The artificial urinary sphincter (AUS) is the gold standard in the treatment of male stress urinary incontinence (UI). There are different AUS designs. This device presents differentiating characteristics in relation to others: pre-connected, pre-filled, without connections, it is not necessary to place an abdominal reservoir and it allows cuff volume and pressure adjustments, both intraoperative and postoperative. We present our experience with the ZSI375 (Zephir)

Descriptive, retrospective study carried out between April 2021 and December 2023 at our Center. Twenty-three ZSI375 EUA implants were performed in 21 patients. Results prior to surgery are obtained and functional results, efficacy, satisfaction and complications of implants are presented. The surgical technique performed is the one described in the literature through 2 incisions, perineal and lateropeneal (1).

Patients had a mean age of 71 years (57-81), BMI 29 (26-37)
The etiology of the UI was post-surgical in all cases: laparoscopic radical prostatectomy 53.33%, retropubic 6.66%, adenomectomy (26.66%), radical cystectomy (Studer-type neobladder) in 1 case (6.66%), TUR of the prostate 1 case (6.66%)
The evolution time of the UI was 5 years (2-13). 1 patient had received radiotherapy treatment prior to implantation (6.66%). 4 patients (26.66%) had previously presented stricture of the urethra/urethrovesical junction). 5 patients (33%) had previously had another device implanted: ATOMS (3), AMS800 (2) performing the explant at the time of surgery in 3 cases.
The pad test 24h prior to surgery was 1042 ml on average (700-1500).
Median follow-up at the time of this review of 489 days (124-1090).
All patients were discharged after 24 hours and no complications were reported in the immediate postoperative period. During the first month, urinary tract infection was reported in 2 patients (13.33%). In the initial follow-up, after activation of the sphincter, continence is achieved in 60% of cases (defined as total continence or minimal leaks on heavy exertion), with an overall continence improvement of 86%. 2 implants are pending activation. Regulation of the cuff volume was performed in 3 patients (20%). During follow-up no urethral erosions were reported. In 2 cases there was mechanical failure of the device due to loss of fluid from the cuff circuit, performing sphincter replacement in both, with subsequent recovery of continence. 1 case of infection is reported performing sphincter explantation.

The results obtained in our series are comparable to other studies. The rate of complications related to the ZSI375 reported in our series is lower than that published, probably due to a shorter follow-up time compared to other studies. The efficacy rates are similar to those published in multicenter studies (1,2,3).

In our experience, EUA ZSI375 has adequate efficacy and safety for the treatment of male SUI.

Llorens C, Pottek T. Urinary artificial sphincter ZSI375 for the treatment of stress urinary incontinence in men: 5 and 7 years follow-up report. Urology. 2017; 84(4): 263-266
Ostrowski I, Blewniewski M, Neugart F, et al. Multicentre experience with ZSI375 artificial urinary sphincter for the treatment of stress urinary incontinence in men. Urology. 2017; 84(3): 148-152
Ostrowski I, Golabek T, Ciechan J, et al. Preliminary outcomes of the European multicenter experience with the ZSI375 artificial urinary sphincter for the treatment of stress urinary incontinence in men. Cent European J Urol. 2019; 72:263-269