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.

Introduction: A prospective evaluation of outcomes in a series of patients with post-prostatectomy incontinence (PPI) treated with two different devices is presented. Methods: Consecutive patients with PPI underwent interventions with an adjustable transobturator male system (ATOMS) or artificial urinary sphincter (AUS). Decisions were based on patient preference after physician counselling. Patient characteristics and operative and postoperative parameters including dryness, satisfaction, complications, revision and device durability were evaluated.

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(1) Background: The Adjustable Transobturator Male System (ATOMS) device is increasingly used to treat post-prostatectomy incontinence as it enhances residual urinary sphincteric function and allows continence recovery or improvement by dorsal compression of the bulbar urethra through a fixed transobturator mesh passage. The mode of action and the profile of the patients with best results are not totally understood. (2) Methods: Intraoperative urethral pressure measurements at different filling levels of the ATOMS device show increased urethral resistance and enhanced residual sphincteric activity. We evaluated whether the pattern of urethral pressure change secondary to serial progressive intraoperative filling of the cushion can predict postoperative results after ATOMS placement. (3) Results: The regression analysis showed a significant direct relationship between cushion volume and intraurethral pressure (p = 0.000). The median intraurethral pressure at atmospheric pressure was 51 ± 22.7 cm H2O, and at atmospheric pressure plus 4 mL was 80 ± 23.1 cm H2O). Cluster analyses defined a group of patients (n = 6) formed by patients with a distensible urethra and 100% continence after adjustment in contrast to another group (n = 3) with rigid urethras and 33% continence after adjustment. (4) Conclusions: As a part of its continence mechanism, the ATOMS device leads to continence by increasing intraurethral pressure owing to the stretching effect on the urethral wall caused by cushion filling that increases urethral resistance.

(1) Background: Male stress incontinence in patients with previously treated urethral or bladder neck stricture is a therapeutic challenge. The efficacy and safety of the adjustable trans-obturator male system (ATOMS) in these patients is unknown. (2) Methods: All patients with primary ATOMS implants in our institution between 2014 and 2021 were included. The outcomes of patients with previously treated urethral or bladder neck stricture (≥6 months before ATOMS implant) and stable 16Ch urethral caliber were compared to those without a history of stricture. The primary endpoint was the dry patient rate, defined as the pad test ≤ 20 mL/day, and complication rate, including device removal. The secondary variable was self-perceived satisfaction using the Patient Global Impression of Improvement (PGI-I) scale. Wilcoxon rank sum test, Fisher’s exact test and logistic regression were performed. (3) Results: One hundred and forty-nine consecutive patients were included, twenty-one (14%) previously treated for urethral or bladder neck stricture (seven urethroplasty, nine internal urethrotomy and five bladder neck incision). After ATOMS adjustment, 38% of the patients with treated stricture were continent compared to 83% of those without (p < 0.0001). After weighted matched observations using propensity score pairing, the proportion of continent patients without a previous stricture was 56% (p = 0.236). Complications occurred in 29% of the patients with stricture and in 20% of those without (p = 0.34). The severity of the complications was distributed evenly among the groups (p = 0.42). Regarding self-perceived satisfaction with the implant, 90% of the patients with stricture perceived the results satisfactorily (PGI-I 1–3) compared to 97% of the rest (p = 0.167). Stricture was associated with radiotherapy (p < 0.0001) and time from prostatectomy to implantation (p = 0.012). There was a moderate correlation between previous stricture and the severity of incontinence, both evaluated according to the 24-h pad test (Rho = 0.378; p < 0.0001) and the ICIQ-SF questionnaire (Rho = 0.351; p < 0.0001). Multivariate analysis for the factors predictive of failure after ATOMS adjustment revealed previous stricture (OR 4.66; 95% CI 1.2–18.87), baseline 24-h pad test (per 100 mL, OR 1.28; 95% CI 1.09–1.52) and final cushion volume (per mL, OR 1.34; 95% CI 1.19–1.55). This model predicted dryness with an AUC of 92%. After the PSMATCH procedure using a propensity score, the model remained unchanged, with the previous stricture (OR 8.05; 95% CI 1.08–110.83), baseline 24-h pad test (per 100 mL, OR 1.53; 95% CI 1.15–2.26) and final cushion volume (per mL, OR 1.45; 95% CI 1.17–2) being independent predictors and an AUC of 93%. (4) Conclusions: ATOMS can be used to treat male stress incontinence in patients with a history of stricture, although the effectiveness of the device is reduced. On the other hand, the security and perceived satisfaction were equivalent for both groups.

Objective To evaluate whether urodynamic voiding risk factors can be predictive of failure of postprostatectomy urinary incontinence (PPI) treatment with adjustable transobturator male system (ATOMS). Materials and Methods We carried out a longitudinal study on 77 males treated for PPI with ATOMS. Patients were submitted preoperatively to a urodynamic study. The postoperative outcome was checked by pad‐test. Treatment success was defined as daily pad‐test below 10 mL. Statistical analysis used were Fisher exact test, χ2 lineal by lineal test, Student t test, and logistic regression analysis. The signification level was set at 95% bilateral. Results Treatment was successful in 54 patients (70%) achieving continence. The urodynamic parameters that related to postoperative continence outcome were the cystometric bladder capacity (direct relationship with continence (P = .019), type of voiding (more probability to achieve continence in patients who voided voluntarily followed by patients with involuntary voiding and abdominal straining voiding) (P = .034), Bladder Outlet Obstruction Index (BOOI) (inversely related with continence) (P = .025), and maximum voiding abdominal pressure (inversely related with continence) (P = .049). Multivariate analysis showed that cystometric bladder capacity (odds ratio [OR], 1.01; confidence interval [CI], 1.02‐1.00), BOOI (OR, 0.97; CI, 0.99‐0.94), and maximum abdominal bladder pressure (OR, 0.97; CI, 0.98‐0.94) were independent risk factors to predict treatment success after ATOMS implant. Conclusions The study of functional voiding parameters is useful to know the risk factors that influence postoperative outcome of PPI with ATOMS device. These findings could be of primary importance to facilitate optimum patient selection for this implant and therefore improve operative results.

Introduction: This analysis, based on pre- and postoperative urodynamic data, is the first to elucidate the influence of the adjustable transobturator male system (ATOMS, A.M.I. GmbH, Feldkirch, Austria) on the lower urinary tract and disclose possible obstructive properties. Methods: A prospective study was performed in patients who had stress urinary incontinence and were scheduled for ATOMS implantation after radical prostatectomy. Apart from continence assessment (24-hour pad test, International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form [ICIQ-SF]), urodynamic testing was done with International Continence Society (ICS)-standardized pressure-flow analysis before and after ATOMS implantation/adjustment. The Wilcoxon signed-rank test was used for statistical analysis. Results: The analysis included 12 consecutive patients from two centers (mean 69 years) with a mean followup of 246 days. Median urine leakage dropped from 240 (72–1250) to 70 (0–700) g/24 hours postoperatively, with a pad reduction of 4 to 0.9 pads/day. Pressure-flow analysis revealed a significant change only in the bladder outlet obstruction index (BOOI). The bladder contractility index, intravesical pressure conditions, and uroflowmetry were not significantly affected. None of the patients showed de novo obstruction postoperatively in the ICS analysis. Conclusions: The ATOMS significantly increases the BOOI in conjunction with good continence results. However, no case reached pathological level according to the BOOI and thus there is no potential danger to the lower urinary tract or urethral integrity.

Objective: To assess changes in voiding phase, especially urethral resistance after post-prostatectomy urinary incontinence (PPI) treatment with the Adjustable TransObturator Male System (ATOMS). Material and Methods:A longitudinal prospective study was performed on 45 men treated with ATOMS for PPI, with the intention to evaluate the changes produced by the implant on the voiding phase. Patients with preoperative urodynamic study were offered postoperative urodynamic evaluation, and both studies were compared. The following urodynamic date were evaluated: maximum voiding detrusor pressure, detrusor pressure at maximum flow rate, maximum flow rate (Qmax), voiding volume, post-void residue, bladder outlet obstruction index (BOOI), urethral resistance factor (URA), and bladder contractility index (BCI). The statistical analysis used were the mean comparison test for dependent groups (Student's t test) for parametric variables and the Wilcoxon test for non-parametric variables. The signification level was set at 95% bilateral.Results: A total of 37 patients (82.2%) used zero pads/day at the time of urodynamic postoperative evaluation and pad-test evolved from 592 ± 289 ml baseline to 25 ± 40 ml (p = 0.0001). Significant differences were observed in Qmax (15 ± 8.3 before and 11 ± 8.3 after surgery; p = 0.008), voiding volume (282 ± 130.7 before and 184 ± 99.92 after surgery). BOOI (−12 ± 23.9 before and −2 ± 21.4 after surgery; p = 0.025) and BCI (93 ± 46.4 before and 76 ± 46.0 after surgery; p = 0.044). In no case did we observe postoperative bladder outlet obstruction, according to URA parameter below 29 cm H 2 O in all cases.There was not a significant variation either in post-void urinary residual volume (15 ± 47.4 before and 14 ± 24.2 after surgery, p = 0.867). Conclusions:The ATOMS implant induces a decrease of Qmax, voided volume, and bladder contractility and an increase of BOOI. However, our findings suggest that ATOMS device does not cause bladder outlet obstruction.