Abstract
BackgroundPrevious studies demonstrate that tolterodine extended release (ER) significantly improves urgency urinary incontinence (UUI) episodes. Instruments that measure patient-reported outcomes (PROs) provide additional information that is valuable for assessing whether clinical improvements are meaningful to the patient. This study determined the correlation of changes in bladder diary variables and other PROs in subjects with overactive bladder (OAB).MethodsSubjects with OAB, urinary frequency, and UUI were treated with 4 mg once-daily tolterodine ER or placebo for 12 weeks. Subjects completed 7-day bladder diaries, the Patient Perception of Bladder Condition (PPBC), and the King's Health Questionnaire (KHQ) at baseline and week 12. Only subjects who reported at least some minor bladder-related problems at baseline (PPBC score ≥ 3) were included in this analysis.ResultsReductions in UUI episodes per week were significantly greater in the tolterodine ER group (n = 500) compared with the placebo group (n = 487) at week 12 (-71% vs -33%, P < 0.0001). A significantly greater percentage of subjects in the tolterodine ER group reported improvement on the PPBC versus placebo (58% vs 45%, P < 0.0001), and 7 of 10 KHQ domains were significantly improved versus placebo (all P < 0.05). Significant correlations were found for median percentage changes in UUI episodes with changes in PPBC scores (r = 0.35,P < 0.0001) and the 7 improved KHQ domains (r = 0.16–0.32, P ≤ 0.0011). Changes in PPBC scores and all KHQ domains were significantly correlated (r = 0.13–0.38, P ≤ 0.009) in the tolterodine ER group. Correlations among endpoints in the placebo group were similar to those observed in the tolterodine ER group.ConclusionImprovement in UUI episodes after 12 weeks of treatment with tolterodine ER or placebo was correlated with improvements in patients' perception of their bladder-related problems and health-related quality of life. Correlations were moderate in magnitude but statistically significant, suggesting that PROs are important and relevant measures for evaluating OAB treatment.
Highlights
Previous studies demonstrate that tolterodine extended release (ER) significantly improves urgency urinary incontinence (UUI) episodes
Subjects treated with tolterodine ER showed a significantly greater median percentage (-71% vs -33%, P < 0.0001) and mean (-11.8 vs -6.9, P < 0.0001) reduction in UUI episodes per week than did subjects treated with placebo
A significantly greater percentage of subjects treated with tolterodine ER showed improvement in Perception of Bladder Condition (PPBC) scores (58%; 30% with ≥ 2-point improvement) than did subjects treated with placebo (45%; 21% with ≥ 2-point improvement; P < 0.0001)
Summary
Previous studies demonstrate that tolterodine extended release (ER) significantly improves urgency urinary incontinence (UUI) episodes. This study determined the correlation of changes in bladder diary variables and other PROs in subjects with overactive bladder (OAB). Overactive bladder (OAB) is defined by the International Continence Society (ICS) as urgency, with or without urgency urinary incontinence (UUI), usually with increased daytime frequency and nocturia [1,2]. It was demonstrated that the prevalence of OAB increases with advancing age, occurring in 20% of subjects who are ≥ 60 years of age. Antimuscarinics, such as tolterodine, are first-line treatments for OAB and have proven efficacy and tolerability [6]. Several questionnaires, measuring a broad array of concepts, have been validated for use in subjects with OAB, including the King's Health Questionnaire (KHQ) [8] and Patient Perception of Bladder Condition (PPBC) [9]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
