3/22/2017

ERECTILE DYSFUNCTION MALE SEXUAL DYSFUNCTION

AND ITS NEW TREATMENT - Disorders of sexual desire:
• Hypoactive sexual desire disorder
• Sexual aversion disorder
- Disorders of erection:
• Erectile dysfunction
Wimpie Pangkahila • Prolonged erection
Department of Andrology and Sexology - Disorders of ejaculation:
Center for Study of Anti-Aging Medicine • Rapid ejaculation
Medical Faculty Udayana University • Retarded ejaculation
- Disorders of orgasm:
• Anorgasm
Wimpie Pangkahila - Center for Study of Anti-Aging Medicine, Department of Andrology and Sexology
Medical Faculty Udayana University - Indonesian Center for Anti-Aging Medicine

We’re born
together, grew
Erectile dysfunction (ED)
up together, but
- Persistent or recurrent inability to why you died
earlier? Huu
achieve or maintain an erection adequate
for sexual intercourse
- Most frequent sexual dysfunction in male
besides premature ejaculation

Wimpie Pangkahila - Center for Study of Anti-Aging Medicine, Department of Andrology and Sexology Wimpie Pangkahila - Center for Study of Anti-Aging Medicine, Department of Andrology and Sexology
Medical Faculty Udayana University - Indonesian Center for Anti-Aging Medicine Medical Faculty Udayana University - Indonesian Center for Anti-Aging Medicine

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Diagnosis:
Cause-result correlation
1.Sexual history.

• Erectile insufficiency
• Altered sexual desire? Female Male
• Nocturnal and morning erection Sexual Sexual
• Ejaculation, orgasm, genital pain DysfunctionD DysfunctionD
• Partner sexual function
• International Index of Erectile Function-
5 (IIEF-5)

Diagnosis:
2. Medical history
• Lifestyle factors, smoking
• Chronic medical illness
• Pelvic/perineal/penile trauma and
surgery, pelvic radiotherapy
• Medications/recreational drug use
• Neurological disease, endocrine
disease
• Psychological state, psychiatric
problem
Diagnosis:
3. Clinical examination
a. General examination:
- Body configuration: fat distribution,
gynaecomastia
- Degree of virilization: hair distribution,
muscle, skin
- Blood pressure, cardiovascular
- neurological

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Erection Hardness Score (EHS)

• Clinical examination
Severe ED Moderate ED Mild ED No ED
b. Penis examination: IIEF 6 - 10 IIEF 11 - 15 IIEF 16 - 20 IIEF 21 - 25

secondary sexual characteristics,

hypospadia, epispadia, phimosis,
scars, other pathological conditions.
c. Testis examination: Penis is Penis is hard Penis is hard
Position, consistency: palpation. larger but but not hard enough for
not hard enough for penetration Penis is
penetration but not completely
Volume: orchidometer. completely hard and
hard fully rigid

Erection Hardness Score (EHS)

Severe ED Moderate ED Mild ED No ED
IIEF 6 - 10 IIEF 11 - 15 IIEF 16 - 20 IIEF 21 - 25

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4. Laboratory tests:
LFT, Lipid tests, Glucose.
Testosterone assay: low sexual desire
and diminished size testes.

5. Additional testing:
erectiometer, Doppler stethoscope,
Rigiscan

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TREATMENT OF ERECTILE DYSFUNCTION

Next step is treatment

However, make sure that the diagnosis is ED, At the beginning treatment of ED was
not sexual desire disorder considered as not ideal treatment

ED is disorder of sexual arousal, not disorder There is an evolution in

of sexual desire the treatment of ED

Evolution of ED Treatments and Efficacy

Ideal treatment
•Sildenafil
•Vardenafil Today 1. Treatment of the etiology.
•Tadalafil
Treat the causes or risk factors of ED.
•Vardenafil (®Levitra) Also consider the role of female partner in
•Tadalafil (®Cialis) 2000
case she is involved as the etiology or in
•PDE-5i Sildenafil (®Viagra) 1990s the
condition where patient need psychological
•PGE1
•Papaverine 1980s support or erotic stimulation
•Pumps
•Yohimbine 1970s
•Surgery

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Intracavernous injection
Ideal treatment

2. Treatment to recover the erectile function:

- First line therapy is oral agent PDE-5
inhibitor. There are 3 kinds of legal PDE-5
inhibitors that are widely used.
- Second line therapy is intracavernosal
injection of vasodilator agent: alprostadil
- Third line therapy is surgery which is now
rarely practiced.

Ideal treatment A study by Torres et al (2004) reported that

men’s expectation to medicine for ED is:
Oral erectogenic agent is the first line and
ideal therapy based on its a.89% give satisfaction to the partner
b.89% result in rigid erection
- simple use c.87% recover self confidence
- effectiveness
- safety

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Based on the report of MALES study (Eardley

et al, 2004), men want medicine for ED that is Since PDE5 inhibitor used in 1998, it is used
on-demand before sexual intercourse
- effective
- good tolerability • On-demand PDE5 inhibitors have
- safe demonstrated efficacy and safety in treating
erectile dysfunction 1-5
- can be used with other medicines

1. Wespes et al. Eur Urol 2006;49:806-15. 4. Hellstrom et al. J Androl

2. Hatzimouratidis et al. Eur Urol 2007;51:75-88. 2002;23:763-71.
3. Goldstein et al. N Engl J Med 1998;338:1397-404.5. Carson et al. BJU Int 2004;93:1276-81.

• However, planning sexual activity around

taking a pill is burdensome to some patients
and their partners 1,2
Many studies have been performed to prove
the effectiveness and safety of
OD tadalafil for ED
• Taking an ED medication once daily (OD) or
once a day OAD) may be one way for
patients to be ready for sexual activity when
they choose 2

• Once-daily dosing would offer an alternative

for couples who prefer spontaneous
instead of scheduled sexual activities, or for
those who anticipate frequent sexual
activities
1. Hanson-Divers C et al. J Urol 1998;159:1541-7. 1. Hanson-Divers C et al. J Urol 1998;159:1541-7.
2. Dunn M et al. Int J Impot Res 2007;19:119-23. 2. Dunn M et al. Int J Impot Res 2007;19:119-23.

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Why the Once-Daily (OD) Option?

Predicted Tadalafil
Concentration-Versus
Concentration-Versus--Time Profiles
♦Dosing paradigms that eliminate coordinating Tadalafil Plasma Concentrations Over 1 Week
dosing with sexual activity are desirable to 400

Tadalafil Plasma Concentration (ng/mL)

accommodate individual patterns and 350
Tadalafil 5 mg OD
spontaneity of sexual intimacy 1-3 300 Tadalafil 20 mg single dose
250
200
♦Tadalafil is suited for use OD for ED therapy, 150
owing to its long half-life (17.5 hours)4
100
50
0
0 24 48 72 96 120 144 168
Time (hours)
1. Carson C et al. BJU Int 2004;93:1276-81. 3. Dunn M et al. Int J Impot Res 2007;19:119-23.
Wrishko R et al. J Sex Med 2009;6:2039-48.
2. Rajfer J et al. Int J Impot Res 2007;19:95-103. 4. Forgue S et al. Br J Clin Pharmacol
2006;61:280-8.

Once-Daily Tadalafil for ED

♦Tadalafil OD is an effective treatment for
patients with ED
• Significant improvements in primary study
endpoints
− IIEF EF
− SEP2 (insertion into vagina)
− SEP3 (successful intercourse)
• Longterm effectiveness (1- and 2-year)
• Efficacy that is numerically similar to that
with tadalafil on-demand analyses
1. Porst H et al. Eur Urol 2006;50(2):351-359.
2. Rajfer J et al. Int J Impot Res 2007;19(1):95-103.
3. Hatzichristou D et al. Diabet Med 2008;25(2):138-146.
4. Porst H et al. J Sex Med 2008;5(9):2160-2169.
5. Brock GB et al. J Urol 2002:168(4):1332-1336.
6. Carson CC et al. BJU Int 2004;93(9):1276-1281.
PDE5 Inhibitors in Diabetic Men
♦ While PDE5 inhibitors are a common, effective
treatment for ED, they are less effective in men with
ED and diabetes1
♦ Possible reasons for the lower efficacy include:
• Impaired endothelium-derived factors in
penile arteries2
• Underlying endothelial dysfunction1,3
Wimpie Pangkahila - Center for Study of Anti-Aging Medicine, Department of Andrology and Sexology
Medical Faculty Udayana University - Indonesian Center for Anti-Aging Medicine
1. Nehra A. Mayo Clin Proc 2009 Feb;84(2):139-48. 3. Billups KL et al. Curr Urol Rep 2005;6(6):439-
2. Angulo J et al. J Sex Med 2005;2(3):341-346. 444.

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Adverse Events 24-Week Once-Daily Study

(Study 2 General ED)
TEAEs Reported in ≥3% of Patients, Any Placebo Tadalafil 2.5 mg Tadalafil 5 mg
Treatment Group (n=94) Once-Daily (n=96) Once-Daily (n=97)

Nasopharyngitis 5% 6% 6%
Influenza 3% 5% 3%
Gastroenteritis, Viral 2% 3% 5% Once-Daily Tadalafil:
Back Pain
Upper Respiratory Tract Infection
3%
0
5%
3%
2%
4%
Longterm Effectiveness
Dyspepsia 1% 4% 1%
Nasal Congestion 0 0 4%
Gastroesophageal Reflux Disease 0 3% 2%
Myalgia 2% 4% 1%
Headache 3% 3% 1%
Hypertension 0 1% 3%
Bronchitis 3% 3% 0
Sinus Congestion 0 0 3%
Discontinuations Due to AE 2% 6% 4%
AE=Adverse Event; ED=Erectile
Wimpie PangkahilaDysfunction; TEAE=Treatment-Emergent
- Center for Study Adverse
of Anti-Aging Medicine, Department Events.and Sexology
of Andrology Wimpie Pangkahila - Center for Study of Anti-Aging Medicine, Department of Andrology and Sexology
Medical Faculty Udayana University - Indonesian Center for Anti-Aging Medicine Medical Faculty Udayana University - Indonesian Center for Anti-Aging Medicine
Rajfer J et al. Int J Impot Res 2007;19:95-103.

OD Longterm Effectiveness: Conclusions

• Efficacy improvements observed after 12
and 24 weeks in the placebo-controlled study
periods were maintained as effectiveness
improvements after 1 and 2 years of
open-label treatment1,2,3
• There was no evidence of tolerance or
treatment resistance (tachyphylaxis) after up
to 2 years of tadalafil 5 mg OD dosing3
• Longterm, OD tadalafil treatment provides a
viable treatment alternative to on-demand
dosing of tadalafil for men with ED3
Wimpie Pangkahila - Center for Study of Anti-Aging Medicine, Department of Andrology and Sexology
Medical Faculty Udayana University - Indonesian Center for Anti-Aging Medicine
1. Porst H et al. Eur Urol 2006;50:351-359. 3. Porst H et al. J Sex Med 2008;5(9):2160-2169.
2. Rajfer J et al. Int J Impot Res 2007;19:95-103.