Understanding Erectile Dysfunction and Its Causes

By definition, Grade A evidence is evidence about which the Panel has a high

General Considerations

Quality of Studies and Determination of Evidence Strength. The quality of published systematic reviews was assessed using A Measurement Tool to Assess Systematic Reviews (AMSTAR).1 Individual studies that were RCTs or CCTs were assessed using the Cochrane Risk of Bias tool.2 The quality of case-control studies and comparative observational studies was rated using the Newcastle-Ottawa Quality Assessment Scale.1004 Because there is no widely-agreed upon quality assessment tool for single cohort observational studies, the quality of these studies was not assessed. The categorization of evidence strength is conceptually distinct from the quality of individual studies. Evidence strength refers to the body of evidence available for a particular question and includes not only individual study quality but consideration of study design; consistency of findings across studies; adequacy of sample sizes; and generalizability of samples, settings, and treatments for the purposes of the guideline. The American Urological Association (AUA) categorizes body of evidence strength as Grade A (well-conducted and highly-generalizable RCTs or exceptionally strong observational studies with consistent findings), Grade B (RCTs with some weaknesses of procedure or generalizability or moderately strong observational studies with consistent findings), or Grade C (RCTs with serious deficiencies of procedure or generalizability or extremely small sample sizes or observational studies that are inconsistent, have small sample sizes, or have other problems that potentially confound interpretation of data). level of certainty, Grade B evidence is evidence about which the Panel has a

• ED is often a sign of underlying health problems.
• Cardiovascular health directly affects erectile function.
• Managing chronic illnesses can prevent or improve ED.
• Proactive lifestyle and medical management are essential.
• Emotional well-being is also a key factor.
• Addressing root causes offers the best long-term solution.

moderate level of certainty, and Grade C evidence is evidence about which the Panel

• PDE5 inhibitors require sexual arousal to work effectively.
• They are contraindicated with nitrates for chest pain.
• Possible side effects include headaches and flushing.
• These medications do not cause an erection without stimulation.
• Effectiveness varies among individuals tested during clinical trials.
• Consult a doctor before starting any ED medication.

has a low level of certainty.3 AUA Nomenclature: Linking Statement Type to Evidence Strength.

The AUA nomenclature system explicitly links statement type to body of evidence strength, level of certainty, magnitude of benefit or risk/burdens, and the Panel's judgment regarding the balance between benefits and risks/burdens (See the Table 1 button below).

Strong Recommendations are directive statements that an action should (benefits outweigh risks/burdens) or should

• Penile implants are a surgical option for severe ED cases.
• Types include inflatable and semi-rigid devices.
• Surgery has a high success rate but involves risks.
• Implants are usually considered after other treatments fail.
• They provide a permanent solution to ED.
• Requires consultation with a urologic surgeon.

not (risks/burdens outweigh benefits) be undertaken because net benefit or net harm is substantial.

Moderate Recommendations are directive statements that an action should (benefits outweigh risks/burdens) or should

Seek care right away

This guideline's purpose is to provide direction to clinicians and to men who have ED. The guideline focuses on how to recognize ED, how to conduct a valid diagnostic process, and how to approach treatment with the goals of restoring sexual function and enhancing the man and his partner's quality of life (QoL) while minimizing adverse events (AEs) and diagnosis- and treatment-associated burden. The strategies and approaches recommended in this document were derived from evidence-based and consensus-based processes. There is a continually expanding literature on ED; the Panel notes that this document constitutes a clinical strategy; it is intended to be interpreted with appreciation for the dynamic, evolving understanding of ED causes and treatments. The most effective approach for a particular man is best determined by that man (in consultation with his partner, when applicable) in collaboration with the clinician and with full consideration of the relevant history, values, and goals for treatment using a shared decision-making (SDM) approach.

Are there any natural remedies for erectile dysfunction?

As our understanding of ED evolves and improves, the strategies presented here will be amended to remain consistent with the highest standards of clinical care. A systematic review was conducted to identify published articles relevant to the diagnosis and treatment of ED. Literature searches were performed on English-language publications using the Pubmed, Embase, and Cochrane databases from 1/1/1965 to 7/29/2017. Data from studies published after the literature search cut-off will be incorporated into the next version of this guideline. Preclinical studies (e.g., animal models), commentary, and editorials were excluded.

Gastrointestinal Disorders

Additional exclusion criteria included data not relevant to current practice (e.g., reports on medications not in current clinical use, outcomes for prostheses models that are no longer available), articles focused primarily on surgical technique with minimal or no patient information or outcomes reported, no outcomes reported or outcomes data not extractable, or duplicate report of data presented elsewhere. Review article references were checked to ensure inclusion of all possibly relevant studies. Multiple reports on the same patient group were carefully examined to ensure inclusion of only non-redundant information. The systematic review yielded a total of 999 publications relevant to preparation of the guideline. Data on study type (e.g., published systematic review/meta-analysis, randomized controlled trial [RCT], controlled clinical trial [CCT], observational study), treatment parameters (e.g., type of treatment, dosing, follow-up), patient characteristics (e.g., age, symptom duration, ED severity), outcomes (e.g., effects on erectile function, QoL), and AEs were extracted. not (risks/burdens outweigh benefits) be undertaken because net benefit or net harm is moderate.

Why trust our experts?

A systematic review of the literature using the Pubmed, Embase, and Cochrane databases (search dates 1/1/1965 to 7/29/17) was conducted to identify peer-reviewed publications relevant to the diagnosis and treatment of ED. The review yielded an evidence base of 999 articles after application of inclusion/exclusion criteria. These publications were used to create the guideline statements. If sufficient evidence existed, then the body of evidence for a particular treatment was assigned a strength rating of A (high quality evidence; high certainty), B (moderate quality evidence; moderate certainty), or C (low quality evidence; low certainty). Evidence-based statements of Strong, Moderate, or Conditional Recommendation, which can be supported by any body of evidence strength, were developed based on the balance of benefits and risks/burdens to men and their partners.

Frequently Asked Questions

Additional information is provided as Clinical Principles and Expert Opinion when insufficient evidence existed. Men presenting with symptoms of ED should undergo a thorough medical, sexual, and psychosocial history; a physical examination; and selective laboratory testing. For the man with ED, validated questionnaires are recommended to assess the severity of ED, to measure treatment effectiveness, and to guide future management. Men should be counseled that ED is a risk marker for underlying cardiovascular disease (CVD) and other health conditions that may warrant evaluation and treatment. In men with ED, morning serum total testosterone levels should be measured.

How do I know if erectile dysfunction medication is right for me?

For some men with ED, specialized testing and evaluation may be necessary to guide treatment. For men being treated for ED, referral to a mental health professional should be considered to promote treatment adherence, reduce performance anxiety, and integrate treatments into a sexual relationship. Clinicians should counsel men with ED who have comorbidities known to negatively affect erectile function that lifestyle modifications, including changes in diet and increased physical activity, improve overall health and may improve erectile function. Men with ED should be informed regarding the treatment option of an FDA-approved oral phosphodiesterase type 5 inhibitor (PDE5i), including discussion of benefits and risks/burdens, unless contraindicated. When men are prescribed an oral PDE5i for the treatment of ED, instructions should be provided to maximize benefit/efficacy. Conditional Recommendations are non-directive statements used when the evidence indicates that there is no

apparent net benefit or harm or when the balance between benefits and risks/burden is unclear.

OTHER THERAPEUTIC OPTIONS

For men who are prescribed PDE5i, the dose should be titrated to provide optimal efficacy. Men who desire preservation of erectile function after treatment for prostate cancer by radical prostatectomy (RP) or radiotherapy (RT) should be informed that early use of PDE5i post-treatment may not improve spontaneous, unassisted erectile function. Men with ED and testosterone deficiency (TD) who are considering ED treatment with a PDE5i should be informed that PDE5i may be more effective if combined with testosterone therapy. Men with ED should be informed regarding the treatment option of a vacuum erection device (VED), including discussion of benefits and risks/burdens. Men with ED should be informed regarding the treatment option of intraurethral (IU) alprostadil, including discussion of benefits and risks/burdens.

Part 1 of ED treatment: Treating underlying health factors

For men with ED who are considering the use of IU alprostadil, an in-office test should be performed. Men with ED should be informed regarding the treatment option of intracavernosal injections (ICI), including discussion of benefits and risks/burdens. For men with ED who are considering ICI therapy, an in-office injection test should be performed. Men with ED should be informed regarding the blue tablets treatment option of penile prosthesis implantation, including discussion of benefits and risks/burdens. Men with ED who have decided on penile implantation surgery should be counseled regarding post-operative expectations.

Reduce stress

Penile prosthetic surgery should not be performed in the presence of systemic, cutaneous, or urinary tract infection. For young men with ED and focal pelvic/penile arterial occlusion and without documented generalized vascular disease or veno-occlusive dysfunction, penile arterial reconstruction may be considered. For men with ED, penile venous surgery is not recommended. For men with ED, low-intensity extracorporeal shock wave therapy (ESWT) should be considered investigational. For men with ED, intracavernosal stem cell therapy should be considered investigational: (Conditional Recommendation; Evidence Level: Grade C) For men with ED, platelet-rich plasma (PRP) therapy should be considered experimental.