|Erectile Dysfunction – Surgical Treatment|
At the end of the 1900s, with the development of effective oral agents for erectile dysfunction (ED), it has been said by many that the era of surgery for ED is over. However, in the understanding of what occurs in the pathophysiology of ED in the modern era of molecular science, it was discovered that corpora cavernosal sinus smooth muscle does deteriorate and is replaced by fibrotic tissue. When the corpora cavernosal tissue is no longer functional because of replacement by a certain critical amount of this fibrotic tissue, the only solution for ED in many cases is the placement of a penile prosthesis. Penile prosthetic surgery has progressed and modern penile prostheses have become very reliable, such that prosthetic surgery for ED is a very viable area of surgery for the urologist.
Vascular surgical procedures, in particular penile revascularization and penile venous surgery, are recommended for only a very select group of patients. An example would be the case of a very young male who has significant vascular injury of vessels leading directly to the corpora cavernosa; revascularization surgery is often very successful in such a case. Part of the failure of revascularization surgery may be that many of those patients in whom revascularization is used have significant end-organ disease already, such that revascularization is doomed to failure even though vascular lesions may be part of the pathologic process. In addition, in some arterialization surgery, there is a problem because of poor runoff after rearterialization for damaged arterial systems. The corpora cavernosa are areas of very high resistance, and, unless adequate runoff into the corpora tissue is present, vascular surgery may, again, be doomed to failure. Penile venous surgery can still be indicated in patients who have congenital venous abnormalities of drainage of the corpora cavernosa tissue, but most of the venous surgery addressed to ED has occurred in patients who have significant intracorporeal tissue disease. Therefore, surgery directed at decreasing venous runoff beyond the corpora may provide only temporary relief.
As with all treatments of ED, there is a large mixture of organic and psychological properties to the disorder, and the high placebo effect in any type of treatment of ED must be constantly kept in mind by the surgeon. The history of ED surgery has been reviewed by several authors (Gee, 1975; Lewis, 1990; Kim and Carson, 1993; Das, 1994). Some of these early procedures were amazingly similar to procedures that later became popular, such as the venous plication procedure and venous ligation surgery as proposed by Lowsley and Reuda (1953) in their presentation of a large group of patients that updated their previous report of their surgery in 1936. Beheri, in 1966, and Pearman, in 1972, were the first to report on intracavernous placement of polyethylene and silicone prostheses, respectively, with dilatation of the corporeal space with Hegar dilators. A major development was the inflatable penile prosthesis, which was first reported by Scott and his coworkers in 1973. Ebbehoj and Wagner (1979) can be given credit for the first modern surgical approach to correction of abnormal drainage of the cavernous tissue based on diagnostic dynamic cavernosography techniques. Mikal (1980) should be considered the father of modern vascular surgery for impotence with his presentation of various arterial revascularization procedures to treat this disorder in the 1970s. Another pioneer in revascularization surgery was Virag (1982), who first introduced deep dorsal vein arterialization.
In this chapter, the focus is primarily on prosthetic surgery used for ED, but some of the tenets of vascular surgery for ED, which again should be reserved for very select patients, are dealt with.
PATIENT COUNSELING FOR ERECTILE DYSFUNCTION SURGERY
The choice of incision for erectile surgery varies markedly, and this should also be explained to the patient in the preoperative counseling sessions. For placement of semirigid devices or for performance of a corpus cavernosal/glans shunt in priapism, a subcoronal partial or complete circumferential incision is adequate, but circumcision, if foreskin is present, is necessary to avoid an edematous inner-tube deformity of the subglanular skin. However, if balanitis or posthitis is present, a first-stage circumcision is necessary before placement of a penile prosthesis, because the risk of infection would be too great with simultaneous placement.
For placement of a two- or three-piece inflatable penile prosthesis, a penile scrotal or infrapubic incision (in either case, vertical or horizontal) is optimal, depending on the preference of the surgeon. It is easier to place the suprapubic reservoir, and the tubing from the cylinders is in a more protected position in the infrapubic incision, but dilatation of the corpora is slightly more difficult. Conversely, dilatation and access to the intracavernous space with clearer vision of the urethra, a definite advantage in the presence of intracavernosal fibrosis, is easier with the penile-scrotal incision but placement of a suprapubic reservoir is more difficult and is performed blindly. Tubing from one of the penile cylinders to the pump crosses over the urethra with this incision, and the tubing is covered by less overlying tissue.
A semicircular incision on one side of the scrotal skin around the base of the penis, through which the entire penile shaft and access to the infrapubic region can be obtained, is the incision of choice for penile vein dissection and ligation surgery. Although some authors believe that a paramedian incision is the best way to expose the inferior epigastric vessel complex in penile revascularization, I prefer a midline abdominal incision from umbilicus to base of penis, which will provide access to bilateral inferior epigastric vessel complexes, if this becomes necessary, without having to make a second paramedian incision. The more preferable incision for more extensive cavernosal-to-spongiosal shunts in the management of persistent priapism is the midline perineal incision, which is also the best way to approach a crural erosion of a cylinder.
The self-contained inflatable penile prosthesis that was introduced by American Medical Systems to the American market in May 1990 has been discontinued by the company (Kabalin and Kuo, 1997; Anafarta et al, 1998). This device, called the Dynaflex, caused tissue expansion with the deterioration in rigidity of erections and was considered the most difficult inflatable prosthesis for patients to operate, with an initial dissatisfaction rate of more than 16% (Wilson et al, 1996b).
In the United States, two companies make the more sophisticated two- or three-piece hydraulic devices. The first, the originator of inflatable devices, continues to make the device entirely of silicone polymers except for Dacron reinforcement sleeves in the cylinders. The second company constructs the cylinders and reservoirs of a proprietary polyurethane-containing compound but uses silicone polymer tubing and some silicone polymers for tubing connection sites and the pump . No penile prostheses contain silicone gel. Several of the two- and three-piece device pumps and cylinders are preconnected by tubing, and some are prefilled with saline solution. One available model has length expansion. The two-piece inflatable device called Ambicor is a prefilled, closed hydraulic system similar to the Dynaflex prosthesis, but there is a tiny pump preconnected to the cylinders instead of having the pump located at the end of each cylinder. The three-piece devices have a scrotal pump and a reservoir that is placed suprapubically, usually in the space between the rectus muscle and the peritoneum or intraperitoneally.
Mentor Corporation (Santa Barbara, Calif), in January 2000, launched an enhanced reservoir with a lockout valve for its three-piece prosthesis. This is designed to prevent autoinflation by inhibiting fluid transfer from the reservoir when not under demand by the pump (Goldstein and Geffin, 1999; Wilson et al, 1999a).
Selection of the appropriate device for the individual patient is largely based on three considerations: the patient's preference, the cost of the device, and the surgeon's preference. A review of current types of prostheses and current indications has been prepared by Wang and Lewis (2000a). The advantages of the various devices should be explained for the patient to make a more informed choice (Mulcahy, 1997a).
Patients who use condom catheters are more likely to have neurologic disease and lack of penile sensation and are, therefore, more prone to cylinder erosion with the semirigid or malleable devices (Gross et al, 1996). Besides this drawback of the semirigid devices, other disadvantages include less concealability and inability of change in girth.
An advantage of the two-piece device includes easier surgical placement, because of lack of need for suprapubic reservoir placement; but, because less fluid is transferred in and out of the cylinders with the erect and flaccid states, the degree of rigidity and change in girth and length are not as good as with the three-piece inflatable device. The three-piece devices provide a flaccid state and an erect state that more closely mimic natural erection, but one mandatory caution to be made to the prospective recipient is that no penile prosthesis will restore the full length previously achieved by the patient with his natural erection. Also, because the inflatable prostheses contain multiple mechanical parts, the chance of mechanical wear is higher than that experienced with the more simple devices.
Some surgeons prefer the more permanently rigid devices for impotence surgery associated with Peyronie's disease, but others prefer the three-piece inflatable device for this type of patient. Patients with severe arthritis or restrictive hand problems may have difficulty working a scrotal pump and may want to avoid such a device unless a willing partner is available to assist. There are two modified three-piece inflatable penile prostheses that have smaller diameter and, in one instance, a smaller pump. These devices are excellent for use in cases in which there is significant corpora cavernosa fibrosis.
Most experienced implant surgeons prefer to have the patient placed in the supine position . Placement of a Foley urinary catheter is recommended, especially in patients with corporeal fibrosis and in patients who will have placement of a suprapubic reservoir, because an empty bladder facilitates creation of the reservoir pouch and avoids injury to the bladder. It is not absolutely required for primary placement of other devices. Special tools are limited but consist of tools to dilate the corpora cavernosa tissue for placement of the cylinders (a set of Hegar dilators [No. 7/8 to No. 13/14], a dilamezinsert, or Brooks dilators), a cylinder-measuring device, cylinder protection devices for placement of tunica albuginea corporeal sutures once the cylinders are in place, a long-nosed nasal forceps for assistance in placement of the suprapubic reservoir through a penile scrotal incision, shodded hemostatic clamps for safe temporary clamping of device tubing, special connector pliers for those devices requiring this type of connector placement, special blunt-tipped needles for filling of components of the inflatable devices, and a cylinder placement tool. Sutures used to close the corporotomy can be permanent, but absorbable monofilament suture material (polydioxanone, Ethicon, Inc/Johnson & Johnson, Somerville, NJ) of 2-0 size is my preference.
Once the appropriate incision (see earlier discussion) is made and the tunica albuginea surface is exposed on the lateral surface of the corpus cavernosum, a corporotomy incision is started with a No. 15 blade and then extended with a straight Mayo scissors for a distance of 2.5 to 4 cm ( Fig. 47–7). If the device is placed through a circumcision-like incision, the corporotomy is started distally 2 to 3 cm from the glanular edge and carried proximally toward the crural portion of the corpora until the appropriate length is achieved. If the incision in the corporeal bodies is more proximal, such as that achieved with a penile scrotal or infrapubic incision, the most proximal incision is best placed 6 to 7 cm from the crural end of the corpora. This allows minimal extender use and ensures exit of the cylinder tubing in a more direct manner, which will eliminate later cylinder wear from tubing lying against the cylinder under the tunica albuginea ( Fig. 47–8).
The next step is dilatation of the corporeal space. This should be done carefully by placement of the dilatation tool of choice toward the crura or the glans, taking care to abut against the ischial tuberosity in the crural direction, because this is where intraoperative perforation is most likely to occur, and to advance under the glans distally to ensure proper placement of the cylinder to avoid a floppy SST deformity of the glans. This distal dilatation is safely performed by keeping the tip of the dilator lateral as it is advanced under the glans. Perforation into the urethra may also result if too vigorous distal dilatation is performed or in patients with some distal corporeal fibrosis. Corporeal dilatation should be easily performed, and any difficulty should suggest to the surgeon an improper plane, crossover into the opposite corpora through the midline septum, or perforation ( Fig. 47–9).
Once dilatation of a corporeal body has been accomplished proximally and distally, the corporeal closure sutures can be placed on either side of the corporotomy, which makes closure of the corporotomy incision much easier and less risky for an inflatable cylinder perforation ( Fig. 47–10). Montague (1993) suggested a novel way of tying horizontally placed sutures in two stages, tying the distal strands of opposite sutures first followed by a second knot of the proximal strands, so that two knots are made with each oppositely placed suture. This is an excellent closure for primary device placement, but double-strand tying of opposite preplaced vertical sutures is recommended for replacement or revision surgery. Preplacement of the corporotomy sutures is not necessary for noninflatable cylinders, because this closure can be interrupted or running and be made over the cylinder. A protective tool is used for placement of suture over a previously placed inflatable cylinder.
Most surgeons make the corporotomy incision and perform corporeal dilatation bilaterally before placement of either cylinder. If there is a question of not being able to place the maximum diameter device of the model selected for the patient, placement of a Hegar dilator into both of the corporeal spaces will indicate a tightness that will require selection of a smaller diameter. Careful measurement of the length of the corporeal space is made using the special cylinder-measuring device. The appropriate-length individual cylinders with or without rear-tip extenders (total length 1 cm less with the AMS Ultrex cylinder) are then placed into their respective intracorporeal spaces directly for the semirigid devices and with a cylinder placement tool for inflatable devices. The tool incorporates a cylinder suture attached to a Keith needle, which is inserted through the glans ( Fig. 47–11A and B).
Immediately before placement of the cylinders, the corporeal spaces are irrigated with an antibiotic solution, as are all subsequent spaces for the pump and the reservoir at the time of exposure. For placement of semirigid devices, it is usually easier to place the crural end of the device first. For the Duraphase (Timm Medical Technology) device, owing to its lesser flexibility, the subcoronal approach is the easiest with placement of the crural end first. Then, using a small hooked retractor, such as an eyelid retractor, to elevate the more distal end of the corporotomy incision, the glanular end can be flipped into the dilated corporeal space. Length selection with this device is somewhat different, and the manufacturer's instructions for measurement should be followed.
With inflatable cylinders that have attached tubing, direct exit at the tubing connection site is preferable, and care is taken in tying the previous placed corporotomy suture on either side of the tubing to ensure this ( Fig. 47–12). For the semirigid devices, once the cylinders are placed and the corporotomies are closed, skin closure using chromic catgut or other absorbable braided suture completes the surgery.
For the two- and three-piece devices, a space is created in the subdartos scrotum for placement of the reservoir/pump or the pump with the index and middle finger or sometimes with a large Hegar dilator or Kelly clamp ( Fig. 47–13). Preattached pump devices are placed in this space, after antibiotic irrigation, and the tubing from each of the cylinders is sometimes separated with sutured tissue to keep them separated to prevent tubing-to-tubing wear. I have not found this to be a common cause of mechanical failure in patients who have not routinely had the compartmentalization. If the pump is not preconnected to the cylinders, the order of reservoir or pump placement is not important.
For placement of the suprapubic reservoir in three-piece devices, a space is created behind the rectus muscle by making a midline vertical incision in the rectus fascia first and, under direct vision, creating a space behind the rectus muscle preperitoneally. Some surgeons make the reservoir space through the external inguinal ring, puncturing the inguinal floor and subsequently dilating the space behind the rectus muscle. This can be facilitated by a long-nosed nasal speculum or a special dilatation tool.
Placing the pump into the peritoneum has been advocated by some surgeons to eliminate risk of entrapment of the reservoir, which might lead to autoinflation. This can be avoided by carefully creating an adequate space initially, which can be ascertained when filling the reservoir after placement. I add 5 ml more than the size of the capacity of the reservoir and leave the tubing connected to the syringe, expecting to see spontaneous filling of the syringe to 5 ml once pressure is taken off the barrel of the syringe. If more than 5 ml returns, I check the position of the reservoir and expand the space until this no longer occurs. If the reservoir continues to fill the syringe passively with more than the 5 ml, it is left filled with this zero pressure volume (which may be less than the recommended volume) to avoid autoinflation. As mentioned previously, Mentor Corporation has introduced a lockout valve, activated only by negative pressure induced by pumping the scrotal pump, to prevent autoinflation.
The wound is closed in a couple of layers, and appropriate dressings are put in place. A surgical drain is not usually required, although some implant surgeons prefer a fenestrated tubular suction drain for 24 to 48 hours postoperatively, specifically when there is a large amount of intraoperative bleeding. If an indwelling Foley catheter was placed, it is removed the afternoon of surgery or the following morning. The patient is most comfortable, initially, with the penis taped to the lower abdomen. An attempt is made to inflate the device 4 to 6 weeks after surgery. For noninflatable devices, intercourse trials can begin, if all wounds are healed, at this same time. Individual surgeons who have described operative techniques that may be more variable than that described previously are included in the reference section (Montague and Lakin, 1993; Mulcahy, 1993; Carson, 1999).
A common intraoperative problem is crural perforation. This can be managed with a separate perineal direct closure of the tear after placement of the device or, as suggested by Mulcahy, an artificial windsock repair (Mulcahy, 1987; Fishman, 1993) ( Fig. 47–14). With the two- or three-piece inflatable devices with attached tubing, I have found that placing a tunica albuginea closure suture on either side of the exit tubing keeps the cylinder in place, provided the ischial tuberosity can be sounded with the dilatation or measuring device and the ipsilateral cylinder can be placed similar to the opposite cylinder, so that repair of a simple tear is not necessary. If this approach is followed, the device should remain in the deflated state for 6 weeks. If a distal corporeal perforation occurs on the first side of dilatation in primary implant procedures, the procedure should be abandoned and rescheduled at a later time. However, if this occurs in patients with severe intracorporeal scarring or a previous history of such an injury and the surgeon has prepared the patient for urinary diversion, a catheterized diverting perineal urethrostomy or suprapubic vesicostomy can be performed, if the perforation can be directly repaired by means of a circumcision-like incision.
The patient should be kept on broad-spectrum antibiotics for 2 to 3 weeks postoperatively, and a retrograde urethrogram at that time should be normal before removing the diverting catheter. The perineal catheter is preferred over the suprapubic route because bladder spasm around the catheter usually results in leakage in the perineum and not into the penile urethra. Also, bladder spasms are less often seen with the urethral catheter.
There is less agreement on a recommendation for management of distal perforation at the time of dilatation of the second corpora after an atraumatic dilatation of the opposite side. Again, the distal injury must be identified and repaired. No cylinder is placed on the side of the perforation, but urinary diversion can make the placement of the contralateral cylinder and the remainder of the device possible. The reasoning for such placement is that stopping the operation and returning at another time, which is an option, will result in bilateral corporeal fibrosis. If the procedure is abandoned, the placement of fenestrated tubular drains into the corporeal spaces for around-the-clock irrigation with an antibiotic solution every 4 hours for 2 to 3 postoperative days will decrease subsequent fibrosis (Maatman and Montague, 1984).
One of the most dreaded complications associated with penile prostheses is infection. In excellent reviews by Carson (1989, 1993), the reported incidence is 0.6% to 8.9%. It has been reported that infection rates were not different when scrotal or infrapubic surgical approaches were used (Garber and Marcus, 1998). Infection is more common in patients with spinal cord injuries, those with diabetes mellitus (particularly those with poor control of their glucose levels; implantation should not be performed in patients with a glycosylated hemoglobin value greater than 11.5%), those with a history of urinary tract infections, and those having a replacement device operation (Rossier and Fam, 1984; Kabalin and Kessler, 1988; Bishop et al, 1992; Radomski and Herschorn, 1992; Quesada and Light, 1993; Lewis, 1995; Kaufman et al, 1998). Other authors have questioned the high glycosylated hemoglobin levels as posing a greater infection risk (Wilson et al, 1998). Patients with history of external-beam radiation therapy for prostate cancer do not have increased infection or complication rates (Dubocq et al, 1997).
Most infection associated with penile prostheses occurs in the first 3 months after surgery, but delayed infection or infection from hematogenous sources has been reported in the literature (Carson and Robertson, 1988; Kabalin and Kessler, 1988). It is probably wise to advise patients with penile prostheses who are going to have dental work or other surgery in which there is a high risk of infection to have prophylactic antibiotic coverage.
Table 47–3 presents preventive measures, which are probably the most important elements in the management of infection. In those patients who have no previous history of genitourinary or prosthetic infection, a first-generation cephalosporin given as surgical prophylaxis is adequate. For others, a combination of an aminoglycoside and vancomycin surgical prophylaxis is recommended. The use of oral postoperative antibiotics is variable (Rossier and Fam, 1984; Kabalin and Kessler, 1988; Bishop et al 1992; Radomski and Herschorn, 1992; Quesada and Light, 1993; Lewis, 1995) but certainly should be considered in those patients who have had previous penile prosthetic infection or surgery.
Salvage surgery for infection in penile prostheses is debatable; but in carefully selected patients, such an approach is not unreasonable (Lewis and McLaren, 1993; Wilson and Delk, 1995). Previous dogma has advised immediate removal of the penile implant and reinsertion of a prosthesis 3 to 6 months later, which almost always results in corporeal fibrosis, scarring, and penile shortening. It is advisable that in the face of frank purulent material, the entire device be removed. If the device is removed, intracorporeal drainage with intermittent antibiotic irrigation is recommended to help decrease subsequent fibrosis (Maatman and Montague, 1984).
Because more successful salvage procedures were reported, immediate replacement of the infected penile prosthesis has become possible. We previously reported our successful salvage operation in 17 of 21 patients (81%) (Lewis and McLaren, 1993). We placed a fenestrated drain along with the new prosthesis to allow for intermittent irrigation for 5 to 7 days with Dabs antibiotic solution (500 mg neomycin, 80 mg gentamicin, and 100 mg polymyxin in 100 ml normal saline solution). This is a rather complicated regimen. See Table 47–4 for an outline of our salvage procedure.
Knoll (1998) compared delayed and immediate salvage techniques in managing penile prosthetic infection. A delayed salvage procedure (3 days) included complete removal of all of the prosthesis, intraoperative antibiotic irrigation with Dabs solution of all locations where a component of the device was placed, and placement of drains in these locations. This was followed by postoperative intermittent drain irrigation with Dabs solution every 8 hours clamped for 20 minutes for 3 days and subsequent reimplantation of a new three-piece device. An immediate salvage procedure was performed by following the same kind of protocol mentioned earlier by Brant and colleagues. Knoll found that an immediate salvage appears as successful as a delayed salvage procedure.
Other surgical complications include problems with position, pain, cosmetics and size, encapsulation, and pressure erosion. The three most common position problems are inadequate cylinder length, resulting in an SST deformity, a high-riding pump or pump/reservoir combination, and a kinked reservoir neck. The SST deformity is corrected by the Ball procedure (Ball, 1980) ( Fig. 47–15), and the other disorders are corrected by open surgical repair if the position problem is interfering with the function of the device. It is not unusual for the patient to experience some degree of discomfort or minor penile pain 4 to 6 weeks postoperatively. Severe pain or pain associated with an elevated white blood cell count or temperature elevation should alert the physician to the possibility of infection during this early postoperative period. Persistence of pain beyond this time also suggests a smoldering infection. The use of oversized cylinders can also produce pain. Buckling of inflatable cylinders has been reported as a cause for prolonged penile pain and can be diagnosed by MRI (Moncada et al, 1998).
Wilson and associates (1996a) reported the development of anS-shaped deformity with the use of Ultrex cylinders in 39% of 59 patients receiving an Ultrex cylinder from 1990 to 1992. They stressed the need to downsize, by 1 cm, the length of cylinder placed in the measured corporeal space and to avoid prolonged inflation. They also recommended the device not be implanted in cases of Peyronie's disease or for replacement of a malleable or self-contained inflatable implant. Kowalczyk and Mulcahy (1996) recommended replacing the Ultrex device with the 700 CX prosthesis when penile curvature and aneurysmal defects occur necessitating reoperation. Encapsulation of a reservoir or a pump/reservoir can lead to the inability to fully deflate the cylinders of an inflatable device and also autoinflation, both of which necessitate open surgery to repair. Exposure is usually limited to connection sites where the connection can be taken down, tubing can be cannulated by a syringe connected to a blunt tip needle, and the reservoir hydraulically dilated to rupture the encapsulation.
Pressure erosion does not necessarily indicate the need to remove the entire device, especially in the absence of frank pus (Furlow and Goldwasser, 1987). Erosion of a penile prosthesis is uncommon, but it can be calamitous. The most common sites of erosion are the distal cylinder and scrotal pump. Cylinder erosion is mostly caused by loss of distal penile sensation in the patient with spinal cord injury or diabetes or after irradiation. Erosion can also result from oversizing of the prosthesis or from failure to keep the prosthesis deflated when not in use. Management of erosion associated with obvious infection should follow the principles for treating infection, as mentioned earlier.
We attempt to perform salvage surgery for every patient with erosion without frank purulent material. Erosion of the reservoir into the bladder or into the bowel is a rare occurrence. This is often caused by the tension on the tubing leading from the reservoir or a small reservoir cavity that exerts pressure on the balloon, pushing it into the viscus. This will require the affected bowel segment to be resected or bladder closed and the reservoir replaced into a new site with an adequate cavity without tension on the tubing (Mulcahy, 1997b). Scrotal erosion may be salvaged by transferring the pump or pump/reservoir combinations to the opposite scrotum. Impending erosion of the proximal cylinders or the rear-tip extenders in the perineum can often be repaired through a perineal incision.
Distal erosion or impending erosion of the penile prosthesis can be repaired with a variety of methods. Mulcahy (1999) described a distal corporoplasty to repair lateral impending erosion. He 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 containing it. One of the authors (RWL) has used this technique for more than 10 years and has always found normal-appearing corporeal tissue after making an incision into the dorsal medial wall of the old cylinder sheath. This corporeal tissue can be easily dilated to make a space for inserting the cylinder in the appropriate subglanular position. In Mulcahy's report, all 14 patients who underwent corporoplasty using this technique had satisfactory results after 2 years of follow-up.
Alter and coworkers (1988) reported their successful two-stage procedure with prefabricated tunica vaginalis fascia flaps to repair recurrent penile prosthesis extrusion in two patients. A variety of synthetic and natural substitutes have also been used for corporeal reconstruction to repair the distal erosion. These include polyester, polypropylene mesh, PTFE, rectus fascia, and fascia lata. There was a report of the use of human cadaveric allograft skin for reconstruction of the corpus cavernosum in the repair of distal erosion of a penile prosthesis (Landman and Bar-Chama, 1999). Smith and associates (1998) treated five patients with impending erosion of penile prosthesis with a PTFE distal windsock graft. All patients had satisfactory and functional erections after 32-month follow-up. Again, as mentioned earlier, use of synthetic material has been controversial, owing to a possible increased risk of penile prosthesis infection. We agree with Smith and associates (1998) that the simple addition of a synthetic graft will not increase the rate of penile prosthesis infection.
Urethral erosion is a more difficult problem to manage. As a preventive measure, it is recommended that a temporary proximal urinary diversion be performed in patients who are undergoing self-intermittent catheterization and desire a penile implant. We prefer perineal urethrostomy. When urethral erosion is diagnosed, the eroded cylinder should be removed and inserted at a later date after the urethra heals completely. It is important to determine whether there is a communication with the cylinder on the opposite side during the surgery. If this cylinder is not involved, it can be left in place to help maintain the length of the penis; otherwise, this cylinder should also be removed if it is communicating with the erosive process. Whether the remainder of the prosthesis should be kept or removed depends on the duration of the erosion and the associated infection. Should any question about the infection of a multicomponent exist, the device should be removed and a salvage procedure performed.
Certain clarifications should be discussed regarding the data presented in Table 47–6. The American Medical System (AMS; Minnetonka, Minn) 700 series was performed before Dacron sleeve reinforcement of the cylinders and the double-wall layer of silicone, which is present in the 700 CX and Ultrex Plus. The AMS-PPT was an investigational device. Many of the mechanical failures reported by Wilson for the Mentor Corporation device were metallic connector problems; these connectors were subsequently discontinued. Although the follow-up data for the AMS-700 were from the same institution in the reports by Furlow and colleagues (1988) and Lewis and McLaren (1993), the increased mechanical failure in the latter report was the result not only of longer follow-up but also from the fact that the latter report included patients who had the device placed at other institutions as well. The earlier report and the later 1995 report by Lewis included only patients who had the original device placed at the Mayo Clinic.
The unusually low mechanical failure rate of the AMS-700 CX reported by Quesada and Light (1993) has not been the experience of many other implanters; silicone polymer cylinders do have significant wear reported in other series. However, series with higher rates of secondary placement usually result in higher subsequent mechanical failure, perhaps suggesting a difference in wear owing to patient variability in handling the device.
In summary, what can be said about mechanical reliability of the modern penile prosthesis based on analysis of the reported literature? We must try to base our knowledge of long-term reliability of a particular device only after it has been followed for at least 5 years, which has been difficult in the past because of the many design changes in response to attempts to deliver an improved device to the patient. Real-time follow-up, preferable in a prospective manner, versus life table statistics is a better way of determining actual mechanical reliability of a given prosthetic. It is preferable to have large populations followed by single institutions or a combination of institutions with significant numbers from each participant. Some multigroup reports indicate that two or three implants were used per participant. For patients who have primary placement of a modern penile prosthesis, reoperation for mechanical failure can be expected in 5% of the cases when the device has been in place for 5 to 10 years. The chance of mechanical failure is greater in patients who have experienced previous prosthetic problems. These patients requiring secondary placement also have a more significant risk for infection, as well as those with other predisposing infection risk factors.
In operating for leakage of fluid from an inflatable penile prosthesis with tubing connectors, exploration of the connector sites first is recommended, because this is the area most frequently associated with pressure-induced failure. This complication, of course, is less likely to occur in those devices in which connectors between the cylinders and the pump have been eliminated. If only a connector has to be replaced in the AMS device, a tie-on connector has to be used instead of the quick connector. The second most likely source of fluid leak after tubing and tubing connectors is the cylinders, and the site of wear is most often near the input tubing attachment. It is rare to find reservoir problems or leakage in the three-piece inflatable devices. Hydraulic rupture of encapsulation of a reservoir, when a problem, can usually be accomplished at the tubing connector site, and exposure of the reservoir is rarely needed. When replacing a failed part of a multicomponent device, it is recommended that, if the device has been present for 5 years or longer, all of the device be replaced.
The patient needs to be informed that reoperation, particularly the reoperation involving corporeal reconstruction, may have 10 to 20 times higher infection rates (Jarow, 1996). For a patient with multiple histories of prosthetic removal from infection, 3 days of cephalexin preoperatively are also used to maximize the prevention of reinfection. We also suggest that these patients have a Hibiclens scrub every day for 3 days preoperatively. Immediately preoperatively, the patient receives parenteral antibiotic therapy. If the patient is a diabetic or has a history of prior infection with the prosthetic device, the best antibiotics are a vancomycin-gentamicin regimen. We use a single dose of vancomycin (1 g IV), and gentamicin (5 mg/kg IV), preoperatively. A vancomycin-gentamicin regimen is given for 24 hours postoperatively. Oral cefazolin or ciprofloxacin is given thereafter for 4 to 6 weeks to patients who underwent reoperation because of an infection or for a complex reoperation.
The most difficult problem in reoperation is intracorporeal fibrosis. It is often necessary to make more than one corporeal incision to prepare a space for placement of a new cylinder. A penile scrotal incision may be the best for total corporeal exposure. Some prefer a midline perineal incision (Rajpurkar et al, 1999). Sometimes, it is necessary to develop a plane between the dense fibrotic tissue and the internal surface of the tunica albuginea sharply under direct vision. Special tools such as the Carrion-Rossello cavernotomes may be helpful ( Fig. 47–16). These cavernotomes are sized 9 to 12 mm with cutting rasp–like surfaces, which enhance passage through the fibrotic tissue. A new penile cavernotome that allows drilling a space in fibrotic corpora was reported by Mooreville and associates (1999) ( Fig. 47–17). If there is a paucity of tunica albuginea for coverage after removal of the fibrous tissue, it may be necessary to cover the cylinder with a patch of Dacron, PFTE, or newer acellular prepared tissue.
Even with optimal corporeal dilatation, the standard penile prosthesis cylinder will be unable to be placed in the majority of cases of severe fibrosis without corporeal reconstruction. We now have more choices for penile prostheses than at any time before. As a matter of fact, we are now routinely using downsized versions of prostheses (Mentor Alpha 1 [Narrow Base] and AMS 700 CXM) for patients with severe corporeal fibrosis. We have found the Mentor Alpha 1 (Narrow Base) to be very useful because of its narrow-base feature, better girth expansion, and softer tip than the AMS 700 CXM. Carbone and coworkers, in 1998, also reported their experience in the management of severe corporeal fibrosis with placement of the AMS 700 CXM prosthesis. In all 26 men with severe corporeal fibrosis, the AMS 700 CXM prostheses were successfully implanted with primary closure of the tunica albuginea without need for corporeal reconstruction.
Even after successful penile prosthesis implantation in patients with extensive penile fibrosis, some patients will complain of insufficient penile length for satisfactory sexual intercourse. It is important to discuss limitations of the reoperation for penile implantation thoroughly to make sure that patients understand the penile shortening is caused by severe fibrosis and scar contraction. Use of AMS 700 Ultrex or Ultrex Plus with a hope of length enhancement has been disappointing. Daitch and associates (1997) also demonstrated that Ultrex cylinders exhibited an increased mechanical failure rate. If functional penile length will not reach more than 10 cm after implantation of a penile prosthesis, then release of the suspensory ligament,V-Y flap advancement, and/or lower abdominal tissue debulking may gain an additional penile length. Knoll and associates (1996) reported their experience in 11 patients with extensive cavernous fibrosis who underwent penile prosthesis implantation with a modified suprapubicV-Y advancement flap and lower abdominal tissue debulking. An additional 3.5 to 6.5 cm of functional penile length was obtained.
Patient and Partner Outcome
Use in Peyronie's Disease
VASCULAR SURGERY FOR ERECTILE DYSFUNCTION
Patients with arterial disease or a combination of arterial and veno-occlusive disease should be offered an in-depth discussion of alternative therapeutic choices such as vacuum constriction devices and penile prostheses. Many patients with mild to moderate vascular disease will also respond to vasoactive agent injection or oral sildenafil with improved erections that are suitable for vaginal intercourse.
Criteria for recommending surgery for a veno-occlusive disorder consist of the following: (1) a patient complaint of short duration erections or tumescence only with sexual stimulation, (2) failure to obtain or maintain an erection from the use of oral sildenafil and/or intracavernous injection on multiple trials with different agents with sexual stimulation, (3) normal cavernous arteries on color duplex Doppler studies or second phase of DICC, (4) a faulty veno-occlusive mechanism as determined by infusion pump or gravity pharmacocavernosometry that is amenable to surgery (no massive venous leakage), (5) location of the site of venous leakage from the corpora cavernosa on pharmacocavernosography, (6) no medical contraindication to surgery, (7) complete elimination of tobacco use, and (8) selection of presentation of alternative therapeutic choices in the presence of a long-term success rate of 40% to 50%. It is a rare patient who should be offered venous surgery for the treatment of ED. Wespes and coworkers (1994) have suggested that responders to surgery need to have a crucial percentage of smooth muscle (>29%) present in the cavernosal tissue. In fact, the same authors, in 1997, question the wisdom of venous surgery because sinus smooth muscle seems to play such a crucial role in the veno-occlusive mechanism (Wespes et al, 1997). But when smooth muscle content is determined before surgery, as a criteria for selection, long-term results are not better, being 52% at greater than 1 year (Sasso et al, 1999).
Hatzichristou and Goldstein (1993) have presented an excellent description of penile revascularization surgery, stressing microvascular arterial surgery principles updated by Mulhall and colleagues in 1999. Surgical technique is illustrated in Figures 47–18 through 47–20, and the general nature of this type of vascular surgery is presented in Table 47–9. Certain points of technique need to be stressed. There is no single type of revascularization surgery that fits every case (see Fig. 47–19).
The preoperative arteriogram is necessary for selection of the preferable recipient vessel. It is preferable to connect the donor arterial vessel, usually the inferior epigastric artery (occasionally in the absence of a suitable epigastric artery, a saphenous vein connected to the femoral artery may serve as the input arterial supply), to a branch of the dorsal penile artery in an end-to-side fashion or, when able, with an end-to-end anastomosis, which allows the most efficient runoff. This is possible if the dorsal artery has demonstrated good connections to the intracavernosal deep penile artery on the preoperative arteriogram. When there is no such connection nor suitable dorsal arteries, revascularization of an isolated segment of deep dorsal vein with good communicators to the intracavernous tissue is the choice for recipient vessel. Another possibility is the use of a Y-branch of the inferior epigastric artery or two inferior epigastric arteries for anastomosis to the dorsal artery and an isolated segment of deep dorsal vein.
The dissection of the epigastric artery incorporates the accompanying veins, because separation is almost impossible or would be too time-consuming to control bleeding venous branches. Usually, branches isolated during the dissection are both artery and vein, which can be commonly ligated or clipped using small vascular clips. The inferior epigastric artery is dissected as far distally as possible, usually to, or slightly above, the level of the umbilicus. Small branches near its origin are also ligated or clipped so that, once divided, the full arterial length can be used as the artery is brought to the base of the penis for microscopic anastomosis in gentle curving nontension fashion.
The recipient vessel should be prepared before the inferior epigastric artery is divided. Hatzichristou and Goldstein (1993) recommend preservation of the fundiform and suspensory ligament of the penis. I prefer an end-to-end anastomosis to the deep dorsal vein if this is the vessel to be used and thus take down these structures to prepare a good free vein for anastomosis. I do reanastomose the base of the penis back to the infrapubic periosteum after such vein preparation with a silk suture. When anastomosing to the deep dorsal artery in either an end-to-side or an end-to-end fashion, the two ligaments can be preserved. The initial multiple branches of the deep dorsal vein near the glans are ligated with a nonpermanent suture, as well as large trunks of the deep dorsal vein that anastomose to the spongiosum laterally along the shaft of the penis. Valves in the deep dorsal vein are removed with a 2-mm LeMaitre valvulotome or a similarly sized Fogarty balloon catheter. Adventitia is removed only at the sites of anastomosis of the two vessels. The anastomosis is accomplished microscopically using 8-0 to 10-0 monofilament vascular suture. I prefer the 10-0 suture. The vessels are clamped with low-tension vascular bulldog clamps. The inferior epigastric artery is usually flushed with a dilute heparin and/or papaverine solution just before the anastomosis.
For venous dissection and ligation surgery, the entire penis can be inverted into the wound for access to all-important venous channels along the shaft of the penis using a combination of sharp and blunt dissection. See Figure 47–21 for a general outline of the steps of venous dissection surgery. Communicating veins between the deep and the superficial system are ligated as exposed with absorbable suture because the patient will be able to palpate permanent ligatures, and these can often be a nuisance. After the penile shaft eversion is accomplished, a butterfly needle can be placed into one of the corpora cavernosa, fixing this in place with a purse-string ligature in the tunica albuginea, for introduction of indigo carmine for greater demarcation of draining cavernosal veins or intraoperative or postdissection pharmacocavernosometry.
As the penis is dissected more proximally and as the fundiform and suspensory ligaments are dissected and divided, communicating veins to the perineal side wall and the pubic regions are usually isolated and divided so that exposure of the deeper venous drainage system is facilitated. The suspensory ligament must be taken down in its entirety for proper exposure to the more distal deep dorsal penile vein and the cavernosal veins, when present.
Once the penis is fully mobilized, an incision in Buck's fascia directly over the deep dorsal penile vein is made in the midshaft, the vein is divided between ligatures, and then distal or proximal dissection is begun, ligating communicating tributaries encountered in this dissection of the deep dorsal vein or veins. Care is taken to stay in the midline over the deep dorsal vein to avoid injury to the slightly more laterally positioned dorsal penile arteries and penile sensory nerves. Distally along the penile shaft, the dissection of the deep dorsal vein is taken to 1 to 1.5 cm from the glanular sulcus where the multitrunk origins of this vein are dissected and individually ligated.
Along the penile shaft, communicating circumflex veins near the corpora cavernosa and the spongiosum are identified, exposed under Buck's fascia, and ligated. Any use of electrocoagulation along the penile shaft should be performed with a bipolar unit to prevent transmission of possible coagulation to arteries or nerves of the penile shaft. The deep dorsal vein is dissected proximally to under the pubis, where it is ligated with a heavy permanent suture. It is in this area that the cavernosal veins can be found for dissection and ligation. Some expert surgeons also recommend crural plication sutures along the lateral surface of the tunica albuginea of each of the corpora cavernosa.
An attempt is made after the venous dissection to reapproximate the suspensory ligament attachment of the base of the penis, using a permanent suture from the pubis to the midline tunica albuginea of the corpora in the midline sulcus, where the deep dorsal vein had been. A fenestrated tubular drain is placed in the infrapubic regions and exits out a separate stab wound where it is affixed to the skin. This stays usually for 24 to 48 hours and is removed at the time of minimal drainage. The skin closure is done carefully to match the various layers of depth and equal side-to-side approximation; failure to do so will result in dense fixation of this scrotal or infrapubic skin to the penile shaft. A loose elastic dressing is applied to the penile shaft, and the catheter is usually removed the following morning. This dressing is used to avoid glanular edema. Some authors recommend perineal plication procedures or spongiolysis, which I have described in a previous publication, but these procedures are rarely indicated (Lewis, 1993).
Two significant complications of penile vascular surgery are penile numbness, or hypoesthesia, and penile shortening from scar entrapment, which is experienced in as many as 20% of patients. Penile sensation usually returns 12 to 18 months after surgery if no major penile sensory nerve has been significantly severed. The penile shortening from severe scar entrapment may require subsequent scar release surgery and the use of relaxing Z-plasty incisions or scrotal flap coverage.
Mechanical disruption of the microvascular anastomosis has been reported by Hatzichristou and Goldstein (1993). Resumption of sexual activity should begin 6 weeks after this surgery. Another complication of deep dorsal penile vein arterialization is glans hyperemia, which occurs when a communicating vein from the revascularized deep dorsal vein to the glans in the distal dissection is missed. Surgical exploration and ligation of the arterialized communicator resolves the problem.
SURGERY FOR PRIAPISM
When a shunting procedure is indicated, the use of a transglanular to corpus cavernosal scalpel or needle core biopsy technique of Ebbehoj or Winter is the first reasonable approach (Ebbehoj, 1974; Winter, 1976). The El-Ghorab procedure, illustrated in Figure 47–22, is a more aggressive open surgical modification of this type of shunting maneuver (Ercole et al, 1981). On the rare occasion that more involved surgery is needed, the best is that described by Sacher and coworkers (1972) through a perineal approach, as seen in Figure 47–23. One caution should be stated about this approach. The anastomotic windows should be placed at different levels so that a urethral stricture can be avoided. The suture used for this procedure is 2-0 chromic catgut.
In those patients who have postarterial traumatic high-flow priapism and fistulous flow into the cavernous tissue that the interventional radiologist has been unable to embolize, careful surgical approach to ligate the feeding arterial vessel is needed. I have performed this procedure in three individuals using intraoperative color duplex ultrasonography to help localize the site of entry into the corpus cavernosum, to localize the feeding vessel above the tear for ligation. Surgery was successful, and, after 6 months, all had regained potency, presumably by collateral circulation, because permanent suture material was used for ligation. All of the patients were young individuals who had sustained some perineal trauma.
The literature associates Peyronie's disease with many entities. Some have stood the test of time; in others, the association has not. In a study published by Nyberg and colleagues, Peyronie's disease was associated with Dupuytren's contracture. Dupuytren's contracture has a familial pattern known to be transmitted in an autosomal dominant pattern. Thirty percent to 40% of men with Peyronie's disease will also have Dupuytren's contracture (Nyberg et al, 1982; Ralph et al, 1997). Other associated conditions are plantar fascial contracture (Lederhose's disease) and tympanosclerosis. Peyronie's disease is also reported as seen in patients with external trauma to the penis, diabetes mellitus, gout, Paget's disease, use of β blockers, use of phenytoin, and urethral instrumentation (Carrieri et al, 1998). An example, however, of an association that has not stood the test of time is that of phenytoin. In the postmarketing study for phenytoin, there were patients taking phenytoin who developed Peyronie's disease. Because phenytoin is associated with hyperplastic tissue growth phenomena, the association of Peyronie's disease to phenytoin was made and published in thePhysicians' Desk Reference. No other report of a causal relationship, and, in fact, no other report linking phenytoin use with Peyronie's disease, has been published.
The symptomatic incidence of Peyronie's disease has been estimated at 1%. In white men, the average age at onset of Peyronie's disease is 53 years. The asymptomatic prevalence is estimated at 0.4% to 1.0%. In another study of 100 men without known Peyronie's disease, 22 of the 100, on autopsy, were found to have fibrotic lesions of the tunica albuginea compatible with Peyronie's disease (Smith, 1969; Gelbard et al, 1990; Lindsay et al, 1991; Carson et al, 1999). There clearly is a suggestion that the clinical incidence of Peyronie's disease is increasing. This increase, however, may be associated with, and seems to coincide with, the use of erection-enhancing medications.
In examining the etiology of Peyronie's disease, it is important to review some facts concerning the anatomy of the corpora cavernosa ( Fig. 47–24). The tunica albuginea is bilaminar throughout most of its circumference. It is composed of an outer longitudinal layer and an inner circular layer. The corpora are separated by an incompetent septum. In the pendulous portion of the penis, there are intracavernous supporting fibers that anchor the inner layer of the corpora cavernosa at the 2-o'clock and 6-o'clock positions. The tunica albuginea varies in thickness from 1.5 to 3 mm, depending on the position on the circumference. The outer longitudinal layer attenuates in the ventral midline, and thus the tunica is monolaminar at that point. The outer longitudinal layer is thickest on the ventrum adjacent to the corpus spongiosum and on the dorsum and thinnest on the lateral aspect. Most patients with Peyronie's disease demonstrate lesions dorsally. Because the tunica albuginea is bilaminar on the dorsum, with buckling trauma, it is possible that these layers might delaminate. Also, on the ventrum, as mentioned, the longitudinal layer is absent, thus potentially allowing more easily for dorsal buckling (Devine and Horton, 1988; Border and Ruoslahti, 1992; Brock et al, 1997; Devine et al, 1997; Jarow and Lowe, 1997).
It has been proposed that the avascular nature of the tunica albuginea may impede clearance of many of these growth factors. The transforming growth factors, particularly transforming growth factor–β (TGF-β), are capable of autoinducement. Thus, the accumulation of TGF-β1 is capable of inducement of further accumulation. The presence of TGF-β stimulating further release of TGF-β1 could possibly lead to an ongoing, smoldering, inflammatory process ending with disordered healing. There is good reason to suspect TGF-β1 as possibly involved with the formation of Peyronie's plaque, because it has been implicated in a number of soft tissue fibroses as well as with ED (Border and Ruoslahti, 1992; Border and Noble, 1994; Davis, 1997; Diegelmann, 1997; Van De Water, 1997; Moreland, 1998).
TGF-β1 is synthesized as a latent peptide by many cells; those pertinent to this discussion are platelets, macrophages, and fibroblasts. On activation, TGF-β1 binds to cell surface receptors and eventually results in synthesis of connective tissues with inhibition of collagenases (El-Sakka et al, 1997a, 1997b, 1998). The net results of this trauma with disordered healing is the formation of plaques that appear like scars and impede expansion of the tunica albuginea during erection, which results in curvature, indentation, and/or foreshortening ( Fig. 47–26).
When the urologist is confronted with a patient with Peyronie's disease, it is imperative that he or she understand the mindset of that patient, and indeed of the couple. It has been shown that couples with the male with Peyronie's disease, when compared with age-matched adult couples, seem to engage in more frequent intercourse, more vigorous intercourse, and often use positions of intercourse that are potentially traumatic to the penis. These couples seem to relate by intercourse. It could be said that Peyronie's disease is a disease of aging tissue in a patient with a youthful libido (Williams and Thomas, 1970; Gelbard et al, 1990; Jordan, 1998).
The relationship of ED in Peyronie's disease is a very difficult one to ascertain. Mention of ED after surgery begins with the first report of surgery for Peyronie's disease (Lowsley and Boyce, 1950) using excision and grafting. In that series, ED postoperatively was a major source of failure. Interestingly, in that series, patients with ventral curvature were singled out as particularly at risk. The poor prognosis for that group of patients seems to persist into current series. Returning to articles concerning the natural history (Williams and Thomas, 1970; Gelbard et al, 1990), ED again is prominently mentioned in both. In Gelbard and colleagues' manuscript (1990), a large number of patients discussed poor erections/ED. In that analysis, almost 80% of the patients complained of "the psychological effects" of Peyronie's disease. Of note is the fact that of those 80%, 70% complained that their psychological complaints did not improve, despite the fact that their disease went into a quiescent phase. A major failure of the literature is that patients are not stratified with regard to functional issues versus organic issues as they relate to ED.
Since Brock and Lue's analysis (1993), there are now 9 or 10reports that have attempted to stratify patients preoperatively with functional testing. In those articles, there is wide variance of opinion concerning the coexistence of ED with Peyronie's disease. Jordan and Angermeier (1993) showed ED in almost 100% of patients; Jarow and Lowe (1997) showed 76 of 95 patients were impotent by testing; and Ralph and coworkers (1992) showed that, of 20 patients with ED who were studied with duplex ultrasonography, 90% had complaints of ED because of functional, not organic, causes. Thus, what is in the literature is not clear other than the fact that patients preoperatively complain in large numbers of the psychological impact of their Peyronie's disease, and those psychological aspects continue to plague good surgical results.
Jones (1997) deals best with the counseling issues of men with sexual dysfunction. His comments are based on interviews in over 1500 men with Peyronie's disease. He describes counseling a patient with Peyronie's disease as being much the same as counseling a person who has suffered a death and is grieving. As with death, grieving is complicated by denial, ambivalence, anxiety, depression, shame, embarrassment, and, in the case of this particular group of patients, self-disgust. Most of these patients are not good talkers. Jones (1997) suggests that these patients tend not to like to talk about their problems with their spouses and spurn counseling in many instances.
A major point made by Jones (1997) in dealing with Peyronie's patients is that to avoid/limit emotional factors, patients and their partners need to hear the suggestion that they must "keep sexual expression alive, be active to whatever degree possible at every stage of the progression or regression of their Peyronie's disease course." Patients' understanding of Peyronie's disease is made worse many times by the comments of urologists and primary care physicians who in general likewise do not understand the disease. Many patients have been told that Peyronie's disease is probably the end of their sex life. Many of these couples have related by the belief that "sex was intercourse." Thus, when coitus is precluded, they avoid all sexual activity. Most men with Peyronie's disease have ignored, at one point, the plea of their partners who have asked for intimacy regardless of whether there was intercourse. As mentioned, the relationship of the functional aspects to the organic aspects remains elusive. To define these aspects, there must be uniformity in history taking; there must be uniformity in preoperative assessment with regard to erectile function; and, in failures, there must be uniformity in postoperative assessment with regard to ED.
The presenting symptoms of Peyronie's disease include (1) in many patients, penile pain with erection; (2) penile deformity; (3) shortening with and without an erection; (4) notice of a plaque or indurated area in the penis; and (5) in many patients, ED. On physical examination, virtually all patients have either a well-defined plaque or an area of induration palpable. The plaque is usually located on the dorsal surface of the penis, intimately associated with the insertion of the septal fibers. Patients not uncommonly can tolerate rather significant dorsal curvature (up to 45 degrees). Patients with lateral components or ventral Peyronie's disease tolerate deformity far less well.
Pain may be persistent in the inflammatory stage of the disease; it is usually not severe, but it can interfere with sexual function. Some patients also complain of being awakened in the morning with pain during their erection. Spontaneous improvement in pain virtually always occurs as the inflammation resolves. A small group of patients with extensive disease will have "circumferential plaques" and, owing to the resulting hinge effect, an unstable penis. Most patients, however, complain of distal flaccidity. In DICC studies, it was found, however, that the pressures were equal proximally and distally in the plaque (Jordan and Angermeier, 1993). There is, however, variance of opinion with regard to the cause of distal tip flaccidity, with one study using ultrasound seemingly showing cavernosal fibrosis that ostensibly could interfere with distal perfusion of the corpus cavernosum (Ralph et al, 1992). However, this study comes from a center that, at the time of the writing of that study, has dealt with the deformity of Peyronie's disease with plication techniques only. Thus, to our knowledge, there is no corroboration of the finding of diffuse cavernosal fibrosis when these patients were taken to the operating room (Ralph et al, 1996).
When the urologist is confronted with the patient with Peyronie's disease, the medical history should include the mode and time of onset (sudden vs. gradual). The course of disease is helpful with regard to determining the phase the patient is in. History of prior penile surgery, urethral instrumentation or external trauma, medication or drug abuse, and history of fibromatosis including Dupuytren's, Lederhose, and, of course, Peyronie's disease must be included. Family history of the other fibromatoses is revealing. Because most patients with Peyronie's disease have an element, or at least the aura, of ED, risk factors for ED should also be assessed. Detailed psychosexual history is imperative. Photographs of the patient's erect penis are very helpful in identifying the direction of curvature and degree of curvature, and they provide some information with regard to the patient's erectile function.
The penis should be examined on stretch. This helps identify the location and size of the plaque as well as defining its consistency (e.g., tender, indurated). The hands and feet must be examined; and in the rare patient, the examination of the ears will identify tympanosclerosis. Although many patients will have thickening in the palmar area of the dominant hand, except in manual laborers, callus formation in the palmar area of the nondominant hand is indicative of Dupuytren's contracture. A sketch of the penis, including stretched penile length, is helpful for record keeping.
The literature is filled with treatment protocols. It is imperative to understand that these should be used only as guides. Individualization with regard to patients' requirements (their findings and assessments) is imperative. This individualization will allow us to determine which patients require only reassurance, which need vigorous investigation, which are appropriate to treat with medical management, and which few patients are appropriate to treat with surgery.
Tamoxifen, it is believed, facilitates the release of TGF-β from fibroblasts. Teloken (1999), in a small controlled report, used tamoxifen versus a placebo and did not demonstrate a therapeutic advantage. Should one desire to prescribe tamoxifen, it is used at a dosage of 20 mg twice daily. The use of colchicine was originally proposed by Gelbard (personal communication, 1995). There are no blinded or controlled studies that have examined the use of colchicine (Akkus et al, 1994). Four actions are attributed to colchicine. Colchicine binds tubulin and causes it to depolinerize and thus inhibits mobility and adhesion of leukocytes. It inhibits cell mitosis by disrupting spindle cell fibers and thus functions as a potent anti-inflammatory agent. It blocks the lipoxygenase pathway of arachidonic acid metabolism, furthering its anti-inflammatory effect. It interferes with the transcellular movement of protocollagen. Colchicine is reasonably well tolerated. Approximately one third of patients, however, will have diarrhea. It is inexpensive. If used, the dosage is 0.6 mg three times per day with meals. Nonsteroidal anti-inflammatory drugs and corticosteroids have been used anecdotally, based on the belief that inflammation was integral to the development of Peyronie's disease. There are no studies that support an indication for the use of these drugs.
A number of intralesional injection protocols have been examined. Teasley reported the use of intralesional corticosteroids, as did a number of other studies (Bodner et al, 1954). It is the recommendation of the consensus committee on penile curvatures that the use of intralesional corticosteroids be eliminated or at least initiated with extreme caution because of the rather significant local side effects, the inconsistent pattern of improvement in well-established curvature, the lack of studies showing proven efficacy, and reports of patients who believed their condition deteriorated after the injections (Jardin et al, 1999).
The calcium antagonist verapamil was first used as intralesional therapy and results were reported by Levine and colleagues (1994). A number of nonblinded studies have suggested efficacy with the use of intralesional verapamil. There are no blinded studies that suggest that the use of verapamil as an intralesional agent is efficacious. A number of injection protocols have been discussed. A "full course" could consist of 12 injections (10 mg/10 ml) given once every 2 to 4 weeks. Realistically, up to that total dose, injections are discontinued when satisfactory improvement is noted.
The use of purified clostridial collagenase was first studied in vitro by Gelbard and associates (Gelbard et al, 1982, 1983). Collagenase has since been subjected to two double-blind studies (Gelbard, 1993; Jordan, in preparation).Intralesional collagenase is available only on study protocol. Both double-blind studies and an open-label study have suggested some efficacy.
Verapamil is well tolerated. Complications are associated only with the injection procedure per se and are minimal. Almost all patients injected with interferon develop a "flu-like syndrome." It is expensive, and, given the lack of blinded studies, its use cannot be recommended. There currently is enthusiasm for the topical use of verapamil, but no blinded studies have been done to show efficacy. Corticosteroids have been used in association with ultrasound (iontophoresis). Again, no blinded studies have shown efficacy. Currently, protocols are examining the use of ultrasound with topical verapamil.
Surgical Correction of Peyronie's Disease
Lue (Akkus et al, 1997; Gholami and Lue, accepted for publication) performs a correction in which he omits the excision of the tunica albuginea and merely plicates the opposite aspect of the corpora cavernosa. Although this technique historically did not yield durable results in patients with congenital curvature, in the patient with Peyronie's disease, in whom accumulated intracavernosal pressures are probably less, it possibly can be expected to be more effective. Lue emphasizes the use of permanent suture that is "loosely tied" to correct the deformity. Although the techniques of both Pryor and Fitzpatrick (1979) and Lue are valid in some patients, many patients are already concerned by the shortening of their penis as a result of Peyronie's disease, and, thus, surgery that offers the suggestion of further shortening of the penis is unacceptable. Likewise, the use of permanent suture as described by Lue is not well accepted by some patients. The procedure described by Yachia (1993) and discussed in Chapter 110 under the correction of congenital curvatures represents a corporoplasty technique that can be very effectively used for curvatures associated with Peyronie's disease. Plication and corporoplasty techniques seem to be useful especially for patients with associated ED where grafting procedures could be expected to cause further deterioration of erectile function.
Gelbard (1989) described a surgical technique that involved incising the plaque of Peyronie's disease. He reported a series of patients in whom incisions were made in the plaque and grafts of temporalis fascia were used to fill the defects. His technique was based on the theory that by creating a number of incisions, thus expanding the scar, and then filling them with compliant material, a smoother correction of curvature would result. He has reported good results with this procedure.
Das and Amar (1982) described a procedure in which the plaque is excised and the corporotomy defect is filled with tunica vaginalis graft. They believed that the tunica vaginalis was an easy donor site for the urologist and that it gave the same results as the dermal graft. Our experience has been that tunica vaginalis is a suitable substitute for dermis in select patients with well-defined, small lesions. In patients in whom the corporotomy defect is large, however, we have not been pleased with the use of tunica vaginalis.
Lockhart (1991) has employed a procedure in which the plaque is excised and the corporotomy defect is closed using tunica vaginalis as an island based on a dartos fascial and cremasteric flap. He found that his results were better with the improved vascularity of the tunica vaginalis transposed as a paddle on a flap.
Buncke (cited in Stefanovic et al, 1994) reported an experimental animal series in which the lesion is excised and the corporotomy defect is replaced with temporalis fascia and transferred to the area of the penis as a microvascular free transfer flap. To date, this procedure has not been reported in humans.
Lue and El-Sakka (1998) have also described a procedure using incisions but patching the corporotomy defects with vein grafts. He initially believed that the excised deep dorsal vein provided an adequate donor site for his vein grafts. With time, however, he found that the donor site offered inadequate amounts of donor tissue, and he now harvests saphenous vein to create his vein graft patches. Lue believes that the intracorporeal space represents a large vessel, and, therefore, a patch of vessel wall represents a physiologic procedure. He reports good results with this procedure.
Krishnamurti (1995) reports the use of de-epithelialized penile skin used as a paddle carried on the dartos fascia. He cites increased dependability of flaps, not a fact that is totally validated in the literature. We have attempted to "de-epithelialize" penile skin using the dermabrader as described by Krishnamurti. However, histology of these "de-epithelialized islands" actually show many areas where the entire thickness of the skin has been removed. Thus, in our minds, the precise histologic composition of Krishnamurti's "epithelialized islands" is not clear.
Hellstrom (1994) has reported the use of a number of nonautologous grafts. Recently, Hellstrom and Reddy (2000) report the use of cadaver pericardium in a small series, and, currently, there are centers examining the use of inert collagen matrix patches. Our experience is that nonautologous "grafts" (e.g., Silastic, Gore-Tex, Dacron), in the absence of concomitant prosthetic implantation, inevitably yield poor results.
Devine and Horton (1974) described a procedure for correction of deformity of Peyronie's disease in which the plaque is excised and replaced with a dermal graft. We continue to use this procedure selectively in our center. In addition, we now also have a relatively large series of patients who have been treated by creating incisions through the plaque and patching the corporotomy defects with dermis. With the exception of those patients with severely calcified plaques, in recent years, we have preferentially used the technique of incision with dermal grafting. Our early results indicate that the technique of plaque incision is at least as successful as the technique of plaque excision; however, it has not yet been determined whether there is a difference between the techniques with regard to preservation of ED and/or limitation of the occurrence of graft-induced veno-occlusive dysfunction.
The initial skin incision is dependent on the location of the lesion. Ventral plaques can be approached through a midline incision of the ventral aspect of the penis, and dorsal plaques are most effectively approached using a circumferential incision. In the patient who has been previously circumcised, the incision should be placed through the original circumcision incision ( Fig. 47–27). In many patients, the circumcision scar may be displaced far down the shaft of the penis. We have not encountered any problems, however, with reapproaching the penis through the circumcising incision, even when this is the case.
The shaft of the penis is then degloved to its base. This maneuver gives good exposure for mid-shaft and distal lesions. For proximal plaques, or in patients who have relatively redundant foreskin, a second incision is created on the scrotum, lateral to the base of the penis ( Fig. 47–28). After degloving the shaft of the penis, it is delivered into the scrotal incision, laying the shaft skin aside and covering it with a warm sponge. This protects the penile skin from trauma until the end of the procedure, when it is returned to the shaft. Optionally, a counterincision can be made at the penoscrotal junction in the scrotal raphe.
The dorsal neurovascular bundle is elevated in concert with Buck's fascia. This can be accomplished by several techniques. Incisions can be made just lateral to the corpus spongiosum, with Buck's fascia and the dorsal neurovascular bundle dissected off the lateral and dorsal aspects of the corpora cavernosa. Alternatively, we currently approach dorsal plaques by dissecting sharply through the bed of the deep dorsal vein and perform a modified vein dissection ( Figs. 47–29 through 47–31). We initially used this approach to investigate the potential effect of a modified vein dissection with regard to limitation of graft-induced veno-occlusive dysfunction. Although the beneficial effects of this are yet to be determined, approaching the dorsal plaque through the bed of the dorsal vein appears to be a superior approach technically.
In the past, if preoperative testing suggested veno-occlusive dysfunction, we proceeded with a formal vein dissection, ligation, and excision. More recent experience has shown, however, that vein dissection does not offer durable results in patients with Peyronie's disease, and it is currently believed that patients who demonstrate severe veno-occlusive dysfunction are better treated by using a surgical approach to straightening the penis and prosthetic implantation for their ED. Optimally, some patients might do well with a plication or corporoplasty technique and then postoperatively undergo management of the ED pharmaceutically.
After dorsal exposure of the tunica ( Fig. 47–32), the inelasticity of the plaque will be evident, and its extent can be delineated by feeling the surface of the tunica albuginea. An artificial erection accurately defines the curvature. Incisions are then planned to either incise or excise the plaque. We use Prolene to place stay sutures in the midline, proximal and distal to the plaque, and mark the planned incisions. Depending on the technique selected, the plaque can be excised or incised ( Figs. 47–33 and 47–34). If an excisional technique is employed, lateral incisions in the tunica are used to convert the corporotomy defect from ovoid to stellate ( Fig. 47–35). This serves to release the tightness of the defect's edges and to increase the areas of the corporotomy defect by approximately 1.5 to 2 times the size of the plaque that was excised. We do not favor the use of a tourniquet for either control of bleeding or induction of an artificial erection, because tourniquets can conceal proximal curvatures.
Once the plaque has been excised, or incisions created, we measure the defect(s), stretching the penis to ensure accurate coverage. The dermal graft is then outlined on the donor site ( Fig. 47–36). We prefer to use the skin of the abdomen just above the iliac crest, lateral to the hairline. The graft site is de-epithelialized, either free-hand or using a dermatome. We discard the epidermis and then harvest and meticulously de-fat the dermal graft. The donor site is closed per primam with subcuticular sutures, using either a pull-out or the newer absorbable long-acting monofilament suture.
After completion of the dermal graft inlays, we anatomically close the penis. Buck's fascia is reapposed using PDS suture, and small suction drains are placed superficial to Buck's fascia but deep to the dartos layer. We then coapt the skin incisions using either chromic or small Vicryl sutures. If a ventral midline incision was created that crosses the penoscrotal junction, a Z-plasty should be used to prevent penoscrotal tethering.
In 1998, in suitable patients, we further modified our technique of plaque incision. The technique of incision was described by Lue. In this technique, the plaque is exposed as already illustrated and discussed. Artificial erection is used to identify the curvature and the point of maximal curvature ( Fig. 47–38). At that point an H-shaped incision is created and the flaps are allowed to slide ( Figs. 47–39 through 47–41). They are then sutured, leaving an approximately square defect. If there is indentation, the flaps are darted, allowing for expansion. A graft is then sutured into the defect ( Figs. 47–42 and 47–43). It is clear that the penis can be effectively straightened with this incision and graft technique alone in about 70% of patients. Thirty percent will require touch-up plication or corporoplasty. It is also clear that graft size is limited, whether it be dermis or vein. It is not clear whether this technique is more reliable or effective with regard to preservation of erectile function.
The penis is dressed with a Bioclusive dressing, loosely applied and extending from the base of the penis to the level of the mid glans. A mildly compressing Kling dressing is wrapped over the Bioclusive dressing, to limit edema and allow better collapse of the surgical spaces around the suction drains. The Kling dressing is left in place for 4 hours, during which the glans is checked every 30 minutes. A No. 14-Fr Foley catheter is left until the patient ambulates on the morning after surgery. The suction drains are removed on the first postoperative day, and usually the patient is discharged on that day. We suppress erections with diazepam and amyl nitrite.
Dermal grafts mature in the same manner as other grafts: first nourished by imbibition of tissue fluids while inosculation occurs from adjacent blood vessels. Remodeling takes place during the late phase of maturation, with the graft tending to first contract and then become compliant. In the first 3 months, the graft may contact enough to re-create some of the curvature, but, as the graft softens, straightening occurs. This is seen less in patients who have had incisions as opposed to excisions. Patients should be forewarned of this sequence of events to avoid undue anxiety.
Although there is a place for prosthetic implantation in the treatment of ED associated with Peyronie's disease, in our experience, most patients do not require prosthetic placement. However, patients who demonstrate poor erectile function before contemplation of surgery are properly treated with prosthetic placement and an associated procedure to straighten the penis. Prosthetic techniques are addressed earlier in this chapter.
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