Diagnosis and Assessment

  • The initial evaluation in patients with lower urinary tract symptoms is carried out to establish BPH as the cause of symptoms.
  • Nonprostatic causes of symptoms can be excluded in a significant number of patients on the basis of a medical history, focused physical examination, and urinalysis.12
  • Medical history can help identify other causes of voiding dysfunction or comorbidities that may complicate treatment (eg, hypertension).12
  • Physical examination should include a digital rectal examination to exclude locally advanced prostate cancer and a focused neurological examination to assess patient’s mental status, ambulatory status, neuromuscular function, and anal sphincter tone.12
  • Urine analysis should be performed to check for hematuria. Absence of hematuria or pyuria helps rule out bladder cancer, UTIs, urethral strictures, and other conditions that may cause lower urinary tract symptoms.12
  • Some patients with BPH may require PSA tests or urine cytology to rule out prostate cancer or bladder cancer.12
  • The AUA Symptom Index (identical to the 7 symptom questions of the IPSS) should be used as the symptom-scoring instrument in the initial assessment of each patient presenting with BPH.12
References
  1. Fenter TC, Naslund MJ, Shah MB, et al. The cost of treating the 10 most prevalent diseases in men 50 years of age or older. Am J Manag Care. 2006;12(4 suppl):S90-S98.
  2. RAPAFLO® (silodosin) Capsules full Prescribing Information, November 2009.
  3. Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Rapid efficacy of the highly selective α1A-adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies. J Urol. 2009;181:2634-2640.
  4. National Institute of Diabetes and Digestive and Kidney Diseases. Prostate enlargement: benign prostatic hyperplasia. NIH Publication No. 07-3012. June 2006.
  5. Bruskewitz RC. Quality of life and sexual function in patients with benign prostatic hyperplasia. Rev Urol. 2003;5:72-80.
  6. Roberts RO, Jacobsen SJ, Rhodes T, et al. Natural history of prostatism: impaired health status in men with lower urinary tract symptoms. J Urol. 1997;157:1711-1717.
  7. http://www.dictionary.com
  8. Atlas of Human Anatomy, Frank H. Netter, MD, Ciba-Geigy Corporation, Summit, NJ, 1989.
  9. Data on file, Watson Laboratories, Inc.
  10. Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Silodosin in the treatment of the signs and symptoms of benign prostatic hyperplasia: a 9-month, open-label extension study. Urology. 2009;74:1318-1322.
  11. Agency for Healthcare Quality and Research (U.S. Dept Health and Human Services): Quick Tips When Talking With Your Doctor. Available at: http://www.ahrq.gov/consumer/quicktips/doctalk.htm. Accessed July 28, 2010.
  12. American Urological Association. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170:530-547.
  13. Fagelman E, Lowe FC. Herbal medications in the treatment of benign prostatic hyperplasia (BPH). Urol Clin N Am. 2002;29:23-29, vii.
  14. National Institute on Aging: Talking With Your Doctor: A Guide For Older People. NIH Publication No. 05-3452. August 2005 (Reprinted April 2010). Available at: http://www.nia.nih.gov/NR/rdonlyres/90DF996C-DF5F-4245-B7CA-B2E1B993D8C7/0/TWYD_0521_web.pdf. Accessed July 29, 2010.
  15. Medline Plus Medical Encyclopedia from NIH: Enlarged Prostate. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/000381.htm. Accessed July 29, 2010.
  16. Shvartzman P, Borkan JM, Stoliar L, et al. Second-hand prostatism: effects of prostatic symptoms on spouses’ quality of life, daily routines and family relationships. Family Pract. 2001;18:610-613.
  17. Kuritzky L. A primary care physician’s perspective on benign prostatic hyperplasia. Rev Urol. 2003;5(suppl 5):S42-S48.
  18. Wolters R, et al: Lower urinary tract symptoms: social influence is more important than symptoms in seeking medical care. BJU Int. 2002;90:655–661.
  19. Rosen RC, Giuliano F, Cason CC. Sexual dysfunction and lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). Eur Urol. 2005;47:824–837.
  20. Ponholzer A, Madersbacher S. Lower urinary tract symptoms and erectile dysfunction; links for diagnosis, management and treatment. Int J Impot Res. 2007;19:544-550.
  21. MacDiarmid SA, Hill LA, Volinn W, Hoel G. Lack of pharmacodynamic interaction of silodosin, a highly selective α1a-adrenoceptor antagonist, with the phosphodiesterase-5 inhibitors sildenafil and tadalafil in healthy men. Urology. 2010;75:520-525.
  22. Marks LS. Reply to editorial comment. Urology. 2009;74:1323-1324.
  23. Schwinn DA, Roehrborn CG. α1-Adrenoceptor subtypes and lower urinary tract symptoms. Int J Urol. 2008;15:193-199.
  24. Straus SM, Kors JA, De Bruin ML, et al. Prolonged QTc interval and risk of sudden cardiac death in a population of older adults. J Am Coll Cardiol. 2006;47:362-367.
  25. Carbone DJ, Hodges S. Medical therapy for benign prostatic hyperplasia: sexual dysfunction and impact on quality of life. Int J Impot Res. 2003;15:299-306.
  26. Nomiya M, Yamaguchi O. A quantitative analysis of mRNA expression of alpha 1 and beta-adrenoceptor subtypes and their functional roles in human normal and obstructed bladders. J Urol. 2003;170(2 Pt 1):649-653.
  27. Murata S, Taniguchi T, Takahashi M, et al. Tissue selectivity of KMD-3213, an α1-adrenoreceptor antagonist, in human prostate and vasculature. J Urol. 2000;164:578-583.
  28. Stafford-Smith M, Bartz R, Wilson K, et al. Alpha-adrenergic mRNA subtype expression in the human nasal turbinate. Can J Anesth. 2007;54:549-555.
  29. Wei JT, Calhoun E, Jacobsen SJ. Urologic Diseases in America Project: benign prostatic hyperplasia. J Urol. 2008;179(5 Suppl.):S75-S80.
  30. Issa MM, Regan T. Medical therapy for benign prostatic hyperplasia—present and future impact. Am J Manag Care. 2007;13:S4-S9.
  31. Berry SJ, Coffey DS, Walsh PC, et al. The development of human benign prostatic hyperplasia with age. J Urol. 1984;132:474.
  32. Nickel JC. Comparison of clinical trials with finasteride and dutasteride. Rev Urol. 2004;6 Suppl 9:S31-39.
  33. Hernández C, Estivill E, Prieto M, et al. Nocturia in Spanish patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH). Curr Med Res Opin. 2008;24:1033-1038.

RAPAFLO® is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). RAPAFLO® is not indicated for the treatment of hypertension.

Important Safety Information

RAPAFLO® is contraindicated in patients with severe renal impairment (CCr <30 mL/min), severe hepatic impairment (Child-Pugh score ≥10), and with use of strong CYP3A4 inhibitors. Postural hypotension with or without symptoms (eg, dizziness) may develop when beginning treatment with RAPAFLO®. As with all alpha-blockers, there is a potential for syncope. Patients should be warned of the possible occurrences of such events and should avoid situations where injury could result. RAPAFLO® should be used with caution in patients with moderate renal impairment. Patients should be assessed to rule out the presence of prostate cancer prior to starting treatment with RAPAFLO®. Patients planning cataract surgery should inform their ophthalmologist that they are taking RAPAFLO®.

The most common side effects are retrograde ejaculation, dizziness, diarrhea, orthostatic hypotension, headache, nasopharyngitis, and nasal congestion.