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The efficacy and safety of tadalafil, dosed once a day for the treatment of erectile dysfunction, was assessed in a randomized, double-blind, placebo-controlled, parallel-design study at 15 US centers. Following a 4-week treatment-free run-in period, patients (>or=18 years of age) were randomly assigned to 24 weeks treatment with tadalafil 2.5 mg, tadalafil 5 mg or placebo. Primary efficacy endpoints were change at 24 weeks in International Index of Erectile Function Erectile Function (EF) Domain score and mean per-patient percentage 'yes' responses to Sexual Encounter Profile diary questions 2 and 3. Tadalafil significantly improved erectile function compared with placebo for all three co-primary efficacy endpoints. Few patients discontinued because of adverse events (2.1%, placebo; 6.3%, tadalafil 2.5 mg; 4.1%, tadalafil 5 mg). Common treatment-emergent adverse events (>or=5%) were nasopharyngitis, influenza, viral gastroenteritis and back pain. Tadalafil 2.5 mg and 5 mg, dosed once a day for 24 weeks, was well tolerated and significantly improved erectile function.

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OBJECTIVES: Finasteride, a common agent used to treat benign prostatic hyperplasia (BPH), inhibits 5-alpha-reductase. Testosterone is converted by 5-alpha-reductase to the more potent dihydrotestosterone, which is the primary androgen in the prostate. Leuprolide is a stronger antiandrogen that is used to downstage prostate cancer before radical prostatectomy. Leuprolide induces marked atrophy of prostate carcinoma cells, which sometimes makes pathologic diagnosis of cancer difficult, although evaluation at radical prostatectomy is easier than at biopsy. It is unknown whether finasteride produces similar changes, which would result in greater diagnostic difficulty because such changes would be seen on biopsy to rule out cancer in men with suspicious clinical findings treated for BPH. The current study investigated the histologic effects of finasteride therapy on human prostate cancer and benign prostatic tissue on needle biopsy. METHODS: In blinded manner, we reviewed 53 needle biopsy specimens showing prostate carcinoma (35 treated with finasteride, 18 with placebo). Also reviewed in blinded manner were 50 benign needle biopsy specimens (25 treated with finasteride, 25 with placebo). The Gleason score, number of cores involved, percentage cancer involvement in a core, percentage of atrophic changes in cancer cells, presence of mitoses, blue-tinged mucinous secretions, prominent nucleoli, and high-grade prostatic intraepithelial neoplasia were documented for each case in the cancer group. The percentage of atrophy, basal cell hyperplasia, transitional metaplasia, chronic inflammation, and stromal proliferation was documented for each case in the benign group. RESULTS: No significant histologic differences were present in either the benign or cancer group between cases treated with finasteride and placebo. CONCLUSIONS: We conclude that finasteride treatment for BPH does not cause difficulty in the diagnosis of cancer in prostate needle specimens. It is possible that there are severely atrophic areas resulting from finasteride treatment that are undersampled. However, the conclusion that cancer seen on needle biopsy in men treated with finasteride is unaltered and readily identified as cancer remains valid.

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Deep dorsal vein (DDV) arterialization has developed as a treatment option for patients with arteriogenic impotence, especially in situations where artery-to-artery bypass is not feasible. The inferior epigastric artery (IEA), harvested through a lower abdominal incision, has usually served as the neoarterial source. Using dynamic infusion cavernosometry and cavernosography (DICC) to evaluate arterial and venous erection factors and pudendal arteriography to define arterial anatomy, we have identified 16 patients with cavernosal artery (CA) obstruction and a normal dorsal artery (DA) to serve as the neoarterial source. All patients were less than 50 years old (mean 34.8 +/- 8.6 years). During DICC, the gradient between systemic and CA systolic occlusion pressures averaged 38.7 mmHg. Two patients showed moderate and two minimal corporal veno-occlusive dysfunction (CVOD). From 1991-94, all 16 underwent microscopic DA-DDV arterialization. Four of these patients also underwent venous ligation procedures and three had IEA bypass to the other DA. With adequate follow-up in 15 men, the results for six are considered excellent or normal (40%); eight improved (53.3%) and one was unchanged. In the improved group are three men who did not respond adequately to maximum penile injection therapy before surgery but used small doses afterward with success. Of the three smokers in the series, two were improved and one unchanged. Excellent results were found in four of five men (80%) under age 30 but only one of five (20%) over age 40. Complications included two instances of penile shortening and one of glans hyperemia requiring reoperation. By avoiding an abdominal approach, operative times, morbidity and recovery were substantially shortened. This operative approach can provide an excellent treatment for nonsmokers with CA obstruction and a normal DA.

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A retrospective multi-institutional study was performed to document and characterize the arterial vascular disease in the hypogastric-cavernous arterial bed and/or veno-occlusive dysfunction of the corpora cavernosa in patients with end stage renal disease. We evaluated 20 impotent patients (mean age 40 +/- 9 years) with chronic renal failure using pharmaco-cavernosometry and pharmacocavernosography (4 also underwent pharmaco-arteriography). Patients were divided into groups based on the treatment (14 with renal transplantation and 6 with hemodialysis or peritoneal dialysis), as well as by history of vascular risk factors (16 with and 4 without risk factors). Of the patients 19 revealed abnormal intracavernous pressure responses to repeated intracavenous injections of vasoactive agents implying vascular disease of the penis. Cavernous artery occlusive disease was found in 78% of the patients. All patients who underwent arteriography had diffuse atherosclerotic disease of the distal penile arteries. Corporeal veno-occlusive dysfunction was found in 90% of the patients, of whom 60% had diffuse pan-cavernous leakage involving the dorsal, cavernous and crural veins, glans penis and corpus spongiosum. This renal failure-associated vascular disease of the penis was found to occur independently of the presence of known systemic atherosclerotic vascular risk factors. Patients who underwent early treatment of the uremia by renal transplantation had vasculogenic impotence only in the case of rejection of the renal transplant, suggesting that early renal transplantation may delay or prevent the development of the penile vasculopathy. The most likely pathophysiology of the vascular impairment includes renal failure-associated atherosclerosis, and renal failure-associated hypoxia changes of the contractile (smooth muscle) and structural (collagen/elastin) components of the erectile tissue. Strategies for future research and clinical therapies are suggested.

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The aim of this clinical investigation was to obtain preliminary treatment outcome data concerning the Mentor Alpha-1, the first 3-piece inflatable penile prosthesis with pre-connected tubing between the pump and the penile cylinders. The study was designed to be the first multi-institutional treatment outcome report for any clinically available penile prosthesis with data analysis to be independent of the participating surgeons. A total of 12 board-certified urologists of mixed surgical training backgrounds and practices implanted the Alpha-1 device in 112 consecutive patients. With a mean of 27 +/- 5 months of followup the surgical complication rate included a 4% mechanical malfunction, 2% infection rate and 9% reoperation rate. Patient experience with the implanted device was computed from information on 96 of the 112 patients who returned a questionnaire. Of the patients 82% stated that the device fulfilled expectations as a treatment for impotence and 83% had improved sexual intercourse by 8 weeks after implantation. Patient satisfaction was computed on a scale of 12 equally weighted interrelated variables. Of the patients 77% recorded 9 or more cumulative satisfaction points. Patient and physician questionnaire data were analyzed for their relation to the cumulative prosthesis satisfaction score. A significant difference in cumulative scores was found for physician reported long-term postoperative problems (mean satisfaction score 8.1 for patients with problems versus 10.2 for patients without problems, p = 0.018). The Alpha-1, with its feature of pre-connected tubing, is a reliable 3-piece inflatable penile prosthesis associated with a high level of patient satisfaction.

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In a cooperative, private practice, multi-institutional impotence study, dynamic infusion cavernosometry and cavernosography (DICC) was performed on 743 patients to make an accurate diagnosis and/or identify candidates for penile revascularization. Maximum equilibrium intracorporeal pressure achieved following papaverine and phentolamine injection (Phase I) averaged 29.42 +/- 0.76 mm Hg, approximately one third of normal erection pressure. Corporeal pressure fall from 150 mm Hg over thirty seconds (cavernosometry) averaged 82.38 +/- 1.33 mm Hg (Phase II). The gradient between systolic and cavernosal artery pressure averaged 42.84 +/- 1.12 mm Hg on the right and 43.33 +/- 1.13 mm Hg on the left (Phase III). Cavernosography at 90 mm Hg erection pressure was performed in Phase IV. Of the 124 patients from one center who were reviewed in greater detail, pure cavernosal artery insufficiency (CAI) was found in 25 (20.2%), corporeal veno-occlusive dysfunction (CVOD) in 26 (21.0%), and 73 patients (58.9%) demonstrated combined CAI and CVOD. Diabetics (n = 69) achieved lower equilibrium intracorporeal pressures than nondiabetics, had similar CVOD, and worse CAI. Smokers (n = 365) and patients with Peyronie's disease (n = 32) had erectile dysfunction similar to those without these conditions. Patients impotent after trauma (n = 124) were younger, achieved higher intracorporeal pressures, and showed better corporeal veno-occlusive function than those without trauma. Complications of DICC were minimal and infrequent. After DICC, 169 patients underwent internal pudendal arteriography, 105 had arterial bypass surgery with or without penile venous ligation procedures, and 45 had venous surgery alone. Dynamic infusion cavernosometry and cavernosography is a useful erectile function study to evaluate impotence and can be performed easily in a private practice setting.

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We reviewed the results of microsurgical penile revascularization, with or without a combined procedure to correct cavernosal venous leakage, in 50 consecutive patients with vasculogenic impotence. All patients underwent an extensive preoperative evaluation, including dynamic infusion cavernosography and cavernosometry, and selective penile arteriography. Overall 48% (24 patients) had an excellent postoperative result, 40% (20 patients) were improved and 12% (6 patients) failed, with a median followup of 24 months (range 19 to 56). Furthermore, these results appear durable with no significant difference in length of followup between groups irrespective of surgical outcome (p > 0.05). Analysis of surgical outcomes by preoperative etiology of impotence (pure arterial versus arterial combined with corporeal venous dysfunction) revealed a statistically significant advantage of an excellent surgical outcome in patients with pure arterial impotence compared to those with mixed etiology with results of 67% and 42%, respectively (p < 0.01). There was no significant difference in outcome when patients were analyzed with respect to age or duration of impotence (p > 0.05). We conclude that in patients with arteriogenic impotence identification of concomitant corporeal veno-occlusive dysfunction diagnosed by preoperative dynamic infusion cavernosography and cavernosometry may be helpful, not only in planning a more physiological surgical procedure but also in predicting long-term postoperative success.

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We report a case of erosion of an inflatable penile prosthesis reservoir into the bladder, which evidently occurred during a revision procedure for replacement of a defective pump. There was a significant delay between the time of failure of the prosthesis and the time of revision. Inflatable penile prostheses should be repaired as soon as possible after discovery of leakage.

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Three patients had carcinoma of the stomach, rectum, and lung, respectively, metastatic to the ureter in the absence of other known metastasis. Two of the three patients had abdominal pain, while the other patient had no upper urinary tract symptoms. All patients had excretory urograms that showed delayed or no excretion of contrast medium on the side of obstruction. Obstruction was confirmed with retrograde pyelography in each case. Two of three patients were treated with nephrectomy. Metastatic carcinoma of the ureter should be considered in patients with malignant disease with initial symptoms consistent with ureteral obstruction. The diagnosis may be suggested by pyelographic demonstration of an obstructed ureter. Symptomatic patients may require nephrectomy.

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Of 115 cases of renal trauma 75 injuries were blunt and 40 were penetrating. Primary exploration was done in20 per cent of the patients with blunt injuries and in 100 per cent of those with penetrating injuries. A reparative procedure was done in 60 per cent of the patients operated on for blunt trauma and in 73 per cent of those operated upon for penetrating trauma. Only 3 per cent of the patients with blunt injury and 28 per cent of those with penetrating injury required a nephrectomy. We have concluded that renal injuries should be classified by type and extent rather than by etiology, that the extent of injury should be determined and not surmised, and that the management of renal trauma is a function of the extent of injury and the over-all status of the patient. In addition, the non-operative management of an inadequately defined renal injury cannot be considered conservative management.

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