The treatment of choice for patients who have moderate to severe iatrogenic stress urinary incontinence is the implantation of an artificial urinary sphincter [1]. We analyzed the outcomes of the artificial urinary sphincter (AUS) Zephyr Surgical Implants (ZSI) 375 implantation for stress urinary incontinence in men, focusing on quality of life assessment (QoL).

The ZSI 375 device is a one-piece device consisting of an adjustable cuff, molded to fit around the urethra, which is connected by a tube to a pump and a pressure-regulating tank. It has no abdominal reservoir. [2]
	The study had a retrospective, non-randomized format design. It was conducted in one urological department in Portugal. Between May 2021 and December 2022, 18 consecutive artificial urinary sphincter ZSI 375 were implanted in men with iatrogenic moderate to severe stress urinary incontinence according to 24h pad weight test. The pre-operative protocol included a 24h pad weight test, cystoscopy and a pressure-flow study. All patients had a previous pelvic floor muscle training program. 
	The follow up was completed in January 2023. Complications and number of pads used to manage incontinence were recorded. Perioperative complications were categorized according to the Clavien-Dindo classification. The quality of life was assessed based on the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) performed before surgery and in the follow-up after device activation. A qualitative grade of satisfaction was also recorded.

A total of 18 patients had the ZSI 375 device implanted, with a mean (range) follow-up of 10 (3-20) months. The averaged (range) patient age was 71,5 (62-80) years old. The indications were incontinence following radical prostatectomy (RP, n=9), RP and radiotherapy (n=8) and transurethral resection of prostate (TURP, n=1), with a 24h pad weight test above 200g. The mean (range) operative time was 66 (35-90) minutes, and the mean hospital stay was 1 day with catheter removal on the same day. The device was activated six weeks later by routine. Complications leading to a revision or permanent device removal arose in 4 patients: 2 erosions of the urethra with device explantation, 2 infections and 1 mechanical failure with device re-implantation. Perioperatively, one patient was classified as grade 2, while the remaining were classified as grade I in the Clavien-Dindo classification.
	Three (16,7%) patients achieved total continence (0 pads per day), 9 (50%) social continence (1 pad per day), and 6 (33,3%) failures with incontinence (>1 pad per day). The mean reduction (range) in the ICIQ-SF score was 10,7 (3-21) points in a scale from 0-21.  The grade of satisfaction with the device was 77,7%.

In this study we report our short-time experience in 18 patients with an implanted ZSI 375 device. During the median follow-up period of 10 months the overall success rate (total and social continence) was 66,7%. The AUS AMS 800 is currently the gold standard therapy of severe SUI in men. However, there are some concerns about it, including complexity of the procedure with consequent time consuming, inability to adjust the pressure in the device, or to readjust the cuff in the case of postsurgical urethral atrophy. ZSI 375 is a relatively new device. With our study we observed the simplicity of the surgical procedure with short surgical time even in the early learning curve. One important advantage of this device is the possibility to adjust the internal pressures via the in situ trans-scrotal applicator, in an office outpatient setting, in order to obtain a better outcome even after surgery. 
	The most frequent complication was urethral erosion which affected 2 (11,1%) of the patients, a rate comparable to that of AMS 800. One of the 2 patients had previous radiotherapy, a well-known adverse factor for insertion of the sphincter. Mechanical failure resulting in device re-implantation affected 1 (5,5%) patient at the early stage of the study, probably related with the inexperience of the surgeons with the implantation of this new device. This rate is also comparable with the AMS 800 [3]. Our total rate of complications is comparable to other series of ZSI 375 implantations reported. The QoL assessed by ICIQ-SF questionnaire showed a significant improvement. A high grade of satisfaction with the device was also noted, probably due to the simplicity of the device. 
	Finally, this present study is limited by a short time of follow-up and the small quantity of patients included. Also, the weight pad test after device activation would be a more accurate marker to achieve the continence real improvement.

In this short-time follow-up study, the ZSI 375 AUS was successful in the treatment of moderate to severe male stress urinary incontinence, with a good success rate and an acceptable low rate of complications. The QoL was assessed using ICIQ-SF with significant improvement demonstrated. The simplicity of the surgical procedure with a short learning curve was also observed. In conclusion the ZSI 375 AUS is a good option for treatment of moderate to severe stress urinary incontinence in men.

Ostrowski I, Sledz E, Ciechan J, et al. Current interventional management of male stress urinary incontinence following urological procedures. Cent European J Urol. 2015; 68: 340-347
Ostrowski I, Ciechan J, Sledz E, Dys W, Golabek T, Chlosta PL. Four-year follow-up on a ZSI 375 artificial urinary sphincter for male urinary incontinence from one urological centre in Poland. Cent European J Urol. 2018; 71: 320-325
Hajivassiliou CA. A review of the complications and results of implantation of the AMS artificial urinary sphincter. Eur Urol. 1999; 35: 36-44