BSSM ED practical guide

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What is erectile dysfunction (ED)?

ED is the persistent inability to attain and/or maintain an erection sufficient for satisfactory sexual performance
ED is caused by various vascular, neuronal, hormonal and metabolic factors, mediated by endothelial and smooth-muscle dysfunction
Although most causes of ED are physical, some are due to psychosexual issues; nevertheless, all patients with ED should have a history, examination and investigations performed, even if a psychological cause is suspected
ED is a cardiovascular (CV) risk factor, posing a risk equivalent to that of current, moderate smoking
ED is also an important marker for future CV events, with symptoms occurring some 3–5 years before an event
The physical and psychosocial effects of ED can significantly affect the quality of life of patients and their partners

Who is at risk?

The risk factors for ED are similar to those for cardiovascular disease (CVD):
- older age
- sedentary lifestyle
- obesity
- dyslipidaemia
- metabolic syndrome
- diabetes
- smoking

What are the other benefits of case-finding ED in practice?

Increasing awareness regarding the availability of safe and effective oral drugs for ED, has led to more men seeking help for this condition, which facilitates the early detection of:
- diabetes (ED may be the first symptom in up to 20% of men)
- dyslipidaemia (may not require treatment according to primary prevention guidelines, but may be a major reversible component in ED)
- occult cardiac disease (in an otherwise asymptomatic man, ED may be a marker for underlying coronary artery disease)
- testosterone deficiency (TD; a reversible cause of ED that may not require specific ED treatment, and which also has other long-term health implications)
- associated lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH) (ED and LUTS severity are closely related, and treatments for one condition may beneficially or adversely affect the other)

History taking
Obtain a detailed description of the problem, including: symptom duration predisposing, precipitating and maintaining factors (if identified) any subsequent investigations previous/current treatment interventions and response reported tumescence, rigidity and quality of morning, spontaneous, masturbatory and/or partner-related erections sexual desire ejaculatory timing, control and orgasmic dysfunction previous erectile capacity any personal issues regarding sexual aversion or pain any partner issues, such as low sexual desire, menopause or gynaecological pain
Record concurrent medical, psychiatric and surgical history, current relationship status, history of sexual partners and relationships, alcohol intake, smoking status and recreational drug use
Consider the use of validated questionnaires, (such as the IIEF, shorter version of the SHIM, IPSS or AMS scale) to assess sexual function domains and response to therapy
Note any issues regarding sexual orientation and gender identity
Abbreviations: IIEF=International Index of Erectile Function; SHIM=Sexual Health Inventory for Men; IPSS=International Prostate Symptom Score; AMS=Aging Males’ Symptoms

Physical examination
Measure heart rate, blood pressure, abdominal circumference, weight, and height if body mass index required
Conduct a DRE of the prostate if there are genitourinary or protracted secondary ejaculatory symptoms
Perform a genital examination, particularly with pain of sudden onset, deviation of the penis during tumescence, symptoms of TD, or other urological symptoms (past or present)
Abbreviations: DRE=digital rectal examination; TD=testosterone deficiency

Investigations
Check serum lipids, fasting plasma glucose and/or glycated haemoglobin
Measure serum TT in the morning (before 11 am), in the fasting state. If low (TT <8 nmol/l) or borderline (TT 8–⁠12 nmol/l), repeat with serum LH and prolactin. FT has a greater correlation with clinical symptoms of TD (FT and bioavailable testosterone can be calculated from TT, SHBG and albumin; an online FT calculator and downloadable app, sponsored by the Primary Care Testosterone Advisory Group (PCTAG), can be found at http://www.pctag.uk/testosterone-calculator/. If levels are abnormal, consider specialist referral
Consider specialist investigations in men who: wish to know the aetiology of their ED have an arterial abnormality on Doppler ultrasound have a history of traumaa are young and: have always had trouble obtaining/maintaining an erection have a primary CV abnormality have suspected primary venous leakage are being considered for surgical intervention have an abnormality of the penis or testes have not responded to medical therapy and may want surgical treatment
Consider measuring PSA if clinically indicated, and certainly before commencing testosterone therapy and at 3, 6, and 12 months afterwards
Consider thyroid function tests
Abbreviations: TT=total testosterone; LH=luteinising hormone; FT=free testosterone; TD=testosterone deficiency; SHBG=sex hormone-binding globulin; ED=erectile dysfunction; CV=cardiovascular; PSA=prostate-specific antigen

Diagnosing and managing ED in primary care

The primary objective in the management of ED is to enable the man or couple to enjoy a satisfactory sexual experience
When managing ED, consider not only the efficacy and safety of the different treatments, but also patient and partner preference, and all the factors that may influence this
It is of paramount importance to use the opportunity to manage any previously undiagnosed comorbidities that present following the patient assessment, and to treat to target any existing conditions and make lifestyle modifications, where necessary

Algorithm on diagnosing and managing ED in primary care. Download a PDF of this algorithm.

ED therapies
PDE5I ~25–50% of men fail to respond within 12 months rates are higher in men with T2DM or post-RP inadequate prescribing/ instruction is the main cause of treatment failure daily/frequent dosing regimens may salvage men who’ve failed with on-demand therapy correction of testosterone levels <10.4 nmol/l may salvage non‑responders nitrates may be safely discontinued (with a cardiologist’s approval), to aid therapy co-administration with antihypertensives may increase the drop in blood pressure Contraindications include:^[A] use of nitrates in any form, guanylate cyclase stimulators, potent CYP3A4 inhibitors loss of vision in one eye due to NAION severe renal/hepatic impairment hypotension Dose adjustments may be required in:^[A] renal or hepatic impairment concomitant use of CYP3A4 inhibitors Apply caution in:^[A] patients receiving alpha‑blockers and those with anatomical penile deformities or a predisposition to priapism Possible adverse effects include:^[A] headache dizziness flushing dyspepsia nasal congestion	Intra-urethral alprostadil less invasive than injection therapy but works for only ~30–⁠60% of patients higher doses of MUSE (500/1000 mcg) are usually required Contraindications include: anatomical deformity of the penis predisposition to priapism Apply caution in: men whose partners could be pregnant (a condom must be used) Possible adverse effects include: penile pain haematoma headache dizziness hypotension muscle spasm	Intracavernous injections include alprostadil and aviptadil+phentolamine (A/P) alprostadil is effective in >70% of men, but compliance rates may be low A/P has similar efficacy to alprostadil, with less painful injections unlike alprostadil, A/P injections need to be accompanied by some form of sexual stimulation for an optimal erection Apply caution in:^[A] men at increased risk of bleeding (anticoagulants are contraindicated with A/P) Contraindications include:^[A] predisposition to priapism penile implants Possible adverse effects include:^[A] bruising and haematoma at injection site penile pain (alprostadil) flushing of face/trunk (A/P)
Vacuum erection devices highly effective, regardless of ED aetiology reported satisfaction rates vary between 35% to 84% can be a useful adjunct to PDE5I/injection therapy post-RP, and to salvage treatment failures work best if the man and his partner receive sufficient instruction, and have positive attitudes towards their use Contraindications include: bleeding disorders concurrent anticoagulant therapy Possible adverse effects include: bruising local pain failure to ejaculate coldness of the penis	Alprostadil cream store alprostadil cream (Vitaros) in the refrigerator apply 300 mcg in 100 mg (3 mg/g) into the urethral meatus at room temperature improved tumescence of the glans may be useful in men post-penile prosthesis has been shown to produce a 2.5‑point increase in IIEF and a 15% relative increase in successful intercourse attempts Contraindications include: anatomical deformity of the penis predisposition to priapism Apply caution in: men whose partners could be pregnant (a condom must be used) Possible adverse effects include: penile/genital pain/erythema urethral pain
[A] See the individual Summary of Product Characteristics for full details, because these vary between products. Abbreviations: T2DM=type 2 diabetes mellitus; RP=radical prostatectomy; CYP3A4=cytochrome P450 3A4; NAION=non-arteritic anterior ischaemic optic neuropathy; MUSE=Medicated Urethral System for Erections; ED=erectile dysfunction; PDE5I=phosphodiesterase type 5 inhibitor; IIEF=International Index of Erectile Function

ED therapies

PDE5I

~25–50% of men fail to respond within 12 months
- rates are higher in men with T2DM or post-RP
inadequate prescribing/ instruction is the main cause of treatment failure
daily/frequent dosing regimens may salvage men who’ve failed with on-demand therapy
correction of testosterone levels <10.4 nmol/l may salvage non‑responders
nitrates may be safely discontinued (with a cardiologist’s approval), to aid therapy
co-administration with antihypertensives may increase the drop in blood pressure

Contraindications include:^[A]

use of nitrates in any form, guanylate cyclase stimulators, potent CYP3A4 inhibitors
loss of vision in one eye due to NAION
severe renal/hepatic impairment
hypotension

Dose adjustments may be required in:^[A]

renal or hepatic impairment
concomitant use of CYP3A4 inhibitors

Apply caution in:^[A]

patients receiving alpha‑blockers and those with anatomical penile deformities or a predisposition to priapism

Possible adverse effects include:^[A]

headache
dizziness
flushing
dyspepsia
nasal congestion

Intra-urethral alprostadil

less invasive than injection therapy but works for only ~30–⁠60% of patients
higher doses of MUSE (500/1000 mcg) are usually required

Contraindications include:

anatomical deformity of the penis
predisposition to priapism

Apply caution in:

men whose partners could be pregnant (a condom must be used)

Possible adverse effects include:

penile pain
haematoma
headache
dizziness
hypotension
muscle spasm

Intracavernous injections

include alprostadil and aviptadil+phentolamine (A/P)
alprostadil is effective in >70% of men, but compliance rates may be low
A/P has similar efficacy to alprostadil, with less painful injections
unlike alprostadil, A/P injections need to be accompanied by some form of sexual stimulation for an optimal erection

Apply caution in:^[A]

men at increased risk of bleeding (anticoagulants are contraindicated with A/P)

Contraindications include:^[A]

predisposition to priapism
penile implants

Possible adverse effects include:^[A]

bruising and haematoma at injection site
penile pain (alprostadil)
flushing of face/trunk (A/P)

Vacuum erection devices

highly effective, regardless of ED aetiology
reported satisfaction rates vary between 35% to 84%
can be a useful adjunct to PDE5I/injection therapy post-RP, and to salvage treatment failures
work best if the man and his partner receive sufficient instruction, and have positive attitudes towards their use

Contraindications include:

bleeding disorders
concurrent anticoagulant therapy

Possible adverse effects include:

bruising
local pain
failure to ejaculate
coldness of the penis

Alprostadil cream

store alprostadil cream (Vitaros) in the refrigerator
apply 300 mcg in 100 mg (3 mg/g) into the urethral meatus at room temperature
improved tumescence of the glans may be useful in men post-penile prosthesis
has been shown to produce a 2.5‑point increase in IIEF and a 15% relative increase in successful intercourse attempts

Contraindications include:

anatomical deformity of the penis
predisposition to priapism

Apply caution in:

men whose partners could be pregnant (a condom must be used)

Possible adverse effects include:

penile/genital pain/erythema
urethral pain

[A] See the individual Summary of Product Characteristics for full details, because these vary between products.

Abbreviations: T2DM=type 2 diabetes mellitus; RP=radical prostatectomy; CYP3A4=cytochrome P450 3A4; NAION=non-arteritic anterior ischaemic optic neuropathy; MUSE=Medicated Urethral System for Erections; ED=erectile dysfunction; PDE5I=phosphodiesterase type 5 inhibitor; IIEF=International Index of Erectile Function

Full guideline:

British Society for Sexual Medicine. A practical guide on managing erectile dysfunction. BSSM, 2018. Available at: www.bssm.org.uk/wp-content/uploads/2018/09/ED-Practical-Guide-v3-for-BSSM-review.pdf.