Hydrophilic-coated inflatable penile prosthesis: one-year experience.

Penile prosthesis infections are a devastating complication to both patient and surgeon. Though relatively uncommon, novel efforts are being made to reduce the risk of infection from these elective procedures. The Titan inflatable penile prosthesis (Mentor Corp, Santa Barbara, CA) is coated with polyvinylpyrrolidone (PVP), a hydrophilic substance that reduces bacterial adherence and absorbs and elutes the antibiotics the device is immersed with intraoperatively. The Titan device was introduced to the American market in September 2002. Two-thousand three hundred fifty-seven Titan prostheses were implanted in the US from September 2002 to August 2003, compared with 482 non-coated Alpha-1 IPPs implanted over the same time period. Infection rates were compared, along with bacterial culture data. All data were collected from Mentor's internal database, as generated from the FDA's mandatory reporting of explanted medical devices and available on the Internet. The infection rate for the coated Titan IPP was 1.06% (25/2357). Over the same time period, the infection rate for the Alpha-1 noncoated prosthesis was 2.07% (10/482) (P < 0.05). Staphylococcus species predominated in both groups (9/25 Titan, 6/10 Alpha-1). At 1 year of follow-up, the database demonstrates that the hydrophilic-coated Titan IPP confers a significant advantage in reducing the rate of infection over the non-coated device. Long-term follow-up on this first-year database is needed before this innovation is accepted as the standard of care for penile prosthetic surgery. Nevertheless, the theoretical reduction in bacterial adhesion conferred by the hydrophilic PVP surface and the ability to choose which antibiotic the device is immersed intra-operatively gives the implanting surgeon distinct advantages with this new product.

Christopher E. Wolter, Atul Rajpurkar, Muammer Kendirci, Chirpriya Dhabumala, and Wayne J.G. Hellstrom. Tulane University Department of Urology, New Orleans, LA.