The physical examination, including the palpation of tissue and visual assessment, has been the most prevalent and successful diagnostic technique in the history of medicine. This of course holds true for the assessment of pelvic floor disorders. However, translating a physical examination into quantifiable measures through the available means has shortcomings. Pelvic floor tissue properties are often appreciated on a physical examination and often impact our clinical judgment, but cannot be objectively measured with our current assessment tools. When the human finger palpates soft tissue, the brain tries to estimate the pressure response versus the finger motion. Let's take a look at this tissue model. It contains two separate regions that have distinct elasticities. While different tissue characteristics may be detectable with side-by-side palpation, the human finger cannot distinguish these two regions in the model if they're separated in time or space. The brain cannot remember the finer aspects of tissue elasticity reliably. We can palpate the two regions using the probe and observe the resulting 3D tactile images. The software creates these images automatically by measuring the pressure versus the tissue displacement. This allows it to quantify the tissue elasticity and calculate the local Young's modulus. The tactile imaging device offers recordable and reproducible measurements for tissue evaluation. We define tactile imaging as a medical imaging modality that translates the sense of touch into a digital image. The tactile image is a function of the pressure P that is measured at coordinates X and Y when the soft tissue surface is deformed. The tactile image is a pressure map of the examined tissue. The objective of this study is to identify new tactile imaging and muscle contraction markers to characterize female pelvic floor conditions. We designed a new vaginal tactile imaging probe. The probe has an orientation sensor, temperature sensors, and 96 sensors positioned 2.5 millimeters along both sides of the exam probe. We will present a demonstration of the technique with a silicon model for better clarity. The examination procedure includes four steps. Step one, probe insertion. This step provides the pressure responses for the anterior and posterior compartments along the entire vaginal length. We can use this information to calculate the pressure gradients in anatomical dimensions. Step two, probe elevation. This step provides the pressure responses for apical, anterior, and posterior compartments that are related to the pelvic floor support structures. We can use this information to calculate the pressure gradients in anatomical dimensions. Step three, probe rotation. This step provides the pressure patterns for the left and right sides of the vagina and the circumferential tactile image of the vaginal walls. We can use this information to detect irregularities related to underlying muscles or tissue abnormalities, such as foreign body implants, scar tissue, hypertonic muscles, etc. Step four, pelvic floor muscle contraction. This step provides the muscle dynamic pressure responses of the pelvic floor muscle contraction recorded from opposite sides along the entire vaginal length. In 2013, we enrolled 22 subjects into an observational case-controlled study. The analyzed data set includes 20 subjects aged from 41 to 70 years. A standard physical examination was performed by a urogynecologist. The tactile imaging data from all of the examinations was consolidated into a single data set with no knowledge of the subject's pelvic floor to avoid bias in data selection processing. The probe insertion reveals the tissue distribution along the anterior and posterior compartments for the entire vagina. We have identified four parameters that are potential markers for pelvic floor conditions. They demonstrate good correlations from 0.52 to 0.58 with the normal and stage 1-4 conditions. They also demonstrate changes due to patient age and parity. This step provides the pressure responses for the apical anterior and posterior compartments that are related to the pelvic floor support structures. We have identified five parameters that are potential markers for pelvic floor conditions. They demonstrate correlations from 0.34 to 0.51 with pelvic floor conditions. They also demonstrate changes due to patient age and parity. This step provides the pressure patterns for the left and right sides of the vagina. This is a circumferential tactile image from the vaginal walls. We have identified one parameter that is a potential marker for the pelvic floor conditions. This step provides the muscle dynamic pressure responses from pelvic floor muscle contractions recorded from opposite sides along the entire vagina. We have identified four parameters that are potential markers for pelvic floor conditions. The contraction capabilities of five specific pelvic floor muscles are observed using the VTI during Step 4 of the examination procedure. A typical examination consisting of four steps takes one to two minutes and the acquired data is used to generate a patient examination report. 54% of the patients classified the VTI comfort level as more comfortable than manual palpation. 36% reported it as the same. 73% of the patients classified the VTI pain as none, 24% as mildly painful, and 3% as painful. Our findings suggest that the tactile imaging markers such as pressure, pressure gradient, and dynamic pressure response during muscle contraction may be used for the quantitative characterization of female pelvic floor conditions. This research is being supported by the National Institutes of Health, National Institute of Aging. Thank you for your attention.

tactile imaging

pelvic floor disorders

probe insertion

probe rotation

observational study