The Efficacy and Safety of Tamsulosin 0.2mg/day on Sexual Function in BPH: A Multicenter Open-label, Non-comparative, 3 Months Observational, Phase IV Prospective Study

Abstract

Purpose: The aim of this study was to assess the efficacy and safety of tamsulosin, 0.2mg/day on sexual function in Korean BPH patients. Patients and Methods: 116 patients (mean age: 60 yrs) with BPH were enrolled in this study and 0.2mg of tamsulosin was administrated every night for 3 months. Primary efficacy was evaluated with changes of IIEF and GEQ. Secondary efficacy parameters were changes of IPSS and QoL, uroflowmetry, changes of total IIEF and IIEF domain score according to the severity of IPSS, and retrograde ejaculation. Results: Before treatment, patients of moderate IPSS (8-19) and severe IPSS (20-35) were 56% and 44% and QoL<3 and QoL>3 were 33.6% and 66.4%. In primary efficacy evaluation, total IIEF score was significantly increased from 37.0±18.2 to 40.5±18.9 (p<0.01). All domains of IIEF except orgasmic function were significantly improved. GEQ showed improvement of erection in 34.4% and intercourse ability in 30.1%. In secondary efficacy evaluation, IPSS was significantly decreased from 18.4±6.9 to 12.9±6.7 (p<0.01) and QoL was significantly improved from 3.8±1.1 to 2.7±1.4 (p<0.01). Qmax significantly increased from 14.2±8.3 to 16.5±11.3 ml/sec (p<0.01). Total IIEF score and EF domain score were significantly improved from 36.8±18.5 to 41.8±19.1 (p<0.01) and from 13.0±7.1 to 14.7±7.9 (p<0.01) in patients of moderate IPSS but no improvement in severe patients. Retrograde ejaculation occurred in 2 patients (2%). No serious adverse reactions were observed. Conclusions: Tamsulosin, 0.2mg/day was effective and safe dose for the improvement of LUTS and sexual function for Korean BPH/LUTS patients.