James S. Cochran

DISAPPOINTING INITIAL RESULTS WITH TRANSURETHRAL ALPROSTADIL FOR ERECTILE DYSFUNCTION IN A UROLOGY PRACTICE SETTING

PURPOSE We evaluate the response to intraurethral alprostadil administration using the Medicated Urethral System for Erection (MUSE) in unselect men with a history of erectile dysfunction. We determine the effects on blood pressure during in office monitoring and assess safety of this form of treatment. We compare the efficacy of MUSE in an office setting with the placebo controlled pivotal study. MATERIALS AND METHODS A total of 115 men with erectile dysfunction underwent in office testing with MUSE following the algorithm recommended by the manufacturer and outlined in the original pivotal study. Patients were asked to rate the rigidity of erection from 1 to 5 with scores 4 and 5 for erections sufficient for intercourse, and level of discomfort from 1 (very uncomfortable) to 5 (very comfortable) at 15-minute intervals. Patients who did not achieve a sufficient erection were scheduled to return for in office testing using the next higher dose up to 1,000 microg. Patient supine and sitting blood pressures were recorded by a nurse before and every 15 minutes after administration. Telephone contact with patients 2 to 3 months after the last in office testing was made to determine whether they were using the system. RESULTS Mean plus or minus standard deviation rigidity scores independent of dosage increased from 2.34+/-0.99 at 15 minutes to 2.49+/-0.96 at 30 minutes and decreased thereafter. Although the 1,000 microg. dosage resulted in highest mean score at all times, the differences between dosages were not significant. Rigidity score 4 or 5 was achieved in 13.2% (500 microg.) and 30% (1,000 microg.) of patients at 30 minutes. Mean level of discomfort was 3.6+/-1.2 at 15 minutes and improved thereafter. Comfort levels were not significantly different among dosages. Overall, at 15 minutes 16.8% of patients were uncomfortable (score 1 or 2) and 41.3% were somewhat uncomfortable (1, 2 or 3). For all dosages supine and sitting systolic and diastolic blood pressures decreased significantly from before treatment to 15 minutes and stayed lower during monitoring. Defined by strict criteria 41.2% of patients experienced orthostatic hypotension during in office testing. A total of 21 patients had adverse events, including pain, discomfort and burning in the penis (the most common), dizziness and chest pain. One patient had a syncopal episode and fell in the office. At last followup only 18.6% of the tested patients continued to use MUSE at home, while the remainder discontinued treatment due to pain, insufficient erections for intercourse and cost. CONCLUSIONS We were unable to achieve similar results to the pivotal study following manufacturer instructions and the algorithm provided by that study. Independent of age and etiology no more than 30% of patients at any given time using any dose achieved erections sufficient for intercourse during in office testing. Because of this limited efficacy, discomfort, pain and burning associated with treatment, and cost, more than 80% of patients did not continue to use MUSE at home.

Serum Alpha-Fetoprotein and Human Chorionic Gonadotropin in Patients with Seminoma

We analyzed the case histories of 31 patients who initially had a diagnosis of seminoma and elevated serum levels of alpha-fetoprotein or human chorionic gonadotropin. We concluded that an elevated alpha-fetoprotein level is firm evidence of the presence of non-seminomatous germ cell tumor and that the patient should be treated accordingly. However, if the level of human chorionic gonadotropin alone is elevated the diagnosis may be either non-seminomatous tumor or seminoma. Patients with seminoma and an elevated level of human chorionic gonadotropin do respond well to radiation therapy if they have low stage disease but if metastatic seminoma is present an elevated human chorionic gonadotropin level appears to be a poor prognostic sign if conventional treatment is given. A plan of treatment is proposed for these patients.

The Endocrinology of Human Chorionic Gonadotropin-Secreting Testicular Tumors: New Methods in Diagnosis

Serum from 59 men with testicular masses was examined for the presence of human chorionic gonadotropin-beta. Results indicate: 1) In patients with testicular tumor human chorionic gonadotropin-beta serves as a sensitive and specific marker of tumor activity with an incidence of 28%. 2) Because human chorionic gonadotropin-beta levels correlate with response to therapy this test will be useful in selecting men for adjunctive irradiation or chemotherapy. 3) Radioimmunoassay for human chorionic gonadotropin-beta is far more sensitive and specific than conventional methods for detecting human chorionic gonadotropin production. 4) After unilateral orchiectomy for carcinoma of the testis elevated serum luteinizing hormone levels are common and may be unrelated to the presence or activity of residual tumor. 5) Human chorionic gonadotropin-beta-producing tumors were associated with increased estradiol and testosterone levels and significantly depressed serum follicle stimulating hormone levels in this series. 6) The prognostic implications of the presence of human chorionic gonadotropin-beta are not yet fully understood. The importance of this study is the fact that men with testicular tumors have a high incidence of human chorionic gonadotropin-beta secretion and this fact provides the physician with a powerful new tool for examining the various aspects of tumor activity. It also shows the feasibility for prospective screening of patients with a wide variety of neoplasms of differing histologic types.

The Seminoma Decoy: Measurement of Serum Human Chorionic Gonadotropin in Patients with Seminoma

Serum human chorionic gonadotropin levels were determined in 20 patients with histologically proved seminoma. The test was positive in 2 of the 20 patients and was predictive of non-seminomatous metastasis in each case. Serum human chorionic gonadotropin is a useful tumor marker in detecting and following non-seminomatous metastases in men with pure seminoma of the testis.