title: Efficacy and safety of the ZSI375 artificial urinary sphincter for male stress urinary incontinence: lessons learned.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Urology, Ludwig-Maximilians-University, Campus Großhadern, Marchioninistrasse 15, 81377, Munich, Germany. Alexander.kretschmer@med.uni-muenchen.de.|Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada. Alexander.kretschmer@med.uni-muenchen.de.
authors.forename: Alexander
authors.initials: A
authors.lastname: Kretschmer
authors.affiliation: Department of Urology and Paediatric Urology, University Hospital Frankfurt, Frankfurt, Germany.
authors.forename: Tanja
authors.initials: T
authors.lastname: Hüsch
authors.affiliation: Department of Urology and Paediatric Urology, University Hospital Frankfurt, Frankfurt, Germany.
authors.forename: Frauke
authors.initials: F
authors.lastname: Thomsen
authors.affiliation: Department of Urology and Paediatric Urology, University Hospital Frankfurt, Frankfurt, Germany.
authors.forename: Dominik
authors.initials: D
authors.lastname: Kronlachner
authors.affiliation: Department of Urology, Asklepios Hospital West Hamburg, Hamburg, Germany.
authors.forename: Tobias
authors.initials: T
authors.lastname: Pottek
authors.affiliation: Department of Urology, St. Bernward Hospital, Hildesheim, Germany.
authors.forename: Alice
authors.initials: A
authors.lastname: Obaje
authors.affiliation: Department of Urology and Paediatric Urology, University Hospital Bonn, Bonn, Germany.
authors.forename: Ralf
authors.initials: R
authors.lastname: Anding
authors.affiliation: Department of Urology and Paediatric Urology, Helios Hospital Duisburg, Duisburg, Germany.
authors.forename: Achim
authors.initials: A
authors.lastname: Rose
authors.affiliation: Department of Urology, Hospital Lueneburg, Lueneburg, Germany.
authors.forename: Roberto
authors.initials: R
authors.lastname: Olianas
authors.affiliation: Department of Urology, Göttlicher Heiland Vienna, Vienna, Austria.
authors.forename: Alexander
authors.initials: A
authors.lastname: Friedl
authors.affiliation: Department of Urology, Hospital Weinviertel Korneuburg, Korneuburg, Austria.
authors.forename: Wilhelm
authors.initials: W
authors.lastname: Hübner
authors.affiliation: Department of Urology and Paediatric Urology, St. Barbara Hospital Hamm GmbH, Hamm, Germany.
authors.forename: Roland
authors.initials: R
authors.lastname: Homberg
authors.affiliation: Department of Urology, Evangelic Hospital Bielefeld, Bielefeld, Germany.
authors.forename: Jesco
authors.initials: J
authors.lastname: Pfitzenmaier
authors.affiliation: Department of Urology and Paediatric Urology, Helios Hospital Schwelm, Schwelm, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Grein
authors.affiliation: Department of Urology, University Hospital Muenster, Muenster, Germany.
authors.forename: Fabian
authors.initials: F
authors.lastname: Queissert
authors.affiliation: Department of Urology and Paediatric Urology, University Hospital Kiel, Kiel, Germany.
authors.forename: Carsten M
authors.initials: CM
authors.lastname: Naumann
authors.affiliation: Department of Urology and Paediatric Urology, Catholic Hospital St. Johann Nepomuk, Erfurt, Germany.
authors.forename: Josef
authors.initials: J
authors.lastname: Schweiger
authors.affiliation: Department of Urology, Diakonie Hospital Stuttgart, Stuttgart, Germany.
authors.forename: Carola
authors.initials: C
authors.lastname: Wotzka
authors.affiliation: Department of Urology and Paediatric Urology, University Hospital Heidelberg, Heidelberg, Germany.
authors.forename: Joanne N
authors.initials: JN
authors.lastname: Nyarangi-Dix
authors.affiliation: Department of Urology, Diakonie Hospital Schwäbisch Hall, Schwäbisch Hall, Germany.
authors.forename: Torben
authors.initials: T
authors.lastname: Hofmann
authors.affiliation: Department of Urology, Ludwig-Maximilians-University, Campus Großhadern, Marchioninistrasse 15, 81377, Munich, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Buchner
authors.affiliation: Department of Urology and Paediatric Urology, University Hospital Frankfurt, Frankfurt, Germany.
authors.forename: Axel
authors.initials: A
authors.lastname: Haferkamp
authors.affiliation: Department of Urology, Ludwig-Maximilians-University, Campus Großhadern, Marchioninistrasse 15, 81377, Munich, Germany.
authors.forename: Ricarda M
authors.initials: RM
authors.lastname: Bauer
mesh_terms: D000368:Aged; D006801:Humans; D008297:Male; D011183:Postoperative Complications; D011474:Prosthesis Design; D019919:Prosthesis Implantation / Q000379:methods*; D016896:Treatment Outcome; D014521:Urethra / Q000601:surgery*; D014550:Urinary Incontinence, Stress / Q000503:physiopathology / Q000601:surgery*; D016741:Urinary Sphincter, Artificial; D014554:Urination / Q000502:physiology*
keywords: Artificial urinary sphincter; Complications; Male urinary stress incontinence; Postprostatectomy incontinence; Zephyr ZSI375