INFLATABLE

PENILE

EXPERIENCE

WITH 175 PATIENTS

WILLIAM

L. FURLOW,

PROSTHESIS:

MAYO CLINIC

M.D.

From the Mayo Clinic and Mayo Foundation, Rochester, Minnesota

ABSTRACT - Sex prosthetics have become an established alternative of therapy for both the organically and the psychogenically impotent male patient. Functional success with the implantation of the inflatable penile prosthesis can be anticipated in 90 to 95 per cent of the patients. Both mechanical and pathologic complications occur, but with relatively low frequency. There have been no reported operative or postoperative deaths associated with the implantation of more than 6,000 devices. The availability of penile prostheses to impotent patients should be limited only by the patient’s ability to meet the rigid criteria for selection of patients. When these criteria are fulfilled and the patient’s expectations are in harmony with the known results that can be provided by implantation, uniformly successful results can be expected.

As urologists, we have long been aware of our inability to manage surgically the problem of failure of erection in men. The various new sex therapy techniques known to be effective in the treatment of psychogenic impotence are rarely applicable to those patients whose impotence is the result of organic disease. Scardino’ first recognized the needs of these patients and realistically endeavored to reestablish a functionally erect penis by using a centrally placed acrylic rod beneath Buck’s fascia on the dorsum of the penis. The result was a flaccid penis reinforced against buckling of the shaft, which thereby provided for adequate vaginal penetration. Goodwin and Scott,’ Lash, Zimmerman, and Loeffler,3 Loeffler and Sayegh,4 and Pearman’ were among the early pioneers in the surgical correction of failure of erection with use of the semirigid rod prosthesis. Even though results with these various devices were reported as satisfactory, a review of the literature does not

Presented at the meeting of the American Urological ciation, Washington, D.C., May 21, 1978.

166

Asso-

suggest widespread use of these early prostheses. Centrally placed single semirigid rod prosthetic devices were soon replaced by paired semirigid rods implanted within the corpora cavernosa of the penis. Beheri,’ Small, Carrion, and Gordon7 and, more recently, Finney’ have applied their techniques to this problem in a further effort to provide a more nearly normal erectile state suitable for vaginal penetration and satisfactory intercourse. In this regard, these prosthetic devices have been reported to be highly satisfactory. The hydraulically inflatable penile prosthesis, devised by Scott, Bradley, and Timm,g was first introduced in 1973 for the surgical correction of organic impotence. This device has undergone considerable modification and simplification. In its present form, the device consists of four separate parts: an inflate-deflate pump, a storage reservoir, and paired inflatable cylinders (all composed of medical-grade silicone elastomer) (Fig. 1). Long-term results with the inflatable penile prosthesis have been excellent and are comparable to those reported with use of paired semirigid rods. lo-l4

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FIGURE 1. InfEatable penile prosthesis. {From Furlow WL: Surgical treatment of erectile impotence using the injlatable penile prosthesis, Sexuality Disof Human ability 1: Winter [1978]. By pemlission Sciences Press.)

Material

and

Methods

At the Mayo Clinic, the inflatable penile prosthesis has been in use for surgical correction of male impotence for the past three and onehalf years. Since the inception of our implant program in October, 1974, 249 patients have undergone implantation of an inflatable penile prosthesis. This report summarizes our experience with the first 175 consecutive patients, who now have been followed up for a period of six months or more. Selection

of patients

In this series, impotence was presumed to follow as a recognized complication of certain disease states (Table I). To distinguish organic from psychogenic impotence in a clinical setting, we rely on the history, the Minnesota Multiphasic Personality Inventory (MMPI), psychologic consultation, and lengthy discussion with the patient and with his spouse if he is married and, in some instances, with the patient’s fianEarly in our cee if permission has been granted. experience, we excluded as surgical candidates those patients with functional or psychogenic impotence; however, we have found that there are patients with psychogenic impotence who

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FIGURE 2. Model of male torso with injatable in place. (By permission of the penile prosthesis Mayo Clinic [Mayo Foundation].12)

TABLE I. Etiologic factors Cause

Organic Diabetes mellitus Radical prostatectomy Postperineal trauma Neurologic disorders Radical cystectomy Aortoiliac disease Peyronie disease Coronary artery disease Proctocolectomy Aortic aneurysmectomy Estrogen therapy Perineal adenectomy Postradiation Psychogenic Physiologic

(175 patients)

No. of Patients 141 57 20 18 16 9 6 6 3 2 1 1 1 1 22 12

are refractory to new sex therapy but who are, in fact, excellent candidates for implantation of a prosthetic device. Twenty-two of 175 patients in this series have undergone implantation of the inflatable penile prosthesis after having been diagnosed as being functionally or psychogenically impotent.

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We also consider it essential to be certain of the patient’s motivation to undergo implantation. To this end, an important feature of the interview has been the description and demonstration of the prosthetic device, including its advantages and the potential complications and risks involved. At this point, we have found it important to establish a clear understanding of FIGURE 3.

TABLE II.

Age distribution (175 patients)

Age (Yr.)

No. of Patients

20-29 30-39 40-49 50-59 60-69 70-79 80-89

14 22 38 43 51 6 1

III. Pathologic complications (175 patients)

TABLE

Complication Infection Scrotal hematoma Scrotal erosion Phimosis Wound erosion

IV.

Buckling of cylinder Ballooning of cylinder Rupture of cylinder Leak in cylinder Inadequate cylinder length Kink in tubing Loss of fluid Inadequate fluid volume Defect in pump Malposition of pump TOTAL

168

Disposition

6 3 1 2

Removed Drained Repositioned Circumcision Removed

1

Mechanical complications (175 patients)

Complication

*Three

No. of Patients

13

TOTAL

TABLE

No. of Patients

Disposition

5

Replaced

9 1 2

Replaced Replaced Replaced

2 8 6

Replaced Corrected New prosthesis

1 1

Fluid added Replaced Repositioned

2 37*

patients

Furlow tool for cylinder insertion.

had two mechanical

complications

each.

the patient’s expectations in order that these expectations do not exceed what can be achieved by means of implantation. To aid in this discussion, we use a model of the male torso with the prosthesis in place (Fig. 2).

Age distribution The youngest patient in this series was a twenty-two-year-old man with an imperforate anus, neurogenic bladder dysfunction, and lifelong impotence. The oldest man in the series was eighty-one years of age (Table II). In the absence of a chronic and debilitating disease state, age alone should not be a factor in selection of patients.

Surgical technique The operative technique used is a modification of that originally described by Scott and associates.g The entire implant can be inserted through a small transverse suprapubic incision made approximately 1 cm. above the upper border of the symphysis pubis. Through this incision, the corpora cavernosa can be exposed infrapubically and the paired cylinders can be inserted by means of the newly designed Furlow insertion tool (Fig. 3). This tool ensures accurate determination of cylinder size and rapid, accurate, and atraumatic positioning of the distal ends of the cylinder beneath the glans penis. The technique of implantation also has been modified to include rerouting of the tubing from each cylinder subcutaneously into the area of the right external inguinal ring. The inflate-deflate pump is then positioned well down in the dependent portion of the right hemiscrotum, lateral to the right testicle. The reservoir is placed beneath the right rectus muscle, and the tubing is brought out through the external inguinal ring. All connections involving the pump, cylinders, and reservoirs are then made in the subcutaneous region near the right external inguinal ring.

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With this new technique, the tubing no longer needs to be routed through the left and right inguinal canals, as described by Scott et ~1.~ Kinks in the tubing are avoided by using rightangle, stainless steel connectors to join the cylinder tubing to the pump tubing. Surgical

involving some portion of the prosthetic device. In each instance, it was necessary to remove the entire device to eradicate the infection. One patient had the device removed because recurrent transitional cell carcinoma of the urethra developed two years after he had had a radical cystectomy for bladder carcinoma.

Results

Comment

Complications have occurred in 47 of 175 patients. Complications associated with this surgical procedure can be divided into two categories, pathologic (Table III) and mechanical (Table IV). The pathologic complications included infection of the prosthesis, scrotal hematoma, and scrotal erosion. The two instances of postoperative phimosis occurred early in our series. Concomitant circumcision is now done when indi-

Implantation of the inflatable penile prosthesis has thus far proved to be a highly satisfactory method of treating both organic and psychogenic impotence. Our experience originally was limited to patients considered to have organic impotence. We have extended our guidelines for selection of patients to include those with functional or psychogenic impotence considered refractory to current forms of sex

TABLE V. Number of patients with mechanical complications Cumulative Incidence No. %

Complications Group*

No.

I (36) II (27) III (40) IV (72)

%

4 13t 10 7 (44)

11 48 25 10 (6%)

4l36 17163 271103 34/175

11 27 26 19

*Figures in parentheses represent total number of patients. tThree of these patients had two complications each. t Omitting those with kinks in tubing.

therapy. Through careful screening of patients and the cooperative efforts of a clinical psychologist or psychiatrist who is expressly interested in the problems of human sexual behavior, we have avoided implanting the device in patients who, because of deep-seated emotional problems, would not benefit from implantation. This decision is often difficult when such emotional problems exist in an organically impotent man. We believe that use of the MMPI and psychiatric consultation are essential for good selection of patients. The urologist must be prepared to accept and manage the possible consequences of the strong dependence on the physician that may occur as a result of implantation of any prosthetic device in an otherwise emotionally stable patient. In the case of patients with psychogenic impotence, transfer of this dependence from the

cated. Infection of the prosthesis is the most serious complication because it necessitates total removal of the prosthesis to permit eradication of the infection. Fortunately, the incidence of infection remains low, having occurred in only 6 of 175 patients (3 per cent). Mechanical complications with this device have occurred in 34 patients. Several of these problems that occurred early in the series are now readily avoided by strict adherence to specific surgical guidelines. All of these mechanical complications were correctable, although secondary and occasionally tertiary surgical procedures were required. Results of implantition with the inflatable penile prosthesis in our first 175 patients have been extremely satisfactory. Of these 175 patients, 168 have normally functioning prostheses. Six of the failures resulted from infection

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psychiatrist to the urologist, if it occurs, may be premature and unsettling for both the physician and the patient. The patient/partner acceptance has been excellent. If orgasmic sensation was present before the onset of the impotence, it is preserved. Ejaculation usually is not affected. Pain has not been a problem after the first six weeks unless associated with some form of complication. Long-standing low-grade pain that moves from one portion of the prosthesis to another suggests infection within the spaces surrounding the implanted material. From our experience with the genitourinary sphincter, we found that infection may be present for months and cause only lowgrade pain, finally becoming evident clinically after reaching the skin surface in a dependent portion of the prosthesis - either in the scrotal pouch or in the distal end of the corpus cavernosum. Mechanical problems encountered initially have been minimized appreciably with further experience in the surgical technique of implantation. l3 These mechanical problems can be recognized easily if the physician understands the function of the device. A 12 per cent diatrizoate (Hypaque) solution used to fill the system permits reliable roentgenographic visualization of the device. In our experience mechanical complications always have been correctable, but only by surgical intervention. A recent review of our results has shown a decrease in mechanical complications from 48 per cent to 10 per cent (Table V; group IV). Strictly speaking, kinks in the tubing are not the result of device malfunction; if these complications are not included, the rate of mechanical complications has been reduced to 6 per cent. We firmly believe that all of the mechanical complications associated with kinking of the silicone tubing could be prevented by strict adherence to the principles of surgical implantation. In addition, specific guidelines for postoperative care should be followed to ensure the success of the surgical procedure. l3 Implantation of the inflatable penile prosthesis is a highly acceptable method of treating organic impotence. The principal advantage of this device is the nearly physiologic function. When the prosthesis has been implanted, the patient is able to have an erection when desired and also can maintain an inconspicuous flaccid penis at other times. The penile shaft attains a rigidity that is nearly normal to palpation, and patient/partner acceptance has been excellent.

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In this series, the over-all functional success rate with the inflatable prosthesis has been 96 per cent; of the 175 patients, 168 have satisfactory function and 7 had poor results. The main disadvantage of this device is that it is a mechanical prosthesis and therefore is susceptible to the complications experienced with most artificially implanted devices. The mechanical nature of this device has caused some degree of physician dependency by the patient. In our experience, these disadvantages have not been important deterrents for most patients. As our clinical experience has increased, it has become evident that there are specific indications for the implantation of an inflatable prosthetic device in those patients who probably will require subsequent cystoscopic manipulation - in the form of a transurethral surgical procedure, follow-up examination for a bladder tumor, or periodic evaluation in the case of neurogenic bladder dysfunction. This is especially true with the large population of patients with diabetes who are now seeking correction of their organically induced impotence; it has been estimated that neurogenic bladder dysfunction will develop in at least 50 to 70 per cent of these patients. l5 C y stoscopic manipulation and examination can be performed easily in the presence of an inflatable penile prosthesis when the penis is in the flaccid state. Several patients in this series have returned at a later date with symptoms of progressive obstruction caused by benign prostatic hyperplasia and have successfully undergone transurethral prostatic resection without the need for perineal urethrostomy, as is required in patients with the semirigid prostheses. Section of Publications Mayo Clinic Rochester, Minnesota 55901 References 1. Scardino PL: Cited by Goodwin WE, and Scott WW.’ 2. Goodwin WE, and Scott WW: Phalloplasty, J. Urol. 68: 903 (1952). 3. Lash H, Zimmerman DC, and Loeffler RA: Silicone implantation: inlay method, Plast. Reconstr. Surg. 34: 75 (1964). 4. Loeffler RA, and Sayegh ES: Perforated acrylic implants in management of organic impotence, J. Urol. 84: 559 (1960). 5. Pearman RO: Treatment of organic impotence by implantation of a penile prosthesis, ibid. 97: 716 (1967). 6. Beheri GE: Surgical treatment of impotence, Plast. Reconstr. Surg. 38: 92 (1966). 7. Small MP, Carrion HM, and Gordon JA: Small-Carrion penile prosthesis: new implant for the management of impotence, Urology 5: 479 (1975).

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12. Furlow WL: Surgical management of impotence using the inflatable penile prosthesis: experience with 36 patients, Mayo Clin. Proc. 51: 325 (1976). 13. IDEM: The current status of the inflatable penile prosthesis in the management of impotence: Mayo Clinic experience updated, J. Ural. 119: 363 (1978). of impotence using the inflata14. IDEM: Surgical management ble penile prosthesis: experience with 103 patients, Br. J. Urol. 50: 114 (1978). 15. Ellenberg M: Impotence in diabetes: the neurologic factor, Ann. Intern. Med. 75: 213 (1971).

8. Finney RP: New hinged silicone penile implant, J. Urol. 118: 585 (1977). 9. Scott FB, Bradley WE, and Timm GW: Management of erectile impotence: use of implantable inflatable prosthesis, Urology 2: 80 (1973). 10. Ambrose RB: Treatment of organic erectile impotence: experiences with the Scott procedure, J. Med. Sot. N.J. 72: 805 (1975). 11. Malloy TR, and Voneschenbach AC: Surgical treatment of erectile impotence with inflatable penile prosthesis, J. Ural. 118: 49 (1977).

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Inflatable penile prosthesis: Mayo Clinic experience with 175 patients.

INFLATABLE PENILE EXPERIENCE WITH 175 PATIENTS WILLIAM L. FURLOW, PROSTHESIS: MAYO CLINIC M.D. From the Mayo Clinic and Mayo Foundation, Roch...
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