We report on our multicentre evaluation of the occurrence and management of complications with the ATOMS device (A.M.I., Austria).
Between 10/09 and 09/18, a total of 187 patients with persistent postoperative stress urinary incontinence received an ATOMS device in Madrid (n = 101) or Halle (n = 86). This prospective evaluation was carried out consecutively. In addition to complications, patient age, BMI, comorbidities and previous treatments for prostate cancer and urinary incontinence were examined. Statistical analysis was performed with GraphPad Prism 7® (GraphPad Software, Inc., La Jolla, USA); p < 0.05 was considered significant.
The average age of the overall population was 69.4 years, with a mean CCI of 4.3. In total, 18.2% of the patients had diabetes mellitus, 21.9% were irradiated, and 14.1% and 22.9% underwent previous surgery for urinary incontinence and urethral stricture, respectively. The overall success rate of the device was 80.2%. A total of 51 postoperative complications (51/187, 27.3%) were observed, with 18 grade I (9.6%), 1 grade II (0.5%), 3 grade IIIa (1.6%) and 29 grade IIIb (15.5%) complications. The most serious postoperative complications were primary wound infection (8/187, 4.3%) and long-term cutaneous erosion with subsequent infection (15/187, 8.02%). The main risk factors for complications were previous radiotherapy (p = 0.003) and surgery for urethral stricture (p = 0.017). No other parameters were significant in bivariate analysis (p > 0.05).
The most severe complications of ATOMS implantation were primary wound infection and cutaneous erosion, especially in the presence of previous radiotherapy. Particular focus on performing hygienic and accurate implantation techniques is recommended.
World journal of urology. 2019 Sep 21 [Epub ahead of print]
Sandra Mühlstädt, Javier C Angulo, Nasreldin Mohammed, André Schumann, Paolo Fornara
Department of Urology and Kidney Transplantation, Martin Luther University, Ernst-Grube-Straße 40, 06120, Halle (Saale), Germany. ., Clinical Department, European University of Madrid, Urology Service, Getafe University Hospital, Madrid, Spain., Department of Urology and Kidney Transplantation, Martin Luther University, Ernst-Grube-Straße 40, 06120, Halle (Saale), Germany.