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Depth of thermal dispersion of monopolar radiofrequency heating in the vaginal wall
Ian A Carr1, Monica Garcia1, Diane Cordray1
1US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, United States of America.
Abstract:
The use of energy-based devices to treat genitourinary syndrome of menopause, termed vaginal thermotherapy (VTT), has gained significant interest in recent years. Among the primary safety concerns of this relatively new procedure is the possibility of unintentionally heating tissues adjacent to the vaginal wall, i.e., heating too deeply. Herein we use numerical simulations to evaluate monopolar radiofrequency-based (RF) VTT specifically focusing on the resultant depth of heating through a range of input parameters. Varying RF power, exposure time, and the simulated rate of blood perfusion, we map the parameter space identifying which combinations of input parameters are likely to heat past the depth of the vaginal wall and affect adjacent tissue. We found that the device parameters commonly used in the literature are likely to heat past the vaginal wall and merit further investigation. In addition, we found that the parameter typically used to describe VTT devices, total energy delivered, does not reliably indicate the resultant depth of heat dispersion.
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