Tamsulosin in the treatment of LUTS/BPH: an Italian multicentre trial.

Author(s): Muzzonigro G

Affiliation(s): Department of Urology and Division of Urology, A.O. Umberto I-Torrette, Polytechnic University of the Marche Region, Ancona, Italy. g.muzzonigro@unian.it

Publication date & source: 2005-03, Arch Ital Urol Androl., 77(1):13-7.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

OBJECTIVE: to assess the efficacy and tolerability of tamsulosin (0.4 mg MR o.d.)for 12 weeks in out-patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) at Italian urology centres. MATERIAL AND METHODS: Multicentre clinical trial in 261 patients aged > or =45 years, with a diagnosis of LUTS/BPH and total International Prostate Symptom Score (I-PSS) > or =8. Patients were given tamsulosin (0.4 mg MR o.d.) for 12 weeks and examined three times: at a screening visit (2 weeks before inclusion), at inclusion and at the end of treatment. Primary efficacy parameter: Total I-PSS score. Secondary efficacy parameters: obstructive and irritative I-PSS, I-PSS individual items, I-PSS responders, Maximum urinary flow rate (Qmax), Qmax responders. Tolerability was evaluated on the basis of AEs. RESULTS: The total I-PSS diminished significantly by 33.1% (P = 0.0001). Both obstructive and irritative symptoms were significantly reduced by 35.4% and 30.3%, respectively (both P = 0.0001). All the 7 individual I-PSS items improved significantly (P = 0.0001), including quality of life. The mean +/-SD Qmax increased significantly by 11.1%. Seven patients (2.6%) reported 11 adverse events; hypotension was not documented as well as no cases of abnormal ejaculation were reported. All events resolved after discontinuation of treatment. CONCLUSION: Tamsulosin is effective and well tolerated. The low incidence or absence of documented hypotension is the main advantage of tamsulosin over the other non selective alpha blockers in the treatment of patients with LUTS/BPH within the setting of an Italian urology referral centre.