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Canadian Experience with the Adjustable Trans-Obturator Male System (ATOMS) for Post-prostatectomy Incontinence: A Multi-Centered Study.

PURPOSE
To assess the efficacy and safety profile of the Adjustable Trans-Obturator Male System (ATOMS) for post-prostatectomy incontinence (PPI) in a multi-centered North American setting.


MATERIALS AND METHODS
We reviewed outcomes from 8 centers in men undergoing treatment for PPI with ATOMS. Primary outcomes were pad change and continence (defined as requiring ≤1.0 pad postoperatively for patients requiring ≥2.0 pads preoperatively, and 0 pads for those requiring >1.0-2.0 pad preoperatively). Secondary outcomes included improvement, 90-day complications and patient satisfaction.


RESULTS
160 patients total were enrolled with a median follow-up of 9.0 months. Preoperative median pad use was 4 pads/day (Q1, Q3: 3, 5). 36.3% of patients reported severe preoperative incontinence, 31.3% had prior radiotherapy (RT) and 16.3% had previous incontinence surgery. Median post-operative pad use after adjustments was 0.5 pads/day (0-1; p<0.001) - overall continence was 80.0% with improvement in 87.8%. 70.1% patients underwent a mean of 2.4 adjustments (±2.7; 0-16). Patient satisfaction was 86.3%, 22.3% of patients experienced 90-day complications (any grade) and 4.4% (n=7) of patients experienced Clavien III complications primarily related to the injection port. Patients with a history of RT 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 (57.7%), improvement (73.1%) and satisfaction (69.6%).


CONCLUSION
In the short-term, ATOMS is a safe and efficacious device for the treatment of post prostatectomy incontinence. Patients with concurrent RT and previous incontinence surgery respond to treatment but are less likely to be continent, improved or satisfied.