A brief scientific reminder for those who have any doubt about the efficacy of MUSE:
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
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.
For more information, contact VIVUS at: product@vivus.com. For medical information, contact VIVUS at: medical@vivus.com. Please include your mailing address so that information can be sent to you.
Alternatively, you may call our toll-free informational hot-lines:
If you are a patient, call: 1-888-367-MUSE
If you are a healthcare professional, call: 1-888-345-MUSE
--------------------------------------------------------------------------------
|| About Erectile Dysfunction | For Men And Their Partners | Our Products ||
|| VIVUS Corporate | For Healthcare Professionals | Search | Home ||
--------------------------------------------------------------------------------
VIVUS, Inc.
605 East Fairchild Drive
Mountain View, California 94043
650-934-5200
Comments about our web site? webmaster |
