Intermediate- and Long-term Results After Adjustable Transobturator Male System Implantation.

Objective: To assess outcomes of continence and complications after implantation of Adjustable TransObturator Male System (ATOMS) for the treatment of male stress urinary incontinence (SUI).

Materials And Methods: Data of 80 patients receiving an ATOMS implantation between 2010 and 2021 at a tertiary academic referral center were retrospectively analyzed. Primary endpoints were outcomes of continence and complications. Implant survival rate was estimated by the Kaplan-Meier method, risk factors for explantation were analyzed by univariable Cox regression.

Results: During a median follow-up of 3 years, the number of pads decreased significantly from 4-2 pads per day (P<.001). After 5 years, 17 patients experienced an explantation, 8 of them during the first year following ATOMS implantation, resulting in 1- and 5-year-implant-survival rates of 0.89 (95%CI:0.80-0.95) and 0.71 (95%CI:0.56-0.81), respectively. During the total observation time, ATOMS was explanted in 22 (27.5%) patients (Kaplan-Meier estimate for explantation: 0.35 [95%CI:0.09-0.64]) after a median time of 2.3 (0.1, 10.2) years. The risk for explantation was higher in patients after previous incontinence surgery (HR=3.4, 95%CI:1.4-8.2, P=.007), ISUP (International Society of Urological Pathology) ≥4 (Gleason score ≥8) in surgery specimens (HR=4.4, 95%CI:1.03-27.1 compared to ISUP 1, P=.046), and a preoperative daily pad weight >250 g (HR=3.1, 95%CI:1.18-8.17, P=.022).

Conclusion: ATOMS lead to a significant reduction of pad usage. During the intermediate-term follow-up, approximately every third patient experienced device explantation. In particular, patients with recurrent SUI and patients with severe SUI have to be warned about a relevant risk of explantation.