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Volume 336:1-7 January 2, 1997 Number 1 Next

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ABSTRACT

Background Erectile dysfunction in men is common. We evaluated a system by which alprostadil (prostaglandin E₁) is delivered transurethrally to treat this disorder.

Methods Alprostadil was delivered transurethrally in a double-blind, placebo-controlled study of 1511 men, 27 to 88 years of age, who had chronic erectile dysfunction from various organic causes. The men were first tested in the clinic with up to four doses of the drug (125, 250, 500, and 1000 µg); those who had sufficient responses were randomly assigned to treatment with either the effective dose of alprostadil or placebo for three months at home.

Results During in-clinic testing, 996 men (65.9 percent) had erections sufficient for intercourse. Of these men, 961 reported the results of at least one home treatment; 299 of the 461 treated with alprostadil (64.9 percent) had intercourse successfully at least once, as compared with 93 of the 500 who received placebo (18.6 percent, P<0.001). On average, 7 of 10 alprostadil administrations were followed by intercourse in men responsive to treatment. The efficacy of alprostadil was similar regardless of age or the cause of erectile dysfunction, including vascular disease, diabetes, surgery, and trauma (P<0.001 for all comparisons with placebo). The most common side effect was mild penile pain, which occurred after 10.8 percent of alprostadil treatments, but the pain rarely resulted in refusal to continue in the study. Hypotension occurred in the clinic in 3.3 percent of men receiving alprostadil. Hypotension-related symptoms were uncommon at home. No men had priapism or penile fibrosis.

Conclusions In men with erectile dysfunction, transurethral alprostadil therapy resulted in erections in the clinic and in intercourse at home.

Source Information

From the Department of Urology, University of Southern California, Los Angeles, and the Male Clinic, Santa Monica, Calif. (H.P.-N.); the Department of Urology, Tulane University Medical Center, New Orleans (W.J.G.H.); the Division of Geriatric Medicine, St. Louis University School of Medicine, St. Louis (F.E.K.); the Division of Urology, University of Utah, Salt Lake City (R.F.L.); the Department of Urology, University of California, San Francisco (T.F.L.); the Section of Endocrinology, University of Wisconsin, Madison (W.E.N.); the Peachwood Medical Group, Clovis, Calif. (P.C.N.); the Department of Clinical Research, Vivus, Inc., Menlo Park, Calif. (C.A.P., P.Y.T., V.A.P., N.G.); and the Department of Urology, Columbia–Presbyterian Hospital, New York (R.S.). Other authors were Christy Cowley, B.S., Kerry J. Nemo, Alfred P. Spivack, M.D., Darby E. Stephens, B.S., and Leslie K. Todd, B.A. — all from Vivus, Inc., Menlo Park, Calif.Presented in part at the annual meeting of the American Geriatric Society, Chicago, May 1–5, 1996, and at the annual meeting of the American Urologic Association, Orlando, Fla., May 4–9, 1996.

Address reprint requests to Dr. Gesundheit at Vivus, 545 Middlefield Rd., Suite 200, Menlo Park, CA 94025.

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