Long-Term Revision Rate due to Infection in Hydrophilic-Coated Inflatable Penile Prostheses: 11-Year Follow-up

摘要

Introduction. Penile implant surgery continues to be an important option for men with erectile dysfunction. Advancements in technology of implants have contributed to improved survival from mechanical breakdown. Prosthesis infection remains a serious adverse event. For the last 8 years, the Titan implant (Coloplast Corporation, Minneapolis, MN, USA) has been available with an infection-retardant polyvinylpyrrolidone coating. Aim. To compare the infection rates between coated three-piece inflatable penile prostheses (IPPs) with the previous non-coated model. Main Outcome Measures. Infection-related revisions reported in the physician-generated, manufacturer-tabulated patient information forms (PIFs). Methods. PIFs reported into the voluntary, post-market registry of Coloplast Corporation from July 14, 2000 to September 30, 2011 were retrospectively reviewed. Infection-related revisions entered into the product evaluation database for coated and non-coated IPPs were compared. Data were analyzed using Pearson's chi-squared test. Results. The database included 36,391 PIFs related to primary IPP implantation. At 11 years of follow-up, 4.6% (7,031) of non-coated IPPs were removed or replaced due to infections, whereas 1.4% (29,360) of hydrophilic-coated implants reported replacements due to device infections. The hydrophilic coating of the IPP components makes the device slippery and prevents bacterial attachment. The hydrophilic coating allows rapid absorption of antibiotics in an aqueous solution and allows these water-soluble antibiotics to elute off the device into the implant spaces. Unfortunately, information pertaining to what agents were used in the studies patients was not tabulated. The rate of revision due to device infection was reduced 69.56% in patients with hydrophilic-coated IPPs (P<0.001). Conclusion. To the best of our knowledge, this is the longest post-marketing registry report related to IPP infections. At 8 years of follow-up, the hydrophilic-coated IPPs demonstrated a significant reduction in revision rates due to infection when compared with the 11-year follow-up of non-coated implants. Since there was no information or uniformity of antibiotics used in the soaking solution, it is uncertain which antibiotic selection provided the best results. In vitro testing against known infectious agents may further benefit IPP patients by reducing the prosthesis infection rate.