L eiaculazione precoce. Giovanni Corona MD, PhD Endocrinology Unit Medical Department, Ospedale Maggiore Bologna, Italy
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1 L eiaculazione precoce Giovanni Corona MD, PhD Endocrinology Unit Medical Department, Ospedale Maggiore Bologna, Italy
2 Corona et al., Nat Rew Urol 2012;9:508
3 ... ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration, the inability to delay ejaculation on all or nearly all vaginal penetrations, and the presence of negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy McMahon et al., J Sex Med. 2013;10:204.
4 Intravaginal ejaculation latency time measured with stopwatch in 110 men with lifelong premature ejaculation 90% Waldinger et al., Int J Psychiatry Clin Pract 1998;2:287
5 ... The epidemiological studies demonstrate the varying prevalence estimates ranging from 30% down to 3%. McMahon et al., J Sex Med. 2013;10:204.
6 A total of 2,593 couples (mean age, 41.9 ± 12.7 years for males and 38.2 ± 12.1 years for females) were enrolled. Five-hundred twelve subjects (20.0%) complained of ejaculating prematurely. The median self-estimated IELTs of the patients who described lifelong, acquired or natural variable PE were approximately 1 minute, 1 2 mintues and 2 3 minutes Serefoglu et al., J Sex Med. 2011;8:540
7 1. Ejaculation that always or nearly always occurs prior to or within about 1 minute of vaginal penetration (lifelong PE) or a clinically significant and bothersome reduction in latency time, often to about 3 minutes or less (acquired PE). 2. The inability to delay ejaculation on all or nearly all vaginal penetrations. 3. Negative personal consequences, such as distress, bother, frustration, and/or the avoidance of sexual intimacy. Serefoglu et al., J Sex Med. 2014;11:1423
8 Patient-reported measures of the Premature Ejaculation Profile Patrick et al., J Sex Med. 2007;4:780.
9 Perceived control is better than IELT Patrick et al., J Sex Med. 2007;4:780.
10 Aetiology Life - long PE Psychological or relationship problems Acquired Organic Urological dysfunctions: -Prostatitis -ED Hormonal dysfunction McMahon et al., J Sex Med. 2013;10:204.
11 Aetiology Life - long PE McMahon et al., J Sex Med. 2013;10:204.
12 Praventricular nucleus Cortex Medial preotic Nucleus Locus ceruleus Paragigantocellular nucleus 5HT 2C 5HT 1B agonists = delay ejaculation 5HT 1A agonists = accelerate ejaculation
13 Zuccarello et al., J Sex Med. 2012;9:1659
14 The present results indicate that no difference exists in SLC6A4 polymorphisms frequency between PE patients and controls. Zuccarello et al., J Sex Med. 2012;9:1659
15 Forest plot of LPE risk associated with the 5- HTTLPR gene polymorphism (LL vs. SS) Forest plot of LPE risk associated with the 5- HTTLPR gene polymorphism (LL +LS vs. SS) Zhu et al., Plose One. 2013;8:e54994
16 Premature ejaculation 1. Genetic factors might underlie ejaculatory control.
17 Aetiology Life - long PE Psychological or relationship problems Acquired Organic McMahon et al., J Sex Med. 2013;10:204.
18 Internet-based survey (the PE Prevalence and Attitudes [PEPA] survey) among men ages in the United States, Germany, and Italy (n = 12,133 mean age 41.6±11.6 years ols) Porst et al., Eur Urol. 2007;51:816
19 Percentages of men reporting comorbid conditions 30 * p<0.05 * PE 25 * No PE % 20 * Depression Anxiety Excessive stress Porst et al., Eur Urol. 2007;51:816
20
21 Anxiety symptoms (MHQ-score) in subjects with or without PE according to Premature Ejaculation Diagnostic Tool (PEDT) score HR=1.185[1.006;1.395]; p=0.046 MHQ-A score Adjusted for age No YES
22 Consecutive series of 244 men (mean age 35.2 ± 7.8) with couple infertility Lotti et al., J Sex Med. 2012;9:2698.
23 Premature ejaculation 1. Genetic factors might underlie ejaculatory control. 2. Anxiety symptoms are associated with PE
24 Aetiology Life - long PE Psychological or relationship problems Acquired Organic Urological dysfunctions: -Prostatitis -ED Hormonal dysfunction McMahon et al., J Sex Med. 2013;10:204.
25 % PE ED HSD Dogan &Dogan., Int J Impot Res. 2008;20:218
26 Premature ejaculation 1. Genetic factors might underlie ejaculatory control. 2. Anxiety symptoms are associated with PE 3. PE is a couple problem
27 Aetiology Life - long PE Psychological or relationship problems Acquired Organic Urological dysfunctions: -Prostatitis -ED Hormonal dysfunction McMahon et al., J Sex Med. 2013;10:204.
28
29 EP Total n=46 EP Prim. n=21 EP Second. n=25 Healthy Control n=30 Screponi et al., Urology 2001;58:198
30 Prevalence of chornic prostatitis % Lifelong PE Aquired PE n=709 n=558 Zhang et al., J Sex Med. 2013;10:1603
31 Consecutive series of 244 men (mean age 35.2 ± 7.8) with couple infertility Lotti et al., J Sex Med. 2012;9:2698.
32 Premature ejaculation 1. Genetic factors might underlie ejaculatory control. 2. Anxiety symptoms are associated with PE 3. PE is a couple problem 4. Prostatitis are frequently associated with acquired PE
33 145 men with acquired PE 64.8% bacterial prostatitis (94 subjects)
34 Magri et al., Asian J Androl. 2013;13:819
35 Magri et al., Asian J Androl. 2013;13:819
36 Premature ejaculation 1. Genetic factors might underlie ejaculatory control. 2. Anxiety symptoms are associated with PE 3. PE is a couple problem 4. Prostatitis are frequently associated with acquired PE 5. Antibiotic treatment improve prostatitis-related PE
37 Aetiology Life - long PE Psychological or relationship problems Acquired Organic Urological dysfunctions: -Prostatitis -ED Hormonal dysfunction McMahon et al., J Sex Med. 2013;10:204.
38 Serefoglu et al., J Sex Med. 2011;8:540
39 95% 5 % Concomitant ED No ED Although PE is considered the most common sexual problem in men The vast majority of patients do not seek help for PE until it is comorbid with ED (Waldlinger, 2002). Corona et al., Eur. Urol. 2004; 46: 615
40 Percentages of men reporting erectile dysfunction : PEPA study % * p< PE 1 2 No PE Porst et al., Eur Urol. 2007;51:816
41 DE ED Attempts to obtain excitation Possible relationship between ED and PE Attempts to delay excitation PE
42 Premature ejaculation 1. Genetic factors might underlie ejaculatory control. 2. Anxiety symptoms are associated with PE 3. PE is a couple problem 4. Prostatitis are frequently associated with acquired PE 5. ED is frequently associated with PE ins subjects seeking medical care
43 Aetiology Life - long PE Psychological or relationship problems Acquired Organic Urological dysfunctions: -Prostatitis -ED Hormonal dysfunction McMahon et al., J Sex Med. 2013;10:204.
44 Hormonal control of ejaculation: outline Thyroid hormones Testosterone Prolactin
45 Hormonal control of ejaculation: outline Thyroid hormones Testosterone Prolactin
46 755 male subjects with sexual dysfunction
47 n=2652; mean age 51.6±13.0 years Corona et al. Int J Androl. 2010;33:1
48 p = Log 10 [TSH] mu/l Severe Mild Mild Severe Moderate Moderate Anejaculation PE No EP-DE DE Corona et al. Int J Androl. 2010;33:1
49 Hormonal control of ejaculation 1. Thyroid hormones modulate ejaculatory reflex.
50 Waldinger et al., J Sex Med 2005;2:865
51 No association between PE and thyroid hormones in subjects with lifelong PE Waldinger et al., J Sex Med 2005;2:865
52 Corona et al., Nat Rew Urol 2012;9:508
53 No association between PE and thyroid hormones in subjects with lifelong PE Corona et al., Nat Rew Urol 2012;9:508
54 Hormonal control of ejaculation 1. Thyroid hormones modulate ejaculatory reflex. 2. Hyperthyroidism is a cause of acquired PE
55 Prevalence of sexual dysfunction before and after recovery from hyperthyroidism (A) and hypothyroidism (B) Carani et al., J Clin Endocrinol and Metab 2005;90:6472
56 Hormonal control of ejaculation 1. Thyroid hormones modulate ejaculatory reflex. 2. Hyperthyroidism is a cause of acquired PE 3. Treatment of hyperthyroidism or hypothyroidism improves ejaculatory problems
57 ..
58 ..
59 Hormonal control of ejaculation: outline Thyroid hormones Testosterone Prolactin
60 n=1632; mean age 50.1±12.0 years Corona et al. J Androl. 2006;27:453
61 Relative risk for the parameters correlated to delayed ejaculation (DE) after adjustment for confounding factors Stress at work Psychiatric diseases Serotoninergic drugs Anti-dopaminergic drugs Neurological diseases PRL>288 mu/l T <10.4 nm HSD Loss of partner s climax Loss of partner s libido 0, , No DE DE Corona et al. J Androl. 2006;27:453
62 p = Testosterone (nmol/l) Severe Mild Mild Severe Moderate Moderate Anejaculation PE No EP-DE DE Corona et al. Int J Androl. 2010;33:1
63 Effect size (with 95%CI) of testosterone supplementation (TS) versus placebo on orgasm component Source Orgasm component standardized mean differences Diff. in mean LL, 95% CI UL, 95% CI p -5,00-4,00-3,00-2,00-1,00 0,00 1,00 2,00 3,00 4,00 5,00 Skakkebaek et al., ,46 0,52 2,40 0,00 Davidson et al., ,06-0,26 2,39 0,12 Kwan et al., ,58-0,26 3,41 0,09 Gluud et al., ,11-0,27 0,49 0,58 Carani et al., ,79-0,38 1,97 0,19 Schiavi et al., ,62 0,30 2,94 0,02 Cavallini et al., ,00 0,54 1,46 0,00 Chaing et al., ,97 0,31 1,62 0,00 Jones et al., ,05-0,24 0,34 0,74 Hackett et al., ,42 0,13 0,72 0,00 Overall ,68 0,34 1,02 0,00 Placebo TS Corona et al., J Sex Med. 2014;11:1577
64 Meta-regression analysis for total testosterone Effect size on orgasm component Std diff in means 2,00 1,80 1,60 1,40 1,20 1,00 0,80 0,60 0,40 0,20 Regression of mean at baseline T on Std diff in means 0,00-0,46 0,0 1,89 4,24 6,59 8,94 11,29 13,63 15,98 18,33 20,68 23,03 Mean baseline mean total at baseline testosterone T (nmol/l) S=-0.039[-0.070;-0.008];p=0.015 I=0.844[0.468;1.221];p< Corona et al., J Sex Med. 2014;11:1577
65 Hormonal control of ejaculation 1. Thyroid hormones modulate ejaculatory reflex. 2. Hyperthyroidism is a cause of acquired PE 3. Treatment of hyperthyroidism or hypothyroidism improves ejaculatory problems 4. Testosterone modulates ejaculatory reflex
66 Hormonal control of ejaculation: outline Thyroid hormones Testosterone Prolactin
67 A consecutive series of 2,496 male patients (w/o hyperprolactinemia and medication) attending the outpatient clinic for sexual dysfunction at the University of Florence, Florence, Italy Corona et al., J Sex Med. 2009;6:1457
68 30 Sexual parameters Premature ejaculation % Adj.r -0.09; p< Adjusted for age Smoking BMI Medicaments PRL-quartiles Corona et al., J Sex Med. 2009;6:1457
69 p = Log 10 [PRL] mu/l Severe Mild Mild Severe Moderate Moderate Anejaculation PE No EP-DE DE Corona et al. Int J Androl. 2010;33:1
70 NEUROENDOCRINOLOGICAL PRL CONTROL Prolactin-inhibiting factors DA (tuberohypophyseal TIDA system) endothelin-1 TGFβ1 TIDA 5HT Prolactin-releasing factors 5HT TRH VIP Oxytocin EGF Basic FGF Opioid TRH
71 Biological functions of 5HT in CNS: Sexual responsiveness sexual desire Ejaculatory time Mood Food intake Metabolism 5HT rostral Raphe nuclei caudal Hyposerotonergic tone: - decreased orgasm - anxiety & depression - metabolic syndrome
72
73 Hypoprolactinemia= Hyposerotonergic tone HYPOTHESIS?
74 Comparisons between subjects with prolactin-secreting pituitary adenomas (8 micro and 5 macroadenomas) and age-bmi-smoking habit- testosterone matched controls (1:5 ratio). Case patients Controls p< Age (years) 47.8± ±11.0 ns BMI (Kg/m 2 ) 27.5± ±3.3 ns Total testosterone (nmol/l) 10.6± ±4.5 ns Current smoker (%) ns Hypoactive sexual desire (%) Premature ejaculation (%) ns Total cholesterol mg/dl 201.1± ±39.7 ns LDL-cholesterol mg/dl 120.5± ±32.3 ns Triglycerides mg/dl 98[78-165] 123[82-180] ns Glycaemia mg/dl 90 [83-99] 93[88-102] ns Dynamic PSV (cm/sec) 52.5± ±24.3 ns MHQ-A score (free-floating anxiety symptoms) 5.3± ±3.1 ns Corona et al., J Sex Med. 2009;6:1457
75 Comparisons between subjects with prolactin-secreting pituitary adenomas (8 micro and 5 macroadenomas) and age-bmi-smoking habit- testosterone matched controls (1:5 ratio). Case patients Controls p< Age (years) 47.8± ±11.0 ns BMI (Kg/m 2 ) 27.5± ±3.3 ns Total testosterone (nmol/l) 10.6± ±4.5 ns Current smoker (%) ns Hypoactive sexual desire (%) Premature ejaculation (%) ns Total cholesterol mg/dl 201.1± ±39.7 ns LDL-cholesterol mg/dl 120.5± ±32.3 ns Triglycerides mg/dl 98[78-165] 123[82-180] ns Glycaemia mg/dl 90 [83-99] 93[88-102] ns Dynamic PSV (cm/sec) 52.5± ±24.3 ns MHQ-A score (free-floating anxiety symptoms) 5.3± ±3.1 ns Corona et al., J Sex Med. 2009;6:1457
76 Hyposerotonergic tone: - decreased orgasm - anxiety & depression - metabolic syndrome 2935 subjects mean age (60±11 years old) PRL in the blood = 5HT in the brain? 5HT Corona et al., J Sex Med 2013
77 Relationship between orgasmic enjoyment change and PRL levels in EMAS study Wald= 6.840;p=0.009 Adjusted for age Centres Testosterone, estradiol, TSH Antidepressants Number of morbidities Log 10 [PRL] ng/ml Increased Increased Same Decreased Decreased a lot moderately moderately a lot Change in orgasm enjoyment Corona et al., J Sex Med 2013
78 Hormonal control of ejaculation 1. Thyroid hormones modulate ejaculatory reflex. 2. Hyperthyroidism is a cause of acquired PE 3. Treatment of hyperthyroidism or hypothyroidism improves ejaculatory problems 4. Testosterone modulates ejaculatory reflex 5. Low prolactin might be a marker of a reduced serotonergic tone
79 A consecutive series of 288 males of infertile couples, (36.6 ± 4.4 years) attending the outpatient clinic for sexual dysfunction at the University of Florence, Florence, Italy Lotti et al., Andrology 2013
80 Lotti et al., Andrology 2013
81 Lotti et al., Andrology 2013
82 Comparisons between subjects with prolactin (PRL) < 140 mu/l (case patients) and age-, total testosterone-, TSH-matched controls (1:1 ratio). Lotti et al., Andrology 2013
83 Hormonal control of ejaculation 1. Thyroid hormones modulate ejaculatory reflex. 2. Hyperthyroidism is a cause of acquired PE 3. Treatment of hyperthyroidism or hypothyroidism improves ejaculatory problems 4. Testosterone modulates ejaculatory reflex 5. Low prolactin might be a marker of a reduced serotonergic tone 6. Prolactin might play a direct peripheral effect in modulating ejaculatory effect
84 Hazard ratio for premature ejaculation according to the hormonal milieu in 1962 subjects with sexual dysfunction (w/o hyperprolactinemia and medication) at the University of Florence, Italy Log 10 [TSH] mu/l Log 10 [PRL] mu/l Log 10 [Total testosterone] nm Adjusted for: Age Smooking and drinking behaviours ED severity Anxiety and depressive symptoms Psychiatric disease Hazard ratio for decreased orgasm Corona et al., Nat Rev Urol. 2012;9:508
85 Corona et al., Nat Rev Urol. 2012;9:508
86 MCMahon et al., J Sex Med. 2013;10:204
87 MCMahon et al., J Sex Med. 2013;10:204
88 Reccomadation#2: Self-estimation by the patient and partner of ejaculatory latency should be used to determine IELT in clinical practice (level 1) Standardized assessment measures such as validated questionnaires and patient-reported outcome measures can be used as an adjunct to a full medical/sexual history and selfestimation of ejaculatory latency in the evaluation of men presenting with self-reported PE (level 1) MCMahon et al., J Sex Med. 2013;10:204
89 Reccomadation#2: Self-estimation by the patient and partner of ejaculatory latency should be used to determine IELT in clinical practice (level 1) Standardized assessment measures such as validated questionnaires and patient-reported outcome measures can be used as an adjunct to a full medical/sexual history and selfestimation of ejaculatory latency in the evaluation of men presenting with self-reported PE (level 1) - Premature ejaculation diagnostic tool (PEDT) score > 8: PE
90
91 5HT INCREASE IN EJACULATORY LATENCY SEROTONERGIC MEDICATIONS PRL DECREASE IN SEXUAL DESIRE
92 Single- and multiple-dose plasma concentration profiles of dapoxetine 30 mg Modi et al., J Clin Pharmacol 2006;46:301
93 Dapoxetine has more rapid pharmacokinetics than other SSRIs. Andersson et al., BJU Int 2006;97:311
94 Non selective SSRI mg/daily 25 mg on demand 2) SSRI mg/daily mg on demand mg/daily 20 mg on demand mg/daily
95
96 Plasma concentrations of dapoxetine in young and elderly men Dressers et al., J Clin Pharmacol 2006;46:1023
97 Plasma concentrations of dapoxetine after a high fat meal. Dressers et al., J Clin Pharmacol 2006;46:1023
98 Plasma concentrations of dapoxetine after administration of dapoxetine alone or with tadalafil or sildenafil Dressers et al., Int J Impot Res 2006;18:104
99 Caution in patients with moderate/severe hepatic or renal insufficiency No limitation with meals Caution with alcohol Main recommendations
100
101 Buvat et al., Eur Urol 2009;55:957
102 Mean average intravaginal ejaculatory latency time (IELT) over time. Buvat et al., Eur Urol 2009;55:957
103 Percentages of subjects reporting good or very good control over ejaculation over time. Percentages of subjects reporting good or very good satisfaction with sexual intercourse over time. Buvat et al., Eur Urol 2009;55:957
104 Percentages of subjects reporting moderately, quite a bit, or extremely distress related to ejaculation Percentages of subjects reporting moderately, quite a bit, or extremely interpersonal difficulty related to ejaculation Buvat et al., Eur Urol 2009;55:957
105 Treatment-emergent adverse events occurring in 2% of subjects Buvat et al., Eur Urol 2009;55:957
106 McMahon et al., J Sex Med 2011;8:524
107 McMahon et al., J Sex Med 2011;8:524
108 Changes in IELT over time McMahon et al., J Sex Med 2011;8:524
109 Percentages of subjects reporting that their PE was better or much better at week 12 Overall Baseline IELT 60 sec Baseline IELT 30 sec McMahon et al., J Sex Med 2011;8:524
110 Treatment-emergent adverse events occurring in at least 2% of subjects McMahon et al., J Sex Med 2011;8:524
111 Studies of SSRIs in patients with major psychiatric disorders, such as depression or obsessive compulsive disorder, have suggested that SSRIs are potentially associated with certain safety risks, including anxiety, akathisia, changes in mood, and suicidality (in adolescents) Coupland et al.; J Clin Psychopharmacol 1996;16: Tamam & Ozpoyraz Adv Ther 2002;19: Zajecka et al., J Clin Psychiatry 1997;58:291 7.
112 Mean (SD) scores for BDI-II, MADRS, HAM-A, and BARS at baseline and end point BDI-II = Beck Depression Inventory-II MADRS = Montgomery-Åsberg Depression Rating Scale HAM-A = Hamilton Anxiety Scale; BARS = Barnes Akathisia Rating Scale McMahon et al., J Sex Med 2011;8:524
113 Evaluation of suicidality: responses to BDI-II (Item 9) and MADRS (Item 10), n (%) BDI-II = Beck Depression Inventory-II MADRS = Montgomery-Åsberg Depression Rating Scale McMahon et al., J Sex Med 2011;8:524
114 Mirone et al., Eur Urol. 2014;65:733
115 Mirone et al., Eur Urol. 2014;65:733
116 Mirone et al., Eur Urol. 2014;65:733
117 Caution in patients with moderate/severe hepatic or renal insufficiency No limitation with meals Caution with alcohol Main recommendations Concomitant use of Priligy with PDE5 inhibitors may result in orthostatic hypotension. The efficacy and safety of Priligy in patients with both premature ejaculation and erectile dysfunction concomitantly treated with Priligy and PDE5 inhibitors have not been established
118 McMahon et al., J Sex Med 2013;10:2312
119 McMahon et al., J Sex Med 2013;10:2312
120 McMahon et al., J Sex Med 2013;10:2312
121 McMahon et al., J Sex Med 2013;10:2312
122 Acknowledgements University of Florence Prof G. Forti Dr E. Mannucci Dr E Maseroli Dr G Rastrelli Dr F. Lotti Dr AD Fisher Dr V Boddi Dr L. Petrone Dr R. Mansani Dr C. Krausz Dr A. Magini University of Marche Dr G. Balercia University of L Aquila Prof EA Jannini Maggiore-Bellaria Hospital Dr A.Sforza
123 PROF MARIO MAGGI CHIEF OF Sexual Medicine & Andrology Unit, University of Florence, Florence, Italy THANK YOU
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