Aimee E. Rogers, MD
■ Stanley Zaslau, MD, MBA, FACS
■ Erectile dysfunction affects approximately 300,000 to 400,000 American men each year.1
■ The prevalence of erectile dysfunction increases with age.
• Of men aged 40 and older, 52% have some degree of erectile dysfunction.2
■ Most men with erectile dysfunction are initially offered systemic therapy with a phosphodiesterase type 5 (PDE-5) inhibitor, such as sildenafil (Viagra). When systemic therapy fails, and the man wishes to continue treatment, second- and third-line therapies, such as vacuum erection devices and intracavernosal injections, are usually considered.
■ Surgical intervention still has a clear role in the management of patients with erectile dysfunction when both the systemic and other approaches fail or are contraindicated.
■ The surgical treatments of erectile dysfunction will be reviewed in this chapter. These include:
• Penile revascularization surgery
• Venous ligation
• Penile prostheses
■ Correction of penile curvature, as well as other aspects of erectile dysfunction, will be discussed separately.
■ Penile Prostheses History
■ The use of penile prostheses for the treatment of erectile dysfunction began in the 1950s.
• The first implants consisted of rib cartilage, modeled after the penis of some animals.3
• As technology advanced, other materials were placed subcutaneously, such as:
■ Polyethylene rods
■ Acrylic splints
■ Pure silicone implants
• A major advance in penile prosthetic surgery was the insertion of these devices into the paired corpora cavernosa, which provided greater cosmetic and functional results.4
• During the early years of penile prosthetic implantation, most of these devices were plagued by mechanical failure that usually required revision or removal.
• Today, penile prostheses have become reliable mechanical devices associated with a relatively high level of patient satisfaction.5
Malleable versus Inflatable Prostheses
■ There are currently four types of penile prostheses available to men in the United States:
• The semirigid rod
• The positional prosthesis
• The two-piece inflatable prosthesis
• The three-piece inflatable prosthesis.
■ These four types of prostheses belong to two principal categories of penile prostheses: the inflatable and the malleable, or semirigid, devices.
• Inflatable devices are selected most often by patients because they mimic a normally functioning penis in that they are able to achieve both rigidity and flaccidity.
• Insertion of a malleable prosthesis, on the other hand, results in a “permanent” erection that is bent up or down, depending on the situation and the needs of the patient.
• Malleable, or semirigid, devices make up less than 10% of all implanted penile prostheses and are typically used by patients with less manual dexterity because of their ease of use.6
■ Several factors determine which type of implant to use in a given patient.
■ The first factor to consider is the mental and manual dexterity of the patient.
• Older men, especially those with limited mental and/or manual dexterity, are usually better served by a malleable prosthesis. This is because it may be too challenging or cumbersome for these men to manipulate the pump and deflation mechanisms in the inflatable devices.7
■ Patients with injuries to the spinal cord that result in diminished sensation in the penis may be better served by an inflatable device.
• This is due to the risk of prolonged excessive pressure that the firm prosthetic rods of a malleable device would exert on the penile tissues, resulting in erosion of the rods through the skin or urethra.8
■ In general, most men with adequate mental function and manual dexterity choose the inflatable penile prosthesis because they prefer its capability to mimic the normal penis, both for its usual state of flaccidity and for its ability to become rigid for sexual activity.9
Types of Prostheses
Malleable or Semirigid Prosthesis
■ Malleable penile prostheses are semirigid devices with a central core that allows the penis to be bent down when not in use and bent upward for sexual activity.10
■ They have been available for several decades.
■ When a malleable prosthesis is implanted, a permanent erection occurs.
• However, the prosthetic device can be bent down close to the body and can be relatively well concealed under clothing.
• When sexual activity is anticipated, the penis is simply bent upward.
■ Malleable prostheses bend with relative ease, but they do have a springback phenomenon. They have some “memory” as to their original shape and ultimately return to some degree to their original straight position.11
■ Malleable devices have the advantage of very low mechanical failure rates and ease of use. Disadvantages include constant penile rigidity and an increased risk of erosion.12
■ The positional penile prosthesis (Dura II, American Medical Systems Inc., Minnetonka, MN) is similar to the malleable prosthesis in that it is also a semirigid device.
■ However, unlike the malleable device, the positional penile prosthesis has a central series of articulating segments held together with a spring on each end. This device is therefore better able to maintain its upward and downward positions, and thus has less of a springback phenomenon.13
■ The advantages and disadvantages of this device are similar to that of the malleable semirigid prosthesis.
Two-Piece Inflatable Prosthesis
■ The two-piece penile prosthesis is one of the two inflatable devices offered to men with erectile dysfunction.
■ It consists of two cylinders connected to a small scrotal pump.
■ Inflation of the device is achieved by squeezing the scrotal pump, which redistributes fluid from the rear tip reservoirs of the cylinders into a nondistensible central chamber in the front of the cylinders.
• This creates rigidity in the outward aspect of the corpora cavernosa, thus creating an erection.
■ Deflation is accomplished by bending the cylinders within the penis, which activates a valve that allows the fluid to return to the reservoir area at the base of the cylinders.14
■ The main advantage of the two-piece penile prosthesis is that there is no need for a separate reservoir, which makes implantation easier than that of the three-piece prosthesis.
■ The device also comes complete and requires no filling or connections intra-operatively.
■ The two-piece implant is well suited for men who have had prior pelvic or inguinal surgery, in whom surgical placement of a separate reservoir may be more problematic.
■ The two-piece device also requires less dexterity and digital sensitivity than do other multicomponent devices.
■ On the other hand, the two-piece prosthesis appears fuller than the three-piece device in the flaccid state because less fluid can be transferred to the smaller reservoir area.15
■ A disadvantage compared with the malleable devices is the increased risk of mechanical failure.
Three-Piece Inflatable Prosthesis
■ The ideal prosthesis would provide its recipient with a penis that mimics as closely as possible normal penile flaccidity and erection. Only three-piece inflatable devices that transfer a large volume of fluid into the penile cylinders for erection and out of the cylinders for flaccid- ity approach this ideal.16
■ Three-piece prostheses consist of:
• Paired corporeal cylinders
• A scrotal pump/deflation mechanism
• An abdominal fluid reservoir
■ Erection is achieved by repeatedly squeezing the pump located within the scrotum.
• Each compression transfers fluid from the reservoir to the intracorporeal cylinders until adequate pressure is achieved, thus creating an erection.
■ Deflation is achieved by pressing a valve mechanism located next to the scrotal pump, permitting fluid to flow out of the cylinders and return to the reservoir.17
■ Both the two-piece and three-piece penile prostheses are designed to approximate the rigidity and flaccidity of the normally functioning penis.
■ With these devices, two hollow cylinders are placed within the corpora cavernosa, a fluid reservoir is placed behind the pubic bone, and a pump is situated in the scrotum.
• Rear tip extenders can be added to the back of the cylinders to modify penile length further.18
■ All three-piece devices provide penile girth expansion and rigidity similar to that of a normal erection. One device, the AMS 700 Ultrex (American Medical Systems Inc., Minnetonka, MN), also provides length expansion.19
■ The advantages of three-piece devices are similar to those of the two-piece device: They mimic a normally functioning penis and pose less risk of erosion.
■ The main disadvantages of three-piece penile prostheses are the increased risk of mechanical failure and the relative complexity of its insertion. Furthermore, the three- piece device does require relative mental and manual dexterity on the part of the patient for its successful use.20
■ Discussions regarding the treatment of erectile dysfunction ideally should include the patient’s partner, but this is not always possible.
■ Penile prosthesis implantation should not be considered to treat a man with erectile dysfunction that is situational, the result of a relationship conflict, or potentially reversible.
• For these men and their partners, psychological consultation and sex therapy are more appropriate.
■ Once a decision has been made regarding insertion of a penile prosthesis, the various types of penile prostheses along with their advantages and disadvantages should be discussed.
■ It is important for the patient to understand that penile prostheses produce an erectionlike state. The glans penis is not included in an erection achieved using a prosthesis, and for most men the length of their erect penis is shorter than their normal erection.
■ Many men with erectile dysfunction have normal libido, and most have normal penile sensation and orgasm with ejaculation. Penile prosthesis implantation preserves orgasm and ejaculation if present, but does not restore them if they are absent.21
■ Prior to the procedure, the patient should be informed of the various risks and benefits of the procedure. This includes the risk of:
• Mechanical failure
■ The patient should be informed that infection would likely result in complete explantation of the implant, with resulting scarring of the bilateral corpora.
■ He should also understand that mechanical failure is possible and correcting it requires device revision or replacement.22
■ Preoperative preparation of the prosthesis recipient is directed primarily at reducing the risk of infection.
• The recipient should be free of urinary tract infection.
• He should have no infections elsewhere that might result in bacterial seeding during the healing phase.23
• While better control of diabetes mellitus may reduce risk of infection, the literature fails to demonstrate a consistent benefit.24
• There should be no other wounds, dermatitis, or other breaks in the skin in the operative field.
■ The procedure is performed with the patient in the supine position under either spinal or general anesthesia.
■ The operative area is shaved immediately prior to the first incision to avoid bacterial colonization of small skin breaks that might occur if shaving is performed by the patient prior to the procedure.
■ After the patient is shaved, a thorough 10-minute skin preparation is performed.25
■ Broad-spectrum intravenous antibiotics providing both gram-positive and gram-negative coverage are administered prophylactically before the initial incision is made and may be continued for 24 to 48 hours postoperatively.26
• Frequently used antibiotics for gram-positive coverage include ampicillin, vancomycin, or the cephalosporins. For gram-negative coverage, aminoglycosides or fluoroquinolones are suggested.
■ Placement of the prosthetic device can be performed through a penoscrotal, infrapubic, or subcoronal approach.
• The subcoronal approach is used only for implantation of malleable or positional devices.
■ A 4-cm transverse incision is made about one centimeter below the penoscrotal junction. This incision is dissected down to the level of the dartos fascia, toward the urethra and the corporal bodies.
■ The underside of the dartos fascia is dissected away from the urethra and the proximal portion of the corpora, or crura.
■ Corporotomies of 2 cm are made, and two horizontal mattress sutures are placed on each side.
• These sutures are used as guides during corporeal dilation and measurement, and are ultimately used to close each corporotomy after the cylinders are placed.
■ Dilation of the corpora then begins with an 8-mm dilator and proceeds to 16 mm proximally and to 14 mm distally. The proximal portion is dilated to a greater extent to accommodate both the cylinder and the cylinder tubing.
■ Following dilation, both proximal and distal measurements are taken from their respective ends of the corporotomy.
■ After corporeal measurements are taken, the appropriate cylinder size is chosen, both in terms of length and diameter.
■ Both cylinders are then inserted into the bilateral corpora with the use of a cylinder inserter.
■ Rear tip extenders are added to the ends of the cylinders as needed.
■ Both corporotomies are then closed by tying the proximal and distal ends of the preplaced horizontal mattress sutures.27
■ The pump is placed in the scrotum via a second incision made through the dartos fascia in the scrotal septum.
■ If a three-piece implant is chosen, a separate reservoir is placed into the retropubic space through the primary penoscrotal incision via the external inguinal ring, or through a separate lower abdominal incision.
■ The operation may be performed as an outpatient procedure.
■ The patient is instructed to avoid using the device for four to six weeks to allow for adequate healing.28
■ A urethral catheter is maintained to gravity drainage until the following morning.
■ Oral antibiotic therapy is usually continued for one week after discharge.
■ Oral narcotics are usually required for about a week after surgery.
■ If a reservoir has been placed, the patient is instructed to avoid lifting and other activities that might result in reservoir displacement.
■ Approximately one month after surgery, most men are ready to learn how to operate the device.
• The patient is instructed to inflate the device using the pump located within the scrotum.
• He then can deflate the device by applying pressure to the deflation mechanism, also located within the scrotum.
■ The patient practices ‘cycling’ the device twice daily for approximately one month.
■ After a month, the patient is given permission to use the device for sexual intercourse whenever inflation can be accomplished with ease and without discomfort.29
■ The patient considering penile prosthesis implantation should be made aware of the potential complications of the procedure, including:
• Mechanical failure and resulting reoperation
• Penile shortening
• Urethral injury
• Impaired sensation30
■ The most serious complication of penile prosthesis implantation is infection.
■ According to Jarow and colleagues, infection occurs in approximately 3% of cases, and in up to 10% of higher- risk cases, such as in men with diabetes, spinal cord injury, or prior implants.31
■ Causative organisms are usually skin flora, in particular, staphylococcus species such as staphylococcus epidermi- dis, suggesting that bacterial seeding occurs at the time of implantation.32
■ Early infections are usually indicated by the presence of:
• Tenderness over the affected area
• Possible purulent drainage
• Occasionally fever
■ Late infections are usually manifested only by persistent or recurrent long-term pain in the area of the implant.
• With long-term infections, the scrotal skin has been found to be adherent to the pump.33
■ Treatment of the prosthetic infection with intravenous antibiotics usually results in clinical improvement, but the antibiotic treatment rarely permanently eradicates this type of infection.
• According to Abouassaly and colleagues, this is thought to be due to harboring of microorganisms within a biofilm that is adherent to the device.34
• For this reason, when a prosthesis is infected, all components of the device should be removed.
• Therefore, infection is considered by many to be the most significant complication of genitourinary prosthetic surgery.35
■ In the past, a majority of the penile prostheses that were removed due to infection were not considered
for reimplantation during the same procedure. Reimplantation was often delayed as long as a year.
• During this time, the scar within the corpora would mature, resulting in contraction, which resulted in a smaller penis size and more difficulty with dilation after cylinder reimplantation.
• Reimplantation at that time was therefore more difficult to perform successfully.
• However, pump and reservoir reimplantation was and still is seldom a problem.
■ To minimize loss of penile size and to facilitate corporeal dilation, many experts now perform prosthesis reimplantation as soon as possible after device removal for infection.
■ Reimplantation is usually performed approximately two to three months after device removal, when all the incisions have healed and postoperative edema has resolved.36
■ Mulcahy and colleagues first introduced the concept of prosthesis salvage for infection.
• Their protocol involves removal of all prosthetic components and foreign bodies, followed by copious irrigation with seven antibacterial solutions.
• A new device is implanted thereafter.
• Of 55 patients reimplanted in this fashion, 45 (82%) were free of infection, with follow-up ranging from 6 to 93 months.37
• When salvage procedures are successful, they maintain penile length and rectify the problem with only one operation.
• If the entire device is explanted and all prosthesis compartments are copiously irrigated before a new prosthesis is implanted, the infection rate is not significantly different from the rates seen with first-time prosthesis implantation.38
■ Erosion of a penile prosthesis is uncommon.
■ The most common sites of erosion are the distal cylinder and the scrotal pump. The likely reasons for these sites as areas to erode are the lack of distal penile sensation in the patient with a spinal cord injury, diabetes, or someone who has previously undergone external beam irradation.
■ Erosion is also possible if an oversized prosthesis is used. This can lead to erosion by tissue pressure atrophy and necrosis.
■ Erosion can also occur if a patient keeps the prosthesis inflated when they are not using it. This can also lead to tissue pressure atrophy and necrosis.
■ Erosion of the reservoir into the bladder or into the bowel are extremely rare complications.
■ The scrotally placed penile implant pump can also erode. This can occur in patients with impaired sensation such as diabetics and patients with spinal cord injury.
Mechanical Failure and Subsequent Operation
■ True mechanical failures for inflatable penile prostheses include leakage of fluid from various points including:
• Tubing leak
• Pump leak
• Reservoir leak
• Cylinder aneurysm
■ While individual components may be at fault, it is the author’s recommendation that the individual component be replaced if the implant was initially placed in the preceding 12 months. If the implant has been in place for longer that 12 months, the entire device should be replaced.
■ Penile shortening is likely to occur after placement of a penile prosthesis. This can be due to ischemia of corporal and tunica albiginea layers of the corpus cavernosa. This is common in patients with ED of many years duration.
■ It is important to counsel patients preoperatively about the likelihood of penile shortening after penile prosthesis implantation. This will improve patient satisfaction postoperatively.
■ It is possible to perform a ligation of the penile suspensory ligament in an effort to gain additional penile length. In the author’s opinion, while this may produce additional penile length, the penis is more floppy and can hang lower because of its lack of ligamentous support.
■ Urethral injury can occur during dilation of the corporal bodies during placement of the prosthesis.
■ This injury is likely to be more common in patients who have had prior pelvic external beam irradiation, have diabetes mellitus, or who have suffered a pelvic fracture.
■ Care must be taken not to injure the urethra during the procedure. For distal urethral injuries, the implant procedure should be abandoned and the patient left with a urinary catheter in place. A second procedure can be undertaken after three months. For proximal urethral injuries, the urethral injury can be repaired over a urinary catheter. While one could consider placement of the penile implant at this time, the authors recommend waiting until the urethral injury has healed and then undertake a second operation at a later date.
■ Patients who are diabetics, have a history of spinal cord injury, or have received pelvic irradation are at increased risk for loss of penile sensation after placement of a penile implant.
■ It is likely that the patient’s underlying disease state resulted in the impaired penile sensation rather than the implant procedure causing this complication.
■ In such patients, malleable penile implants are more likely to cause erosion particularly because the patient will not feel the implant. In fact, such patients may not realized that erosion has occurred until there is secondary infection present. These patients are better served with a three-piece inflatable prosthesis because it can be deflated, which can minimize the risk of erosion.
■ Vascular Surgery for Erectile Dysfunction History
■ The first cases of penile arterial bypass surgery for erectile dysfunction were reported by Michal and colleagues in the early 1970s, using the inferior epigastric artery as the donor vessel.39
■ Subsequent modifications by Virag and others resulted in a multitude of procedures that used the deep dorsal vein as the recipient vessel.40
■ Crespo and colleagues presented procedures for revascularization of the cavernosal artery directly by use of the inferior epigastric artery as a donor source.41
■ Lack of standardized techniques and selection criteria may contribute to the current low popularity of arterial revascularization. To date, no single procedure has been universally accepted.
■ Vascular surgical procedures, particularly penile arterial revascularization and penile venous surgery, are recommended only for a select group of patients.
■ Several series have reported reasonable success for penile arterial reconstructive surgery if performed in young, nonsmoking, healthy men with recently acquired erectile dysfunction secondary to focal arterial occlusion with no evidence of generalized vascular disease.42
■ According to DePalma and colleagues, only 6—7% of men with vascular erectile dysfunction are candidates for arterial reconstructive surgery.43
■ Another study performed years later revealed that success rates in older men with diabetes or other evidence of generalized vascular disease were also very low.44
■ Surgical intervention has an important role in the management of patients with ED when systemic and other approaches fail or are contraindicated.
■ Physicians must always consider the mental and manual dexterity of the patient when selecting a malleable versus inflatable prosthesis.
■ Physicians must carefully explain to patients and their partners the risks and benefits of penile implant surgery before performing any procedure.
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