The aim of this study was to access the continence and the failure rate after implantation of Adjustable TransObturator Male System (ATOMS) for the treatment of male stress urinary incontinence (SUI), as well as to identify the underlying risk factors for the failure.

The data of all patients receiving an ATOMS implatation between 2010 and 2021 were prospectively entered into our ATOMS-database during the regular follow-up and analysed retrospectively. The primary endpoints were continence (daily pad usage), as well as failure (explantation rate). The implant survival rate was estimated by using the Kaplan-Meier method. The risk factors for explantation (body mass index, age at ATOMS surgery, diabetes mellitus, port generation, previous transurethral or incontinence surgery) were analysed by multivariable Cox regression.

A total of 80 patients underwent an implatation of the ATOMS device during the observation period. The median follow-up was 3 (0,1 to 10,7) years. Mean body mass index was 27.6 (±3.4) kg/m2, mean age at surgery was 69.8 (±7.2) years. Sixty three patients (78.8%) hat stress urinary incontinence, 17 (21.3%) had mixed urinary incontinence. In 63 patients (78.8%) the incontinence occured following open radical prostatectomy, in 5 patients (6.3%) following laparoscopic radical prostatectomy and in 12 patients (15.0%) following transurethral resection of the prostate (TURP). Thirteen patients (16.3 %) had recurrent stress urinary incontinence after previous unsuccessful incontinence surgery. Thirty three patients (41.3%) became an inguinal port, 47 (58.8%) a scrotal port. The median number of pads decreased significantly from 4 (1-12) pads per day preoperatively to 2 (0-10) at the last follow-up (p<0,001). During the first year following ATOMS implantation 8 patients required an explantation, which resulted in a one-year-implant-survival rate of 0.89 (95% confidence interval, CI: 0.80–0.95). After 5 years 17 patients had experienced an explantation, resulting in the 5-year-implant-survival rate of 0.71 (95% CI: 0.56–0.81). During the total observation time 22 explantations (27,5%) were performed (Kaplan-Meier estimate: 0.35 (95% CI:0.09–0.64)). Fourteen patients (17,5 %) were lost to follow-up and 3 patients (3,8 %) had died. The risk for explantation was higher in patients after previous incontinence surgery (hazard ratio = 3.4, 95% CI: 1.4–8.2, P=0.007). For the other defined risk factors no significant association with the explantation rate could be observed (see Table 1).

ATOMS leads to significant reduction of pad usage. During the intermediate-term follow-up approximately every 3rd patient experienced device explantation.

Especially patients with recurrent stress urinary incontinence after previous unsuccessful incontinence surgery should be warned about the relevant risk of explantation. In these patients artificial urinary sphincter might be considered as a primary therapy of choice.