• Erectile Dysfunction Guideline Update Panel. The management of erectile dysfunction: an update. Baltimore (MD): American Urological Association Education and Research, Inc.; 2005. Various p. [78 references]



• Montague DK, Jarow JP, Broderick GA, Dmochowski RR, Heaton JP, Lue TF, Milbank AJ, Nehra A, Sharlip ID, Erectile Dysfunction Guideline Update Panel. The management of erectile dysfunction: an update. Linthicum (MD): American Urologic Association Education and Research, Inc.; 2006 May. Various p. [78 references]

This is the current release of the guideline.

This guideline updates a previous version: Erectile Dysfunction Guideline Update Panel. The management of erectile dysfunction: an update. Baltimore (MD): American Urological Association Education and Research, Inc.; 2005. Various p.

Erectile dysfunction

Evaluation
Management
Treatment

Family Practice
Internal Medicine
Surgery
Urology

Physicians

To provide medical practitioners with a consensus of principles and strategies for the management of erectile dysfunction

Men who have erectile dysfunction after a well-established period of normal erectile function, whose erectile dysfunction is primarily organic rather than psychological in nature, and who have no evidence of hypogonadism or hyperprolactinemia

Evaluation

1. Identification of comorbidities and psychosexual dysfunctions through sexual, medical, and psychosocial history
2. Laboratory tests
3. Focused physical examination
4. Prostate-specific antigen measurement
5. Rectal examination
6. Additional testing, such as testosterone level measurement, vascular and/or neurological assessment and monitoring of nocturnal erections

Management/Treatment

1. Educate patients regarding treatment options and associated risks and benefits
2. Manage risk factors for erectile dysfunction (e.g., lifestyle modifications to prevent or reverse erectile dysfunction [ED])
3. Consider comorbidities when managing patients with ED (e.g., provide appropriate management of patients with ED in the presence of cardiovascular disease)
4. Pharmacologic therapy
   • Phosphodiesterase type 5 (PDE5) inhibitors (sildenafil, tadalafil, and vardenafil)
   • Alprostadil intra-urethral suppositories
   • Intracavernous injection with alprostadil, papaverine, or phentolamine or combinations
5. Vacuum constriction devices
6. Surgery
   • Penile prosthesis implantation with preoperative administration of antibiotics
   • Vascular surgery (penile arterial reconstructive surgery)
7. Periodic follow-up of efficacy, side effects, and change in health status

Note: Guideline developers considered but did not recommend the following treatments for ED: trazodone, testosterone therapy, herbal therapies including yohimbine, topical therapies, and venous reconstructive surgery.

• Erectile function as measured by the International Index of Erectile Function (IIEF)
• Intercourse satisfaction
• Ability to have intercourse
• Return to normal function
• Adverse events

Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases

This update incorporates new U.S. Food and Drug Administration (FDA) product labeling and an updated reference for the Princeton guidelines. In addition to erectile dysfunction (ED), the Panel elected to address three topics relevant to erection, Peyronie's disease, priapism, and premature ejaculation. In the year 2000, MEDLINE® searches of English-language references on human subjects were initiated for each of the four topics. Search strategies ranged from very general to very specific. Citations identified through subsequent targeted searches, such as those specifically focused on individual treatments, and through Panel member suggestions also were added to the database. The erectile dysfunction portion of the searches spanned the years from 1994, when the final literature search for the 1996 Report was completed, to February 2004. The Panel continued to scrutinize key references that were identified up until the peer-review process.

A special review of herbal therapies was performed later in the guideline process since few citations on herbal therapies were initially extracted. The search for herbal therapies included non-English language journals with abstracts written in English.

• 1,021 articles were subjected to a preliminary review and extraction
• 112 were selected for extraction
• 85 articles had acceptable data

Expert Consensus

Not applicable

Review of Published Meta-Analyses
Systematic Review with Evidence Tables

A detailed meta-analysis of study outcomes was attempted. Difficulties were encountered in developing outcome estimates for all therapies because of study inconsistencies in patient selection and outcome measures, the lack of sufficient data, and the reporting of adjusted results. Given these problems with the data, the Panel ultimately decided that meta-analysis was inappropriate.

Expert Consensus

After the evidence was extracted and tabulated, the Panel met several times, both face-to-face and by teleconference, to review the data. Based on the data review and subsequent identification of the data limitations, meta-analysis was not deemed to be appropriate except for the intra-urethral alprostadil suppositories. Even meta-analyzed intra-urethral therapy data were not considered applicable for inclusion in an outcomes table because the patient inclusion criteria biased the results. Thus, the Panel decided to present the results separately for each treatment. In reviewing the data on phosphodiesterase type 5 (PDE5) inhibitors, the panel determined that a comparison of the efficacy and side effects could not be done with presently available data. Studies directly comparing these drugs had not been published at the time of the final literature search. Attempts at developing a comparative outcomes table based on meta-analysis also failed due to inconsistencies in patient selection and incomparable patient populations.

The Panel developed guideline statements based on the limited data. As in the previous guideline, the present guideline statements were graded with respect to the degree of flexibility in application.

A "standard" has the least flexibility as a treatment policy, a "recommendation" has significantly more flexibility, and an "option" is even more flexible. These three levels of flexibility are defined as follows:

1. Standard: A guideline statement is a standard if (1) the health outcomes of the alternative interventions are sufficiently well known to permit meaningful decisions, and (2) there is virtual unanimity about which intervention is preferred.
2. Recommendation: A guideline statement is a recommendation if (1) the health outcomes of the alternative intervention are sufficiently well known to permit meaningful decisions and (2) an appreciable but not unanimous majority agrees on which intervention is preferred.
3. Option: A guideline statement is an option if (1) the health outcomes of the interventions are not sufficiently well known to permit meaningful decisions or (2) preferences are unknown or equivocal.

A formal cost analysis was not performed and published cost analyses were not reviewed.

External Peer Review
Internal Peer Review

This text of the report was developed as a group process with Panel members and consultants writing various sections. The editor was responsible for unifying the sections and incorporating the changes into the multiple drafts. The Panel reviewed each draft and the proposed changes. Several drafts of the guideline were distributed before final Panel approval.

After Panel approval, a draft underwent peer review by 80 individuals, including members of the Practice Guidelines Committee, the American Urological Association (AUA) Board of Directors, and external experts in the management of erectile dysfunction (ED). Peer reviewers' comments were entered into a database that the Panel subsequently met to review. The Guideline was modified where the Panel deemed necessary in response to these comments. A final version of the report was generated and the Panel voted for approval. This version was then forwarded in turn for approval of the Practice Guidelines Committee and the American Urological Association Board of Directors.

None provided

The recommendations are based on current professional literature, clinical experience, and expert opinion.

Overall Potential Benefit

Appropriate management and effective treatment of organic erectile dysfunction

• Sildenafil, tadalafil, and vardenafil have side effects due to peripheral vasodilation such as facial flushing, nasal congestion, headache, and dyspepsia. Both sildenafil and vardenafil, but not tadalafil, have some cross-reactivity with phosphodiesterase type 6 (PDE6) and thus may produce visual side effects. Tadalafil exhibits some cross-reactivity with PDE11, but there are no known side effects due to PDE11 inhibition at this time. Back pain has been reported in a limited number of patients, especially those taking tadalafil, and the pathophysiology of this adverse effect is unknown. A mild prolongation of the QT interval has been observed with vardenafil. The Food and Drug Administration (FDA)-approved product labeling for vardenafil recommends that caution be used when prescribing vardenafil in patients with a known history of QT prolongation or in patients who are receiving agents that prolong the QT interval.
• When considering PDE5 inhibitors for the management of erectile dysfunction (ED), physicians should be aware that even healthy volunteers may experience mild transient systemic vasodilation; this effect may be aggravated by alpha-blocking therapies.
• Hypotension has been reported to occur in approximately 3% of patients after the first dose of alprostadil.
• A healthcare provider should be present to instruct patients on the proper technique of intracavernous drug administration, to determine an effective dose, and to monitor patients for side effects, especially prolonged erection.
• In addition to mechanical failure, inflatable penile prostheses are associated with complications such as pump displacement and auto-inflation.
• Infection is a devastating complication of any prosthetic surgery. Currently available inflatable prostheses have been modified in an attempt to reduce the risk of infection.

• Phosphodiesterase type 5 inhibitors are contraindicated in patients who are taking organic nitrates.
• Magnetic resonance imaging (MRI) is contraindicated in patients with a ferromagnetic implant because of the risks associated with movement, dislodgement, induction of electrical current, excessive heating, and/or misinterpretation artifacts.
• Prosthetic surgery should not be performed in the presence of systemic, cutaneous, or urinary tract infection.

• Some of the medical therapies currently employed in the management of erectile dysfunction (ED) have not been approved by the U.S. Food and Drug Administration (FDA) for this specific indication. Thus, doses and dosing regimens may deviate from that employed for FDA-approved indications, and this difference should be considered in the risk-versus-benefit assessment. This document does not establish a fixed set of rules or define the legal standard of care and it does not pre-empt physician judgment in individual cases.
• The guideline developers decided against reviewing the data on testosterone, as it was beyond the scope of the guideline, and on apomorphine, which was not approved for use in the United States.

An implementation strategy was not provided.

Getting Better
Living with Illness

Effectiveness
Patient-centeredness

• Erectile Dysfunction Guideline Update Panel. The management of erectile dysfunction: an update. Baltimore (MD): American Urological Association Education and Research, Inc.; 2005. Various p. [78 references]



• Montague DK, Jarow JP, Broderick GA, Dmochowski RR, Heaton JP, Lue TF, Milbank AJ, Nehra A, Sharlip ID, Erectile Dysfunction Guideline Update Panel. The management of erectile dysfunction: an update. Linthicum (MD): American Urologic Association Education and Research, Inc.; 2006 May. Various p. [78 references]

Not applicable: Guideline was not adapted from another source.

1996 (addendum released 2006 May)

American Urological Association Education and Research, Inc. - Medical Specialty Society

American Urological Association Education and Research, Inc. (AUA)

Erectile Dysfunction Guideline Update Panel

Panel Members: Drogo K. Montague, MD, Co-chair; Jonathan P. Jarow, MD, Co-chair; Gregory A. Broderick, MD; Roger R. Dmochowski, MD; Jeremy P.W. Heaton, MD; Tom F. Lue, MD; Aaron J. Milbank, MD; Ajay Nehra, MD; Ira D. Sharlip, MD

Consultants: Hanan S. Bell, PhD; Patrick M. Florer; Diann D. Glickman, PharmD

AUA Staff: Kirsten H. Aquino; Edith M. Budd; Michael A. Folmer; Suzanne B. Pope; Carol R. Schwartz

Committee members received no remuneration for their work. Each member of the committee provided a conflict of interest disclosure to the American Urological Association (AUA).

This is the current release of the guideline.

This guideline updates a previous version: Erectile Dysfunction Guideline Update Panel. The management of erectile dysfunction: an update. Baltimore (MD): American Urological Association Education and Research, Inc.; 2005. Various p.

None available

None available

This summary was completed by ECRI on March 26, 1999. The information was verified by the guideline developer as of May 14, 1999. This NGC summary was updated by ECRI on July 20, 2005. The updated information was verified by the guideline developer on August 17, 2005. This NGC summary was updated by ECRI on November 7, 2006. The updated information was verified by the guideline developer on November 29, 2006. This summary was updated by ECRI Institute on November 6, 2007, following the updated U.S. Food and Drug Administration advisory on Viagra, Cialis, Levitra, and Revatio.

This NGC summary is based on the original guideline, which is copyrighted by the American Urological Association Education and Research, Inc. (AUA).