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Home Guidelines Clinical Guidelines Male Sexual Dysfunction: Erectile Dysfunction (2018)

Erectile Dysfunction: AUA Guideline (2018) 

Published 2018

The purpose of this guideline is to provide a clinical strategy for the diagnosis and treatment of erectile dysfunction (ED).

Unabridged version of this Guideline [pdf]

Panel Members

Arthur L. Burnett, MD; Ajay Nehra, MD; Rodney H. Breau, MD; Daniel J. Culkin, MD; Martha M. Faraday, PhD; Lawrence S. Hakim, MD; Joel Heidelbaugh, MD; Mohit Khera, MD; Kevin T. McVary, MD; Martin M. Miner, MD; Christian J. Nelson, PhD; Hossein Sadeghi-Nejad, MD; Allen D. Seftel, MD; Alan W. Shindel, MD.

In Memoriam

The Panel would like to dedicate this guideline to the memory of our friend and colleague,  Ralph Alterowitz. We will forever be grateful to his contributions and devotion to the field of men's sexual health. He brought compassion and joy to all of those who were fortunate enough to work with him.

Purpose 

The purpose of this guideline is to provide a clinical strategy for the diagnosis and treatment of erectile dysfunction (ED). Using the shared decision-making process as a cornerstone for care, all patients should be informed of all treatment modalities that are not contraindicated, regardless of invasiveness or irreversibility, as potential first-line treatments. For each treatment, the clinician should ensure that the man and his partner have a full understanding of the benefits and risk/burdens associated with that choice.

Executive Summary

The sexual response cycle is conceptualized as a sequential series of psychophysiological states that usually occur in an orderly progression.  These phases were characterized by Masters and Johnson as desire, arousal, orgasm, and resolution. Erectile dysfunction (ED) can be conceptualized as an impairment in the arousal phase of sexual response and is defined as the consistent or recurrent inability to attain and/or maintain penile erection sufficient for sexual satisfaction, including satisfactory sexual performance.1,2  The Panel believes that shared decision-making is the cornerstone of the treatment and management of ED, a model that relies on the concepts of autonomy and respect for persons in the clinical encounter.  It is also a process in which the patient and the clinician together determine the best course of therapy based on a discussion of the risks, benefits and desired outcome. Using this approach, all men should be informed of all treatment options that are not medically contraindicated to determine the appropriate treatment. Although many men may choose to begin with the least invasive option, the Panel notes that it is valid for men to begin with any type of treatment, regardless of invasiveness or reversibility. Men also may choose to forego treatment. In each scenario, the clinician's role is to ensure that the man and his partner have a full understanding of the benefits and risks/burdens of the various management strategies.

Methodology

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. Additional information is provided as Clinical Principles and Expert Opinion when insufficient evidence existed.

Guideline Statements

Evaluation and Diagnosis:

  1. Men presenting with symptoms of ED should undergo a thorough medical, sexual, and psychosocial history; a physical examination; and selective laboratory testing.  (Clinical Principle)
  2. For the man with ED, validated questionnaires are recommended to assess the severity of ED, to measure treatment effectiveness, and to guide future management. (Expert Opinion)
  3. 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. (Clinical Principle)
  4. In men with ED, morning serum total testosterone levels should be measured. (Moderate Recommendation; Evidence Level: Grade C)
  5. For some men with ED, specialized testing and evaluation may be necessary to guide treatment. (Expert Opinion) 

Treatment:

6. 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. (Moderate Recommendation; Evidence Level: Grade C)

7. 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. (Moderate Recommendation; Evidence Level: Grade C)

8. 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. (Strong Recommendation; Evidence Level: Grade B)

9. When men are prescribed an oral PDE5i for the treatment of ED, instructions should be provided to maximize benefit/efficacy. (Strong Recommendation; Evidence Level: Grade C)

10. For men who are prescribed PDE5i, the dose should be titrated to provide optimal efficacy. (Strong Recommendation; Evidence Level: Grade B)

11. 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. (Moderate Recommendation; Evidence Level: Grade C)

12. 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. (Moderate Recommendation; Evidence Level: Grade C)

13. Men with ED should be informed regarding the treatment option of a vacuum erection device (VED), including discussion of benefits and risks/burdens. (Moderate Recommendation; Evidence Level: Grade C)

14. Men with ED should be informed regarding the treatment option of intraurethral (IU) alprostadil, including discussion of benefits and risks/burdens. (Conditional Recommendation; Evidence Level: Grade C)

15. For men with ED who are considering the use of IU alprostadil, an in-office test should be performed. (Clinical Principle)

16. Men with ED should be informed regarding the treatment option of intracavernosal injections (ICI), including discussion of benefits and risks/burdens. (Moderate Recommendation; Evidence Level: Grade C)

17. For men with ED who are considering ICI therapy, an in-office injection test should be performed. (Clinical Principle)

18. Men with ED should be informed regarding the treatment option of penile prosthesis implantation, including discussion of benefits and risks/burdens. (Strong Recommendation; Evidence Level: Grade C)

19. Men with ED who have decided on penile implantation surgery should be counseled regarding post-operative expectations. (Clinical Principle)

20. Penile prosthetic surgery should not be performed in the presence of systemic, cutaneous, or urinary tract infection. (Clinical Principle)

21. 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. (Conditional Recommendation; Evidence Level: Grade C)

22. For men with ED, penile venous surgery is not recommended. (Moderate Recommendation; Evidence Level: Grade C)

23. For men with ED, low-intensity extracorporeal shock wave therapy (ESWT) should be considered investigational. (Conditional Recommendation; Evidence Level: Grade C)

24. For men with ED, intracavernosal stem cell therapy should be considered investigational: (Conditional Recommendation; Evidence Level: Grade C)

25. For men with ED, platelet-rich plasma (PRP) therapy should be considered experimental. (Expert Opinion)

Purpose

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. 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.  

Methodology

Systematic review. 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. 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.

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). By definition, Grade A evidence is evidence about which the Panel has a high level of certainty, Grade B evidence is evidence about which the Panel has a moderate level of certainty, and Grade C evidence is evidence about which the Panel 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 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 not (risks/burdens outweigh benefits) be undertaken because net benefit or net harm is moderate. 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. All three statement types may be supported by any body of evidence strength grade. Body of evidence strength Grade A in support of a Strong or Moderate Recommendation indicates that the statement can be applied to most men in most circumstances and that future research is unlikely to change confidence. Body of evidence strength Grade B in support of a Strong or Moderate Recommendation indicates that the statement can be applied to most men in most circumstances but that better evidence could change confidence. Body of evidence strength Grade C in support of a Strong or Moderate Recommendation indicates that the statement can be applied to most men in most circumstances but that better evidence is likely to change confidence. Body of evidence strength Grade C is only rarely used in support of a Strong Recommendation. Conditional Recommendations also can be supported by any body of evidence strength. When body of evidence strength is Grade A, the statement indicates that benefits and risks/burdens appear balanced, the best action depends on the man's circumstances, and future research is unlikely to change confidence. When body of evidence strength Grade B is used, benefits and risks/burdens appear balanced, the best action also depends on individual man's circumstances and better evidence could change confidence. When body of evidence strength Grade C is used, there is uncertainty regarding the balance between benefits and risks/burdens, alternative strategies may be equally reasonable, and better evidence is likely to change confidence.

For some clinical issues there was little or no evidence from which to construct evidence-based statements. Where gaps in the evidence existed, the Panel provides guidance in the form of Clinical Principles or Expert Opinion with consensus achieved using a modified Delphi technique if differences of opinion emerged.4 A Clinical Principle is a statement about a component of clinical care that is widely agreed upon by urologists or other clinicians for which there may or may not be evidence in the medical literature. Expert Opinion refers to a statement, achieved by consensus of the Panel, that is based on members' clinical training, experience, knowledge, and judgment for which there is no evidence.

Process. The Male Sexual Dysfunction Panel was created in 2013 by the American Urological Association Education and Research, Inc. The Practice Guidelines Committee of the AUA selected the Panel Co-Chairs who in turn appointed the additional panel members with specific expertise in this area. The AUA conducted a thorough peer review process. The draft guideline document was distributed to 35 peer reviewers. The Panel reviewed and discussed all submitted comments and revised the draft as needed. Once finalized, the guideline was submitted for approval to the Practice Guidelines Committee, the Science and Quality Council, and subsequently to the AUA Board of Directors for final approval. Funding of the panel was provided by the AUA; panel members received no remuneration for their work.

Table 1


Background

Definition. ED is defined as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.5 The Panel also endorses the Fourth International Consultation on Sexual Medicine's ED definition as the consistent or recurrent inability to attain and/or maintain penile erection sufficient for sexual satisfaction.6

Conceptualization of ED. Sexuality is a uniquely complex aspect of humanness. Sexual function depends on intact anatomical, physiological, and behavioral capacities but occurs in the multi-layered context of a man's beliefs and values about sexuality and maleness, his upbringing and sociocultural mores, his relationship with his partner and the quality of that partnership, and the partner's beliefs and values about sexual activity. No other aspect of human functioning touches upon so many components of a man's identity and leverages this degree of complexity.  

In this complex human context, the Panel conceptualizes ED as the inability to attain and/or maintain sufficient penile rigidity for sexual satisfaction. The Panel advocates that awareness of this perspective informs every aspect of the process in which clinicians support and guide men and their partners in evaluation, diagnosis, and choice of management.

Ample evidence indicates that ED is a risk marker for the presence of treatable underlying medical conditions that, left untreated, reduce quality and length of life (e.g., undiagnosed diabetes, CVD).7,8 In addition, ED can negatively affect a man's mental health, his relationship, and his general well-being. The presence of ED, therefore, provides an opportunity to potentially address multiple issues that affect a man's general health.    

Shared decision-making (SDM). SDM is the cornerstone of patient-centered care, applying the concepts of autonomy and respect for persons to the clinical encounter.1005 SDM is a process in which information about the best available evidence for diagnostic procedures and treatments is shared by clinicians and patients. Patients are then supported during the decision-making process to express preferences and values that ultimately lead to an informed choice aligned with those preferences and values.9 SDM rests on the assumption that individual self-determination is desirable and that patient autonomy is best supported by a strong relationship with an informed and committed clinician who respects the patient's competence and capacity to make decisions.9 To be effective, this process requires commitments by both clinician and patient. The clinician's commitment includes communicating objectively and clearly regarding the patient's condition and the available diagnostic and treatment options, using language and concepts that are understandable to the patient.10,11 This commitment includes the awareness that health literacy varies widely across patients and that patients at all levels of health literacy may struggle to objectively apply information about benefits and risks/burdens of various management options.11 This commitment also requires that the clinician be cognizant that social, cultural, religious, educational, and other factors are important and valid determinants of treatment selection.12,13 The patient's commitment includes the willingness to absorb information, ask questions, and clearly express his and his partner's preferences and values. This process results in a sharing of information and responsibility, allowing a collaborative decision regarding diagnostic and treatment plans. Because of the complexity of sexuality and the impact of a sexual relationship on a man's life, the Panel strongly advocates that a man's partner be invited to participate in this process whenever possible and clinically appropriate.  

Treatment of ED.  Although the principles underlying the treatment of ED are the same for all men - restoring or enhancing sexual function, improving overall physical health, and optimizing QoL and well-being for a man and his partner - every man who presents with ED is unique. Each man brings to the clinical encounter not only his symptoms, but his degree of distress; his associated health conditions; his partner's concerns and issues of relationship quality; and his sociocultural, educational, and religious context. Determining an appropriate treatment requires that the man, his clinician, and ideally his partner navigate all of these issues in order to arrive at a treatment choice that is aligned with the man and his partner's priorities and values. Men should be informed of all treatment options that are not medically contraindicated and supported in the SDM process to determine the appropriate treatment. Although many men may choose to begin with the least invasive options (i.e., oral medications), the Panel notes that it is valid for men to begin with any type of treatment, regardless of invasiveness or reversibility. Men also may choose to forego treatment. In each scenario, the clinician's role is to ensure that the man and his partner have full understanding of the benefits and risks/burdens of the various management strategies. All men, regardless of the decision to treat ED, should be strongly advised to address any underlying medical issues that may contribute to the ED and that constitute independent risk factors for poor health, reduced QoL, and decreased survival.

Epidemiology. Up to 30 million men in the United States and 150 million men worldwide are estimated to be affected by ED.14,15 Independent risk factors for ED and CVD are well recognized and include age, smoking, diabetes mellitus, hypertension, dyslipidemia, depression, obesity, and a sedentary lifestyle.16-19 Compelling evidence exists that the most common underlying mechanism of ED is vascular and that CVD and ED share etiologies as well as pathophysiology.20-22 The degree of ED strongly correlates with severity of CVD, and recent studies suggest that ED may be considered a sentinel marker in men with occult CVD.23, 24 Symptoms of ED may precede a cardiovascular event by up to five years.25, 26 Further, when ED is present in younger men, it predicts a marked increase (up to 50 fold) in the risk of future cardiac events, suggesting that young men with ED in particular would benefit from CVD risk factor screening and intervention.27 The increased number of men with CVD risk factors is paralleled by the worldwide increase in the prevalence of ED.15, 28-30

Hypertension. Hypertension is a highly prevalent condition, affecting 29.1% of U.S. adults between 2011 and 2012.31 It is frequently associated with ED and often contributes to its etiology (i.e., hypertension-related arterial stenotic lesions). It is present in 38% to 42% of men with ED, and approximately 35% of men with hypertension have some degree of ED.32-35

Dyslipidemia. Data from the National Health and Nutrition Examination Survey (2003-2006) indicate that approximately 53% of U.S. adults have lipid abnormalities.36 Up to 42.4% of men with ED also have hyperlipidemia.33 Elevated levels of total cholesterol and low-density lipoprotein cholesterol are significantly correlated with moderate to severe ED.33 Men with poor to very poor erectile function had twice the odds of an elevated total cholesterol/high-density lipoprotein cholesterol ratio compared with men with good and very good erectile function.37

Diabetes mellitus. ED is one of the most common complications of diabetes mellitus. Depending on the severity and duration of diabetes, the prevalence of ED ranges from 20% to 85%.32,38,39 With a projected increase in the number of patients with diabetes to 29 million by 2050, a corresponding increase in those with ED is also expected. Approximately 20% of men with ED also had diabetes.33 The Massachusetts Male Aging Study reported a 28% age-adjusted prevalence of ED in men with diabetes compared with 10% in men without diabetes (a 3-fold increased risk).19 Prevalence of ED is higher in men with diabetes who are older than 50 years, nearly double that in age-matched men without diabetes (45.8% versus 24.1%). In addition, an increase in the relative risk of ED was associated with increased duration of diabetes.37 ED is known to occur at an earlier age in men with diabetes than in those without it.38 In some cases, ED may be a manifestation of previously undiagnosed diabetes mellitus, which highlights the importance of screening men with ED for diabetes-related risk factors.

Other non-cardiovascular comorbidities. Other comorbidities or risk factors commonly associated with ED include depression, smoking, premature ejaculation (PE), lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), and other causes of voiding dysfunction, such as overactive bladder. In 3 surveys of men with ED, depression was reported by 11% and PE by approximately 30% to 60% of respondents.33 Several studies have documented a strong association between LUTS and ED. LUTS/BPH, reported in up to 72% of men with ED, are independent risk factors for each other and share both non-cardiovascular (e.g., age, mental disorders) and cardiovascular (e.g., obesity, hypertension, diabetes mellitus) risk factors.40-43  These relationships underscore the importance of assessing ED in men who present with these common conditions.  

Evaluation and Diagnosis

The Diagnostic Approach. Insufficient literature was identified to constitute an evidence base for diagnosis of ED in clinical practice. This section, therefore, is based primarily on Clinical Principles or Expert Opinions. This section is intended to provide clinicians and men who present to them with a framework for determining whether a diagnosis of ED is appropriate; it is not intended to replace the judgment and experience of the individual clinician faced with a particular man.

    Guideline Statement 1

    1. Men presenting with symptoms of ED should undergo a thorough medical, sexual, and psychosocial history; a physical examination; and selective laboratory testing. (Clinical Principle)

    Discussion


    Guideline Statement 2

    2. For the man with ED, validated questionnaires are recommended to assess the severity of ED, to measure treatment effectiveness, and to guide future management. (Expert Opinion)

    Discussion


    Guideline Statement 3

    3. 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. (Clinical Principle)

    Discussion


    Guideline Statement 4

    4. For men with ED, morning serum total testosterone levels should be measured. (Moderate Recommendation; Evidence Level: Grade C)

    Discussion


    Guideline Statement 5

    5. For some men with ED, specialized testing and evaluation may be necessary to guide treatment. (Expert Opinion)

    Discussion


    Treatment

    Treatment Framework. The Panel advocates the use of a treatment framework that is not predicated on men progressing through ED treatments in order of invasiveness or reversibility (See Appendix A: Erectile Dysfunction Algorithm in the menu on the left). Although many men may choose to begin with the least invasive options (i.e., oral medications), any type of treatment as an initial treatment is a valid choice. For each treatment, the clinician's role is to ensure that the man and his partner have full understanding of the benefits and risks/burdens associated with that choice. 

    Guideline Statement 6

    6. 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. (Moderate Recommendation; Evidence Level: Grade C)

    Discussion


    Guideline Statement 7

    7. 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. (Moderate Recommendation; Evidence Level: Grade C)

    Discussion


    Guideline Statement 8

    8. 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. (Strong Recommendation; Evidence Level: Grade B)

    Discussion


    Guideline Statement 9

    9. When men are prescribed an oral PDE5i for the treatment of ED, instructions should be provided to maximize benefit/efficacy. (Strong Recommendation; Evidence Level: Grade C)

    Discussion


    Guideline Statement 10

    10. For men who are prescribed PDE5i, the dose should be titrated to provide optimal efficacy. (Strong Recommendation; Evidence Level: Grade B)

    Discussion


    Guideline Statement 11

    11. 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. (Moderate Recommendation; Evidence Level: Grade C)

    Discussion


    Guideline Statement 12

    12. 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. (Moderate Recommendation; Evidence Level: Grade C)

    Discussion


    Guideline Statement 13

    13. Men with ED should be informed regarding the treatment option of a vacuum erection device (VED), including discussion of benefits and risks/burdens. (Moderate Recommendation; Evidence Level: Grade C)

    Discussion


    Guideline Statement 14

    14. Men with ED should be informed regarding the treatment option of intraurethral (IU) alprostadil, including discussion of benefits and risks/burdens. (Conditional Recommendation; Evidence Level: Grade C)

    Discussion


    Guideline Statement 15

    15. For men with ED who are considering the use of IU alprostadil, an in-office test should be performed. (Clinical Principle)

    Discussion


    Guideline Statement 16

    16. Men with ED should be informed regarding the treatment option of intracavernosal injections (ICI), including discussion of benefits and risks/burdens. (Moderate Recommendation; Evidence Level: Grade C)

    Discussion


    Guideline Statement 17

    17. For men with ED who are considering ICI therapy, an in-office injection test should be performed. (Clinical Principle)

    Discussion


    Guideline Statement 18

    18. Men with ED should be informed regarding the treatment option of penile prosthesis implantation, including discussion of benefits and risks/burdens. (Strong Recommendation; Evidence Level: Grade C)

    Discussion


    Guideline Statement 19

    19. Men with ED who have decided on penile implantation surgery should be counseled regarding post-operative expectations. (Clinical Principle)

    Discussion


    Guideline Statement 20

    20. Penile prosthetic surgery should not be performed in the presence of systemic, cutaneous, or urinary tract infection. (Clinical Principle)

    Discussion


    Guideline Statement 21

    21. 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. (Conditional Recommendation; Evidence Level: Grade C)

    Discussion


    Guideline Statement 22

    22. For men with ED, penile venous surgery is not recommended. (Moderate Recommendation; Evidence Level: Grade C)

    Discussion


    Guideline Statement 23

    23. For men with ED, low-intensity extracorporeal shock wave therapy (ESWT) should be considered investigational. (Conditional Recommendation; Evidence Level: Grade C)

    Discussion


    Guideline Statement 24

    24. For men with ED, intracavernosal stem cell therapy should be considered investigational. (Conditional Recommendation; Evidence Level: Grade C)

    Discussion


    Guideline Statement 25

    25. For men with ED, platelet-rich plasma (PRP) therapy should be considered experimental. (Expert Opinion)

    Discussion


    Other Treatments

    Discussion


    References

    References


    Research Needs and Future Directions

    Advancements in ED management can be expected to continue into the future in parallel with ongoing progress in the field of sexual medicine more broadly. Developments in health care delivery, diagnostics, and therapeutics will be the underpinnings of improved, evidence-based clinical practice in this field.

    Although much has been learned in the physiology and molecular science of penile erection in recent decades, scientific discovery in this arena will predictably continue to be made. Science and technology are the cornerstone for new developments ranging from new pharmacotherapeutics to surgical innovations. Scientific discovery in the vascular biology and neurophysiology of penile erection will continue to take center stage with particular focus on molecular and cellular signaling pathways and growth factor mechanisms that may be exploited to produce the next generation of pharmacotherapeutics as well as gene, stem cell and regenerative therapies. Technologic advancements can also be expected to impact surgical procedures ranging from penile reconstructive to prosthetic to tissue replacement surgeries (e.g., penile transplantation).

    The field is positioned to bring forward single or combination therapies that characterize angiogenic, neurogenic, anti-fibrotic, anti-apoptotic, and other potential systems biologic approaches, which can be directed toward ED pathophysiologic conditions existing at either peripheral (i.e., genitalia) or central (i.e., brain and spinal cord) axis levels. A near-term practical scheme is to apply such treatments based on the systemic deficiency and severity extent of ED, utilizing a SDM process that is guided by the clinician after thorough discussion of all management considerations and incorporates intervention preferences of the man and his partner. Accordingly, a lesser presentation of vasculogenic ED may do well with as needed oral pharmacotherapy and lifestyle improvement whereas a more severe, tissue fibrotic presentation may require tissue regenerative and/or surgical interventions.

    In the future, diverse ED treatments likely will become available and can be offered in a highly effective, clinicopathologically targeted manner as linked with cause-specific ED-associated disease states. It is conceivable that the ED treatment armamentarium of the future will comprise therapies specific for diabetes-associated ED, for instance, that are distinct from those intended for neurogenic ED or severe vasculogenic ED. Improved diagnostics will have impact in this scope as well. Molecular profiling, genetic biomarkers and advanced imaging techniques may improve the specificity of treatment for each man and usher in an era of "personalized medicine" for ED.

    Current interventions for ED are focused on symptomatic benefit. For example, although oral PDE5i were a major therapeutic breakthrough and now constitute a mainstay of ED management, these medications only mitigate symptoms rather than curing the underlying condition. Therapies with less restrictive, non-repetitive efficacy are greatly needed. The ultimate goal of ED management is to restore physiologically intact and natural erectile function. Durable and clinically significant improvement in erectile function is a less optimal but still desirable goal if total recovery is not an option. Improvements in our ability to definitively manage ED will likely contribute to better life satisfaction and superior overall health outcomes.   

    Appendix A

    Erectile Dysfunction Algorithm [pdf]

    Appendix B: Additional Tables and Plots

    Appendix B1 – Guideline Statement 8:  PDE5i data

    PDE5i have similar efficacy in the general ED populationExamination of data reported by trials that evaluated PDE5i revealed that these medications had similar efficacy among men in the general ED population, defined as men with a variety of underlying conditions that potentially contributed to ED symptoms.  This pattern was evident when raw data were examined [see International Index of Erectile Function-Erectile Function (IIEF-EF) subscale table in guideline] as well as when the subset of data that could be meta-analyzed were pooled.  The same patterns can be seen in the graph below that plots mean IIEF-EF baseline scores and mean post-treatment scores for each study by medication (symbols above the diagonal line reflect increased scores from baseline to post-treatment.  Active treatment groups generally cluster above the placebo groups without clear separation among medications.1 

    PDE5i have similar efficacy in the general ED population


    1 The symbol in the lower left corner is the active treatment arm of Zhang, Xu (2014).  These men had severe ED and did not benefit from sildenafil treatment for one month, illustrating the importance of appropriate patient selection to maximize the possibility of successful treatment with the PDE5i medications.

    Similar patterns are evident for other measures.  Data from the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) are below; mean satisfaction scores (possible range 0 to 100) are similar across active medications (limited data available for tadalafil and vardenafil).

    General ED Population:  Post-Treatment EDITS Scores

    Treatment# study armsMinimumMaximumMean
    Placebo1334.0866.0047.27
    Sildenafil2130.7096.0071.40
    Tadalafil541.0084.0069.36
    Vardenafil337.5074.0759.06

    The same pattern is evident for the Sexual Encounter Profile (SEP) question 2 ("Were you able to insert your penis into your partner's vagina?") and question 3 ("Did your erection last long enough for you to have successful intercourse?").  The percentages of men who respond "yes" are relatively similar across active medications (limited data are available for avanafil).

     General ED Population:  Post-Treatment SEP Questions 2 and 3 Percent "yes" responses   

    TreatmentMeasure# study armsMinimumMaximumMean
    PlaceboSEP_Q2_post-treatment4024.00%82.30%52.94%
    SEP_Q3_post-treatment5120.00%61.50%34.62%
    SildenafilSEP_Q2_post-treatment104.00%96.96%71.40%
    SEP_Q3_post-treatment214.10%86.60%70.49%
    TadalafilSEP_Q2_post-treatment5056.00%96.52%78.00%
    SEP_Q3_post-treatment5937.00%85.00%66.64%
    VardenafilSEP_Q2_post-treatment2765.90%95.76%83.20%
    SEP_Q3_post-treatment3153.50%89.40%74.56%
    AvanafilSEP_Q2_post-treatment464.00%80.20%73.80%
    SEP_Q3_post-treatment441.00%66.60%55.40%

    A subgroup of studies used global assessment questions (GAQ 1 and 2) or global efficacy questions (GEQ 1 and 2).  The phrasing of the questions differs, but essentially question 1 asks whether the study medication has improved erections and question 2 asks whether, if the treatment has improved a man's erections, has his ability to engage in sexual activity improved.  These data are tabulated below.  Again, there are no clear differences across medications (limited data for avanafil).

    General ED Population:  GEQ/GAQ Data by Treatment

    Percent "yes" responses
    TreatmentMeasure# study armsMinimumMaximumMean
    PlaceboGEQ or GAQ Q1 post-treatment556.00%83.00%29.85%
    GEQ or GAQ Q2 post-treatment1317.00%94.00%39.66%
    SildenafilGEQ or GAQ Q1 post-treatment5056.00%100.00%81.94%
    GEQ or GAQ Q2 post-treatment1870.00%100.00%87.47%
    TadalafilGEQ or GAQ Q1 post-treatment4220.00%97.30%78.19%
    GEQ or GAQ Q2 post-treatment742.00%97.00%73.11%
    VardenafilGEQ or GAQ Q1 post-treatment3136.00%96.00%82.15%
    GEQ or GAQ Q2 post-treatmentNo studies   
    AvanafilGEQ or GAQ Q1 post-treatment346.00%61.60%53.53%
    GEQ or GAQ Q2 post-treatment189.00%89.00%89.00%

    Dose-response effects across PDE5i medications are small and non-linear (i.e., doubling the dose does not double the effect).  Higher doses may produce higher average effects but dose groups generally were not statistically significantly different unless comparing extremely low doses to extremely high doses.  The magnitude of average increased effects with increased doses is small and often not clinically significant (e.g., a one or two point increase on the IIEF-EF).  IIEF-EF data for trials of sildenafil, tadalafil, and vardenafil that used fixed doses are below (insufficient data for avanafil).

    General ED Population:  Baseline and Post-Treatment IIEF-EF Scores by Treatment and Dose (mg)

    For Fixed Dose Study Arms
    TreatmentDose (mg)Measure# study armsMinimumMaximumMean
    Sildenafil50.0Mean IIEF-EF Baseline512.2018.2113.98
    Mean IIEF-EF Post-Treatment521.0024.6022.58
    100.0Mean IIEF-EF Baseline712.0017.8014.35
    Mean IIEF-EF Post-Treatment720.8429.0023.84
    Tadalafil5.0Mean IIEF-EF Baseline1213.1015.8014.27
    Mean IIEF-EF Post-Treatment1217.7024.8021.98
    10.0Mean IIEF-EF Baseline139.9015.8014.02
    Mean IIEF-EF Post-Treatment1315.4626.4021.28
    20.0Mean IIEF-EF Baseline3212.0017.3014.84
    Mean IIEF-EF Post-Treatment3219.5030.0024.45
    Vardenafil5.0Mean IIEF-EF Baseline412.5014.2013.33
    Mean IIEF-EF Post-Treatment317.8022.3620.35
    10.0Mean IIEF-EF Baseline1412.4018.0014.60
    Mean IIEF-EF Post-Treatment1315.5025.6422.30
    20.0Mean IIEF-EF Baseline912.6018.1714.17
    Mean IIEF-EF Post-Treatment721.2028.0023.88

    On demand dosing vs. daily dosing for tadalafil appears to produce the same level of efficacy.  Note that daily dosing trials generally used lower doses than did on demand trials.  Trials of sildenafil and avanafil used only on demand dosing.

    General ED Population:  IIEF-EF Baseline and Post-Treatment Scores

    By Treatment Type and Dosing Frequency
    TxDosingMeasureStudy armsMinMaxMean
    PlaceboOn demandMean IIEF-EF Baseline689.5022.9013.66
     Mean IIEF-EF Post-Treatment6510.1122.4015.41
     DailyMean IIEF-EF Baseline613.4015.9014.57
     Mean IIEF-EF Post-Treatment614.6019.3016.17
    SildenafilOn demandMean IIEF-EF Baseline657.2923.8013.61
     Mean IIEF-EF Post-Treatment697.6329.0022.98
    TadalafilOn demandMean IIEF-EF Baseline539.9017.3014.55
     Mean IIEF-EF Post-Treatment5215.4630.0023.01
     DailyMean IIEF-EF Baseline1612.6415.8014.18
    Mean IIEF-EF Post-Treatment1617.0826.4022.27
    VardenafilOn demandMean IIEF-EF Baseline439.5018.1713.66
     Mean IIEF-EF Post-Treatment3317.8028.0023.11
     DailyMean IIEF-EF Baseline217.8017.9017.85
    Mean IIEF-EF Post-Treatment223.5024.5024.00
    AvanafilOn demandMean IIEF-EF Baseline612.6015.2013.34
    Mean IIEF-EF Post-Treatment618.1023.7021.71

    Adverse eventsData from trials that evaluated men from the general ED population are below.

    General ED Population: Frequently-Reported Adverse Events (percent)
    Treatment   Adverse Event# study armsMinimumMaximumMean
    PlaceboDyspepsia660.00%7.50%1.15%
    Headache820.00%12.10%4.05%
    Flushing680.00%9.40%1.52%
    Back pain300.00%14.90%2.18%
    Nasal congestion or rhinitis510.00%9.10%1.35%
    Myalgia210.00%5.00%0.97%
    Visual disturbance280.00%3.70%0.60%
    Dizziness200.00%6.10%1.29%
    SildenafilDyspepsia810.00%16.00%4.81%
    Headache1030.00%32.00%11.15%
    Flushing990.00%45.80%10.45%
    Back pain150.00%6.00%2.07%
    Nasal congestion or rhinitis700.00%18.70%3.80%
    Myalgia140.00%7.40%2.11%
    Visual disturbance560.00%11.00%3.59%
    Dizziness310.00%13.70%2.68%
    TadalafilDyspepsia620.00%22.00%5.57%
    Headache701.00%43.00%8.89%
    Flushing45.30%10.00%3.55%
    Back pain580.00%16.10%4.21%
    Nasal congestion or rhinitis310.00%8.60%3.27%
    Myalgia400.00%9.70%3.36%
    Visual disturbance100.00%3.33%0.64%
    Dizziness170.00%6.20%2.28%
    VardenafilDyspepsia400.00%9.00%3.38%
    Headache53.70%22.00%10.80%
    Flushing53.10%36.00%8.98%
    Back pain160.00%3.10%1.43%
    Nasal congestion or rhinitis43.10%17.00%5.52%
    Myalgia20.00%1.10%0.55%
    Visual disturbance130.00%3.33%1.55%
    Dizziness11.15%2.90%1.56%
    AvanafilDyspepsia20.00%1.43%0.72%
    Headache64.29%10.14%6.87%
    Flushing63.50%13.00%6.94%
    Back pain41.50%2.50%2.10%
    Nasal congestion or rhinitis6.60%4.30%1.96%
    Myalgia20.00%0.00%0.00%
    Visual disturbance20.00%1.43%0.72%
    Dizziness11.30%1.30%1.30%

    Tadalafil was the only medication for which there were substantial on demand vs. daily dosing studies.  Those data are below.

    Tadalafil:  Rates of Commonly-Reported Adverse Events (means)

     # study armsOn demand# study armsDaily
    Dyspepsia426.10174.21
    Headache4810.62194.59
    Flushing343.5083.54
    Back pain404.44153.81
    Nasal congestion253.3862.83
    Myalgia233.87142.59
    Dizziness122.7551.14

    Most AEs follow a dose-response pattern such that men in active treatment arms reported statistically significantly higher rates of AEs than did men in placebo arms and the percentage of men reporting a particular AE increased as dose increases.  Within individual studies, however, the differences between dose groups were usually not statistically significantly different.  Data from studies of men in the general ED population that administered medications at fixed doses (i.e., did not allow the patient to titrate dose up or down) are below.

    General ED Population:  Adverse Event Rates by Drug and Dose (mg)

    TreatmentDose_mgAdverse Event# study armsMinimumMaximumMean
    Placebo0Dyspepsia360.00%3.70%0.84%
    Headache420.00%8.50%4.01%
    Flushing320.00%6.00%1.21%
    Back pain250.00%14.90%2.35%
    Nasal congestion or rhinitis250.00%9.10%1.64%
    Myalgia160.00%4.00%0.96%
    Visual disturbance90.00%2.00%0.52%
    Dizziness90.00%6.10%1.32%
    Sildenafil50Dyspepsia90.00%11.00%3.88%
    Headache110.00%21.00%8.96%
    Flushing110.00%27.00%9.72%
    Back pain16.00%6.00%6.00%
    Nasal congestion or rhinitis61.20%3.00%2.00%
    Myalgia17.40%7.40%7.40%
    Visual disturbance41.00%6.00%2.40%
    Dizziness30.00%2.30%0.93%
    100Dyspepsia100.50%16.00%6.22%
    Headache111.40%32.00%12.86%
    Flushing111.70%20.00%11.00%
    Back pain40.00%0.80%0.35%
    Nasal congestion or rhinitis100.40%11.00%3.80%
    Myalgia20.00%0.00%0.00%
    Visual disturbance80.30%11.00%6.58%
    Dizziness20.80%1.70%1.25%
    Tadalafil2.5Dyspepsia31.00%4.20%2.50%
    Headache32.50%7.00%4.20%
    Flushing11.00%1.00%1.00%
    Back pain32.80%5.20%4.00%
    Nasal congestion or rhinitis20.00%5.00%2.50%
    Myalgia31.50%4.20%2.90%
    Visual disturbance0NRNRNR
    Dizziness0NRNRNR
    5Dyspepsia130.50%9.00%3.85%
    Headache151.00%11.00%4.85%
    Flushing70.80%6.70%3.81%
    Back pain110.00%6.80%3.00%
    Nasal congestion or rhinitis61.10%4.10%2.37%
    Myalgia81.00%4.40%1.89%
    Visual disturbance10.00%0.00%0.00%
    Dizziness30.00%2.40%1.30%
    10Dyspepsia91.20%11.40%6.53%
    Headache102.60%16.70%9.33%
    Flushing43.00%8.00%4.90%
    Back pain100.80%10.80%5.42%
    Nasal congestion or rhinitis51.20%8.00%4.02%
    Myalgia54.00%9.20%5.96%
    Visual disturbance30.00%2.50%0.83%
    Dizziness31.30%4.60%2.80%
    20Dyspepsia280.80%22.00%6.83%
    Headache331.60%43.00%11.44%
    Flushing270.30%10.00%3.76%
    Back pain250.60%16.10%4.54%
    Nasal congestion or rhinitis150.50%8.60%3.43%
    Myalgia190.30%9.70%3.74%
    Visual disturbance60.00%3.33%0.66%
    Dizziness60.70%6.20%2.82%
    Vardenafil5Dyspepsia50.70%2.00%1.34%
    Headache56.80%11.00%9.14%
    Flushing55.00%21.00%9.70%
    Back pain13.10%3.10%3.10%
    Nasal congestion or rhinitis54.00%9.00%5.64%
    Myalgia0NRNRNR
    Visual disturbance11.50%1.50%1.50%
    Dizziness11.40%1.40%1.40%
    10Dyspepsia150.00%6.60%3.19%
    Headache153.50%22.00%10.91%
    Flushing151.30%29.00%9.31%
    Back pain50.00%3.10%1.60%
    Nasal congestion or rhinitis101.20%14.00%6.49%
    Myalgia11.10%1.10%1.10%
    Visual disturbance20.00%2.00%1.00%
    Dizziness41.20%2.90%2.28%
    20Dyspepsia101.00%9.00%5.40%
    Headache1110.40%22.00%16.55%
    Flushing113.00%36.00%13.17%
    Back pain31.00%1.70%1.40%
    Nasal congestion or rhinitis101.11%17.00%9.20%
    Myalgia10.00%0.00%0.00%
    Visual disturbance50.00%3.33%2.17%
    Dizziness12.80%2.80%2.80%

    When means for the general and four special populations (men with diabetes, with BPH/LUTS, post-RP, or post-RT) for which there are substantial data were examined, it appears that men post-RP and men post-RT reported substantially higher rates of AEs than did men in the general ED population.  Whether men who have had prostate cancer treatment are more likely to experience AEs or are more likely to report AEs is not clear.  Men post-RP reported higher rates of AEs in response to sildenafil than in response to other PDE5s.  Men post-RT reported high rates of AEs across PDE5s and in placebo groups.  The high rates of AEs reported by men in placebo groups suggest that men post-RT may have heightened sensitivity to body sensations and may have unmet needs for psychosocial support.  These patterns can be seen in the table below (AEs for which there were 1 or 2 study arms are omitted); see cells in bold.  

    Common AEs by Treatment and Population (mean percentages)

    PLACEBOGen PopDiabetesBPH/LUTSPost-RPPost-RT
    Dyspepsia1.15%0.57%0.40%0.34%21.17%
    Headache4.05%3.12%3.03%3.74%9.28%
    Flushing1.52%0.86%Insufficient data0.00%4.78%
    Nasal congestion1.35%0.94%Insufficient data2.17%11.08%
    Visual disturbance0.60%0.68%NRInsufficient data7.50%
    Myalgia0.97%3.15%Insufficient dataInsufficient dataInsufficient data
    Dizziness1.29%NRNRInsufficient data6.78%
    SILDENAFILGen PopDiabetesBPH/LUTSPost-RPPost-RT
    Dyspepsia4.81%7.57%4.20%10.00%21.14%
    Headache11.15%13.48%7.53%16.55%17.11%
    Flushing10.45%12.53%3.54%16.24%12.43%
    Nasal congestion3.80%3.77%4.00%6.93%9.48%
    Visual disturbance3.59%2.90%NR5.67%10.09%
    Myalgia2.11%Insufficient dataNRNRInsufficient data
    Dizziness2.68%Insufficient dataInsufficient data8.63%7.29%
    TADALAFILGen PopDiabetesBPH/LUTSPost-RPPost-RT
    Dyspepsia5.57%7.94%2.32%4.11%16.95%
    Headache8.89%9.18%3.07%7.65%17.30%
    Flushing3.55%2.78%1.85%9.56%11.38%
    Nasal congestion3.27%2.28%NRInsufficient data2.68%
    Visual disturbance0.64%Insufficient dataNRNRNR
    Myalgia3.36%3.27%2.15%4.66%NR
    Dizziness2.28%Insufficient dataInsufficient dataNRInsufficient data
    VARDENAFILGen PopDiabetesBPH/LUTSPost-RPPost-RT
    Dyspepsia3.38%NRno studies4.14%no studies
    Headache10.80%7.41%no studies15.29%no studies
    Flushing8.98%8.69%no studies10.80%no studies
    Nasal congestion5.52%5.00%no studies19.00%no studies
    Visual disturbance1.55%NRno studiesNRno studies
    Myalgia0.55%NRno studiesNRno studies
    Dizziness1.56%NRno studiesNRno studies

    Appendix B2 – Guideline Statement 16:  Intracavernosal injection (ICI) data

    Commonly reported adverse events in extracted ICI studies:

    Commonly Reported Adverse Events for ICI Medications

    Treatment# study armsMinimumMaximumMean
    ICI papaverinePain_with_injection320.00%71.00%40.33%
    Injection_site_hematoma_or_inflammation417.40%27.40%23.87%
    Penile_fibrosis_nodule_plaque7.00%17.40%9.88%
    Prolonged_painful_erection_percent5.00%8.70%4.92%
    Priapism_percent5.00%15.20%7.14%
    ICI alprostadilPain_with_injection22.23%73.00%25.39%
    Pain_with_erection51.10%74.50%24.32%
    Injection_site_hematoma_or_inflammation17.00%36.00%10.17%
    Penile_pain44.60%28.50%12.77%
    Penile_fibrosis_nodule_plaque24.00%23.30%4.92%
    Penile_deviation_deformity31.00%9.30%4.10%
    Prolonged_painful_erection_percent15.00%43.00%6.31%
    Priapism_percent20.00%10.40%1.78%
    Genital_pain_percent3.35%47.00%27.05%
    Local_bleeding_percent41.00%15.00%6.97%
    ICI papaverine + phentolaminePain_with_injection6.00%78.00%14.43%
    Injection_site_hematoma_or_inflammation91.40%38.30%14.46%
    Penile_pain51.80%48.00%14.06%
    Penile_bruising75.00%47.00%22.14%
    Penile_fibrosis_nodule_plaque15.00%57.00%13.02%
    Penile_deviation_deformity5.00%10.00%3.72%
    Prolonged_painful_erection_percent71.80%16.70%8.90%
    Priapism_percent15.00%13.90%5.50%
    ICI papaverine + phentolamine + alprostadilPain_with_injection4.00%3.50%2.02%
    Injection_site_hematoma_or_inflammation33.70%20.70%14.83%
    Penile_fibrosis_nodule_plaque6.00%8.30%4.53%
    Prolonged_painful_erection_percent21.90%3.70%2.80%
    Priapism_percent5.50%5.70%3.15%
    ICI papaverine + phentolamine + alprostadil + atropinePain_with_injection3.00%.00%.00%
    Injection_site_hematoma_or_inflammation319.30%31.10%26.03%
    Penile_fibrosis_nodule_plaque33.70%9.60%6.26%
    Priapism_percent2.00%9.60%4.80%

    Appendix B3– Guideline Statement 18:  Penile prosthesis data

    Patient and partner satisfaction data:

    Patient Satisfaction Rates with Prosthesis Surgery

    Prosthesis TypeProsthesis Subtype# study armsMinimumMaximumMean
    InflatableAMS 700 Series2065.00%97.30%86.62%
    Coloplast Titan470.00%97.60%85.65%
    Other models or multiple models or unspecified models1377.80%96.40%88.28%
    MalleableAMS Spectra malleable272.20%96.20%84.20%
    AMS 600-650 series malleable534.78%82.50%66.06%
    Other models or unspecified models287.00%90.40%88.70%

    Partner Satisfaction Rates with Prosthesis Surgery

    Prosthesis TypeProsthesis Subtype# study armsMinimumMaximumMean
    InflatableAMS 700 Series869.80%96.00%83.34%
    Other or Multiple or Unspecified Inflatable776.00%98.00%88.24%
    MalleableAMS Spectra malleable284.60%94.30%89.45%
    AMS 600-650 series malleable257.00%75.00%66.00%

    Appendix B4 – Guideline Statement 21:  Penile arterial reconstruction data

    Complete, partial, and non-response rates to surgery: Below are those data; for studies that reported response rates at different durations post-surgery, the latest duration was used.  

    Arterial Reconstruction Studies: Responder Rates by Category

    Responder Category# study armsMeanMinimumMaximum
    Responder_complete3249.69%12.00%81.60%
    Responder_partial2526.72%7.70%53.30%
    Nonresponder2826.83%5.30%59.10%

    Appendix B5 – Guideline Statement 22:  Penile venous surgery data

    Complete, partial, and non-response rates to surgery: The pattern of declining positive response rates over time can be seen in the scatterplot below which plots complete and partial responder rates by follow-up duration.  The exception to this trend is Hsu, Chen (2010) who reported that 85.6% of 167 Taiwanese men at 92.4 mos of follow-up were complete responders to venous ligation surgery[926].  These men had no comorbidities at the time of surgery.  The procedure involved stripping and ligation of the deep dorsal, emissary, and cavernosal veins as well as ligation of the para-arterial veins; some men also had ligation of the crural veins.

    Penile Venous Ligation Surgery

    Overall, there was considerable variability regarding response rates.  Below are those data; for studies that reported response rates at different durations post-surgery, the latest duration was used. 

    Venous Ligation Studies: Responder Rates by Category
    Responder Category# study armsMeanMinimumMaximum
    Responder_complete5938.83%3.40%85.60%
    Responder_partial4625.73%6.10%64.30%
    Nonresponder5541.07%2.40%90.50%

    Abbreviations

    AE    Adverse events
    AMSTARA measurement tool for the assessment of systematic reviews
    AUAAmerican Urological Association
    BPHBenign Prostatic Hyperplasia
    BMIBody mass index
    cGMPCyclic guanasine monophosphate
    CVDCardiovascular disease
    CCTControlled clinical trial
    DREDigital rectal examination
    DUSPenile duplex ultrasound
    EDVEnd diastolic velocity
    EPLCardiovascular disease
    EDErectile dysfunction
    EDITSErectile dysfunction inventory of treatment satisfaction
    EFErectile function
    EHSErection hardness score
    ESWTExtracorporeal shock wave therapy
    IRBInstitutional review board
    IIEFInternational index of erectile function
    ICIIntracavernosal injections
    IUIntraurethral
    LUTSLower urinary tract symptoms
    NAIONNonarteritic anterior ischemic optic neuropathy
    PSVPeak systolic velocity
    PDPeyronie's disease
    PED5iPhosphodiesterase type 5 inhibitor
    PRPPlatelet-rich plasma
    PEPremature ejaculation
    QoLQuality of life
    RPRadial prostatectomy
    RTRadiotherapy
    RCTRandomized controlled trial
    RRRelative risk
    SIPASelective internal pudendal angiography
    SEPSexual encounter profile
    SHIMSexual health inventory for men
    SEARSelf-esteem and relationship questionnaire
    SDMShared decision making
    TDTestosterone deficiency
    VEDVacuum erection device

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