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

IF 1.6 Q3 UROLOGY & NEPHROLOGY BJUI compass Pub Date : 2024-02-11 DOI:10.1002/bco2.329

Javier C. Angulo, Alessandro Giammò, Fabian Queissert, Sandra Schönburg, Carmen González-Enguita, Andreas Gonsior, Antonio Romero, Francisco E. Martins, Tiago Antunes-Lopes, Raquel González, Juliusz Szczesniewski, Carlos Téllez, Francisco Cruz, Keith F. Rourke

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Abstract

Objectives

This 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 methods

Consecutive 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.

Results

Of 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.

Conclusion

ATOMS implantation significantly outperformed in patients without adjuvant radiation over radiated patients.

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可调节经尿道男性系统（ATOMS）在放射治疗患者中的有效性降低：倾向得分匹配分析

本研究旨在比较可调式经尿道男用系统（ATOMS®）治疗放射治疗患者与非放射治疗患者前列腺切除术后尿失禁（PPI）的有效性和安全性，采用倾向得分匹配分析来提高比较的有效性。研究纳入了2016年至2022年期间在9家不同机构接受硅胶覆盖阴囊端口ATOMS（A.M.I.公司，奥地利费尔德基希）治疗的连续男性PPI患者。术前评估包括 24 小时尿垫使用情况、尿道镜检查和尿动力学检查（如有必要）。倾向得分匹配分析基于年龄、随访时间、既往PPI治疗、既往膀胱颈狭窄、雄激素剥夺和尿垫使用情况。主要终点是干燥率，即术后不使用护垫，允许使用安全护垫。次要终点是并发症、装置移除和患者全球改善印象（PGI-I）量表的自我感觉满意度。在纳入的 710 名患者中，有 342 人进行了配对，研究组的基线配对变量是平衡的。两组患者的 24 小时平均基线垫值均为 4.8（P = 0.48）。平均随访时间为 27.5 ± 18.6 个月，两组之间的随访时间相同（p = 0.36）。73例（42.7%）接受放射治疗的患者和115例（67.3%）未接受放射治疗的患者达到了主要结果（p < 0.0001）。最后一次随访时的平均衬垫数分别为 1.5 和 0.8（P < 0.0001）。并发症方面无明显差异（p = 0.94），但手术翻修率和设备拆卸率较高（分别为 p = 0.03 和 p = 0.01），辐射组高度满意（PGI-I = 1）的患者比例较低（p = 0.01）。在敏感性分析中发现，该研究对隐性偏倚具有合理的稳健性。在未接受辅助放射治疗的患者中，ATOMS植入术的效果明显优于接受放射治疗的患者。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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