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.