To investigate the long term outcomes of the initial cohort of men in the United Kingdom who underwent treatment with the Adjustable Transobturator Male System® (ATOMS) for managing stress urinary incontinence between 2015-2019.

71 men (average age: 70.2, range 50-79) were listed for an ATOMS insertion between 2015-2019. One patient was excluded from the study due to his morbid obesity preventing trochar passage and completion of surgery. One was lost to follow up since the data that was previously analysed at 5 years. Follow up data for up to 9 years was analysed (mean: 5.8, range 5-9 years). Of this cohort of men, 65 (93%) had stress urinary incontinence post radical prostatectomy and 16 had previous radiotherapy.

Out of the 69 men, 55 (79.7%) remain dry after ATOMS insertion (defined as using maximum one pad a day for reassurance only) at a 9 year follow up period. This is a higher percentage of dryness compared with the 5 year follow up study (76%), proving long term efficacy of the device. The average number of top ups to achieve dryness was 3.

Out of the 14 men who remained incontinent, 5 underwent ATOMS removal and insertion of an artificial urinary sphincter (7.2%), 3 had their ATOMS device removed (explant rate 4.3%) due to infection (1 of these was an infected scrotal adjustment port resulting in removal of the whole device), 1 had an ileal conduit for bladder cancer, 1 achieved full dryness but deteriorated after 2 years despite further adjustments, and 4 never achieved full dryness and are awaiting further management. Of these 14 men, 6 had undergone previous radiotherapy. There were no cases of urethral erosion associated with the device in this initial cohort.

There were 3 patients who experienced postoperative pelvic pain following ATOMS insertion. 2 of these patients opted for emptying their ATOMS device for a short period of time to improve the pain, but have since agreed to small regular top ups to achieve continence and have been managing the pain better since. It is important to note that 1 of the patients experiencing pain in fact had pelvic pain prior to the ATOMS insertion, and another of the patients had an ultrasound scan to investigate the testicular pain which showed bilateral varicoceles.

The ATOMS device exhibits sustained effectiveness and safety in treating male stress urinary incontinence. Extended follow-up data shows no discernible reduction in efficacy, in contrast to sphincters and the associated urethral atrophy, likely attributable to the implantation location above the spongiosus muscle, and the adjustability of the device over time.

Further longer term assessment spanning over a decade will facilitate a more comprehensive comparison with the current 'gold standard' artificial urinary sphincters.

Continence 12S (2024) 101488
DOI: 10.1016/j.cont.2024.101488