The British Society for Sexual Medicine (BSSM) has recently published its guideline on the management of erectile dysfunction (ED), which it defines as the persistent inability to attain and/or maintain an erection sufficient for sexual performance.1,2 It highlights the targeting of cardiovascular risk factors as one of the key management options for men presenting with this highly prevalent and often distressing condition. Oral therapies are effective in up to 75% of patients, and alternatives can be offered for those who do not respond to treatment. There is a high incidence of ED,3,4 with the majority of patients presenting in primary care, and the new guideline will prove helpful for GPs and nurse practitioners seeking to provide optimal care.
The guideline emphasises the overwhelming evidence that ED is strongly associated with occult or overt cardiovascular, metabolic, or endocrine disorders. It recommends that newly presenting patients should be systematically assessed and that any associated disorders (e.g. cardiovascular disease [CVD], diabetes, hyperlipidaemia) should be identified and managed as appropriate.5,6 The guideline states that: ‘There can no longer be any excuse for avoiding discussions about sexual activity due to embarrassment.’1 The treatment approaches highlighted are well within the remit of primary care. Few patients with ED now require referral for specialist management.
The risk factors for ED are similar to those for CVD. These include:
- a sedentary lifestyle
- metabolic syndrome.
Erectile dysfunction may be the presenting sign of a significant underlying condition such as CVD, diabetes, endocrine factors, or depression.
There are several stages to reaching a diagnosis of ED. The healthcare professional should:
- take a sexual, medical and psychosocial history, including details of lifestyle, relationship status, and partner issues
- make a focused physical evaluation, including measurement of blood pressure, heart rate, waist circumference, weight, and examination of the genitalia—a digital assessment of the prostate should be carried out in the case of genitourinary tract or protracted secondary ejaculatory symptoms
- assess the cardiovascular system and level of sexual activity—‘A man with ED and no cardiac symptoms is a cardiac patient until proven otherwise’1—and undertake rigorous management of concomitant cardiovascular risk factors
- ask patients with cardiovascular disease (and diabetes) about ED—management of these underlying conditions provides an opportunity to assess the patient’s cardiovascular status and risk factors, and offer ED treatments where indicated. Many cardiac patients may be attempting sexual activity even though they are not fully fit and yet this is rarely discussed. There is no evidence that currently licensed treatments for ED add to the overall cardiovascular risk in CVD patients who are properly assessed, therefore, the cardiac risk of sexual activity is from the disease and not the treatment
- undertake recommended investigations, as appropriate. These include:
- fasting plasma glucose and serum lipids along with serum testosterone estimation (to exclude ‘treatable hypogonadism’, and measured on a blood sample taken between 08.00 and 11.00 hours)
- estimation of prostate-specific antigen should be considered if clinically indicated, or before commencing testosterone replacement therapy
- only rarely will patients require more specialised investigations, for example, in young patients with lifelong ED or those who are unresponsive to medication.
Figure 1 contains an algorithm for the management of ED. According to the guideline: ‘The primary goal of the management of ED is to enable the individual or couple to enjoy a satisfactory sexual experience.’1 Management involves:
- lifestyle change and risk factor modification—emphasis is placed on the merits of taking regular exercise, smoking cessation, and weight reduction, and avoiding adverse effects of non-prescription drugs, although the guideline does say that: ‘Pharmacotherapy should not be withheld on the basis that lifestyle changes have not been made’1
- identifying and treating reversible causes of ED, which may be:
- hormonal—treat underlying hypogonadism, thyroid disorder, or hyperprolactinaemia
- post-traumatic—arteriogenic ED in young males
- psychosexual—counselling and therapy should be offered if there is significant relationship dysfunction
- drug-induced—especially when there are strong temporal associations with certain drugs, such as antihypertensive drugs when taken over a longer period
- post-radical prostatectomy—new evidence favours early pro-active treatments
- treatment for hypogonadism and testosterone replacement therapy—the cause of suspected hypogonadism should always be sought before testosterone therapy is initiated, although drug treatment for ED need not be deferred while investigating for hypogonadism (see Figure 2).
Men with total serum testosterone (from a sample taken between 08.00 and 11.00 hours) consistently <11 nmol/l may benefit from a 3-month trial of testosterone replacement therapy for ED, and should be managed according to current guidelines.8
Figure 1: A management algorithm for erectile dysfunction
|Cardiovascular status upon presentation||ED management recommendations for the primary care physician|
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
Figure 2: Algorithm for androgen therapy in a man presenting with erectile dysfunction
|ED=erectile dysfunction; PDE5i=phosphodiesterase type 5 inhibitors
Reproduced with kind permission from the British Society for Sexual Medicine (adapted from Buvat et al. 20067
Phosphodiesterase type 5 (PDE5) inhibitors (sildenafil, tadalafil, and vardenafil) have been used with proven efficacy and safety. Published studies have reported up to 75% of sexual attempts result in successful intercourse after treatment with any of these three drugs in the general population of ED patients, with lower efficacy rates in subgroups, such as in patients with diabetes or post-prostatectomy.9–13 The efficacy and safety of PDE5 inhibitors have now been documented in both clinical trials and actual clinical practice scenarios.14
Sildenafil and vardenafil are relatively short-acting drugs (half-life ~4 hours), whereas tadalafil is longer-acting (half-life ~17.5 hours). Sexual stimulation is required in order for PDE5 inhibitors to facilitate an erection, with the recommendation that patients should receive up to eight optimal doses with sexual stimulation before classing the patient as a non-responder. Some patients may respond to one drug when another has failed. The full guideline highlights the potential for a dangerous interaction between PDE5 inhibitors and nitrates and alpha-blocking drugs.1
Vacuum erection devices are highly effective at inducing erections regardless of the aetiology of ED, with variable satisfaction rates (35–84%). Higher satisfaction rates are achieved if the man and his partner have a positive attitude to these devices and if time is spent demonstrating how to use them effectively. Vacuum erection devices can be prescribed under Schedule 2 of the National Health Service (GMS contract) (Prescription of Drugs, etc) Regulations 2004, and are very cost-effective in the long term, where continued use is higher than for self-injection therapy. Adverse effects include bruising, local discomfort, anejaculation, and partners may report that the penis feels cold. These devices are contraindicated with anticoagulation therapy or bleeding disorders.1
Intracavernous injection therapy (ICI) is an effective form of pharmacotherapy for ED, with efficacy rates of 80% in the general population of patients with ED. Its invasive nature can be off-putting for patients and partners, and poor compliance may result from post-injection penile pain and suboptimal training with lack of follow-up. Rare complications include priapism (1%) and fibrosis (2%).1
Intra-urethral alprostadil (less invasive but also less efficacious than ICI) has a variable efficacy of 30–60%, with high rates reported of penile pain (30–40%). It is also expensive and, in clinical practice, the higher dosages appear more effective.1
Penile prostheses (malleable or inflatable versions) are suitable for those with severe organic ED, which may result from Peyronie’s disease or post priapism, where all other treatment options have proved unsuccessful/unacceptable. Detailed pre-operative counselling of all couples is mandatory.1
Patient and partner education
Ideally the patient’s and their partner’s understanding and expectation of investigations and treatments should be elicited. Principles of treatment options should be explained, with provision of educational information as valuable reinforcement. Any sexual problems the partner has, such as vaginal atrophy, particularly in women over 50 years of age, should be identified and appropriate professional care offered.
The hastily constructed Department of Health documents from 1999 — Treatment for impotence and Treatment for impotence: patients with severe distress — still use grounds of cost to define which patients should be considered eligible for treatment from GPs paid for by the NHS.15,16
Men with ED associated with various medical conditions, including diabetes, prostate cancer, spinal cord injury, and after radical pelvic surgery, are currently deemed to qualify for prescription at NHS expense.15 Referral by GPs for specialist advice is recommended if patients are thought to be suffering severe distress on account of their ED.15 It is the role of the ‘specialist’ to endorse that judgement, taking into account the following factors:15
- significant disruption to normal social and occupational activity
- marked effect on mood, behaviour, and social and environmental awareness
- marked effect on interpersonal relationships.
Frequency of treatment
After an initial titration period, one tablet per week of the prescribed medication is considered to be appropriate for the majority of patients, but if in the clinical judgement of the GP more than one treatment is required, this should also be prescribed on the NHS.16
The guidance for ‘severe distress’ has been interpreted differently across the UK. Strict interpretation involves the hospital continuing ongoing prescribing indefinitely. However, many NHS trusts cannot absorb these costs and have declined to provide any service.1
The availability of effective oral medication has revolutionised the treatment of ED but many patients are still not being diagnosed and treated. The 1999 Department of Health guidance restricts access and frequency of treatments for many patients with ED, significantly compromising their optimal management in primary care.
Sexual activity is associated with benefits to cardiovascular health and improved well being, but despite increasing numbers of men seeking help and more licensed treatments becoming available, surprisingly, there is no current NICE guidance reviewing treatments for ED.
Unfortunately, the new guideline from the BSSM1 cannot directly change the rules on NHS prescribing of licensed ED therapies by GPs for those patients who are most likely to benefit from them — those with severe psychological distress, cardiovascular disorders, depression, anxiety, or patients with no clearly identified causality.
The guideline might have placed greater emphasis on certain aspects of the management of ED, such as:
- the potential benefits of simple lifestyle modifications, including maintaining a sensible alcohol intake and/or smoking cessation
- the fact that the efficacy and safety of PDE5 inhibitors have now been documented in both clinical trials and actual clinical practice scenarios14
- the relative NHS cost per dose (or per appliance) for all licensed ED therapies
- more detail about licensed testosterone replacement therapies, with some guidance on prescribing and monitoring in primary care.
On the whole, however, the BSSM guideline conveys an evidence-based approach to facilitate the pragmatic management of ED in primary care.
- BSSM. British Society for Sexual Medicine Guidelines for Erectile Dysfunction 2007. www.bssm.org.uk
- 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. www.eguidelines.co.uk
- 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.
- Johannes C, Araujo A, Feldman H et al. Incidence of erectile dysfunction in men 40 to 69 years old: longitudinal results from the Massachusetts male aging study. J Urol 2000; 163 (2): 460–463.
- Jackson G, Betteridge J, Dean J et al. A systematic approach to erectile dysfunction in the cardiovascular patient: a consensus statement—update 2002. Int J Clin Pract 2002; 56 (9): 663–671.
- 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.
- 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.
- Nieschlag E, Swerdloff R, Behre H et al. Investigation, treatment and monitoring of late-onset hypogonadism in males. ISA, ISSAM, and EAU recommendations. Eur Urol 2005; 48 (1): 1–4.
- Corbin J, Francis S, Webb D. Phosphodiesterase type 5 as a pharmacologic target in erectile dysfunction. Urology 2002; 60 (2, Suppl 2): 4–11.
- Goldstein I, Young J, Fischer J et al; Vardenafil Diabetes Study Group. Vardenafil, a new phosphodiesterase type 5 inhibitor in the treatment of erectile dysfunction in men with diabetes: a multicenter double-blind placebo-controlled fixed-dose study. Diabetes Care 2003; 26 (3): 777–783.
- Brock G, Mehra A, Lipschulz L et al. Safety and efficacy of vardenafil for the treatment of men with erectile dysfunction after radical retropubic prostatectomy. J Urol 2003; 170 (4, Pt 1): 1278–1283.
- Montorsi F, Verheyden B, Meuleman E et al. Long-term safety and tolerability of tadalafil in the treatment of erectile dysfunction. Eur Urol 2004; 45 (3): 339–344; discussion 344–345.
- Fink H, Mac Donald R, Rutks I et al. Sildenafil for male erectile dysfunction: a systematic review and meta-analysis. Arch Intern Med 2002; 162 (12): 1349–1360.
- Hellstrom W. Current safety and tolerability issues in men with erectile dysfunction receiving PDE5 inhibitors. Int J Clin Pract 2007; 61 (9): 1547–1554.
- Department of Health. Treatment for impotence. HSC 1999/148. London: DH, 1999.
- Department of Health. Treatment for impotence: Patients with severe distress. HSC 1999/177. London: DH, 1999.G