Phase IIb, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to determine effects of elocalcitol in women with overactive bladder and idiopathic detrusor overactivity

Urology

Volumn 80, Issue 1, 2012, Pages 48-54

  Digesu, G Alessandro ^a   Verdi, Elena ^b   Cardozo, Linda ^c   Olivieri, Lorenza ^b   Khullar, Vik ^a   Colli, Enrico ^b  

^a ST MARY S HOSPITAL   (United Kingdom)

^b BioXell SpA   (Italy)

^c KING S COLLEGE HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ELOCALCITOL; PLACEBO;

ADULT; AGED; ANALYSIS OF COVARIANCE; ARTICLE; BLADDER CAPACITY; BREAST DISEASE; CLINICAL ASSESSMENT; CLINICAL ASSESSMENT TOOL; CLINICAL EVALUATION; CONSTIPATION; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG EFFICACY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ELECTROCARDIOGRAPHY; EYE DISEASE; FEMALE; HUMAN; IDIOPATHIC DISEASE; INJURY; INTOXICATION; KIDNEY DISEASE; LABORATORY TEST; LOWER RESPIRATORY TRACT INFECTION; MAJOR CLINICAL STUDY; MIGRAINE; MULTICENTER STUDY; NAUSEA; OVERACTIVE BLADDER; PARALLEL DESIGN; PATIENT PERCEPTION OF BLADDER CONDITION; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; SKIN DISEASE; SOMNOLENCE; TERTIARY HEALTH CARE; URGENCY PERCEPTION SCALE; URINE INCONTINENCE; URODYNAMICS; UROGENITAL TRACT DISEASE; VITAL SIGN;

ADOLESCENT; ADULT; AGED; CALCITRIOL; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MIDDLE AGED; URINARY BLADDER, OVERACTIVE; YOUNG ADULT;

EID: 84862987030     PISSN: 00904295     EISSN: 15279995     Source Type: Journal    
DOI: 10.1016/j.urology.2012.03.035     Document Type: Article

References (30)

1. B.T. Haylen, D. de Ridder, R.M. Freeman An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction Int Urogynecol J Pelvic Floor Dysfunct 21 2010 5 26
2. W.F. Stewart, J.B. Van Rooyen, G.W. Cundiff Prevalence and burden of overactive bladder in the United States World J Urol 20 2003 327 336 (Pubitemid 44175300)
3. I. Milson, P. Abrams, L. Cardozo How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study BJU Int 87 2001 760 766 (Pubitemid 34204313)
4. C.E. DuBeau, D.K. Kiely, N.M. Resnick Quality of life impact of urge incontinence in older persons: a new measure and conceptual structure J Am Geriatr Soc 47 1999 989 994 (Pubitemid 29380493)
5. A. Wein Pharmacological agents for the treatment of urinary incontinence due to overactive bladder Expert Opin Invest Drugs 10 2001 65 83 (Pubitemid 32015601)
6. C.L. Sears, C. Lewis, K. Noel Overactive bladder medication adherence when medication is free to patients J Urol 183 2010 1077 1081
7. A. Athanasopoulos, F. Cruz The medical treatment of overactive bladder, including current and future treatments Expert Opin Pharmacother 12 2011 1041 1055
8. A.O. D'Souza, M.J. Smith, L.A. Miller Persistence, adherence, and switch rates among extended-release and immediate-release overactive bladder medications in a regional managed care plan J Manag Care Pharm 14 2008 291 301 (Pubitemid 351711980)
9. G.J. Christ, K.E. Andersson Rho-kinase and effects of Rho-kinase inhibition on the lower urinary tract Neurourol Urodyn 26 2007 948 954 (Pubitemid 47548232)
10. S.L. Peters, M. Schmidt, M.C. Michel Rho kinase: a target for treating urinary bladder dysfunction? Trends Pharmacol Sci 27 2006 492 497 (Pubitemid 44233691)
11. A.P. Somlyo, A.V. Somlyo Signal transduction by G-proteins, rhokinase and protein phosphatase to smooth muscle and non-muscle myosin II J Physiol 522 2000 177 185 (Pubitemid 30068498)
12. X.Q. Chen, I. Tan, C.H. Ng Characterization of RhoA-binding kinase ROKalpha implication of the pleckstrin homology domain in ROKalpha function using region-specific antibodies J Biol Chem 277 2002 12680 12688 (Pubitemid 34952627)
13. + sensitization via myosin phosphatase inhibition J Biol Chem 277 2002 23441 23446 (Pubitemid 34952177)
14. J.R. Jezior, J.D. Brady, D.I. Rosenstein Dependency of detrusor contractions on calcium sensitization and calcium entry through LOE-908-sensitive channels Br J Pharmacol 134 2001 78 87 (Pubitemid 32835470)
15. K.E. Andersson, A.J. Wein Pharmacology of the lower urinary tract: basis for current and future treatments of urinary incontinence Pharmacol Rev 56 2004 581 631 (Pubitemid 40003785)
16. A. Wibberley, Z. Chen, E. Hu Expression and functional role of Rho-kinase in rat urinary bladder smooth muscle Br J Pharmacol 138 2003 757 766 (Pubitemid 36390631)
17. T. Schneider, C. Fetscher, S. Krege Signal transduction underlying carbachol-induced contraction of human urinary bladder J Pharmacol Exp Ther 309 2004 1148 1153 (Pubitemid 38669703)
18. N.T. Durlu-Kandilci, A.F. Brading Involvement of Rho kinase and protein kinase C in carbachol-induced calcium sensitization in beta-escin skinned rat and guinea-pig bladders Br J Pharmacol 148 2006 376 384 (Pubitemid 43801184)
19. + sensitization in contraction of human bladder smooth muscle J Urol 172 2004 748 752 (Pubitemid 38900254)
20. A. Schroeder, E. Colli, M. Maggi Effects of a vitamin D(3) analogue in a rat model of bladder outlet obstruction BJU Int 98 2006 637 642 (Pubitemid 44185891)
21. C. Crescioli, A.M. Morelli, L. Adorini Human bladder as a novel target for vitamin D receptor ligands J Clin Endocrinol Metab 90 2005 962 972 (Pubitemid 40279222)
22. A. Morelli, L. Vignozzi, S. Filippi BXL628, a vitamin D receptor agonists effective in benign prostatic hyperplasia, prevents RhoA activation and inhibits RhoA/Rho kinase signaling in rat and human bladder Prostate 67 2006 234 247
23. G.R. Bailie, C.A. Johnson Comparative review of the pharmacokinetics of vitamin D analogues Semin Dial 15 2002 352 357
24. G.A. Digesu, A. Hutchings, S. Salvatore Reproducibility and reliability of pressure flow parameters in women Br J Obstet Gynaecol 110 2003 774 776 (Pubitemid 36936781)
25. L. Rentzhog, S.L. Stanton, L. Cardozo Efficacy and safety of tolterodine in patients with detrusor instability: a dose-ranging study Br J Urol 81 1998 42 48 (Pubitemid 28316496)
26. U. Jonas, K. Höfner, H. Madersbacher International Study Group Efficacy and safety of two doses of tolterodine versus placebo in patients with detrusor overactivity and symptoms of frequency, urge incontinence, and urgency: urodynamic evaluation World J Urol 15 1997 144 151 (Pubitemid 127764000)
27. G.A. Digesu, V. Khullar, L. Cardozo overactive bladder symptoms: do we need urodynamics? Neurourol Urodyn 22 2003 105 108 (Pubitemid 36222869)
28. J.P. Gardner, F. Zhang, M.R. Uskokovic Vitamin D analog 25-(OH)-16,23E-Diene-26,27-hexafluoro-vitamin D3 induces differentiation of HL60 cells with minimal effects on cellular calcium homeostasis J Cell Biochem 63 1996 500 512 (Pubitemid 27009269)
29. E. Colli, P. Rigatti, F. Montorsi BXL628, a novel vitamin D3 analog arrests prostate growth in patients with benign prostatic hyperplasia: a randomized clinical trial Eur Urol 49 2006 82 86 (Pubitemid 41789960)
30. Streng T, Andersson KE, Hedlund P, et al. Effects on bladder function of combining elocalcitol and tolterodine in rats with outflow obstruction. BJU Int. Epub 2012 Jan 30.