A new adjustable artificial urinary sphincter for male stress urinary incontinence (VictoTM): preliminary clinical results

Background: To introduce a novel adjustable artificial urinary sphincter (AUS) for treatment of male stress urinary incontinence (SUI) and perform a preliminary clinical investigation to determine the safety and efficacy of the device.Methods: Men with urodynamically proven SUI following radical prostatectomy (RP), transurethral resection of prostate (TURP) and pelvic injuries were implanted with the Victo-AUS. Patients with three or more previous incontinence surgeries were excluded from the series. Patients were monitored over a mean follow up of 29 months (range, 13.7-47.9 months). The device was tested for efficacy by using objective measurements of urinary leakage and continence. We used validated questionnaires at baseline and clinical follow-ups. The key outcomes were overall improvement, patients reported satisfaction and complication rate.Results: A total of 88 patients between December 2016 and December 2019 have been enrolled in this trial. Improvement was defined as a reduction in pad usage per day (p/d) over 50% compared to baseline. In total, 70 (88%) patients were reported to be improved. Treatment success according to the definition of 0-1 p/d was accomplished in 56 (70%) patients. Urethral erosion, infection or mechanical failure occurred in 4 (5%), 4 (5%) and 1 (1.3%) patient respectively. Explantation of the device was mandatory in 6 patients due to erosion, infection or mechanical failure.Conclusions: In this series, a continence rate of 70% was achieved with an acceptable complication-rate. These results together with a high satisfaction rate demonstrate effectiveness and safety of the Victo system in mid-term follow-up for the treatment of male SUI.