0022-534 7/78/1193-0001$02. 00/0 THE JOURNAL OF UROLOGY Copyright © 1978 by The Williams & Wilkins Co.
Vol. 119, March Printed in U.SA.
SMALL-CARRION PENILE PROSTHESIS: A REPORT ON 160 CASES AND REVIEW OF THE LITERATURE MICHAEL P. SMALL* From the Department of Urology, University of Miami School of Medicine, Miami, Florida
The use of the Small-Carrion penile prosthesis in 160 patients is evaluated. Methods to determine those patients who will benefit from the use of this prosthesis and the size prosthesis needed are discussed. Suggestions are made on how to handle problems or complications that may occur during or after the operation, as well as the antibiotic regimen. The literature is reviewed. A search continues for the best penile prosthesis and the most accurate way to determine those patients who will benefit from its use. Herein is evaluated the use of the SmallCarrion penile prosthesis in 160 patients, with a discussion on the complications and the areas of potential problems to the surgeon. METHODS
The Small-Carrion penile prosthesis is available in 13 standard lengths and 2 diameters, as well as in custom sizes. t Standard lengths are 13.3, 14.5, 15.8, 17.0, 18.0, 19.0, 20.0 and 21.0 cm. and diameters are 0.9 and 1.1 cm. with the 18.0 length, as well as all longer prostheses routinely available in the 1.3 cm. diameter tapered to a 1.1 cm. diameter tip. Since it is extremely difficult to determine the size prosthesis needed before the operation all sizes should be available. The technique to measure the corpora by instilling fluid is not recommended since this provides only a gross estimation of the size prosthesis required. 1 The surgeon can get an idea of the size prosthesis needed from the length of the Regar dilator that the corpora accept. However, since this is just an estimate various sizes of prostheses should be tried to determine the proper length and width. It is important to have a proper fit since a prosthesis that is too short may allow flexion of the glans and possible subsequent erosion through the corpora. If the nearest size prosthesis is slightly too long a portion of the proximal solid medical grade silicone can be trimmed so that it will fit properly distally. Usually, the 17.0 or 18.0 cm. length prosthesis with the wide diameter is required (table 1). However, recently I have seen an increased need for the 18.0 cm. length with the 1.3 cm. diameter tailored to a 1.1 cm. tip as well as the 19.0 cm. length in the 1.3 cm. diameter. A narrow diameter is needed for patients in whom it is extremely difficult to dilate the corpora cavernosa because of prior priapism, inflammatory disease of the corpora or extensive penile trauma. An occasional patient will require 1 length of prosthesis on one side and a different length on the contralateral side to make the penis as normal-appearing as possible in the area under the glans. These patients usually are those who have had a pelvic fracture with bone displacement or some patients with Peyronie's disease. To help prevent postoperative wound infections the following antibiotic regimen should be followed: 1) 160 mg. tobramycin sulfate intramuscularly on call to the operating room, 2) after autoclaving soak the prosthesis in a polymyxin B Accepted for publication April 15, 1977. * Requests for reprints: 7413 Miami Lakes Drive, Miami Lakes, Florida 33014. tHeyer Schulte Corporation, Goleta, California.
sulfate/neomycin sulfate solution while the patient is prepared for the operation, 3) 200 mg. doxycycline hyclate intravenously during the operation, 4) corpora and wound should be irrigated with polymyxin B sulfate/neomycin sulfate solution, 5) 80 mg. tobramycin sulfate in 100 cc D5W intravenously on the evening of the operation, 6) tobramycin sulfate intramuscularly on the first 2 postoperative days (160 mg. in morning and 80 mg. in evening), 7) 200 mg. doxycycline hyclate intravenously on the first postoperative morning and 8) 100 mg. doxycycline hyclate orally every 12 hours for 5 days after the operation, starting 2 days postoperatively. The operative technique has been described previously. 2 A urethral catheter is used for identification only and is removed after the bladder is emptied at the completion of the operation. After the corpora cavernosa are entered and dilated and before insertion of the Small-Carrion penile prosthesis the corpora are copiously irrigated with the polymyxin B sulfate/ neomycin sulfate solution. After the proper size prostheses have been inserted the corpora are irrigated with the same solution as is each layer of closure of the wound. During the operation it is imperative that dilation of the corpora be done completely under the glans penis. This procedure enables the prosthesis to fit firmly in this area and not allow the glans to flex over the prosthesis. The dense tissue of the corpora allows easy dilation under the glans. However, care must be taken not to dilate in an overzealous manner since this may cause perforation into the urethra, the urethral-meatal junction or the glans. RESULTS
From February 1973 to December 1976, 160 patients have had the Small-Carrion penile prosthesis inserted (table 2). The patients ranged in age from 19 to 77 years. Complications have been minimal. There was a marked difference in the complication rate between patients treated before antibiotic coverage and those treated with antibiotics (table 3). The over-all complication rate has been less than 0.5 per cent. Pain is difficult to assess and is not considered a complication unless associated with infection. The majority of patients will have no pain upon discharge from the hospital. However, there are some patients in whom it will take 4 to 6 weeks before all evidence of pain or discomfort in the penis and perineum has disappeared. The first few times intercourse is performed a water soluble lubricant is recommended since there may be some discomfort in the glans. This discomfort generally subsides within a few days. DISCUSSION
Diagnosis. Impotence has been a diagnostic as well as a management problem to all physicians. It may be difficult to 365
1. Size prostheses used Diameter (cm.)
1 1 3
12 12 13.3 13.3 14.5 14.5 15.8 15.8 17.0 17.0 18.0 18.0
12 18 24 15 34
1.1 1.1 1.3 with 1.1 tip
* More than 160 because 4 patients have returned for insertion of a larger prosthesis. TABLE
20 patients who did not receive antibiotic coverage* Urinary retention (temporary) Severe wound infection with extrusion of prosthesis Incorrect placement of prosthesis Superficial wound infection, without sequelae Inability to insert prosthesis because of extensive corporeal scarring (post-priapism) 140 patients who received antibiotic therapyt Inability to insert prosthesis because of extensive scarring in corpora (post-priapism) Septicemia requiring removal of prosthesis, incision and drainage of perineum and abscess of corpora (diabetic) Urinary retention (diabetic) Paraphimosis-treated with dorsal relaxing incision Surgical perforation of glans (scleroderma)
2 2 1 3 1 1 1 1 1 1
* 3 serious complications. t 2 serious complications.
2. Small-Carrion prosthesis in 160 patients
Post-prostatectomy, cystectomy, abdominal-perineal resection Aorto-bifemoral bypass Post-priapism
Followup Mean Range (mos.) (mos.) 8-44
Excellent5, good-1 Excellent
Arteriosclerosis or venous insufficiency Spinal cord injury
r Epispadias and exstrophy Hypogonadism Scleroderma
Unable to implant prosthesis One patient had prolonged discomfort in glans Lost 1 prosthesis secondary to infection Plaque not incised Lost 1 prosthesis secondary to infection Required urethroplasty first Infection and septicemia with loss of both prostheses Small phallus Lost 1 prosthesis secondaryto surgical perforation of glans
* Of the 160 cases results were 152 excellent, 5 good and 3 poor.
determine the most effective form of therapy. In any discussion on penile prosthesis the question is when is insertion of a prosthesis indicated. Karacan and associates believe that the determination of whether to give psychological or surgical treatment for impotence necessitates more stringent diagnostic evaluations than have been used in the past. 3 They indicate that it is no longer a matter of pure academic interest to differentiate patients with biogenic impotence from those with psychological impotence. The importance of determining how patients will adjust psychologically to the restoration of erectile capacity is stressed. In their study of rapid eye movement tumescence
only subjects who had little or no nocturnal penile tumescence were recommended for an operation. The others were usually referred for psychological treatment. These authors believe that recordings of nocturnal penile tumescence are the only objective methods to make these determinations. Fisher also indicates that recordings of nocturnal penile tumescence are extremely important in evaluating the patient. 4 I believe that impotent patients who have undergone nocturnal penile tumescence studies and do have erections with rapid eye movement can be totally frustrated when the time for sexual relations approaches. These patients, who usually have psychogenic impotence, should probably have further evaluation, including sexual counseling and psychiatric or psychological evaluation. However, I have found that while counseling and psychiatric and/or psychological evaluation can help to determine the etiology of the impotence the problem often cannot be solved even after extensive therapy. It is these patients with psychogenic impotence who should be given strong consideration for a penile prosthesis if the patient has been cleared by a psychiatrist. Excellent results have been achieved in such patients. Nocturnal penile tumescence studies are being used in an increasing number of patients but whether this is the final answer as to whether a penile prosthesis should be inserted will have to await further laboratory and clinical evaluation. Most patients with impotence have some degree of psychogenic overlay but those with true psychogenic impotence must be evaluated carefully with the various modalities mentioned. Urologic and endocrinologic evaluation, as well as an empiric course of androgen therapy, is indicated in many of these patients. Kaufman indicates that a meticulous neurological evaluation and an assessment of peripheral vascular circulation also are necessary. 5 Osborne has evaluated the use of the Minnesota Multiphasic Personality Inventory test and indicates that it is useful in identifying some emotional factors in impotent patients that increase susceptibility to psychogenic impotence. 6 He also states that the patient and his wife should be seen together to determine if they have similar expectations from the operation and are working toward similar goals. Treatment. The normal state of erection can be achieved by bilateral, intracorporeal placement of the Small-Carrion penile prosthesis. This prosthesis provides adequate length and, more importantly for intercourse, normal width to the penis. Although the prosthesis is firm it has enough flexibility to keep the phallus inconspicuous under various types of shorts in the normal position or against the abdominal wall. The fact that patients will have a permanent erection does not often deter them from having this prosthesis inserted. Raz and Kaufman,1 Goodwin,7 Melman, 8 Nellans and associates, 9 and others have reported excellent results with the SmallCarrion penile prosthesis.
SMALL-CARRION PENILE PROSTHESIS
Surgical technique. Since the introduction of this prosthesis there has been some discussion as to the surgical approach. &-1o Melman states that he avoids placement of the prosthesis via the more potentially infected perineum. 8 He thought that a penile incision at mid point provided greater surgical control than having to manipulate instruments along the entire corporeal length as in the perineal incision. Nellans and associates use a perineal approach but are evaluating a dorsal approach to the cavernosa. 9 I continue to use a perineal approach for insertion of the prosthesis to avoid scar formation on the penile shaft. To diminish the possibility of infection from the perineum Incise Drape* is used to separate the rectum from the sterile field. A more distally placed midline incision may be used to avoid having to dissect through a scarred perineum in patients with marked periurethral induration or scar formation. The perineal approach enables patients to resume sexual activities earlier than those who have had a penile incision. Impotent patients with spinal cord injuries or neurogenic bladders benefit from the added length and girth obtained with this prosthesis. 2 It permits patients with a short phallus to keep easily an external collection device in place. If the patient has not had intercourse for some period before insertion of the prosthesis the longest length and widest diameter that will fit comfortably is inserted. However, 4 of these patients have returned approximately 8 to 12 months postoperatively, requesting a longer and/or wider prosthesis. I believe that flexion of the glans over the prosthesis has occurred because the prosthesis no longer reaches under the glans. The explanation for this may be that, surprisingly, after the prosthesis has been inserted the majority of patients achieve an additional erection as blood again flows through the corpora cavernosa. This happens even though the cavernous tissue has been damaged by dilation and the prosthesis is in place. I also have found that once the patient can again perform intercourse there is additional blood flow to the penis through the corpus spongiosum and to the glans, which are of a different embryologic derivative than the corpus cavernosum. Because of this additional blood flow and penile use the corpora cavernosa tend to become larger and thereby require a larger prosthesis. How frequently patients will return for a larger prosthesis because of this additional blood flow is a point of conjecture at this time. A second surgical procedure to insert a longer prosthesis is quite easy since the operation is carried down to the previously inserted prosthesis. At the initial operation there are usually large veins crossing the crus of the penis and ischiocavernous muscle and care must be taken not to sever these since extensive bleeding can occur. This is usually not the case when a prosthesis is replaced. If a prostatectomy or bladder neck operation needs to be performed it should be done prior to insertion of the prosthesis. There is a high complication rate if one performs a transurethral operation or leaves a catheter in the urethra for a long period postoperatively after the prosthesis has been inserted. This will usually result in periurethral inflammation and infection with possible erosion of the prosthesis into the urethra. If a catheter is required for any period of time postoperatively it should be as non-reactive as possible and only a 10 or 12F, which allows periurethral secretions to exit rather than be a potential source of inflammation or abscess formation. If the aforementioned operations are necessary after insertion of the Small-Carrion penile prosthesis, then they should be performed through a perineal urethrostomy with a catheter left draining the bladder through the urethrostomy. This is a safe approach since the prostheses are widely separated from the urethra in this area. An alternate approach would be a
* Johnson and Johnson, New Brunswick, New Jersey.
suprapubic or retropubic prostatectomy with postoperative drainage being performed by way of a suprapubic cystostomy. Ambrose has suggested another approach when a prostatectomy is indicated after insertion of the Small-Carrion penile prosthesis. 11 He removes the prosthesis and then reinserts it after the patient has recuperated from the prostatic operation. Ambrose points out, and I also have found, that after the prosthesis has been inserted a capsule forms around it. As long as there has been no infection to cause scarring a prosthesis can be replaced since this capsule will remain intact, creating a tunnel for reinsertion of the prosthesis. Recently, I have combined the use of the Rosent incontinence device with insertion of the Small-Carrion penile prosthesis in patients who have impotence and incontinence. Results have been encouraging and the procedure is still being evaluated. Kaufman and Raz have used the Small-Carrion penile prosthesis in combination with the Kaufmann III incontinence prosthesist in 8 patients and report that 7 have been completely rehabilitated. 12 ADDENDUM
As of December 1977 an additional 100 patients have undergone insertion of the Small-Carrion penile prosthesis, for a total of 260 patients. The mean followup now is an additional 12 months added to each group in table 2. There were an additional 3 patients in the post-prostatectomy group, an additional 22 patients in the psychogenic group and an additional 5 patients were operated upon after they became impotent secondary to pelvic fracture. Five additional patients were operated upon because of Peyronie's disease without excision of the plaque. However, a few of these patients did require transverse incisions in the corpora bilaterallly after the prosthesis had been inserted to allow for proper straightening of the penis. An additional 35 arteriosclerotic patients underwent penile prosthetic insertion and 2 additional patients were operated upon because of spinal cord disease or injury. An additional 28 patients underwent insertion of the prosthesis for impotence secondary to diabetes mellitus. There has been only 1 additional complication, which was in a diabetic who had severe postoperative infection requiring removal of the prosthesis. Table 1 lists the lengths and diameters as well as the number of patients who have used each size as of December 1976. As more and more prostheses have been implanted there has been an increasing demand for longer and wider prostheses. In fact, 1 of the reasons for making the prosthesis available in longer and wider diameters is to prevent potential medicolegal problems. It is easy to shorten a long prosthesis by trimming off a small portion of the tail, whereas it might be considered negligent if a prosthesis were inserted that was of an inadequate length or diameter. It is now routine policy to have the 18.0 cm. length in the 1.1 cm. as well as the 1.3 cm. diameters available for all patients since there is an increasing need for these longer lengths and diameters. Routinely, the 19.0, 20.0 and 21.0 cm. lengths also are available in the 1.3 cm. length with the 0.9 cm. diameter have been deleted except as a custom order. Other sizes also may be custom-ordered but I have found that it is impossible to determine the exact size prosthesis needed prior to surgical exploration. Therefore, the importance of having all sizes available in the operating suite is emphasized. REFERENCES
1. Raz, S. and Kaufman, J. J.: Small-Carrion operation for impo-
tence. Urology, 7: 68, 1976. 2. Small, M. P., Carrion, H. M. and Gordon, J. A.: Small-Carrion penile prosthesis. Urology, 5: 479, 1975. 3. Karacan, I., Williams, R. L., Thornby, J. I. and Salis, P. J.:
t Heyer Schulte Corporation,
Sleep-related penile tumescence as a function of age. Amer. J. Psychiat., 132: 9, 1976. Fisher, C.: Conference on penile prostheses. New York: New York Academy of Medicine, October 1976. Kaufman, J. J.: Panel discussion on impotence. American College of Surgeons, Chicago, Illinois, October 1976. Osborne, D., Psychologic evaluation of impotent men. Mayo Clin. Proc., 51: 363, 1976. Goodwin, W. E.: Complications of perinea! prostatectomy. In: Complications of Urologic Surgery. Edited by R. B. Smith and D. G. Skinner. Philadelphia: W. B. Saunders Co., p. 261, 1976.
8. Melman, A.: Experience with implantation of the Small-Carrion penile implant for organic impotence. J. Urol., 116: 49, 1976. 9. Nellans, R. E., Naftel, W., Stein, J., Tansey, L., Perley, J. and Ravera, J.: Experience with the Small-Carrion penile prosthesis. J. Urol., 115: 280, 1976. 10. Merrill, D. C. and Swanson, D. A.: Experience with the SmallCarrion penile prosthesis in the treatment of organic impotence. J. Urol., 115: 277, 1976. 11. Ambrose, R.: Personal communication, January 1976. 12. Kaufman, J. J. and Raz, S.: Use of implantable prosthesis for the treatment of urinary incontinence and impotence. Amer. J. Surg., 130: 244, 1975.