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

• Main Authors: N K Mohanty, R P Arora, Rajiba L Nayak, Vineet Malhotra
• Format: Article
• Language: English
• Published: Wolters Kluwer Medknow Publications 2003-01-01
• Series: Indian Journal of Urology
• Subjects: Medical management; tamsulosin; benign prostate.
• Online Access: http://www.indianjurol.com/article.asp?issn=0970-1591;year=2003;volume=20;issue=1;spage=40;epage=45;aulast=Mohanty

Objective: The rationale of using α1, blockers in the man-agement 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 sym-pathetic 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 effec-tive in the management of BPH cases, not requiring sur-gery, with few side effects and good patient compliance. The improvement was seen both in IPSS (total, obstruc-tive and irritative) and in urodynamic parameters. The differences were consistently superior with tamsulosin as compared to placebo in both the IPSS as well as uroflow-metry 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.