Linda Cardozo1, Andrea Dixon. 1. Urogynaecology Department, King's College Hospital, London, United Kingdom. lcardozo@compuserve.com
Abstract
PURPOSE: We assessed the effect of darifenacin, an M3 selective receptor antagonist, on the warning time associated with urinary urgency. MATERIALS AND METHODS: In this multicenter, double-blind study subjects with urinary urgency for 6 months or greater and episodes of urgency 4 times or greater daily were randomized to darifenacin controlled release tablets (30 mg once daily) or placebo. Warning time was defined as the time from the first sensation of urgency to voluntary micturition or incontinence. Data were collected using electronic event recorders during 6-hour clinic visits or 3 urge-void cycles, if shorter, at baseline and at treatment end. RESULTS:A total of 72 subjects entered the study and 67 were included in the primary efficacy analysis (darifenacin in 32 and placebo in 35). Darifenacin treatment resulted in a significant increase in mean warning time with a median increase of 4.3 minutes compared with placebo (p = 0.003). Overall 47% of darifenacin treated subjects compared with 20% receiving placebo achieved a 30% increase or greater in mean warning time (OR 5.6, p = 0.009). Median and minimum warning times were also significantly increased following darifenacin treatment vs placebo (p = 0.004 and 0.017, respectively). The median difference in minimum warning time was 1.9 minutes in favor of darifenacin vs placebo. CONCLUSIONS: To our knowledge this is the first study to evaluate change in warning time, which is potentially important to individuals with symptoms associated with overactive bladder. Darifenacin increases mean, median and minimum warning time compared with placebo, allowing subjects more time to reach a toilet and potentially avoiding the embarrassing experience of incontinence.
RCT Entities:
PURPOSE: We assessed the effect of darifenacin, an M3 selective receptor antagonist, on the warning time associated with urinary urgency. MATERIALS AND METHODS: In this multicenter, double-blind study subjects with urinary urgency for 6 months or greater and episodes of urgency 4 times or greater daily were randomized to darifenacin controlled release tablets (30 mg once daily) or placebo. Warning time was defined as the time from the first sensation of urgency to voluntary micturition or incontinence. Data were collected using electronic event recorders during 6-hour clinic visits or 3 urge-void cycles, if shorter, at baseline and at treatment end. RESULTS: A total of 72 subjects entered the study and 67 were included in the primary efficacy analysis (darifenacin in 32 and placebo in 35). Darifenacin treatment resulted in a significant increase in mean warning time with a median increase of 4.3 minutes compared with placebo (p = 0.003). Overall 47% of darifenacin treated subjects compared with 20% receiving placebo achieved a 30% increase or greater in mean warning time (OR 5.6, p = 0.009). Median and minimum warning times were also significantly increased following darifenacin treatment vs placebo (p = 0.004 and 0.017, respectively). The median difference in minimum warning time was 1.9 minutes in favor of darifenacin vs placebo. CONCLUSIONS: To our knowledge this is the first study to evaluate change in warning time, which is potentially important to individuals with symptoms associated with overactive bladder. Darifenacin increases mean, median and minimum warning time compared with placebo, allowing subjects more time to reach a toilet and potentially avoiding the embarrassing experience of incontinence.
Authors: Marc R Toglia; Donald R Ostergard; Rodney A Appell; Masakazu Andoh; Allam Fakhoury; Iqbal F Hussain Journal: Int Urogynecol J Date: 2010-03-26 Impact factor: 2.894