Clinical evaluation of a wireless intra-vaginal pressure transducer.

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.