Hypothesis / aims of study
Male stress urinary incontinence (SUI) is a prevalent complication following radical prostatectomy (RP). The incidence of SUI after RP varies and affects quality of life (QoL) (1). In this study, we present our initial results regarding the efficacy and safety of the Adjustable Transobturator Male System (ATOMS) and its impact on QoL.
Study design, materials and methods
We retrospectively analyzed patients treated with the ATOMS device between October 2022 and January 2025. The primary indication for ATOMS implantation was persistent SUI lasting ≥12 months after RP. The devices were initially inflated with 9 ml of normal saline. The first evaluation was performed 4 weeks postoperatively, with the readjustment visit at 6 weeks if needed. We recorded patients’ demographics, continent rate (CR), and pad use. The QoL was calculated using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) (2) and Patient Global Impression of Improvement (PGI-I) (3). Informed consent was obtained from all patients.
Results
We included 13 patients, 9 with mild (1–2 pads/day) and 4 with moderate (3–5 pads/day) SUI after RP. Their median age was 61 years. For the patients with mild SUI, 4 patients were continent after the initial procedure and 4 after the readjustment. The remaining 1 patient, continued to experience mild SUI. For the moderate SUI group, one patient was continent after the initial procedure, 2 wore safe pads after the readjustment, and one was incontinent. The overall success rate was 84%, and the CR was 69%.
Pad use decreased from 2.5 pads/day to 0.5 pads/day (p = 0.001). The median score for ICIQ-SF at baseline was 11, which improved to 6 at the follow-up (p = 0.005). For PGI-I, the median score at baseline was 4, which improved to 2 at the follow-up (p = 0.004). The median hospital stay was 2 days, while the catheter was removed after 1 day. No significant complications were observed.
Interpretation of results
Our findings suggest that the ATOMS system is an effective and safe treatment for male stress urinary incontinence following radical prostatectomy, particularly in patients with mild to moderate symptoms. The significant reduction in pad usage and improved QoL scores underscore the device’s clinical value. These early results support the inclusion of ATOMS as a viable option in the management algorithm of postoperative SUI.