ABSTRACT
ObjectiveTo evaluate the efficacy and safety of combination therapy of tamsulosin and solifenacin for benign prostatic hyperplasia ( BPH ) with overactive bladder ( OAB ).Methods82 patients with OAB and coexisting BPH were randomly divided into tamsulosin group ( n = 38 ) and combination group ( n = 44). The ages were from 50 to 75 y ( averaged, 56.8 ± 8.6). Inclusion criteria: the mean frequency of micturition ≥8 times per day, the frequency of nocturia ≥2 times per day, voiding volume ＜200 ml each time; for the overactive bladder symptom score ( OA BSS), the 3 rd score ＞ 2, total score ＞ 3. The tamsulosin group accepted tamsulosin 0.2 mg once daily, the combination group accepted tansulouxin 0.2 mg and solifenacin 0.2 mg once daily. Both groups were maintained the corresponding therapy for 12 weeks.The international prostate symptom score (IPSS), Qmax, residual urine volume, OAB score and adverse reactions were recorded.ResultsThe values of IPSS ( 19.5 ±2.2 vs 15.6 ±2.4, P =0.027), the voiding symptom score ( 15.6 ± 2.4 vs 3.4 ± 1. 7, P = 0. 022) and Qmax ( 13.7 ± 3.8 vs 16.6 ± 4.1, P = 0. 034 )improved significantly after treatment in tamsulosin group ( P ＜ 0. 05 ). The values of IPSS ( 19.7 ± 2.3 vs 9.7 ± 3.0, P ＜0. 001), the storage symptom score (13.8 ± 1.9 vs 5.6 ± 1.6, P ＜0. 001 ), OABSS (10.3 ±1.8 vs 5.3 ±1.3, P ＜0.001) and Qmax(14.1 ±4.1 vs 17.2 ±3.5, P=0.027) also improved significantly after treatment in combination group ( P ＜ 0. 05 ). The values of IPSS ( 9.7 ± 3.0 vs 15.6 ±2.4, P ＜ 0.001 ), the storage symptom score (5.6 ± 1.6 vs 12.0 ± 1.6, P ＜ 0.001 ) and OABSS ( 5.3 ±1.3 vs 9.7 ± 2.7, P ＜ 0. 001 ) improved significantly in combination group than those in tamsulosin group ( P ＜0.001 ). There were no difference between two groups in values of the voiding symptom score, Qmax and residual urine volume ( P ＞ 0.05 ). The incidences of adverse reactions in tamsulosin group and combination group were 7.9％ (3/38) and 20.5％ (9/44) without significant difference. There was no acute urinary retention in both groups.ConclusionsIt is effective and safe for patients with BPH and OAB to accept combination therapy of tamsulosin and solifenacin.
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 QoL3 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.