Combined Implantation of Artificial Sphincter and Penile Prosthesis

0022-534 7/89 /1423-0732$02.00/0 THE JOURNAL OF UROLOGY Copyright© 1989 by AMERICAN UROLOGICAL ASSOCIATION, INC.

Vol. 142, September

Printed in U.S.A.

COMBINED IMPLANTATION OF ARTIFICIAL SPHINCTER AND PENILE PROSTHESIS BHALCHANDRA G. PARULKAR

AND

DAVID M. BARRETT*

From the Department of Urology, Mayo Clinic and Mayo Foundation, Rochester, Minnesota

ABSTRACT

Concurrent sphincteric incontinence and organic impotence are not uncommon; they can be caused by many congenital and acquired conditions. In the past simultaneous implantation of the artificial sphincter and penile prosthesis was met with skepticism. Of 65 patients who had concurrent implantation of the artificial sphincter and various categories of penile prosthesis 60 were followed for a mean of 35.74 months (range 8 to 55 months). Continence was graded as good or satisfactory in 95 per cent of the patients and poor in 5 per cent. The penile implants were functional in 98 per cent of the patients. Of the 60 patients 33 required 59 corrections, for an average of 0.98 correction per patient. These results indicate that staged or concurrent implantation of dual prostheses is feasible technically, functionally and cosmetically, and without increased risk for surgical or mechanical problems. (J. Ural., 142: 732-735, 1989) The field of prosthetics in urological diseases has evolved rapidly during the last 15 years. In selected cases of sphincteric incontinence the artificial sphincter is recognized as the most consistent form of treatment.' Similarly, the use of penile implants for the treatment of organic impotence has become an accepted therapy. 2 Patients who have both problems are seeking concurrent surgical management. Until recently, the concept of combined implantation of an artificial sphincter and a penile prosthesis was met with skepticism." The mechanical quality of the various prostheses has improved during the last few years. Technical changes and newer surgical principles have been introduced, including delayed activation and nocturnal deactivation.4 The application of these principles has encouraged implantation of the artificial sphincter and penile prosthesis in the same patient, often during the same procedure. We review 65 patients who underwent prosthetic implantation to treat incontinence and impotence either during the same procedure or at separate operations. MATERIALS AND METHODS

Subjects. Between November 1974 and October 1987, 65 patients 21 to 74 years old (mean age 55.1 years) underwent combined implantation for incontinence and impotence. In most patients concurrent incontinence and impotence followed radical retropubic prostatectomy (table 1). All patients were documented to have sphincteric incontinence by a combination of uroradiographic, endoscopic and urodynamic tests. Most patients who had impotence after radical retropubic prostatectomy or transpubic urethroplasty, or who had a spinal cord lesion were not subjected to the exhaustive protocol to establish organic impotence. However, for selected cases in which the cause of impotence was indeterminate diagnostic evaluation included 2 nights of study of nocturnal penile tumescence in the sleep laboratory, Doppler recording of penile blood pressure, determination of serum testosterone and prolactin levels, and an interview with a psychologist. The patients were divided into 2 groups according to the model of sphincter implanted: group 1 had had an AS721, AS742, or AS791/792 model of the sphincter, and subsequently received an AS800 model because of malfunction or complica-

tions related to the earlier device. Group 2 received the AS800 model as the sole sphincter implant. Implantation of a penile prosthesis either coincided with, preceded or followed sphincter implantation (table 2). Various penile prostheses, inflatable and semirigid rod, were implanted (table 3). Eleven patients had undergone a previous urethral or vesical operation to improve continence: 1 had periurethral polytetrafluoroethylene (Teflon) injections, in 1 Kaufman incontinence devices were implanted, 1 had a Rosen incontinence device and 8 underwent an endoscopic operation for correction of bladder neck contractures and urethral strictures. Surgical technique. The patients are given prophylactic broad-spectrum parenteral antibiotic cover beginning on the morning of the operation and continuing for 4 days postoperatively. Special precautions are taken to discontinue use of platelet-altering, anti-inflammatory medications 1 week preoperatively to limit the tendency for bleeding during and after the operation. The skin is scrubbed thoroughly with povidoneiodine before incision. Simultaneous implantation of an artificial sphincter and a standard multicomponent inflatable penile prosthesis is done through a low transverse suprapubic incision and, because most of the artificial sphincters have the cuff located around the bulbous urethra, a midline perineal incision for mobilization of the bulbous urethra and placement of the cuff is required. The reservoirs of both prostheses are placed in a pocket under the rectus muscle, 1 on each side. The control assembly (pump) is TABLE 1.

Cause of incontinence in 65 patients who had combined implantation Cause

Group (No. pts.)* 1

Radical retropubic prostatectomy: With radiotherapy Without radiotherapy Transurethral resection of prostate Transpubic urethroplasty Fractured spine Multiple sclerosis Fractured pelvis Totals

2

8 27 9 2 4 1 1

13

52

5 1 1 4

Total No. Pts.

2 8 32 10 3 8 1 3

65

* Group 1-patients who received older models of sphincters (AS721, AS742

Accepted for publication March 10, 1989. *Requests for reprints: Department of Urology, Mayo Clinic, 200 First St., S. W., Rochester, Minnesota 55905.

or AS791/792) before AS800 sphincter implant. Group 2-patients who received AS800 sphincter as the sole implant.

732

733

ARTIFICIAL SPHINCTER AND PENILE PROSTHESIS TABLE 2.

Order of implantation of artificial sphincter and penile prosthesis in 65 patients

Order of Implantation

Group (No. pts.)*

Total No. Pts.

2 Penile preceded sphincter Penile followed sphincter Penile coincided with sphincter Totals

5 7 1

6 7 39

11

14 40

13 52 65 * Group 1-patients who received older models of sphincters (AS721, AS742 or AS791/792) before ASSOO sphincter implant. Group 2-patients who received ASSOO sphincter as the sole implant.

TABLE 3.

Types of penile implants in 65 patients who had combined implantation Type of Implant Semirigid:t Flexirod Jonas AMS600 Multicomponent inflatable::j: AMS700 AMS700 ex U niflate-1000 Unicomponent inflatable:t Flexi-Flate Hydroflex

No. Implants* 10 2 2

31 17 2 3

* Over-all, 68 prostheses were implanted in the 65 patients. t Implanted through a dorsal subcoronal incision. :j: Implanted through a suprapubic incision.

directed into the scrotum on either side to lie finally in a pocket above the testes. Both corpora are opened between stay sutures at the base of the penis and dilated to the appropriate size with Regar dilators. The sphincter implant usually is introduced first, connected and deactivated before the penile prosthesis is introduced. Meticulous sterile precautions, which include repeated irrigation of the operative site with antibiotic solutions (50,000 units bacitracin and 0.1 per cent polymyxin in 1 l. of 0.9 normal saline), are recommended. Extensive subcutaneous dissection potentiates the development of postoperative hematoma. Therefore, we suggest the use of small caliber closed system drains to prevent this complication (that is 3.2 mm. JacksonPratt drainage systems). The drain is retained for an average of 2 days or until drainage stops. A 14F silicone Foley catheter is placed in the bladder at operation and is kept indwelling for 24 to 48 hours. Ice packs to the scrotum help lessen the edema, pain and inflammation. In patients in whom either of the prostheses has been implanted during an independent operation special care is taken to avoid injury to the tubings of the initial implant. This precaution generally requires a new incision away from the previous line of dissection. Preliminary radiographs help to define the location of the prosthetic components (fig. 1). Electrocautery in the cutting mode is used for dissection because it does not damage the silicone components of the previously inserted prosthesis. Semirigid rod and unicomponent inflatable penile implants are inserted through a dorsal subcoronal penile incision with the patient under the same anesthesia as used for the artificial sphincter implantation. When performed as a separate procedure implantation of penile prostheses may be done with the patient under local anesthesia. The sphincter is activated approximately 6 weeks after the initial operation. Voiding is evaluated to confirm continence, and the patient is instructed in the function and use of the control assembly. Similar instructions are given regarding the penile prosthesis. Intercourse may resume when the inflammation and pain related to the operation have abated.

FIG. 1. Radiograph of normally functioning AMS700 CX inflatable penile prosthesis and AMSSOO artificial sphincter with cuff around bulbous urethra. RESULTS

Mean followup was 43.1 months (range 20 to 55 months) in group 1 and 33.9 months (range 8 to 55 months) in group 2. Over-all mean followup was 35.74 months. Four patients were lost to followup at 9 or more months postoperatively and 1 died of unrelated causes. At the last reported followup in these patients continence was rated as good in 2, satisfactory in 1 and poor in 2. Observations during long-term followup of the remaining 60 patients revealed that continence was good (1 pad or less per day) in 54 (90 per cent), satisfactory (improved, 1 to 4 pads per day) in 3 (5 per cent) and poor in 3 (5 per cent). In 59 of these 60 patients (98 per cent) the penile implants were without mechanical problems and functional. One patient (2 per cent) who had lost fluid in the implant elected not to undergo correction. Of the 5 patients lost to followup 1 had malfunction of the device and 4 had functionally useful implants at the last reported examination. The mechanical and technical problems encountered with the AS800 sphincter are outlined in table 4, and the number of revisions done to correct these problems are categorized in table 5. Cuff erosions occurred in 3 patients in group 1 and 4 in group 2 (fig. 2). After erosion at the bladder neck a new cuff was implanted around the bulbous urethra in 1 patient. Of the 8 patients in whom a sphincter was implanted after pelvic radiation combined with radical retropubic prostatectomy only 1 had developed cuff erosion. In 2 patients all components of the sphincter had to be extracted because of infection. Penile prostheses were removed in 2 patients with infection restricted to the penile prosthesis components only. In 3 patients the sphincter and penile implant had to be extracted because of infection (after erosion of the sphincter component in 2 and after erosion of the prosthesis component in 1). Two patients in group 1 and 1 in group 2 refused sphincter reimplantation and were wet (designated as poor result at followup). Thus, of the 60 patients followed in our study 27 required 42 revisions (0.7 revision per patient) of the artificial sphincter (table 5). Among the patients who received inflatable penile prostheses

734

PARULKAR AND BARRETT

TABLE 4.

Malfunctions of the AS800 sphincter in 65 patients who had combined implantation

TABLE 6.

Malfunctions of penile prostheses in 65 patients who had combined implantation

Group* 1 (13 pts.) Mechanical failures: Cuff leak Pump failure Tube kink Balloon leak Loose connector Totals Technical failures: Increased pressure balloon reservoir Decreased cuff size Addition of more fluid to reservoir Pump malrotation Totals

Group*

2 (52 pts.)

3 1 1

5 3 1 1 1

5

IT

2 1

6

3

12

3 2 1

1 2 Totals

2 (52 pts.)

Fluid leak Tube kink Cylinder ballooning Erosion Total No.

3 2 4 3

2 1

12

5

2

No. Pts.

Revisions (No. pts.)

1

2

3

with erosion was dissatisfied with the quality of erection he achieved with semirigid rods and underwent implantation of an AMS700 CX inflatable penile prosthesis. Thus, 12 of the 60 patients (20 per cent) required 17 revisions for the rigid and inflatable penile implants (0.28 revision per patient). Of these patients 6 also had had some corrective procedure for the sphincter prosthesis. Thus, in an over-all analysis, 33 of the 60 patients who were followed required 59 corrections, for an average of 0.98 correction per patient during a mean followup of 35.74 months. At the time of this report 7 patients in group 2 were performing nocturnal deactivation and 4 were performing intermittent catheterization.

13 52

5 22

1 16

1 4

3 2

DISCUSSION

65

27

17

5

5

5. Revisions of artificial sphincter in 65 patients who had combined implantation

Group*

1 (13 pts.)

* Group !-patients who received older models of sphincters (AS721, AS742, or AS791/792) before AS800 sphincter implant. Group 2-patients who received AS800 sphincter as the sole implant.

* Group !-patients who received older models of sphincters (AS721, AS742, or AS791/792) before AS800 sphincter implant. Group 2-patients who received AS800 sphincter as the sole implant.

TABLE

Malfunction

No. Revisions per Pt.t

* Group !-patients who received older models of sphincters (AS721, AS742, or AS791/792) before AS800 sphincter implant. Group 2-patients who received AS800 sphincter as the sole implant. t Total number of revisions was 42. (Erosion of sphincter components and their subsequent replacement are calculated as 2 revisions.)

FIG. 2. Erosion of cuff into bulbous urethra (AS792 sphincter). Reprinted with permission. 4

(mean duration of followup 21.1 months) the AMS700 CX model performed flawlessly (no revisions were needed) in all 17 patients in whom it was implanted. Among the 48 patients who received the other prostheses 12 required 17 revisions: 8 in group 1 (4 required 1 revision and 4 required 2 revisions each) and 4 in group 2 (3 required 1 and 1 required 2 revisions, table 6). One patient each in groups 1 and 2 refused reimplantation of penile prostheses. The patient from group 1 later was lost to followup. In 2 patients whose inflatable prosthesis was extracted after infection semirigid rods were used at reimplantation because the inflatable prosthesis could not be negotiated in the corpora owing to fibrosis after infection. The patient

The introduction of the AS721 artificial sphincter by Scott and associates in 1973 was an effective solution to sphincteric incontinence. 5 The refinement of semirigid penile prostheses and the development of inflatable penile prostheses provided a reasonably consistent means to rectify organic impotence. 6 The neuromuscular functions of continence and erection are linked closely. 7 The incidence of arteriogenic impotence increases after a patient age of 50 years. 8 Most, if not all, patients who undergo radical prostatectomy via the conventional technique are impotent. 9 Complications arising from a prostate operation for benign or malignant growth can lead to sphincteric incontinence. 10 Therefore, some patients inevitably will seek concurrent correction of incontinence and impotence. These patients, who have sphincteric incontinence and organic impotence, are likely to benefit from implantation of a prosthesis. The corporeal and periurethral manipulation and mobilization during combined implantation were judged to be excessive and to increase significantly the chances of ischemia, subsequent erosion and infection. In fact, Graham and associates reported a failure rate of 100 per cent with fistula and abscess formation in patients who received the Kaufman III and SmallCarrion prostheses. 3 This report and the fear of the unknown have discouraged many urologists from approaching the combined problem of sphincteric incontinence and organic impotence with simultaneous prosthetic implants. In our earlier cases the prostheses were implanted by a 2stage approach. Either the sphincter or the penile implant preceded the other by a few months. However, because the results of early cases were encouraging, the idea of simultaneous implantation of both prostheses evolved and was implemented in most of our subsequent patients. Simultaneous implantation is more appealing to the patient because it avoids the anesthesia and discomfort of undergoing 2 operations. The total duration of hospitalization is shorter (about 4 days) than implantation done at 2 independent settings. Also, for a 2-stage procedure the surgeon has to be careful not to injure the tubings or components of the initial implant. Simultaneous procedures may be more demanding technically. Our practice is to implant the sphincter first, connect the components and deactivate the cuff before introducing the penile prosthesis. Proximal corporeal dilation should be done

ARTIFICIAL SPHINCTER AND PENILE PROSTHESIS

735

with care to avoid perforation in the region of the sphincter to the other prosthesis. The incidence of surgical correction in cuff. If this occurs it is best to defer the penile implantation patients with dual implants is similar to that in patients with until another day. Prophylactic antibiotics, antiseptic care, either implant. The rate of good or satisfactory continence is meticulous hemostasis and a closed system drain are important 95 per cent and restoration of sexual function is high. adjuvants to prevent hematoma and infection. CONCLUSION The blood supply to the corpora via the corporeal arteries is compromised during implantation of a penile prosthesis. The In a selected group of patients with sphincteric incontinence nearly continuous compression of the sphincter cuff, especially and organic impotence of variable origin, simultaneous implanat bulbous urethral locations, may compromise the blood supply tation of the sphincter and penile implants is an effective to the urethra and eventually lead to local pressure atrophy. 10 proposal technically, functionally, cosmetically and economiThis is more evident in patients who have irradiation after cally. Dual implants, inserted either concurrently or at indesphincter implantation. 11 pendent operations, for the treatment of incontinence and The total number of erosions with the AS800 and penile impotence are a feasible and recommended concept. prosthesis in our study was 6 in group 1 and 5 in group 2. Therefore, it is obvious that adaptation of the delayed activaREFERENCES tion principle, 12 use of low pressure regulating balloon reser1. Barrett, D. M. and Wein, A. J.: Voiding dysfunction: diagnosis, voirs,• nocturnal deactivation,• avoidance of a secondary operclassification, and management. In: Adult and Pediatric Urology. ation for activation of the AS800 sphincter and use of a con Edited by J. Y. Gillenwater, J. T. Grayhack, S. S. Howards and 13 J. W. Duckett. Chicago: Year Book Medical Publishers, vol. 1, stant girth inflatable penile prosthesis (AMS700 CX chapt. 28,pp.863-962, 1987. cylinders) significantly reduced the incidence of erosion of 2. Barrett, D. M. and Goldwasser, B.: Prosthetics in the treatment of prosthetic components in our study. impotency. In: Advances in Urology. Edited by B. Lytton, W. J. The mechanical quality and structural consistency of the Catalona, L. I. Lipshultz and E. J. McGuire. Chicago: Year Book Medical Publishers, vol. 1, pp. 145-172, 1988. prosthesis are tributes to biomechanical engineering skill. The 3. Graham, S. D., Jr., Carson, C. C., III and Anderson, E. E.: Longseamless reservoirs, nonkink reinforced tubings, dip-coated term results with the Kaufman prosthesis. J. Urol., 128: 328, cuffs, activation/deactivation button in the pump assembly of 1982. the AS800 device, 14 reinforced inflatable cylinders, and newer 4. Barrett, D. M. and Goldwasser, B.: The artificial urinary sphincter: current management philosophy. AUA Update Series, vol. 5, and stronger materials 15 have improved the long-term mechanlesson 32, pp. 1-8, 1986. ical reliability of these prostheses. 5. Scott, F. B., Bradley, W. E. and Timm, G. W.: Treatment of However, simultaneous surgical intervention has a major urinary incontinence by implantable prosthetic sphincter. Uroldisadvantage. In the event of infection of even 1 of the comogy, 1: 252, 1973. 6. Malloy, T. R. and Wein, A. J.: Surgery of the penis. In: Campbell's ponents of either prosthesis it is difficult to avoid a spread to Urology, 5th ed. Edited by P. C. Walsh, R. F. Gittes, A. D. other parts. In this series 3 patients have required removal of Perlmutter and T. A. Stamey. Philadelphia: W. B. Saunders Co., the sphincters and penile implants because of an infection vol. 3, sect XV, chapt. 81, pp. 2888-2914, 1986. arising in 1 of the components. However, early detection and 7. Wein, A. J., Levin, R. M. and Barrett, D. M.: Voiding function: relevant anatomy, physiology, and pharmacology. In: Adult and rapid action in the form of selective extraction, especially in Pediatric Urology. Edited by J. Y. Gillenwater, J. T. Grayhack, the case of impending erosion, sufficed to restrict the loss to S.S. Howards and J. W. Duckett. Chicago: Year Book Medical only sphincters in 2 cases and only the penile implant in 2. In Publishers, vol. 1, chapt. 27, pp. 800-862, 1987. the series of Scott and associates 7 patients had common 8. Ruzbarsky, V. and Michal, V.: Morphologic changes in the arterial bed of the penis with aging: relationship to the pathogenesis of infections of both prostheses that required removal, 8 had impotence. Invest. Urol., 15: 194, 1977. isolated infection of the sphincter and only 1 had isolated 9. Walsh, P. C.: Radical retropubic prostatectomy. In: Campbell's 16 infection of the penile prosthesis. Urology, 5th ed. Edited by P. C. Walsh, R. F. Gittes, A. D. Patient education is important in cases of dual implants. Perlmutter and T. A. Stamey. Philadelphia: W. B. Saunders Co., vol. 3, sect. XV, chapt. 76, pp. 2754-2775, 1986. Patient selection mandates a proper working knowledge of 10. Parulkar, B. G. and Barrett, D. M.: Managemeflt.-Gfincontinence implants and manual dexterity. after radical prostatectomy. In: Difficult Problems in Urologic Results of followup of the AMS700 inflatable penile prostheSurgery. Edited by W. S. McDougal. Chicago: Year Book Medical sis in group 2 (no revisions) have been consistently as favorable Publishers, chapt. 14, pp. 220-237, 1989. as those for the independent implants in 63 patients (3.2 per 11. Kaufman, J. J., Smith, R. B. and Raz, S.: Radiation therapy in carcinoma of the prostate: a contributing cause of urinary inconcent revisions) in the modified (post-fix) AMS700 controlled tinence. J. Urol., 132: 998, 1984. expansion group. 17 Careful life-table analysis of the results with 12. Furlow, W. L. and Barrett, D. M.: The artificial urinary sphincter: the current (post-fix) AMS700 device reveals that this model experience with the AS 800 pump-control assembly for singlestage primary deactivation and activation-a preliminary report. has a 97 per cent chance of maintaining normal mechanical Mayo Clin. Proc., 60: 255, 1985. function for 3 years. 17 The results in group 2 are comparable to 13. Furlow, W. L. and Motley, R. C.: The inflatable penile prosthesis: our observations in patients with incontinence after radical clinical experience with a new controlled expansion cylinder. J. retropubic prostatectomy who were treated with AS800 Urol., 139: 945, 1988. sphincters 18 (33 of 103 required revisions, for an incidence of 14. Barrett, D. M., Furlow, W. L. and Goldwasser, B.: Artificial urinary sphincter. In: Urodynamics and Neurourology: Principles and 32 per cent) and in patients with myelopathy or spinal cord Practice. Edited by S. V. Yalla, E. J. McGuire, J. G. Blaivas and injury treated with the AS800 bladder neck cuff19 (21 of 59 A. El-Badawi. New York: MacMillan Publishing Co., chapt. 33, patients required revisions, for an incidence of 35.6 per cent). p. 474, 1988. In the final analysis, of the 60 patients followed 33 required 15. Merrill, D. C.: Clinical experience with Mentor inflatable penile prosthesis in 206 patients. Urology, 28: 185, 1986. 59 corrections, for an average of 0.98 correction per patient 16. Scott, F. B., Fishman, I. J. and Shotland, Y.: Experience with during a mean followup of 35.74 months. This result compares simultaneous implantation of inflatable penile prosthesis and favorably with that in the study by Scott and associates who artificial urinary sphincter in 72 patients. J. Urol., part 2, 137: 374A, abstract 1084, 1987. reviewed 72 patients between 1973 and 1986 with combined W. L., Goldwasser, B. and Gundian, J. C.: Implantation of implants, 45 of whom had to undergo 161 operations aimed to 17. Furlow, model AMS 700 penile prosthesis: long-term results. J. Urol., correct various surgical and mechanical problems (average 2.24 139: 741, 1988. per patient in the entire group). 16 Satisfaction with the quality 18. Gundian, J.C. and Barrett, D. M.: Radical prostatectomy incontinence and the AS 800 artificial urinary sphincter. J. Urol., part of continence and erection is not different from that when 2, 139: 335A, abstract 691, 1988. either of the prostheses is implanted independently. 19. Parulkar, B. G. and Barrett, D. M.: The model AMS 800 artificial Mechanical problems may develop with each category of urinary sphincter-experience with vesical neck cuff implantaprosthesis but surgical correction is possible without undue risk tion. J. Urol., part 2, 139: 196A, abstract 134, 1988.