The artificial urinary sphincter (AUS) is the standard treatment for moderate-to severe male stress urinary incontinence (SUI).
Recently, new devices have been used for the treatment of mild-to moderate male SUI. Adjustable devices add more surgical possibilities for our patients, including treatment of severe SUI (1). As AUS, these devices have their own complications.
The aim of this study is to report our complications with an adjustable device (ATOMS™) in the treatment of male SUI with a long follow-up.

Retrospective, nonrandomised, multicentre study.
Ninety-two ATOMS™ devices have been implanted in three tertiary hospitals in Spain, from September 2012 to March 2019. 
Data collection of clinical chart and clinical interview and exploration of the patients was performed. Clinical data, etiology and SUI severity were initially collected. Preoperative evaluation was performed by cough stress test, cystoscopy, 24-hours pad-test and urodynamics (flowmetry or complete study). Complications with Clavien-Dindo classification, and evolution were registered at 6, 12, 24, 36 and 60 months. Statistical analysis was done through Stata 2.0.
Mean age was 67 years (±4.8). Radical prostatectomy was the most common cause of SUI (91%). Eighteen patients had received external radiotherapy (ERT) previously (19%). Cervicotomy was performed at 23%. 
Fifty-three patients had severe incontinence and mild-to-moderate SUI was at 43%. Median follow-up was 35 months (±19).

There were no complications during surgery. 
Minor complications (Clavien-Dindo I-II) have been registered: there were 11 spontaneous voided devices which were managed by refilling with solution made with sterile water plus contrast dye. Five patients developed acute urinary retention and voided device was required, total or partially, solving retention in all patients. Seven transient perineal pain, two self-limited haematoma, one scrotal infection and 3 urge de novo.
These complications were less frequent in pre-assembled devices (p<0.04).

Major complications (Clavien-Dindo III): eight valves were removed (8.7%), 3 for infections and 1 for extrusion. Three patients needed burying valve (3%). Six patients needed total device removal (6.5%), due to infection (3 patients) or urethral perforation (3 patients). Other complication was one penile implant extrusion (no relation with ATOMS™ device).
Reoperation rate was 18.2%. Major complications were no related with any risk factor. There were no Calvien-Dindo IV-V complications.
Simultaneous procedures with ATOMS™ implant were performed: three penile prosthesis were implanted and one cervicotomy was performed. 
After ATOMS™ implant, 6 patients have received ERT 8 patients have received endoscopic procedures (urethrotomy and botulinum toxin injection) and 2 patients have penile prosthesis implant.

The AUS has proved its usefulness in the management of male urinary incontinence with a high success rate (2). Nonetheless, a high complications rate including erosion, infection and mechanical failure has been also reported, with a high percentage of patients needing reoperations.  Several devices have beeen marketed, being the most popular the AMS 800™ sphincter which is composed by three components. Other sphincters have been developed pre-assambled and pre-filled.
ATOMS™ is a pre-assambled device that must be filled during surgery and after, pushing the urethra and achieving continence. This device is a safe and effective treatment for male SUI and its effect remains during follow-up. In fact, this device has proved to be an alternative to AUS, in those patients with severe incontinence.
There is no need to manipulate the device and it allows treating more patients than with AUS. 
The majority of minor complications have been solved with pre-assembled valve. The position above the muscle can avoid urethral complications, especially in those patients who have received external radiotherapy. Our complications rate is very similar to previous published in literature (3), but this is the first report of urethral perforations with this device.

Male SUI can be successfully treated with ATOMS™ device. This device is safe, easy to implant and has a lower rate of complications and device explantations than AUS.

Chung E. Contemporary surgical devices for male stress urinary incontinence: a review of technological advances in current continence surgery. Transl Androl Urol. 2017 Jul;6(Suppl 2):S112-S121. doi: 10.21037/tau.2017.04.12
Van der Aa F, Drake MJ, Kasyan GR, Petrolekas A, Cornu JN; Young Academic Urologists Functional Urology Group. The artificial urinary sphincter after a quarter of a century: a critical systematic review of its use in male non-neurogenic incontinence. Eur Urol. 2013 Apr;63(4):681-9. doi: 10.1016/j.eururo.2012.11.034.
Friedl A, Mühlstädt S, Zachoval R, Giammò A, Kivaranovic D, et al. Long-term outcome of the adjustable transobturator male system (ATOMS): results of a European multicentre study. Int. 2017 May;119(5):785-792. doi: 10.1111/bju.13684.