Nelson Bennett Jr., MD
BASICS
DESCRIPTION
• While generally very reliable, penile prostesis can become infected, undergo extrusion and suffer form mechanical failure.
• 2 types of penile prosthesis, malleable (semirigid, noninflatable, nonhydraulic) and inflatable. Inflatables consist of 2-piece (pump and cylinders) and 3-piece (pump, cylinders, and reservoir).
• Implanted via suprapubic or penoscrotal approach.
• Meticulous sterility is required.
• Infections of any or all parts of the device components require removal of the entire device.
• Extrusion/erosion of the device may occur into or through the urethra, penile glans, proximal crura, bladder or bowel, or adjacent vascular structures.
• Mechanical breakdown may manifest as inability to inflate/deflate device, abnormal erectile morphology, or auto inflation.
EPIDEMIOLOGY
Incidence
N/A
Prevalence
• Overall infection rate: 1–8%
• Prosthesis revision infection rate: 10–13%
• Prosthesis revision through infected field infection rate: 18%
• Mechanical failure rate 2-piece: 5% @ 5 yr
• Mechanical failure rate 3-piece: 18% @ 15 yr
RISK FACTORS
• Infection: Diabetes, spinal cord injury, previous penile prosthesis, immunocompromised state, h/o UTI, obesity
• Extrusion/erosion: Previous surgery, previous pelvic radiation, penile fibrosis, aggressive dilation, lack of surgical experience, Peyronie disease, previous penile prosthesis, upsizing of cylinders
• Mechanical failure: Inadequate dilation of reservoir space
Genetics
N/A
PATHOPHYSIOLOGY
• Infection
– 1–8% this percentage increases with number of revision surgeries
– Most common bacteria – Staphylococcus epidermidis
– Other bacteria: MRSA, Pseudomonas, Enterococcus, Prevotella, Morganella
– Gram-negative bacteria may be associated with rapid infection
– Biofilm plays important role in bacterial adherence and infection
• Extrusion/erosion
– Erosion through skin is inherently infected
– Pre-existing infection may hasten erosion
– Iatrogenic-facilitated erosion may result from overaggressive dilation
• Malfunction
– Mechanical failure rates are 15% at 5 yr and 30% at 10 yr
– Common reasons include aneurysm, tubing breakage, reservoir leakage, and connector failure
– Auto inflation is usually due to improperly positioned reservoir
ASSOCIATED CONDITIONS
• Conditions associated with erectile dysfunction
– Adrenal disorders
– AIDS-associated neuropathy
– Alzheimer’s
– Cardiac arterial disease
– CNS infections
– CNS tumors
– Diabetes mellitus (Type I and II)
– History of kidney or liver transplant
– History of myocardial infarction
– History of prostatectomy, cystectomy, or colectomy
– Hyperprolactinemia
– Hypertension
– Hyperthyroidism
– Hypogonadism
– Hypothyroidism
– Liver failure
– Multiple sclerosis
– Peripheral vascular disease
– Renal failure
GENERAL PREVENTION
• The preoperative assessment should include issues such as the patients’ needs and expectations of the device (1,2)
– Issues such as complications and the irreversibility of the procedure should be exhaustively discussed and documented through informed consent
• Infection
– Ensure UTI or infectious skin rash is absent
– Tight control of serum glucose and HbA1C
– Preoperative parenteral antibiotic of vancomycin + aminoglycoside or imipenem
– Meticulous adherence to sterile technique
– Limit OR traffic
– 10-min scrub of operative area
– 10-min scrub for OR staff
– Use of alcohol-based solution for final prep
– Avoid having prosthesis contact skin
– Use antibiotic-coated/antibiotic dripped prosthesis (3)
Postoperative oral antibiotics 7–10 days postoperatively
• Extrusion/erosion
– Avoid aggressive corporal dilation
– Avoid upsizing of cylinders
– Avoid early/premature inflation of device
• Malfunction
– Place corporotomy closing sutures before device insertion to avoid iatrogenic puncture
– Demonstrate proper function and placement of the device prior to conclusion of surgery
DIAGNOSIS
HISTORY
Assess for fever, chills, pain, lethargy, fatigue, change in bowel or bladder function, dysuria, frequency, urethral discharge.
PHYSICAL EXAM
• Assess penis/scrotum for erythema, edema, induration, pain in palpation of penis/scrotum, presence of wound drainage, adherence of prosthesis components to skin.
• Erosion/extrusion of device through glans, urethral meatus, scrotal skin, or perineum.
• Assess functionality of device by inflation/deflation—if suboptimally rigid or deflated pump, consider fluid leak.
• Assess penile contour/morphology upon inflation:
– Buckling of cylinder or S-shaped deformity suggests oversizing of cylinders.
– Floppy glans (SST deformity) suggests undersized cylinders or inadequate corporal dilation.
DIAGNOSTIC TESTS & INTERPRETATION
Lab
• Urinalysis
• Urine culture and sensitivity
• CBC with differential
• Metabolic profile
• Erythrocyte sedimentation rate
Imaging
• Usually not necessary
• Ultrasound scrotum—may reveal abscess
• MRI (with device inflated)—useful in assessment of corporal abnormalities.
Diagnostic Procedures/Surgery
Cystourethroscopy may reveal urethral erosion of cylinders or erosion of device component into bladder.
Pathologic Findings
N/A
DIFFERENTIAL DIAGNOSIS
• Intraoperative complications (4)
– During corporal body dilation: Urethral perforation, cross over perforation of opposite crura during dilation
– Reservoir position: Bladder perforation or improper positioning during the implant procedure
– Component failure: Check device function before implantation; careful technique to avoid cylinder injury during corporal body closure
• Postoperative complications:
– Infection
– Erosion (oversized cylinder): Often associated with pain and buckling
– Undersized cylinder (“concorde deformity” or “floppy glans”) whereby there is excess mobility of the glans
– Cylinder aneurysm
– Fluid leak
– Auto inflation/inability to deflate or inflate
TREATMENT
GENERAL MEASURES
• Broad-spectrum antibiotic should be started if infection is suspected.
• If sepsis is present, resuscitation is indicated prior to explanation of prosthesis.
MEDICATION
First Line
• AUA guidelines recommend the following antibiotic prophylaxis at the time of implantation (See Additional Reading)
– Aminoglycoside (or aztreonam with renal insufficiency) plus
– 1st/2nd-generation cephalosporin or vancomycin
– Alternative regimens include:
Ampicillin/Sulbactam
Ticarcillin/Clavulanate
Piperacillin/Tazobactam
Second Line
N/A
SURGERY/OTHER PROCEDURES
• Infection
– Removal of prosthesis may be completed on a semiurgent basis (within 24 hr)
– Immediate prosthesis salvage (replacement) may be possible in absence of frank purulence, erosion, necrotic tissue, poorly controlled diabetes, immunosuppression
– Mulcahy protocol for prosthesis salvage (4):
1. Antibiotic solution (1 g vancomycin and 80 mg gentamicin in 1 L of normal saline)
2. ½ strength hydrogen peroxide
3. ½ strength betadine
4. Pressure washing with 1 g vancomycin and 80 mg gentamicin in 5-L irrigation
5. ½ strength betadine
6. ½ strength hydrogen peroxide
7. Antibiotic solution
8. Change instruments, gowns, drapes, and gloves immediately before prosthesis insertion
• Extrusion/erosion
– Proximal erosion/extrusion managed by affixing RTE to the interior, proximal corpora with permanent suture
– Alternatively, placing a purse-string suture in the corpora at tubing exit site
– Distal extrusion/erosion (urethral) is best managed by immediately removing offending cylinder and prolonged Foley drainage. If contralateral cylinder has been placed, it may remain in place
• Malfunction
– Floppy glans: Perform corporoplasty to reposition glans or dilate distal corpora
– Cylinder aneurysm: Replace device
– Fluid leak: Replace device
– Auto inflation: Reposition, incise fibrotic capsule, or replace reservoir
ADDITIONAL TREATMENT
Radiation Therapy
N/A
Additional Therapies
N/A
Complementary & Alternative Therapies
N/A
ONGOING CARE
PROGNOSIS
• Prosthesis satisfaction rates approach 95% for patients and partners
• Satisfaction rates for revision surgery is ∼80%
• Infection rates have decreased with antibiotic coated or antibiotic dipped prosthetics
COMPLICATIONS
• Revision surgery may result in infection, extrusion/erosion, or malfunction
• Delay replacement of device may result in corporal fibrosis
FOLLOW-UP
Patient Monitoring
• In case of revision surgery, prolonged antibiotic treatment may be required.
• Biweekly follow-up is indicated until patient is cleared to use the device.
Patient Resources
AUA Foundation. http://www.urologyhealth.org/urology/index.cfm?article=11
REFERENCES
1. Akin-Olugbade O, Parker M, Guhring P, et al. Determinants of patient satisfaction following penile prosthesis surgery. J Sex Med. 2006;3(4):743–748.
2. Bettocchi C, Ditonno P, Palumbo F, et al. Penile prosthesis: What should we do about complications? Adv Urol. 2008;573560. Published online 2008 November 4.
3. Wilson SK, Salem EA, Costerton W. Anti-infection dip suggestions for the coloplast titan inflatable penile prosthesis in the era of the infection retardant coated implant. J Sex Med. 2011;8(9):2647–2654.
4. Mulcahy JJ. Penile prosthesis infection: Progress in prevention and treatment. Curr Urol Rep. 2010;11(6):400–404.
ADDITIONAL READING
• Best Practice Policy Statement on Urologic Surgery Antimicrobial Prophylaxis (2008). http://www.auanet.org/education/guidelines/antimicrobial-prophylaxis.cfm (updated February 2012. Accessed January 3, 2014)
• Bennett NE, Mulhall JP. Complication of surgery for erectile dysfunction and peyronie’s disease. In: Taneja SS, ed. Complications of Urologic Surgery Prevention and Management. 4th ed. Philadelphia, PA: Saunders Elsevier; 2010.
See Also (Topic, Algorithm, Media)
• Erectile Dysfunction (ED)
• Penile Prosthesis, Models and Descriptions
• Penile Prosthesis Problems (Infection/Extrusion/Malfunction) Images 
CODES
ICD9
• 996.39 Other mechanical complication of genitourinary device, implant, and graft
• 996.69 Infection and inflammatory reaction due to other internal prosthetic device, implant, and graft
• 996.76 Other complications due to genitourinary device, implant, and graft
ICD10
• T83.6XXA Infect/inflm react d/t prosth dev/grft in genitl trct, init
• T83.89XA Other specified complication of genitourinary prosthetic devices, implants and grafts, initial encounter
• T83.420A Displacement of penile (implanted) prosthesis, initial encounter
CLINICAL/SURGICAL PEARLS
• Meticulous sterility is required during the implant in the operating room.
• Infections of any or all parts of the device components require removal of the entire device.
• Extrusion/erosion of the device may occur into or through the urethra, penile glans, proximal crura, bladder or bowel, or adjacent vascular structures.
• Mechanical breakdown may manifest as inability to inflate/deflate device, abnormal erectile morphology, or auto inflation.