Efficacy and safety of the ZSI375 artificial urinary sphincter for male stress urinary incontinence: lessons learned

PURPOSE - To analyze efficacy and safety for the ZSI375 artificial urinary sphincter in a multicenter case series.

METHODS - Thirteen male patients with stress urinary incontinence underwent implantation of a ZSI375 artificial urinary sphincter device between 2010 and 2012 in three international continence reference centers.

Perioperative characteristics and postoperative complications were analyzed using the Clavien-Dindo scale. Re-hospitalization and explantation rates, and functional outcome were assessed. Inner-group and between-group differences were analyzed using Wilcoxon, Mann-Whitney U, and Fisher's exact test whenever indicated. Kaplan-Meier analysis was performed to assess device survival. A p value below 0.05 was considered statistically significant.

RESULTS - There were no intraoperative complications. Median follow-up was 13.5 months. In this period, four device defects (30.8 %) could be observed, being the main cause for device explantation, followed by device infection (15.4 %), non-resolvable pain (7.7 %), and urethral erosion (7.7 %). There were no Clavien IV or Clavien V complications. Overall explantation rate was 61.5 %. Mean time-to-explantation was 279 ± 308 days. There was no significant influence of previous irradiation and previous invasive incontinence therapy (p = 0.587 and p = 0.685, respectively). Mean daily pad usage decreased from 5.8 ± 1.5 to 2.4 ± 2.1 (p = 0.066). One patient (7.7 %) did not use any pads. Social continence (0-1 pads) was achieved in 15.4 % of the patients.

CONCLUSIONS - This is the most current study that is investigating the outcome after ZSI375 implantation in a multicenter case series. Based on our results, explantation rates after ZSI375 implantation are high and efficacy rates seem lower than previously described. Addressing this high failure rate, the system has undergone a two-step modification in the meantime.

World journal of urology. 2016 Feb 25 [Epub ahead of print]

Alexander Kretschmer, Tanja Hüsch, Frauke Thomsen, Dominik Kronlachner, Tobias Pottek, Alice Obaje, Ralf Anding, Achim Rose, Roberto Olianas, Alexander Friedl, Wilhelm Hübner, Roland Homberg, Jesco Pfitzenmaier, Ulrich Grein, Fabian Queissert, Carsten M Naumann, Josef Schweiger, Carola Wotzka, Joanne N Nyarangi-Dix, Torben Hofmann, Alexander Buchner, Axel Haferkamp, Ricarda M Bauer, Debates On Male Incontinence (DOMINO)-Project

Department of Urology, Ludwig-Maximilians-University, Campus Großhadern, Marchioninistrasse 15, 81377, Munich, Germany. ., Department of Urology and Paediatric Urology, University Hospital Frankfurt, Frankfurt, Germany., Department of Urology and Paediatric Urology, University Hospital Frankfurt, Frankfurt, Germany., Department of Urology and Paediatric Urology, University Hospital Frankfurt, Frankfurt, Germany., Department of Urology, Asklepios Hospital West Hamburg, Hamburg, Germany., Department of Urology, St. Bernward Hospital, Hildesheim, Germany., Department of Urology and Paediatric Urology, University Hospital Bonn, Bonn, Germany., Department of Urology and Paediatric Urology, Helios Hospital Duisburg, Duisburg, Germany., Department of Urology, Hospital Lueneburg, Lueneburg, Germany., Department of Urology, Göttlicher Heiland Vienna, Vienna, Austria., Department of Urology, Hospital Weinviertel Korneuburg, Korneuburg, Austria., Department of Urology and Paediatric Urology, St. Barbara Hospital Hamm GmbH, Hamm, Germany., Department of Urology, Evangelic Hospital Bielefeld, Bielefeld, Germany., Department of Urology and Paediatric Urology, Helios Hospital Schwelm, Schwelm, Germany., Department of Urology, University Hospital Muenster, Muenster, Germany., Department of Urology and Paediatric Urology, University Hospital Kiel, Kiel, Germany., Department of Urology and Paediatric Urology, Catholic Hospital St. Johann Nepomuk, Erfurt, Germany., Department of Urology, Diakonie Hospital Stuttgart, Stuttgart, Germany., Department of Urology and Paediatric Urology, University Hospital Heidelberg, Heidelberg, Germany., Department of Urology, Diakonie Hospital Schwäbisch Hall, Schwäbisch Hall, Germany., Department of Urology, Ludwig-Maximilians-University, Campus Großhadern, Marchioninistrasse 15, 81377, Munich, Germany., Department of Urology and Paediatric Urology, University Hospital Frankfurt, Frankfurt, Germany., Department of Urology, Ludwig-Maximilians-University, Campus Großhadern, Marchioninistrasse 15, 81377, Munich, Germany.

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