Stesura Seveso Archivio Italiano di Urologia e Andrologia 2024; 96(3):12661 1 ORIGINAL PAPER impairment of the external urethral sphincter, predomi- nantly resulting from radical prostate cancer treatment (2). Irrespective of its underlying causes, SUI significant- ly diminishes the quality of life for those who experience it (3-9). The primary approach for managing male SUI involves pelvic floor muscle training, biofeedback, and electrical stimulation. If these conservative methods prove ineffective, surgical interventions are the only avail- able alternative (1-16). In 1973, the artificial urinary sphincter (AUS) was initially developed to address male moderate-to-severe SUI, even- tually establishing itself as the preferred treatment for this pathology (17-19). However, the process of inserting an AUS remains intricate and carries the potential for compli- cations such as erosion, infection, and mechanical failure. Introduced in 1983, the last version of American Medical Systems (AMS) 800 device stands as the gold standard of AUS and continues to be utilized to this day (4, 5, 9, 12). While it has demonstrated favorable long-term outcomes, it is important to note that the preparation and execution of the procedure remain intricate, carrying a potential risk of complications. In instances of postoperative ure- thral atrophy, it is not feasible to readjust the cuff, and once activated, there are no available options to modify the pressure of the device (4, 5, 9, 13-16, 20). The success of the procedure relies heavily on the metic- ulous preparation of the sphincter, proper connection of its components, and the surgeon's expertise, considering the lengthy learning curve. The majority of AUS inser- tions are performed by surgeons who only conduct a few procedures (between 1 and 3) per year. Less than 10% of AUS insertions in the USA are carried out by surgeons who have completed at least 100 procedures, which indi- cates a lower level of experience (21). As a result, the like- lihood of requiring additional surgery increases from 13% to 24% (22). The purpose of designing Zephyr Surgical Implants (ZSI) 375 is to simplify the process of inserting the AUS. The first implantation of ZSI 375 took place in March 2009, making it a relatively recent innovation (23). The cuff is adaptable and placed around the urethra, already con- nected beforehand. Additionally, ZSI 375 eliminates the need for an abdominal reservoir, leading to reduced oper- ating time and avoiding the requirement for abdominal Purpose: Radical prostate cancer treatment is the predominant cause of iatrogenic stress urinary incontinence (SUI) in men, significantly impacting their quality of life (QoL). This prospective single-center study in Portugal aimed to evaluate the outcomes of men with moderate- to-severe SUI treated with a single-component artificial urinary sphincter (AUS). Materials and methods: Male patients with iatrogenic moderate- to-severe SUI, determined by a 24-hour pad weight test, were included. The single-component device comprises a cuff linked to a pump unit through a kink-resistant tube. The implantation involved perineal incision for cuff placement and an inguinal incision for pump and tank positioning within the scrotum. Complications, pad usage, perioperative complications (Clavien- Dindo classification), and quality of life assessment using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) questionnaire were documented. Results: Between May 2021 and March 2023, 20 consecutive single-component AUS insertions were conducted at a Portuguese urology department. Follow-up concluded in July 2023, with a mean follow-up duration of 15 months (range: 5-27). Four patients experienced complications necessitating device revision or removal (erosion = 2, infection = 1, mechani- cal failure = 1). Social continence (0/1 pad/day) was achieved in 70% (14/20 patients), while 30% (6/20 patients) experienced incontinence. Perioperatively, one patient was classified as grade 2, while the remaining were grade 0/1 in the Clavien- Dindo classification. The mean ICIQ-SF score reduction was 10.5 points. Conclusions: The single-component AUS shows promising effica- cy in managing moderate-to-severe male SUI, offering a good success rate, acceptable complications, improved QoL, and a straightforward surgical procedure. KEY WORDS: Artificial urinary sphincter; Zephyr Surgical Implants 375; Male stress urinary incontinence; Radical prostate- ctomy; Quality of life. Submitted 13 May 2024; Accepted 6 June 2024 INTRODUCTION The prevalence of urinary incontinence (UI) in men can reach up to 39% and tends to rise with advancing age (1). The primary cause of stress urinary incontinence (SUI) among adult men is commonly attributed to iatrogenic Single-component artificial urinary sphincter: Outcomes from one centre in Portugal João Aragão Vital 1, Miguel Marques Monteiro 1, Bernardo Lobão Teixeira 1, Gonçalo Grilo Mendes 1, Alexandra Rocha 1, Mariana Madanelo 1, Sofia Mesquita 1, Nuno Vinagre 1, Beatriz Oliveira 1, Martinha Magalhães 1, Ana Isabel Lopes 1, Carlos Ferreira 2, Paulo Príncipe 1, Avelino Fraga 1 1 Centro Hospitalar Universitário de Santo António (CHUdSA), Porto, Portugal; 2 Centro Hospitalar Universitário de São João (CHUSJ), Porto, Portugal. DOI: 10.4081/aiua.2024.12661 Summary Archivio Italiano di Urologia e Andrologia 2024; 96(3):12661 J. Aragão Vital, M. Marques Monteiro, B. Lobão Teixeira, et al. 2 incision and dissection in previously scarred retroperi- toneum. By increasing the pressure, it enhances the patient's continence (10, 24). We conducted an analysis of the outcomes of the AUS ZSI 375 implantation for stress urinary incontinence in 20 male patients, and its influence on the individual's quali- ty of life (QoL). MATERIALS AND METHODS Patients The study employed a prospective, non-randomized design and was conducted at a single urological depart- ment in Portugal. Between May 2021 and March 2023, 20 consecutive placements of the AUS ZSI 375 were per- formed in male patients presenting iatrogenic moderate to severe SUI as determined by the 24-hour pad weight test. The procedures were carried out by two experienced surgeons. Prior to surgery, the pre-operative protocol encompassed patient history assessment, physical exami- nation, urinalysis, cystoscopy to rule out stenosis, a 24- hour pad weight test, and urodynamics to exclude over- active bladder. All patients had previously undergone pelvic floor muscle training. In preparation for the surgi- cal procedures, all patients completed the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF questionnaire). The study was approved by the Ethical Committee of our center. All study participants provided written informed consent. ZSI 375 Device The ZSI 375 is a single-component device made up of a cuff linked to a pump unit through a kink-resistant tube. The adaptable cuff is designed in a curved shape to pre- vent creasing. It is positioned around the urethra, while the pump unit, which includes a pressure-regulating tank and pump, is situated within the scrotum, specifically in the subdartos pouch. It has no abdominal reservoir. Once activated, the hydraulic circuit's pressure can be adjusted up or down to enhance the patient's continence (25). The improved hydraulic system of the ZSI 375 PF (pre-filled) has been in use since March 2015, and it is anticipated that the reduced operating time will lead to decreased infection and mechanical failure rates (25). Surgical procedure The implantation surgical procedure was carried out under general anesthesia with the patient in the lithotomy position. The surgical technique consists in a perineal incision for cuff placement and an inguinal incision for pump and tank placement in the scrotum. A 14 Fr Foley urethral catheter is placed for guidance and was removed by routine in the day after surgery. The device was acti- vated six weeks later. Follow-up after implantation The scheduled appointments occurred at intervals of 1, 3, and 6 months following device activation, with subse- quent annual appointments. Patients documented their daily pad usage in a 7-day diary prior to each visit. The fol- low-up process was concluded in July 2023. Total conti- nence was defined as the absence of any pad usage, while social continence was characterized by the use of 1 pad per day. Incontinence was ascribed to individuals who required > 1 pad per day. Success was defined as achiev- ing social continence, which encompassed the range of pad usage from 0 to 1 per day. Perioperative complica- tions were classified using the Clavien-Dindo classification system. The quality of life was evaluated by means of the ICIQ-SF questionnaire, administered both before the sur- gical procedure and during the follow-up period subse- quent to device activation. Additionally, a subjective assessment of patient satisfaction was documented. RESULTS Patient characteristics A total of 20 patients had the ZSI 375 device implanted, with a mean (range) follow-up of 15 (5-27) months. The averaged (range) patient age was 71.5 (62-80) years old. The indications were incontinence following radical prostatectomy (RP, n = 11), RP and radiotherapy (n = 8) and transurethral resection of prostate (TURP, n = 1). Five (25%) patients with a 24h pad weight test between 200-400g and 15 (75%) > 400g. The mean (range) ICIQ- SF score before surgery was 20,8 (17-21) points. The mean (range) operative time was 69 (35-100) 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 Complications leading to a revision or permanent device removal arose in 4 patients: 2 erosions of the urethra with device explantation, 1 infection and 1 mechanical failure both with device re-implantation. Perioperatively, one patient was classified as grade 2, while the remaining were classified as grade 0 or 1 in the Clavien-Dindo clas- sification (Table 1). Pressure adjustment In 5 (25%) patients, there was a need for device pressure adjustment under radiographic control, in an outpatient setting, to improve continence. Efficacy Three (15%) patients achieved total continence (0 pads per day), 11 (55%) social continence (1 pad per day), and Table 1. The aetiology of the incontinence and complications. Aetiology Infections Urethral erosions Mechanical complications of incontinence n (%) n (%) n (%) RP (11 patients) 0 1 (9.1) 1 (9.1) RP+RT (8 patients) 1 (12.5) 1 (12.5) 0 TURP (1 patients) 0 0 0 Total (20 patients) 1 (5) 2 (10) 1 (5) RP: radical prostatectomy; RT: radiotherapy; TURP: transurethral resection of prostate. Archivio Italiano di Urologia e Andrologia 2024; 96(3):12661 3 Single-component artificial urinary sphincter 6 (30%) experienced incontinence (> 1 pad per day), resulting in an overall success rate of 70% (total and social continence). The mean (range) ICIQ-SF score after surgery was 10,5 (0-18) points with a mean reduction of 10,3 points in a scale from 0-21. The grade of satisfaction with the device was 75% (Table 2). DISCUSSION In this study, we present our short-term experience with 20 patients who received the ZSI 375 AUS. Over a medi- an follow-up period of 15 months, the overall success rate, encompassing total and social continence, reached 70%. While the AUS AMS 800 currently stands as the gold standard therapy for moderate to severe SUI in men, concerns regarding its complexity, time-consuming nature, inability to adjust device pressure, and the chal- lenge of cuff readjustment in cases of postsurgical ure- thral atrophy have arisen (4). The ZSI 375 device represents a relatively recent addition to this field. Our study highlighted the simplicity of the surgical procedure, even during the early stages of the learning curve, with notably short surgical times. One significant advantage of this device lies in its capacity to adjust internal pressures using the in situ trans-scrotal applicator within an office outpatient setting, offering the potential for improved outcomes post-surgery. Enhanced management of pressure escalation following activation is expected to reduce the incidence of urethral erosion (25). In our study, this procedure was necessary for five patients. Regrettably, as of the conclusion date, it has not been possible to assess post-adjustment outcomes. The most frequent complication observed was urethral erosion, which affected 2 (10%) of the patients, a rate comparable to that of AMS 800 (11, 16, 24, 26, 27). Notably, one of these two patients had undergone previ- ous radiotherapy, a well-recognized adverse factor for sphincter insertion (28). The second patient was catheter- ized in primary healthcare following a suspected episode of urinary retention, indicating a potential iatrogenic cause. Mechanical failure necessitating device re-implantation occurred in 1 (5%) patient during the early stages of the study, likely attributed to the surgeons' relative inexperi- ence with implanting this new device. This rate is also in line with that reported for the AMS 800 (12, 24, 27). Our overall complication rate aligns with that of other report- ed series involving ZSI 375 implantations (10, 23-25, 29, 30). Assessment of QoL using the ICIQ-SF questionnaire revealed a significant improvement, and a high level of patient satisfaction with the device was noted, possibly attributable to its simplicity. Finally, this study has limitations, including a short fol- low-up duration and a small patient cohort. Some patients with prior AMS 800 AUS procedures underwent surgery, and the study was conducted during the early stages of the surgical learning curve. Additionally, utiliz- ing the weight pad test after device activation may offer a more accurate measure for assessing real improvements in incontinence. CONCLUSIONS In this short-term follow-up study, the ZSI 375 AUS demonstrated effectiveness in the management of moder- ate to severe male SUI, exhibiting a commendable success rate while maintaining a low incidence of complications. The QoL was evaluated using the ICIQ-SF questionnaire, revealing a significant improvement. Notably, the surgical procedure proved to be straightforward with a brief learn- ing curve. In conclusion, the ZSI 375 AUS emerges as a promising treatment option for moderate to severe SUI in male patients. REFERENCES 1. Bauer RM, Gozzi C, Hübner W, et al. Contemporary management of postprostatectomy incontinence. Eur Urol. 2011; 59:985-996. 2. Shamliyan TA, Wyman JF, Ping R, et al. Male urinary inconti- nence: prevalence, risk factors, and preventive interventions. Rev Urol. 2009; 11:145-165. 3. 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Correspondence João Aragão Vital, MD joaopvital@gmail.com Miguel Marques Monteiro, MD mmonteiro.iam@gmail.com Bernardo Lobão Teixeira, MD bernardolat@gmail.com Gonçalo Grilo Mendes, MD goncalo.grilomendes@gmail.com Alexandra Rocha, MD marialexandrarocha@gmail.com Mariana Madanelo, MD marianacmadanelo@gmail.com Sofia Mesquita, MD sofiaoplmesquita@gmail.com Nuno Vinagre, MD nunomrvinagre@gmail.com Beatriz Oliveira, MD ana.bia.5@hotmail.com Martinha Magalhães, MD martinha.a.magalhaes@gmail.com Ana Isabel Lopes, BSc analopes.urodinamica@chporto.min-saude.pt Paulo Príncipe, MD paulo.principe@gmail.com Avelino Fraga, MD PhD avfraga@gmail.com Urology Department, Santo António University Hospital Center Largo do Prof. Abel Salazar, 4099-001 Porto, Portugal Carlos Ferreira, MD carlosferreira.esr@gmail.com Centro Hospitalar Universitário de São João (CHUSJ) Conflict of interest: The authors declare no potential conflict of interest.