Efficacy and Safety of Tamsulosin With and Without Flavoxate in the Treatment of Symptomatic Benign Prostastic Hypoplasia: A Randomized, Single-Blind Study

Abstract

Abbreviations and AcronymsBPH = benign prostatic hyperplasia IPSS = International Prostate Symptom Score LUTS = lower urinary tract symptoms OAB = overactive bladder PSA = prostate-specific antigen PVR = postvoid residual QoL = quality of life Qmax = maximum urinary flow rate. ABSTRACT INTRODUCTION:The purpose of the study was to evaluate the efficacy and safety of tamsulosin plus flavoxate with tamsulosin plus a placebo for the treatment of clinically proven lower urinary tract symptoms (LUTS) in patients with benign prostatic hyperplasia (BPH). METHODS:The participants were 120 patients with BPH and LUTS who were randomized into 2 equal groups.Group 1 received tamsulosin modified release (0.4 mg) once daily and flavoxate (200 mg) 3 times daily; group 2 received tamsulosin modified release (0.4 mg) once daily and a placebo 3 times daily. All patients took the medications orally for 12 weeks. Patients were evaluated before and after treatment by the total International Prostate Symptoms Score (IPSS), the irritative symptoms, voiding symptoms, and quality of life (QoL) IPSS subscores, maximum urinary flow rate (Qmax), and postvoid residual (PVR) urine volume. Adverse events were also summarized. The t test was used for group comparisons in response to treatment. RESULTS:All patients responded positively to treatment. The group taking tamsulosin plus flavoxate had significant improvement in the mean total IPSS (P < .001), irritative symptom subscore (P < .002), and QoL score (P < .002) when compared with the group taking tamsulosin plus placebo. There was no significant group difference in the mean voiding symptom subscore, Qmax, or PVR volume. Group differences in mean frequency and nocturia at the end of 12 weeks approached statistical significance (P = .05); patients taking tamsulosin plus flavoxate had fewer episodes. There was no significant group difference in urgency. One patient withdrew from each group due to complaints of impotence and ejaculatory dysfunction; all other adverse events were mild and transient. CONCLUSION:Taking a combination of tamsulosin with flavoxate improved IPSS, irritating symptoms, and QoL significantly more than taking the alpha blocker alone. The combined drugs had good safety and can be considered as a therapeutic option for treatment of LUTS associated with BPH. UroToday International Journal ® UI J