* See Appendix for complete list of contributors.reductions in mean ( SD ) voids/24 h with solifenacin 5 mg, at − 1.93 (1.97), and 10 mg, at − 2.19 (2.09), and propiverine 20 mg, at − 1.87 (2.70), than with placebo, at − 0.94 (2.29) ( P < 0.001 for all). Solifenacin (5 and 10 mg) was superior to placebo, and no worse than propiverine 20 mg, for this variable. There were significantly fewer mean ( SD ) urgency, incontinence and urgency incontinence episodes with solifenacin and propiverine than with placebo, with respective changes on placebo of − 1.28 (2.90), − 0.72 (1.95) and − 0.69 (2.00); solifenacin 5 mg, − 2.41 (2.88), − 1.59 (2.12) and − 1.45 (1.89) ( P < 0.001 for all), and 10 mg, − 2.78 (2.82), − 1.60 (1.81) and − 1.52 (1.77) ( P < 0.001 for all), and propiverine 20 mg, − 2.30 (3.08), − 1.25 (2.79) and − 1.19 (2.20) ( P < 0.001, = 0.002 and = 0.002 respectively). All active treatments vs placebo improved the volume voided ( P < 0.001 for all) and QoL; solifenacin 10 mg reduced nocturia episodes ( P = 0.021) and significantly improved urgency episodes ( P = 0.012) and volume voided ( P = 0.009) vs propiverine 20 mg, and solifenacin 5 mg caused less dry mouth ( P = 0.003). Solifenacin 10 mg caused more dry mouth ( P = 0.012) and occurrences of constipation ( P = 0.004) than propiverine 20 mg, but discontinuation rates between both treatment groups were similar. Continence was restored at endpoint in more than half of the patients on active treatment.
CONCLUSIONSolifenacin 5 and 10 mg once daily significantly improved the symptoms of OAB compared with placebo. Solifenacin therapy at 5 mg once daily is well-tolerated; 10 mg can be given if additional efficacy is required.
KEYWORDSoveractive bladder, solifenacin succinate, propiverine hydrochloride, efficacy, tolerability, quality of life Study Type -Therapy (RCT) Level of Evidence 1b
OBJECTIVESTo compare solifenacin succinate (5 and 10 mg once-daily) to placebo and propiverine hydrochloride (20 mg once-daily), respectively, in Japanese patients with overactive bladder syndrome (OAB).
PATIENTS AND METHODSA multicentre, 12-week, double-blind phase III trial randomized men and women aged ≥ 20 years with OAB to solifenacin 5 or 10 mg, propiverine 20 mg, or placebo. Changes at endpoint in number of voids/24 h, urgency, incontinence, urgency incontinence and nocturia episodes, volume voided/void, restoration of continence and quality of life (QoL) were examined.
RESULTSOf 1593 patients randomized, 1584 were treated; at the endpoint there were greater