Hypothesis / aims of study
Male stress urinary incontinence remains a debilitating issue worldwide. Adjustable sub-urethral devices improve both symptoms and quality of life in the short term. We investigated the long term outcomes for the ATOMs device in terms of efficacy, safety profile, management of ongoing incontinence and complications.
Study design, materials and methods
The first 70 men (average age: 70.3, range: 50-81) who had an ATOMs device inserted in the UK since 2015 were identified. Out of these men, 94% had SUI post prostatectomy. Others due to AP resection, TURP or BNI. One patient was lost to follow up. Long term retrospective analysis of all the patient records was performed.
Results
Of the 69 men, 74% (51) remained dry, defined as using zero or a maximum of 1 pad a day for reassurance only. Average top ups were 3 (range: 0-6). The follow-up period was up to 10 years (mean: 7 years, range: 5-10 years).
7 had no significant improvement. Of these, 4 underwent artificial sphincter (AUS) insertion with no intraoperative difficulties or immediate complications.
11 patients were dry initially, then deteriorated over time. Out of these, 2 underwent an AUS, 1 developed myeloma resulting in significant weight loss and 1 had a cystectomy and ileal conduit for bladder cancer.
6 ATOMS were removed due to infection (8.7%). 2 scrotal ports were removed for erosion (without infection) without total explantation and maintaining continence. 2 patients had ongoing pain at 3 month follow up, which settled after 12 months.
Interpretation of results
The probability of device survival over time was 92.8% at 12 months, 88.4% at 24 months, 82.5% at 40 months, 73.5% at 60 months and 60.2% at 90 months (Figure 1). Radiotherapy (n=17) and age over 75 (n=20) were independent risk factors for decreased device survivability, with less than 50% survival after 60 months and 90 months respectively.
Concluding message
This analysis is the first to demonstrate the long-term efficacy and safety of the ATOMS device, while also providing a detailed exploration of associated complications and their management over a decade.
Notably, the device's efficacy appears to be sustained over the long term, with minimal complications. Finally, for patients who continue to experience incontinence, transitioning to an AUS seems to be a straightforward option.