Abstract
Objective
To describe the development, feasibility and validity of a wireless intra-vaginal pressure transducer (IVT) which can be used to measure intra-abdominal pressure in real-world settings.
Study design
A feasibility study was conducted in sixteen physically active women to determine retention and comfort of various IVT prototype designs during activity. A criterion validity study was conducted among women undergoing urodynamic testing to determine the accuracy of the IVT prototypes when compared to accepted clinical standards.
Results
A final prototype wireless IVT was developed after four design revisions of the second generation model. The feasibility study found that women reported the final prototype comfortable to wear and easily retained during physical activity. Intra-abdominal pressure measurements from the final prototype IVT compared favorably to standard urodynamic transducers, thus confirming evidence of its utility.
Conclusion
We have successfully advanced the design of a wireless, intra-vaginal pressure transducer which provides accurate measures of intra-abdominal pressure. The final wireless IVT is better tolerated by patients and overcomes limitations of traditional urodynamic testing while laying the foundations for intra-abdominal pressure monitoring outside of the clinic environment.
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Acknowledgments
We would like to acknowledge the contribution of Jan Baker and Shirley Ranke to data collection.
Funding
Grant support acknowledgement: The project described was supported by Grant Number R01HD061787-01 from the Eunice Kennedy Schriver National Institute of Child Health and Human Development. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health.
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Yvonne Hsu is a consultant for American Medical Systems.
Robert Hitchcock is a shareholder in Catheter Connections, Inc and a consultant to Navigen Inc.
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Hsu, Y., Coleman, T.J., Hitchcock, R.W. et al. Clinical evaluation of a wireless intra-vaginal pressure transducer. Int Urogynecol J 23, 1741–1747 (2012). https://doi.org/10.1007/s00192-012-1811-2
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DOI: https://doi.org/10.1007/s00192-012-1811-2