Results of Adjustable Trans-Obturator Male System for Stress Urinary Incontinence after Transurethral Resection or Holmium Laser Enucleation of the Prostate: International Multicenter Study.

Abstract

Background: Male stress urinary incontinence (SUI) after surgical treatment of benign prostatic enlargement (BPE) is an infrequent but dreadful complication and constitutes a therapeutic challenge. The efficacy and safety of the adjustable trans-obturator male system (ATOMS®) in these patients is rather unknown, mainly due to the rarity of this condition. We aimed to assess the results of ATOMS to treat SUI after transurethral resection (TURP) or holmium laser enucleation (HoLEP) of the prostate. Methods: Retrospective multicenter study evaluating patients with SUI after TURP or HoLEP for BPE primarily treated with silicone-covered scrotal port (SSP) ATOMS implants in ten different institutions in Europe and Canada between 2018 and 2022. Inclusion criteria were pure SUI for >1 year after endoscopic treatment for BPE and informed consent to receive an ATOMS. The primary endpoint of the study was a dry rate (pad test ≤ 20 mL/day after adjustment). The secondary endpoints were: the total continence rate (no pads and no leakage), complication rate (Clavien-Dindo classification) and self-perceived satisfaction (Patient Global Impression of Improvement (PGI-I) scale 1 to 3). Descriptive analytics, Wilcoxon's rank sum test and Fisher's exact test were performed. Results: A total of 40 consecutive patients fulfilled the inclusion criteria, 23 following TURP and 17 HoLEP. After ATOMS adjustment, 32 (80%) patients were dry (78.3% TURP and 82.4% HoLEP; p = 1) and total continence was achieved in 18 (45%) patients (43.5% TURP and 47% HoLEP; p = 0.82). The median pad test was at a 500 (IQR 300) mL baseline (648 (IQR 650) TURP and 500 (IQR 340) HoLEP; p = 0.62) and 20 (IQR 89) mL (40 (IQR 90) RTUP and 10 (IQR 89) HoLEP; p = 0.56) after adjustment. Satisfaction (PGI-I ≤ 3) was reported in 37 (92.5%) patients (95.6% TURP and 88.2% HoLEP; p = 0.5). There were no significant differences between patients treated with TURP or HoLEP regarding the patient age, radiotherapy and number of adjustments needed. After 32.5 (IQR 30.5) months, median follow-up postoperative complications occurred in seven (17.5%) cases (two grade I and five grade II; three after TURP and four HoLEP) and two devices were removed (5%, both HoLEP). Conclusions: ATOMS is an efficacious and safe alternative to treat SUI due to sphincteric damage produced by endoscopic surgery for BPE, both TURP and HoLEP. Future studies with a larger number of patients may identify predictive factors that would allow better patient selection for ATOMS in this scenario.