The evidence-based guideline on erectile dysfunction from the BSSM will help the primary care team manage this common condition, explains Dr Geoff Hackett
  • Erectile dysfunction and other sexual disorders have been shown to be closely linked with breakdown of relationships and development of depression, and GPs are able to assess the wider impact of these sexual problems within the family
  • Half of men aged over 50 years are affected by the condition
  • There is a direct relationship between ED and CVD in 80% of cases, with the severity of ED acting as a reliable predictor of the severity of CVD—if a patient presents with ED, it is an early opportunity for the GP to tackle any symptoms of CVD
  • Assessment of ED should be included in the GP’s chronic disease management
  • Medications, such as those for hypertension, can have a great effect on sexual function—unnecessary nitrate therapy in patients with stable coronary disease should be stopped and phosphodiesterase type 5 inhibitors prescribed, which are beneficial for pulmonary hypertension and peripheral vascular disease, diabetes and LUTS

The new guideline from the British Society for Sexual Medicine (BSSM) on management of erectile dysfunction (ED) has recently been released.1 It was developed by a multidisciplinary team of urologists, sexual health physicians, psychiatrists, sex therapists, endocrinologists, primary care physicians, and nurses in response to the lack of clear evidence-based guidance available.

Need for the guideline

The development of effective oral therapy for ED initially led to the production of company-sponsored guidelines from the Erectile Dysfunction in Primary Care Group (unpublished) and the Erectile Dysfunction Alliance,2 both of which suffered from a lack of independence.

In 1999, the Department of Health published Treatment for impotence (HSC 148),3 followed by Treatment for impotence: patients with severe distress (HSC 177) in the same year.4 These documents were not evidence based and no mention was made of the composition of the expert panel. In 2001, despite acknowledging several hundred letters of objection, it was announced by the Department of Health that, after consultation, it had been decided that no changes to prescribing for impotence would be made.5 Surprisingly, there is no published or planned NICE guidance on the management of ED.

Department of Health documents and strategies on sexual health have focused on sexually transmitted disease and unplanned pregnancy, ignoring sexual problems in men and women. Erectile dysfunction, ejaculatory problems, sexual desire problems in men and women, and arousal or orgasm problems in women have been shown to be closely associated with marital and relationship breakdown and depression.6 It is open to question whether the Department of Health strategy is influenced by concerns over the potential costs of medication for sexual problems. For these reasons the BSSM believed that independent UK-specific guidelines were needed.

Erectile dysfunction and cardiovascular disease

Several publications in international peer-reviewed journals have shown the clear links between ED and cardiovascular disease (CVD) and it is now acknowledged that 80% of cases of ED are directly related to CVD.7,8 Erectile dysfunction has essentially the same risk factors as chronic heart disease and is believed to be a manifestation of endothelial dysfunction, which occurs 3 to 5 years before development of coronary disease.8 The severity of ED reliably predicts the severity of coronary artery disease found at angiography and precedes the onset of coronary symptoms by 3 to 5 years.9 The Princeton cardiology expert panel concluded that the newly presenting patient with ED is ‘a cardiac patient until proven otherwise’.8

Research into ED, particularly its associations with diabetes, has revealed important links with androgen deficiency syndrome or hypogonadism.10 For this reason, the BSSM guideline also includes information on the management of hypogonadism.1

Quality of the evidence

In 2004, under the auspices of the World Health Organization, more than 200 experts in sexual medicine met to grade, and subsequently publish, the clinical evidence of research into sexual medicine according to recognised evidence-based medicine standards.11 Following this, in 2006, the International Society for Sexual Medicine published Standard Practice in Sexual Medicine to update the procedure.12 The American Urological Association and European Association of Urology produced guidelines for the management of ED in 2006.13 All these publications have included grading of scientific evidence in their publications.

In many ways, despite the clear associations with CVD, ED is a unique therapy area for guidelines, as the successful outcome is essentially decided by the couple and not the physician. The main outcome of therapy is a ‘satisfactory sexual experience’1 and, under current UK guidance,3,4 this has usually been financed by the couple at their own expense. This has led to the concept of ‘patient preference’ in addition to efficacy, and for this reason, the panel included evidence from preference studies, where the evidence is, at best, grade 2.14

Measuring outcomes

Outcome measures depend on questionnaires such as the International Index of Erectile Function15 or the shortened version, the Sexual Health Inventory for Men,16 and a sexual encounter profile, which were developed in the late 1990s to facilitate the assessment of responses to oral therapy for ED.

Guideline content

The BSSM guideline includes recommendations on the following:1

  • diagnosis, including initial assessment, physical examination, laboratory testing, the cardiovascular system, and specialised investigations
  • lifestyle management
  • treatment objectives and options
  • patient/partner education
  • referral.

A management algorithm, which takes into account graded cardiovascular risk, and includes recommendations for the primary care physician, is also included (see Figure 1).

Figure 1: A management algorithm

Management algorithm for ED
Grading
of risk
Cardiovascular status upon presentation ED management recommendations for the primary care physician
Low risk
  • Controlled hypertension
  • Asymptomatic ?3 risk factors for CAD – excluding age and gender
  • Mild valvular disease
  • Minimal/mild stable angina
  • Post successful revascularisation
  • CHF (NYHA class I)
  • Manage within the primary care setting
  • Review treatment options with patient and his partner (where possible)
Intermediate risk
  • Recent MI or CVA (i.e. within last 6 weeks)
  • Asymptomatic but >3 risk factors for CAD – excluding age and gender
  • LVD/CHF (NYHA class II)
  • Murmur of unknown cause
  • Moderate stable angina
  • Heart transplant
  • Recurrent TIAs
  • Specialised evaluation recommended (e.g. exercise test for angina, echocardiogram for murmur)
  • Patient to be placed in high or low risk category, depending upon outcome of testing
High risk
  • Severe or unstable or refractory angina
  • Uncontrolled hypertension (SBP >180 mmHg)
  • CHF (NYHA class III, IV)
  • Recent MI or CVA (i.e. within last 14 days)
  • High risk arrhythmias
  • Hypertrophic cardiomyopathy
  • Moderate/severe valve disease
  • Refer for specialised cardiac evaluation and management
  • Treatment for ED to be deferred until cardiac condition established and/or specialist evaluation completed

ED= erectile dysfunction; CHD=coronary heart disease; CAD= coronary artery disease; CHF= congestive heart failure;NYHA= New York Heart Association; MI= myocardial infarction; CVA= cerebral vascular accident; LVD= left ventricular dysfunction; TIA= transient ischaemic attack; SBP= systolic blood pressure.

Reproduced with kind permission from the British Society for Sexual Medicine

How will this guideline improve management of ED?

Traditionally ED was managed by urologists and psychosexual therapists, as the perception until the late 1980s was that the majority of cases were ‘psychogenic’ and the rest involved diseases of the penis, which might require surgery or a prosthesis. Over the past 15 years, accumulated evidence has shown ED to be a vascular and endocrine disorder requiring assessment of cardiovascular, diabetic, and endocrine risk, and needing a multidisciplinary approach,8 which secondary care physicians have been slow to develop.

Essentially, the sheer magnitude of the problem, with 50% of men aged over 50 years affected,17 means that ED should be managed by the primary care team in conjunction with their daily management of chronic diseases. General practitioners may also be better acquainted with their patients and their families and are best placed to assess the wider impact of sexual problems.

Unfortunately, the current GP contract18 has ignored ED in its quality and outcomes targets. The single decision to recognise the clear importance of ED as a marker for CVD7–9 is likely to have a major influence on the quality of ED management. Unfortunately concepts such as ‘lifestyle medications’ and ‘recreational activities’ have been allowed to trivialise the real issues.

Since 1998, the Department of Health guidance has been a major drawback to effective management. Essentially this ‘guidance on good practice’ has been the main influence on clinical decision making in the management of ED.3,4 These documents have no evidence value whatsoever and are a clear effort to control treatment costs. They define patients with arbitrary conditions, mainly neurological, as qualifying for NHS treatment, and consign the rest to privately funded treatment, particularly the bulk of patients with CVD. If a patient can convince his GP that he suffers from ‘severe distress’, a newly created concept defined in the follow-up document,4 then the patient can receive treatment which is funded by a hospital, after consultant endorsement. Research has shown that this care pathway doubles the cost of treatment and is in direct contradiction to the principles of practice-based commissioning and payment by results.19

Barriers to BSSM guideline implementation

The major barrier to widespread adoption of the BSSM guideline is the difficulty that male patients, and healthcare professionals of either sex, still have in talking about sexual problems. Many healthcare professionals still fail to see the clinical importance of ED as a symptom of CVD and an opportunity for early intervention, and prefer to divert the workload to relationship counselling. General practitioners are under pressure to reduce prescribing costs and ED therapy is a prime target for cuts because of the perception that this will have little impact on disease mortality associated with cutbacks. The recent licence of one phosphodiesterase 5 inhibitor, tadalafil, for daily dosing,20 will not help this issue, but the expiry of the first patent, for sildenafil citrate, in 3 years time, should make a significant difference.21

The implementation of testosterone therapy guidance represents a completely different problem. Despite evidence to the contrary from meta-analyses, there is still a belief that there could be an association with prostate cancer, or a fear based on lessons learned from the use of hormone replacement therapy in women.12 It is to be hoped that further large ongoing studies will address these concerns.

How will the guideline promote best practice in primary care?

Currently only 10% of patients with ED receive a consultation from a healthcare professional,22 and the BSSM guideline should give the primary care physician sufficient confidence to include ED in chronic disease management.

The medications that are prescribed for hypertension23 and chronic heart disease can have profound effects on sexual function and this guideline will rationalise patient therapy. Currently, many patients resort to obtaining medication via the internet, without an adequate assessment of endocrine or cardiac risk factors, many of which are treatable. There are potential risks if these patients, who may later develop coronary artery disease, are then prescribed nitrates. The guideline from BSSM will facilitate the discontinuation of unnecessary nitrate therapy in patients with stable coronary disease and ED, and who need to take phosphodiesterase type 5 inhibitors.24

Recent studies show beneficial effects of phosphodiesterase type 5 inhibitors on endothelial dysfunction,25 not only in pulmonary hypertension but also in peripheral vascular diseases, diabetes, and for lower urinary tract symptoms.26

Future developments

It is hoped that this evidence-based guideline will form the reference for clinical decision making and enable us to discard the outdated Department of Health guidance, freeing up secondary care consultations for appropriate referrals.

The importance of testosterone in the management of ED (see Figure 2),27 and the evolving role in insulin resistance in type 2 diabetes10 are very exciting areas for future research. The requirement to manage ED through evidence-based guidelines will lead to a comprehensive review of risk factors in men’s health. We already know that cardiovascular and endocrine factors are also important in female sexual conditions, but research and evidence-based guidelines for these are some way from development.

Figure 2: Algorithm for androgen therapy in a man presenting with ED (adapted from Buvat et al. 2006)12

Figure 2: Algorith for androgen therapy in a man presenting with ED

  • ED should be seen as an indicator of underlying CVD unless proved otherwise
  • It precedes the onset of frank CVD by 3–5 years
  • A full CVD risk assessment plus preventive therapy could reduce later costs of treating manifest CVD
  • Most cases can be managed in primary care without referral by using the management algorithm
  • Few patients with ED but without diabetes are eligible for NHS drug treatment
  • Tariff prices: urology outpatient = £161 (new), £80 (follow-up)
  1. British Society for Sexual Medicine. Guidelines on the management of erectile dysfunction. In: Foord-Kelcey G, Editor. Guidelines—summarising clinical guidelines for primary care. 32nd ed. Berkhamsted: MGP Ltd, June 2007, pp. 277–285. And online at www.guidelines.co.uk
  2. Ralph D, McNicholas T. UK management guidelines for erectile dysfunction. Br Med J 2000; 321 (7259): 499–503.
  3. Department of Health. Treatment for impotence. HSC 1999/148. London: Department of Health, 1999.
  4. Department of Health. Treatment for impotence: patients with severe distress. HSC 1999/177. London: Department of Health, 1999.
  5. www.dh.gov.uk/en/Publicationsandstatistics/Pressreleases/DH_4011390
  6. Laumann E, Paik A, Rosen R. Sexual dysfunction in the United States: prevalence and predictors. JAMA 1999; 281 (6): 537–544.
  7. Thompson I, Tangen C, Goodman P et al. Erectile dysfunction and subsequent cardiovascular disease. JAMA 2005; 294 (23): 2996–3002.
  8. Jackson G, Rosen R, Kloner R, Kostis J. The second Princeton consensus on sexual dysfunction and cardiac risk: new guidelines for sexual medicine. J Sex Med 2006; 3 (1): 28–36; discussion 36.
  9. Montorsi P, Ravagnani P, Galli S et al. Association between erectile dysfunction and coronary artery disease. Role of coronary clinical presentation and extent of coronary vessels involvement: the COBRA trial. Eur Heart J 2006; 27 (22): 2632–2639.
  10. Kapoor D, Aldred H, Clark S et al. Clinical and biochemical assessment of hypogonadism in men with type 2 diabetes: correlations with bioavailable testosterone and visceral adiposity. Diabetes Care 2007; 30 (4): 911–917.
  11. Lue T, Giuliano F, Montorsi F et al. Summary of the recommendations on sexual dysfunctions in men. J Sex Med 2004; 1 (1): 6–23.
  12. Buvat J, Shabsigh R, Guay A et al. Hormones, metabolism, aging and men’s health. In: Porst H, Buvat J and the Standards Committee of the International Society for Sexual Medicine, Editors. Standard Practice in Sexual Medicine. Oxford: Blackwell Publishing: 2006, pp. 225–286.
  13. Wespes E, Amar E, Hatzichristou D et al. EAU Guidelines on erectile dysfunction: an update. Eur Urol 2006; 49 (5): 806–815.
  14. Eardley I, Mirone V, Montorsi F et al. An open-label, multicentre, randomized, crossover study comparing sildenafil citrate and tadalafil for treating erectile dysfunction in men naive to phosphodiesterase 5 inhibitor therapy. BJU Int 2005; 96 (9): 1323–1332.
  15. Rosen R, Riley A, Wagner G et al. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology 1997; 49 (6): 822–830.
  16. Vroege J. The sexual health inventory for men (IIEF-5). Int J Impot Res 1999; 11 (3): 177.
  17. Feldman H, Goldstein I, Hatzichristou D et al. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol 1994; 151 (1): 54–61.
  18. British Medical Association. Revisions to the GMS contract 2006/2007: Delivering Investment in General Practice. London: BMA, 2006.
  19. Hackett G. Schedule 11—impact on treating erectile dysfunction. Br J Diabetes Vasc Dis 2002; 2: 315–320.
  20. Porst H, Guiliano F, Glina S et al. Evaluation of the efficacy and safety of once a day dosing of tadalafil 5 mg and 10 mg in the treatment of erectile dysfunction: Results of a multicenter, randomized, double-blind, placebo-controlled trial. European Urology 2006; 50 (2): 351–359.
  21. http://news.bbc.co.uk/1/hi/business/1013244.stm
  22. Fisher W, Meryn S, Sand M et al. and the Strike Up a Conversation Study Team. Communication about erectile dysfunction among men with ED, partners of men with ED, and physicians: The Strike Up a Conversation Study [Part I]. The Journal of Men’s Health & Gender 2005; 2 (1): 64–78.
  23. Grimm R, Grandits G, Prineas R et al. Long-term effects on sexual function of five antihypertensive drugs and nutritional hygienic treatment in hypertensive men and women. Treatment of Mild Hypertension Study (TOMHS). Hypertension 1997; 29 (1 Pt 1): 8–14.
  24. Jackson G, Martin E, McGing E, Cooper A. Successful withdrawal of oral long-acting nitrates to facilitate phosphodiesterase type 5 inhibitor use in stable coronary disease patients with erectile dysfunction. J Sex Med 2005; 2 (5): 513–516.
  25. Rosano G, Aversa A, Vitale C et al. Chronic treatment with tadalafil improves endothelial function in men with increased cardiovascular risk. Eur Urol 2005; 47 (2): 214–220
  26. McVary K, Roehrborn C, Kaminetsky J et al. Tadalafil relieves lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol 2007; 177 (4): 1401–1407.
  27. Shabsigh R, Kaufman J, Steidle C, Padma-Nathan H. Randomized study of testosterone gel as adjunctive therapy to sildenafil in hypogonadal men with erectile dysfunction who do not respond to sildenafil alone. J Urol 2004; 172 (2): 658–663.G