OBJECTIVES: To evaluate the clinical efficacy of initial combined treatment of alpha-blocker plus dose-dependent anticholinergic agent compared to the alpha-blocker monotherapy in benign prostatic hyperplasia patients with overactive bladder. METHODS:Male lower urinary tract symptoms (LUTS) patients with International Prostate Symptom Score (IPSS) of 8 or higher, total overactive bladder Symptom Score (OABSS) of 3 or higher, and 2 points or higher in the OABSS questionnaire number 2 were enrolled. Eligible subjects (totaln = 146) were randomly assigned to receive tamsulosin 0.2 mg (Group I, n = 44), tamsulosin 0.2 mg plus solifenacin 5 mg (Group II, n = 55), or tamsulosin 0.2 mg plus solifenacin 10 mg (Group III, n = 47) for 12 weeks. Efficacy and safety assessments for each group were done using detailed questionnaires, and evaluating urinary parameters such as maximal urinary flow rate (Qmax) and postvoid residual volume (PVR) at 4 and 12 weeks. RESULTS: Groups II and III (combined use of tamsulosin and solifenacin) showed significant improvement in storage symptoms compared to group I (tamsulosin monotherapy), as reflected by IPSS storage subscore and OABSS (P < 0.05). Dry mouth developed in four (7%) and eight (17%) cases in group II and III, respectively, so that one (2%) and three (6%) cases dropped out in group II and III, respectively. Two cases (4%) of AUR developed in group III, and one of them was withdrawn (2%) from the study. CONCLUSIONS: Initial combined treatment of tamsulosin plus solifenacin for men with LUTS improves storage symptoms significantly, but dose modification is necessary to prevent adverse events.
RCT Entities:
OBJECTIVES: To evaluate the clinical efficacy of initial combined treatment of alpha-blocker plus dose-dependent anticholinergic agent compared to the alpha-blocker monotherapy in benign prostatic hyperplasiapatients with overactive bladder. METHODS: Male lower urinary tract symptoms (LUTS) patients with International Prostate Symptom Score (IPSS) of 8 or higher, total overactive bladder Symptom Score (OABSS) of 3 or higher, and 2 points or higher in the OABSS questionnaire number 2 were enrolled. Eligible subjects (total n = 146) were randomly assigned to receive tamsulosin 0.2 mg (Group I, n = 44), tamsulosin 0.2 mg plus solifenacin 5 mg (Group II, n = 55), or tamsulosin 0.2 mg plus solifenacin 10 mg (Group III, n = 47) for 12 weeks. Efficacy and safety assessments for each group were done using detailed questionnaires, and evaluating urinary parameters such as maximal urinary flow rate (Qmax) and postvoid residual volume (PVR) at 4 and 12 weeks. RESULTS: Groups II and III (combined use of tamsulosin and solifenacin) showed significant improvement in storage symptoms compared to group I (tamsulosin monotherapy), as reflected by IPSS storage subscore and OABSS (P < 0.05). Dry mouth developed in four (7%) and eight (17%) cases in group II and III, respectively, so that one (2%) and three (6%) cases dropped out in group II and III, respectively. Two cases (4%) of AUR developed in group III, and one of them was withdrawn (2%) from the study. CONCLUSIONS: Initial combined treatment of tamsulosin plus solifenacin for men with LUTS improves storage symptoms significantly, but dose modification is necessary to prevent adverse events.