The journal of obstetrics and gynaecology research · 2011
Comparisons of urodynamic effects, therapeutic efficacy and safety of solifenacin versus tolterodine for female overactive bladder syndrome.
Клиническое исследование IV фазыСравнительное исследованиеСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Hsiao Sheng-Mou, Chang Ting-Chen, Wu Wen-Yih, Chen Chi-Hau, Yu Hung-Jeng, Lin Ho-Hsiung
Аннотация
AIM: To evaluate the urodynamic effects, therapeutic efficacy and safety of solifenacin versus tolterodine treatment for women with overactive bladder syndrome.
METHODS: Patients were randomized to receive either solifenacin 5 mg or tolterodine ER 4 mg once a day for 12 weeks at each four-week visit in a post-marketing study. Only women (solifenacin [n = 26] vs. tolterodine [n = 22]) were included in this subgroup analysis. Adverse events and changes of urodynamic values and clinical data were compared between the solifenacin and tolterodine groups.
RESULTS: The volume voided per micturition increased in the solifenacin group (n = 21) (P = 0.04). The strong desire to void and pad-test result improved in the tolterodine group (n = 21; P = 0.02 and 0.03, respectively). There were no between-group differences in changes of any urodynamic data, voiding diary values or adverse events after treatment; however, changes of heart rate differed between the two groups (P = 0.0004), especially at visit 2 (solifenacin vs. tolterodine, -4.3 vs. 3.8, P = 0.02) and visit 3 (-3.2 vs. 4.8, P = 0.03).
CONCLUSIONS: Both solifenacin and tolterodine had similar urodynamic effects, therapeutic efficacy and adverse events in treating women with overactive bladder syndrome; however, tolterodine had a greater effect in increasing heart rate than solifenacin.
METHODS: Patients were randomized to receive either solifenacin 5 mg or tolterodine ER 4 mg once a day for 12 weeks at each four-week visit in a post-marketing study. Only women (solifenacin [n = 26] vs. tolterodine [n = 22]) were included in this subgroup analysis. Adverse events and changes of urodynamic values and clinical data were compared between the solifenacin and tolterodine groups.
RESULTS: The volume voided per micturition increased in the solifenacin group (n = 21) (P = 0.04). The strong desire to void and pad-test result improved in the tolterodine group (n = 21; P = 0.02 and 0.03, respectively). There were no between-group differences in changes of any urodynamic data, voiding diary values or adverse events after treatment; however, changes of heart rate differed between the two groups (P = 0.0004), especially at visit 2 (solifenacin vs. tolterodine, -4.3 vs. 3.8, P = 0.02) and visit 3 (-3.2 vs. 4.8, P = 0.03).
CONCLUSIONS: Both solifenacin and tolterodine had similar urodynamic effects, therapeutic efficacy and adverse events in treating women with overactive bladder syndrome; however, tolterodine had a greater effect in increasing heart rate than solifenacin.