OBJECTIVE: To assess the onset of efficacy of tolterodine extended release (ER) in patients with overactive bladder (OAB). RESEARCH DESIGN AND METHODS: A post hoc analysis was conducted using 3-day bladder diary data from a 12-week, multicenter, prospective, open-label study of tolterodine ER (4 mg qd) in patients (aged > or = 18 years) with urinary frequency (> or = 8 micturitions/24 h) and urgency (strong and sudden desire to urinate) with or without urgency urinary incontinence (UUI). MAIN OUTCOME MEASURES: Changes in micturition frequency, urgency, and UUI episodes/24 h were evaluated for treatment Days 5, 6, and 7. The percentages of patients who achieved normal micturition frequency (< 8/day) and 50%, 70%, 90%, and 100% reductions in urgency and UUI episodes (i.e., responders) were determined at Days 5, 6, and 7. Week 12 data are presented as a referent for the magnitude of treatment efficacy during Week 1. RESULTS: This analysis included 698 patients. On Day 5, there were significant reductions in all three diary variables (all p < 0.0001), and improvements continued on Days 6 and 7. More than half of the patients reported > or = 50% reductions in urgency or UUI episodes on Day 5. Responder rates for all three symptoms increased through Week 12. CONCLUSIONS: Patients with OAB experienced significant reductions in OAB symptoms as early as Day 5 of treatment with tolterodine ER. These data extend the findings of a previous analysis, in which all 3 days of the bladder diary were pooled, that demonstrated improvements in micturition frequency, urgency episodes, and UUI episodes in patients with OAB after 1 week of treatment with tolterodine ER. Limitations are that efficacy was not assessed before Day 5, this was a post hoc analysis, and the study was not placebo-controlled.
RCT Entities:
OBJECTIVE: To assess the onset of efficacy of tolterodine extended release (ER) in patients with overactive bladder (OAB). RESEARCH DESIGN AND METHODS: A post hoc analysis was conducted using 3-day bladder diary data from a 12-week, multicenter, prospective, open-label study of tolterodine ER (4 mg qd) in patients (aged > or = 18 years) with urinary frequency (> or = 8 micturitions/24 h) and urgency (strong and sudden desire to urinate) with or without urgency urinary incontinence (UUI). MAIN OUTCOME MEASURES: Changes in micturition frequency, urgency, and UUI episodes/24 h were evaluated for treatment Days 5, 6, and 7. The percentages of patients who achieved normal micturition frequency (< 8/day) and 50%, 70%, 90%, and 100% reductions in urgency and UUI episodes (i.e., responders) were determined at Days 5, 6, and 7. Week 12 data are presented as a referent for the magnitude of treatment efficacy during Week 1. RESULTS: This analysis included 698 patients. On Day 5, there were significant reductions in all three diary variables (all p < 0.0001), and improvements continued on Days 6 and 7. More than half of the patients reported > or = 50% reductions in urgency or UUI episodes on Day 5. Responder rates for all three symptoms increased through Week 12. CONCLUSIONS:Patients with OAB experienced significant reductions in OAB symptoms as early as Day 5 of treatment with tolterodine ER. These data extend the findings of a previous analysis, in which all 3 days of the bladder diary were pooled, that demonstrated improvements in micturition frequency, urgency episodes, and UUI episodes in patients with OAB after 1 week of treatment with tolterodine ER. Limitations are that efficacy was not assessed before Day 5, this was a post hoc analysis, and the study was not placebo-controlled.
Authors: Sender Herschorn; David Staskin; Le Mai Tu; Jonathan Fialkov; Terry Walsh; Katherine Gooch; Carol R Schermer Journal: Health Qual Life Outcomes Date: 2018-04-19 Impact factor: 3.186
Authors: S A Kaplan; L Cardozo; S Herschorn; L Grenabo; M Carlsson; D Arumi; T J Crook; L Whelan; D Scholfield; F Ntanios Journal: Int J Clin Pract Date: 2014-06-04 Impact factor: 2.503