Tag Archive for: male stress urinary incontinence

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Article of the Week: Evaluation of the ATOMS

Every week the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

If you only have time to read one article this week, it should be this one.

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

Alexander Friedl*, Sandra Muhlstadt, Roman Zachoval, Alessandro Giammo§Danijel Kivaranovic, Maximilian Rom**, Paolo Fornara† and Clemens Brossner*
*Department of Urology, Hospital Gottlicher Heiland, Vienna, Austria, Klinik and Poliklinik of Urology and Kidney Transplantation, University Hospital, Martin-Luther-University, Halle-Wittenberg, Halle/Saale, Germany, Thomayer Hospital, Department of Urology and 1st and 3rd Medical Faculty, Charles University, Prague, Czech Republic, §Neuro-Urology Department, CTO-Spinal Unit Hospital, Turin, Italy, Center for Medical Statistics, Informatics, and Intelligent Systems, and **Department of Urology, Medical University Vienna, Vienna, Austria

How to Cite

Friedl, A., Mühlstädt, S., Zachoval, R., Giammò, A., Kivaranovic, D., Rom, M., Fornara, P. and Brössner, C. (2017), Long-term outcome of the adjustable transobturator male system (ATOMS): results of a European multicentre study. BJU International, 119: 785–792. doi: 10.1111/bju.13684

Objective

To evaluate the long-term effectiveness and safety of the adjustable transobturator male system (ATOMS®, Agency for Medical Innovations A.M.I., Feldkirch, Austria) in a European-wide multicentre setting.

Patients and Methods

In all, 287 men with stress urinary incontinence (SUI) were treated with the ATOMS device between June 2009 and March 2016. Continence parameters (daily pad test/pad use), urodynamics (maximum urinary flow rate, voiding volume, residual urine), and pain/quality of life (QoL) ratings (visual analogue scale/Leeds Assessment of Neuropathic Symptoms and Signs, International Consultation on Incontinence Questionnaire-Short Form [ICIQ-SF]/Patient Global Impression of Improvement [PGI-I]) were compared preoperatively and after intermediate (12 months) as well as after individual maximum follow-up. Overall success rate, dry rate (<10 mL/day and 0–1 pad/day), device durability, treatment failure, and device complications were recorded. Nonparametric tests were used for statistical analyses.

may-aotw-2-results

Results

After a median (interquartile range [IQR]) follow-up of 31 (10–54) months and a median (IQR) of 3 (2–4) adjustments, the overall success rate was 90% (258 men) and the dry rate was 64% (184). Daily pad test and pad use decreased from a median of 400 mL/day and 4 pads/day to a median of 18 mL/day and 1 pad/day (both P < 0.001), concomitantly QoL ratings significantly improved and changed to a high level of satisfaction (PGI-I 4 to 2, ICIQ-SF 17 to 5; both P < 0.001). The UI results at 12 months were comparable to those at final follow-up. Chronic pain and intraoperative complications did not occur. Most of the postoperative complications were Clavien–Dindo grade I–III (no grade IV or V). At present, 231 (80%) of all the ATOMS devices are still functioning; 56 (20%) were removed, the most common reason being local titanium intolerance (41%) and leak/dysfunction (30%). The operating time and continence outcome varied between port generations. In this regard the latest port generation (silicone-covered scrotal port) was superior to its predecessors. Primary implantation (P = 0.002), good physical health (P = 0.001), and no history of radiotherapy (P < 0.001) were prognostic factors for beneficial treatment outcome.

Conclusion

The ATOMS device is safe and shows high treatment efficacy and patient satisfaction in the largest cohort study to date. The latest generation, with its pre-attached silicone-covered scrotal port, is superior to its predecessors. Significantly better results were achieved with primary implantation and in those without a history of radiotherapy.

Editorial: The ATOMS… Is it really all so easy?

The adjustable transobturator male system (ATOMS® Agency for Medical Innovations A.M.I., Feldkirch, Austria) is an interesting device (the design is evocative of the historical Kaufmann sling) that is now incorporated into the wide spectrum of post-prostatectomy incontinence treatments, and which confirms the real existing pathology despite the introduction of optimised robot-assisted prostate surgery. An interesting article in the present issue of BJUI describes the long-term outcome of the ATOMS device [1].

But there are some considerations that I would like to raise about this device. Only the first generation of ATOMS (inguinal port, IP) has long-term follow-up data and 15% of implanted devices have been explanted within 6–33 months [2]. So, I think we have to be prudent and wait for further long-term results for the third-generation silicone-covered scrotal port (SSP) system, as it has only 2–7 months of previously published outcome data.

As the explantation rates of all other silicone devices are still high, between 12% and 35% in the mid- to long-term, why should we not expect this for the ATOMS SSP third generation? All devices (sphincters, Argus, Reemex etc.) have an explantation risk and the causes are, in most cases infections and erosions, i.e. still trophic problems.

As stated, the explant rate of silicone devices is still high, but the removal of silicone parts is relatively easy because of the ‘coating’ by a collagenous capsule. On the other hand, male slings (mesh) are really rarely infected and require explantation, but if this happens a complete removal of the transobturator tape (TOT) male mesh sling is needed, which is still relatively challenging surgery and incapacitating for the patient, especially if the mesh has become ingrown.

Another point in the study of Friedl et al. [1] is that titanium intolerance is described as one of the main causes of device explantation (41%). We have to consider the broad use of titanium-covered meshes or titanium artificial hips, as in the literature prosthesis explantation caused by titanium intolerance have not been reported at such high percentages. It thus seems unlikely that titanium intolerance should be the problem rather than trophic or mechanical factors leading to erosion (41% of ATOMS explants in long-term follow-up [1]).

Lastly, we know that patients with minimal and moderate incontinence can be treated successfully by a simple tissue-fixed TOT sling. Patients with more intrinsic sphincter deficiency, with repeated anastomotic incisions or resections need a more compressive device, and compression needs adjustability over time, a field for devices such as Argus and Reemex for example. Also at night time, patients with incontinence (real and severe intrinsic sphincter deficiency) need an artificial sphincter for continence and good unobstructed voiding (on/off). So which group of patients should be targeted for this combination between a hydraulic-filled balloon, adjustable subcutaneous port and TOT sling, as 60–70% of patients with mild-to-moderate incontinence are dry using the sling alone [3]. Should it be the first choice for all non-irradiated patients? or for those that have TOT failure? Or artificial sphincter failure? Or intrinsic sphincter deficiency? Therefore, what we need to clarify is the real indications for this combined tri-component device (silicone port, silicone balloon and TOT mesh). And we must also not forget that there could be atrophy of the membranous urethra due to the bulking effect of the silicone balloon. This is another point that has to be considered.

In the treatment of male incontinence we must focus not only on the effectiveness but also on the safety of the device used. This is particularly important considering the warning issued by the USA Food and Drug Administration (FDA) for female mesh slings.

How to Cite

Gozzi, C. (2017), Considerations about the adjustable transobturator male system (ATOMS®) device… is it really all so easy?. BJU International, 119: 655–656. doi: 10.1111/bju.13830

 

Christian Gozzi
Department of Urology, Marienklinik, Bolzano, Italy

 

References

 

 

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