Hypothesis / aims of study
The artificial urinary sphincter (AUS) Victo ™ (Promedon, Cordoba, Argentina) is a preconnected 3-component artificial urinary sphincter that is characterized by its adjustability during the follow up after the implantation. The device is adjusted by re-filling the system with more liquid through an auto-sealant port placed in the pump. The objective of this study is evaluate the results of the early experience in different centers in Spain.
Study design, materials and methods
A mjulticenter retrospective analysis was conducted including pateints with severe stress urinary incontinence who underwent Victo™ AUS implantation between December 2023 and July 2025. Preoperative assessment included medical history, physical examination, urinanalysis, urethrocystoscopy and post-void residual measurement. Continence outcomes were evaluated using the 24-hour pad-weight test (24hPWT) anddaily pad count. Surgical complications were graded according to Clavien-Dindo classification. The number of postoperative adjusments and patient satisfaction (yes/no) were recorded.
Results
A total of 26 patients underwent Victo™ 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 previous 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%): 2 were minor (Clavien-Dindo <=2) and 2 major (Clavien-Dindo 3). 2 patients developed and infection at the injection site; on resolved with antibiotics, while the other required explantation and represented the only therapeutic failure. 2 cases of upward pump migration were obsered; 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 1 refill and 57,7% two or more (meadian 2, IQR 1-2; range 0-4). Median 24hPWT decreased from 800g (IQR 500-1200) to 30 gr (IQR 15-105), and pad/day count from 5 (IQR 3-5) to q (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.
Interpretation of results
Curently, the artificial urinary sphincter is the standard of care for male severe stress urinary incontinence, being the AMS 800™ (Boston Scientific) the most used device historically. However, it presents its limitations, including notable revision rates, complications (e.g. urethral atrophy, erosion, infection, mechanical failure), and suboptimal continence outcomes, specially at long term. In order to improve these results, the Victo™ AUS enables personalized urethral compression, potentially ameliorating functional outcomes and reducing long term ischemic complications.
In. these study we show that the earlly experience Victo™ AUS confirms acceptable short-term efficacy in terms of continence and very good satisfaction from the patients.