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World Journal of Urology

, Volume 34, Issue 10, pp 1457–1463 | Cite as

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

  • 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
Original Article

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.

Keywords

Male urinary stress incontinence Artificial urinary sphincter Complications Postprostatectomy incontinence Zephyr ZSI375 

Abbreviations

AUS

Artificial urinary sphincter

BMI

Body mass index

SUI

Stress urinary incontinence

SD

Standard deviation

Notes

Author contributions

A. Kretschmer was involved in protocol/project development, data collection or management, data analysis, and manuscript writing. T. Hüsch and T. Pottek contributed to protocol/project development, data collection or management, data analysis, and manuscript editing. F. Thomsen and D. Kronlachner were involved in data collection or management and data analysis. Alice Obaje, Ralf Anding, Achim Rose, Roberto Olianas, Roland Homberg, Jesco Pfitzenmaier, Ulrich Grein, Fabian Queissert, Fabian Queissert, Carsten M. Naumann, Josef Schweiger, Carola Wotzka, Joanne N. Nyarangi-Dix, Torben Hofmann, and Axel Haferkamp developed the protocol/project and edited the manuscript. Alexander Friedl and Wilhelm Hübner contributed to protocol/project development, manuscript editing, and data collection or management.Alexander Buchner was involved in protocol/project development, manuscript editing, and data analysis. Ricarda M. Bauer contributed to protocol/project development, manuscript editing, data collection or management, and data analysis.

Compliance with ethical standards

Conflict of interest

R. M. Bauer declares consultancy work, lectures, and participation in clinical trials for AMS (Minnetonka, USA) and Promedon (Cordoba, Argentina). T. Pottek declares consultancy work, lectures for AMS, Zephyr (Geneva, Switzerland), and Teleflex (Limerick, USA). R. Anding declares consultancy work, lectures, and participation in clinical trials for AMS. C.M. Naumann declares consultancy work, lectures, and participation in clinical trials for Coloplast (Fredensborg, Denmark). W. Hübner declares consultancy work, lectures, and participation in clinical trials for Uromedica (Plymouth, MN, USA) and Promedon. The remaining authors have nothing to disclose.

Research involving human participants and/or animals

The study was approved by a local ethics committee.

Informed consent

An informed consent was sent to all potential participants. No participant was further contacted without having signed the informed consent.

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Copyright information

© Springer-Verlag Berlin Heidelberg 2016

Authors and Affiliations

  • Alexander Kretschmer
    • 1
    • 2
  • Tanja Hüsch
    • 3
  • Frauke Thomsen
    • 3
  • Dominik Kronlachner
    • 3
  • Tobias Pottek
    • 4
  • Alice Obaje
    • 5
  • Ralf Anding
    • 6
  • Achim Rose
    • 7
  • Roberto Olianas
    • 8
  • Alexander Friedl
    • 9
  • Wilhelm Hübner
    • 10
  • Roland Homberg
    • 11
  • Jesco Pfitzenmaier
    • 12
  • Ulrich Grein
    • 13
  • Fabian Queissert
    • 14
  • Carsten M. Naumann
    • 15
  • Josef Schweiger
    • 16
  • Carola Wotzka
    • 17
  • Joanne N. Nyarangi-Dix
    • 18
  • Torben Hofmann
    • 19
  • Alexander Buchner
    • 1
  • Axel Haferkamp
    • 3
  • Ricarda M. Bauer
    • 1
  • Debates On Male Incontinence (DOMINO)-Project
  1. 1.Department of UrologyLudwig-Maximilians-UniversityMunichGermany
  2. 2.Department of Urologic SciencesUniversity of British ColumbiaVancouverCanada
  3. 3.Department of Urology and Paediatric UrologyUniversity Hospital FrankfurtFrankfurtGermany
  4. 4.Department of UrologyAsklepios Hospital West HamburgHamburgGermany
  5. 5.Department of UrologySt. Bernward HospitalHildesheimGermany
  6. 6.Department of Urology and Paediatric UrologyUniversity Hospital BonnBonnGermany
  7. 7.Department of Urology and Paediatric UrologyHelios Hospital DuisburgDuisburgGermany
  8. 8.Department of UrologyHospital LueneburgLueneburgGermany
  9. 9.Department of UrologyGöttlicher Heiland ViennaViennaAustria
  10. 10.Department of UrologyHospital Weinviertel KorneuburgKorneuburgAustria
  11. 11.Department of Urology and Paediatric UrologySt. Barbara Hospital Hamm GmbHHammGermany
  12. 12.Department of UrologyEvangelic Hospital BielefeldBielefeldGermany
  13. 13.Department of Urology and Paediatric UrologyHelios Hospital SchwelmSchwelmGermany
  14. 14.Department of UrologyUniversity Hospital MuensterMuensterGermany
  15. 15.Department of Urology and Paediatric UrologyUniversity Hospital KielKielGermany
  16. 16.Department of Urology and Paediatric UrologyCatholic Hospital St. Johann NepomukErfurtGermany
  17. 17.Department of UrologyDiakonie Hospital StuttgartStuttgartGermany
  18. 18.Department of Urology and Paediatric UrologyUniversity Hospital HeidelbergHeidelbergGermany
  19. 19.Department of UrologyDiakonie Hospital Schwäbisch HallSchwäbisch HallGermany

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