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«GUIDELINES ON MALE SEXUAL DYSFUNCTION: Erectile Dysfunction and Premature Ejaculation (Text update March 2013) E. Wespes (chair), I. Eardley, F. ...»

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With antibiotic prophylaxis, the infection rate is 2-3% and may be further reduced by using an antibiotic-impregnated or hydrophilic-coated implant. Infection requires removing the prosthesis, antibiotic administration and re-implantation after 6-12 months.

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PDE5 inhibitor = phosphodiesterase type 5 inhibitor.

136 Male Sexual Dysfunction

PREMATURE EJACULATION

Definition, epidemiology and risk factors The International Society for Sexual Medicine (ISSM) has adopted a completely new definition of lifelong PE, which is the first evidence-based definition: ‘Premature ejaculation is a male sexual dysfunction characterized by ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration; and inability to delay ejaculation on all or nearly all vaginal penetrations; and negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy’.

Thus, PE may be classified as ‘lifelong’ (primary) or ‘acquired’ (secondary). Lifelong PE is characterised by onset from the first sexual experience and remains a problem during life.

Acquired PE is characterised by a gradual or sudden onset with ejaculation being normal before onset of the problem.

Time to ejaculation is short, but not usually as fast as in lifelong PE.

Premature ejaculation has a detrimental effect on self-confidence and relationship with the partner. It may cause mental distress, anxiety, embarrassment, and depression. However, most men with PE do not seek help.

Diagnostic work-up Diagnosis of PE is based on the patient’s medical and sexual history. The history should classify PE as lifelong or acquired and determine whether PE is situational (under specific circumstances or with a specific partner) or consistent. Special attention should be given to the length of time of ejaculation, degree of sexual stimulus, impact on sexual activity and QoL, and drug use or abuse. It is also important to distinguish PE from ED.

Male Sexual Dysfunction 137 Recommendations for diagnosis of PE LE GR Diagnosis and classification of PE is based on medical and sexual history.

It should be multidimensional and assess IELT, 1a A perceived control, distress, and interpersonal difficulty due to the ejaculatory dysfunction.

Clinical use of self-estimated IELT is adequate. 2a B Stopwatch-measured IELT is necessary in clinical trials.

Patient-reported outcomes have the potential 3 C to identify men with PE. Further research is needed before they can be recommended for clinical use.

Physical examination may be necessary in initial 3 C assessment of PE to identify underlying medical conditions associated with PE or other sexual dysfunctions particularly ED.

Routine laboratory or neurophysiological tests 3 C are not recommended. Additional tests should be directed by specific findings from history or physical examination.

IELT = intravaginal ejaculatory latency time.

Treatment of PE In many relationships, PE causes few, if any, problems. In such cases, treatment should be limited to psychosexual counselling. Before beginning treatment, it is essential to discuss patient expectations thoroughly. Erectile dysfunction or other sexual dysfunction or genitourinary infection (e.g.

prostatitis) should be treated first or at the same time as PE.

Various behavioural techniques have demonstrated benefit in treating PE. In lifelong PE, behavioural techniques are not recommended for first-line treatment. They are time-intensive, require the support of a partner, and can be difficult to do.

138 Male Sexual Dysfunction Pharmacotherapy is the basis of treatment in lifelong PE but all medical treatments are off-label indications. Only chronic selective serotonin reuptake inhibitors (SSRIs) and ondemand topical anaesthetic agents have consistently shown efficacy in PE. A treatment algorithm for PE is presented in Fig. 3.

Psychological/behavioural strategies Behavioural strategies mainly include the ‘stop-start’ programme developed by Semans and its modification, the ‘squeeze’ technique, proposed by Masters and Johnson (several modifications exist). Masturbation before anticipation of sexual intercourse is another technique used by many younger men.

Overall, success rates of 50-60% have been reported short term. Improvements achieved with these techniques are generally not maintained long term.

Topical anaesthetic agents Lidocaine-prilocaine cream (5%) is applied for 20-30 min prior to intercourse. A condom is required to avoid diffusion of the topical anaesthetic agent into the vaginal wall causing numbness in the partner. In two RCTs, lidocaine-prilocaine cream significantly increased the stopwatch-measured IELT compared to placebo. No significant side-effects have been reported. An aerosol formulation of lidocaine 7.5 mg plus prilocaine 2.5 mg (Topical Eutectic Mixture for Premature Ejaculation, TEMPE) is under evaluation and has shown similar results.

SS-cream is a topical anaesthetic agent made from the extracts of nine herbs. It is applied to the glans penis 1 h before and washed off immediately prior to coitus. In a RCT, application of 0.2 g SS-cream significantly improved IELT

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Selective serotonin reuptake inhibitors Commonly used selective serotonin reuptake inhibitors (SSRIs) include paroxetine (20-40 mg/day), sertraline (25mg/day), and fluoxetine (10-60 mg). Selective serotonin reuptake inhibitors were expected to increase the geometric mean IELT by 2.6-fold to 13.2-fold. Paroxetine was found to be superior to fluoxetine, clomipramine, and sertraline.

Ejaculation delay may start a few days after drug intake, but it is more evident after 1-2 weeks and may be maintained for several years. Common side-effects of SSRIs include fatigue, drowsiness, yawning, nausea, vomiting, dry mouth, diarrhoea, and perspiration; they are usually mild and gradually improve after 2-3 weeks. Decreased libido, anorgasmia, anejaculation, and ED have been also reported. On-demand treatment is inferior to daily dosing, but may be combined with an initial trial of daily treatment or concomitant low-dose daily treatment to reduce adverse effects.

Dapoxetine is a potent SSRI, which has been specially designed as an on-demand oral treatment for PE. An integrated analysis of two RCTs reported that dapoxetine, 30 and 60 mg, improved IELT significantly compared to placebo.

Improved ejaculation control was reported by 51% and 58% of patients in the 30 mg and 60 mg dosage groups, respectively. Both dapoxetine doses were effective on the first dose.

Common adverse events were nausea, diarrhoea, headache, and dizziness. Dapoxetine has been approved (December

2008) for the on-demand treatment of PE in seven European countries (Sweden, Austria, Finland, Germany, Spain, Italy, and Portugal). This is currently the first and only drug approved for

140 Male Sexual Dysfunctionsuch an indication.

Phosphodiesterase type 5 inhibitors Several recent studies have supported the therapeutic role of PDE5Is in PE. However, there is only one RCT comparing sildenafil to placebo. Although IELT was not significantly improved, sildenafil increased confidence, the perception of ejaculatory control and overall sexual satisfaction, reduced anxiety, and decreased the refractory time to achieve a second erection after ejaculation.

Recommendations for PE treatment LE GR Erectile dysfunction, other sexual dysfunction, 2a B or genitourinary infection (e.g. prostatitis) should be treated first.

Behavioural techniques can benefit PE. 3 C However, they are time intensive, require the support of a partner, and can be difficult to do.

Pharmacotherapy is the basis of treatment in 1a A lifelong PE.

Daily SSRIs are first-line, off-label, pharmaco- 1a A logical treatment for PE. The pharmacokinetic profile of currently available SSRIs is not amenable to on-demand dosing.

Dapoxetine, a short-acting SSRI, has already 1a A been approved for the on-demand treatment of PE in seven European countries.

Topical anaesthetic agents provide viable alter- 1b A natives to SSRIs (off-label).

A trial of PDE5Is may be attempted. 2b C Recurrence is likely after treatment cessation. 1b A Behavioural therapy may augment pharmaco- 3 C therapy to enhance prevention of relapse.

SSRI = selective serotonin reuptake inhibitor.

Male Sexual Dysfunction 141 Fig. 3: Management of PE

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Attempt graduated withdrawal of Drug therapy after 6-8 weeks

• Behavioural therapy includes stop/starttechnique, squeeze sensate focus

• Pharmacotherapy (off label) includes SSRIs (daily use) and topical anaesthetics; it is recommended as first-line treatment option in lifelong PE

• Consider dapoxetine for on-demand use (the only approved drug for PE) PE = premature ejaculation; IELT = intravaginal ejaculatory latency time; ED = erectile dysfunction; SSRI = selective serotonin receptor inhibitor.

Adapted from Lue et al. Summary of the recommendations on sexual dysfunctions in men. J Sex Med 2004;1:6-23.

142 Male Sexual Dysfunction This short booklet text is based on the more comprehensive EAU guidelines (ISBN 978-90-79754-71-7), available to all members of the European Association of Urology at their website, http://www.uroweb.org.

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