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

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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.

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Abbreviations

AUS:

Artificial urinary sphincter

BMI:

Body mass index

SUI:

Stress urinary incontinence

SD:

Standard deviation

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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.

Author information

Authors and Affiliations

  1. Department of Urology, Ludwig-Maximilians-University, Campus Großhadern, Marchioninistrasse 15, 81377, Munich, Germany

    Alexander Kretschmer, Alexander Buchner & Ricarda M. Bauer

  2. Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada

    Alexander Kretschmer

  3. Department of Urology and Paediatric Urology, University Hospital Frankfurt, Frankfurt, Germany

    Tanja Hüsch, Frauke Thomsen, Dominik Kronlachner & Axel Haferkamp

  4. Department of Urology, Asklepios Hospital West Hamburg, Hamburg, Germany

    Tobias Pottek

  5. Department of Urology, St. Bernward Hospital, Hildesheim, Germany

    Alice Obaje

  6. Department of Urology and Paediatric Urology, University Hospital Bonn, Bonn, Germany

    Ralf Anding

  7. Department of Urology and Paediatric Urology, Helios Hospital Duisburg, Duisburg, Germany

    Achim Rose

  8. Department of Urology, Hospital Lueneburg, Lueneburg, Germany

    Roberto Olianas

  9. Department of Urology, Göttlicher Heiland Vienna, Vienna, Austria

    Alexander Friedl

  10. Department of Urology, Hospital Weinviertel Korneuburg, Korneuburg, Austria

    Wilhelm Hübner

  11. Department of Urology and Paediatric Urology, St. Barbara Hospital Hamm GmbH, Hamm, Germany

    Roland Homberg

  12. Department of Urology, Evangelic Hospital Bielefeld, Bielefeld, Germany

    Jesco Pfitzenmaier

  13. Department of Urology and Paediatric Urology, Helios Hospital Schwelm, Schwelm, Germany

    Ulrich Grein

  14. Department of Urology, University Hospital Muenster, Muenster, Germany

    Fabian Queissert

  15. Department of Urology and Paediatric Urology, University Hospital Kiel, Kiel, Germany

    Carsten M. Naumann

  16. Department of Urology and Paediatric Urology, Catholic Hospital St. Johann Nepomuk, Erfurt, Germany

    Josef Schweiger

  17. Department of Urology, Diakonie Hospital Stuttgart, Stuttgart, Germany

    Carola Wotzka

  18. Department of Urology and Paediatric Urology, University Hospital Heidelberg, Heidelberg, Germany

    Joanne N. Nyarangi-Dix

  19. Department of Urology, Diakonie Hospital Schwäbisch Hall, Schwäbisch Hall, Germany

    Torben Hofmann

Authors
  1. Alexander Kretschmer
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  2. Tanja Hüsch
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  3. Frauke Thomsen
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  4. Dominik Kronlachner
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  5. Tobias Pottek
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  6. Alice Obaje
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  7. Ralf Anding
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  8. Achim Rose
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  9. Roberto Olianas
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  10. Alexander Friedl
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  11. Wilhelm Hübner
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  12. Roland Homberg
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  13. Jesco Pfitzenmaier
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  14. Ulrich Grein
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  15. Fabian Queissert
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  16. Carsten M. Naumann
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  17. Josef Schweiger
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  18. Carola Wotzka
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  19. Joanne N. Nyarangi-Dix
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  20. Torben Hofmann
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  21. Alexander Buchner
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  22. Axel Haferkamp
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  23. Ricarda M. Bauer
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Consortia

Debates On Male Incontinence (DOMINO)-Project

Corresponding author

Correspondence to Alexander Kretschmer.

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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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Kretschmer, A., Hüsch, T., Thomsen, F. et al. Efficacy and safety of the ZSI375 artificial urinary sphincter for male stress urinary incontinence: lessons learned. World J Urol 34, 1457–1463 (2016). https://doi.org/10.1007/s00345-016-1787-5

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  • DOI: https://doi.org/10.1007/s00345-016-1787-5

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