Long‐term outcome of adjustable transobturator male system for stress urinary incontinence in the Iberian multicentre study

Abstract

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.

Outcomes of a Series of Patients with Post-Prostatectomy Incontinence Treated with an Adjustable Transobturator Male System or Artificial Urinary Sphincter

“…We confirm the major complications that can be anticipated for AUS are urethral erosion, urethral atrophy and mechanical failure [5,6,22]. On the other hand, the most likely complications for ATOMS are port erosion, infection and postoperative pain [9,15,23,24]. One of our findings is that pain in the early postoperative period is very similar with both devices.…”

“…Recent multicentre international experience has shown dryness in 58% and surgical revision in 30.7% of the cases in the mid-term, partly determined by institutional case load [6]. Another recent multicentre long-term study with ATOMS reported a 72.1% continence rate and 11.6% explant rate at 5 years [15]. The experience we present confirms both AUS and ATOMS are effective to treat PPI; however, we could not prove superiority of either equivalency for the devices.…”

“…However, for several reasons it is not suitable for all patients. The development of less invasive [14,15]. ATOMS can be especially considered in patients with impaired cognition, diminished manual dexterity or unwilling to manipulate an AUS as well as patients with recurrent incontinence after a failed sling or AUS and reluctant to repeat the same device [16].…”

Artificial urinary sphincter or a second adjustable transobturator male system offer equivalent outcomes in patients whom required revision on the initial ATOMS device: An international multi‐institutional experience

“…Independent risk-factors for explant were baseline incontinence severity (>5 pads/day), complications, and irradiation. 12 Our new study confirmed a surgical revision rate of 8.65% at 4-years, with a mean time between first implant and revision reached 2-years. Revision rate increases with follow-up, 3,12 but does not seem to depend too much on case load.…”

Standing cough test stratification of moderate male stress urinary incontinence

“…Our study is also limited by the absence of adjustable devices for mild to moderate SUI. The adjustable transobturator male sling (ATOMS), Remeex, ProACT, and ARGUS slings have all demonstrated safety and efficacy (29,30). These adjustable slings may prove to have a greater role in the moderate SUI population; however, additional studies will be needed comparing these devices to AUS and retropubic slings for men with varying degrees of SUI.…”