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A randomised , double-blind , parallel design , multi-institutional , non-inferiority phase IV trial of imidafenacin versus fesoterodine for overactive bladder . AIMS Our objective was to compare the efficacy and safety of imidafenacin over fesoterodine in patients with overactive bladder ( OAB ) . METHODS This study is a randomised , double-blind , parallel-group , fesoterodine-controlled study in patients with continuous OAB symptoms for ≥ 3 months , daily mean voiding frequency ( DMVF ) ≥ 8 , and daily mean urgency or urgency incontinence frequency ≥ 2 . A twice-daily 0.1 mg imidafenacin with placebo , or once-daily 4 mg fesoterodine with placebo were administered for 12 weeks . The primary efficacy end-point was the difference in DMVF at 12 weeks . The secondary efficacy end-points were differences in daily mean : ( i ) voiding frequency at 4 and 8 weeks ; ( ii ) urgency frequency ; ( iii ) urgency incontinence frequency ; ( iv ) incontinence frequency ; ( v ) nocturia frequency ; and ( vi ) quality of life score . The variables for safety analysis were adverse events , vital signs , residual urine volume and clinical laboratory tests . An efficacy analysis was conducted in per-protocol patients and the safety analysis was conducted in all randomised patients . RESULTS The differences in DMVF at 12 weeks were -3.38 ± 3.63 and -2.45 ± 3.73 in the imidafenacin and fesoterodine groups , respectively , and the difference was not significant between the two groups . Imidafenacin was non-inferior to fesoterodine , and the lower limit of 95 % two-sided confidence intervals was -0.53 . The other six secondary end-points and variables for safety analysis showed no difference between the two groups . CONCLUSIONS Imidafenacin was non-inferior to fesoterodine in terms of efficacy , and showed no significant difference in terms of safety .
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Intervention_Pharmacological
imidafenacin versus fesoterodine
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Intervention_Pharmacological
imidafenacin
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Intervention_Pharmacological
fesoterodine
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Intervention_Control
fesoterodine-controlled
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Outcome_Other
efficacy and safety
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Outcome_Other
clinical laboratory tests
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Participant_Condition
overactive bladder .
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Participant_Age
patients with overactive bladder ( OAB ) .