Clinical evaluation of a high-fidelity wireless intravaginal pressure sensor

Area of Science:

• Urogynecology
• Biomedical Engineering
• Medical Device Development

Background:

• Abdominal pressure (P(abd)) monitoring is crucial for guiding post-operative advice in women.
• Current methods use fluid-filled intrarectal catheters, which may have limitations in comfort and accuracy.
• A novel wireless intravaginal pressure sensor (IVPS) has been developed to improve P(abd) measurement.

Purpose of the Study:

• To compare the performance, comfort, retention, and acceptability of the IVPS against a standard intrarectal catheter.
• To evaluate the IVPS for measuring P(abd) changes during exercise and daily activities in a urodynamics setting.

Main Methods:

• A pilot study involving 27 women undergoing urodynamics.
• Concurrent insertion of the IVPS and a standard intrarectal catheter.
• Comparison of device comfort, retention, and acceptability using visual analogue scales and preference ratings.
• Bland-Altman analysis to assess agreement between devices for peak pressures during cough, Valsalva, and star jumps.

Main Results:

• The IVPS was preferred by 67% of participants, with significantly higher comfort scores (0.9 vs. 2.1, p=0.049).
• Moderate agreement (level of agreement) was found between the IVPS and intrarectal catheter, with wider differences during dynamic activities like star jumps.
• The IVPS demonstrated good retention and acceptability.

Conclusions:

• The wireless intravaginal pressure sensor (IVPS) offers superior comfort and preference compared to traditional intrarectal catheters for measuring abdominal pressure.
• While agreement is moderate, the IVPS's high sampling rate and reduced motion artifacts suggest potential for more accurate clinical data.
• The IVPS is a promising alternative for monitoring P(abd) in urodynamics and guiding patient care.