Treatment of male stress urinary incontinence with the adjustable transobturator male system: Outcomes of a multi‐center Iberian study

Angulo, Javier C.; Cruz, Francisco; Esquinas, Cristina; Arance, I.; Manso, Margarida; Rodríguez, Andrés Mauricio Quevedo; Pereira, Javier; Ojea, A; Carballo, Manuel; Rabassa, Miguel; Teyrouz, Antoine; Escribano, G; Rodrı́guez, Elena; Teba, Fernando; Celada, Guillermo; Madurga, Blanca; Álvarez-Ossorio, J.L.; Marcelino, J.; Martins, Francisco E.

doi:10.1002/nau.23474

Cited by 35 publications

(59 citation statements)

References 24 publications

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“…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%

“…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%

“…However, in the light of our results, we prove the concept that ATOMS implant after failed male sling or failed AUS is feasible and could be a reasonable alternative, especially in patients with former urethral reconstruction due to sling or AUS erosion. The low risk of urethral erosion and other postoperative complications [14,20] favor the choice of ATOMS, as it may be subject to less mechanical failures and need of revision surgery. Ultimately, the decision must be individualized and made taking into consideration the patient's expectations and the risks of further complications.…”

Section: Discussionmentioning

confidence: 99%

“…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. Also, incontinence severity and previous irradiation appear risk factors for ATOMS failure [12,14], but it should be taken into account that these are also risk factors for retropubic sling and AUS.…”

Section: Discussionmentioning

confidence: 99%

“…These patients are registered as part of a multi-institutional study performed in Spain and Portugal [14]. This study does not intend to compare ATOMS or AUS after failed device to treat male stress incontinence but is a proof of concept to evaluate whether ATOMS can be a secure and efficient alternative after failed male sling or failed AUS.…”

Section: Introductionmentioning

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: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

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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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 adjustable transobturator male system for stress urinary incontinence in the Iberian multicentre study

Angulo

Chamorro

Arance

et al. 2020

Neurourology and Urodynamics

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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.

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Treatment of male stress urinary incontinence with the adjustable transobturator male system: Outcomes of a multi‐center Iberian study

Abstract: This study confirms ATOMS device is safe and achieves high treatment efficacy and patient satisfaction in a multicenter setting. Significantly better results are achieved in less severe and non-irradiated cases. Durability of the device is reassuring in the short-term.

Cited by 35 publications

References 24 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

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

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

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