Introduction

Artificial urinary sphincter (AUS) is considered the gold standard for moderate-to-severe male SUI. The aim of our study is to assess efficacy and safety in a large multi-institutional cohort of patients with long follow-up (FU) and to build a model to assess predictive factors of social continence (SC) and surgical revision (SR)._x000D_

Methods

The study included 892 patients from 16 tertiary referral centres, submitted to primary AUS implant, between 1993 and 2012, with a minimum FU of 1-year. Patients were evaluated at 1, 6 and 12 months after surgery and yearly thereafter. SC was defined as 1 security pad or less and SR as any further surgery for failure or complications. To identify predictors of SC and SR we accounted for the following variables: age, diabetes mellitus (DM), anticoagulation therapy (AC), previous incontinence surgery (PIS), radiotherapy (RT), double cuff (DC), cuff size (CS) and surgical volume (SV). Patients were sub-divided into two groups according to the median number of implants per center/year (most informative cut-off), to define low and high SV centres. We also evaluated complication rate (CR): erosions and infections and failure rate (FR): urethral atrophy and mechanical failures.

Results

Overall 126/892 (14.1%) previously underwent TURP and 766 (85.9%) RP: the two groups differ only in terms of DM and AC (all p<0.05). Mean FU was 32 months (median 20, range 12-300); A total of 218/892 (24.4%) patients had PIS, namely: male sling surgery (n=75, 8.4%), peri-urethral injections (n=50; 5.6%) or peri-urethral balloons (n=92, 10.4%). Overall 257/892 (28.9%) patients had adjuvant RT. The median number of implants-per centre/year resulted to be 4: according to this cut-off value, 303 patients (34%) resulted to be treated in low-volume and 589 (66%) in high-volume centres. Erosion and infections were observed in 60/892 patients (6.7%) and 38/892 (4.2%) respectively. Urethral atrophy and mechanical failures were observed in 32/892 (3.5%) and 121/892 (13.5%), respectively. Overall SC and SR rates were 55% (n=489) and 30.6% (n=273) respectively. Multivariable analysis showed PIS to be the only predictor of lower SC rate (OR: 1.49, p=0.02) and SV the only variable associated with a higher risk of SR (OR: 1.53; p=0.016).

Conclusions

Our large-cohort long-FU study, confirms AUS as gold standard for post-op SUI. However it is still associated with high SR rates. PIS resulted to be negatively associated with SC. The results concerning SV confirm previous studies reporting no plateau for learning curve, with reduction of revisions only after 200 procedures. These results represent a further step in counselling and treatment of SUI after prostatic surgery.

Funding

none