The effectiveness of adjustable trans‐obturator male system (ATOMS) in radiated patients is reduced: A propensity score‐matched analysis

Abstract

AbstractObjectivesThis study aimed to compare the effectiveness and safety of the adjustable trans‐obturator male system (ATOMS®) to treat post‐prostatectomy incontinence (PPI) in radiated patients compared with non‐radiated patients, using propensity score‐matching analysis to enhance the validity of the comparison.Patients and methodsConsecutive men with PPI treated with silicone‐covered scrotal port ATOMS (A.M.I., Feldkirch, Austria) in nine different institutions between 2016 and 2022 were included. Preoperative assessment evaluated 24‐h pad usage, urethroscopy and urodynamics, if indicated. Propensity score‐matching analysis was based on age, length of follow‐up, previous PPI treatment, previous bladder neck stricture, androgen deprivation and pad usage. The primary endpoint was dry rate, defined as no pads post‐operatively with a security pad allowed. The secondary endpoints were complications, device removal and self‐perceived satisfaction with the Patient Global Impression of Improvement (PGI‐I) scale.ResultsOf the 710 included patients, 342 were matched, and the study groups were balanced for the baseline matched variables. The mean baseline 24‐h pad was 4.8 in both groups (p = 0.48). The mean follow‐up was 27.5 ± 18.6 months, which was also equivalent between groups (p = 0.36). The primary outcome was achieved in 73 (42.7%) radiated patients and in 115 (67.3%) non‐radiated patients (p < 0.0001). The mean pad count at the last follow‐up was 1.5 and 0.8, respectively (p < 0.0001). There was no significant difference in complications (p = 0.94), but surgical revision and device explant rates were higher (p = 0.03 and p = 0.01, respectively), and the proportion of patients highly satisfied (PGI‐I = 1) was lower in the radiated group (p = 0.01). At sensitivity analysis, the study was found to be reasonably robust to hidden bias.ConclusionATOMS implantation significantly outperformed in patients without adjuvant radiation over radiated patients.