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.
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.
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.
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.
Introduction: In Uganda, an estimated 120 obstetrician/gynecologists serve a population of 30 million people demonstrating the need to train additional skilled clinician leaders in reproductive health. In 2012, a partnership was formed with the Mbarara Regional Referral Hospital (MRRH) in southwest Uganda and the Massachusetts General Hospital (MGH) in Boston, USA, in part to increase access to specialist training. This report presents an update in the development of a teaching conference between the institutions.
Methods: In June 2012, a didactic teleconference between the institutions was instituted. Various conferencing tools were tried: direct telephone connection, Ventrilo™ conferencing system and Skype™ via personal computer or smart phone. In Mbarara, Internet was accessed via cellular data. In Boston, Internet was accessed via hospital network or cellular data. All lectures were HIPAA compliant. PowerPoint lectures were stored in a collective Dropbox™ that could be accessed and downloaded prior to lecture dates.
Results: Over 30 months, 30 lectures were given. Lecturers included faculty and fellows from maternal fetal medicine, gynecology oncology, urogynecology, family planning, psychiatry and obstetric anesthesia. A patient case pertinent to the teaching topic framed the discussion. About 20 participants attended each lecture. Internet connectivity was the biggest challenge. Ultimately audio Skype via cellular data proved the most successful modality and became the method of choice.
Conclusion: A successful collaboration in medical education via teleconference is sustainable, low cost, and beneficial to both resource-rich and resource-poor institutions. Expertise can be shared bilaterally and internationally by individuals potentially unable travel.
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.
Objectives: Urinary incontinence (UI) impacts all aspects of life activities. This study aims to characterize change in mobility within the community utilizing the Life Space Assessment (LSA) questionnaire in women undergoing non-surgical UI treatment.
Design: Prospective cohort study, performed from July 2007 to March 2009, which followed women seeking non-surgical UI treatment and assessed their mobility and symptoms using LSA, Urogenital Distress Inventory (UDI-6), and Incontinence Impact Questionnaire (IIQ-7) at baseline and 2, 6, and 12 months post-treatment. Estimated Percent Improvement (EPI) and Patient Satisfaction Question (PSQ) were obtained post-treatment.
Setting: Outpatient tertiary-care clinic.
Participants: 70 ambulatory, community-dwelling women, aged 65 years or older, seeking non-surgical care for UI.
Intervention: Multi-component behavioral and/or pharmacologic therapies.
Measurements: We hypothesized LSA would improve with treatment. Repeated measures analysis with Tukey's HSD and backwards selection linear regression model were performed.
Results: LSA score decreased from baseline to 2 months (mean±SD; 63±29 to 56±28, p<0.001) and was sustained at 6 and 12 months (54±28, 54±28). UDI scores improved from 36±23 to 25±24, p<0.001, at 2 months, and improvement persisted at 6 and 12 months (22±22, 21±24). Improvements in UDI and patient perceived improvement in UI were not associated with LSA change. Age, race, and depression impacted LSA, which decreased 1-point for each additional year of age (p=0.004), 6-points for each point higher on the Geriatric Depression Scale (GDS) (p=0.002), and 6-points for African American race (p=0.048).
Conclusion: Decreased mobility represented by LSA was related to age, depression, and race, but not UI symptom improvement.
Objective: To determine which maternal characteristics or birth events independently predict severity of levator ani muscle (LA) tears at first vaginal birth in a longitudinal/observational investigation in a tertiary care hospital.
Sample: Ninety primiparas with at least one at risk for LA tear inclusion factor at vaginal birth: maternal age ≥ 33 years, second stage ≥ 150 minutes, macrosomia, instrumented delivery, and/or anal sphincter laceration were studied.
Methods: Magnetic Resonance Imaging (MRI) was obtained early postpartum (mean ± sd 48.9 ± 21.6 days) to identify LA tear. Severity of LA muscle fiber loss was graded on an ordinal scale of: "0" as no loss, "1" as <50% unilateral loss, "2" as ≥50% unilateral or <50% bilateral loss, and "3" as ≥50% bilateral loss. Data were analyzed using proportional odds modeling. Inclusion factors were explored as predictors of LA tear severity and at analysis episiotomy, time spent actively pushing, epidural, and oxytocin were also considered. The main outcome measures of interest included grading of severity of LA muscle fiber loss on an ordinal scale.
Results: Respective counts/percentages of women within each 0 thru 3 ordered category of LA tear severity were: "0" = 58(64%), "1" = 9(10%), "2" = 15(17%), and "3" = 8(9%). Estimates and 95% CI for significant demographic or obstetric univariate predictors of LA tear severity level were age, OR 1.093 (CI 1.012 - 1.180), p = 0.023; and time spent in active pushing, OR 1.089 (CI 1.005 - 1.180), p = 0.038. The other factors considered were not significant. There were too few women with forceps deliveries to analyze. CONCLUSION: In our enriched sample of primiparous women, 26% showed a significant LA tear. Maternal age and time spent actively pushing independently predict LA tear severity.
Objective: Smoking cessation during pregnancy is a modifiable intervention that can improve maternal and neonatal outcomes. Encouraging smoking cessation is an assessed measure of the Meaningful Use incentives to ensure best practices with the increased use of the electronic medical record (EMR). Physician EMR prompts have been used shown to be successful with preventive care but there is a paucity of data evaluating prompts within obstetrics. The objective of this study is to determine the effectiveness of enhanced smoking cessation prompts in a prenatal EMR.
Methods: A retrospective cohort study of an enhanced smoking cessation prompting system within our prenatal EMR was performed. Pregnant women who reported tobacco use at first prenatal visit were included. The number of times a smoking cessation method was offered and documented, the number of documented attempts at smoking cessation, and the final number of cigarettes smoked were compared pre and post the enhancement of the smoking cessation prompting system.
Results: 95 patients were included (48 pre-enhancement; 47 post-enhancement). Post-enhancement, the documentation of smoking cessation method offered increased (0 vs. 1, p = 0.03) and documentation of smoking cessation attempts increased (1 vs. 2, p = 0.006). There was no change in the final number of cigarettes smoked (p = 0.9).
Conclusions: Enhanced prompting systems increase documentation related to smoking cessation with no change in number of cigarettes smoked. In the era of Meaningful Use guidelines which focus on documentation in the EMR, continued research must be done to assure that software enhancements and improved documentation truly result in improved patient care.