective in males with mild to severe postprostatectomy urinary incontinence over 36 months. Virtue could be considered an interesting option for postradical prostatectomy urinary incontinence with positive results over time even in patients with high BMI. The predictive model should be validated by further studies.