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

European Urology

Volumn 61, Issue 5, 2012, Pages 917-925

  Oelke, Matthias ^a   Giuliano, Franois ^b   Mirone, Vincenzo ^c   Xu, Lei ^d   Cox, David ^d   Viktrup, Lars ^d  

^a HANNOVER MEDICAL SCHOOL   (Germany)

^b LABORATOIRE DES SCIENCES DU CLIMAT ET DE L ENVIRONNEMENT   (France)

^c UNIVERSITY OF NAPLES FEDERICO II   (Italy)

^d ELI LILLY AND COMPANY   (United States)

Author keywords

Benign prostatic hyperplasia; Erectile dysfunction; Lower urinary tract symptoms; Phosphodiesterase type 5 inhibitors; Tadalafil; Tamsulosin

Indexed keywords

PLACEBO; TADALAFIL; TAMSULOSIN;

ADULT; AGED; ARTICLE; BACKACHE; CONTROLLED STUDY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; DYSPEPSIA; EJACULATION DISORDER; FOLLOW UP; HEADACHE; HUMAN; LOWER URINARY TRACT SYMPTOM; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PROSTATE HYPERTROPHY; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; TREATMENT DURATION; TREATMENT OUTCOME; URINE FLOW RATE;

ADRENERGIC ALPHA-1 RECEPTOR ANTAGONISTS; AGED; AGED, 80 AND OVER; CARBOLINES; ERECTILE DYSFUNCTION; HUMANS; LOWER URINARY TRACT SYMPTOMS; MALE; MIDDLE AGED; PATIENT SATISFACTION; PROSTATIC HYPERPLASIA; SULFONAMIDES; TREATMENT OUTCOME; VASODILATOR AGENTS;

EID: 84862777267     PISSN: 03022838     EISSN: 18737560     Source Type: Journal    
DOI: 10.1016/j.eururo.2012.01.013     Document Type: Article

References (30)

1. Management of benign prostatic hyperplasia (BPH). American Urological Association Web site. http://www.auanet.org/content/guidelines-and-quality-care/ clinical-guidelines.cfm?sub=bph. Updated 2010.
2. Guidelines on the Treatment of Non-neurogenic Male LUTS. European Association of Urology Web site. http://www.uroweb.org/?id=217&tyid=2. Updated 2011.
3. K.E. Andersson, W.C. de Groat, and K.T. McVary Tadalafil for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia: pathophysiology and mechanism(s) of action Neurourol Urodyn 30 2011 292 301
4. R. Rosen, J. Altwein, and P. Boyle Lower urinary tract symptoms and male sexual dysfunction: the Multinational Survey of the Aging Male (MSAM-7) Eur Urol 44 2003 637 649 (Pubitemid 37542920)
5. V. Mirone, A. Sessa, F. Giuliano, R. Berges, M. Kirby, and I. Moncada Current benign prostatic hyperplasia treatment: impact on sexual function and management of related sexual adverse events Int J Clin Pract 65 2011 1005 1013
6. K.T. McVary, C.G. Roehrborn, and J.C. Kaminetsky Tadalafil relieves lower urinary tract symptoms secondary to benign prostatic hyperplasia J Urol 177 2007 1401 1407 (Pubitemid 46435965)
7. C.G. Roehrborn, K.T. McVary, A. Elion-Mboussa, and L. Viktrup Tadalafil administered once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a dose finding study J Urol 180 2008 1228 1234
8. G.A. Broderick, G.B. Brock, C.G. Roehrborn, S.D. Watts, A. Elion-Mboussa, and L. Viktrup Effects of tadalafil on lower urinary tract symptoms secondary to benign prostatic hyperplasia in men with or without erectile dysfunction Urology 75 2010 1452 1458
9. H. Porst, E.D. Kim, A.R. Casabé for the LVHJ study team 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 1113
10. R.B. Egerdie, S. Auerbach, and C.G. Roehrborn 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 271 281
11. D. Behr-Roussel, S. Oger, and S. Caisey Vardenafil decreases bladder afferent nerve activity in unanesthetized, decerebrate, spinal cord-injured rats Eur Urol 59 2011 272 279
12. G.T. Kedia, S. Uckert, U. Jonas, M.A. Kuczyk, and M. Burchardt The nitric oxide pathway in the human prostate: clinical implications in men with lower urinary tract symptoms World J Urol 26 2008 603 609
13. A. Morelli, S. Filippi, and P. Sandner Vardenafil modulates bladder contractility through cGMP-mediated inhibition of RhoA/Rho kinase signaling pathway in spontaneously hypertensive rats J Sex Med 6 2009 1594 1608
14. S. Uckert, M. Sormes, and G. Kedia Effects of phosphodiesterase inhibitors on tension induced by norepinephrine and accumulation of cyclic nucleotides in isolated human prostatic tissue Urology 71 2008 526 530 (Pubitemid 351374723)
15. A. Morelli, E. Sarchielli, and P. Comeglio Phosphodiesterase type 5 expression in human and rat lower urinary tract tissues and the effect of tadalafil on prostate gland oxygenation in spontaneously hypertensive rats J Sex Med 8 2011 2746 2760
16. Flomax prescribing information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. 2011.
17. M.J. Barry, F.J. Fowler Jr., and M.P. O'Leary The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association J Urol 148 1992 1549 1557
18. M.J. Barry, F.J. Fowler Jr., M.P. O'Leary, R.C. Bruskewitz, H.L. Holtgrewe, and W.K. Mebust Measuring disease-specific health status in men with benign prostatic hyperplasia. Measurement Committee of the American Urological Association Med Care 33 1995 AS145 AS155
19. R.C. Rosen, A. Riley, G. Wagner, I.H. Osterloh, J. Kirkpatrick, and A. Mishra The International Index of Erectile Function (IIEF): a multidimensional scale for assessment of erectile dysfunction Urology 49 1997 822 830 (Pubitemid 27246947)
20. I. Yalcin, and R.C. Bump Validation of two global impression questionnaires for incontinence Am J Obstet Gynecol 189 2003 98 101 (Pubitemid 36886531)
21. I. Yalcin, and L. Viktrup Comparison of physician and patient assessments of incontinence severity and improvement Int Urogynecol J Pelvic Floor Dysfunct 18 2007 1291 1295 (Pubitemid 47521472)
22. A. Hareendran, and L. Abraham Using a treatment satisfaction measure in an early trial to inform the evaluation of a new treatment for benign prostatic hyperplasia Value Health 8 Suppl 1 2005 S35 S40
23. S. Chul Kim, J. Kwan Park, and S. Woong Kim Tadalafil administered once daily for treatment of lower urinary tract symptoms in Korean men with benign prostatic hyperplasia: results from a placebo-controlled pilot study using tamsulosin as an active control LUTS 3 2011 86 93
24. H.K. Laydner, P. Oliveira, and C.R. Oliveira Phosphodiesterase 5 inhibitors for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a systematic review BJU Int 107 2011 1104 1109
25. C.G. Roehrborn, J.C. Kaminetsky, S.M. Auerbach, R.M. Montelongo, A. Elion-Mboussa, and L. Viktrup Changes in peak urinary flow and voiding efficiency in men with signs and symptoms of benign prostatic hyperplasia during once daily tadalafil treatment BJU Int 105 2010 502 507
26. N.A. Tamimi, I. Mincik, S. Haughie, J. Lamb, A. Crossland, and P. Ellis A placebo-controlled study investigating the efficacy and safety of the phosphodiesterase type 5 inhibitor UK-369,003 for the treatment of men with lower urinary tract symptoms associated with clinical benign prostatic hyperplasia BJU Int 106 2010 674 680
27. S. Filippi, A. Morelli, and P. Sandner Characterization and functional role of androgen-dependent PDE5 activity in the bladder Endocrinology 148 2007 1019 1029
28. S. Oger, D. Behr-Roussel, and D. Gorny Combination of doxazosin and sildenafil exerts an additive relaxing effect compared with each compound alone on human cavernosal and prostatic tissue J Sex Med 6 2009 836 847
29. R. Dmochowski, C. Roehrborn, S. Klise, L. Xu, J. Kaminetsky, and S. Kraus Urodynamic effects of once daily tadalafil in men with lower urinary tract symptoms secondary to clinical benign prostatic hyperplasia: a randomized, placebo controlled 12-week clinical trial J Urol 183 2010 1092 1097
30. C.F. Donatucci, G.B. Brock, and E.R. Goldfischer 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 1116