Victo is an adjustable artificial urinary sphincter (AUS), consisting of three parts which are preconnected. A pressure regulating balloon, a cuff, and a pump, which includes a self-sealing port for adjustment.
The objective of the present study is to evaluate the efficiency and safety of the VICTO AUS in the treatment of male stress urinary incontinence (SUI).

A total of 116 patients were included between 9/2017 and 4/2023. The prospective part of the trial started on 1/2020 and is still ongoing, and the estimates end of the clinical trial is May 2025. This analysis should evaluate the safety and efficacy in an extended follow-up.
In this cohort we included also high risks patients and patient with fragile urethra, only patients with neurogenic lower urinary tract dysfunctions were excluded. The fragile urethra was defined as previous procedure for SUI (n=36; 31%), prior pelvic irradiation (n=52; 45%) and procedure for bladder neck pathologies (n=25; 22%) or urethra strictures (n=10; 9%). High risk patients were defined as patients under androgen deprivation therapy (n=22; 19%), with diabetes (n=23; 20%) and patients with vascular disease (n=52; 45%) as these risk factors can have impact on postoperative outcomes and urethral erosion. 
Postoperatively a standardized 24-hour pad test and pad usage(p/d) were evaluated. To compare pre-and postoperative continence status nonparametric t test was used. A p-value of <.05 was defined as statistically significant.

Median preoperative urine loss in the 24-hours pad test was 520ml (min.50- max. 2000) and was significantly improved at any point in follow-up. After a median follow-up of 32 months, 51% of the patients were totally dry (a maximum of 20g in the 24-hour pad test), additionally 7,3% used only 1 p/d (in average 39.8g) and were socially dry. In total 81% of the patients had an improved continence situation regarding p/d and 19%were classified as failed (<50% improvement). Regarding urin loss (g) in 24- hour pad use an improvement of ≥ 50% was observed in 84% of the patients. Erosion and infection were reported in 9,5% and a device dysfunction was described in 2,6%.

The majority of the patients in this cohort were patients with fragile urethra and as we know from the literature, this group of patients are at higher risk for failure or complication. Despite this fact an improvement of more than 50% was observed in 81% of the cohort and the complication rate was acceptable.

An effectiveness can be demonstrated also in high-risk patients in an extended follow-up. The complication rate was comparable to the literature for AUS devices and the satisfaction rate was high.

Continence 12S (2024) 101481
DOI: 10.1016/j.cont.2024.101481