The artificial urinary sphincter (AUS) is the standard treatment for moderate-to severe male stress urinary incontinence (SUI).
Recently, adjustable devices have been used for the treatment of mild-to moderate male SUI. These devices add more surgical possibilities for our patients.

The aim of this study is to report our experience with ATOMS® device in the treatment of male SUI with a long follow-up.

Retrospective, nonrandomised, multicentre study.

Seven-hundred twelve ATOMS® devices have been implanted in thirty-nine tertiary hospitals in Spain, from September 2012 to March 2021.
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 when necessary). Outcomes, complications, and evolution were registered at 6, 12, 24, 36 and 60 months. Global improvement was analyzed with PGI-I questionnaire and scale of satisfaction with device.
Continence rate was stablished: cured (as no leakage), and improvement (as more than 50% of leakage reduction).
Statistical analysis was done through Stata 2.0.

Mean age was 69.3 years (±7.3). Radical prostatectomy was the most common cause of SUI (86.3%). One-hundred fifty-six patients had received external radiotherapy (ERT) previously (22.2%).
Fifty-five percent of patients had mild-to-moderate SUI, and 45% were severe SUI. Four-hundred ninety-five patients had 12 months follow-up, 282 had 2 years, and 184 patients had 3 years.

Continence rate: 89% at 12 months (60.9% cured), 89.2% at 24 months (65.3% cured), and 86.9% at 36 months (66.2% cured).

Lower continence rate was found in ERT patients, severe incontinence, and those with urethrotomy (p<0.0001).

No relation between adjustments, device volume, and SUI severity were found.

Fifty-four abdominal valves (7.7%), fifty scrotal valves (7.1%) and 598 scrotal pre-assembled valves (85.2%) have been implanted. 

There were 1% complications during surgery. 
Minor complications have been registered: there were 17 (2.4%) spontaneous voided devices which were managed by refilling with solution made with sterile water plus contrast dye. Twenty-seven patients developed acute urinary retention and voided device was required, solving retention in all patients. Sixteen patients had hematoma, with conservative management and 89 patients developed transient perineal pain.
These complications were not associated with any risk factor (p>0.05).


Major complications: twenty-one valve infections and 45 valve extrusions. Twenty-nine patients needed valve removal. Forty-three patients needed total device removal due to valve extrusion, device infection, or device disfunction (6%).
Total device removal was associated with previous ERT (p<0.003).

Changes were found between pre and post-treatment flowmetry, with 2 points Q max reduction (-2.14 (-3.42, -0.87), p 0.001).

According to the PGI questionnaire, 77.4% of patients felt much better.
The degree of patient satisfaction was high (84% moderate to high).

ATOMS® 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, including in those patients with severe incontinence.
There is no need to manipulate the device and it allows treating more patients than with AUS. 
The position above the muscle can avoid urethral complications, especially in those patients who have received external radiotherapy. Our complications rate and risk factors associated to persistent incontinence are very similar to previous published in literature (1).

Male SUI can be successfully treated with ATOMS® device. This device is safe, easy to implant and has a low rate of complications and device explantations. Previous ERT might influence the achievement of complete continence after implantation. Counselling with radiated patient before implantation is necessary to warn about lower rates of total continence.

Angulo, J.C.; Téllez, C.; Giammò, A.; González-Enguita, C.; Schoenburg, S.; Queissert, F.; Szczesniewski, J.; González, R.; Romero, A.; Gonsior, A.; et al. Results of Adjustable Trans-Obturator Male System in Patients with Prostate Cancer Treated with Prostatectomy and Radiotherapy: A Multicenter Study. J. Clin. Med. 2023, 12, 4721. https://doi.org/10.3390/jcm12144721

Continence 12S (2024) 101487
DOI: 10.1016/j.cont.2024.101487