Direct effects of Tadalafil on lower urinary tract symptoms versus indirect effects mediated through erectile dysfunction symptom improvement: Integrated data analyses from 4 placebo controlled clinical studies

Journal of Urology

Volumn 191, Issue 2, 2014, Pages 405-411

  Brock, Gerald B ^a   McVary, Kevin T ^b   Roehrborn, Claus G ^c   Watts, Steven ^d   Ni, Xiao ^d   Viktrup, Lars ^d   Wong, David G ^d   Donatucci, Craig ^d  

^a UNIVERSITY OF WESTERN ONTARIO   (Canada)

^b SOUTHERN ILLINOIS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^d ELI LILLY AND COMPANY   (United States)

Author keywords

erectile dysfunction; phosphodiesterase 5 inhibitors; prostatic hyperplasia; tadalafil

Indexed keywords

PLACEBO; TADALAFIL;

ADULT; ARTICLE; DRUG EFFECT; ERECTILE DYSFUNCTION; FOLLOW UP; GENERAL CONDITION IMPROVEMENT; HUMAN; INTERNATIONAL INDEX OF ERECTILE FUNCTION ERECTILE FUNCTION DOMAIN SCORE; INTERNATIONAL PROSTATE SYMPTOM SCORE; LOWER URINARY TRACT SYMPTOM; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; NAMED INVENTORIES, QUESTIONNAIRES AND RATING SCALES; PATH ANALYSIS; PRIORITY JOURNAL; PROSTATE HYPERTROPHY; RANDOMIZED CONTROLLED TRIAL (TOPIC); SEXUAL BEHAVIOR; ASSESSMENT OF HUMANS; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; INTERNATIONAL INDEX OF ERECTILE FUNCTION-ERECTILE FUNCTION DOMAIN SCORE; SINGLE DRUG DOSE; TREATMENT RESPONSE;

BENIGN PROSTATIC HYPERPLASIA; BPH; ED; ERECTILE DYSFUNCTION; LOWER URINARY TRACT SYMPTOMS; LUTS; PDE5; PHOSPHODIESTERASE 5 INHIBITORS; PHOSPHODIESTERASE TYPE 5; PROSTATIC HYPERPLASIA; TADALAFIL;

AGED; CARBOLINES; COMORBIDITY; ERECTILE DYSFUNCTION; HUMANS; LOWER URINARY TRACT SYMPTOMS; MALE; MIDDLE AGED; PROSTATIC HYPERPLASIA; TREATMENT OUTCOME;

EID: 84891919214     PISSN: 00225347     EISSN: 15273792     Source Type: Journal    
DOI: 10.1016/j.juro.2013.09.057     Document Type: Article

References (20)

1. R.C. Rosen Lower urinary tract symptoms and sexual dysfunction: additional evidence of an association BJU Int 9 2004 689
2. K. McVary Lower urinary tract symptoms and sexual dysfunction: epidemiology and pathophysiology BJU Int 97 2006 23
3. A.D. Seftel, J. de la Rosette, and J. Birt et al. Coexisting lower urinary tract symptoms and erectile dysfunction: systematic review of epidemiological data Int J Clin Pract 67 2013 32
4. American Urological Association Guideline: Management of benign prostatic hyperplasia (BPH) 2010 American Urological Association Education and Research, Inc. Linthicum, Maryland
5. M. Oelke, F. Giuliano, and V. Mirone et al. Monotherapy with tadalafil or tamsulosin similarly improved lower urinary tract symptoms suggestive of benign prostatic hyperplasia in an international, randomised, parallel, placebo-controlled clinical trial Eur Urol 61 2012 917
6. R.B. Egerdie, S. Auerbach, and C.G. Roehrborn et al. Tadalafil 2.5 or 5 mg administered once-daily for 12 weeks in men with both erectile dysfunction and signs and symptoms of benign prostatic hyperplasia: results of a randomized, placebo-controlled, double-blind study J Sex Med 9 2012 271
7. H. Porst, E.D. Kim, and A.R. Casabé et al. Efficacy and safety of tadalafil once daily in the treatment of men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: results of an international randomized, double-blind, placebo-controlled trial Eur Urol 60 2011 1105
8. C.G. Roehrborn, K.T. McVary, and A. Elion-Mboussa et al. Tadalafil administered once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a dose finding study J Urol 180 2008 1228
9. C.F. Donatucci, G.B. Brock, and E.R. Goldfischer et al. Tadalafil administered once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a 1-year, open-label extension study BJU Int 107 2011 1110
10. D.P. MacKinnon Path analysis mediation models Introduction to Statistical Mediation Analysis 2008 Lawrence Erlbaum Associates, Taylor & Francis Group New York chapt 6, pp 127-170
11. R.C. Rosen, S.N. Seidman, and M.A. Menza et al. Quality of life, mood, and sexual function: a path analytic model of treatment effects in men with erectile dysfunction and depressive symptoms Int J Impot Res 16 2004 334
12. L.M. Arnold, A. Rosen, and Y.L. Pritchett et al. A randomized, double-blind, placebo-controlled trial of duloxetine in the treatment of women with fibromyalgia with or without major depressive disorder Pain 119 2005 5
13. J. Cohen Differences between correlation coefficients Statistical Power Analysis for the Behavioral Sciences 2nd ed. 1988 Lawrence Erlbaum Associates Hillsdale, New Jersey chapt 4, pp 109-144
14. D. Hooper, J. Coughlan, and M. Mullen Structural equation modelling: guidelines for determining model fit Electronic J Business Research Methods 6 2008 53
15. L. Hu, and P.M. Bentler Cutoff criteria for fit indexes in covariance structure analysis: conventional criteria versus new alternatives Struct Equ Modeling 6 1999 1
16. P.M. Bentler, and E.H. Freeman Test for stability in linear structural equation systems Psychometrika 48 1983 143
17. S.L. Washington 3rd, and A.W. Shindel A once-daily dose of tadalafil for erectile dysfunction: compliance and efficacy Drug Des Devel Ther 4 2010 159
18. K.E. Andersson, W.C. de Groat, and K.T. McVary et al. Tadalafil for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia: pathophysiology and mechanism(s) of action Neurourol Urodyn 30 2011 292
19. F. Giuliano, S. Uckert, and M. Maggi et al. The mechanism of action of phosphodiesterase type 5 inhibitors in the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia Eur Urol 63 2013 506
20. R. Shabsigh, J. Kaufman, and M. Magee et al. A multicenter, double-blind, placebo-controlled trial to assess the efficacy of sildenafil citrate in men with unrecognized erectile dysfunction Urology 76 2010 373