Efficacy of the Artificial Urinary Sphincter ZSI 375 for Treatment of Post-Radical Prostatectomy Incontinence in Patients with Intrinsic Sphincter Deficiency: A Preliminary Study

Abstract

Objectives: To evaluate the efficacy of the ZSI 375 artificial urinary sphincter (AUS) (Zephyr Artificial Sphincter, Geneva, Switzerland) for the treatment of patients with post-radical prostatectomy urinary incontinence. Methods: This was a retrospective, non-randomised, multicentre study open to patients with moderate-to-severe urinary incontinence due to intrinsic sphincter deficiency after radical prostatectomy. Efficacy and safety was evaluated on continence status, complications, and surgical revision. Results: Twenty-seven patients were recruited between September 2013 and April 2016 and followed up to April 2017. Mean age was 67.70 years old (range: 55–78). Twenty-six patients (96.30%) presented with incontinence post-radical prostatectomy and one patient (3.70%) after post-radical prostatectomy plus adjuvant radiotherapy. Follow-up ranged from 12 months–42 months (mean: 27.11). The success rate was 88.90% after 12 months follow-up, 94.12% after 24 months follow-up and 83.33% after 36 months follow-up. Three patients (11.11%) presented with a scrotal infection, two patients (7.41%) suffered a urethral erosion, and two patients (7.41%) had a mechanical failure. The revision rate was 22.22% (six patients). Conclusion: The follow-up time of this preliminary clinical study was long enough to demonstrate that the ZSI 375 AUS offers a good rate of continence to patients with urinary stress incontinence.