Purpose: We assessed the efficacy and safety profile of the ATOMS® (Adjustable Transobturator Male System) for post-prostatectomy incontinence in a multicenter North American setting.
Materials and methods: We reviewed outcomes from 8 centers in men who underwent treatment of post-prostatectomy incontinence with an ATOMS. Primary study outcomes were pad changes and continence, defined as requiring 1.0 or 0 pad postoperatively in patients who required 2.0 or more pads preoperatively and 0 pad in those who required more than 1.0 or 2.0 pads preoperatively. Secondary outcomes included improvement, 90-day complications and patient satisfaction.
Results: A total of 160 patients were enrolled in study with a median followup of 9.0 months. Preoperative median pad use was 4 per day (IQR 3-5). Of the patients 36.3% reported severe preoperative incontinence, 31.3% received prior radiotherapy and 16.3% underwent previous incontinence surgery. Median postoperative pad use after adjustments was 0.5 per day (IQR 0-1, p <0.001). The overall continence rate was 80.0% with improvement in 87.8% of cases. Of the patients 70.1% underwent a mean ± SD of 2.4 ± 2.7 adjustments (IQR 0-16). The patient satisfaction rate was 86.3%, 22.3% experienced 90-day complications of any grade and 7 (4.4%) experienced Clavien III complications primarily related to the injection port. Patients with a history of radiotherapy were less likely to be continent (62.5% vs 87.9%, p=0.002), improved (77.1% vs 92.6%, p=0.02) or satisfied (69.8% vs 93.2%, p=0.001). Similarly patients with previous incontinence surgery had lower rates of continence, improvement and satisfaction (57.7%, 73.1% and 69.6%, respectively).
Conclusions: In the short term the ATOMS is a safe and efficacious device to treat post-prostatectomy incontinence. Patients with concurrent radiotherapy and previous incontinence surgery respond to treatment but are less likely to be continent, improved or satisfied.
Keywords: male; prostatectomy; prostheses and implants; stress; urethra; urinary incontinence.