Characterization of Perineum Elasticity and Pubic Bone-Perineal Critical Distance with a Novel Tactile Probe: Results of an Intraobserver Reproducibility Study.

Abstract

Background: Tactile imaging provides biomechanical mapping of soft tissues. Objective biomechanical and anatomical assessment of critical structures within the vagina and pelvis may allow development and validation of a clinical tool that could assist with clinical decisions regarding obstetrical procedures and mode of delivery. Objective: To assess intraobserver reproducibility of measurements of perineal elasticity and pubic bone-perineal critical distance with a novel tactile probe in pregnant women.

Methods: An Antepartum Tactile Imager (ATI) was designed with a vaginal probe resembling a fetal skull. The probe comprises 128 tactile sensors on a double curved surface and measures 46 mm in width and 72 mm in length. The probe has a motion tracking sensor that allows acquisition of 3D tactile images. There were two arms of the study. In the first arm, biomechanical mapping of the perineum and pelvic bone location was performed in 10 non-pregnant women for purposes of demonstrating safety and feasibility. In the second arm, biomechanical mapping was performed in 10 pregnant women to explore intraobserver reproducibility. Each subject had two standardized examinations over 3 - 5 minutes by the same observer. Examination comfort and pain levels were assessed by post-procedure survey. Reproducibility was analyzed by intraclass correlation coefficients (ICC) with 95% confidence intervals and Bland-Altman plots. Bias and the 95% limits of agreement were also calculated.

Results: The safety and feasibility arm of the study demonstrated high degree of safety and tolerability and reliable acquisition of tactile signals. In the reproducibility arm, 10 pregnant women were recruited at mean gestational age of 34.2 ± 6.5 weeks. The mean perineum elasticity (Young's modulus, E) was 9.8 ± 5.9 kPa, and the mean pubic bone-perineal critical distance (D) at 20 kPa load was 34.6 ± 6.2 mm. The ICC was 0.97 [95% confidence interval (CI) 0.91, 0.99] and 0.82 [CI 0.44, 0.95] for E and D respectively, consistent with excellent intrarater agreement. The bias and the 95% limits of agreement of E were -6.3% and -29.4% to +16.7%, respectively. The bias and the 95% limits of agreement of D were -2.6% and -25.3% to +20.2%, respectively.

Conclusions: The tactile imaging data obtained in the study reproducibly characterized perineal elasticity and pubic bone-perineal critical distance. Further evaluation of this tool in clinical settings is warranted.