Long-term efficacy and safety of artificial urinary sphincter AMS 800<sup>ТМ</sup> implantations

Abstract

Introduction. Stress urinary incontinence in men in most cases occurs after radical prostatectomy or surgery of benign prostate hyperplasia. In addition to a significant reduction in the quality of life, the treatment and care of such patients require significant financial costs. Purpose of the study . To study the long-term efficacy and safety of artificial urinary sphincter (AUS) implantation. Materials and methods . AUS was implanted in 52 patients with severe stress urinary incontinence (UI) from 2004 to 2020. Urine loss was estimated by the urinary diary. A cure was considered as the use of ≤ 1 pad per day («social continence»). The quality of life was assessed using a numeric scale (from 0 to 100), IPSS-QoL, and the ICIQ-UI SF questionnaire. Complications were described according to the Clavien-Dindo classification. Results. The median age was 67.5 years (IQR 63 - 72 years). The causes of severe stress UI were the following: radical prostatectomy - 29 (55.8%) patients, transurethral resection of the prostate — 12 (23.1%), transvesical simple prostatectomy — 5 (9.6%), others — 6 (11.5%) patients. Median time after the intervention that caused UI was 24 months (IQR 13-36 months). Both perineal (67%) and penoscrotal (33%) approaches were used. The results of implantation efficiency were evaluated in 43 patients. A significant decrease in the median urine loss from 800 ml (IQR 700 - 1100 ml) to 0 ml (IQR 0-30 ml) was registered at a median follow-up of 100.4 months (IQR 70.5 - 136.9 months). There was also a statistically significant reduction in daily pad use from 7 (IQR 6-8) to 1 (IQR 0 - 1). 36 (84%) patients met the cure criteria. Improvement was noted in 6 (14%) patients, failure - in 1 (2%) patient. Median IPSS-QoL scores decreased from 4 (IQR 4-5) to 2 (IQR 1 - 2), p < 0.05, numeric analog scale scores improved from 25 (IQR 20 - 35) to 80 (IQR 60 - 90), p < 0.05., The ICIQ-UI SF score was 7 (IQR 1-9) after treatment. Complications more than grade II according to the Clavien-Dindo classification were registered in 15 (28.8%) patients. Conclusion. AUS implantation provides satisfactory results in reducing urine loss and improving quality of life but it's accompanied by a high rate of complications and revisions in long-term follow-up.