Technology Assessment Program

Technology Assessment Program Report No. 11

Treatment Options for Male Erectile Dysfunction: A Systematic Review of Published

Studies of Effectiveness

Authors: Contributors:

The VA Coordinating Center of the Cochrane Review Group in Prostate Diseases and Urologic Malignancies, the Minneapolis/VISN 13 Center for Chronic Diseases Outcomes Research and the Section of Urology, Minneapolis VAMC.

Timothy J. Wilt, M.D., M.P.H., Coordinating Editor Howard A. Fink, M.D., Research Fellow Roderick MacDonald, M.S., Coordinator Indulis R. Rutks, B.S., Trials Search Coordinator Douglas Schow, M.D., Staff Physician

Karen Flynn, D.D.S., M.S., Manager, Technology Assessment Program Elaine Alligood, M.L.S., MDRC Information Center Librarian Jennifer Cheslog, Data Assistant, Technology Assessment Program Elizabeth Adams, R.R.T., M.P.H., Management and Program Analyst, Technology

Assessment Program

Report Date: January 1999

MTA98-016

The Health Services Research and Development Service (HSR&D) is a program within the Veterans Health Administration's Office of Research and Development. HSR&D provides expertise in health services research, a field that examines the effects of organization, financing and management on a wide range of problems in health care delivery quality of care, access, cost and patient outcomes. Its programs span the continuum of health care research and delivery, from basic research to the dissemination of research results, and ultimately to the application of these findings to clinical, managerial and policy decisions.

Technology Assessment Program Management Decision and Research Center (152M) Health Services Research and Development Service

Office of Research and Development VA Medical Center

150 South Huntington Avenue Boston, MA 02130

Tel: (617) 278-4469 FTS: (700) 839-4469 Fax: (617) 278-4438 Karen.Flynn@med. g.mdrc-ta@forum.

Released September 1999

ACKNOWLEDGEMENTS

January 1999

The program wishes to thank the following people for their contributions to the report. The MDRC takes full responsibility for the views expressed herein, and their participation does not imply endorsement.

Sue Simpson, PhD

Department of Public Health & Epidemiology University of Birmingham Birmingham, U.K.

Amanda Burls, BA (Oxon), MSc, MB BS, MFPHM

Department of Public Health & Epidemiology University of Birmingham Birmingham, U.K.

Drogo K. Montague, MD

Director, Center for Sexual Function Department of Urology Cleveland Clinic Foundation Cleveland, OH

Ira D. Sharlip, MD

Assistant Clinical Professor Department of Urology University of CA, San Francisco & Secretary, Society for the Study of Impotence, Inc.

And the members of the Technology Recommendations Panel: Paul Billings, MD, PhD, Denis FitzGerald, MD, Lawrence Flesh, MD, Daniel Hinshaw, MD, Thomas Holohan, MD, Robert Jones, MD, MBA, Valerie Lawrence, MD, Neil Otchin, MD, James Reagan, PhD, Richard Robinson, JD, and Richard Wannemacher, Jr.

The MDRC Technology Assessment Program wishes to thank Matthew Eberle, Kevin Rys, and the staff of the Information Dissemination Program for their help with the report.

MTA98-016

MDRC Technology Assessment Program - Erectile Dysfunction - Page i

January 1999

Treatment Options for Male Erectile Dysfunction: A Systematic Review of Published Studies of Effectiveness

EXECUTIVE SUMMARY

Purpose This report was written in response to a request to VA's Technology Recommendations Panel (TRP) regarding treatment options for male erectile dysfunction (ED). The TRP, a national committee, is "responsible for the evaluation of health care technologies and for preparing recommendations regarding the use of such technologies" (TRP Charter, unpublished, 1997). The Health Services Research and Development Service, Management Decision and Research Center Technology Assessment Program commissioned the review on behalf of the TRP.

The intent of this report is to update and expand information from the 1996 American Urological Association Clinical Guidelines Panel on Erectile Dysfunction: Summary Report on the Treatment of Organic Erectile Dysfunction. The current report relies primarily on results from randomized controlled trials of treatment for ED published from January 1995-January 1999. It also includes results from additional sources including patient preference studies, post marketing reports, product inserts and FDA announcements. It focuses on new FDA-approved therapies for ED of greatest clinical and resource significance to the VA, i.e. oral sildenafil (Viagra); intraurethral alprostadil (MUSE); and intracavernous injections of alprostadil (Caverject).

Background ED is defined as the persistent inability to achieve or maintain an erection sufficient for satisfactory sexual performance (Anon, 1993). The prevalence of ED increases with age and comorbid conditions such as diabetes, heart disease, hypertension, neurologic and psychiatric conditions, smoking and some surgical therapies. ED, while not life threatening, can result in withdrawal from sexual intimacy and reduced quality of life. ED is common, accounting for 525,000 physician visits in 1985. Nearly 10% of men aged 40-70 have reported complete ED and 52% some degree of dysfunction. If these findings are extrapolated to male veteran users of the VA medical system then an estimated 1.7 million veterans may have some degree of ED.

The treatment of ED (without evidence of hypogonadism) includes a number of options that are generally viewed by patients, partners and providers as effective in initially restoring erectile function: vacuum constriction devices, penile prosthesis implantation, vasoactive drug injection and oral therapies. However, for many treatments there is a high rate of treatment cessation. Therefore, efforts to optimize treatment should target improvements not only in physiologic/clinical measures of erectile function but also patient/partner satisfaction and preference. The NIH Consensus Statement on Impotence encourages physicians to try the least invasive treatment first. The ideal treatment is effective, useful `on demand,' free of toxicity and side effects, easy to administer (oral or topical) and affordable.

Key Findings ? ED is a common condition that results in reduction in quality of life. The number of men seeking help

is likely to increase with enhanced awareness of ED and of its treatment options.

MTA98-016

MDRC Technology Assessment Program - Erectile Dysfunction - Page ii

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