LAUSR

INTRODUCTION AND OBJECTIVE: Aim of the study was to evaluate the efficacy and safety of VICTO system after a follow-up 1yr. METHODS: VICTO is a preconnected adjustable AUS. The pressure in the occluding cuff is regulated by a small silicone balloon and the control pump contains a selfsealing port for pressure adjustment. Adjustments can be performed easily at any time after implantation by injection or removal of fluid. Between 12/2016 and 8/2019 the device was indicated in 80 patients with stress urinary incontinence after prostate surgery. We included the data from 45 patients (VICTO n [ 19, VICTOplus n[26) with a mean FU of 19.4 mo (range 12-20.4). Patients with 3 prior incontinence surgeries were excluded (n[7). Functional urinary outcomes were assessed according to daily pad use and a standardized questionnaire. Data were collected as part of the follow up care of these patients. RESULTS: The indwelling catheter was removed after 24 hours in all included cases and prolonged antibiotic treatment (> 5 days) was required in only a few cases (n[3). The pad per day usage (p/d) improved from 6.5 (rang 2-12) to 1.1 (range 0-3) and the continence rate (max. 1 p/d) was 80% (n[36). 5 patients (11.1%) reported max. 2 p/ d and 4 (8.9%) used 3 p/d. Between 1-5 readjustments(IQR[2) were needed to achieve a sufficient result.On average the continence situation improved about 82% and the overall satisfaction was 88.6%. The most common adverse events were postoperative pain and hematoma 11% (n[ 4). No revisions have been recorded due to mechanical failure, infection, erosion or atrophy. In 7 cases we have done optimizing surgeries according to our learning curve to improve the overall results (n[4 smaller cuff because of persistent incontinence, n[3 pump reposition). For validation purposes, we did subgroup analysis and compared the results of the patients with previous incontinence surgeries (n[7) and radiotherapy (n[17) with index patients. Results in term of p/d were similar and showed no statistically relevant differences between the groups. CONCLUSIONS: The device provides adjustability in regulating pressure in situ. In this cohort we achieved a continence rate of 80% and there have been no revisions due to mechanical failure, infection, erosion or atrophy. The complete absence of erosions proves the implant to be particularly safe. These results are promising and challenge prior AUS series. Adjusting the system pressure to the lowest level providing continence may reduce the long-term rate of complications, however bigger cohorts and long-term follow-ups are needed.