Evaluating the Efficacy of Cervical Tactile Ultrasound Technique as a Predictive Tool for Spontaneous Preterm Birth

Background: Premature cervical softening and shortening may be considered an early mechanical failure that predispose to preterm birth. Purpose: This study aims to explore the applicability of an innovative cervical tactile ultrasound approach for predicting spontaneous preterm birth (sPTB). Materials and Methods: Eligible participants were women with low-risk singleton pregnancies in their second trimester, enrolled in this prospective observational study. A Cervix Monitor (CM) device was designed with a vaginal probe comprising four tactile sensors and a single ultrasound transducer operating at 5 MHz. The probe enabled the application of controllable pressure to the external cervical surface, facilitating the acquisition of stress-strain data from both anterior and posterior cervical sectors. Gestational age at delivery was recorded and compared against cervical elasticity. Results: CM examination data were analyzed for 127 women at 240/7 - 286/7 gestational weeks. sPTB was observed in 6.3% of the cases. The preterm group exhibited a lower average cervical stress-to-strain ratio (elasticity) of 0.70 ± 0.26 kPa/mm compared to the term group’s 1.63 ± 0.65 kPa/mm with a p-value of 1.1 × 10−4. Diagnostic accuracy for predicting spontaneous preterm birth based solely on cervical elasticity data was found to be 95.0% (95% CI, 88.5 - 100.0). Conclusion: These findings suggest that measuring cervical elasticity with the designed tactile ultrasound probe has the potential to predict spontaneous preterm birth in a cost-effective manner.

Tactile and Ultrasound Image Fusion for Functional Assessment of the Female Pelvic Floor

Introduction: The true etiology of pelvic organ prolapse and urinary incontinence and variations observed among individuals are not entirely understood. Tactile (stress) and ultrasound (anatomy, strain) image fusion may furnish new insights into the female pelvic floor conditions. This study aimed to explore imaging performance and clinical value of vaginal tactile and ultrasound image fusion for characterization of the female pelvic floor. Methods: A novel probe with 96 tactile and 192 ultrasound transducers was designed. Women scheduled for a urogynecological visit were considered eligible for enrollment to observational study. Intravaginal tactile and ultrasound images were acquired for vaginal wall deformations at probe insertion, elevation, rotation, Valsalva maneuver, voluntary contractions, involuntary relaxation, and reflex pelvic muscle contractions. Biomechanical mapping has included tactile/ultrasound imaging and functional imaging. Results: Twenty women were successfully studied with the probe. Tactile and ultrasound images for tissues deformation as well as functional images were recorded. Tactile (stress) and ultrasound (strain) images allowed creation of stress-strain maps for the tissues of interest in absolute scale. Functional images allowed identification of active pelvic structures and their biomechanical characterization (anatomical measurements, contractive mobility and strength). Fusion of the modalities has allowed recognition and characterization of levator ani muscles (pubococcygeal, puborectal, iliococcygeal), perineum, urethral and anorectal complexes critical in prolapse and/or incontinence development. Conclusions: Vaginal tactile and ultrasound image fusion provides unique data for biomechanical characterization of the female pelvic floor. Bringing novel biomechanical characterization for critical soft tissues/structures may provide extended scientific knowledge and improve clinical practice.

Biomechanical Mapping of the Female Pelvic Floor: Prolapse versus Normal Conditions

Background: Quantitative biomechanical characterization of pelvic supportive structures and functions in vivo is thought to provide insight into pathophysiology of pelvic organ prolapse (POP). An innovative approach—vaginal tactile imaging—allows biomechanical mapping of the female pelvic floor to quantify tissue elasticity, pelvic support, and pelvic muscle functions. The Vaginal Tactile Imager (VTI) records high definition pressure patterns from vaginal walls under an applied tissue deformation and during pelvic floor muscle contractions. Objective: To explore an extended set of 52 biomechanical parameters for differentiation and characterization of POP relative to normal pelvic floor conditions. Methods: 96 subjects with normal and POP conditions were included in the data analysis from multi-site observational, case-controlled studies;42 subjects had normal pelvic floor conditions and 54 subjects had POP. The VTI, model 2S, was used with an analytical software package to calculate automatically 52 biomechanical parameters for 8 VTI test procedures (probe insertion, elevation, rotation, Valsalva maneuver, voluntary muscle contractions in 2 planes, relaxation, and reflex contraction). The groups were equalized for subject age and parity. Results: The ranges, mean values, and standard deviations for all 52 VTI parameters were established. 33 of 52 parameters were identified as statistically sensitive (p 0.05;t-test) to the POP development. Among these 33 parameters, 11 parameters show changes (decrease) in tissue elasticity, 8 parameters show deteriorations in pelvic support and 14 parameters show weakness in muscle functions for POP versus normal conditions. Conclusions: The biomechanical mapping of the female pelvic floor with the VTI provides a unique set of parameters characterizing POP versus normal conditions. These objectively measurable biomechanical transformations of pelvic tissues, support structures, and functions under POP may be used in future research and practical applications.

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

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.

Cervical Characterization with Tactile-Ultrasound Probe

Background: Premature cervical softening and shortening may be considered an early mechanical failure that predisposes to preterm birth. Preliminary clinical studies demonstrate that cervical elastography may be able to quantify this phenomenon and predict spontaneous preterm delivery. Objective: To explore a new approach for cervix elasticity and length measurements with tactile-ultrasound probe. Methods: Cervix probe has tactile array and ultrasound transducer designed to apply controllable load to cervix and acquire stress-strain data for calculation of cervical elasticity (Young’s modulus) and cervical length for four cervix sectors. Average values, standard deviations, intraclass correlation coefficients and the 95% limits of agreement (Bland-Altman plots) were estimated. Results: Ten non-pregnant and ten pregnant women were examined with the probe. The study with non-pregnant women demonstrated a reliable acquisition of the tactile signals. The ultrasound signals had a prolonged appearance;identification of the internal os of the cervix in these signals was not reliable. The study with pregnant women with the gestational age of 25.4 ± 2.3 weeks demonstrated reliable data acquisition with real-time visualization of the ultrasound signals. Average values for cervical elasticity and standard deviations of 19.7 ± 15.4 kPa and length of 30.7 ± 6.6 mm were calculated based on two measurements per 4 sectors. Measurement repeatability calculated as intraclass correlation coefficients between two measurements at the same cervix sector on pregnant women was found to be 0.97 for cervical elasticity and 0.93 for the cervical length. The 95% limits of agreement of 1) cervical elasticity were from ?22.4% to +14.9%, and 2) cervical length from ?13.3% to +16.5%. Conclusions: This study demonstrated clinically acceptable measurement performance and reproducibility. The availability of stress-strain data allowed the computation of cervical elasticity and length. This approach has the potential to provide cervical markers to predict spontaneous preterm delivery.

Tactile Imaging Markers to Characterize Female Pelvic Floor Conditions

The Vaginal Tactile Imager (VTI) records pressure patterns from vaginal walls under an applied tissue deformation and during pelvic floor muscle contractions. The objective of this study is to validate tactile imaging and muscle contraction parameters (markers) sensitive to the female pelvic floor conditions. Twenty-two women with normal and prolapse conditions were examined by a vaginal tactile imaging probe. We identified 9 parameters which were sensitive to prolapse conditions (p < 0.05 for one-way ANOVA and/or p < 0.05 for t-test with correlation factor r from -0.73 to -0.56). The list of parameters includes pressure, pressure gradient and dynamic pressure response during muscle contraction at identified locations. These parameters may be used for biomechanical characterization of female pelvic floor conditions to support an effective management of pelvic floor prolapse.