Abstract
ObjectivesPatients with overactive bladder (OAB) often have trouble perceiving urgency because of difficulties in distinguishing between urgency and desire to void. Empirical antimuscarinic treatment of patients with frequency only may be reasonable if conservative management has failed. We compared the efficacy of solifenacin in patients with frequency with or without urgency.Materials and MethodsThis multicenter, 12-week, open-label, comparative, non-inferiority clinical trial assessed whether the solifenacin efficacy for frequency without urgency is non-inferior to its efficacy for frequency with urgency. All patients had micturition frequency ≥8 voids/day with or without urgency. Primary efficacy variable: daily frequency change at 12 weeks relative to baseline. Secondary efficacy variables: change at 12 weeks relative to baseline in Patients' Perception of Bladder Condition (PPBC), OAB Symptom Score (OABSS), and Benefit, Satisfaction, Willingness to continue (BSW) questionnaire.ResultsOf the 286 enrolled patients, 240 (83.9%) completed the study (without urgency n = 115; with urgency n = 125). Full dataset analysis revealed that the groups without and with urgency exhibited significant reductions in daily micturition frequency of −2.49±0.35 (mean ± standard error) and −2.63±0.37, respectively. The lower limit of the 95% two-sided CI of the comparison of the two group means was −1.14, which is smaller than the −0.8 margin of clinical equivalence. The two groups did not differ in improvement in PPBC, OABSS, or BSW scores. Both tolerated the treatment well.ConclusionsIt was not possible to verify that the solifenacin efficacy for frequency alone was non-inferior to its efficacy for OAB. Nevertheless, solifenacin tended to be effective for frequency regardless of urgency.Trial RegistrationClinicalTrials.gov NCT00979472
Highlights
Overactive bladder (OAB) is defined by the International Continence Society (ICS) as urgency [with or without urgency urinary incontinence (UUI)] that is usually associated with frequency and nocturia [1]
The lower limit of the 95% two-sided CI of the comparison of the two group means was 21.14, which is smaller than the 20.8 margin of clinical equivalence
The two groups did not differ in improvement in Perception of Bladder Condition (PPBC), OAB Symptom Score (OABSS), or BSW scores
Summary
Overactive bladder (OAB) is defined by the International Continence Society (ICS) as urgency [with or without urgency urinary incontinence (UUI)] that is usually associated with frequency and nocturia [1]. The ICS defines urgency as ‘‘the complaint of a sudden compelling desire to pass urine which is difficult to defer’’ [1]. This assumes that urgency is an abnormal or pathological bladder sensation that is distinguishable from the normal physiological sensation of urge to void [2,3]. Greater clarity has been needed in the development of instruments for measuring urgency, because it is generally difficult for patient with OAB to perceive urgency and to differentiate urgency from urge to void [4]
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