Long‐term outcome of the adjustable transobturator male system (ATOMS): results of a European multicentre study

Friedl, Alexander; Mühlstädt, Sandra; Zachoval, Reinhart; Giammò, Alessandro; Kivaranovic, Danijel; Rom, Maximilian; Fornara, Paolo; Brössner, Clemens

doi:10.1111/bju.13684

Cited by 74 publications

(69 citation statements)

References 30 publications

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“…Later, Friedl et al [33] analyzed the risk factor for ATOMS failure and concluded that previous ineffective implants are a significant factor for new implant removal. The long-term outcomes of the same ATOMS series confirmed secondary and tertiary implantation, also including failed ATOMS, are at higher risk of failure; while former urethral surgeries and strictures do not influence device durability [30]. However, titanium intolerance was the most frequent complication leading to explant in this series, associated to IP, an outdated design of device not used in our series.…”

Section: Discussionsupporting

confidence: 66%

“…The complications reported in studies with old-generation devices (mainly inguinal port [IP]) have little to do with studies that predominantly or exclusively report pre-attached scrotal port devices [14,30,31]. One study with the first-generation inguinal titanium port device described a high complication and explantation rate, but patient satisfaction was very high and 56% of the patients in this cohort would recommend the system to their best friends [32].…”

Section: Discussionmentioning

confidence: 99%

“…Within ATOMS literature, uretral erosion has been reported only twice, in a case associated to perineal infection [32] and in another patient who had undergone surgery for incontinence on 4 separate occasions and had experienced erosion of an AUS 6-month before receiving the ATOMS implant [11]. No more cases were reported in large multicenter studies [14,30] or in any other series so far. The current study does not aim to compare the outcomes of ATOMS implantation with a non-ATOMS surgical procedure to treat post-prostatectomy incontinence.…”

Section: Discussionmentioning

confidence: 99%

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Adjustable Transobturator Male System after Failed Surgical Devices for Male Stress Urinary Incontinence: A Feasibility Study

et al. 2018

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Objectives: Feasibility study to evaluate the efficacy and safety of Adjustable Transobturator Male System (ATOMS) after failed surgical devices for male stress urinary incontinence (SUI). Materials and Methods: Thirty patients were implanted with ATOMS after they were implanted with surgical device/s previously. SUI severity was evaluated as dryness (0–1 pad/day), mild (2 pads/day), moderate (3–5 pads/day), or severe (≥6 pads/day). Change in pad-test and pad-count after adjustment, operative parameters, patient satisfaction, and number and grade of complications were investigated. Results: Previous failed treatment methods were artificial urinary sphincter (AUS; n = 19), Advance (n = 10), and Virtue (n = 1). Six cases had multiple previous treatments. Preoperative SUI was mild 6 (20%), moderate 11 (36.7%), and severe 13 (43.3%). Median pad-test decreased from 435 mL baseline to 10 mL after adjustment and pad-count from 4 to 0. Dry-rate was 76.7 and 83.3% declared satisfied. Postoperative SUI distribution was mild in 3 (10%) and moderate in 4 (13.3%). No patient had urinary retention after catheter removal. Complications presented in 4 (13.3%; 3 grade-I, 1 grade-II). After a median of 24 months follow-up, no system experienced infection or urethral erosion and 1 (3.3%) was removed for inefficacy. Conclusion: Based on short-term efficacy and patient satisfaction, ATOMS can be a realistic alternative for male SUI after other failed systems, including AUS. The absence of urethral erosion and limited infective problems makes this alternative attractive for cases with previous failed treatments.

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Section: Discussionsupporting

confidence: 66%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Adjustable Transobturator Male System after Failed Surgical Devices for Male Stress Urinary Incontinence: A Feasibility Study

et al. 2018

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“…Irradiated patients should be cautioned about the greater risk of failure of the ProACT technique and increased risk of urethral erosion. Results of male slings in previously irradiated patients have also shown lower efficacy results although some adjustable slings have shown favorable results in this patient group . Impact of previous radiation on AUS safety and efficacy outcomes remains debated …”

Section: Discussionmentioning

confidence: 99%

“…14 have also shown lower efficacy results 28 although some adjustable slings have shown favorable results in this patient group. 35,36 Impact of previous radiation on AUS safety and efficacy outcomes remains debated. 37,38 Male slings are primarily indicated for mild and moderate patients, 26 while AUS is typically reserved for more severe patients.…”

Section: Discussionmentioning

confidence: 99%

Adjustable continence therapy (ProACT) for the treatment of male stress urinary incontinence: A systematic review and meta‐analysis

Larson

Jhaveri

Yeung

2019

Neurourology and Urodynamics

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Aims First, to evaluate the efficacy of adjustable balloon devices or adjustable continence therapy (ProACT) in the treatment for male stress urinary incontinence (SUI). Second, to investigate the safety profile and rates of adverse events associated with the implantation of adjustable balloon devices. Method A review of the literature was performed by searching the PubMed database with the most applicable search terms. We narrowed included studies with adult male patients with SUI; outcomes included pads or pad weight per day and quality of life (QOL) questionnaires, as well as safety outcomes. Results In total, 19 studies were included with a total of 1264 patients and 4517 patient‐years of follow‐up data (mean follow‐up time 3.6 years). ProACT implantation resulted in an incontinence QOL improvement of 30.8 points from baseline. At baseline, patients on average were using 4.0 pads per day (PPD) (95% confidence interval [CI]: 2.6‐5.4), which was reduced to an average of 1.1 PPD (95% CI: 0.5‐1.7) after ProACT implantation. The number of patients that were considered “dry” was 60.2% (95% CI: 54.2%‐65.9%) and the number of patients who were found to be either “dry” or improved greater than 50% was 81.9% (95% CI: 74%‐87.8%). Conclusions Implantation of adjustable balloon devices is efficacious and safe for the treatment of male SUI. Given the minimal invasiveness of the therapy, adjustable balloon devices may be a serious option as a first‐line treatment in nonirradiated patients with SUI who are not ideal candidates for the artificial urinary sphincter.

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

Angulo,

Giammò,

Queissert

et al. 2024

BJUI Compass

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ObjectivesThis 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.Patients and methodsConsecutive 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.ResultsOf 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.ConclusionATOMS implantation significantly outperformed in patients without adjuvant radiation over radiated patients.

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Long‐term outcome of the adjustable transobturator male system (ATOMS): results of a European multicentre study

Cited by 74 publications

References 30 publications

Adjustable Transobturator Male System after Failed Surgical Devices for Male Stress Urinary Incontinence: A Feasibility Study

Adjustable Transobturator Male System after Failed Surgical Devices for Male Stress Urinary Incontinence: A Feasibility Study

Adjustable continence therapy (ProACT) for the treatment of male stress urinary incontinence: A systematic review and meta‐analysis

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

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