Botulinum Toxin Injection for the Treatment of Premature Ejaculation
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Botulinum Toxin Injection for the Treatment of Premature Ejaculation
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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)
- 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
- 11. Ætiology: Organic Theories • Penile hypersensitivity • Central 5-HT receptor sensitivity • Hyperexcitable ejaculatory reflex – Faster emission and/or expulsion phase – Faster bulbocavernosus 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
- 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
- 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)
- 21. Chan et al, 2010
- 22. BEFORE AFTER
- 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.