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

Abstract

Background: Artificial urinary sphinkter (AUS) are still the gold standard for treatment of male stress urinary incontinence with good clinical outcomes and high patient's reported satisfaction rate. However, more than half of the patients with an AUS will require additional procedures, most likely revisions. To introduce a novel adjustable AUS for treatment of male stress urinary incontinence 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.