The Quality and Outcomes Framework (QoF) 2013 aims to include questioning of men with diabetes about their erectile function, with recording of the prevalence of such and the offer of lifestyle advice and treatment options if indicated.

 

Erectile failure occurs in at least 50% of all diabetic men and affects 55% of those aged over 60 years. The cause is often multi-factorial. Vascular and neuropathic causes are common, but psychological factors may be partly responsible in some cases. Drugs, especially anti-hypertensive agents and statins, as well as alcohol may also be involved. Rarely testosterone deficiency and hyper-prolactinaemia may cause loss of libido and where present, the possibility of an underlying pituitary tumour should be excluded. All men with diabetes who complain of erectile dysfunction (ED) require a history and examination.

 

Hypogonadism is a syndrome which comprises sexual symptoms (including ED, loss of libido, lack of morning erections) and biochemical evidence of testosterone deficiency.

 

 

History

 

The patient will usually describe a failure to achieve an erection sufficient to achieve penetration. Slow onset, loss of morning erections and consistency suggest a mainly organic cause. The situation will always be the same with self-stimulation.

While psychological overlay may be present the classic non-organic presentation of ED. (rapid onset, inconsistency and presence of morning erection) is rare in patients with diabetes.

Should loss of libido be part of the history, further investigations may be considered to exclude an endocrine cause (but see below).

 

Examination

 

A simple and quick examination will suffice normally. Check the following:

  • Blood pressure
  • Urinalysis
  • Evidence of PVD
  • Evidence of neuropathy
  • Exclude testicular atrophy

 

It is worth ensuring that a recent TSH, Lipid profile and HbA1c has been checked. If there is loss of libido or other symptoms of hypogonadism (see below), then further investigations may be merited as per the Guidance below.  Only check testosterone if the patient is willing to consider replacement and take the risks of prostatic problems and polycythemia (see below).

 

Please note that measurements of total testosterone should be made on an early morning sample (between 8.00 & 10.00 am) and on at least 2 occasions before the diagnosis can be made and testing should not be done during acute or sub-acute illness.


According to the European Male Ageing Study (EMAS), a diagnosis of late onset hypogonadism can be considered if the total testosterone value is <7-11nmol/l and the following symptoms are present

  • ED
  • Loss of morning erections
  • Loss of libido

 

Other Guidelines suggest a level of <7nmol/l may be more appropriate (see below).

 

A low (or low normal) LH in the presence of a low testosterone may suggest hypopituitarism. Further investigations including MRI of pituitary are warranted and referral to Diabetes or Endocrinology services should be made (see flow chart).  Conversely a high LH (& FSH) with a low testosterone is suggestive of primary hypogonadism. Gonadal examination should be performed if not already done.

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Management of Erectile Dysfunction

  1. General Measures
  • Improve glycaemic control
  • Reduce alcohol intake
  • Withdraw causative drugs where possible
  • Correct associated endocrine disease where present
  • Involve partner as appropriate

 

    2.   Pharmacological Treatments

  • Oral preparations - PDE5 inhibitors
  • Intra-cavernosal injection of vasoactive drugs e.g. alprostadil
  • Intra-urethral agents e.g. alprostadil

 

  3.   Vacuum Devices

  4.   Surgical Treatment

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Phosphodiesterase 5 (PDE5) Inhibitors

 

Action: These drugs potentiate the action of Nitric Oxide (NO), producing cavernosal smooth muscle relaxation and penile erection. They are only a treatment for loss of erections and in studies have been shown to have no effect on libido or sexual desire.

Efficacy: PDE5 Inhibitors are effective in restoring natural erectile function in patients with ED of psychogenic, organic and mixed causes. In men with diabetes, studies have shown an efficacy rate of 56%.

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Drugs and doses:

 

Sildenafil

  • Starting dose 50mg , reduce dose in elderly to 25mg
  • Titrate dose up to a maximum of 100mg

Vardenafil

  • Starting dose 10mg, 5mg in elderly
  • Titrate dose up to a maximum of 20mg

Sildenafil and Vardenafil have the same duration of effect, which is about 4-5hrs.

Tadalafil

  • Starting dose 10mg
  • Maximum dose 20mg

Tadalafil is a longer acting PDE5 inhibitor and its effect may last 24-48hrs. It therefore sometimes dissociates taking a pill with sex, which may be important to some men. Head to head studies of efficacy are awaited.

 

For all drugs: see BNF for further information

  • Higher doses are associated with an increased incidence of side effects.
  • Instruct patient to take a tablet approximately 1 hour prior to anticipated sexual activity.
  • Worth trying for up to eight separate occasions at maximum dose, over a period of time chosen by the patient, before dismissing as ineffective.
  • If failure with one agent, worth trying alternative PDE5I

 

Adverse Effects: All side effects appear more frequently with increased doses

  • Headache is commonest.
  • Other vasculogenic effects e.g. flushing and dizziness occur occasionally.
  • Dyspepsia (in up to 5%).
  • Proximal myalgia.
  • Nasal congestion.

 

Drug Interactions:

  • PDE5 inhibitors can potentiate the action of nitrates therefore in patients who take nitrates of any type, including sublingual GTN or oral nicorandil, concurrent use of any PDE5
  • inhibitor is contra-indicated.

 

Cautions:

  • Cardiovascular disease.
  • Anatomical deformity of penis (e.g. Peyronies disease).
  • Predisposition to prolonged erection (e.g. leukaemia, multiple myeloma).
  • Hepatic impairment.
  • Renal impairment.

 

Contra-indications:

  • Concomitant Nitrate (including oral, buccal or sublingual) or nicorandil therapy.
  • Conditions in which sexual activity is inadvisable.
  • Recent stroke/myocardial infarction within 3 months.
  • Hypotension (BP less than 90/50mmHg).
  • Severe hepatic dysfunction.
  • Hereditary degenerative retinal disorders.
  • Concomitant treatment for ED (except counselling).

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Centrally Acting Drugs

 

Prescribing Restrictions:

  • In most cases, GPs are limited in their use of NHS prescriptions for the drug treatment of ED. However this restriction does not apply to men with diabetes.
  • Community pharmacists are unable to dispense NHS prescriptions that do not contain the endorsement 'SLS'.
  • The Dept of Health suggests that one treatment per week is appropriate.
  • If the GP considers that more than one treatment per week is reasonable, then this may be prescribed on the NHS.

 

 

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 Algorithm for Management of ED and Diabetes

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Management of Hypogonadism

 

The aim of testosterone replacement therapy (TRT) is to restore testosterone to mid-reference range using appropriate formulations of testosterone replacement available.

 

Before considering treatment, digital rectal examination should be performed to assess the prostate morphology.  Screening investigations should also include haematocrit, PSA and testosterone and these should be rechecked at 2, 6 and 12 months and thereafter annually if stable.

 

It is also worth considering an assessment of bone health by requesting a DEXA scan, especially if there have been any low trauma fractures.

 

Reversable Causes of Hypogonadism:

  • Opioids – esp. methadone
  • Sleep apnoea
  • Obesity

 

Potential Benefits of TRT:

  • Libido (the only statistically significant evidence based benefit)
  • ED
  • Morning erections
  • Increasing bone mineral density
  • ?? energy levels

 

Risks of TRT:

  • Polycythemia
  • Prostatic enlargement(benign or malignant, though N.B. TRT does NOT cause prostatic cancer)
  • CV disease in the elderly (> 65)
  • Sleep apnoea
  • Psychological problems

 

Contraindications to TRT  include:

  • Prostate cancer
  • Breast cancer
  • Untreated obstructive sleep apnoea
  • Untreated heart failure
  • Raised PSA
  • Pre-exisiting erythrocytosis (haematocrit > 0.54) / polycythemia

 

Generally those treatments which achieve the best physiological testosterone replacement include topical gels, long acting testosterone injections and buccal tablets. Older oral preparations of testosterone are rarely used nowadays due to their reduced bio-availability, but if used, then monitoring of LFTs is required.

 

It is important to recognise that symptomatic improvement on TRT may take up to six months and sometimes longer.  Likewise, the benefits in ED can take up to six months and beyond and many of these patients will still require specific ED therapy in addition.

 

If patients have previously failed on ED therapy consider the introduction of ED therapy once testosterone levels have been achieved as up to 60% of PDE5i non-responders can be converted to responders by the co-administration of TRT.

 

 

 

NHS Tayside Diabetes MCN QOF Checklist for Erectile Dysfunction

 

1) Ask about ED

 

In those with positive response (but untreated):

  • record advice and assessment of contributory factors and treatment options

 

In conjunction with ED Guidance and Pathway in Tayside Diabetes Handbook:

 

2) History:

  • Loss of libido (sex drive)?
  • Morning erections?
  • Speed of ED onset – slow/fast
  • Alcohol FAST Screen
  • Smoking status
  • Previous signs of Peyronies disease (anatomical deformity of penis)

 

3) Basic Examination:

  • Blood pressure
  • Evidence of PVD
  • Evidence of neuropathy
  • Exclude testicular atrophy

 

4) Assessment of contributory and other relevant factors

  • Poor glycaemic or blood pressure control
  • Stress / psychological factors
  • Causative drugs (esp. ACE Inhibitors, statins, b-blockers, antidepressants, antipsychotics, anticonvulsants, antihistamines, H2 antagonists) Discuss pros & cons of discontinuation with patient
  • Cycling (for more than 3 hours per week is an independent risk factor for ED)
  • Underlying associated endocrine disease – see below and Tayside Guidance
  • Nitrate Therapy for angina

 

5) Investigations

  • Urinalysis
  • Recent TSH, Lipid profile and HbA1c
  • If loss of libido or signs/symptoms of hypogonadism, consider checking FSH, LH, Testosterone (early morning sample), Free Androgen Index (FAI) and Prolactin (see Tayside Diabetes Handbook ED Guideline)

 

6) Advice

  • Brief Intervention re alcohol reduction if appropriate [see (2) above]
  • Smoking Cessation advice if appropriate [see (2) above]
  • Discussion re. optimisation of glucose and BP
  • Discussion re. benefits of weight loss and exercise
  • Discussion re. treatment options:
    • First line: usually PDE5Inhibitors (sildenafil, vardenafil & tadalafil) as per Tayside Guideline
    • Second Line Therapy - following referral to Andrology Clinic - including intra-cavernosal injection (alprostadil), intra-urethral alprostadil (muse), vacuum devices & surgical implants