Alexander Kretschmer1,2, Tanja Hüsch3, Frauke Thomsen3, Dominik Kronlachner3, Tobias Pottek4, Alice Obaje5, Ralf Anding6, Achim Rose7, Roberto Olianas8, Alexander Friedl9, Wilhelm Hübner10, Roland Homberg11, Jesco Pfitzenmaier12, Ulrich Grein13, Fabian Queissert14, Carsten M Naumann15, Josef Schweiger16, Carola Wotzka17, Joanne N Nyarangi-Dix18, Torben Hofmann19, Alexander Buchner20, Axel Haferkamp3, Ricarda M Bauer20. 1. Department of Urology, Ludwig-Maximilians-University, Campus Großhadern, Marchioninistrasse 15, 81377, Munich, Germany. Alexander.kretschmer@med.uni-muenchen.de. 2. Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada. Alexander.kretschmer@med.uni-muenchen.de. 3. Department of Urology and Paediatric Urology, University Hospital Frankfurt, Frankfurt, Germany. 4. Department of Urology, Asklepios Hospital West Hamburg, Hamburg, Germany. 5. Department of Urology, St. Bernward Hospital, Hildesheim, Germany. 6. Department of Urology and Paediatric Urology, University Hospital Bonn, Bonn, Germany. 7. Department of Urology and Paediatric Urology, Helios Hospital Duisburg, Duisburg, Germany. 8. Department of Urology, Hospital Lueneburg, Lueneburg, Germany. 9. Department of Urology, Göttlicher Heiland Vienna, Vienna, Austria. 10. Department of Urology, Hospital Weinviertel Korneuburg, Korneuburg, Austria. 11. Department of Urology and Paediatric Urology, St. Barbara Hospital Hamm GmbH, Hamm, Germany. 12. Department of Urology, Evangelic Hospital Bielefeld, Bielefeld, Germany. 13. Department of Urology and Paediatric Urology, Helios Hospital Schwelm, Schwelm, Germany. 14. Department of Urology, University Hospital Muenster, Muenster, Germany. 15. Department of Urology and Paediatric Urology, University Hospital Kiel, Kiel, Germany. 16. Department of Urology and Paediatric Urology, Catholic Hospital St. Johann Nepomuk, Erfurt, Germany. 17. Department of Urology, Diakonie Hospital Stuttgart, Stuttgart, Germany. 18. Department of Urology and Paediatric Urology, University Hospital Heidelberg, Heidelberg, Germany. 19. Department of Urology, Diakonie Hospital Schwäbisch Hall, Schwäbisch Hall, Germany. 20. Department of Urology, Ludwig-Maximilians-University, Campus Großhadern, Marchioninistrasse 15, 81377, Munich, Germany.
Abstract
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. CONCLUSION: 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.
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. CONCLUSION: 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: Alexander Kretschmer; Alexander Buchner; Markus Grabbert; Christian G Stief; Micaela Pavlicek; Ricarda M Bauer Journal: World J Urol Date: 2015-08-08 Impact factor: 4.226
Authors: R Corey O'Connor; Dana K Nanigian; Bhavin N Patel; Michael L Guralnick; Lars M Ellision; Anthony R Stone Journal: Urology Date: 2007-01 Impact factor: 2.649
Authors: Malcolm G Lucas; Ruud J L Bosch; Fiona C Burkhard; Francisco Cruz; Thomas B Madden; Arjun K Nambiar; Andreas Neisius; Dirk J M K de Ridder; Andrea Tubaro; William H Turner; Robert S Pickard Journal: Eur Urol Date: 2012-09-17 Impact factor: 20.096
Authors: Frank Van der Aa; Marcus J Drake; George R Kasyan; Andreas Petrolekas; Jean-Nicolas Cornu Journal: Eur Urol Date: 2012-11-23 Impact factor: 20.096
Authors: Malcolm G Lucas; Ruud J L Bosch; Fiona C Burkhard; Francisco Cruz; Thomas B Madden; Arjun K Nambiar; Andreas Neisius; Dirk J M K de Ridder; Andrea Tubaro; William H Turner; Robert S Pickard Journal: Eur Urol Date: 2012-08-31 Impact factor: 20.096
Authors: M Grabbert; T Hüsch; A Kretschmer; R Kirschner-Hermanns; R Anding; A Rose; A Friedl; A Obaje; A Heidenreich; B Brehmer; C M Naumann; F Queissert; H Loertzer; J Pfitzenmaier; J Nyarangi-Dix; M Kurosch; R Olianas; R Homberg; R Abdunnur; J Schweiger; T Hofmann; C Wotzka; T Pottek; W Huebner; A Haferkamp; R M Bauer Journal: World J Urol Date: 2018-10-19 Impact factor: 4.226
Authors: Alexander Kretschmer; Tanja Hüsch; Ralf Anding; Tobias Pottek; Achim Rose; Werner Struss; Fabian Queissert; Carsten M Naumann; Joanne N Nyarangi-Dix; Bernhard Brehmer; Axel Haferkamp; Ricarda M Bauer Journal: Int Braz J Urol Date: 2020 Jul-Aug Impact factor: 1.541