Efficacy of the Artificial Urinary Sphincter ZSI 375 for Treatment of Post-Radical Prostatectomy Incontinence in Patients with Intrinsic Sphincter Deficiency: A Preliminary Study
*Alejandro Carvajal Obando,1 Federico Gavira Gil,2 Álvaro Gutiérrez Martinez,3 Luis Fernando Echeverry Molina,4 Juan Carlos Castaño Botero5
1. Hospital Universitario San Vicente Fundación, Medellín, Antioquia, Colombia
2. Hospital Pablo Tobón Uribe Calle, Medellín, Antioquia, Colombia
3. Urobosque Centro Urologico, Bogotá, Cundinamarca, Colombia
4. Fundación SaluVite, Cali, Colombia
5. Clínica Universitaria CES, Medellín, Colombia
*Correspondence to firstname.lastname@example.org
Disclosure: The authors have declared no conflicts of interest.
Support: The publication of this study was supported by Zephyr Surgical Implants. The content is solely the responsibility of the authors and does not necessarily represent the official view of Zephyr Surgical Implants.
Received: 05.04.17 Accepted: 09.05.17
Citation: EMJ. 2017;2:22-26.
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.
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