Frosty,
Abstract Presented by Dr. Harin Padma-Nathan
at the 1996 Annual Meeting of the
American Urological Association
May 6, 1996
MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF TRANSURETHRAL ALPROSTADIL IN MEN WITH CHRONIC ERECTILE DYSFUNCTION. Harin Padma-Nathan, Los Angeles, CA; Stephen M. Auerbach, Newport Beach, CA; James H. Barada, Albany, NY; Arthur L. Burnett, Baltimore, MD; Raymond A. Costabile, Washington, DC; Robert G. Ferrigni, Scottsdale, AZ; Jay Y. Gillenwater, Charlottesville, VA; Wayne J. G. Hellstrom, New Orleans, LA; Tom F. Lue, San Francisco, CA; David E. Patterson, Rochester, MN; Nicholas A. Romas, Ridwan Shabsigh, New York, NY; Paul R. Young, Jacksonville, FL; Neil Gesundheit, Alfred P. Spivack, Virgil A. Place, Menlo Park, CA, and the VIVUS-MUSE Study Group. (Presented by Dr. Padma-Nathan)
INTRODUCTION/OBJECTIVES: Short-term studies have previously shown that transurethral alprostadil produces erections and sexual intercourse in men with erectile dysfunction. The safety and efficacy of transurethral alprostadil has now been tested in a large group of patients with chronic erectile dysfunction in a three-month, double-blind, placebo-controlled study.
METHODS: 1511 adult men and their partners were enrolled in a prospective, two-part study at 58 study centers. The mean duration of a complaint of erectile dysfunction was 48.0 months. In Part I, patients self-administered transurethral alprostadil (125, 250, 500, and 1000 æg) in the clinic; the erectile response was recorded on a five-point Erection Assessment Scale where 1=no response, 2=some enlargement, 3=full enlargement, 4=erection sufficient for intercourse and 5=rigid erection. In Part II, patients (mean age ~62) achieving a score of "4" or "5" in the clinic were randomly assigned to home treatment with either active drug (at their selected dose) or placebo.
RESULTS: In Part I of the study (in the clinic), 66% of men achieved a "4" or "5" on the Erection Assessment Scale. 29% of patients chose the lowest doses (125 or 250 æg); 30% chose the middle dose (500 æg), and 41% chose the highest dose (1000 æg) of transurethral alprostadil. In Part II (home treatment), 64.9% of patients on active medication had intercourse compared to 18.6% on placebo (p < 0.001). Treatment efficacy was shown in all etiologies of erectile dysfunction studied: vasculogenic, diabetic, post-surgical, and "other." The most common side effect, penile pain, occurred in 10.9% of home administrations. Hypotension occurred in 2.8% of patients in the clinic. There were no reports of priapism (rigid erection lasting >= 6 hours) at home or in the clinic. 88% of subjects completed the 3 months of home treatment.
CONCLUSIONS: Transurethral alprostadil is well tolerated and can restore erections and sexual intercourse in men with chronic erectile dysfunction.
Frosty,
The multicenter studies donne on thousands of men showed about the same success rate that Edderd has of about 2/3.
Why is it that all of a sudden 2 small biased single center studies on about 100 men becomes significant? |
