Performance of the artificial urinary sphincter implantation in men with urinary incontinence: Results from a contemporary long-term real-world nationwide analysis.

PURPOSE: The artificial urinary sphincter (AUS) is one of the most effective surgical treatments for male urinary incontinence regardless of its severity. Current knowledge comes from high-volume centers, but little is known about the performance of this surgery from community practices. This study aims to report contemporary AUS performance in a nationwide observational study in Colombia. METHODS: Male patients who underwent AUS surgery with AMS 800™ between 2000 and 2020 in more than 17 centers and four cities were identified. Pre, intra, and postoperative characteristics were evaluated, mainly addressing patient reported outcomes measurements in the postoperative period. Retrospective and prospective data collection and descriptive analysis were completed. Kaplan-Meier analysis was used to determine AUS survival rate. RESULTS: Out of an initial 667 cases, a total of 215 patients met inclusion and exclusion criteria and were included. Mean age was 67 ± 9.4 years, and mean follow-up was 6.0 ± 4.4 years with maximum range of 14 years. The etiology of urinary incontinence was prostate cancer surgery in 141 (81%) of the cases. The rest of the cases were related to benign prostatic disease or spinal cord injury. It is noteworthy that out of 115 patients, only 59 (51.3%) reported previous formal pelvic floor rehabilitation. Subjective severity of urinary incontinence determined by a visual analog scale showed a decrease in 4.5 points after sphincter implantation. Sphincter removal was required in 50 (23.2%) cases. The main reasons for implant removal were urethral erosion and infection. The sphincter survival rate at 2, 5, 8, 10, and 14 years was 76%, 70%, 60%, 57%, and 17%, respectively. Of the subjects at the last follow-up with the device still in place, 80.7% defined their urinary condition as "does not cause or causes minor discomfort," and 99% would recommend the device to a friend or relative in the same condition. CONCLUSIONS: This series from a community-based practice shows the lack of adherence to clinical practice guidelines and the lack of standardized data collection. In contrast, this study provides real-world data on explantation and revision rates, allows physicians to inform patients and to have clear metrics for a shared decision-making process before the procedure.

Effectiveness of the Remeex system™ in Colombian women with recurrent stress urinary incontinence or intrinsic sphincter deficiency.

INTRODUCTION AND HYPOTHESIS: We report our experience with the Remeex system™ in women with recurrent stress urinary incontinence (SUI) or intrinsic sphincter deficiency (ISD). METHODS: A multicenter retrospective study was conducted in women who underwent an adjustable sling procedure between 2011 and 2016. We used urodynamic studies (UDS) preoperatively and the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and cough stress test (CST) pre- and postoperatively. Primary outcomes were subjective (no leakage reported by the patient) and objective (no leakage during CST) cure and improvement rates (reduction of ≥4 points in ICIQ-SF). Descriptive and inferential statistics were employed. RESULTS: A total of 50 patients were included. Mean age was 62 years (SD ± 11.35). Median follow-up was 19.5 months [interquartile range (IQR) 12.95-41.38]. Urinary incontinence (UI) was described as moderate and severe by 8 (16%) and 42 (84%) patients, respectively, and 25 (50%) had stress-predominant mixed urinary incontinence (MUI). Objective and subjective cure rates were 90% and 48%, respectively, while 82% of patients achieved improvement. Impact of UI on quality of life (QoL) improved from 10 (IQR 9-10) to 2 (IQR 0-5) (p < 0.0001). Clavien-Dindo II complications occurred in 14 (28%) patients, and one (2%) had IIIa. Tape erosion occurred in one (2%) patient, and five (10%) required readjustments. Logistic regression identified MUI [odds ratio (OR) 3.3, 95% confidence interval (CI) 1.02-10.89] and vaginal atrophy (OR 4.2, 95% CI 1.06-16.03) as predictors of low subjective cure rate. CONCLUSIONS: Adjustable slings represent a valuable and safe option in the management of recurrent SUI or ISD, with improvement in QoL. Results should be carefully interpreted due to our small sample and retrospective design.