Factors influencing efficacy endpoints in clinical trials for new oral medicinal treatments for overactive bladder: a systematic literature review and meta-analysis

Factors influencing efficacy endpoints in clinical trials for new oral medicinal treatments for... Purpose Overactive bladder (OAB) is a symptom-based disease; therefore, clinical trials to evaluate treatments for OAB employ a range of efficacy endpoints. Since factors that influence efficacy endpoints can affect trial outcomes, their identifi - cation could aid in the design of future OAB clinical trials. We investigated factors influencing different efficacy endpoints used in clinical trials with OAB patients and examined their characteristics to determine future clinical trial strategies for new medicinal treatments for OAB. Methods Data from placebo-controlled double-blind trials in patients with OAB were extracted via a systematic literature review. The integrated differences for efficacy endpoints were calculated. Heterogeneity was assessed using the Q statistic and I statistic. Factors influencing efficacy endpoints were identified through univariate and multivariate meta-regression analyses. Results Forty-one controlled trials were analyzed. Substantial heterogeneity between studies was observed for each efficacy endpoint (P > 0.001, I > 70%). We found with multivariate meta-regression analysis that period of recording in a bladder diary and year of publication were significantly likely to influence the change from baseline in the mean number of urgency episodes in 24 h, year of publication and gender were significantly likely to influence the change from baseline in the mean number http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png International Urology and Nephrology Springer Journals

Factors influencing efficacy endpoints in clinical trials for new oral medicinal treatments for overactive bladder: a systematic literature review and meta-analysis

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Publisher
Springer Journals
Copyright
Copyright © 2018 by Springer Science+Business Media B.V., part of Springer Nature
Subject
Medicine & Public Health; Nephrology; Urology
ISSN
0301-1623
eISSN
1573-2584
D.O.I.
10.1007/s11255-018-1869-y
Publisher site
See Article on Publisher Site

Abstract

Purpose Overactive bladder (OAB) is a symptom-based disease; therefore, clinical trials to evaluate treatments for OAB employ a range of efficacy endpoints. Since factors that influence efficacy endpoints can affect trial outcomes, their identifi - cation could aid in the design of future OAB clinical trials. We investigated factors influencing different efficacy endpoints used in clinical trials with OAB patients and examined their characteristics to determine future clinical trial strategies for new medicinal treatments for OAB. Methods Data from placebo-controlled double-blind trials in patients with OAB were extracted via a systematic literature review. The integrated differences for efficacy endpoints were calculated. Heterogeneity was assessed using the Q statistic and I statistic. Factors influencing efficacy endpoints were identified through univariate and multivariate meta-regression analyses. Results Forty-one controlled trials were analyzed. Substantial heterogeneity between studies was observed for each efficacy endpoint (P > 0.001, I > 70%). We found with multivariate meta-regression analysis that period of recording in a bladder diary and year of publication were significantly likely to influence the change from baseline in the mean number of urgency episodes in 24 h, year of publication and gender were significantly likely to influence the change from baseline in the mean number

Journal

International Urology and NephrologySpringer Journals

Published: Apr 12, 2018

References

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