The artificial urinary sphincter is the gold standard treatment for male urinary incontinence, but it has a high complication rate. Stress urinary incontinence has an impact on the quality of life and has significant economic consequences. More data is needed to informe polypathological elderly patients with history of radiation, previous incontinence surgery or complex urethra surgery. Indeed, many studies investigate the risk factors for failure of AUS, in order to improve its efficacy and safety but the heterogeneity of the evaluation criteria and the population sizes must be considered. The aim of this study was to assess risk factors for artificial urinary sphincter explantation in a large multicentre cohort.

We retrospectively reviewed the charts of all 1233 non-neurological male artificial urinary sphincter implantations between 2005 and 2020 at 13 French centers. Neurological patients were excluded. The primary endpoint was explantation-free survival. A Kaplan Meier survival analysis, followed by a multivariate Cox analysis was performed in order to investigate factors associated with explantation-free survival. Explantation was defined as the complete removal of the device, as opposed to revision which was the change of components.

We included 1003 patients with artificial urinary sphincter, of whom 281 had an explantation. Median survival without explantation was 83 months, mainly for infection and erosion. Mean age ranged between 70 and 75 years old. Pre-operative pad test was between 3,5 and 4 pad per day. History of radiotherapy was found for 289 patients (28,81%) and  165 patients (16,45%) had an a history of incontinence surgery. The primary surgical approach was perineal approach, used in 60,32% of the cases. Risk factors for explantation in univariate analysis were age >75 years (34.6% in explanted vs. 25.8% in explanted-free, p=0.007), history of radiotherapy (43.5% vs. 31.3%, p=0.001), and use of anticoagulant drugs (15% vs. 8.6%, p<0.001). In logistic regression, the only significant risk factor was radiotherapy (OR 2.05, p<0.05). In Cox analysis, the two factors associated with earlier explantations were transcorporal cuff implantation (HR 1.70, p=0.01) and annual center case-load (HR=1.08; p=0.02).

Transcorporal cuff position and surgery center size were the two factors associated with earlier explantations. History or radiotherapy was associated with the overall rate of explantation, as we removed time from the assessment. The most likely hypothesis is that these two variables are directly related to the complexity of the surgery (fragile urethra, multioperated) or the patient (elderly).

This large multicenter study showed the risk of radiotherapy, but also to reinforce the notion of fragile urethra, which often lead to a transcorporal approach.

Continence 7S1 (2023) 100842
DOI: 10.1016/j.cont.2023.100842