How the use of antibiotic irrigation solution affected the infection rates in penile prosthesis implantation?

Abstract

AimIt is common practice to immerse penile implants in antibiotic solution prior to implantation. Our aim was to investigate the effect of irrigation with antibiotic solution prior to implantation of penile prostheses on surgical outcomes and infection rates.MethodsWe retrospectively evaluated the data of 123 patients who underwent penile prosthesis implantation surgery at our clinic between August 2015 and August 2020. We evaluated the effect of irrigation of the prosthesis with an antibiotic solution on success and complications.ResultsThe mean age of the patients was 62 years. The average length of hospital stays was 3.3 days, and the average duration of the operation was 70 minutes. Preoperative antibiotic prophylaxis included the administration of 1 g of vancomycin once a day and twice daily doses of 3rd generation cephalosporins. None of the patients experienced any perioperative complications. Of the prostheses, 83 were single-piece (Promedon), 5 were two-piece (Ambicor), 35 were three-piece (AMS 700 CXP). All prostheses were irrigated with an antibiotic solution. After surgery, 5 patients had penile pain, 1 patient had penoscrotal tenderness and itchy lesions, and 4 patients had an infection of the surgical incision site that responded to medical therapy. In addition, 3 patients required the removal of the penile prosthesis.ConclusionProsthesis infection may be characterized by only pain without signs of infection, or may progress to penile necrosis and loss. During the first prosthetic surgeries, urologists used a number of solutions based on their previous clinical experience to provide protection from infection. The surgical area was washed with a solution before the incision and every 15 minutes thereafter. After corporotomy, corpus cavernosum washed 3 times using this solution, and the penile prosthesis was implanted after prewashing.

Keywords

Introduction

Erectile dysfunction is defined as the persistent inability to achieve or maintain an erection adequate for satisfactory sexual activity. Its incidence increases with advancing age. The prevalence of erectile dysfunction of all degrees is estimated at 52% in men aged 40–70, with higher rates in those older than 70 years.¹
Erectile dysfunction significantly reduces quality of life. Risk factors include aging, chronic illnesses, various medications, and cigarette smoking.² Identification can be made through questionnaires or a complete medical and sexual history.³
Treatment should be carried out stepwise. First, lifestyle changes and oral treatment are recommended. Intraurethral treatment and vacuum devices may also be tried. If insufficient, intracavernosal treatment can be initiated. Penile prosthesis implantation is recommended as a third-line treatment if there is no response to the first two steps.⁴ Considerable progress has been made in penile prostheses since their first use, reducing surgical and mechanical complications and increasing patient–partner satisfaction.⁵
Penile prosthesis infections are extremely challenging for surgeons and patients. The skin flora is usually the cause. Because human skin flora contains many pathogens, thorough physical and chemical skin cleansing is required before surgery. *Staphylococcus epidermidis* is the most common causative agent, but *E. coli*, *P. aeruginosa*, *S. marcescens*, *P. mirabilis*, and methicillin-resistant *Staphylococcus aureus* can also be encountered.^6-7 Prosthetic infections occur in 1–3% of primary prosthesis applications, but rates increase to 7% and 18% in revision and reconstructive surgeries. Importantly, many implanted prostheses do not show typical clinical signs of infection. One study found bacterial colonies in 40–80% of prostheses removed for non-infectious reasons.^8-9
Preventive measures are critical. Hospital stay should be minimized, surgical area shaved in the operating room, and simultaneous surgeries or additional synthetic materials avoided. Before surgery, the area should be cleaned with chlorhexidine or povidone-iodine, unnecessary entry/exit to the operating room prevented, bleeding controlled effectively, and co-morbid diseases managed preoperatively.^10-11
In this study, we planned to evaluate the efficacy of irrigation of penile prostheses with an antibiotic solution before implantation against infections.

Materials and Methods

The study started with the ethical approval of SBU Antalya Training and Research Hospital, dated 01.10.2020 and numbered 298. We retrospectively evaluated the data of n = 123 patients who underwent penile prosthesis implantation surgery in our clinic between August 2015 and August 2020. All patients underwent general physical examination before surgery. Additional investigations included hormonal tests, intracavernosal injection and stimulation tests, and penile color Doppler ultrasonography before deciding on surgery.
Before implantation, a preliminary interview was held with patients and their partners. They were informed about the surgical procedure, prosthesis types, advantages and disadvantages, and possible complications. Psychosocial and sexual evaluation was performed by a psychiatrist. Preoperative evaluation included essential biochemical investigations. Normal urine analysis and culture were expected. Patients with diabetes mellitus and HbA1c ≥ 6.8 were operated only after blood glucose control. All patients received a standard antibiotic regimen. Prostheses were not checked for antibiotic coating before surgery.
Each case was scheduled as the first of the day. All patients underwent mechanical cleaning of the surgical site before surgery. Entry and exit from the operating room were restricted. The surgical field was washed with povidone-iodine for 15 minutes before sterile dressing, then covered with a sterile drape.
An antibiotic solution was prepared for surgical prophylaxis containing 2400 mg gentamicin and 5000 mg rifampicin in 1000 cc isotonic saline, plus 500 cc of 10% povidone-iodine. The prosthesis and its parts were placed in this solution until implantation. The surgical area was washed with solution before incision and every 15 minutes thereafter. After corporotomy, corpus cavernosum was washed 3 times using this solution, and the prosthesis was implanted after prewashing.
All patients underwent spinal anesthesia. Postoperatively, patients were re-informed about prosthesis use. If no additional precaution was required, prosthesis use was allowed in the 6th postoperative week.
The type of prosthesis, success, and complication rates were recorded. For patients who developed complications, subsequent treatments and outcomes were evaluated.Ethical ApprovalEthics Committee approval for the study was obtained.

Results

Demographical analysis revealed diabetes mellitus (DM) in 46 patients (37.3%), hypertension (HT) in 73 patients (59.3%), coronary artery disease (CAD) in 32 patients (26.0%), smoking in 28 patients (22.7%), Peyronie’s disease in 4 patients (3.2%), radiotherapy history in 6 patients (4.8%), and radical prostatectomy history in 22 patients (17.8%).
Preoperative IIEF scoring showed severe ED in all patients. Doppler USG revealed bilateral arterial insufficiency in 90 patients (73.1%), mixed type in 10 patients (8.1%), and left arterial insufficiency in 5 patients (4%) (Table 1).
The mean age of n = 123 patients who underwent penile prosthesis surgery was 62 years. The mean duration of ED was 29 months. The mean duration of hospital stay, operation, and follow-up was 3.3 days, 70 minutes, and 13 months, respectively (Table 2).
All patients underwent spinal anesthesia and mechanical cleaning of the surgical site before surgery. The surgical field was washed with povidone-iodine for 15 minutes before sterile dressing. During surgery, the area was periodically washed with a solution containing gentamicin, rifampicin, and povidone-iodine. Preoperative antibiotic prophylaxis included 1 g vancomycin once daily and twice-daily doses of 3rd generation cephalosporins. After discharge, patients used 750 mg ciprofloxacin tablets twice daily for 7 days. None experienced perioperative complications.
Of the prostheses, 83 were single-piece (Promedon), 5 two-piece (Ambicor), and 35 three-piece (AMS 700 CXP). Postoperatively, 12 patients (9.7%) developed complications: penile pain in 5, penoscrotal tenderness and itchy lesions, and incision site infection responding to medical therapy in 4. Three patients required prosthesis removal (1 AMS 700 CXP, 2 Promedon) due to uncontrolled infections. One had a history of radical prostatectomy and hypertension, while the other two had controlled DM. All 3 were smokers.
These patients underwent removal and reimplantation of prostheses with the same characteristics in the same session. No recurrence occurred after salvage surgery. Prosthesis use was allowed 6 weeks after the second surgery. The post-discharge antibiotic regimen was extended to 2 weeks. No problems were encountered during the 6-month follow-up (Table 3).

Discussion

It is common practice to immerse penile implants in antibiotic solution prior to implantation. One of the most important complications of penile prosthesis implantation is infection. The most common infectious agents are *Staphylococcus epidermidis*, *Proteus mirabilis*, *P. aeruginosa*, and *Escherichia coli*.^12-13 Both the American Urological Association (AUA) and the European Association of Urology (EAU) have developed surgical prophylaxis guidelines for penile prosthesis operations. Prosthesis infection may present only with pain or progress to penile necrosis and loss. Its incidence varies between 1–10%, but today averages between 1–3%.^14-16
Initially, urologists used various solutions based on clinical experience, but no standard procedure was described. Antiseptic solutions and concentrations have not been systematically evaluated. When implant infection occurs, salvage procedures involve immediate replacement of the infected implant after antiseptic washing of implant cavities.⁸
According to Mulcah’s protocol, the infected prosthesis is removed with all parts, and the corpus cavernosum and anatomical spaces are irrigated with kanamycin + bacitracin, hydrogen peroxide, vancomycin + gentamycin, and povidone-iodine, followed by hydrogen peroxide and kanamycin + bacitracin. A new prosthesis is then implanted in the same session.¹⁷
Pan et al. (2003–2018) recommended washing body cavities and the scrotal pump area with povidone-iodine for ≥ 3 minutes, followed by saline and antibiotic irrigation, but did not specify antibiotic type, concentration, or administration method.¹⁸
In this study, we describe a new procedure using a mixture of 2400 mg gentamicin, 5000 mg rifampicin, and 500 cc of 10% povidone-iodine in 1000 cc isotonic saline. Prostheses and parts were immersed until implantation. The surgical area was washed before incision and every 15 minutes thereafter. After corporotomy, corpus cavernosum was washed 3 times with this solution, and the prosthesis implanted after prewashing. Prosthesis infection occurred in 3 patients requiring revision surgery (3.2%). These patients underwent salvage surgery with the same procedures repeated.
Henry et al. reported positive cultures and visible bacterial biofilms on clinically non-infected inflatable prostheses during revision surgery. Revision washout reduced bacterial load on implant capsule tissue.¹⁹
Recently, manufacturers have produced prostheses coated with antibiotics (minocycline + rifampicin) that absorb agents from immersion solutions, reducing infection rates. Although infection remains a problem, advances in antibiotic-coated devices and antiseptic irrigation have lowered incidence.^20-21
A recent study reported that repeated antibiotic irrigations in revision surgeries achieved infection rates comparable to primary implantation.²² In our study, all prostheses were irrigated with antibiotic solution regardless of coating. Three patients required revision surgery (2.4%).

Conclusion

Measures to prevent the formation of penile prosthesis infections, rather than their treatment, are of great importance. Although manufacturers produce antibiotic-coated prostheses, the development of infections is the most feared complication of penile prosthesis implantation. Our study on infections had a retrospective design. All penile prostheses to be implanted were not checked for antibiotic coating before surgery. No samples were taken for culture study during revision surgery. We believe that this study will shed light on more comprehensive studies on this subject, thanks to the new solution we have described.

Declarations

References

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