Abstract
Intra-abdominal pressure may be one of the few modifiable risk factors associated with developing a pelvic floor disorder. With one in eight women having surgery to correct a pelvic floor disorder in their lifetimes, intra-abdominal pressure may be a key to understanding the disease etiology and how to mitigate its occurrence and progression. Many traditional methods of intra-abdominal pressure measurement have limitations in data quality, environment of use, and patient comfort. We have modified a previously reported intravaginal pressure transducer that has been shown to overcome other intra-abdominal pressure measurement technique limitations (Coleman et al. 2012). Our modifications to the intravaginal pressure transducer make it easier to use, less costly, and more reliable than previous designs, while maintaining accuracy, integrity, and quality of data. This device has been used in over 400 participants to date as part of one of the most comprehensive studies examining the relationship between intra-abdominal pressure and pelvic floor disorders.
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Acknowledgements
The authors would like to thank Jens Thomsen for his assistance in firmware development of the wired IVT.
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The authors declare that they have no conflict of interest.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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Informed consent was obtained from all individual participants included in the study.
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The research protocol described was approved by the Institutional Review Boards (IRBs) at the University of Utah and Intermountain Healthcare. All participants will complete an informed consent process in either English or Spanish which will be documented in writing.
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The project described was supported by grant number 1P01HD080629 from the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Eunice Kennedy Shriver National Institute of Child Health and Human Development or the National Institutes of Health.
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Niederauer, S., de Gennaro, J., Nygaard, I. et al. Development of a novel intra-abdominal pressure transducer for large scale clinical studies. Biomed Microdevices 19, 80 (2017). https://doi.org/10.1007/s10544-017-0211-2
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DOI: https://doi.org/10.1007/s10544-017-0211-2