TY - JOUR
T1 - The hydrophilic-coated inflatable penile prosthesis
T2 - 1-year experience
AU - Wolter, Christopher E.
AU - Hellstrom, Wayne J.G.
N1 - Funding Information:
The hydrophilic, PVP‐coated Titan IPP offers an advantage in reducing penile prosthesis‐associated infections in patients. This is supported by both laboratory and clinical data. With continued follow‐up, it will likely become a durable and lasting advantage to both physicians and patients. The flexibility the coating affords the implanting urologist in choosing antibiotics perioperatively, and the reduction in biofilm formation, make this PVP‐coated device a safe and rational surgical choice for men with severe ED.
PY - 2004
Y1 - 2004
N2 - Introduction. Penile prosthesis infections are a devastating complication for both patient and surgeon. Efforts to reduce the risk of infection from these elective procedures are a major focus of research and development by the major prosthesis companies. The Titan inflatable penile prosthesis (Mentor Corporation, 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 in intraoperatively. The Titan device was introduced to the American market in September 2002. This study reports the 1-year experience in the U.S. with the Titan and compares infection rates with the noncoated Alpha-1 IPP made by Mentor. Materials and methods. Two thousand three hundred and fifty-seven Titan prostheses were implanted in the U.S. from September 2002 to August 2003, compared with the 482 noncoated 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. Results. The infection rate for the coated Titan IPP was 1.06% (25/2357). During the same time period, the infection rate for the Alpha-1 noncoated prosthesis was 2.07% (10/482). Staphylococcus species predominated in both groups (9/25 Titan, 6/10 Alpha-1). Conclusions. At 1 year of follow-up, the data demonstrate that the hydrophilic coating on the Titan IPP confers a significant advantage in reducing the rate of infection over the noncoated device. Long-term follow-up on this first year database is needed before this innovation is accepted as the standard of care for 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 in intraoperatively gives the implanting surgeon distinct advantages with this new product.
AB - Introduction. Penile prosthesis infections are a devastating complication for both patient and surgeon. Efforts to reduce the risk of infection from these elective procedures are a major focus of research and development by the major prosthesis companies. The Titan inflatable penile prosthesis (Mentor Corporation, 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 in intraoperatively. The Titan device was introduced to the American market in September 2002. This study reports the 1-year experience in the U.S. with the Titan and compares infection rates with the noncoated Alpha-1 IPP made by Mentor. Materials and methods. Two thousand three hundred and fifty-seven Titan prostheses were implanted in the U.S. from September 2002 to August 2003, compared with the 482 noncoated 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. Results. The infection rate for the coated Titan IPP was 1.06% (25/2357). During the same time period, the infection rate for the Alpha-1 noncoated prosthesis was 2.07% (10/482). Staphylococcus species predominated in both groups (9/25 Titan, 6/10 Alpha-1). Conclusions. At 1 year of follow-up, the data demonstrate that the hydrophilic coating on the Titan IPP confers a significant advantage in reducing the rate of infection over the noncoated device. Long-term follow-up on this first year database is needed before this innovation is accepted as the standard of care for 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 in intraoperatively gives the implanting surgeon distinct advantages with this new product.
KW - Biofilm
KW - Erectile dysfunction
KW - Penile
KW - Prosthesis
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U2 - 10.1111/j.1743-6109.2004.04032.x
DO - 10.1111/j.1743-6109.2004.04032.x
M3 - Article
C2 - 16429621
AN - SCOPUS:15844379523
SN - 1743-6095
VL - 1
SP - 221
EP - 224
JO - Journal of Sexual Medicine
JF - Journal of Sexual Medicine
IS - 2
ER -