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RESEARCH ARTICLE
Year : 2003  |  Volume : 20  |  Issue : 1  |  Page : 40-45

A randomized comparative study of tamsulosin vs placebo in the treatment of benign prostatic hyperplasia


Department of Urology, V.M. Medical College and Safdarjang Hospital, New Delhi, India

Correspondence Address:
N K Mohanty
C-II/124, Moti Bagh-1, New Delhi - 110 021
India
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Source of Support: None, Conflict of Interest: None


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Objective: The rationale of using α1, blockers in the man­agement of benign prostatic hyperplasia (BPH) is based upon blocking the adrenergic receptors which regulate urinary outflow The prostate adenoma is predominantly stromal, having 40% of smooth muscle innervated by sym­pathetic adrenergic nerves stimulation of which accounts for 50% of outflow obstruction. Tamsulosin is an uroselective α1a/d blocker, controls both the lower urinary irritative and obstructive symptoms. The present study is a placebo controlled study evaluating the efficacy, safety and advantages of tamsulosin in the management of BPH. Methods: A total number of 72 patients between 40-80 years of age were randomized to two groups. One group (38 patients) received tamsulosin (0.4 mg) daily and the other group (34 patients) received placebo for a period of two months with periodic follow up at 2nd , 4 th and 8 th week with IPSS (International Prostate Symptom Score) and uroflowmetry and ultrasonography at 8 th week. Results: Our results show tamsulosin to be very effec­tive in the management of BPH cases, not requiring sur­gery, with few side effects and good patient compliance. The improvement was seen both in IPSS (total, obstruc­tive and irritative) and in urodynamic parameters. The differences were consistently superior with tamsulosin as compared to placebo in both the IPSS as well as uroflow­metry measurements. Conclusion: Tamsulosin was found to be a very safe, well tolerated drug showing significant improvement in urinary outflow symptoms, reducing post void urine volume and decreasing IPSS with minimal tolerable adverse events.


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