The Journal of Urology
Volume 184, Issue 2 , Pages 616-622 , August 2010

A Multicenter, Double-Blind, Randomized, Placebo Controlled Trial of a Neurokinin-1 Receptor Antagonist for Overactive Bladder

  • Tara L. Frenkl

      Affiliations

    • Corresponding Author InformationCorrespondence: P.O. Box 1000, UG3D-66, North Wales, Pennsylvania 19454 (telephone: 267-305-1281)
    • Financial interest and/or other relationship with Merck & Co, Inc.
  • ,
  • Haiyuan Zhu

      Affiliations

    • Financial interest and/or other relationship with Merck & Co, Inc.
  • ,
  • Theodore Reiss

      Affiliations

    • Financial interest and/or other relationship with Merck & Co, Inc.
  • ,
  • Olga Seltzer

      Affiliations

    • Financial interest and/or other relationship with Merck & Co, Inc.
  • ,
  • Elizabeth Rosenberg

      Affiliations

    • Financial interest and/or other relationship with Merck & Co, Inc.
  • ,
  • Stuart Green

      Affiliations

    • Financial interest and/or other relationship with Merck & Co, Inc.

Received 18 December 2009

References 

  1. Abrams P, Cardozo L, Fall M, et al. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21:167
  2. Milsom I, Abrams P, Cardozo L, et al. How widespread are the symptoms of an overactive bladder and how are they managed? (A population-based prevalence study). BJU Int. 2001;87:760
  3. Stewart WF, Van Rooyen JB, Cundiff GW, et al. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003;20:327
  4. Irwin DE, Milsom I, Kopp Z, et al. Impact of overactive bladder symptoms on employment, social interactions and emotional well-being in six European countries. BJU Int. 2006;97:96
  5. Serels S. The wet patient: understanding patients with overactive bladder and incontinence. Curr Med Res Opin. 2004;20:791
  6. Andersson KE, Chapple CR, Cardozo L, et al. Pharmacological treatment of overactive bladder: report from the International Consultation on Incontinence. Curr Opin Urol. 2009;19:380
  7. Abrams P, Andersson KE. Muscarinic receptor antagonists for overactive bladder. BJU Int. 2007;100:987
  8. 2009 Tolterodine PI. Tolterodine tartrate extended release capsules. New York, New York: Pfizer Inc; 2009;revised 2008
  9. Mussap CJ, Geraghty DP, Burcher E. Tachykinin receptors: a radioligand binding perspective. J Neurochem. 1993;60:1987
  10. Caberlotto L, Hurd YL, Murdock P, et al. Neurokinin 1 receptor and relative abundance of the short and long isoforms in the human brain. Eur J Neurosci. 2003;17:1736
  11. Otsuka M, Yoshioka K. Neurotransmitter functions of mammalian tachykinins. Physiol Rev. 1993;73:229
  12. Abdel-Gawad M, Dion SB, Elhilali MM. Evidence of a peripheral role of neurokinins in detrusor hyperreflexia: a further study of selective tachykinin antagonists in chronic spinal injured rats. J Urol. 2001;165:1739
  13. Quinn T, Collins C, Baird AW. Mechanisms of neurokinin A- and substance P-induced contractions in rat detrusor smooth muscle in vitro. BJU Int. 2004;94:651
  14. Lecci A, Giuliani S, Santicioli P, et al. Involvement of spinal tachykinin NK1 and NK2 receptors in detrusor hyperreflexia during chemical cystitis in anaesthetized rats. Eur J Pharmacol. 1994;259:129
  15. Moore KH, Gilpin SA, Dixon JS, et al. Increase in presumptive sensory nerves of the urinary bladder in idiopathic detrusor instability. Br J Urol. 1992;70:370
  16. Doi T, Kamo I, Imai S, et al. Effects of TAK-637, a tachykinin receptor antagonist, on the micturition reflex in guinea pigs. Eur J Pharmacol. 2000;395:241
  17. Andersson KE. Tachykinins: role in detrusor overactivity?. Eur Urol. 2006;49:423
  18. Chou FH, Ho CH, Chir MB, et al. Normal ranges of variability for urodynamic studies of neurogenic bladders in spinal cord injury. J Spinal Cord Med. 2006;29:26
  19. Silva C, Silva J, Ribeiro MJ, et al. Urodynamic effect of intravesical resiniferatoxin in patients with neurogenic detrusor overactivity of spinal origin: results of a double-blind randomized placebo-controlled trial. Eur Urol. 2005;48:650
  20. Chancellor MB, de Groat WC. Intravesical capsaicin and resiniferatoxin therapy: spicing up the ways to treat the overactive bladder. J Urol. 1999;162:3
  21. Green SA, Alon A, Ianus J, et al. Efficacy and safety of a neurokinin-1 receptor antagonist in postmenopausal women with overactive bladder with urge urinary incontinence. J Urol. 2006;176:2535
  22. Data on file, Merck & Co., Inc., Rahway, New Jersey 2009.
  23. Brown JS, McNaughton KS, Wyman JF, et al. Measurement characteristics of a voiding diary for use by men and women with overactive bladder. Urology. 2003;61:802
  24. Herschorn S, Swift S, Guan Z, et al. Comparison of fesoterodine and tolterodine extended release for the treatment of overactive bladder: a head-to-head placebo-controlled trial. BJU Int. 2010;105:58
  25. Bergstrom M, Hargreaves RJ, Burns HD, et al. Human positron emission tomography studies of brain neurokinin 1 receptor occupancy by aprepitant. Biol Psychiatry. 2004;55:1007
  26. Zinner NR, Mattiasson A, Stanton SL. Efficacy, safety, and tolerability of extended-release once-daily tolterodine treatment for overactive bladder in older versus younger patients. J Am Geriatr Soc. 2002;50:799
  27. Michel MC, Schneider T, Krege S, et al. Does gender or age affect the efficacy and safety of tolterodine?. J Urol. 2002;168:1027

 Study received institutional review board approval.

 Clinical Trial Registration NCT00290563 (www.clinicaltrials.gov).

 Supported by Merck & Co., Inc.

 For other articles on a related topic see pages 762, 769 and 783.

PII: S0022-5347(10)03275-1

doi: 10.1016/j.juro.2010.03.147

The Journal of Urology
Volume 184, Issue 2 , Pages 616-622 , August 2010