Artificial urinary sphincter implantation: outcomes evaluation in a cohort of patients beyond a ten-year follow-up

Abstract

Introduction. Implantation of an artificial urinary sphincter (AUS) is the main treatment method for patients with intrinsic sphincteric deficiency. There are few studies investigating the effectiveness, safety, and impact on the quality of life of the AUS implantation beyond a ten-year follow-up.Objective. To evaluate the outcomes of the AUS implantation in terms of safety, efficacy, and impact on quality of life in a group of patients beyond a ten-year follow-up.Materials & methods. From 2004 to 2023, AUS were implanted in 62 patients with severe stress urinary incontinence, of whom 14 had a follow-up period of more than 10 years. Urine loss is estimated using bladder diary. The use of ≤1 pad per day (“social continence”) was considered as cure. The quality of life was assessed using the IPSS-QoL scale and the ICIQ-UI SF questionnaire. Complications are described according to the Clavien-Dindo classification.Results. The median age of the patient at the time of implantation was 66 [63; 68] years. The causes of severe stress urinary incontinence were the following interventions: radical prostatectomy — 11 patients, radical cystectomy — two patients, transurethral resection of the prostate — one patient. The median time after the intervention that caused urinary incontinence was 20 [15; 26] months. The effectiveness of implantation was evaluated in 11 patients, three patients had complications preventing the use of the AUS. Median follow-up was 137 [124; 160] months. There was a statistically significant decrease in the median urine loss from 700,0 [600; 800] to 12,5 [1; 60] ml. There was also a significant reduction in the use of pads per day from 7 [7; 8] to 1 [0; 2]. Five patients did not use pads. Seven patients met the criterion of cure. Median IPSS-QoL scores decreased from 4 [4; 5] to 2 [1; 2]. After treatment, the score of the ICIQ-UI SF questionnaire was 8 [6; 10]. Complications superior to Clavien-Dindo II were noted in 8 of 14 patients. Eight patients underwent 15 revisions, six of them repeated. The AUS was partially or completely removed in six patients.Conclusions. Over a ten-year follow-up period, a significant number of patients developed complications, including those requiring removal or replacement of the AUS or its components, and therefore patients with an AUS require regular long-term follow-up. Despite a significant proportion of patients who required an AUS revision, implantation leads to a statistically significant reduction in urine loss and an improvement in the quality of life.