Sexual dysfunction in male LUTS M. Gacci Department of Urology, University of Florence Roma, 25-26 June, 2015
Cross-sectional population-based study of 4800 men (40 79 yr of age) UK, Netherlands, France, Korea currently having ED consulted a doctor for this reason Boyle P, BJU Int 2003
Proportion of men with enlarged prostate and their spouses reporting specific relationship concerns Moderate-to-severe LUTS can adversely affect important areas of personal relationships Men with mild symptoms (n=216) Men with moderate-to-severe symptoms (n=203) Spouses of men with enlarged prostate (n=77) Lack of physical intimacy Anger or conflict Avoidance or withdrawal A feeling of distance or isolation Lack of communication Measured through questionnaire-based survey: EP in American Men Survey Roehrborn C, Prostate Can Prost. Dis. 2006 3
GENERAL population based studies BPH /ED population based studies 20 70% of men have ED 44 90% of men have LUTS 58 82 % of men with LUTS have ED 8 26% of men with ED have LUTS Gacci M et al; Eur Urol 2011; ;60(4):809-25
% of men who have erections US and six European countries 34 800 surveys were mailed out, 14 254 were completed and returned, and 12 815 analyzed Sexual dysfunction is strongly related to both age and severity of BPH symptoms 50% of men 50 59 years with moderate LUTS have erectile dysfunction 100 90 80 70 60 50 40 30 20 10 0 Age cohort No, I cannot get an erection Net reduction in stiffness 50-59 years 60-69 years 70-79 years LUTS severity 50-59 years 60-69 years Adapted from Rosen R at al; Eur Urol. 2003; 44(6):637-49
Adapted from Rosen R at al; Eur Urol. 2003; 44(6):637-49
MetS & Prostate Hammarsten J et al; Prostate Can & Pros Dis, 1998; 1(3):157-162
MetS & ED Multicenter, cross-sectional, study in 2238 men with T deficiency (1094 subjects with MetS) Garcia Cruz E et al; J Sex Med 2013; 10(10):2529-38
MetS & LUTS 271 consecutive men treated with OP in two tertiary referral centers for LUTS/BPH. Gacci M. at al; Prostate Can Prost Dis 2013; 16(1):101-6
MetS & LUTS 271 consecutive men treated with OP in two tertiary referral centers for LUTS/BPH. 60cc 45mm Gacci M. at al; Prostate Can Prost Dis 2013; 16(1):101-6
MetS, LUTS and Inflammation A multi-center cohort of BPH patients (n = 244) + effects of MetS insults on (hbph) Vignozzi L, Gacci M; Prostate. 2013 Sep;73(13):1391-402
Inflammatory Score MetS, LUTS & ED: Inflammation 44 Pts treated with OP/TURP for persistent severe LUTS, refractory to medical treatment 9 8 7 6 5 4 3 Placebo PDE5-I Placebo PDE5-I without MetS With MetS Vignozzi L, Gacci M; Prostate 2013; 73(8):789-800
CDU: Color doppler ultrasound Lotti et al: Asian j Urol 2014
IPSS total score 171 infertile subjects, mean age 36.5±8.3 years Age-Adj.r= 0.162 p<0.02 30-26 25-22 <22 (192) (30) (17) IIEF erectile function score Lotti A, Andrology, 2013
Prostate volume (ml) Lotti A, Andrology, 2013 171 infertile subjects, mean age 36.5±8.3 years p for trend at ANOVA < 0.0001 Waist ( 102 cm) Glycemia ( 6.1 mmol/l)/t HDL (<1.03 mmol/l)/t Triglycerides ( 1.7 mmol/l)/t Blood Pressure ( 130/85 mmhg)/t 0 (76) 1 (47) 2 (26) 3 (16) Number of MetS components 4 (6) 0.7 0.9 1 1.1 1.3 Prostate volume (ml)
Cross-sectional multicenter survey on 3369 community-dwelling men (mean age 60y) Corona G et al et al; J Sex Med 2010; 7(4 Pt 1):1362-80
BPH /LUTS ED CVD Adapted from Gacci M et al. Eur Urol 2011; 60: 809-825
MetS & ED Liu, Int J Impot Res 2014
MetS & ED Overall RR: 1,60 (1,27-2,02) Liu, Int J Impot Res 2014
MetS & BPE Gacci M, Corona G, BJU Int 2015
MetS & BPE Total prostate volume mean differences (ml) 1.80 (> 30mL: 2.13) Gacci M, Corona G, BJU Int 2015
MetS & BPE AGE Waist HDL-C Gacci M, Corona G, BJU Int 2015
Peak systolic velocity (cm/sec) Increased WC is associated to more severe ED and worst PCDU parameters Corona G, Asian Journal of Andrology (2014) 16, 581 591
A multi-center cohort of BPH patients (n = 378), 238 with MetS Gacci M et al, BJU Int 2015
IPSS TOTAL IPSS irritative Gacci M et al, BJU Int 2015 A multi-center cohort of BPH patients (n = 378), 238 with MetS 25 20 10 8 15 10 5 6 4 2 0 PRE POST 0 PRE POST WC < 102 cm WC 102 cm WC < 102 cm WC 102 cm
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Ferrario C, J Clin Hypert, 2002 Ferrario C, J Clin Hypert, 2002
Tacklind J, Cochrane Library, 2012
Tacklind J, Cochrane Library, 2012
Larson TR, Urology. 2003 Apr;61(4):692-8.
Singh DV, J Sex Med,2013
Singh DV, J Sex Med,2013
Mean Prostate Volume: 50 ml Casabè A, J Urol 2014
IPSS Mean Prostate Volume: 50 ml IIEF Casabè A, J Urol 2014
Eur Urol 2011 Curr Bladde Dys Rep 2013
160 men (pla) vs. 160 men (tad) 5 mg once daily for 12 wk Porst H. Eur Urol. 2011
Run-in placebo Basale Total IPSS 25 Placebo Tad 2,5 Tad 5,0 Tad 10,0 Tad 20,0 Estensione in aperto In aperto fino a variazione endpoint media (DS) -2,2 (5,3) Tad 5,0 Tad 5,0 Tad 5,0 Tad 5,0 Tad 5,0-2,5 (5,1) 0,2 (5,4) -0,2 (5,8) 0,8 (6,4) 20 Endpoint n=416 (LOCF) Mean IPSS 15 10 Weeks. -4 0 12 16 24 38 51 64 299 men (69.9%) completed the 1-year, open-label extension period 427 402 351 Donatucci BJU Int 2011
Placebo Tadalafil Overall (N=92) 2,5 mg (N=96) 5 mg (N=83) 10 mg (N=85) 20 mg (N=71) (N=427) IPSS total (n) 89 95 82 81 69 416 Change: Week 0 - E -4,1±6,8-5,7±5,4-5,0±7,2-5,7±6,4-4,6±7,7-5,0±6,7 Change: Week 12 E -2,2±5,3-2,5±5,1 0,2±5,4-0,2±5,8 0,8±6,4-0,9±5,7 IPSS irritative(n) 89 95 82 81 69 416 Change: Week 0 E -1,6±3,2-2,1±2,6-2,1±3,1-1,9±2,7-1,8±3,3-1,9±3,0 Change: Week 12 E -0,9±2,4-1,0±2,7-0,0±2,4 0,2±2,7 0,3±2,8-0,3±2,6 IPSS obstructive (n) 89 95 82 81 69 416 Change: Week 0 - E -2,5±4,2-3,6±3,6-3,0±4,8-3,8±4,3-2,8±4,9-3,1±4,4 Change: Week 12 - E -1,3±3,6-1,6±3,1 0,2±3,4-0,5±3,6 0,4±4,2-0,6±3,6 Donatucci BJU Int 2011
Gacci M et al, Research & Rep 2013 Gacci M et al, Eur Urol 2012
IPSS Mean difference in IPSS: -2,8 (ALL) - 1,6 to - 4,1 (TADALAFIL) Reduction of both irritative (storage) an obstructive (voiding) LUTS Timing: 4 weeks (3/4) 12 weeks (1/4): (lasting 12 months) Dose dependent
IIEF PDE5-Is alone: +5,5 IIEF Mean difference in IIEF: + 5,5 (ALL) + 4,0 PDE5-Is + α-blocker: +3,6 IIEF to 6,9 (TADALAFIL)
BPH + ED Placebo (N = 105), Tadalafil 5 mg (N = 106), Tamsulosin 0.4 mg (N = 99) International Index of Erectile Function - Orgasmic Function IIEF-Question 9 (IIEF-Q9) (ejaculatory frequency) IIEF-Question 10 (IIEFQ10) (orgasmic frequency) Giuliano F; J Sex Med 2013
Gacci M & Maggi M, j Sex Med, 2014
Alpha blocker vs. Placebo 5 ARI vs. Placebo OR 7.03 OR 2.90 Gacci M & Maggi M, j Sex Med, 2014
Combination Vs. Alpha blocker Combination Vs. 5 ARI OR: 4,7-3,3 Gacci M & Maggi M, j Sex Med, 2014
TAKE HOME MESSAGE: Epidemiology Trends in age-standardised BMI between 1980 and 2008 in adults 20 yr or older Finucane MM et al., Lancet. 2011;377:557-67
TAKE HOME MESSAGE: Pathophysiology LUTS /BPE Adapted from Gandaglia G et al; Eur Urol 2013; E-Pub ahead of print
TAKE HOME MESSAGE: Co-Diagnosis Kirby M et al; Int J Clin Prat 2013; 67(7):606-18
TAKE HOME MESSAGE: Treatments Drug Age ED LUTS Comorbidities Pool «American» billiard Five-pin «Italian» billiard