We conducted an in vivo pilot study to evaluate the pressure exerted by a feminine hygiene pad worn in the traditional way in the genital area and behind the knee, as measured using a novel pressure sensor device. The purpose was to determine whether pressure measured behind the knee correlated with genital pressure, thereby showing that behind-the-knee pressure measurements could be extrapolated to genital pressures recorded under clinical in-use conditions. Four female volunteers wore each of 3 currently marketed feminine hygiene pads and the sensors on the genital area and behind the knee while walking, sitting, and standing for approximately 2 minutes of each activity. Four participants completed the walking and sitting portions of the study and three completed the walking, sitting, and standing portions. The pressure data collected for all 3 pads in both the genital and BTK locations were similar inn both clinical tests. The preliminary results obtained in this clinical pilot study successfully confirm that pressure exerted from feminine hygiene pads in the BTK clinical test model is very similar to real product wear conditions.
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