Abstract
Introduction and hypothesis
We present the design of a randomized controlled trial, Fluids Affecting Bladder Urgency and Lower Urinary Symptoms (FABULUS), with the purpose of testing the common clinical advice of treating overactive bladder by eliminating potentially irritating beverages (PIBs) that are caffeinated, artificially sweetened, citric, or alcoholic. The primary hypothesis is that women taught to reduce PIBs will show less void frequency compared with a control group instructed in diet/exercise recommendations. Secondary outcomes include change in urgency symptoms and volume per void.
Methods
We report the methods for FABULUS and discuss how challenges presented in the literature and from a prior proof-of-concept feasibility trial are addressed by strengthening study design, procedures, and instruments. We introduce the concept of standardized automated tutorials for assisting participants in compliance from study start to finish. The tutorials contain a detailed explanation of the study, including tips for complying with the extensive diary requirements, and parallel tutorials to intervention and control groups for consistency in format and time of instructional content. The intervention tutorial on eliminating PIBs places emphasis on maintaining steady fluid intake volume, as fluctuations have been a confounder in prior work.
Results
Study results promise to inform about both the tutorial approach and specific PIB reduction for effectively treating overactive bladder.
Conclusions
OAB can have a negative impact on quality of life, and current medical treatments carry costs and side-effect risks. If simple lifestyle changes can improve or prevent these bladder symptoms, multiple medical and public health advances could result.
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Acknowledgements
The authors thank Sarah Block for her assistance with manuscript preparation, Caroline Garcia for her assistance with producing the tutorials, and study staff Ruta Misiunas and Meg Tolbert for recruitment and data collection.
Funding
The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the Pfizer Global Investigator-Initiated Research Grant (grant no. GA6120A8) and Blue Cross Blue Shield of Michigan Foundation, Investigator-Initiated Grant (grant no. 002607.II).
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MO Schimpf: Protocol/project development, Data collection/management, Data analysis, Manuscript writing/editing.
AR Smith: Protocol/project development, Data collection/management, Data analysis, Manuscript writing/editing.
JM Miller: Protocol/project development, Data collection/management, Data analysis, Manuscript writing/editing.
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Schimpf, M.O., Smith, A.R. & Miller, J.M. Fluids affecting bladder urgency and lower urinary symptoms (FABULUS): methods and protocol for a randomized controlled trial. Int Urogynecol J 31, 1033–1040 (2020). https://doi.org/10.1007/s00192-019-04209-z
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DOI: https://doi.org/10.1007/s00192-019-04209-z