Chandrapur Call girls 8617370543 Provides all area service COD available
Botulinum Toxin Injection for the Treatment of Premature Ejaculation
1. A NOVEL APPROACH IN THE TREATMENT OF
LIFELONG PREMATURE EJACULATION
BOTULINUM TOXIN A
INJECTION
Ege C. Serefoglu, M.D.
2. Botulinum Toxin A Injection for PE
• Physiology of Ejaculation
• Premature Ejaculation (PE)
• Ætiology
• Treatment
• Btx-A injection for PE
3. Physiology of Ejaculation
• Constituted by 2 phases
– Emmision: Ejection of the semen into the posterior urethra
Contraction of testes, epididymes, VD, SV, prostate
– Expulsion: Ejection of sperm from urethra
REFLEX response to the presence of semen in BU
Rhythmic contractions of perineal muscles (BS/IC)
4.
5. Premature Ejaculation
◦ Cited as “the most common male sexual dysfunction”
◦ Affects 20 - 30% of sexually active men
◦ Diminished self-esteem, anxiety, embarrassment
◦ Partner dissatisfaction, interpersonal difficulty
Porst et al. 2007;Symonds et al, 2003; Patrick et al. 2005
6. Porst et al. 2007
0
10
20
30
40
50
18-24 25-34 35-44 45-54 55-64 65-70Age group (yrs)
Prevalence(%)
PE
The Premature Ejaculation Prevalence and
Attitudes: Multi-National Survey
18%
23% 23% 24% 25%
20%
7. What is different in men with PE?
PE
“Normal” male
sexual
response
Steep
Excitement
phase
Short
Plateau
phase
Rapid ejaculation and
associated orgasm
“PE” male
sexual
response
Master & Johnson, 1970
8. Ætiology: Organic Theories
• Penile hypersensitivity
• Central 5-HT receptor sensitivity
• Hyperexcitable ejaculatory reflex
Colpi et al. 1996; Waldinger, et al. 1998; Waldinger 2002-2004
9. Ætiology: Organic Theories
• Penile hypersensitivity
– Reach ejaculatory threshold more rapidly
– Lower ejaculatory threshold
• Central 5-HT receptor sensitivity
• Hyperexcitable ejaculatory reflex
Colpi et al. 1996; Waldinger, et al. 1998; Waldinger 2002-2004
10. Ætiology: Organic Theories
• Penile hypersensitivity
• Central 5-HT receptor sensitivity
–Lower 5-HT neurotransmission in PE
–5-HT2C receptor hyposensitivity
–5-HT1A receptor hypersensitivity
–Genetic predisposition
• Hyperexcitable ejaculatory reflex
Colpi et al. 1996; Waldinger, et al. 1998; Waldinger 2002-2004
12. Treatment
• Penile hypersensitivity Topical anaesthetics*
» interference with the spontaneity of having sex
» Penile and vaginal hyposthesia / skin reactions
• Central 5-HT receptor sensitivity Anti-depressants*
– sexual dysfunctions, insomnia, fatigue, nausea, constipation
– Poorly accepted by patients and partners
• Hyperexcitable ejaculatory reflex Btx-A (?)
– No side effects / No pills - creams / Spontenous sex
* Unlicensed application
13.
14.
15. From: Allergan Medical Affairs Department [IR-MedicalAffairsResearch@Allergan.com]
Sent: Monday, August 01, 2011 7:43 PM
To: Hellstrom, Wayne J
Subject: Decline Trial - Email - Trial ID#IIT-000344
RE: Trial ID: 000344
Title: Efficacy of Botulinum Toxin Type A for the Treatment of Life-Long Premature
Ejaculation; A Randomized, Double-Blind, Placebo-Controlled Phase III Trial
Dear Wayne Hellstrom,
Thank you for your proposal entitled "Efficacy of Botulinum Toxin Type A for the
Treatment of Life-Long Premature Ejaculation; A Randomized, Double-Blind, Placebo-
Controlled Phase III Trial". We have reviewed your proposal and determined,
unfortunately, that we are unable to support this trial.
Should you have any further questions regarding this proposal, please contact me.
Again, thank you for submitting your proposal to Allergan.
Sincerely,
Urology Therapeutic Area Manager
16.
17. Effects of Btx-A Injection on Male Rat
Ejaculatory Behavior
• Long-Evans rats (33 males)
• ~2 weeks to adapt to the light–dark cycle
1) Placebo: Saline injection (0.1 ml)
2) Low Dose: Botulinum toxin-A (0.5 U in 0.1 ml)
3) High Dose: Botulinum toxin-A (1 U in 0.1 ml)
23. The Effects of Btx-A Injection on Male Rat
Ejaculatory Behavior
402,3
453,8
361,6
590,2
302,8
668
0
100
200
300
400
500
600
700
800
900
Pre-Inj Post-Inj Pre-Inj Post-Inj Pre-Inj Post-Inj
Time(sec.)
p=0.53
P=0.04*
P=0.013*
PLACEBO LOW-DOSE HIGH-DOSE
* Paired-sample T-test
24. Conclusion
• Btx-A injection into the BSM is a safe and
effective treatment which can lengthen the
latency time to ejaculate in rats, without
suppressing sexual behavior.
• Further studies are required to evaluate the
therapeutic concept of this drug in PE
patients.