Rigi10™ Malleable Penile Prosthesis
Also Known As
IPP infection prevention, Penile implant infection control, Prophylaxis for penile implant infection, Surgical site infection (SSI) prevention in penile prosthesis surgery.
Definition
Penile prosthesis infection prophylaxis refers to the comprehensive set of evidence-based medical and surgical measures undertaken to prevent infections before, during, and after the implantation of a penile prosthesis (also known as an inflatable penile prosthesis or IPP). Penile prostheses are medical devices implanted to treat erectile dysfunction (ED) that is refractory to other treatments.¹&³ The primary purpose of infection prophylaxis in this context is to minimize the risk of microbial contamination of the surgical site and the implant itself, which can lead to serious complications, device failure, and the need for revision surgery.¹&⁻³ Prophylactic strategies typically involve a multi-faceted approach including patient optimization, meticulous surgical techniques, appropriate antibiotic administration, and potentially the use of specialized device coatings.¹&˒² Biofilm formation on the prosthesis surface is a key factor in the pathogenesis of IPP infections, making prevention critical.¹ Current guidelines from urological associations provide recommendations, though some variations exist, for instance, regarding the duration of antibiotic coverage or the inclusion of antifungal agents in specific high-risk scenarios.¹
Clinical Context
Penile prosthesis infection prophylaxis is a critical consideration in all patients undergoing IPP implantation for severe erectile dysfunction.¹&⁻³ The incidence of infection after primary IPP surgery is generally low, reported to be around 1-3%, but can increase significantly in revision surgeries (up to 7-21%) or in patients with specific risk factors.¹&⁻³
Patient Selection and Risk Factors:
Key patient-related risk factors that necessitate careful prophylactic measures include uncontrolled diabetes mellitus (especially with HbA1c > 8.5%), obesity, immunosuppression, smoking, advanced age (>75 years), prior pelvic radiation, spinal cord injury, and positive HIV status.¹&⁻³ Optimization of these comorbid conditions preoperatively is an important prophylactic step.²
Surgical Procedures and Prophylactic Measures:
Prophylaxis spans the entire perioperative period:
- Preoperative: This includes treating any existing systemic, cutaneous, or urinary tract infections.¹ Patient optimization, such as glycemic control, is advised, though strict HbA1c cutoffs are debated.² Surgical field preparation using chlorhexidine-based solutions has shown superiority over iodine-based solutions for skin antisepsis.² Appropriately selected systemic perioperative antibiotics, administered prior to surgical incision, are crucial.²
- Intraoperative: Meticulous surgical technique is paramount. The “no-touch” technique, which minimizes direct contact between the prosthesis and the patient’s skin, significantly reduces infection risk.² The use of antibiotic-coated or hydrophilic-coated prostheses is another important intraoperative measure.² Operative time should be minimized, as longer durations are associated with increased infection risk.¹ High surgeon and hospital case volumes have been linked to lower infection rates, suggesting experience plays a role.³
- Postoperative: The role of extended postoperative antibiotic administration is less clear, with some evidence suggesting it may not significantly reduce infection rates beyond the initial perioperative coverage.² However, guidelines vary on this aspect.¹
Expected Outcomes:
Effective prophylaxis aims to maintain a low infection rate, ensuring the long-term success and functionality of the penile prosthesis and preserving patient quality of life.¹ Successful prevention avoids the need for complex salvage procedures or device explantation, which carry higher risks and lower success rates, particularly for fungal infections.¹