Functional outcomes of artificial urinary sphincter AMS 800 implantation with distal bulbar double cuff in patients with a history of external beam radiotherapy in comparison to non-irradiated patients: an analysis of a prospective database.

To analyze functional outcomes and complication rates of artificial urinary sphincter (AUS) implantation with a distal bulbar double-cuff (DC) for the treatment of severe urinary incontinence (SUI) in patients with a history of external beam radiotherapy (RT).

Data of all patients undergoing AUS implantation with a DC (DC-AUS) were collected prospectively from 2009-2015. Indications for DC implantation were based on ground of urethral risk factors in terms of RT and previous proximal bulbar urethral interventions including endoscopic or open surgery for urethral stricture or urinary incontinence. Implantation was carried out to a standardized protocol. Activation of the AUS was performed 6 weeks after implantation. Further follow-up (FU) included pad test, uroflowmetry, post-void residual urine measurements, radiography and standardized questionnaire. Continence and complication rates were compared between RT and non-RT patients. Explantation-free survival was estimated using Kaplan-Meier curves and log-rank test. Firth's penalized Cox-regression analyses were performed to analyze proportional hazard ratios for explantation.

A total of 150 patients (median age 70 years ([IQR] 66-74]) after DC-AUS implantation were available for analysis. Overall 73 patients (48.7%) had a history of RT. Median FU was 24 months ([IQR] 7.25-36]). Baseline clinical characteristics only differed regarding previous open SUI surgery (p=0.016). Social and objective continence was achieved in 94.8% and 84.3% of all patients treated by implantation of DC-AUS, respectively. Between RT and non-RT patients there were no statistically significant differences regarding continence rates [social continenece: 100% vs. 90.2%, (p=0.194); objective continence: 87% vs. 82%; (p=0.877)]. In terms of complication rates no significant differences were seen in comparison of irradiated and non-irradiated patients after DC-AUS implantation [infection: (p=0.09), erosion (p=0.31); mechanical failures (p=0.14)]. According to Kaplan-Meier analysis explantation rates in patients with a history of RT (26.0%) compared to non irradiated patients (20.8%), estimated explantation-free survival and AUS durability did not differ significantly (log-rank p=0.219).

Our data from a large institutional series indicate DC-AUS implantation to be an effective and safe treatment strategy in patients with SUI and a history of RT. This article is protected by copyright. All rights reserved.

BJU international. 2019 Jul 27 [Epub ahead of print]

Valentin Maurer, Phillip Marks, Roland Dahlem, Clemens M Rosenbaum, Christian P Meyer, Silke Riechardt, Margit Fisch, Tim Ludwig

Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

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