Purpose: Sling as a therapeutic option for male stress urinary incontinence (SUI) has been reviewed in the last two decades, as it is a relatively simpliest surgery compared to artificial urinary sphincter and has the ability to modulate urethral compression. This study aims to evaluate the efficacy, rate of complications, quality of life and the effects on bladder emptying of the Argus T ® compressive and ajustable sling in moderate and severe male SUI treatment. Materials and Methods: Men eligible for stress urinary incontinence treatment after radical prostatectomy were recruited and prospectively evaluated, from March 2010 to November 2016. It was selected outpatient men with moderate and severe SUI, after 12 months of radical prostatectomy, who have failed conservative treatment. All patients had a complete clinical and urodynamic pre and post treatment evaluation, by means of clinical history, physical examination, urine culture, 1-hour pad test and ICIq-SF questionnaire. The UDS was performed after 12, 18 and 24 months postoperatively. Results: Thirty-seven men underwent sling surgery, 19 patients (51.4%) with moderate and 18 (48.6%) with severe SUI. The minimum follow-up time was 5 years. Overall, we had a success rate of 56.7% at 60 months follow-up. After surgery, we did not observe significant changes in the urodynamic parameters evaluated during the follow-up. No patient had urodynamic bladder outlet obstruction (BOO) after sling implantation. Readjustment of the Argus T ® sling was performed in 16 (41%) of the patients and 51% of the patients reported some adverse event. Conclusion: We demonstrate a long-term efficacy and safety of Sling Argus T ® as an alternative to moderate and severe male SUI treatment. Furthermore, in our study bulbar urethra compression does not lead to bladder outlet obstruction.
maintained public database that contains anonymous, voluntary medical device reports. Herein, we review device-related adverse events reported in the MAUDE database associated with BPH surgeries.METHODS: The MAUDE database was queried for "Aquablation, Rezum, Loop Resection, Morcellator, Greenlight Laser, Holmium Laser, and Urolift" from 2018 through 2021. A complication classification system (Level 1-4) based on the Clavien-Dindo system was used to categorize events based on outcomes. These events were then correlated with device malfunctions and classified as "product related" and "non-product related." Chi squared analysis was performed to identify associations between BPH surgery type and complication classification distribution.RESULTS: A total of 873 device related events were identified. The entries by surgical subtype included: rezum 304 (35%), urolift 33 (4%), TURP 134 (15%), HOLEP 40 (4%), Aquablation 294 (34%), Greenlight laser 68 (8%). 553 complications (63%) were Level I (mild/ none), 138 (16%) were Level II (medical management), 164 (19%) were Level III (surgical management), and 16 (2%) was Level IV (life threatening). The most common level II-IV complications by BPH surgery type: aquablation -hematuria (50%), rezum -lower urinary tract symptoms (23%), HOLEP e retained adenoma (23%), urolift e acute urinary retention (12%), greenlight laser e urethral necrosis (2%), transurethral resection of prostate e bladder perforation (3%). Using chi squared analysis, aquablation (p<0.017) and Rezum (p<0.012) were associated with the highest risk of Level II-IV complications compared with other device classes. Overall, "product related" malfunctions were not associated with level II-IV complications.CONCLUSIONS: Aquablation and rezum were associated with a higher proportion of level II-IV complications. However, this difference is not accounted for by "product related" malfunctions, which highlights surgeon experience or other unknown factors as potential sources for adverse events with newer products. A limitation of this study is the total complications per surgical subtype are not fully captured.
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