The artificial urinary sphincter (AUS) remains the gold standard for treating severe male stress urinary incontinence (SUI) due to striated sphincter deficiency (1). While highly effective, traditional non-adjustable AUS devices present challenges in postoperative management (2). Adjustable AUS devices have been developed to allow minimally invasive postoperative pressure adjustments to optimize continence without compromising urethral blood supply. This may lead to reduction in erosion and the necessity of surgical revision. The aim of this study is to evaluate the safety, efficacy, and quality of life (QoL) outcomes of a novel adjustable AUS in a cohort of 50 male patients.

A retrospective analysis was conducted on a dataset of 50 male patients who underwent implantation of an adjustable AUS for the treatment of SUI. Baseline characteristics, intraoperative details, and postoperative outcomes were evaluated. The primary efficacy outcome was the objective cure rate, defined as the use of ≤1 pad per day (social continence). Secondary outcomes included changes in the number of pads used per day, complication and  explantation rates, and patient-reported QoL (measured on a scale of 1-10). Statistical analyses included the Wilcoxon signed-rank test for paired continuous variables, and Spearman's rank correlation for monotonic associations between pad use and QoL. Multivariable Firth penalized logistic regression was used to evaluate predictors of treatment failure.

The cohort had a mean age of 68.3 (SD 8.5) years and a mean BMI of 26.7 (SD 3.7) kg/m2. The primary etiology of SUI was radical prostatectomy (94%); the remaining 6% included GreenLight laser vaporization, transurethral resection of the prostate, and pelvic trauma. Regarding patient characteristics, 44% had undergone radiation therapy, 16% had a history of prior incontinence surgery, 22% had urethral stenosis, and 14% were on hormonal blockade. After a mean follow-up of 21.0 (SD 9.9) months, the objective cure rate (≤1 pad/day) was 72.0% (36/50), with 40.0% (20/50) being completely dry (0 pads/day). The median number of pads used per day decreased from 5.0 (IQR 4.0-6.0) preoperatively to 1.0 (IQR 0.0-2.0) at follow-up (p < 0.001), with a large effect size (robust Cohen’s d = -2.17). A strong inverse association was observed between postoperative pad use and QoL scores (Spearman’s ρ = -0.58, p < 0.001). Patient satisfaction was high or very high (score 7-10) in 76% of cases. Complications were reported in 11 patients (22.0%), predominantly Clavien-Dindo grade I-II (12%), with grade IIIb in 6% (3/50, all explantations). Adjustment of the device volume was required in 66% of patients, with a median of 2.0 readjustments. In the multivariable analysis, smoking (OR 3.13), higher baseline pad use (OR 1.34), and increased BMI (OR 1.11) showed positive associations with treatment failure, although these did not reach statistical significance (p > 0.05).

The adjustable AUS demonstrated significant efficacy in reducing pad usage, with 72% achieving social continence and 40% complete dryness, aligning with established outcomes for gold-standard devices (1). The high patient satisfaction rate (76%) and the significant inverse correlation between postoperative pad use and QoL underscore the clinical value of minimizing pad reliance. The adjustability feature allowed for postoperative titration (mean final volume 20.4 ml), which is particularly beneficial for managing persistent SUI without the morbidity of a full revision surgery. The complication profile was favorable, with the majority being low-grade (Clavien-Dindo I-II), and rates comparable to the current literature for male SUI surgical interventions (3).

The implantation of this adjustable artificial urinary sphincter is a safe and effective surgical treatment for male SUI. It provides significant improvements in objective continence parameters and patient quality of life, with an acceptable and manageable safety profile.

Kretschmer A, Nitti V. Surgical Treatment of Male Postprostatectomy Incontinence: Current Concepts. Eur Urol Focus. 2017;3(4-5):364-376.
Comiter CV, Dobberfuhl AD. The artificial urinary sphincter and male sling for postprostatectomy incontinence: Which patient should get which procedure? Investig Clin Urol. 2016;57(1):3-13.
Giammò A, Falcone M, Blecher G, et al. A Novel Artificial Urinary Sphincter (VICTO) for the Management of Postprostatectomy Urinary Incontinence: Description of the Surgical Technique and Preliminary Results from a Multicenter Series. Urol Int. 2021;105(5-6):414-420.