Long-term efficacy and compliance of intracorporeal (IC) injection for erectile dysfunction following radical prostatectomy: SHIM (IIEF-5) analysis.

Baseline and follow-up data from 102 patients using intracorporeal (IC) injection for erectile dysfunction (ED) following RP were retrospectively collected. We compared baseline International Index for Erectile Function (IIEF) questionnaires with the abridged IIEF-5 questionnaires, referred to as the Sexual Health Inventory of Men (SHIM) to determine drug efficacy. The mean presurgery SHIM score was 21.75+/-5.23, which decreased to 4.23+/-3.48 after surgery and increased to 19.46+/-8.78 post-treatment. Overall, 68% (69/102) of patients achieved and maintained erections sufficient for sexual intercourse and 48% (49/102) of patients continued long-term therapy with a mean use of 3.7+/-1.9 y. In all, 52% (53/102) patients discontinued IC therapy. However when excluding patients who switched to oral therapy, had loss of partner or return of normal erections; the compliance to IC injections was 70.6% (71/102). There was no difference in the SHIM analysis between the nerve sparing (NS) and the non-NS or between the types of medications used. IC injections can provide excellent long-term efficacy and compliance in up to 70% of the patients. This study suggests that IC injections are an excellent salvage option in NS patients who fail oral therapy and a first option in patients with non-NS procedures.

Penile prosthesis infections.

In this retrospective review we looked at infection rates and risk factors in penile prosthesis recipients. Computer registry records of patients implanted with three-piece inflatable prostheses from April 1986 to March 1999 were reviewed. Bacteriological culture report data were obtained from the medical records. There were 491 three-piece inflatable penile prosthesis recipients with follow-up ranging from 1 to 168 months (mean 83). All patients were implanted more than 1 y ago. There were 10 infections in 491 recipients (2.0%). In 285 primary prosthesis recipients there were seven infections (2.5%). In 206 secondary prosthesis recipients there were three infections (1.5%). Seven infections occurred in 354 non-diabetics (2.0%) and three infections occurred in 137 diabetics (2.2%). None of these differences were statistically significant. Explants for infection were performed in 8 weeks or less following implantation in eight patients. In two patients explants occurred at 17 and 26 months following implantation. Cultures from the periprosthetic space grew E. coli (four), Proteus mirabilis (two), Staph. aureus (two), and bacteroides (two). Infections occurred in 2.0% of three-piece inflatable penile prosthesis recipients. There were no statistically significant differences in infection rates between first time and repeat prosthesis recipients and between diabetic and non-diabetic recipients. Eight of the 10 infections occurred 8 weeks or less following implantation.

Management of erectile dysfunction following radical prostatectomy.

Radical prostatectomy is the standard treatment for organ/specimen-confined prostate cancer, yet erectile dysfunction in selected series is still reported as high as 90% after this procedure. Thus, most men need adjuvant treatments to be sexually active following radical prostatectomy. These include vacuum constriction devices, intracorporeal injections of vasoactive drugs, and transurethral dilators, all of which have reported response rates of 50% to 70%. Unfortunately, long-term compliance is suboptimal, with a discontinuation rate of nearly 50% at one year. These non-oral options should be offered on an individual basis to patients who have failed oral therapy since efficacy and compliance vary. Also, these options should be considered in the early postoperative period to enhance sexual activity and penile oxygenation, which may prevent corporeal fibrosis. Early penile rehabilitation with intracavernosal injections or vacuum constriction devices should be encouraged to increase chances for recovery of rigid erections. In patients with some preservation of nerve tissue, oral sildenafil may be effective in promoting an earlier return of erectile function. The potential impact of sildenafil and other new oral therapies should encourage urologists to continue to perform and perfect the nerve-sparing approach.

Role of Viagra after radical prostatectomy.

OBJECTIVES: To determine whether the response to sildenafil citrate (Viagra) in patients with erectile dysfunction after radical prostatectomy was influenced by the presence or absence of neurovascular bundles, the interval from surgery to the initiation of drug therapy, and the dose of the drug. METHODS: Baseline and follow-up data from 91 patients presenting with erectile dysfunction after radical prostatectomy were obtained. The patients were stratified according to the type of nerve-sparing (NS) procedure: bilateral NS, unilateral NS, and non-NS. They were interviewed using the Cleveland Clinic Post Prostatectomy (CCPP) questionnaire and the International Index of Erectile Function (IIEF) questionnaire. RESULTS: The presence or absence of the neurovascular bundles influenced the ability to achieve vaginal intercourse. In the patients who had undergone bilateral NS, 71.7% (38 of 53) responded; in those with unilateral NS, 50% (6 of 12) responded; and in those with non-NS, 15.4% (4 of 26) responded. The IIEF questionnaire confirmed the quality of the positive responses, with significant improvements in response to question 3 (frequency of penetration), question 4 (frequency of maintenance of erection), and question 7 (satisfaction with intercourse). The magnitude of improvement in responses was higher in the bilateral NS group than in the unilateral NS and non-NS groups (P <0.05). When the data of the 48 positive responders were analyzed, no difference in the response rate was found when the interval from surgery to drug therapy was stratified by the following three intervals: 0 to 6 months (44%), 6 to 12 months (55%), and greater than 12 months (53%). Of the positive responders, 14 (29.1%) required the 50-mg dose, and 34 (70.9%) required the 100-mg dose. The most common side effects were transient headaches (28.6%), flushing (21.9%), dizziness (8.8%), dyspepsia (6.5%), and nasal congestion (5.4%), with an increase in the incidence of headaches seen at the higher dose (P = 0.04). CONCLUSIONS: Successful treatment of erectile dysfunction with sildenafil citrate after radical prostatectomy depends on the presence of the neurovascular bundles. Our data suggest that the response to sildenafil is not related to the interval between the surgery and initiation of drug therapy but is related to the dose.

Treatment of erectile dysfunction with sildenafil citrate (Viagra) after radiation therapy for prostate cancer.

OBJECTIVES: To determine the response to sildenafil citrate (Viagra) in patients with erectile dysfunction after radiation therapy for localized prostate cancer. METHODS: Baseline and follow-up data from 21 patients presenting with erectile dysfunction after radiation treatment for clinical T1-2 prostate cancer were obtained. Two patients had undergone iodine-125 seed implantation and the remaining 19 conformal external beam irradiation. All 21 patients were considered to have erectile dysfunction as assessed by the International Index of Erectile Function (IIEF) and were prescribed sildenafil at a dosage of 50 mg, with a titration to 100 mg if needed. The mean time between the completion of radiation therapy and initiation of sildenafil was 24.6 +/- 5.8 months. The quality of the erectile function was assessed after a minimum of four doses by using the Cleveland Clinic Erectile Function (CCEF) questionnaire and the IIEF questionnaire. A positive response to sildenafil on the CCEF questionnaire was defined as an erection sufficient for vaginal penetration. The responses on the IIEF questionnaire were rated on a scale of 1 (almost never) to 5 (almost always), with 0 being no sexual activity. RESULTS: On the CCEF questionnaire, 71% (15 of 21) of patients had a positive response, with a mean duration of 12.7 +/- 2.5 minutes of intercourse, and a corresponding spousal satisfaction rate of 71%. Twelve (80%) of the 15 responders required titration to the 100-mg dosage for maximal effect. The most common side effects seen were transient flushing (19%), abnormal color vision (14%), and headaches (10%). No patient discontinued the drug because of side effects. On the IIEF questionnaire, the responses to questions 3 (frequency of penetration), 4 (maintenance of erection), 7 (satisfactory intercourse), and 15 (erection confidence) increased from mean baseline scores of 1.3, 1.1, 1.2, and 1.8 to final mean scores of 4.0, 3.9, 3.2, and 3.4, respectively (P <0.001). On the global efficacy question (ability to achieve firm erections), 71% of the patients responded positively. CONCLUSIONS: Sildenafil citrate can improve the ability to achieve and maintain an erection in most patients with erectile dysfunction after radiation therapy for prostate cancer.

Management of severe corporeal fibrosis with implantation of prosthesis via a transverse scrotal approach.

PURPOSE: We reviewed our experience in the management of severe corporeal fibrosis with placement of the AMS 700 CXM* prosthesis to determine the efficacy of this approach. MATERIALS AND METHODS: The records of 26 men with severe corporeal fibrosis who underwent placement of the AMS 700 CXM prosthesis via a transverse scrotal approach between August 1991 and July 1996 were reviewed. RESULTS: In all cases the AMS 700 CXM prosthesis was successfully implanted with primary closure of the tunica albuginea, although 2 patients required extended corporotomies. Followup data were available on all 26 men. At a mean followup of 22.5 months (range 3 to 63) 24 of the 26 men had a functional device (92%). One patient required explantation for infection and 1 underwent explantation for cylinder cross-over. CONCLUSIONS: Implantation of the AMS 700 CXM prosthesis in patients with severe corporeal fibrosis produced good results at approximately 2 years of followup.

Long-term mechanical reliability of AMS 700 series inflatable penile prostheses: comparison of CX/CXM and Ultrex cylinders.

PURPOSE: Recently, we have noted an increasing incidence of revisions being performed in patients implanted with the length and girth expanding AMS 700 Ultrex* inflatable penile prosthesis. This observation prompted us to compare the long-term mechanical reliability of the AMS Ultrex inflatable penile prosthesis versus the girth-expanding AMS 700 CX* or CXM* inflatable penile prosthesis in men with organic erectile dysfunction. MATERIALS AND METHODS: Using chart review, mailed questionnaires and telephone interviews, we obtained accurate followup on 111 of 142 (78.2%) patients with CX/CXM implanted between June 1986 and September 1995, and on 152 of 179 (84.9%) patients implanted with Ultrex between October 1989 and September 1995. The CX/CXM and Ultrex groups were compared with regard to 3 end points: 1) mechanical failure caused by any malfunctioning component, 2) device failure caused by any cylinder complication and 3) cylinder aneurysms/leaks. RESULTS: Followup ranged from 1.0 to 112.0 months for the CX/CXM group (mean 47.2 months), and 0.7 to 71.5 months for the Ultrex group (mean 34.4 months). CX/CXM versus Ultrex group comparison demonstrated 10 CX/CXM mechanical failures (9.0%) versus 26 Ultrex failures (17.1%), p = 0.001; 5 CX/CXM cylinder complications (4.5%) versus 13 Ultrex cylinder complications (8.6%), p = 0.0292; and 3 CX/CXM cylinder aneurysms/leaks (2.7%) versus 9 in the Ultrex group (5.9%), p = 0.0162. Kaplan-Meier estimates demonstrated significantly decreased mechanical survival in all 3 categories for Ultrex inflatable penile prosthesis versus CX/CXM inflatable penile prosthesis. CONCLUSIONS: Although Ultrex cylinders provide length and girth expansion, Ultrex cylinders exhibit an increased mechanical failure rate at shorter followup compared with CX/CXM cylinders. This increased propensity for Ultrex cylinder problems should be closely monitored.

AMS 3-piece inflatable penile prosthesis implantation in men with Peyronie's disease: comparison of CX and Ultrex cylinders.

PURPOSE: We compared the ability of the CX and Ultrex cylinders to straighten the penis in men who received a 3-piece AMS 700 series inflatable penile prosthesis for erectile dysfunction and erectile deformity due to Peyronie's disease. MATERIALS AND METHODS: The records of 34 and 38 patients receiving devices CX and Ultrex cylinders, respectively, were reviewed. RESULTS: All 34 patients receiving the CX cylinders achieved complete penile straightening with cylinder inflation and bending alone. In 10 of 38 patients receiving the Ultrex cylinders complete straightening with cylinder inflation and bending could not be achieved, and simultaneous corporoplasty was necessary. CONCLUSIONS: Girth expanding CX cylinders have better penile straightening properties than girth and length expanding Ultrex cylinders. We recommend use of CX cylinders for 3-piece AMS 700 series inflatable penile prosthesis implantation in men with Peyronie's disease.

Penile scarring with intracavernous injection therapy using prostaglandin E1: a risk factor analysis.

PURPOSE: We attempted to identify risk factors for penile scarring in patients using prostaglandin E1 injection therapy. MATERIALS AND METHODS: Records of 92 patients using prostaglandin E1 therapeutically were reviewed. With statistical methods, patients with (15) and without (77) scarring were compared. RESULTS: No significant differences between the 2 groups were found regarding duration of followup, injection frequency, prostaglandin E1 dose per injection, total number of injections or total prostaglandin E1 dose. Patients with initial penile scarring did not have a significantly higher incidence of further scarring with prostaglandin E1. CONCLUSIONS: Penile scarring with prostaglandin E1 injection therapy is sporadic and unpredictable. Patients with initial penile scarring do not have a higher incidence of further scarring.

Efficacy of the vacuum constriction device in patients with corporeal venous occlusive dysfunction.

OBJECTIVES: The vacuum constriction device (VED) is an effective nonsurgical treatment for erectile dysfunction. Its efficacy in specific patient groups, however, has not been extensively studied. Only one study to date has examined the use of the VED in patients with corporeal veno-occlusive dysfunction (CVOD). This study used a mailed questionnaire and no statistical analysis of the data. The purpose of this study was to examine the efficacy of the VED in patients with documented CVOD. METHODS: From 1989 to 1992, 294 patients chose to use a VED as treatment for erectile dysfunction. All patients were evaluated with a thorough history and physical examination, hormonal testing, glucose tolerance testing, and nocturnal penile tumescence studies. Ninety-eight patients underwent additional vascular testing. When seen in follow-up, patients were asked to assess erection quality and overall satisfaction with the device. RESULTS: Fifty patients had documented CVOD (33 by cavernosometry, 16 by ultrasound, and 1 by cavernosography). Twenty-eight patients (56%) were satisfied, 13 patients (26%) were unsatisfied, and in 9 patients (18%) satisfaction could not be determined. Thirty-eight patients (76%) achieved an erection of at least 7 on a scale of 1 to 10. There was no relationship between the severity of disease (as measured by cavernosometry) and the rating of erection (Kruskal-Wallis test, P = 0.77) or satisfaction with the device (Fisher's exact test, P = 0.95). CONCLUSIONS: The VED is an acceptable nonsurgical treatment for patients with erectile dysfunction secondary to CVOD regardless of severity. Its success rate is comparable to other therapeutic modalities such as injection therapy.

Cultures from genitourinary prostheses at reoperation: questioning the role of Staphylococcus epidermidis in periprosthetic infection.

PURPOSE: We determine the colony counts of organisms present on culture of clinically uninfected genitourinary prostheses at reoperation for reasons other than infection. These results served as control data for comparison with cultures from infected devices to determine the relative incidence of organisms involved. MATERIALS AND METHODS: Cultures were prospectively obtained from 65 penile prostheses and 22 artificial urinary sphincters. Patients were followed for a minimum of 12 months after reoperation or until development of infection (mean 27 months) at which time cultures were again obtained. RESULTS: Low colony counts of Staphylococcus epidermidis were isolated from 40% of uninfected penile prostheses and 36% of artificial urinary sphincters. Only 3 of these devices later became infected (9%) and in all cases a higher colony count of another organism was found at explanation. CONCLUSIONS: While Staph. epidermidis can cause prosthesis infection, low colony counts of the organism may not be associated with clinical infection. Therefore, the high incidence of infection attributed to this organism may be overestimated.

Primary erectile dysfunction in a man with congenital isolation of the corpora cavernosa.

We report on a 33-year-old man with primary erectile dysfunction, isolated cavernous bodies, corporeal veno-occlusive dysfunction, and hypoplastic cavernous arteries. To our knowledge, this is only the second reported case of absence of communication between the corpora cavernosa.

Penile venous ligation in 18 patients with 1 to 3 years of followup.

We report the results of penile venous ligation in 18 consecutive patients with erectile insufficiency due to corporeal venous occlusive dysfunction. Patient age ranged from 25 to 65 years (mean 47). Duration of erectile dysfunction ranged from 9 to 468 months (mean 95) and followup ranged from 12 to 37 months (mean 24). Of 18 patients 11 (61%) have sufficient persistent improvement in erections to permit unaided coitus. Of 7 failures 6 had temporary improvement in erections after the procedure: in 5 the improvement lasted 6 months or less, while only 1 had lasting improvement (24 months) before relapse. Reports of results of penile venous ligation should not include patients who have been followed for less than 12 months. Longer followup is needed before results of penile venous ligation beyond 2 years are known.

Treatment of organic impotence with penile prosthesis in renal transplant patients.

Seven patients were identified who underwent both renal transplantation and penile prosthesis implantation at our institution between June 1980 and June 1990, and their charts were retrospectively reviewed. A total of nine penile prostheses were placed in these patients, five prior to transplantation and four following transplantation. One patient received two prostheses prior to transplantation. One patient received a prosthesis both before and after transplantation. No complications were seen in the four prostheses placed following transplantation with a follow-up of one to forty months (mean 18 months). Of the five prostheses placed prior to transplantation, two were removed due to periprosthetic infections, a cylinder leak developed in one, and one was complicated by penile and scrotal erythema with sepsis.

Early experience with the controlled girth and length expanding cylinder of the American Medical Systems Ultrex penile prosthesis.

A prospective study was done to evaluate length expansion characteristics of the AMS Ultrex penile prosthesis cylinder intraoperatively and in the early postoperative period. A total of 50 patients 30 to 74 years old (mean age 55.2 years) underwent implantation of this device. Intraoperative changes in the pubis to mid glans distance between deflation and inflation ranged from 1 to 4 cm. (mean 1.9). Postoperative followup measurements were obtained in 46 patients at 1 to 15 months (mean 4). There was a 1 cm. decrease in the amount of postoperative length expansion for 6 patients, while length expansion increased by 1 cm. for 12 and for 28 the postoperative length expansion was the same as the intraoperative length expansion.

False diagnoses of venous leak impotence.

Tests for erectile dysfunction using intracavernous injections of vasoactive drugs are currently popular and have resulted in frequent diagnoses of venous leak impotence. Tests used to make this diagnosis, however, have not been validated by study in control subjects. We present 2 cases of false diagnoses of venous leak impotence. Anxiety mediated through the sympathetic nervous system may block the action of intracavernous smooth muscle relaxants. The resulting incidence of false diagnoses of venous leak impotence is unknown.

Infusion pharmacocavernosometry and nocturnal penile tumescence findings in men with erectile dysfunction.

Infusion pharmacocavernosometry and nocturnal penile tumescence findings were compared in 50 men with erectile dysfunction of either organic or psychogenic etiology. Of the men 29 had abnormal and 21 had normal nocturnal penile tumescence. Infusion pharmacocavernosometry parameters (equilibrium pressure, maintenance flow rate and 30-second pressure fall) were compared to nocturnal penile tumescence status (normal versus abnormal). When traditional normal values were used for infusion pharmacocavernosometry parameters poor correlation with nocturnal penile tumescence status was found. When new cutpoints for infusion pharmacocavernosometry parameters were chosen a stronger correlation was noted. This study suggests that when vasoactive drugs are injected intracavernously for diagnostic purposes, anxiety and/or the absence of sexual stimulation following the injection may prevent complete cavernous smooth muscle relaxation resulting in falsely abnormal values. Therefore, over reliance on infusion pharmacocavernosometry as a single test for evaluation and treatment decisions concerning erectile dysfunction should be avoided.

Intracavernous injection therapy: analysis of results and complications.

Experience with 100 patients who used intracavernous injection therapy with a combination of papaverine with or without phentolamine for 29 months is analyzed in detail. The largest group of patients had vasculogenic erectile failure (56%). At the end of followup 50% of the patients were no longer performing injection. Those who discontinued injection therapy were slightly older and had more vasculogenic erectile failure. The nonfibrotic complications were mild in all instances and did not result in discontinuation of injection therapy. These complications consisted of small hematomas in 20.9% of the patients, mild discomfort in 13.6% and mild liver enzyme abnormalities in 9.8%. No episode of priapism or infection occurred during therapy. Fibrotic complications consisted of nodules or plaques, and correlated significantly with the number of months on injection and the number of injections. At 12 months the fibrotic complication rate was 31 +/- 8.6%. Our study suggests caution regarding the long-term complication rate of intracavernous injection therapy with these compounds and underscores the importance of routine followup examinations. While injection therapy is an effective form of treatment for erectile failure, it is not a satisfactory alternative for many patients and is associated with a significant fibrotic complication rate.