AMS malleable penile prosthesis

AMS malleable penile prosthesis

AMS MALLEABLE TORBEN PENILE PROSTHESIS DORFLINGER, REGINALD BRUSKEWITZ, M.D. M.D. From the Urology Section, William S. Middleton Memorial Vetera...

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AMS MALLEABLE TORBEN

PENILE PROSTHESIS

DORFLINGER,

REGINALD

BRUSKEWITZ,

M.D. M.D.

From the Urology Section, William S. Middleton Memorial Veterans Hospital, and School of Medicine, University of Wisconsin, Madison, Wisconsin

ABSTRACTThe American Medical Systems CAMS) * malleable penile prosthesis was implanted in 57 patients from January, 1983 to 1985. Fifty-one per cent of the procedures were performed under local anesthesia, and 28 per cent in ambulatory (day) surgery. The prosthesis was evaluated in terms of cosmetic result, patient satisfaction and function, and postoperative complications. Ninety-one per cent of patients were satisfied with their decision to select the malleable prosthesis, and 66 per cent reported no difficulty with concealment. A comparison is made with data available from the alternative Jonas malleable prosthesis.

Since Pearman1~2 and Beheri3 introduced the concept of implantation of silicone rods under either the Buck fascia or within the corpora cavernosa for treatment of impotence, several penile prostheses have been introduced and evaluated.4-8 In 1985, nine or ten different types of penile prostheses were available. Ideally, a penile prosthesis would allow complication-free surgical placement and total patient satisfaction by providing restoration of a full length and girth erection of normal rigidity while allowing complete penile detumescence after intercourse. As such, it would not cause embarrassment in the locker room or unnatural bulging when wearing recreational or street clothes. In addition to being a reliable device free of mechanical complications, it should not cause pain or alter urination. While no single prosthesis can offer all of these qualities, the AMS penile prosthesis provides reliability, a good quality erection, a low complication rate, simple surgical placement, and reasonable concealment. While it is best to have available various alternative devices, for those implanters performing fewer implants, a malleable-type prosthesis such as this may represent the best single option. *American

480

Medical Systems,

Minnetonka,

Minnesota.

Material and Methods Prosthesis The AMS malleable prosthesis is made of silicone rubber with a cone-shaped proximal end to conform to the configuration of the crus of the corpora cavernosa. The distal end of the prosthesis is gradually tapered and has a more rounded distal end to conform to the glans end of the corpora. Within the prosthesis is a series of twisted stainless steel wires which are malleable and permit direction and redirection with stabilization of the penis in various positions. This affords concealability when bent down around the scrotum and sufficient straightness, rigidity, and stability for intercourse when erected. It is available in a diameter of 13 mm which can be reduced to 11 mm by removing a silicone sleeve with scissors. It comes in three lengths of 12, 16, and 20 cm. There are rear-tip extenders of 1, 2, and 3 cm which allow a full range of prostheses measuring 12 cm to 23 cm (or longer) in l-cm increments. A sizing device is available for accurate measurement of prosthesis length. The scheme allows hospital stocking for all prosthesis sizes with just three units. Patient population Between January, 1983, and January, 1985, 57 men with erectile impotence underwent

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TABLE I.

Causes of impotence -PatientsNo.

Cause Diabetes mellitus Neurogenic Vasculogenic Pelvic surgery or trauma Peyronie disease Radiation therapy Bilateral orchiectomy Psychogenic Unknown

14 7 12 12 1 1 1 3 6

% 25 12 21 20 2 2 2 5 11

placement of the malleable penile prosthesis at the University of Wisconsin Clinical Science Center and the William S. Middleton Veterans Hospital in Madison. Patients ranged in age from twenty-four to seventy-six years (median age 57). The etiology for impotence is described in Table I. All patients were prepared for surgery by undergoing a vigorous cleansing of the genitalia with hexachlorophene soap. With the patient supine, the groin was prepped and draped; in cases performed under local anesthesia, 10 cc of 1 per cent lidocaine was infiltrated subcutaneously around the base of the penis under the dartos layer. An additional 5 cc of lidocaine was infiltrated subcoronally circumferentially just behind the glans. An additional 5 cc of 1 per cent plain lidocaine may be injected intracorporeally and held in the penis by digital compression of the base of the penis for two minutes. The total dose of 1 per cent lidocaine never exceeded 25 cc to avoid lidocaine toxicity. At this point a circumcising incision was made 1 cm proximal to the corona and then the penile skin retracted to midshaft. Longitudinal 2 cm corporotomy incisions were made laterally between temporary stay sutures at 3 and 9 o’clock with their midpositions centered 3 cm proximal to the corona. The corpora cavernosa were then dilated proximally and distally with Pratt dilators starting with 25 F proximally to a size between 31F and 39F as the corpora would permit, taking great care not to push through the distal corpora into the glans tissue; 33 F corresponds to an 11 mm prosthesis and 39F to the 13 mm. The AMS corporeal sizer was then used to measure the total stretched length of the corpora. It has been our practice to subtract 1 cm from the total maximum measurement when selecting the prosthesis size. Whenever possible the 13 mm prosthesis was implanted unless pro-

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hibited by the diameter of the corpora, in which case the outer sleeve was trimmed and the 11 mm diameter inserted. The wound was copiously and frequently irrigated with bacitratin 5,000 units mixed with neomycin 1 Gm in 200 cc of saline. The rear tip extenders (if any are needed) are pushed on the rear end of the prosthesis and the prosthesis inserted-crus end first followed by glans end. The fit is then assessed. If too short, the glans may droop downward; if too long, the penile shaft is very tense particularly under the glans, or the penile shaft bows outward. If necessary, the prosthesis is removed and the length adjusted. After the prosthesis was positioned, the corpora cavernosa were closed with running 2-O polyglycolic acid suture and the circumcising incision reapproximated with interrupted 3-O chromic suture. Patients were routinely given a preoperative parenteral cephalosporin antibiotic which was continued for twenty-four to forty-eight hours postoperatively; generally this was supplemented with cephalosporin oral antibiotic for five additional days. It is now our custom to administer antibiotics for only the first twentyfour hours postoperatively. When performing the operation under spinal or general anesthesia, identical incisions were

TABLE

II. Size of implanted and rear-tip extenders

Size Rod lengths 12 cm 16 cm 20 cm Varying’ Not recorded Rear-tip extender length 0 cm 1 cm 2 cm 3 cm Varying* Not recorded Rod diameter 11 cm 12 mm1 13 mm Not recorded

rods

-PatientsNo.

%

2 39 10 3 3

4 68 18

13 8 17 8 8 3

23 14 30 14 14 5

18 5 27 7

32 9 47 12

55

*Patient had unequal lengths placed. IEarly AMS trial device (not available).

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TABLE III.

Complications

of malleable penile prosthesis

No.of Complication

Comment

Pts.

MINOR

Edema Urethral bleeding

2 1

Paraphimosis

1

Phimosis

1

Rotational instability of prosthesis Infection (minor)

1

No treatment necessary Occurred 2 wk post-surgery; no treatment None-responded to conservative treatment Pt. not adequately circumcised-recircumcised Pt. holds base of penis for vaginal insertion Cellulitis and suture-line eruption, treatment with antibiotics (1 pt .); superficial pressure necrosis, treated with antibiotics (1 pt.)

2

MAJOR Erosion

of rod

through

Pt. had had three operations for IPP placement or repair before implantation of malleable prosthesis; malleable prosthesis replaced by another IPP Both rods removed (2 pts,)*; one rod removed (1 pt.) Corrected surgically Occurred one day after ambulatory surgery, resolved fully

1

crus

Infection (major) *

3

Prosthesis too short Cerebral vascular accident t

1 1

*One of three infections occurred in paraplegic who had inflatable prosthesis removed because of infection. tone patient had two complications-infection and cerebral vascular accident.

made and infiltration of lidocaine was not utilized. In cases where inflatable penile prostheses were in position, the same technique was utilized and the inflatable cylinders were removed through the distal corporotomy incisions. In addition, an incision was made (with lidocaine infiltration in local cases) over the pump in the scrotum and this was removed, the cavity pocket irrigated with antibiotic solution and closed in two running layers with chromic suture. No attempt was made to remove the inflatable penile prosthesis reservoir. The success of prosthesis implantation was determined by reviewing hospital records. In addition, patients were interviewed by telephone between two and twenty-three months postimplantation to determine postoperative complications and personal satisfaction with the prosthesis using a modification of the Kaufman et al. questionnaire.e

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Results The anesthesia utilized was local in 29 procedures (51%), general in 18 (32%), spinal in 8 (14 % ), and epidural in 2 (3 % ) . Sixteen patients (28%) had a penile prosthesis implanted in ambulatory surgery. A malfunctioning inflatable penile prosthesis was removed from 9 patients and a SmallCarrion prosthesis was removed from 1 patient at the time of implantation of the malleable prosthesis. In addition, 2 patients had had prior surgery to remove an inflatable prosthesis for infection. Sizes of the prostheses implanted are shown in Table II. The median postoperative hospital stay was two days (range O-10 days; Veterans Hospital median = 2 days [range l-101; UW Hospital median = 1 day [range O-41). One patient remained in the hospital for ten days postoperatively to participate in another study. No

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TABLE IV Frequency after penile prosthesis Frequency of Intercourse

TABLE V. Comparison of quality pre-impotence vs post implantation

of intercourse implantation -PatientsNo.

Per month <1 2-31 Per week 1 2-3 4-5

%

5 2 8

14 6 23

8 11 1

23 31 3

follow-up data could be obtained in 2 patients. Table III shows the postoperative complications in the remaining 55 patients. Two to twenty-three months after surgery (median 11 months), 35 patients (61%) answered the questionnaire. Twenty-two patients were not interviewed for the following reasons: (1) lapse of less than two months since surgery (8 patients); (2) extensive hospitalization for causes unrelated to penile prosthesis implantation, prohibiting evaluation of the penile prosthesis (2 patients); (3) death caused by progressive neurologic disease (1 patient); (4) removal of prosthesis (3 patients); and (5) no contact possible (8 patients). Urinary retention did not develop in any patient after hospital discharge following prosthesis implantation. Six patients (17%) noticed a change in urination, including frequency (2 patients), dysuria (1 patient), terminal dribbling (1 patient), deviation of stream (1 patient), and slowed stream (1 patient). Twenty-three of the patients (66%) were completely satisfied with the fit of their clothes after prosthesis implantation. Eight patients (23 % ) were satisfied but nevertheless stated that the fit left something to be desired. Four patients (11%) were dissatisfied and felt that concealment was poor. Twenty-one patients (66 % ) were comfortable in public showers and/ or locker rooms, 3 patients (9%) felt embarrassed, and 11 patients (31%) avoided such places. Twenty-eight patients (80 % ) were married, 4 (11% ) were unmarried, and 3 (9 % ) were divorced. There were no changes in marital status after prosthesis implantation. Two patients complained of mild pain during intercourse, and 4 patients had mild pain without intercourse. In these 6 patients, pain

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-----PatientsNo.

Comparison Length Shorter Longer Turgidity Softer Harder Diameter Smaller Larger Glans penis Softer

TABLE VI.

71 11

9 18

26 51

9 2

26 6

26

74

adjustment

-PatientsNo.

Good to excellent Fair Poor to very poor

27 7 1

TABLE VII.

Attitude

Preoperative % No. 5 5 25

14 14 72

%

25 4

General emotional to prosthesis

Emotional Adjustment

Positive Neutral Negative

of erection of prosthesis

toward

% 77 20 3

self Postoperative % No. 28 5 2

80 14 6

was localized in the glans penis (2 patients), the penile shaft (1 patient), and the base of the penis (1 patient). One patient could not localize the site of the pain. All patients with pain were content with their decision to have prosthesis placement. Frequency of intercourse after prosthesis implantation is shown in Table IV Most patients noticed a change in the quality of erection following surgery compared with before impotence (Table V). Seventy-seven per cent of the patients reported good to excellent emotional adjustment to the prosthesis (Table VI), and the prosthesis produced a positive change in the self-image in 80 per cent of the patients (Table VII). Sixty-six per cent of the patients reported good to very good marital adjustment to the prosthesis, and

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TABLE IX. TABLE VIII. Marital adjustment to penile prosthesis -PatientsNo.

Rating of Marital Adjustment Good to very good Fair Poor to very poor Not married

23 3 2 7

only 2 patients (6%) reported justment (Table VIII). The

poor marital

Patient Rating % 66 8 6 20

ad-

patients’ overall satisfaction with the penile prosthesis is outlined in Table IX. No breakage of the stainless steel wires within the prosthesis was observed. Comment Placement of the penile prosthesis under local anesthesia is not a new concept.e,8 However, we reasoned that once a decision was made to use local anesthesia, placement in an ambulatory (day) surgery center was a reasonable alternative to hospitalization. In contrast, Benson, Barrett and Patterson8 reported that those patients undergoing local anesthesia for placement of Jonas prosthesis were hospitalized for 2.8 days average as opposed to 4.1 days for general anesthesia. We found that no patient who was treated in a day surgery center required subsequent hospitalization for pain management or other short-term complications. However, one of the patients did experience both infection and a minor cerebral vascular accident postoperatively and one other with an infected prosthesis required postoperative hospitalization. While it was our custom to use 1 per cent lidocaine, we would agree with Benson et ~1.~ that a reduced dose of 0.25 per cent local anesthetic agent would be sufficient and reduce the risk for systemic toxicity. We have started antibiotic coverage in the immediate preoperative period and continued it for one week postoperatively. There is no adequate study done with penile prosthesis to address properly the question of antibiotic management, but to borrow a chapter from the nonurologic surgical disciplines, particularly those employing prostheses, it is probably only a single preoperative dose that is crucial.12 Recently we reduced coverage to twenty-four hours and continue intraopertive wound irriga-

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Patient satisfaction with penile prosthesis

Satisfied Good/very good Fair Dissatisfied No answer

-PatientsNo. 24 8 2 1

% 68 23 6 3

tion with antibiotic solution. Although we have had no problem, we no longer irrigate with neomycin solution for fear of ototoxicity. The distal circumcising-type incision with lateral longitudinal corporeal incisions has not resulted in injury to the neural vascular bundle with consequent penile numbness, and longterm postoperative edema has not generally .been a problem. We do find that men having any penile prostheses inserted by any technique tend to experience a cool glans penis particularly when outside during the cold Wisconsin winters. This is likely not related to neurologic injury, but secondary to decreased penile blood flow. When preoperatively counseling patients on selection of penile prosthesis, we are careful to caution that a penile prosthesis of whatever type will often be shorter than the erection they were accustomed to. In addition, the glans penis will be soft, and they should be prepared for these developments. It is only the AMS inflatable penile prosthesis which increases in length with inflation. In our experience, the Mentor inflatable prosthesis does not; and if length is a crucial issue, perhaps an AMS inflatable one is a better choice. The inflatable prosthesis also increases in girth with inflation, To address the girth issue with the malleable prosthesis, it is better to insert the larger diameter whenever possible. This will give better girth and better patient satisfaction. It is also the inflatable-type prosthesis which gives better concealment. When considering malleable prostheses, the characteristics of rigidity, stability, and concealment result in trade-offs of one characteristic against the other. Increased rigidity results in a prosthesis which is increasingly more difficult to bend under the scrotum and conceal, but which may hold the down position well. If rigidity is increased too greatly, a rotational instability of

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the curved penis may result during attempts at intercourse. While we have limited experience with the Jonas malleable prosthesis, we believe that the AMS prosthesis provides a reasonable mix of these three variables. Benson et al. 8reported that 90/ 100 (90 % ) patients were satisfied with their selection of the Jonas prosthesis. In this report, 32/35 patients (91%) answering the questionnaire felt they had made the right choice. In the study by Benson et al. of the Jonas prosthesis, 70/100 (70%) patients were content with the concealment provided by the Jonas prosthesis. In this report, 23/35 patients (66%) were completely satisfied with fit of the clothing after the procedure. An additional 8 patients (23%) were satisfied, but felt that the fit left something to be desired. On the contrary, all patients but 1 noted that the rigidity was sufficient for intercourse, and 1 patient noted some rotational instability which he readily overcame by stabilizing the base of the penis during intercourse. An additional point of importance when selecting a prosthesis is the number of devices necessary for a full inventory. All AMS sizes can be stocked with the purchase of just three units. This would be a particularly attractive feature to infrequent implanters.

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600 Highland Avenue Madison, Wisconsin 53792 (DR. BRUSKEWITZ) ACKNOWLEDGMENT:To Drs. Edward Messing, Paul Madsen, Dave Joseph, Mike Kuglitsch, Paul Rodriquez, and Rich Roach for providing patient data. References 1. Pearman RO: Insertion of a Silastic penile prosthesis for treatment of organic sexual impotence, J Urol 107: 692 (1972). 2. IDEM:Treatmentof organic impotence by implantation of a penile prosthesis,ibid 97: 716 (1967). 3. Beheri GE: Surgical treatment of impotence, Plast Reconstr Surg 38: 92 (1966). 4. Melman A: Experience with implantation of the SmallCarrion penile implant for organic impotence, J Urol 116: 49 (1976). 5. Malloy TR, Wein AJ, and Carpinello VL: Improved mechanical survival with revised model inflatable penile prosthesis using rear-tip extenders, ibid 128: 489 (1982). 6. Kaufman JJ, Lindner A, and Raz S: Complications of penile prosthesis surgery for impotence., ibid 128: 1192 (1982). 7. Barry JM, Giesy JD, and McDuffie R: Actuarial survivals of inflatable and flexible, hinged penile prostheses, Urology 20: 605 (1982). 8. Benson RC, Barrett DM, and Patterson DE: The Jonas prosthesis, J Urol 130: 920 (1983). 9. Kaufman J, Boxer R, Boxer B, and Quinn M: Physical and psychological results of penile prosthesis, ibid 126: 173 (1981). 10. Fallon B, Rosenberg S, and Culp DA: Long term followup in patients with an inflatable prosthesis, ibid 132: 270 (1984). 11. Beutler LE, et al: Women’s satisfaction with partner’s penile implant, Urology 24: 552 (1984). 12. Hirshmann JV, and Invi TS: Antimicrobial prophylaxis: a critique of recent trials, Rev Infect Dis 2: 1 (1980).