Abstract Introduction Severe male stress urinary incontinence (SUI) remains a challenging condition that profoundly affects quality of life. The artificial urinary sphincter (AUS) is the standard of care, with the AMS 800 (Boston Scientific) historically regarded as the gold standard. However, it presents limitations, including notable revision rates, complications (e.g.,urethral atrophy,erosion,infection,mechanical failure), and suboptimal continence outcomes (45–60%). The VICTOTM AUS (Promedon) introduces a preconnected 3-component design with a self-sealing port allowing in-office postoperative pressure adjustment. This enables personalized urethral compression, potentially improving functional outcomes and reducing ischemic complications. Objective The aim of this study was to evaluate the safety and early outcomes of the VICTOTM AUS in a multicenter cohort of patients with severe SUI. Methods A multicenter retrospective analysis was conducted including patients with severe SUI who underwent VICTOTM AUS implantation between December 2023 and July 2025. Preoperative assessment included medical history, physical examination, urinalysis, bladder diary, urethrocystoscopy, and post-void residual measurement. Continence outcomes were evaluated using the 24-hour pad- weight test (24hPWT) and daily pad count. Surgical complications were graded according to Clavien–Dindo. The number of postoperative adjustments and patient satisfaction (yes/no) were recorded. Results A total of 26 patients underwent VICTOTM implantation, including a subset of high-risk cases: 15 (57.7%) presented at least one risk factor such as prior prostate radiotherapy, urethral surgery, or sling placement. The median follow-up was 5.8 months (IQR 4.6; range:2.2–16.4). Postoperative complications occurred in 4/26 patients (15.4%): two were minor (Clavien–Dindo ≤II) and two major (Clavien–Dindo III). Two patients developed an infection at the injection site-one resolved with antibiotics, while the other required explantation and represented the only therapeutic failure. Two cases of upward pump migration were observed; one did not require reoperation, as the patient was still able to operate the device effectively. No intraoperative complications or postoperative urinary retention occurred. After activation, 84.6% of patients required at least one refill and 57.7% two or more (median 2, IQR 1-2; range 0- 4). Median 24hPWT decreased from 800 g (IQR 500–1200) to 30 g (IQR 15–105), and pad/day count from 5 (IQR 3–5) to 1 (IQR 1– 2), with both reductions reaching statistical significance (p 0.001, Wilcoxon test; n=23 and n=25). Except for the single therapeutic failure, the majority of patients (96.2%) reported being satisfied with the outcome. Conclusions The VICTOTM AUS appeared safe and effective, with high patient satisfaction; most patients required at least one postoperative adjustment. Disclosure No
Poblador et al. (Mon,) studied this question.