Assessment of patient-reported outcome of patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia and treated with tamsulosin HCl in Korea

Abstract

OBJECTIVES: To evaluate the effect of tamsulosin 0.2 mg once daily in treatment of patients with benign prostatic hyperplasia (BPH) using the new subjective assessment of patient-reported outcomes and the lower urinary tract symptoms (LUTS) outcome score (LOS).

METHODS: Of 370 patients from 9 urology outpatient clinics, 299 finished this study. Tamsulosin 0.2 mg once daily was administered orally in a nonblind design for a 12-week period. The primary endpoint of this study was to evaluate the effect of tamsulosin with new assessing parameters; the most bothersome symptoms, BPH K1-short form and LOS. The secondary endpoint was to evaluate the effect of tamsulosin with conventional parameters, International Prostate Symptom Score (IPSS), maximum flow rate (Q(max.)), and postvoiding residual urine volume.

RESULTS: A total of 189 (63.2%) of 299 patients responded that their most bothersome symptom had been improved at 12 weeks after study. All 9 items in BPH K1-short form showed statistically significant improvement (P <.05). Overall, 20 (6.7%) patients met criteria for cured, 246 (82.3%) for improved, and 33 (11.0%) for failed. Statistically significant improvements were observed in IPSS, Q(max.), and postvoiding residual urine volume (P <.05).

CONCLUSIONS: Tamsulosin 0.2 mg once daily may be an effective treatment, subjectively and objectively in patients with BPH. To evaluate the effect of the treatment in patients with BPH, it may be more effective to use the subjective quality of life questionnaire and the subjective-objective data integrated LOS than the currently used IPSS and Q(max.).