Between January 1988 and December 1992 the AMS800* artificial urinary sphincter was inserted in 81 men with urinary incontinence due to major pelvic surgery and/or radiation therapy. Radical retropubic prostatectomy had been performed in 38 men, radical retropubic prostatectomy with adjuvant radiation in 28, definitive radiation therapy for prostatic carcinoma in 5, abdominoperineal resection with adjuvant radiation in 1 and radical cystectomy with orthotopic urinary diversion in 8, while 1 suffered major pelvic trauma with urethral rupture. A bulbar urethral cuff was used exclusively, with pressure regulating balloons of 51 to 60 and 61 to 70 cm. water. The interval for primary activation ranged from 4 to 12 weeks (mean 7.7), with all irradiated patients waiting 12 weeks. Surgical revision was required in 38% of the patients totaling 43 operations. Inadequate cuff compression after presumed urethral atrophy secondary to hypovascularity accounted for 74% of the procedures, whereas infection with or without erosion necessitated 8 revisions, mostly attributable to improper placement elsewhere of an indwelling catheter after the artificial urinary sphincter had been activated. Mechanical malfunction was responsible for 7% of the revisions. Overall, socially acceptable continence was achieved in 91% of the study population. Despite a significantly greater need for revision in this high risk group (38% versus 22% in the literature for low risk groups) with meticulous surgical and sterile techniques as well as diligent followup, the long-term outcome in terms of continence and device survival may be excellent regardless of the underlying etiology. We conclude that use of the AMS800 artificial sphincter for significant male urinary incontinence is undoubtedly the most efficacious treatment currently available for which even the most adverse candidate should not necessarily be excluded.

This study confirms ATOMS device is safe and achieves high treatment efficacy and patient satisfaction in a multicenter setting. Significantly better results are achieved in less severe and non-irradiated cases. Durability of the device is reassuring in the short-term.

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Treatment of severe male SUI after radical prostatectomy with pre-attached scrotal port ATOMS is safe and very effective in the short term. A positive cough test before implant and intraoperative overfilling of the system may optimize patient selection and results.

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Aim The aim of this study is to evaluate long‐term durability and effectiveness of the adjustable transobturator male system (ATOMS). Materials and Methods The retrospective multicenter Iberian ATOMS study (n = 215) was updated to evaluate long‐term continence status, complications, explants, and secondary treatments. Mean follow‐up from surgery to March 2020 was 60.6 ± 18.4 months (range, 39‐91). Eleven patients deceased of an unrelated causes. Kaplan‐Meier curves were performed to evaluate device durability and incontinence free of recurrence interval. The multivariate analysis defined the population at risk of device explant. Results A total of 155 patients were dry at the last follow‐up visit (72.1%); 99 (46%) used no pads and 56 (26%) used a security pad/day with urine loss less than 10 mL; 96% of dry patients after adjustment remained free of incontinence 1 year later, 93.6% 2 years later, 91.1% 3 years later, 89.2% 5 years later, and 86.7% 8 years later. Complications during follow‐up occurred in 43 of 215 (20%). In total, 25 (11.6%) devices were explanted and causes were inefficacy 11 (44%), inefficacy and pain 3 (12%), port erosion 10 (40%), and wound infection 1 (4%). The secondary implant was performed in 11 (5.1%) cases, 6 artificial urinary sphincter and 5 repeated ATOMS. Time to explant was associated to complications (P < .0001), baseline stress urinary incontinence (SUI) severity (P = .01), and former irradiation (P = .03). Multivariate analysis revealed complications (hazard ratio [HR] = 8.71; 3.83‐19.82), baseline SUI severity (>5 compared to 1‐2 pads/day; HR = 14.9; 1.87‐125), and irradiation before ATOMS (HR = 2.26; 1.02‐5.18) predicted earlier ATOMS explant. Three cases received radiation after implant without complication. Conclusions ATOMS device is efficacious and safe in the long term. Determinants for device explant include complications, baseline severity of incontinence, and previous irradiation. Currently, the durability of the device after 5 years is reassuring.

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