Efficacy and safety of the ZSI375 artificial urinary sphincter for male stress urinary incontinence: lessons learned
- 228 Downloads
To analyze efficacy and safety for the ZSI375 artificial urinary sphincter in a multicenter case series.
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.
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.
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.
KeywordsMale urinary stress incontinence Artificial urinary sphincter Complications Postprostatectomy incontinence Zephyr ZSI375
Artificial urinary sphincter
Body mass index
Stress urinary incontinence
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.
An informed consent was sent to all potential participants. No participant was further contacted without having signed the informed consent.