Penile Prosthesis Complications: Planning, Prevention, and Decision Making

REVIEW

Penile Prosthesis Complications: Planning, Prevention, and Decision Making Nickolas D. Scherzer, BS, Brian Dick, BS, Andrew T. Gabrielson, BA, Laith M. Alzweri, MD, and Wayne J. G. Hellstrom, MD

ABSTRACT

Introduction: Inflatable penile prosthesis (IPP) is an established treatment option for men with erectile dysfunction (ED) refractory to medical therapy. Standardization of surgical technique and improvements in device construction have reduced all-cause complication rates to less than 5% in recent reports. Nonetheless, complications do exist, and can strongly impact morbidity and the quality of life of patients. Prosthetic urologists must be aware of the constellation of complications that can arise during or after IPP placement. Aim: To provide a comprehensive review of penile prosthesis complications and discuss preventative strategies, as well as proper preoperative, intraoperative, and postoperative decision making. Methods: A review of the available literature from 1973 to 2018 was performed using PubMed with regard to IPP complications. Main Outcome Measures: We reviewed publications that outlined preoperative planning strategies and the following IPP complications: hematoma, floppy glans, corporal fibrosis, corporal perforation and crossover, urethral injury, infection, impending erosion, and glandular ischemia. Results: Careful patient and device selection, setting realistic expectations of postsurgical outcomes, and adherence to a perioperative checklist is essential in the preoperative period. Intraoperatively, anticipate corporal fibrosis situations and always dilate laterally during corporal passage to reduce the risk of crossover and urethral injury. Limit perioperative antiplatelet therapy, apply compressive dressing, use a closed suction drain if indicated, and leave the device partially inflated postoperatively to reduce risk of hematoma. After surgery, monitor patients for potential complications that may warrant device explantation or salvage: IPP infection, glans ischemia, and impending erosion. Conclusions: By using evidence and expert opinion-based decision-making strategies in the preoperative, intraoperative, and postoperative period of IPP placement, surgeons can reduce the risk of complications and dissatisfaction, even in ED patients with multiple comorbid conditions. Scherzer ND, Dick B, Gabrielson AT, et al. Penile Prosthesis Complications: Planning, Prevention, and Decision Making. Sex Med Rev 2018;XX:XXXeXXX. Copyright
2018, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

Key Words: Penile Prosthesis; Complications

INTRODUCTION Inflatable penile prosthesis (IPP) is the established treatment option for erectile dysfunction (ED) refractory to medical therapy, with more than 20,000 implants performed each year in the United States.1 Given that the prevalence of ED correlates with advancing age, increasing life expectancies have expanded the Received February 19, 2018. Accepted April 11, 2018. Tulane University School of Medicine, Department of Urology, New Orleans, LA, USA Copyright ª 2018, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved. https://doi.org/10.1016/j.sxmr.2018.04.002

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pool of men who can benefit from an IPP.2 The first prototype of a penile prosthesis was constructed by Ambroise Parè in the 16th century (Figure 1). Parè created an artificial penis using a wooden pipe to facilitate micturition from the standing position in a patient with traumatic penile amputation. Although not intended for facilitating sexual intercourse, it is considered the earliest iteration of a penile prosthesis.3 An autologous penile implant specifically designed to simulate an erection was performed by Russian surgeon Nikolaj A. Bogaraz in 1936 using a patient’s rib cartilage. The first report of an inflatable penile implant was published in 1973 by Scott et al.4 Since that time, penile prosthesis has evolved from the semi-rigid implant and 1-piece inflatable prosthesis to the modern 2- and 3-piece inflatable 1

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device. Today, IPP is currently the gold standard treatment for patients with ED refractory to lifestyle, oral, injectable, and other device-assisted modalities. In addition to ED that is nonresponsive or contraindicated to medical therapy, IPP is indicated for post-pelvic surgery ED, severe Peyronie’s disease (PD) with concomitant ED, and neophallus. Potential complications of IPP include, but are not limited to, infection, hematoma formation, floppy glans, corporal fibrosis causing difficulty with implantation and penile deformity, proximal and distal corporal perforation, device crossover, urethral injury, erosion, and glandular ischemia. Complications have been reported in fewer than 5% of cases, in part due to standardization of surgical technique and improvement in device construction.5 Proper planning, including cost, patient, and prosthesis selection, and surgeon preference are important considerations. Penile implants are extremely effective, with a high level of patient and partner satisfaction, and generally require only a one-time fee for the procedure. However, IPP implantation is still an invasive surgery, and the incidence of complications in the perioperative and postoperative setting are important for the urologist to consider. In addition, patients must be made aware that the implant will not restore spontaneous or natural erections but rather allow for reversible tumescence to allow sexual intercourse.6 Patient and partner satisfaction has been documented to be between 82% and 97%, and the overall survival rate of the IPP at 5, 10, and 15 years is 89.1%, 71.4%, and 60.5%, respectively.7,8 The aim of this review is to provide an evidenceand expert opinionebased overview of preoperative prevention strategies, intraoperative decision making when recognizing an evolving complication, and postoperative interventions considered in IPP placement.

PREOPERATIVE STRATEGIES AND PLANNING As stated in the Introduction, IPP is indicated for patients with severe ED refractory to medical therapy (first- and secondline options are vacuum erection devices and intracavernosal injection therapy), but it can also be offered to patients who have failed or have contraindicated phosphodiesterase type 5-inhibitor therapy and do not wish to try the second-line options. It is also recommended to obtain objective evidence of ED using duplex ultrasonography when the diagnosis is in doubt. Preoperative counseling is essential to limit unrealistic expectations, boost postoperative satisfaction, and inform patients of possible complications.5 It is critical to identify patients with preexisting psychosocial variables that can negatively affect operative success and long-term satisfaction.9 These patients are at greater risk for postoperative dissatisfaction. Physicians must also set realistic expectations about becoming a better lover and for penile length after surgery. The implanted phallus, in general, will be longer than before surgery in the deflated state, and shorter than before surgery in the inflated state.10 More than 70% of patients endorse a loss in length, even in the absence of measurable

Figure 1. Schematic of the first penile prosthesis prototype constructed by Ambroise Paré in the 16th century.

evidence.11 This perception may be related to lack of glans engorgement after prosthetic implantation, acquisition of infrapubic adiposity, or a distorted recollection of youthful potency. Preoperative stretched length provides a realistic expectation for postoperative results.12 It is helpful to clearly document this measured length for future reference. Recent evidence has suggested that patients with certain comorbidities (eg, uncontrolled diabetes mellitus, immunosuppression, and spinal cord injuries) have a greater risk of complications, especially infection and erosion.13 A penile implantation checklist has been proposed by Masterson et al,14 and it consists of medical evaluation, 2 days preoperative prophylactic measures, and day-of surgical considerations (Table 1). Although most physicians in the United States opt for the gold standard 3-piece IPP, varying types of penile prosthesis are used for specific indications. A malleable, non-inflatable prosthesis is sometimes recommended for salvage surgery after infection, and is occasionally used for its low cost, simplicity of implantation, and ease of use for patients without the manual dexterity necessary to operate an IPP pump. For PD, girth-expanding CX cylinders have better penile straightening properties than girthand length-expanding LGX cylinders (Boston Scientific, Marlborough, MA, USA). Therefore most authorities recommend the use of CX cylinders for 3-piece AMS 700 series IPP implantation in men with PD.15 Nevertheless, LGX is known to have less axial rigidity than the classical CX model. Similarly, excellent functional outcomes after using the Titan IPP (Coloplast, Minneapolis, MN, USA) for PD have been reported. For patients with severe fibrosis, the AMS CXR/narrow base and Coloplast narrow base are both excellent choices in these difficult circumstances. For patients with large and wide penises, the Coloplast Titan is suggested to be the preferred choice in order to achieve significant girth expansion.16 The choice of the implant used is decided on a case-by-case basis by the operating surgeon and represents an amalgam of considerations: indication for implant, availability and cost of the implant, the surgeon’s experience, and the Sex Med Rev 2018;-:1e11

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Table 1. Checklist for penile implant surgery14 Preoperative

2 days prior to surgery Day of surgery

Cardiology/medical clearance Urine culture Optimize HbA1c in diabetic patients Stop antiplatelet meds 7 days prior Oral antibiotics Hibiclens scrub twice a day Wash with soap and water Perioperative antibiotics: gentamicin and vancomycin, or a second-generation cephalosporin Hair removal: clippers and razors Chlorhexidine scrub prep

patient’s preferences and goals. To date, there is no high-quality evidence to support the superiority of one model over the other. All available penile prosthesis models can be the best implant when used in properly selected patients with the appropriate indication. Preoperative strategies are summarized in Table 2.

INTRAOPERATIVE COMPLICATIONS Hematoma Formation Hematoma formation after surgery typically develops in the scrotum, since it is a dependent organ and allows for blood and fluid to collect.17 It is usually evident in the immediate postoperative period when adequate hemostasis has not yet been achieved. The overall incidence ranges from 0.2% to 3.6% of penile prosthesis implantations.17 A combination of postoperative compressive dressing in conjunction with partial device inflation has been used in studies in an attempt to achieve hemostasis and prevent hematoma formation. In 1 study, the application of a compressive dressing alone resulted in a hematoma complication rate of 2.9%. Incorporating closed suction drainage and partial device inflation in addition to compressive dressing led to a statistically significant decrease in hematoma complication rate to 0.9% (P ¼.009).17e19 It is also important to hold anticoagulation therapy after surgery and limit physical

activity for 1 to 2 weeks, because delayed hematoma formation has been associated with these factors.20 Drain placement has not been associated with an increased risk of infection.21

Floppy glans Glans hypermobility is often due to inadequate prosthetic cylinder sizing or positioning, causing insufficient compression of the deep dorsal and circumflex veins between Buck’s fascia and the corpora cavernosa. Anatomic variation in patients can contribute to this phenomenon, because the corpora do not always extend the full distance into the glans region. Furthermore, some patients have underlying poor glandular support due to laxity of the corpora-glans ligament.17 Choosing a cylinder that is undersized can also cause the glans to be hypermobile dorsally, ventrally, laterally, or in multiple directions upon device inflation.22 When it occurs ventrally, it is sometimes referred to as the “supersonic transport (SST)” deformity because of its resemblance to the Concord aircraft.22 Glans hypermobility is more common in uncircumcised patients.23 The incidence of glans hypermobility and the SST deformity has been reported in up to 5% of patients undergoing penile prosthesis placement.17,24 Often, this defect will correct on its own due to normal healing and capsule formation. However, surgical correction may need to be considered if the patient has persistent complaints. To correct the defect, a hemi-circumcisional incision is made opposite to the direction of tilting. The glans is dissected from the distal tips of the corpora with the cylinders inflated. Care is taken to avoid damage to the neurovascular bundle and the cylinders. A permanent suture is placed in the glans tissue using a large curved needle and anchored to the distal tunica albuginea while being mindful to avoid puncturing the deflated cylinders. After each suture is placed, the sutures are tied to fix the floppy glans to the distal tunica, thereby correcting the problem.25,26

Corporal Fibrosis Corporal fibrosis, which refers to the replacement of smooth muscle cells with fibrotic tissue within the corporal bodies or

Table 2. Preventative Strategies Patient selection

1. 2. 3. 4. 5.

Optimize HbA1c in diabetic patients Cardiology/medical clearance Beware of psychosocial variables that can negatively affect operative success and patient outcomes Obtain urine culture Stop antiplatelet therapy 7 days prior

Device selection

1. 2. 3. 4.

Determine if patient preference for inflatable vs malleable Peyronie’s disease: Use Boston Scientific CX or Coloplast Titan Severe fibrosis: Use Coloplast or Boston Scientific narrow base devices Large and wide penis: Use Coloplast Titan

Informed consent

Inform and counsel patient and set realistic expectations about: 1. 2. 3. 4. 5.

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Size of erect penis Sensation changes Ejaculatory effects Postoperative pain Possibility of repeat operation for mechanical repair, failure, infection, or erosion

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tunica albuginea, is another potential finding that can complicate IPP placement. Milder cases of corporal fibrosis are typically observed in patients with a history of diabetes or previous intracorporal injection therapy. More severe cases are observed in patients with a history of ischemic priapism or who have had an infected IPP removed without immediate replacement—the latter being less common, because it is now accepted to remove an infected prosthesis, wash out the area, and implant a new device in the same operation as a salvage procedure.17,27 Patients with PD vary in amount of fibrotic tissues depending on how far the disease has progressed. Corporal dilation in the setting of corporal fibrosis requires increased effort to break through the effect of the fibrotic plaque(s), thereby increasing the likelihood of perforation.28,29 Multiple corporotomies and excavation were traditionally performed to remove fibrotic tissue from the tunica albuginea, but the 1-year prosthesis survival rate with this technique has been reported to be only 50%.30 In 1999 a single/multiple small incision technique was tested by Rajpurkar et al31 and found to be complication free in 97% of patients.32 A preferred technique uses cavernotomes (Carrion-Rossello, Minneapolis, MN, USA), a rasping tool that allows surgeons to tunnel through corporal tissue with a twisting motion. Uramix (Lansdowne, PA, USA) produces double-bladed cavernotomes with linear blades that are good for creating an initial channel through the corpora.27 Carrion-Rossello cavernotomes have a smooth zone and a cutting zone with 10 pointed edges and carving grooves. The Carrion-Rosello cavernotome is inserted into the channel (formed by the Uramix model), with its smooth edge facing medially to avoid inadvertent urethral injury. The channel is dilated with an inward-outward movement.33 Progressively larger cavernotomes are used until a large enough tunnel is created to accommodate an implant. In cases of severe corporal fibrosis, a downsized implant may be then selected. Although these smaller implants may cause a loss of penile length and girth, they expand the tunnel over time and can allow for implantation of a regularsized prosthesis if needed in the future.34 In addition to being prone to fibrotic buildup from the plaque, a patient with PD may show substantial curvature after placement of the IPP. Once inserted, IPPs need to be inflated to check for residual penile curvature. According to a study involving 36 patients, Mulhall et al30 found that all patients with < 30 of preoperative curvature had complete resolution of curvature with implantation and inflation of an IPP. Of patients with > 45 of preoperative penile curvature, 86% required additional intervention to resolve curvature adequately.33 Manual modeling, plication, and plaque-releasing incisions are 3 techniques of increasing invasiveness that surgeons can use to resolve residual curvature. Manual modeling is the bending of the penis contralateral to the natural bend after the insertion and inflation of the IPP device. Wilson et al35 performed this technique in 138 patients

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with a success rate of 86%; urethral perforations occurred in 3% of patients. Plication is an alternative to manual modeling and can be done before or after IPP insertion. The penis is shortened via an imbricating procedure on the contralateral side to the bend, resolving the curvature. It carries less risk of urethral injury, but 73% of patients experience penile shortening.36 Patients with severe fibrotic buildup or a preoperative curve >60 will often require incisions through fibrotic plaques to resolve curvature. The IPP is inserted and inflated, the tunica albuginea is exposed, and electrocautery is used to incise the area of maximum curvature until the erect penis is adequately straight.37 If incision results in tunical defects >2 cm, a graft is recommended to lower the risk of cicatrix contraction or cylinder herniation.38

Corporal Crossover and Perforation Corporal crossover, as well as proximal and distal corporal perforations, are relatively common complications during IPP placement in the setting of fibrotic corpora. Corporal crossover typically occurs during corporal dilation or cylinder placement. When crossover occurs, the contralateral cylinder can be perforated by the Keith needle during placement of the ipsilateral cylinder.26 To prevent this, both Keith needles should be placed into their position through the glans before placing the cylinders. It is also important to direct initial dilation of the corpora laterally and proceed gradually.26 Mooreville et al26 positioned 16 IPP placements into fibrotic corpora using cavernotomes and reported a 31% intraoperative, proximal perforation rate and a 25% postoperative, distal perforation rate. Proximal perforation can be identified as a sudden loss of resistance while vigorously dilating the proximal corpora. To confirm, the surgeon can perform a “field goal” test in which dilators are inserted into the proximal corpora and used to measure length (Figure 2).36 There is some minor anatomic variation in proximal corporal length but differences >1 cm are highly suggestive of a perforation.34 Once identified, a proximal perforation can be treated by inserting corporotomy sutures above and below the outlet tubing in addition to a rear tip extender sling or windsock patch to prevent proximal migration of the implant (Figure 3).22,33 The unaffected corpora should be used to size the implant, and the surgery can be continued as usual.39 Leaving the device deflated for 6 weeks allows the area to fibrose over and provides preserved corporal stability for the prosthesis. Distal corporal perforations are a more serious complication due to the risk of urethral injury. If a distal perforation occurs during dilation of the initial side, the surgery should be aborted and performed at a future date. If it occurs during placement of the implant on the other side, the previously placed cylinder is left in place and may provide enough rigidity for patient satisfaction.33 Otherwise, the contralateral removed cylinder can be placed at a later date. To check for urethral injury caused by a distal perforation, a “distal fluid challenge test” may be performed. Irrigation fluid is flushed into

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Figure 2. Demonstration of the “field goal” test, in which dilators are inserted into the proximal corpora and their lengths are compared. Panel A shows equal proximal corporal length. Panel B shows discordance in exposed dilator lengths in the setting of proximal perforation.

the affected corpora and the surgeon checks for fluid passing around the urethral catheter and out the tip of the penis.23

Urethral Injury Urethral injury is a rarer complication of IPP. Rates of urethral perforation have been reported to be between 0.1% and 4.0%.40 To avoid urethral injury by crossover through the septum, it is important to stay as lateral as possible when performing dilation of the corpora. Other causes are inadequate protection of the glans, oversized cylinder, and whether vigorous modeling is performed. If the distal urethra is perforated, the case is aborted. As previously stated, the surgeon may leave 1 cylinder in place if already present. Alternatively, as described by Anele et al, 41 the urethra can be directly repaired, bilateral cylinders inserted, and urine diverted with a suprapubic cystostomy for 4 to 8 weeks before the prosthesis is activated. An injured urethra should be repaired over a Foley catheter. The follow-up procedure can be rescheduled after 6 weeks.42 Proximal or mid laceration of the urethra during scrotal exposure can be directly repaired, and insertion of the prosthesis may continue. Care must be taken to

avoid contacting the suture lines when closing the urethral and tunical defects because of the chance of fistula and infection developing.26 In rare cases, the surrounding tissues or structures can be damaged.

Bladder, Vascular, and Bowel Injury If blood is found in the catheter, cystoscopy ± cystogram is performed to assess for potential bladder injury or disruption of the urethra. To reduce the risk of bladder injury, always completely drain the bladder fully before attempting reservoir placement. If a fibrotic pelvis, mesh graft, or pelvic transplant exists, a submuscular placement of the reservoir or use of a 2-piece IPP to circumvent this potential problem may be considered.34 In the case of bladder injury, it is recommended to perform an immediate 2-layered repair, with contralateral or ectopic placement of the reservoir.22 If the vasculature is injured, apply direct pressure and hemostatic/packing agents, extend the incision, and immediately consult vascular surgery.22 If the bowel is injured, abandon the implantation procedure, and consult general surgery. The implantation procedure can be safely reattempted after full

Figure 3. A proximal perforation treated by inserting corporotomy sutures above and below the outlet tubing in addition to a rear tip extender sling or windsock patch to prevent proximal migration of the implant. Sex Med Rev 2018;-:1e11

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Table 3. Intraoperative Decision Making Hematoma formation

1. Ensure antiplatelet therapy is discontinued 7 days pre-op 2. Apply compressive dressing to scrotal area in operating room 3. Incorporate closed suction drain if indicated

Floppy glans

1. Ensure cylinder is correct size 2. If surgical correction is warranted, perform glanspexy

Corporal fibrosis

1. Take special care in patients with history of ischemic priapism, Peyronie’s disease, diabetes, or previous history of intracorporal injection therapy 2. Utilize Carrion-Rossello cavernotomes 3. Perform manual modeling, plication, or incision and grafting in Peyronie’s disease with greater than 30 curvature present after device inflation

Corporal Crossover and Perforation

1. Perform “field goal” test to confirm proximal perforation 2. Place Keith needles through glans before placing cylinders. Initial dilation should be done gradually and directed laterally 3. Repair with corporostomy sutures above and below the outlet tubing in addition to a RTE sling or windsock patch to prevent proximal migration of the implant 4. Abort surgery if distal perforation, perform distal fluid challenge test to assess for urethral injury

Urethral injury

1. Important to stay as lateral as possible when dilating the corpora 2. Close proximal or mid urethral injury directly and proceed with implant 3. Abort procedure, or in special circumstances repair distal injury and place suprapubic cystostomy for 4e8 weeks before activating implant

Bladder, vascular, and bowel injury

1. Always drain bladder prior to reservoir placement to reduce risk of bladder injury 2. If bladder is injured, perform immediate 2-layered repair. Contralateral or ectopic placement of reservoir is recommended 3. If vascular injury, apply direct pressure and hemostatic agents. Consult vascular surgery 4. If bowel is injured, abandon procedure and consult general surgery

RTE ¼ rear tip extender.

recovery of the bowel, bladder, or urethral injury.38 Intraoperative challenges and solutions are summarized in Table 3.

POSTOPERATIVE COMPLICATIONS Infection The risk of infection with a primary implant ranges between 1% and 4%.40 However, spinal cord injuries, IPP revision surgery, penile reconstruction, and patients receiving long-term steroids have an increased risk of infection.43e45 Patients with a spinal cord injury are at higher risk of infection because they are more prone to development of a urinary tract infection associated with their neurogenic bladder.46 The risk of infection is also positively correlated with length of surgery.47 Therefore revision (mean time 110 minutes) and penile reconstruction (mean time 255 minutes) confer an increased infection risk over a primary implant (mean time 98 minutes).47 Transplant recipients on immunosuppressive therapy must be evaluated with the criteria of Barry48 before IPP, which consists of stable graft function for >6 months, avoidance of intraabdominal reservoir, and low-dose immunosuppression. There has been much debate over the infection risk in diabetic patients. Wilson et al49 noted an 8.7% infection rate in diabetic patients versus 4% in non-diabetic patients, but no correlation between infection and HbA1c or fasting sugar levels was found. However, Christodoulidou and Pearce50 performed a systematic review examining the rate of IPP infections in patients with diabetes mellitus. Their findings revealed no statistically significant increase in the risk of infection in patients with diabetes

mellitus.40,50 Nonetheless, most authorities require diabetic control before surgical intervention with prosthetics. The most common organism implicated in infection has traditionally been Staphylococcus epidermidis, because skin flora can be introduced during the operation. In recent years, gram negatives, anaerobes, and fungal organisms are becoming more commonly implicated, mainly with increased body mass index and diabetes (3 times increased risk).51e53 In a 2017 series by Gross et al,54 227 intraoperative cultures were obtained during salvage or explantation surgery. No culture growth was noted in 33% of cases, and gram-positive and gram-negative organisms were identified in 73% and 39% of positive cultures, respectively. Candida species (11.1%), anaerobes (10.5%), and methicillin-resistant Staphylococcus aureus (9.2%) constituted nearly one third of 153 positive cultures. Multi-organism infections occurred in 25% of positive cultures.54 To prevent infection, the following preoperative steps are implemented: i) the surgeon must ensure negative urine cultures; ii) bathe the genital region with strong antiseptic soap; iii) shave the pubic hair in the OR after induction; and iv) use a chlorhexidine-alcohol skin preparation (associated with a 40% lower surgical-site infection rate than traditional povidone-iodine preparation).55 The following perioperative steps can be taken to prevent infection: perioperative intravenous (IV) antibiotics starting 1 hour prior to incision and continuing up to 24 hours in the postoperative period. American Urological Association (AUA) guidelines recommend gentamicin and vancomycin; however, gentamicin and a second-generation cephalosporin may Sex Med Rev 2018;-:1e11

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Table 4. Postoperative Complications Postoperative Complications Infection

1. Proper patient selection: a) Optimize HbA1c in diabetic patients b) Transplant patients on immunosuppressive therapy at higher risk. Lower immunosuppressive dose if possible c) Spinal cord injury patients higher risk due to neurogenic bladder leading to urinary tract infection (UTI). Resolve any UTI before surgery 2. Limit duration of surgery and operating room traffic 3. Employ “no-skin touch” concept as much as possible 4. Use antibiotic-impregnated hydrophilic-coated implants 5. Perform frequent irrigation of field with antibiotic solution 6. At the start of a clinical infection, attempt course of antibiotics 7. If surgery is indicated, perform explantation or Mulcahy salvage procedure

Impending Erosion

1. More likely when urethra is violated during surgery and in patients with a spinal cord injury 2. Device must be explanted or salvage procedure performed

Glandular Ischemia

1. Due to interruption of normal blood supply 2. Be on the lookout for a “dusky glans” on post-operative day 1 3. Treat with immediate prosthesis removal

be used in the case of resistant Enterococcus species. Urethral catheterization is also recommended. During surgery, the “noskin touch” technique has been demonstrated to decrease infection risk to 0.7% as compared with 2.2% in the control group.56 Frequent irrigation of the field with an antibiotic solution of rifampin or bacitracin and gentamicin can also be performed. After surgery, no antibiotics are given beyond 24 hours of surgery because studies suggest that most infectious agents are introduced during the operation. In addition, the surgery should be performed as day surgery with same-day admission and discharge on the same day or on the first postoperative day, because increased hospital stay is associated with the development of infections with more virulent organisms. Implant coatings have also decreased the infection rate. The inhibiZone-coated AMS implants (Minnetonka, MN, USA), consisting of rifampin and minocycline, reduced infection rates to 1.77% in comparison to 3.09% in noncoated implants.57,58 In addition, soaking hydrophilic polyvinylpyrrolidone (Coloplast) implants in various antibiotic solutions reduced infection rates. A significant reduction in the incidence of implantassociated infection was observed when a series of surgeries using the hydrophilic-coated Titan implants (1.06%) was compared with a group of non-hydrophilic-coated a1 implants (2.07%).59,60 John et al60 found that, by investigating the in vitro antibacterial activity of various tested mixtures, the best solution for soaking the Titan implant prior to insertion was rifampin 10 mg/mL and gentamicin 1 mg/mL.59,60 In the case of clinically apparent infection, a trial of antibiotics can be attempted. Parsons et al61 concluded that Ciprofloxacin 500 mg bid for 10 to 12 weeks had a 60% success rate in clearing an evolving infection. If pain improves with treatment, continue for 10 to 12 weeks. If pain returns on cessation of antibiotics or fails to resolve the infection, surgical intervention must be considered. If a patient presents with signs consistent with device infection, it is recommended that the patient be admitted to the Sex Med Rev 2018;-:1e11

hospital. If necessary, lance the scrotum, obtain cultures, and observe the patient for 48 hours while on broad-spectrum IV antibiotics.40 If the patient’s condition improves, the salvage procedure should be discussed. If the patient’s condition worsens, remove the prosthesis and begin therapy with a vacuum erection device for 20 minutes a day as soon as possible. If the patient is hemodynamically unstable, it is reasonable to leave the reservoir behind after implant removal and retrieve it once the patient’s condition stabilizes and a computed tomography scan is performed to localize the component. It is worth stressing that the reservoir should be retrieved when the patient is stable, because an abscess can form around the retained reservoir even in the distant future, when it may be challenging to find by another surgeon. In rare cases, if the patient is toxic and showing systemic signs such as high fever, positive blood culture, or diabetic ketoacidosis, urgent device explant is required.40 Complete removal and wash-out of the implant spaces with antiseptic solutions eliminates bacteria and their associated biofilm from the surgically created spaces. It is advisable for the surgeon to reinsert a prosthesis 3 to 6 months after removal to minimize the formation of corporal fibrosis. Often times, a remnant of the old corporal cavity can be found in the patient who has had his device removed for infection.40 In the case of a salvage procedure, the Mulcahy protocol, or a variant, is followed.62 Once the prosthesis and all foreign material are removed, the implant cavities are thoroughly irrigated with a series of antiseptic solutions. After the gloves, drapes, and instruments are changed, a new prosthesis is placed, and a course of oral antibiotics guided by reported microbial culture and sensitivities is prescribed after surgery. The Mulcahy salvage procedure has a reported success rate of 84%.62 The salvage procedure is contraindicated in septic patients, diabetic patients with severe ketoacidosis, significant necrotic tissue, rapidly developing infection, diabetes with significant virulence, and any cylinder extrusion.49

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Impending Erosion

DISCUSSION

Impending erosion can involve the distal lateral corpora, urethra, glans, and other nearby structures.40 Erosion has a reported incidence of 1% to 6%.63,64 Erosion is more likely to occur when the urethra is violated during surgery. It is more likely in patients with spinal cord injuries as a result of decreased or absent sensation masking the pain of impending erosion. In addition, many patients with spinal cord injuries are dependent on clean intermittent catheterization for bladder management; frequent passage of the catheter per urethra may place them at a higher risk of urethral erosion. In a cohort of 48 patients with spinal cord injury who underwent malleable prosthesis insertion, 2 patients (4.8%) suffered erosion, 1 each of urethral and glandular erosions, both requiring explantation of the device.40,64

Despite the widespread availability of safe and efficacious oral and injectable therapy, penile prosthesis continues to be the definitive solution for the treatment of organic ED refractory to medical therapy. The advent of advanced surgical techniques (ie, no-touch technique) and infection-resistant materials with enhanced longevity (ie, Parylene) has significantly reduced the likelihood of development of intraoperative and postoperative complications warranting revision surgery. Despite these advances, anatomic variation and concurrent comorbid conditions in properly selected patients can give rise to several notable complications of which the prosthetic surgeon should be cognizant.

In the case of erosion plus infection, the whole device must be explanted. In the case of ventrolateral or ventrodistal impending erosion, Mulcahy’s corporoplasty, which reseats the cylinder in a more medial and secure position under the glans penis by creating a new cavity for the cylinder behind the back wall of the fibrotic sheath, should be performed.43,65 If there is ventromedial impending erosion, manage it like a urethral injury.66

Glandular Ischemia Glandular ischemia is a dreaded postoperative complication of IPP surgery that may lead to penile gangrene and organ loss. Because very few cases have been reported, the incidence is difficult to determine.67 The patient often presents with a dusky glans on the first postoperative day. The cause of ischemia is likely due to an interruption of the blood supply to the glans through the dorsal penile arteries and corpus spongiosum muscle. Glandular ischemia has occurred with all types of prosthesis: malleable and 2- and 3-piece inflatable models.68e70 It is therefore not associated with any one specific device. The largest reported case series of glandular ischemia and necrosis was published by Wilson et al,71 involving 21 patients. Preoperative risk factors for glandular ischemia included atherosclerotic cardiovascular disease (90%), diabetes mellitus (81%), smoking (81%), previous prosthetic explantation (57%), and radiation therapy (48%). In patients with multiple risk factors, coincident subcoronal incisions, circumcision, or penile degloving (69%), distal urethral repairs (25%) and occlusive elastic penile bandages (50%) increase the risk of glandular ischemia and should be avoided. Most patients (17/21 or 81%) that were managed expectantly (observation and implant preservation) had significant glandular loss. 4 patients were managed with immediate prosthesis removal and healed without sequelae.71 Therefore immediate prosthesis removal is recommended in any case of glandular ischemia. Another case report conducted by Gómez et al72 supports this approach to managing glandular necrosis and highlights the importance of rapid action to remove the prosthesis to minimize necrosis. Postoperative complications are reviewed in Table 4.

In the preoperative setting, urologists can reduce the likelihood of encountering complications during the intraoperative and postoperative period by careful patient selection and proper counseling of postsurgical outcomes to set realistic expectations. Prosthetic surgeons need to be wary of offering implantation to patients with preexisting psychosocial variables who may exhibit unrealistic expectations or compulsive behavior or have concomitant psychiatric conditions. These patients are at a higher risk of dissatisfaction and less likely to be compliant with postoperative care. Physicians should routinely document preoperative penile measurements and set realistic expectations for penile length after surgery. The implanted deflated phallus will be longer than before surgery and shorter in the inflated state than before surgery, because a degree of corporal fibrosis and nanocapsule formation is inevitable with any surgical intervention involving the tunica albuginea. Determining the type of prosthesis to be implanted (IPP vs malleable) is done on a caseby-case basis, with emphasis placed on the indication, patient dexterity and preference, cost of the implant, and the surgeon’s experience and preference. For example, as demonstrated in the review by Oliver et al,73 a 2-piece prosthesis might be a better option for pelvic organ transplant recipients, seemingly because of the lack of reservoir placement. All available penile prosthetics can be the “best” prosthesis in the properly selected patient. In the intraoperative period, the physician needs to be vigilant about the potential for development of a scrotal hematoma, urethral injury, corporal perforation, and floppy glans. Holding anticoagulation therapy and reducing physical activity after surgery reduces the risk of scrotal hematoma formation. Corporal fibrosis must be taken into consideration after corporotomy to avoid corporal perforation. Milder corporal fibrosis is often observed in patients with diabetes mellitus or who have a history of previous intracavernosal injection use. Severe fibrosis is typically observed in patients with a history of ischemic priapism or who have had an infected IPP removed without salvage replacement. Mild fibrosis is typically amenable to careful dilation; however, more severe fibrosis may require placement of a smaller implant to allow slow dilation of the scarred corpora over time and possible future prosthetic upsizing. Corporal fibrosis is

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Review of Penile Prosthesis Complications

a risk factor for corporal perforation, which can occur both distally (worse) or proximally. The “field goal” test with a difference in dilator depth greater than 1 cm should raise suspicion for proximal perforation. Distal perforations with or without urethral injury can be diagnosed by a distal fluid challenge test. Urethral injury often occurs when corporal dilation is performed too medially or there is inadequate protection of the glans, oversized cylinders, or overaggressive modeling in patients with PD. Floppy glans is an observed complication of IPP placement and occurs in up to 5% of patients. It develops because of inadequate sizing of the prosthesis. Fortunately, this complication is self-limiting after normal healing and capsule formation, and surgical intervention is not usually necessary. The main postoperative complications that surgeons dread are infection and erosion of the prosthesis into adjacent structures. The prosthetic infection rate remains low in the treatment of primary patients; however, there is an elevated risk in patients with spinal cord injuries, IPP revision, penile reconstruction, those receiving long-term glucocorticoids, and those with increased length of surgery. In the past, IPP infections were mostly attributed to contamination with skin flora (coagulasenegative Staphylococcus) during implantation. However, with the advent of improved sterile techniques, coated prosthetic devices, and the growth in the diabetic population, there has been a shift in the causative organisms toward gram-negative, anaerobic, and fungal organisms. Urologists can minimize the risk of infection by obtaining preoperative negative urine cultures, performing thorough antiseptic technique, and prescribing perioperative antibiotics with gentamicin plus either vancomycin or a secondgeneration cephalosporin. Surgeons should consider broadening coverage to include fungal organisms for patients at elevated risk of device infection as outlined above.54 Currently, there is no scientific evidence to demonstrate a preventative benefit by administering postoperative antibiotics beyond 24 hours after surgery. Same-day admission and early discharge is also preferred to prevent infection with more virulent organisms. Erosion should be screened by physical exam during follow-up visits, especially in patients who had an intraoperative urethral injury, because these factors can predispose patients to development of prosthetic infection.

CONCLUSION IPP is a safe, highly effective, and well-tolerated treatment modality for the management of refractory ED. Despite advances in surgical technique and infection-resistant materials, complications still occur and can lead to significant patient morbidity and, potentially, IPP removal. Thorough preoperative planning and counseling can significantly reduce the risks of intraoperative and postoperative complications and disappointment, even in patients with multiple comorbid conditions. Corresponding Author: Wayne J.G. Hellstrom, MD, Department of Urology, Tulane University, School of Medicine, Sex Med Rev 2018;-:1e11

1430 Tulane Avenue 86-42, New Orleans, LA 70112, USA. Tel: 504-988-3361; Fax: 504-588-5059; E-mail: [email protected] Conflict of Interest: Dr. Hellstrom is a consultant/advisor for Coloplast and Boston Scientific Funding: None.

STATEMENT OF AUTHORSHIP Category 1 (a) Conception and Design Nickolas D. Scherzer; Brian Dick; Andrew T. Gabrielson; Laith M. Alzweri; Wayne J.G. Hellstrom (b) Acquisition of Data Nickolas D. Scherzer; Andrew T. Gabrielson; Brian Dick (c) Analysis and Interpretation of Data Nickolas D. Scherzer; Andrew T. Gabrielson; Brian Dick; Laith M. Alzweri Category 2 (a) Drafting the Article Nickolas D. Scherzer; Andrew T. Gabrielson; Brian Dick (b) Revising It for Intellectual Content Laith M. Alzweri; Wayne J.G. Hellstrom Category 3 (a) Final Approval of the Completed Article Nickolas D. Scherzer; Brian Dick; Andrew T. Gabrielson; Laith M. Alzweri; Wayne J.G. Hellstrom

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