Long-term outcome of the adjustable transobturator male system (ATOMS): results of a European multicentre study
Abstrakt
To evaluate the long-term effectiveness and safety of the adjustable transobturator male system (ATOMS (R), 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. 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.
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.