Since they introduction in the treatment of erectile dysfunction (ED), phosphodiesterase type 5 (PDE-5) inhibitors have achieved widespread acceptance. Today PDE-5 inhibitors are considered as first-line oral pharmacotherapy in the management of ED (Hatzimouratidis et al., 2010). However, penile implants are still a popular choice, especially in patients who have failed to achieve erections by chemical enhancement, who prefer a permanent solution to their condition or in those who have considerable scar tissue in the penis resulting in erection deformalities (Mulcahy 1999). Despite its invasiveness, penile prostheses provide high satisfaction rates (Montague & Angermeier 2001).
The types of prosthesis most commonly implanted are the two-piece and the three-piece inflatable device, and the soft and malleable prosthesis. In the last few years the three-piece inflatable device has been used for preference, as it improves the erection with the most acceptable functional and cosmetical results (Minervini et al., 2006; Bettocchi et al., 2008).
Engineering changes and designs revisions have reduced the mechanical malfunctions associated with inflatable penis prostheses to less than 5 % (Carson et al., 2000; Carson 2004). As penile prostheses are now expected to function for an average of 8-12 years post implantation, infection has become a more significant problem. The incidence of infection has been reported to range from 0.5 to 17.7% (Quesada & Light, 1993; Wilson & Delk, 1995) usually about 1-3 % in case of primary implantation, and about 10-13 % in case of revision or reimplantation (Abouassaly et al., 2004).
The traditional treatment of penile prosthesis infection is systematic and local antibiotics application with the complete removal of the device followed by reinsertion within 2–12 months. However, removal of the device can lead to corporeal fibrosis, making dilation of the corporeal bodies difficult and reinsertion of a new device more complicated (Brant et al., 1996; Mulcahy, 1999).
To reduce the risk of device associated infections and to avoid the difficulties associated with late reinsertions many modifications have been developed such as antibiotic or hydrophilic coated devices and immediate replacement of the infected prosthesis (salvage techniques).
The aim of this chapter is to summarize the different methods of prevention and treatment of penile prosthesis infections.
Penile prostheses get infected predominantly secondary to bacterial seeding at the time of surgery. Prosthetic materials attract bacteria and support subsequent biofilm formation. In a multicenter study culture positive bacteria were found in 70% of patients with clinically uninfected penile prostheses during revision surgery for mechanical malfunction.
Penile prosthesis infections can be divided into clinically apparent and subclinical infections. Clinical infections present with, penile pain, induration, erythema, fever, purulent drainage from the wound and extrusion. Subclinical infections most often manifest by chronic prosthesis-associated pain.
3. Risk factors
Known risk factors for penile prosthesis infection include urinary tract infection, infections elsewhere in the body and hematogenous spread (Carson & Robertson, 1988; Little & Rhodus, 1992). There is an increased incidence of infection among patients undergoing primary implantation with penile reconstruction or secondary prosthesis revision compared to primary implantation alone, probably due to the increased duration of surgery (Quesada & Light, 1993; Jarow, 1996). The role of diabetes mellitus and spinal chord injury, as risk factors of penile prosthesis infection are contradictory (Jarow, 1996; Cakan et al., 2003).
4.1. General aspects
Because in most cases bacterial contamination occurs at the time of surgery, it is essential to use appropriate preoperative preparations. Short preoperative hospital stays have been documented to maintain low virulence (Carson, 2003). It is important to eliminate skin infections and to have sterile urine prior to surgery. Washing the genital region with strong soap in the days before the procedure, preoperative shaving and an aggressive scrub of the operating area is recommended to decrease the risk of infection (Mulcahy, 1999; Gomelsky & Dmochowski, 2003).
During surgery adequate sterile technique, short operating time, minimal tissue devitalization along with effective wound closure can all decrease the rate of perioperative infections (Scott, 1987).
4.2. Perioperative antibiotic prophylaxis
Athough the effectiveness of prophylactic perioperative antibiotics for implantation of penile prosthesis has never been proven by prospective studies, their use has become established and favored by most urologists. Antibiotics should be administered 1-2 hours prior to surgery and continued for 36-48 hours postoperative. Most common pathogenic organisms most likely to produce infections must be targeted when choosing prophylactic antibiotics. Therefore traditional prophylaxis include a parenteral aminoglycoside for Gram-negative and a first- or second generation cephalosporin or vancomycin for Gram-positive organisms coverage (Schwartz et al., 1996; Naber et al., 2001). Schwarz et al found in a randomized prospective trial of 20 patients that oral fluoroquinolone (ofloxacin) administered 2 hours before surgery achieved significantly higher intracavernosal levels and was more cost-effective than the combination of gentamicin and cefazolin (Schwartz et al., 1996). To estimate the safety and efficacy of this prophylaxis modality, further studies with similar settings, but bigger sample size should be performed.
4.3. Antibiotic impregnation
Early efforts in device impregnation focused on coating catheters with antibiotics. In 1995 Raad et al reported that in
In a retrospective study Carson et al reported 61,7% decrease in perioperative infection with InhibiZone compared to controls at 1 year post infection (Carson, 2004). The same group recently published their long-term clinical outcomes of almost 40,000 implants. There were significantly less revisions due to infections in the impregnated compared to the non-impregnated group at up to 7.7 years of follow-up (1.1% vs 2.5%, respectively)(Carson et al., 2011). In a subset of diabetic patients in the same series, the rate of infection-related revisions was significantly lower in the impregnated group compared to the controls at 7 years (1,62 % vs 4,24 %)(Mulcahy & Carson, 2011).
In 2007 Wilson et al. began a prospective randomized study comparing the infection rate of rifampin and minocycline coated implants with implants without impregnation (Wilson et al., 2007). After it became evident that the infection rate was less with the impregnated group they abandoned the other arm because of ethical considerations and compared they results with the previously published series of the same surgical team with noncoated implants (Wilson & Delk, 1995; Wilson et al. 1998). The use of antibiotic coated inflatable penile prosthesis resulted in a statistically significant reduction in the infection rates compared with the historical data in nondiabetic virgin implant patients (
4.4. Hydrophilic coating
In 2002 a hydrophilic penile prosthesis coating was developed which has been shown to decrease bacterial adherence
Mansouri and colleagues compared the spectrum and durability, both in vitro and in vivo of the hydrophilic coated prosthesis dipped in vancomycin and the InhibiZone implants, and found that the antibiotic pre-impregnated prosthesis had a broader spectrum in vitro and a more durable antimicrobial activity in vitro and in an animal model than implants dipped in vancomycin (Mansouri et al. 2009).
Clinical data on the hydrophilic coated inflatable penile prosthesis is limited. Wolter et
Subclinical infections may be more common than clinically apparent infections. These infections are difficult to diagnose and even more challenging to treat. Parsons
In case of clinically apparent infection surgical intervention along with antibiotics is of critical importance. The traditional treatment consists of the immediate removal of all the components followed by delayed reimplantation 2-12 months later (Gomelsky & Dmochowski, 2003; Mulcahy, 2003). The advantage of this solution is that the new implant is scheduled only when the infection has completely cleared. However, removal of the device along with inflammation from the infectious process leads to corporeal fibrosis and scarring, which almost always results in penile shortening and may make dilation of the corporeal bodies very difficult, resulting reinsertion of a new device more complicated and sometimes impossible (Brant et al., 1996; Mulcahy, 1999).
A salvage protocol was instituted in 1991 to avoid difficult reinsertion and maintain as much penile length as possible. The salvage procedure involves removing all parts of the infected prosthesis, washing the wound, and replacing the device at the same procedure. Mulcahy
The delayed salvage procedure consists of placement of a drainage tube after removal of the prosthesis; antibiotic solution is irrigated through the drain and a new prosthesis is placed about 3 days later. However, Knoll et al could not find a statistically significant difference between immediate and delayed salvage procedure (Knoll, 1998), while there are the additional cost of the second surgical procedure.
6. Further research
Prospective studies and long-term follow up are needed to make stronger recommendations about the different methods in the prevention or treatment of penile prostheses infections, especially about the hydrophilic coated penile prosthesis.
The efforts to apply more effective methods of prevention and the new developments of prosthesis coatings resulted a significant reduction of the infectious complications of penile prosthesis implantation. Further improvements of surgical procedures and prosthesis materials and coatings can lead to further decrease of the infection rates in the future.
Abouassaly R. Montague D. K. et al. 2004 Antibiotic-coated medical devices: with an emphasis on inflatable penile prosthesis.Asian J Androl 6 3 249 57
Bettocchi C. Ditonno P. et al. 2008 Penile Prosthesis: What Should We Do about Complications?Adv Urol: 573560.
Brant M. D. Ludlow J. K. et al. 1996 The prosthesis salvage operation: immediate replacement of the infected penile prosthesisJ Urol 155 1 155
Cakan M. Demirel F. et al. 2003 Risk factors for penile prosthetic infectionInt Urol Nephrol 35 2 209 13
Carson C. 2004 Antibiotic impregnation of inflatable penile prostheses: effect on perioperative infectionExpert Rev Med Devices 1 2 165
Carson C. C. 1989 Infections in genitourinary prostheses.Urol Clin North Am 16 1 139 47
Carson C. C. 2003Diagnosis, treatment and prevention of penile prosthesis infection." Int J Impot Res 15 Suppl 5: S 139 46
Carson C. C. 3rd 2004 Efficacy of antibiotic impregnation of inflatable penile prostheses in decreasing infection in original implantsJ Urol 171 4 1611
Carson C. C. 3rd Mulcahy J. J. et al. 2011 Long-term infection outcomes after original antibiotic impregnated inflatable penile prosthesis implants: up to 7.7 years of followupJ Urol 185 2 614 8
Carson C. C. Mulcahy J. J. et al. 2000Efficacy, safety and patient satisfaction outcomes of the AMS 700CX inflatable penile prosthesis: results of a long-term multicenter study. AMS 700CX Study Group." J Urol 164 2 376
Carson C. C. Robertson C. N. 1988 Late hematogenous infection of penile prostheses.J Urol 139 1 50 2
Choong S. Whitfield H. 2000 Biofilms and their role in infections in urology.BJU Int. 86((8)): 935 EOF 41 EOF
Gomelsky A. Dmochowski R. R. 2003 Antibiotic prophylaxis in urologic prosthetic surgery.Curr Pharm Des 9 12 989 96
Hatzimouratidis K. Amar E. 2010 Guidelines on male sexual dysfunction: erectile dysfunction and premature ejaculationEur Urol 57 5 804 14
Hellstrom W. J. Hyun J. S. et al. 2003 Antimicrobial activity of antibiotic-soaked, Resist-coated Bioflex.Int J Impot Res 15 1 18 21
Henry G. D. Wilson S. K. et al. 2004 Penile prosthesis cultures during revision surgery: a multicenter study.J Urol 172 1 153 6
Jarow J. P. 1996 Risk factors for penile prosthetic infection.J Urol 156(2 Pt 1): 402 4
Knoll L. D. 1998 Penile prosthetic infection: management by delayed and immediate salvage techniques. 52 2 287 90
Little J. W. Rhodus N. L. 1992 The need for antibiotic prophylaxis of patients with penile implants during invasive dental procedures: a national survey of urologists.J Urol 148 6 1801 4
Mansouri M. D. Boone T. B. et al. 2009 Comparative assessment of antimicrobial activities of antibiotic-treated penile prosthesesEur Urol 56 6 1039
Minervini A. Ralph D. J. et al. 2006 Outcome of penile prosthesis implantation for treating erectile dysfunction: experience with 504 proceduresBJU Int 97(1): 129 33
Montague D. K. Angermeier K. W. 2001 Penile prosthesis implantation.Urol Clin North Am 28 2 355 61x.
Mulcahy J. J. 1999 Management of the infected penile implant--concepts on salvage techniques.Int J Impot Res 11 Suppl 1: S 58 9
Mulcahy J. J. 2003 Treatment alternatives for the infected penile implant.Int J Impot Res 15 Suppl 5: S 147 9
Mulcahy J. J. Brant M. D. et al. 1995 Management of infected penile implants.Tech Urol 1 3 115 9
Mulcahy J. J. Carson C. C. 3rd 2011 Long-Term Infection Rates in Diabetic Patients Implanted With Antibiotic-Impregnated Versus Nonimpregnated Inflatable Penile Prostheses:Eur Urol. 7-Year Outcomes
Naber K. G. Hofstetter A. G. et al. 2001 Guidelines for the perioperative prophylaxis in urological interventions of the urinary and male genital tract.Int J Antimicrob Agents 17 4 321 6
Parsons C. L. Stein P. C. et al. 1993 Diagnosis and therapy of subclinically infected prostheses.Surg Gynecol Obstet 177 5 504 6
Quesada E. T. Light J. K. 1993The AMS 700 inflatable penile prosthesis:long-term experience with the controlled expansion cylinders." J Urol 149(1): 46 8
Raad I. Darouiche R. et al. 1995Antibiotics and prevention of microbial colonization of catheters." Antimicrob Agents Chemother 39 11 2397
Rajpurkar A. Fairfax M. et al. 2004Antibiotic soaked hydrophilic coated bioflex: a new strategy in the prevention of penile prosthesis infection." J Sex Med 1(2): 215 20
Schwartz B. F. Swanzy S. et al. 1996 A randomized prospective comparison of antibiotic tissue levels in the corpora cavernosa of patients undergoing penile prosthesis implantation using gentamicin plus cefazolin versus an oral fluoroquinolone for prophylaxis." J Urol 156 3 991
Scott F. B. 1987Prosthetic infections." J Urol 138(1): 113.
Wilson S. K. Carson C. C. et al. 1998 Quantifying risk of penile prosthesis infection with elevated glycosylated hemoglobin.J Urol 159 5 1537 9discussion 1539-40.
Wilson S. K. Delk J. R. 2nd 1995 Inflatable penile implant infection: predisposing factors and treatment suggestionsJ Urol 153(3 Pt 1): 659 EOF
Wilson S. K. Zumbe J. et al. 2007 Infection reduction using antibiotic-coated inflatable penile prosthesis 70 2 337 40
Wolter C. E. Hellstrom W. J. 2004 The hydrophilic-coated inflatable penile prosthesis: 1-year experienceJ Sex Med 1 2 221 4