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Cover of Diagnosis and Treatment of Erectile Dysfunction

Diagnosis and Treatment of Erectile Dysfunction

Evidence Reports/Technology Assessments, No. 171

Investigators: , MD, MSc, , MSc, , MD, PhD, , MS, , MD, , MD, PhD, , MD, , MD, , MSc(c), , MD, MSc, , MLIS, , BA, and , PhD.

Rockville (MD): Agency for Healthcare Research and Quality (US); .
Report No.: 08(09)-E016

Structured Abstract


To systematically review the evidence on efficacy and harms of pharmaceutical treatments used in the management of male erectile dysfunction (ED); to explore the clinical utility of routine hormonal blood tests (e.g. testosterone, prolactin) for identifying and treating hormonal disorders and thereby affecting therapeutic outcomes for ED.

Data Sources:

MEDLINE®, EMBASE, PsycINFO®, SCOPUS™, and Cochrane CENTRAL were searched up to June 2007. Reference lists of relevant studies were also searched.

Review Methods:

English language primary studies reporting effects of pharmaceutical treatments used to treat men with ED were eligible for inclusion. The records were screened for relevance, abstracted, and assessed for quality by two reviewers independently. The evidence was summarized qualitatively and the results of randomized controlled trials (RCTs) were pooled using meta-analyses. Subgroup and sensitivity analyses were also conducted.


The evidence needed to ascertain the clinical utility of routine hormonal blood tests was limited in terms of the amount and interpretability. Studies were heterogenous with wide variations in the prevalence of hypogonadism or hyperprolactinemia in patients with ED. Overall phosphodiesterase type 5 (PDE-5) inhibitors were superior to placebo in treating patients with ED with clinically important and statistically significant between-group differences. Adverse events however, were more frequent in PDE-5 inhibitor-treated patients. Few trials demonstrated dose-response trends in the degree of efficacy or frequency of adverse events associated with PDE-5 inhibitors. The clinical benefits conferred by use of PDE-5 inhibitors relative to placebo were observed in patients with wide spectrum of comorbidities irrespective of the origin, duration, or severity of ED. In head-to-head trials evaluating PDE-5 inhibitors, more patients preferred tadalafil to sildenafil or vardenafil. Patients treated with intracavernosal or subcutaneous injections experienced pain and priapism. The evidence for topical, intra-urethral, and hormonal treatments for male ED was insufficient and inconclusive.


Evidence comparing cause-specific therapies (i.e. targeting underlying causes of ED) to symptomatic treatments (e.g. PDE-5 inhibitors, injections, hormonal treatments) for management of ED is lacking. Moreover, long-term effects of ED treatments have not been adequately explored in RCTs. Studies using comparable study populations, diagnostic criteria, and types of tests for hormonal disorders are needed to clarify the clinical utility of routine hormonal blood tests in ED patients. There is also a need for trials comparing PDE-5 inhibitors to other symptomatic treatments for ED (e.g. hormonal treatments, injections, topical applications). This review outlined current gaps in knowledge that need to be addressed in future research.


Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services.1 Contract No. 290-02-0021. Prepared by: University of Ottawa Evidence-based Practice Center, Ottawa, Canada.

Suggested citation:

Tsertsvadze A, Yazdi F, Fink HA, MacDonald R, Wilt TJ, Soares-Weiser K, Bella AJ, Deforge D, Garritty C, Ansari M, Sampson M, Daniel R, Moher D. Diagnosis and Treatment of Erectile Dysfunction. Evidence Report/Technology Assessment No.171 (Prepared by the University of Ottawa Evidence-based Practice Centre (UO-EPC) under Contract No. 290-02-0021). AHRQ Publication No. 08(09)-E016, Rockville, MD: Agency for Healthcare Research and Quality. May 2009.

This report is based on research conducted by the University of Ottawa Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-02-0021). The findings and conclusions in this document are those of the author(s), who are responsible for its content, and do not necessarily represent the views of AHRQ. No statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.

The information in this report is intended to help clinicians, employers, policymakers, and others make informed decisions about the provision of health care services. This report is intended as a reference and not as a substitute for clinical judgment.

This report may be used, in whole or in part, as the basis for the development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.

No investigators have any affiliations or financial involvement (e.g. employment, consultancies, honoraria, stock options, expert testimony, grants or patents received or pending, or royalties) that conflict with material presented in this report.


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Bookshelf ID: NBK38721


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