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
Background: To evaluate the efficacy and safety profile of alpha-1A receptor subtype specific antagonist-tamsulosin in benign prostatic hyperplasia.Methods: An open label, non-randomised, prospective, single centred study who were visiting urology department with confirmed diagnosis of benign prostatic hyperplasia (BPH) were included in the study. Thirty patients with BPH were prescribed tamsulosin and were followed up to three months. The initial or baseline data collected were identification of the patients such as international prostate symptom score (IPSS), prostate specific antigen, urine analysis, and ultrasonography of prostate including post void residual urine. The patients were followed up to 3 months to measure clinical and laboratory outcomes (IPSS score, post void residual urine, uroflow rates etc.).Results: In our study, patients receiving tamsulosin 0.4 mg once daily showed a significant improvement in post-void residual urine (PVRU), uroflow rates and IPSS score. The improvements in the above parameters were found to be statistically insignificant at first and third month of follow-up.Conclusions: In our study, tamsulosin an alpha-1A receptor subtype specific antagonist showed significant improvement in BPH symptoms and the drug was well tolerated.
Abbreviations and AcronymsBOO = bladder outlet obstruction BPH = benign prostatic hyperplasia IPSS = International Prostate Symptom Score LUTS = lower urinary tract symptoms MR = modified release PVR = postvoid residual Qmax = maximum urinary flow rate SR = sustained release ABSTRACT
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