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BPH Therapies and Sexual Function

BPH Therapies and Sexual Function. Presented by: Anmar Nassir. Quality of Life and BPH. Factors affecting Quality of Life in BPH patients: Nocturia, Impact of LUTS on daily activities, Anxiety about a possible prostate cancer, Sexuality.

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BPH Therapies and Sexual Function

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  1. BPH Therapies and Sexual Function Presented by: Anmar Nassir

  2. Quality of Life and BPH • Factors affecting Quality of Life in BPH patients: • Nocturia, • Impact of LUTS on daily activities, • Anxiety about a possible prostate cancer, • Sexuality Calais da Silva F, Marquis P, Deschaseaux P et al.Eur urol, 1997, 31(3) : 272-280.

  3. Erectile Dysfunction is Associated with LUTS and BPH ED(n=853) No ED(n=3581) Diabetes 20.2% 3.2% Hypertension 32.0% 13.6% Pelvic surgery 18.8% 2.4% LUTS 72.2% 37.7% Smoker 29.6% 34.6% Regular alcohol 37.5% 42.4% Epidemiology of ED in Germany/Cologne: Co-morbidityBraun M et al., Int J Impot Res 2000; 12:305-311

  4. MSAM-7 Multinational Surveyof the Aging Male • Objective: To evaluate in populations of men • aged 50–80 years: • Incidence of LUTS and their severity • Importance of sexuality and incidence ofsexual disorders • Possible relationship between LUTS and sexual disorders, including impact of co-morbidities (diabetes, hypertension) Rosen R et al. Eur Urol 2003; 44: 637–649

  5. MSAM-7 The largest study on sexual impact of LUTS Materials and methods (1) Patients: More than 14,000 men aged 50 to 80 years in 7 countries (USA, UK, France, Germany, Italy, Spain and The Netherlands) In each country, the sample was representative of the target population Rosen R et al. Eur Urol 2003; 44: 637–649

  6. MSAM-7 The largest study on sexual impact of LUTS Materials and methods (3) • 34,800 questionnaires sent • 14,254 questionnaires returned • 12,815 questionnaires evaluable & analysed (89.9%) Rosen R et al. Eur Urol 2003; 44: 637–649

  7. MSAM-7: 83% of men between 50–80are sexually active 92% 100 83% 83% 90 80 65% 70 60 % of men with sexual activityin the last 4 weeks 50 40 30 20 10 0 Total 50–59 60–69 70–80 Age Rosen R et al. Eur Urol 2003; 44: 637–649 / Data on file

  8. Sexual Activity in the Ageing MaleMSAM-7 12,815 men aged 50-80 y. Representative sample 10 8.8 8.8 8.3 7.8 7.9 8 7.4 Mean Sexual Activity per Mo 6.8 6.0 5.9 5.9 6 5.0 4.9 4.8 5.0 3.7 3.6 4 3.3 3.0 2.8 2.5 2.6 2 0 US FR DE IT NL SP UK 50-59 y. 60-69 y. 70-80 y. Rosen R et al. Eur Urol 2003; 44: 637–649

  9. reducing sexual activity LUTS have a negative impact by reducing stiffness of erection decreasing volume of ejaculate MSAM-7: LUTS have a negative impacton sexual function Sexual impact of LUTS Rosen R et al. Eur Urol 2003; 44: 637–649

  10. Severity of LUTS Impacts Sexual Activity 2,372 French men IIEF 60 48% 50 40 35% 33% 30% 27% % Sexually inactive patients 30 21% 17% 20 15% 11% 9% 9% 10 7% 0 50-59 years 60-69 years 70-79 years IPSS 0 1-7 8-19 20-35 points Richard F et al., J Urol 2000; 163:249A

  11. Surgery and Instrumental Procedures may Impact Sexual Function % % 100 16 Retrograde ejaculation 90 Impotence 14 80 12 70 10 60 50 8 40 6 30 4 20 2 10 0 0 TUMT OPEN TURP TUIP ILC TUNA OPEN TURP TUIP ILC TUNA TUMT McConnell - BPH Clinical Practice Guidelines, 1994

  12. What is the Impact of Medical Therapies? Are there Differences Between Medical Therapies?

  13. VA study PROWESS PLESS study (Lepor et al) (Marberger et al) (McConnell et al) 5-Reductase Impotence Double-Blind Placebo-Controlled Studies Duration 1yr 2 yrs Year 1 Placebo Fina Placebo Fina Placebo Fina n=305 n=310 n=1,591 n=1,577 n=1,376 n=1,384 % % % Decreased 1.0 5.0 2.8 4.0 3.4 6.4 libido Impotence 5.0 9.0 4.7 6.6 3.7 8.1 Decreased NA NA NA NA 0.8 3.7 ejaculation Ejaculation 1.0 2.0 0.6 2.1 0.1 0.8 disorder

  14. 1-Blockers Impotence Double-Blind Placebo-Controlled Studies VA(n=1,229) PREDICT (n=1,094) ALFORTI (n=447) ALFUS (n=536) % % % % Terazosin 6.0 - - - Doxazosin 5.8 - - Alfuzosin - - 10mg: 0.0 10mg: 2.8 15mg: 1.1 Placebo 5.0 3.3 0.6 1.1

  15. * 18% * 6% 0.6% 0.6% Tam 0.4 mg Tam 0.8 mg Alf 10 mg Alf 15 mg Tamsulosin (3 months) Alfuzosin OD (3 months) 1-Blockers Ejaculatory Disorders US Pivotal Studies with Tamsulosin  Alfuzosin ns *p < 0.001 20 20 15 15 Abnormal ejaculation (%) 10 10 5 5 0% 0% 0 0 Pbo Pbo Roehrborn et al. Urology 2001;58:953 Lepor et al. Urology 1998;51:892-900

  16. 1-Blockers Ejaculatory Disorders Long-Term Studies with Tamsulosin  Alfuzosin US open studywithtamsulosin0.4-0.8 mg OD * Meanexposure time: 16 months Tamsulosin European open studywithtamsulosin0.4 mg OD ** Meanexposure time: 4 years Tamsulosin European open studywithalfuzosin 10 mg OD *** Meanexposure time: 9 months Alfuzosin 30% 4.9% 0.6% *Narayan P. et al. Urology 1998 **Schulman C. et al J Urol 2001 ***Van Kerrebroeck et al. Eur Urol. 2000

  17. Alfuzosin has the Lowest Impact on Sexuality…Does Alfuzosin have a Beneficial Effect on Sexuality ?

  18. Sexual Function Following 1 Year Treatment with Alfuzosin 7 6 5 4 Improvement in Sexual Score 3 2 1 0 < 65 years 65-70 years > 70 years Moderate symptoms Severe symptoms Lukacs B et al. Urology, 1996; 48 (5): 731-740

  19. n = 310 * p vs D0 < 0.01 Alfuzosin 10 mg XL may ImproveSexual Dysfunction D0 Dend ** p vs D0 < 0.05 3 2.6 * 2.3 2.3 Weighted score 2.0 ** 2 1.7 * 1.5 1 Reducederection Reducedejaculate Painfulejaculate DAN-PSSsex - J. Urol. 2006, 176, 1051-1056

  20. Treatments How can BPH Interfere with Sexuality? Local Factors Correlated Factors eg. age Deterioration in Sexuality Anxiety Deterioration in QoL Deterioration in Self-Image

  21. PharmacologicalImpact ? How might a-Blockers Impact on Sexuality? Local Factors Reduction of Anxiety Sexuality Improvement in Self-Image Improvement in QoL

  22. ABEJAC StudyMaterials and Methods • Using a randomized, 3-way crossover design, the effects of 5 days of treatment with 0.8 mg tamsulosin daily, 10 mg alfuzosin daily and placebo on ejaculation in healthy adult men were compared. • The primary end points of the study were ejaculate volume and sperm concentration in post-ejaculate urine on each treatment. • The healthy volunteers who completed the study were 48. J Urol. 2006 Oct;176(4 Pt 1):1529-33.

  23. 3 2 Change in urine sperm conc. (million/ml) 1 0 ABEJAC Results Change inejaculate volume Change in urinesperm concetration 3 p=ns *Tam vs Pbo, p<0.001 Tam vs Alfu, p<0.001 2 +1.7 +0.4 +0.3 +1.4 1 +1.2 Change in ejaculate volume (ml) 0 -1 -2 -2.4 * -3 Mean±sd value at baseline48±0.5 million/ml Mean±sd value at baseline3.4±1.4 ml Tamsulosin 0.8 mg OD Alfuzosin 10mg OD Placebo J Urol. 2006 Oct;176(4 Pt 1):1529-33.

  24. 100 100 80 80 60 % of subjects 60 % of subjects 40 40 20 20 0 0 ABEJAC Results % with decreased ejaculate volume >20% % subjects with no ejaculation * 90% *Tam vs Pbo, p<0.001 Tam vs Alfu, p<0.001 35% 21% 13% 0% 0% Tamsulosin 0.8 mg OD Alfuzosin 10mg OD Placebo Intent to treat population J Urol. 2006 Oct;176(4 Pt 1):1529-33.

  25. Effects of Alfuzosin and Tamsulosin on Sperm Parameters in Healthy Men • Short-Term, Randomized, Double-Blind, Placebo-Controlled, Crossover Study. • Sperm parameters were evaluated in healthy men receiving tamsulosin, alfuzosin, and placebo Published-Ahead-of-Print on February 5, 2009 by Journal of Andrology

  26. Study design • 48 healthy men received 5 days of tamsulosin 0.8 mg once daily (QD), alfuzosin 10 mg QD, and placebo in a randomized, double-blind, 3-way crossover study with a 10-14-day washout period between treatments. Published-Ahead-of-Print on February 5, 2009 by Journal of Andrology

  27. Results • The total sperm count in semen decreased from baseline with tamsulosin -54.6 (24.0) million] but not with placebo [81.5 (18.8) million] or alfuzosin [46.2 (19.0) million]. • The percentage of men with normal semen viscosity was lower with tamsulosin (65%) than with placebo (98%) or alfuzosin (92%). • The change from baseline in semen sperm concentration was 3.1 (8.3) million/mL with tamsulosin, 15.0 (6.5) million/mL with alfuzosin, and 24.4 (6.5) million/mL with placebo. Published-Ahead-of-Print on February 5, 2009 by Journal of Andrology

  28. Safety results • The most common adverse events were • dizziness • (alfuzosin 11%, tamsulosin 14%, placebo 0%) • orthostatic hypotension • (alfuzosin 25%, tamsulosin 11%, placebo 5%). Published-Ahead-of-Print on February 5, 2009 by Journal of Andrology

  29. How can we Explain Differences Between 1-Blockers ?

  30. Potential Targets for a-Blockers • CNS • Spinal cord centers • Prostate • Seminal vesicle • Vas deferens • Penis Hendry et al. in Erectile Dysfunction. Jardin et al. (eds), Health Publication Ltd, Plymouth, 1999:477-50.

  31. Alfuzosin Does not Penetrate the Blood-Brain Barrier Rouquier et al, Eur. J. Pharmacol, 1994, 261, 59-64

  32. The Physiology Of Ejaculation: The Emission Phase • Emission: • seminal vesicle (50-80%) • prostate (15-30%) • Cowper’s gland testis (<0.1%) Mann and Lutwak-Mann. Male reproductive function and semen. Berlin:Springer-Verlag;1981:171-93.

  33. 1-ARs and Seminal Emission • The 1-AR subtype involved in contraction of the human vas deferens and seminal vesicle is most probably the 1A-AR. • SV is responsible for 70% of the amount of ejaculate Silva MA et al. Eur J Pharmacol 1999

  34. Effects of -Blockers on Seminal Vesicle Pressure Tamsulosin (µg/kg) Alfuzosin (µg/kg) 120 *p <0.001 * 80 * 40 0 Vehicle 3 10 3 10 F. Giuliano et al. , ISSIR 2002

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