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

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.

Patient satisfaction with adjustable transobturator male system in the Iberian multicenter study.

BACKGROUNDS: Patient-reported outcome measurements are important for urinary incontinence. We analyze self-assessed patient satisfaction and define the clinical profile of patient with highest satisfaction with the adjustable transobturator male system (ATOMS). METHODS: Patient perception of results was evaluated in a series of 181 patients after ATOMS adjustment. Baseline incontinence severity was defined in pads-per-day (PPD) as mild (2), moderate (3-5) or severe (≥ 6), and dryness as use of none or one security PPD. Post-operative pain at discharge was evaluated by 0-10 visual analogue scale and complications by Clavien-Dindo classification. Multivariate analysis was performed to anticipate "very much better" than baseline perception on patient global impression of improvement and a predictive nomogram was developed. RESULTS: Dryness was achieved in 80.7% (94.9% mild, 80.8% moderate and 65.8% severe groups). Mean pad-test and pad-count decrease with respect to baseline was 458 ± 330 ml and 3.2 ± 1.9 PPD, respectively (both p < .0001). Complications presented in 25 (13.8%). The proportion of patients that self-declared satisfied with the procedure was 87.1%; 90.6% perceived their situation "better" and 48.1% "very much better" than before. Multivariate analysis revealed best perception is defined by dryness after adjustment (p < .0001), baseline severity of incontinence (p = .007), low post-operative pain at discharge (p = .0018) and lack of complications (p = .007). CONCLUSIONS: Self-assessed satisfaction with ATOMS is very high. Factors that predict best perception of improvement include dryness, baseline SUI severity, presence of complications and pain level during admission. Radiotherapy and device generation were not independent predictors. A nomogram to predict patients that are completely satisfied with ATOMS after adjustment is proposed.