Adjustable Transobturator Male System Research Articles

Current status of the adjustable transobturator male system (ATOMSTM) for male stress urinary incontinence.

Male stress urinary incontinence is a debilitating condition, which can occur after prostate surgery. In persistent cases, surgery is indicated and a number of options are available. This includes one of the male slings, Adjustable transobturator male system (ATOMSTM, A.M.I, Austria). There are now an increasing number of studies published. This review provides an overview of the current status of this implant device including technical considerations, surgical outcomes and potential advantages and disadvantages compared to alternatives such as the artificial urinary sphincter.

The effectiveness of adjustable trans-obturator male system (ATOMS) in radiated patients is reduced: A propensity score-matched analysis.

This study aimed to compare the effectiveness and safety of the adjustable trans-obturator male system (ATOMS®) to treat post-prostatectomy incontinence (PPI) in radiated patients compared with non-radiated patients, using propensity score-matching analysis to enhance the validity of the comparison. Consecutive men with PPI treated with silicone-covered scrotal port ATOMS (A.M.I., Feldkirch, Austria) in nine different institutions between 2016 and 2022 were included. Preoperative assessment evaluated 24-h pad usage, urethroscopy and urodynamics, if indicated. Propensity score-matching analysis was based on age, length of follow-up, previous PPI treatment, previous bladder neck stricture, androgen deprivation and pad usage. The primary endpoint was dry rate, defined as no pads post-operatively with a security pad allowed. The secondary endpoints were complications, device removal and self-perceived satisfaction with the Patient Global Impression of Improvement (PGI-I) scale. Of the 710 included patients, 342 were matched, and the study groups were balanced for the baseline matched variables. The mean baseline 24-h pad was 4.8 in both groups (p = 0.48). The mean follow-up was 27.5 ± 18.6 months, which was also equivalent between groups (p = 0.36). The primary outcome was achieved in 73 (42.7%) radiated patients and in 115 (67.3%) non-radiated patients (p < 0.0001). The mean pad count at the last follow-up was 1.5 and 0.8, respectively (p < 0.0001). There was no significant difference in complications (p = 0.94), but surgical revision and device explant rates were higher (p = 0.03 and p = 0.01, respectively), and the proportion of patients highly satisfied (PGI-I = 1) was lower in the radiated group (p = 0.01). At sensitivity analysis, the study was found to be reasonably robust to hidden bias. ATOMS implantation significantly outperformed in patients without adjuvant radiation over radiated patients.

Factors Influencing Postoperative Overactive Bladder after Adjustable Trans-Obturator Male System Implantation for Male Stress Incontinence following Prostatectomy.

We aimed to determine the risk factors for postoperative overactive bladder (OAB) in patients treated with an adjustable trans-obturator male system (ATOMS) for stress incontinence after radical treatment of prostate cancer. A prospective study was performed on 56 patients implanted with an ATOMS for PPI. Clinical and urodynamic information was recorded before and after ATOMS implantation. We built a multivariate model to find out the clinical and urodynamic factors that independently influenced postoperative OAB and the prognostic factors that influenced the efficacy of medical treatment of OAB. We found that the clinical risk factors were the preoperative intensity of urinary incontinence (number of daily pads used and amount of urinary leakage), International Consultation on Incontinence Questionnaire (ICIQ) score, postoperative number of ATOMS adjustments, final cushion volume, and incontinence cure. The urodynamic data associated with OAB were cystometric bladder capacity, voided volume, volume at initial involuntary contraction (IC), maximum flow rate, bladder contractility index (BCI), and urethral resistance (URA). The prognostic factors for the efficacy of oral treatment of OAB were the volume at the first IC (direct relationship) and the maximum abdominal voiding pressure (inverse relationship). The multivariate model showed that the independent clinical risk factors were the daily pad count before the implantation and the ICIQ score at baseline and after treatment. The independent urodynamic data were the volume at the first IC (inverse relationship) and the URA value (direct relationship). Both predictive factors of treatment efficacy were found to be independent. Detrusor overactivity plays an important role in postoperative OAB, although other urodynamic and clinical factors such as the degree of urethral resistance and abdominal strength may influence this condition.

Adjustable transobturator male system (ATOMS) for stress urinary incontinence: the evidence is mounting.

To evaluate the New Zealand clinical experience with the adjustable transobturator male system (ATOMS), a novel continence device in the management of all degrees of stress urinary incontinence (SUI), focusing on efficacy and safety outcomes. A retrospective review of all ATOMS devices placed between May 2015 and November 2020 was conducted. Severity of SUI was assessed (pad usage) before and after surgery. SUI was defined as mild (1-<3 pads/day), moderate (≥3-5 pads/day) or severe (>5 pads/day). The primary outcome measures considered were the overall success rate (improvement in pad use) and the dry rate (with dry defined as either no or 1 safety pad/day). The number of outpatient adjustments and total filling volumes were also documented in each case. Additionally, we documented incidence and severity of device complications and an analysis of treatment failures. A total of 140 patients were reviewed, with the most common indication for ATOMS placement being SUI after radical prostatectomy (82.8%). Of the patients included, 53 (37.9%) had previous radiotherapy, with 26 (18.6%) patients having had a previous continence procedure performed. No intraoperative complications were noted. The median preoperative pad usage was 4 pads/day. After a median follow-up of 11 months, median postoperative pad usage reduced to 1 pad/day. In our cohort, 116 patients (82.9%) reported an improvement in their pad usage and were considered successful with 107 (76.4%) patients reporting themselves to be dry. Complications within the first 90-days after surgery occurred in 20 (14.3%) of patients. Treatment of SUI with the ATOMS is safe and effective. The option of long-term, minimally invasive adjustment to respond to patient needs is a significant advantage.

Results of Adjustable Trans-Obturator Male System in Patients with Prostate Cancer Treated with Prostatectomy and Radiotherapy: A Multicenter Study.

(1) Background: Treatment of male stress incontinence in patients with prostate cancer treated with radical prostatectomy and adjuvant pelvic radiation is a therapeutic challenge. The efficacy and safety of the adjustable trans-obturator male system (ATOMS) in these patients is not well established, despite the general belief that outcomes are worse than in patients without radiation. (2) Methods: Retrospective multicenter study evaluating patients treated with silicone-covered scrotal port (SSP) ATOMS implant after radical prostatectomy and radiotherapy in nine different institutions between 2016 and 2022. The primary endpoint was dry patient rate, defined as pad-test ≤ 20 mL/day. The secondary endpoints were complication rate (defined using Clavien-Dindo classification), device removal and 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 using stepwise method with a 0.15 entry and 0.1 stay criteria. (3) Results: 223 patients fulfilled the criteria for inclusion and 12 (5.4%) received salvage prostatectomy after radiation and 27 (12.1%) previous devices for stress incontinence. After ATOMS adjustment, 95 patients (42.6%) were dry and 36 (16.1%) had complications of any grade (grade I, n = 20; grade II, n = 11; grade III, n = 5) during the first 3 months postoperatively. At a mean of 36 ± 21 months follow-up, the device was explanted in 26 (11.7%) patients. Regarding self-perceived satisfaction with the implant, 105 of 125 patients (84%) considered themselves satisfied (PGI-I 1 to 3). In the univariate analysis, dryness was associated to younger age (p = 0.06), primary prostatectomy (p = 0.08), no previous incontinence surgery (p = 0.02), absence of overactive bladder symptoms (p = 0.04), absence of bladder neck stricture (p = 0.001), no need of surgical revision (p = 0.008) and lower baseline incontinence severity (p = 0.0003). Multivariate analysis identified absence of surgical revision (p = 0.018), absence of bladder neck stricture (p = 0.05), primary prostatectomy (p = 0.07) and lower baseline incontinence severity (p < 0.0001) were independent predictors of dryness. A logistic regression model was proposed and internally validated. (4) Conclusions: ATOMS is an efficacious and safe alternative to treat male incontinence after radical prostatectomy and adjuvant radiotherapy. Factors predictive of dryness are identified in this complex scenario to allow for better patient selection.

Update on Adjustable Trans-Obturator Male System (ATOMS) for Male Incontinence after Prostate Cancer Surgery.

(1) Background: The adjustable trans-obturator male system (ATOMS) is a surgical device developed to treat post-prostatectomy incontinence (PPI) after prostate cancer treatment. We review the current literature on this anti-incontinence device with the intention of assessing the effectiveness, safety and duration of the silicone-covered scrotal port (SSP) ATOMS, the only generation of the device that is currently available. (2) Material and Methods: Non-systematic literature review is performed. Forty-eight full-text articles are assessed for eligibility. Case reports, expert opinions or commentaries without specific data reported (n = 6), studies with patients who underwent intervention before 2014 (IP or SP ATOMS; n = 10), and studies with incontinence after transurethral resection of the prostate (TUR-P; n = 2) are excluded for analysis. Thirty studies with SSP ATOMS are included in a qualitative synthesis that incorporates systematic reviews (n = 3), articles partially overlapping with other previously published studies (e.g., follow-up or series updates; n = 9), and studies focusing on specific populations (n = 8). Only articles revealing outcomes of SSP ATOMS were included in the quantitative synthesis of results (n = 10). (3) Results: the pooled data of 1515 patients from the 10 studies with SSP ATOMS confirmed very satisfactory results with this device after adjustment: dry rate: 63-82%, improved rate: 85-100%, complication rate: 7-33%, device infection rate: 2.7-6.2% and explant rate: 0-19%. The durability of the device is reassuring, with 89% of devices in place 5 years after implantation. (4) Conclusion: Despite the absence of randomized controlled studies, the literature findings confirm results of SSP ATOMS appear equivalent to those of artificial urinary sphincters (AUSs) in terms of continence, satisfaction and complications, but with a lower rate of revision in the long-term. A prospective study identified that patients with daily pad test results <900 mL and a Male Stress Incontinence Grading Scale (MSIGS) of not 4 (i.e., early and persistent stream or urine loss) are the best candidates. Future studies centered on the elder population at higher risk of impaired cognitive ability and in patients including radiation as prostate cancer treatment are needed.

ATOMS (Adjustable Trans-Obturator Male System) in Patients with Post-Prostatectomy Incontinence and Previously Treated Urethral Stricture or Bladder Neck Contracture.

(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.

Adjustable Transobturator Male System® (ATOMS) as a novel treatment for men with stress urinary incontinence in the United Kingdom

Objectives: To investigate the first experience in the United Kingdom of using the Adjustable Transobturator Male System® (ATOMS) in treating men with stress urinary incontinence (SUI). Methods: Between 2015 and 2021, 71 men (average age: 70.3, range: 50–81 years) were recruited and followed up. Of these, 67 (94%) had SUI secondary to a radical prostatectomy and 16 (23%) had previous radiotherapy post-prostatectomy. Seventy men underwent an insertion of ATOMS® under general anaesthetic. In one patient, due to his underlying morbid obesity, it was not possible to insert ATOMS and thus he was excluded from the study. Follow-up was up to 6 years (mean: 4 years, range: 2–6 years). Results: Out of 70 men, 53 (76%) were dry after ATOMS insertion (defined as using a maximum of one pad per day for reassurance only). Dryness was achieved within 6 months for 34/53 patients (range: 1–24 months). The average pad use was 3.4 pre-operatively and 0.7 post-operatively. Of the men who did not achieve dryness, 7/17 (41%) had previously undergone radiotherapy. There were 11 (16%) complications: two cases of infected device requiring removal, one case of balloon mechanism erosion requiring re-implantation, one case of balloon mechanism require repositioning, four cases of persistent perineal or scrotal pain, two cases of urinary retention and one case of a superficial wound infection treated medically. Overall, five devices were removed. Conclusions: The ATOMS appears to be a safe and efficacious treatment for men with SUI. Previous radiotherapy decreased the efficacy of ATOMS. Further studies on ATOMS with larger numbers of patients and longer follow-ups are required. In particular, establishing randomised control trials to confirm these positive outcomes as well as ascertain its long-term safety profile. Level of evidence: 4

Refined Nomogram Incorporating Standing Cough Test Improves Prediction of Adjustable Trans-Obturator Male System (ATOMS) Success to Treat Post-Prostatectomy Male Stress Incontinence.

(1) Background: The adjustable transobturator male system (ATOMS) device serves to treat post-prostatectomy incontinence, as it enhances residual urinary sphincteric function by dorsal compression of the bulbar urethra. We investigated the clinical parameters affecting continence recovery using this device and developed a decision aid to predict success. (2) Methods: We reviewed consecutive men treated with first-time ATOMS for post-prostatectomy incontinence from 2014 to 2021 at our institution. Patient demographics, reported pads per day (PPD), 24-h pad-test and Standing Cough Test (SCT), results’ grades 1–4, according to Male Stress Incontinence Grading Scale (MSIGS), and the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) questionnaire were assessed. Treatment success was defined as no pads or a single PPD with ≤20-mL 24-h pad-test. Logistic regression was performed using a stepwise model (entry 0.15 and stay criterium 0.1) to evaluate independent variables’ determinant of dryness. Receiver-operating characteristic (ROC) curves for predictive variables were evaluated and their area under curve (AUC) was compared. A nomogram was generated and internally validated to predict probability of treatment success. (3) Results: Overall, 149 men (median age 70 years, IQR 7) were evaluated with a median follow-up of 45 months (IQR 26). Twelve patients (8%) had previous devices for incontinence, and 21 (14.1%) had pelvic radiation. Thirty-five men (23.5%) did not achieve continence after ATOMS adjustment (use of no or one security PPD with ≤20-mL 24-h pad-test). In univariate analysis, Charlson comorbidity index (p = 0.0412), previous urethroplasty (p = 0.0187), baseline PPD (p < 0.0001), 24-h pad-test (p < 0.0001), MSIGS (p < 0.0001), and ICIQ-SF questionnaire score (p < 0.0001) predicted ATOMS failure. In a multivariable model, 24-h pad-test (p = 0.0031), MSIGS (p = 0.0244), and radiotherapy (p = 0.0216) were independent variables, with AUC 0.8221. The association of MSIGS and 24-h pad-test was the superior combination (AUC 0.8236). A nomogram to predict the probability of ATOMS failure using the independent variables identified was proposed. (4) Conclusions: Several variables were identified as predictive of success for ATOMS using clinical history, physical examination (MSIGS), and factors that evaluate urine loss severity (PPD, 24-h pad-test, and ICIQ-SF questionnaire). MSIGS adds prognostic value to 24-h pad-test in assessing success of ATOMS device to treat post-prostatectomy incontinence. A nomogram was proposed to calculate the risk of ATOMS failure, which could be of interest to personalize the decision to use this device or not in the individual patient.

Influence of ATOMS implant on the voiding phase of patients with post-prostatectomy urinary incontinence.

To assess changes in voiding phase, especially urethral resistance after post-prostatectomy urinary incontinence (PPI) treatment with the Adjustable TransObturator Male System (ATOMS). 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. 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 H2 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). 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.

ATOMS (Adjustable Transobturator Male System) Is an Effective and Safe Second-Line Treatment Option for Recurrent Urinary Incontinence after Implantation of an AdVance/AdVance XP Fixed Male Sling? A Multicenter Cohort Analysis.

(1) Background: This study examined outcomes of second-line ATOMS implantation after failure of the fixed male sling (FMS) AdVance/AdVance XP. (2) Methods: A retrospective multicenter cohort analysis was carried out in men implanted with an ATOMS between 2011 and 2020 after failure of an AdVance/AdVance XP. Success was assessed on the basis of objective (dryness, 0–1 pad/24 h or >20 g/24 h pad test) and subjective results (PGI-I). We performed the Wilcoxon rank sum test, Fisher’s exact test, logistic regression, and multivariate analysis. (3) Results: The study included 88 patients from 9 centers with a mean age of 71.3 years. No Clavien–Dindo > II complications occurred within the first 3 months after ATOMS implantation. A total of 10 cases (9%) required revision in the ensuing clinical course. After a mean follow-up of 42.5 months, 76.1% achieved social continence, and 56.8% used no pads at all. Mean urine leakage/24 h dropped from 422 g (3.9 pads) to 38 g (0.69 pads) and the mean ICIQ-SF decreased from 16.25 to 5.3 (p < 0.0001). PROMs (patient-reported outcome measures) showed improvement in 98.9% of cases, and 63.6% gave a “very much better” PGI-I rating. Multivariate analysis identified a lower probability of achieving maximum satisfaction for the following factors: the AdVance XP as first-line therapy (OR 0.35), a lower ICIQ-SF question 1 (OR 0.26), status post-irradiation (OR 0.14), and more severe pain prior to ATOMS implantation (OR 0.51). (4) Conclusions: Implantation of an ATOMS is an effective and safe second-line treatment option for recurrent urinary incontinence after implantation of an AdVance/AdVance XP sling. High patient satisfaction was demonstrated in a long-term follow-up.

Compression or obstruction: Prospective analysis of the function of the Adjustable Transobturator Male System (ATOMS) based on preand postoperative urodynamic data.

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. 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. The analysis included 12 consecutive patients from two centers (mean age 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. 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.

AUTHOR REPLY

The artificial urinary sphincter (AUS) is the most reliable and efficient treatment for post-prostatectomy incontinence (PPI) in patients with complete or nearly complete sphincteric damage. However, evidence is mounting in favor of the adjustable transobturator male system (ATOMS, A.M.I., Feldkirch, Austria) as another gold standard for PPI in cases with partial sphincteric competence, both primarily or as rescue surgery.

Adjustable Transobturator Male System (ATOMS) Infection: Causative Organisms and Clinical Profile

ObjectiveTo evaluate the clinical profile and the organisms producing adjustable transobturator male system (ATOMS) infection in a contemporary series. MethodsMulticenter retrospective study evaluating patients undergoing ATOMS explant for clinical signs of infection from a series of 902 patients treated in 9 academic institutions. Clinical and microbiological data were evaluated. ResultsInfection presented in 24 patients (2.7%). The median age was 73 ± 7yrs and the median interval from ATOMS implantation to explant 11 ± 26.5mo. Infection was diagnosed within 3-months after surgery in 7(29.2%). Scrotal port erosion was present in 6 cases (25%) and systemic symptoms of parenchymatous testicular infection in 2(8.3%). The culture of the periprosthetic fluid was positive in 20(83.3%): 12(50%) Gram-negative bacteria, 9(37.5%) Gram-positive cocci and 1(4.2%) yeast. The most frequent isolates were Enterococcus and Proteus sp. (16.7% each), followed by Pseudomona sp. and S. epidermidis (12.5% each). Methicillin resistant S. aureus was detected only in 1 case (4.2%). Despite the infection 17 patients (70.8%) were satisfied with the implant and 18(75%) received a second device (11 repeated ATOMS and 7 AUS) at a median 9.7 ± 12.6mo after explant. Limitations include retrospective design and lack of microbiological cultures in ATOMS explanted for non-infective cause. ConclusionInfection of a prosthetic device is a disturbing complication. A proportion of patients with ATOMS infection is associated to scrotal port erosion and/or parenchymatous urinary tract infection. Enterococcus and Proteus sp. are the most common organisms producing ATOMS infection and this could have implications for the selection of the most appropriate surgical prophylaxis.

The Mode of Action of Adjustable Transobturator Male System (ATOMS): Intraoperative Urethral Pressure Measurements

(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.

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

To evaluate treatment options after surgical revision of adjustable transobturator male system (ATOMS) and the results of further incontinence implantation. A retrospective multicenter study evaluating patients with surgical revision of ATOMS in academic institutions. Causes and factors affecting revision-free interval were studied and also the frequency of device explant and placement of second ATOMS or artificial urinary sphincter (AUS) at surgeon discretion. Operative results, complications (Clavien-Dindo), and efficacy (postoperative pad-test, pad-count, patient satisfaction, and patient global impression of improvement [PGI-I scale]) of each treatment option were compared. Seventy-eight out of 902 patients (8.65%) with ATOMS underwent surgical revision at 4.1 ± 2.4 years mean follow-up and 75 (8.3%) were explanted. The main causes for revision included persistence of incontinence (35.9%) and scrotal port erosion (34.6%). Independent risk factors of the shortened revision-free interval were previous anti-incontinence surgery (HR, 1.83; 95% CI, 1.06-3.16; p = 0.007) and port erosion (HR, 1.83; 95% CI,1.06-3.16; p = 0.0027). Fifty-eight (6.4%) received a second implant: 31 repeated ATOMS and 27 AUS. Operative time was longer for AUS (p = .003). The visual analog scaleof pain at hospital discharge (p = 0.837) and postoperative complications (p = 0.154) were equivalent. The predominant cuff size for AUS was 4.5 cm (59.3%). Mean follow-up after the second implant was 29.1 ± 25.8 months. Postoperative efficacy of secondary treatment results favored ATOMS based on pad-test (p = 0.016), pad-count (p = 0.029), patient satisfaction (p = 0.04), and PGI-I (p = 0.025). ATOMS surgical revision due to different reasons generally leads to device explant. Rescue treatment is possible with ATOMS or AUS. No difference in postoperative complications was detected between secondary devices, but efficacy favors repeating ATOMS implantation.

EDITORIAL COMMENT

This manuscript details the multi-institutional experience with a device, the Adjustable TransObturator Male System (ATOMS––third generation), designed as an alternative to the standard surgical options for male stress urinary incontinence, an unfortunate but not infrequent complication associated with prior prostatectomy, mainly but not exclusively performed for the treatment of prostate cancer. In contrast to standard management with either a male sling or artificial urinary sphincter, this device purports to allow adequate compression of the bulbous urethra without the need for mechanical cycling when using the latter.

AUTHOR REPLY

Management of postprostatectomy incontinence can often be challenging. Effective medical treatments are lacking and there is no perfect surgical device. Thus, clinicians are constantly on the horns of a dilemma which straddles patient preference and device efficacy. The majority of patients prefer not to have a mechanical pump if given the choice but at the same time would like to be as continent as possible. The adjustable trans-obturator male system is by no means perfect but conveniently fills the niche of efficacy and risk somewhere between the artificial urinary sphincter and various nonadjustable male slings.

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

IntroductionA prospective evaluation of outcomes in a series of patients with post-prostatectomy incontinence (PPI) treated with two different devices is presented.MethodsConsecutive 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.ResultsOne hundred twenty-nine patients were included: 102 (79.1%) received ATOMS and 27 (20.9%) AUS. Mean follow-up was 34.9 ± 15.9 months. No difference was observed between patient age (p = 0.56), ASA score (p = 0.13), Charlson index (p = 0.57) and radiation (p = 0.3). BMI was higher for AUS (27.1 vs. 29.7; p = 0.003) and also baseline incontinence severity (7.9% mild, 44.1% moderate and 48% severe for ATOMS vs. 11.1% moderate and 88.9% severe for AUS; p = 0.0007). Differential pad test was higher for AUS (− 470 vs. − 1000 ml; p < 0.0001) and so was ICIQ-SF (15.62 vs. 18.3; p < 0.001), but total dryness (76.5 vs. 66.7%; p = 0.33), social continence (90.2 vs. 85.2%; p = 0.49) and satisfaction (92.2 vs. 88.9%; p = 0.69) were equivalent. The postoperative complication rate was similar (22.6 vs. 29.6%; p = 0.4). The surgical revision rate was higher for AUS (6.9 vs. 22.2%; p = 0.029) and also the explant rate but did not reach statistical significance (4.9 vs. 14.8%; p = 0.09). Time to explant was shorter for AUS (log-rank p = 0.021). Regression analysis revealed radiation (p = 0.003) and incontinence severity (p = 0.029) predict total dryness, while complications (p < 0.005) and type of device (p = 0.039) independently predict surgical revision.ConclusionsBoth ATOMS and AUS are effective devices. Pad test change for AUS exceeds that of ATOMS. The revision rate is higher for AUS, and durability is superior for ATOMS. The satisfaction rate is equivalent. Larger series and longer follow-up are needed to compare both devices more appropriately. According to our experience, the AUS is not the only gold standard for PPI.Electronic supplementary materialThe online version of this article (10.1007/s12325-020-01563-z) contains supplementary material, which is available to authorized users.

Multicentered Assessment of Clinical Outcomes and Factors Associated With Failure of the Adjustable TransObturator Male System (ATOMS)

To assess postoperative outcomes from the Adjustable TransObturator Male System (ATOMS) and identify factors influencing failure to achieve continence. A multicentered analysis was performed on all patients treated for postprostatectomy incontinence using the third-generation ATOMS at 9 Canadian tertiary referral centers. The primary outcome was continence (defined as requiring ≤1 pad postoperatively for patients requiring ≥2 pads preoperatively and 0 pads for those requiring 1 pad preoperatively). Secondary outcomes included improvement (>50% change in pad use), patient satisfaction, explantation, and postoperative complications. Two hundred and eighty nine patients with a mean age of 68.9 years were analyzed. Pre-operatively mean pad per day use was 4.2 (1-12), 31.5% of patients reported severe incontinence (≥5 pads/day), 33.9% had concurrent radiotherapy and 19.4% had failed previous incontinence surgery. Overall continence rate was 73.3% (n = 212) at a mean follow-up of 19.6 months. More than eighty nine percent (89.3%) (n = 258) of patients experienced >50% improvement, 84.4% (n = 244) of patients were satisfied with the results of surgery. More than seven percent (7.9%) (n = 23) required device explantation. On multivariate Cox regression analysis, concurrent radiotherapy (hazard ratio [H.R.] 2.3, P < .001), diabetes (H.R. 2.2, P = .007) and increased pre-operative pad usage (H.R. 1.1, P = .02) were each associated with failure to achieve continence, while patient age (P = .60), obesity (P = .08), prior urethral stenosis (P = .56), and prior incontinence surgery (P = .13) were not. Radiation therapy was also associated with device explantation (H.R. 2.7, P = .02). ATOMS is a safe and efficacious for treatment of postprostatectomy incontinence. However, patients with prior radiation, increased pre-operative pad use, or diabetes are less likely to achieve continence.