title: Long-term outcome of the adjustable transobturator male system (ATOMS): results of a European multicentre study.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Department of Urology, Hospital Göttlicher Heiland, Vienna, Austria.
authors.forename: Alexander
authors.initials: A
authors.lastname: Friedl
authors.affiliation: Klinik and Poliklinik of Urology and Kidney Transplantation, University Hospital, Martin-Luther-University, Halle-Wittenberg, Halle/Saale, Germany.
authors.forename: Sandra
authors.initials: S
authors.lastname: Mühlstädt
authors.affiliation: Thomayer Hospital, Department of Urology and 1st and 3rd Medical Faculty, Charles University, Prague, Czech Republic.
authors.forename: Roman
authors.initials: R
authors.lastname: Zachoval
authors.affiliation: Neuro-Urology Department, CTO-Spinal Unit Hospital, Turin, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Giammò
authors.affiliation: Center for Medical Statistics, Informatics, and Intelligent Systems, Vienna, Austria.
authors.forename: Danijel
authors.initials: D
authors.lastname: Kivaranovic
authors.affiliation: Department of Urology, Medical University Vienna, Vienna, Austria.
authors.forename: Maximilian
authors.initials: M
authors.lastname: Rom
authors.affiliation: Klinik and Poliklinik of Urology and Kidney Transplantation, University Hospital, Martin-Luther-University, Halle-Wittenberg, Halle/Saale, Germany.
authors.forename: Paolo
authors.initials: P
authors.lastname: Fornara
authors.affiliation: Department of Urology, Hospital Göttlicher Heiland, Vienna, Austria.
authors.forename: Clemens
authors.initials: C
authors.lastname: Brössner
mesh_terms: D000368:Aged; D006801:Humans; D008297:Male; D011474:Prosthesis Design; D012189:Retrospective Studies; D053825:Suburethral Slings / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000601:surgery*
keywords: #Incontinence; adjustable transobturator male system continence device; efficacy; long-term outcome; male stress urinary incontinence; quality of life