Preoperative prolapse phenotype is predictive of surgical outcome with minimally invasive sacrocolpopexy.

BACKGROUND: The gold-standard treatment for advanced pelvic organ prolapse is sacrocolpopexy. However, the preoperative features of prolapse that predict optimal outcomes are unknown. OBJECTIVE: This study aimed to develop a clinical prediction model that uses preoperative scores on the Pelvic Organ Prolapse Quantification examination to predict outcomes after minimally invasive sacrocolpopexy for stages 2, 3, and 4 uterovaginal prolapse and vaginal vault prolapse. STUDY DESIGN: A 2-institution database of pre- and postoperative variables from 881 cases of minimally invasive sacrocolpopexy was analyzed. Data from patients were analyzed in the following 4 groups: stage 2 uterovaginal prolapse, stage 3 to 4 uterovaginal prolapse, stage 2 vaginal vault prolapse, and stage 3 to 4 vaginal vault prolapse. Unsupervised machine learning was used to identify clusters and investigate associations between clusters and outcome. The k-means clustering analysis was performed with preoperative Pelvic Organ Prolapse Quantification points and stratified by previous hysterectomy status. The "optimal" surgical outcome was defined as postoperative Pelvic Organ Prolapse Quantification stage <2. Demographic variables were compared by cluster with Student t and chi-square tests. Odds ratios were calculated to determine whether clusters could predict the outcome. Age at surgery, body mass index, and previous prolapse surgery were used for adjusted odds ratios. RESULTS: Five statistically distinct prolapse clusters (phenotypes C, A, A>P, P, and P>A) were found. These phenotypes reflected the predominant region of prolapse (apical, anterior, or posterior) and whether support was preserved in the nonpredominant region. Phenotype A (anterior compartment prolapse predominant, posterior support preserved) was found in all 4 groups of patients and was considered the reference in the analysis. In 111 patients with stage 2 uterovaginal prolapse, phenotypes A and A>P (greater anterior prolapse than posterior prolapse) were found, and patients with phenotype A were more likely than those with phenotype A>P to have an optimal surgical outcome. In 401 patients with stage 3 to 4 uterovaginal prolapse, phenotypes C (apical compartment predominant, prolapse in all compartments), A, and A>P were found, and patients with phenotype A>P were more likely than those with phenotype A to have ideal surgical outcome. In 72 patients with stage 2 vaginal vault prolapse, phenotypes A, A>P, and P (posterior compartment predominant, anterior support preserved) were found, and those with phenotype A>P were less likely to have an ideal outcome than patients with phenotype A. In 297 patients with stage 3 to 4 vaginal vault prolapse, phenotypes C, A, and P>A (prolapse greater in posterior than in anterior compartment) were found, but there were no significant differences in rate of ideal outcome between phenotypes. CONCLUSION: Five anatomic phenotypes based on preoperative Pelvic Organ Prolapse Quantification scores were present in patients with stages 2 and 3 to 4 uterovaginal prolapse and vaginal vault prolapse. These phenotypes are predictive of surgical outcome after minimally invasive sacrocolpopexy. Further work needs to confirm the presence and predictive nature of these phenotypes. In addition, whether the phenotypes represent a progression of prolapse or discrete prolapse presentations resulting from different anatomic and life course risk profiles is unknown. These phenotypes may be useful in surgical counseling and planning.

Vaginal morphology and position associated with prolapse recurrence after vaginal surgery: A secondary analysis of the DEMAND study.

OBJECTIVE: To identify vaginal morphology and position factors associated with prolapse recurrence following vaginal surgery. DESIGN: Secondary analysis of magnetic resonance images (MRI) of the Defining Mechanisms of Anterior Vaginal Wall Descent cross-sectional study. SETTING: Eight clinical sites in the US Pelvic Floor Disorders Network. POPULATION OR SAMPLE: Women who underwent vaginal mesh hysteropexy (hysteropexy) with sacrospinous fixation or vaginal hysterectomy with uterosacral ligament suspension (hysterectomy) for uterovaginal prolapse between April 2013 and February 2015. METHODS: The MRI (rest, strain) obtained 30-42 months after surgery, or earlier for participants with recurrence who desired reoperation before 30 months, were analysed. MRI-based prolapse recurrence was defined as prolapse beyond the hymen at strain on MRI. Vaginal segmentations (at rest) were used to create three-dimensional models placed in a morphometry algorithm to quantify and compare vaginal morphology (angulation, dimensions) and position. MAIN OUTCOME MEASURES: Vaginal angulation (upper, lower and upper-lower vaginal angles in the sagittal and coronal plane), dimensions (length, maximum transverse width, surface area, volume) and position (apex, mid-vagina) at rest. RESULTS: Of the 82 women analysed, 12/41 (29%) in the hysteropexy group and 22/41 (54%) in the hysterectomy group had prolapse recurrence. After hysteropexy, women with recurrence had a more laterally deviated upper vagina (p = 0.02) at rest than women with successful surgery. After hysterectomy, women with recurrence had a more inferiorly (lower) positioned vaginal apex (p = 0.01) and mid-vagina (p = 0.01) at rest than women with successful surgery. CONCLUSIONS: Vaginal angulation and position were associated with prolapse recurrence and suggestive of vaginal support mechanisms related to surgical technique and potential unaddressed anatomical defects. Future prospective studies in women before and after prolapse surgery may distinguish these two factors.

Pubococcygeal Line Versus H-line as MR Defecography Reference for Bladder Descent.

INTRODUCTION AND HYPOTHESIS: Magnetic resonance defecography imaging techniques have been used widely to study pelvic floor function and diagnose pelvic organ prolapse (POP). The aim of this study was to investigate the diagnostic accuracy of the H-line to detect bladder descent compared with the current landmark, the pubococcygeal line (PCL). METHODS: In this retrospective cohort study, patients who underwent MR defecography in our medical center and were diagnosed with moderate to severe cystocele by radiological measurements were recruited. One rest image and one maximum evacuation image for each subject were used for the following measurements: bladder base perpendicular distance from the genital hiatus (GH), indicative of clinically significant bladder descent, PCL as the current radiological reference line, and the H-line, or minimal levator hiatus line, indicative of pelvic floor muscle and connective tissue support. Subjects were categorized as having clinically significant cystocele if the "bladder base" reached within 1 cm or lower of the GH (stage II or higher cystocele). A comparison was performed to assess differences and predictive capabilities of the reference lines relative to the GH measure. RESULTS: Seventy subjects were included, 30 with clinically significant bladder descent based on distance to GH. Women with bladder descent were older (64.0 ± 11.8 vs 51.2 ± 15.6, p < 0.001), had increased parity (3 [1-7] vs 2 [0-5], p = 0.009), and had a bladder that descended lower than the H-line at rest (1.9 ± 0.5 vs 2.2 ± 0.4, p = 0.003) and evacuation (-2.4 ± 1.6 vs -0.7 ± 1.1, p < 0.001). Multivariate regression analysis confirmed that age, length of the H-line at evacuation, the perpendicular distances between the H-line and the lowest bladder point at rest, and the PCL to the lowest bladder point at evacuation significantly correlated with bladder descent. Receiver operating characteristic analysis was used to identify a measurement threshold to diagnose clinically significant cystocele for both measurements, bladder base to the H-line: -1.2 (80.0, 72.5) area under the curve (AUC) 0.82, and bladder base PCL: -3.3 (77.8, 79.5) AUC 0.86. CONCLUSION: Our data support the application of using the minimal levator hiatus plane and specifically the H-line as a reliable landmark to diagnose bladder descent using MR defecography imaging.

Multimodal measurements of levator bowl volume in nulligravid asymptomatic women: endovaginal ultrasound versus MRI.

INTRODUCTION AND HYPOTHESIS: Measurements of levator bowl volume using advanced imaging, may be predictive of pelvic floor muscle function. The aim of this study was to compare the volume of the levator bowl using both magnetic resonance imaging (MRI) and endovaginal ultrasound (EVU) of healthy asymptomatic women. METHODS: All participants underwent a comprehensive interview including completion of the Pelvic Floor Distress Inventory Questionnaire-20 questionnaire, pelvic examination with a pelvic organ prolapse quantification evaluation, MRI, and EVU. The pelvic floor was segmented using Slicer and the MRI segmentations were trimmed using two methods: soft-tissue landmarks and the field of view (FOV) of the ultrasound volume. The levator bowl volume of the 3D segmented shapes was measured using Blender's 3D printing toolkit. Normality was tested using the Shapiro-Wilks test and comparisons were made using self-paired t tests. RESULTS: The final analysis included 19 patients. Levator bowl volume measured via MRI was larger than that measured in EVU (46.1 ± 7.9 cm3 vs 27.4 ± 5.9 cm3, p<0.001). Reducing the FOV of the MRI to that of EVU caused the MRI volume to be much closer to the EVU volume (35.5 ± 3.3 cm3 vs 27.4 ± 5.9 cm3, p<0.001); however, it remained significantly larger. CONCLUSION: Levator bowl volume measured using MRI was larger than that measured using EVU no matter the method of delineation of the levator muscles. Although EVU is safe, cheap, and easy to perform, it captures a smaller volume of levator bowel than MRI.

Quantifying the effect of an endo-vaginal probe on position of the pelvic floor viscera and muscles.

INTRODUCTION AND HYPOTHESIS: Endovaginal ultrasound has long been hypothesized to have a significant effect on locations of what it visualizes. However, little work has directly quantified its effect. This study aimed to quantify it. METHODS: This cross-sectional study consisted of 20 healthy asymptomatic volunteers who underwent both endovaginal ultrasound and MRI. The urethra, vagina, rectum, pelvic floor, and pubic bone were segmented in both ultrasound and MRI using 3DSlicer. Then, using 3DSlicer's transform tool the volumes were rigidly aligned based on the posterior curvature of the pubic bone. The organs were then split into thirds along their long axis to compare their distal, middle, and proximal sections. Using Houdini, we compared the location of the centroid of each of the urethra, vagina, and rectum and the surface-to-surface difference of the urethra and rectum. The anterior curvature of the pelvic floor was also compared. Normality of all variables was assessed by Shapiro-Wilk test. RESULTS: The largest amount of surface-to-surface distance was observed in the proximal region for the urethra and rectum. Across all three organs, the majority of the deviation was in the anterior direction for geometries obtained from ultrasound versus those from MRI. For each subject, the trace defining the midline of the levator plate was more anterior for ultrasound compared to MRI. CONCLUSIONS: While it has often been assumed that placing a probe in the vagina probably distorts the anatomy, this study quantified the distortion and displacement of the pelvic viscera. This allows for better interpretation of clinical and research findings based on this modality.

Quantifying the physiologic motions of the pelvic viscera during evacuation in nulligravid asymptomatic women.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse (POP) is often diagnosed during an in-office examination, which looks for motion of the vaginal wall while performing a strain maneuver. It is believed that the pelvic organs in adequately supported women are relatively stationary. This study was aimed at investigating the physiological displacements of pelvic organs using MR defecography. METHODS: This prospective cohort study included 19 volunteers. Midsagittal slices representing rest and the maximum movement of the posterior vaginal fornix during three maneuvers were identified. Normalized axes for analysis were defined as the x' (line connecting the inferior-posterior-most point on the pubic symphysis to the anterior edge of the sacrococcygeal joint) and the y' (line orthogonal to the x axis that passed through the sacral promontory). The positions of the posterior vaginal fornix, mid-vagina, bladder neck, anorectal junction, and hymen were recorded. These subjects were then analyzed using the current radiological grading system of POP to determine any overlap between asymptomatic subjects and diagnostic ranges of POP. RESULTS: Evacuation caused the most motion in the landmarks. The majority of the motion of the landmarks was along the y axis. The posterior vaginal fornix experienced significant descent (125% of the initial distance) without much anterior-posterior translation (7% of the initial distance) during defecation. All landmarks experienced similar trends. CONCLUSIONS: We have shown that there is significant rotational motion of the pelvic organs around the pubic bone in adequately supported women. This motion when described using radiological grading is likely to be considered mild or moderate prolapse, which may contribute to overdiagnosis of POP.

A Computational Procedure to Derive the Curve of Carus for Childbirth Computational Modeling.

Computational modeling serves an important role in childbirth-related research. Prescribed fetal descent trajectory is a key characteristic in childbirth simulations. Two major types of fully prescribed fetal descent trajectories can be identified in the literature: straight descent trajectories and curve of Carus. The straight descent trajectory has the advantage of being simpler and can serve as a reasonable approximation for relatively small fetal movements during labor, but it cannot be used to simulate the entire childbirth process. The curve of Carus is the well-recognized fetal descent trajectory with physiological significance. However, no detailed procedure to geometrically define the curve of Carus can be found in existing computational studies. This status of curve of Carus simulation in the literature hinders the direct comparison of results across different studies and the advancement of computational techniques built upon previous research. The goals of this study are: (1) propose a universal approach to derive the curve of Carus for the second stage of labor, from the point when the fetal head engages the pelvis to the point when the fetal head is fully delivered; and (2) demonstrate its utility when considering various fetal head sizes. The current study provides a detailed formulation of the curve of Carus, considering geometries of both the mother and the fetus. The maternal geometries were obtained from MRI data, and the fetal head geometries were based on laser scanning of a replica of a real fetal head.

Urethral support in female urinary continence part 1: dynamic measurements of urethral shape and motion.

INTRODUCTION AND HYPOTHESIS: Urethral closure mechanism dysfunction in female stress urinary incontinence (SUI) is poorly understood. We aimed to quantify these mechanisms through changes in urethral shape and position during squeeze (voluntary closure) and Valsalva (passive closure) via endovaginal ultrasound in women with varying SUI severity. METHODS: In this prospective cohort study, 76 women who presented to our tertiary center for urodynamic testing as preoperative assessment were recruited. Urodynamics were performed according to International Continence Society criteria. Urethral pressures were obtained during serial Valsalva maneuvers. Urethral lengths, thicknesses, and angles were measured in the midsagittal plane via dynamic anterior compartment ultrasound. Statistical shape modeling was carried out by a principal component analysis on aligned urethra shapes. RESULTS: Age, parity, and BMI did not vary by SUI group. Ultrasound detected a larger retropubic angle, urethral knee-pubic bone angle (a novel measure developed for this study), and infrapubic urethral length measurements at Valsalva in women with severe SUI (p = 0.016, 0.015, and 0.010). Shape analysis defined increased "c" shape concavity and distal wall pinching during squeeze and increased "s" shape concavity and distal wall thickening during Valsalva (p < 0.001). It also described significant urethral shape differences across SUI severity groups (p < 0.001). CONCLUSIONS: Dynamic endovaginal ultrasound can visualize and allow for quantification of voluntary and passive urethral closure and variations with SUI severity. In women with severe SUI, excessive bladder neck and distal urethra swinging during Valsalva longitudinally compressed the urethra, resulting in a proportionally thicker wall at the mid-urethra and urethral knee.

3D quantitative analysis of normal clitoral anatomy in nulliparous women by MRI.

INTRODUCTION AND HYPOTHESIS: We present a 3D computational approach for automated clitoral measurements. We hypothesized that computationally derived measurements would be comparable and less variable than reported manual measures. METHODS: In this retrospective study, MRIs of 22 nulliparous women age 20-49 years with normal vaginal and clitoral anatomy were collected. Manual segmentations were performed to reconstruct 3D models of the whole clitoris (glans, body, crura, and bulbs) and vagina. The length, width, and volume of the clitoral structures and the distance between the vagina and clitoral structures were calculated. Computed clitoral morphometrics (length, width) were compared to median [range] values from a previously published cadaver study (N = 22) using the median test and Moses extreme reaction test. Calculated distances were compared to mean (± SD) reported by a 2D MRI study (N = 20) using independent t-test and Levene's test. RESULTS: Overall, computed clitoral morphometrics were similar to manual cadaver measurements, where the majority of length and width measures had ~1-2 mm difference and had less variability (smaller range). All calculated distances were significantly smaller and had smaller SDs than manual 2D MRI values, with two-fold differences in the means and SDs. Large variation was observed in clitoral volumetric measures in our cohort. CONCLUSIONS: The proposed 3D computational method improves the standardization and consistency of clitoral measurements compared to traditional manual approaches. The use of this approach in radiographic studies will give better insight into how clitoral anatomy relates to sexual function and how both are impacted by gynecologic surgery, where outcomes can assist treatment planning.

A soft elastomer alternative to polypropylene for pelvic organ prolapse repair: a preliminary study.

INTRODUCTION AND HYPOTHESIS: We compared the impact of a mesh manufactured from the soft elastomer polydimethylsiloxane (PDMS) to that of a widely used lightweight polypropylene (PP) mesh. To achieve a similar overall device stiffness between meshes, the PDMS mesh was made with more material and therefore was heavier and less porous. We hypothesized that the soft polymer PDMS mesh, despite having more material, would have a similar impact on the vagina as the PP mesh. METHODS: PDMS and PP meshes were implanted onto the vaginas of 20 rabbits via colpopexy. Ten rabbits served as sham. At 12 weeks, mesh-vagina complexes were explanted and assessed for contractile function, histomorphology, total collagen, and glycosaminoglycan content. Outcome measures were compared using one-way ANOVA and Kruskal-Wallis testing with appropriate post-hoc testing. RESULTS: Relative to sham, vaginal contractility was reduced following the implantation of PP (p = 0.035) but not the softer PDMS (p = 0.495). PP had an overall greater negative impact on total collagen and glycosaminoglycan content, decreasing by 53% (p < 0.001) and 54% (p < 0.001) compared to reductions of 35% (p = 0.004 and p < 0.001) with PDMS. However, there were no significant differences in the contractility, collagen fiber thickness, total collagen, and glycosaminoglycan content between the two meshes. CONCLUSIONS: Despite having a substantially higher weight, PDMS had a similar impact on the vagina compared to a low-weight PP mesh, implicating soft polymers as potential alternatives to PP. The notion that heavyweight meshes are associated with a worse host response is not applicable when comparing across materials.

Comparison of 2 single incision slings on the vagina in an ovine model.

BACKGROUND: Stress urinary incontinence carries a significant healthcare burden for women worldwide. Single incision slings are minimally invasive mesh devices designed to treat stress urinary incontinence. For prolapse repair, meshes with higher porosity and lower structural stiffness have been associated with improved outcomes. OBJECTIVE: In this study, we compared the higher stiffness, lower porosity Altis sling with the lower stiffness, higher porosity Solyx sling in an ovine model. We hypothesized that SIS-B would have a negative impact on the host response. STUDY DESIGN: A total of Altis and Solyx single incision slings were implanted suburethrally into sheep according to the manufacturer's instructions on minimal tension. The mesh-urethral-vaginal complex and adjacent ungrafted vagina (no mesh control) were harvested en bloc at 3 months. Masson's trichrome and picrosirius red staining of 6 µm thin sections was performed to measure interfiber distance and tissue integration. Smooth muscle contractility to a 120 mM KCl stimulus was performed in an organ bath to measure myofiber-driven contractions. Standard biochemical assays were used to quantify glycosaminoglycan, total collagen, and elastin content, and collagen subtypes. Bending stiffness was performed in response to a uniaxial force to define susceptibility to folding/buckling. Statistical analysis was performed using Mann-Whitney, Gabriel's pairwise post hoc, Wilcoxon matched-pairs, and chi-square tests. RESULTS: The animals had similar ages (3-5 years), parity (multiparous), and weights (45-72 kg). Trichrome cross sections showed that the Altis sling buckled in a "C" or "S" shape in most samples (8 of 11), whereas buckling after Solyx sling implantation was observed in only a single sample (1 of 13; P=.004). Tissue integration, as measured by the presence of collagen or smooth muscle between the mesh fibers on trichrome 4× imaging, was increased in samples implanted with the Solyx sling compared with the Altis sling (P<.05). Total collagen content decreased significantly with both products when compared with the ungrafted vagina consistent with stress shielding. There was no difference in the 2 groups with regard to glycosaminoglycan or elastin content. The Altis sling mesh tissue complex demonstrated significantly higher amounts of both collagen types I and III than the Solyx sling-implanted tissue and the ungrafted control. Smooth muscle contractility in response to 120 mM KCl was decreased after implantation of both slings compared with the sham (P=.011 and P<.01), with no difference between mesh types (P=.099). Bending stiffness in the Altis sling was more than 4 times lower than in the Solyx, indicating an increased propensity to buckle (0.0186 vs 0.0883). CONCLUSION: The structurally stiffer Altis sling had decreased tissue integration and increased propensity to buckle after implantation. Increased collagen types I and III after the implantation of this device suggests that these changes may be associated with a fibrotic response. In contrast, the Solyx sling largely maintained a flat configuration and had improved tissue integration. The deformation of the Altis sling is not an intended effect and is likely caused by its lower bending stiffness. Both meshes induced a decrease in collagen content and smooth muscle contractility similar to previous findings for prolapse meshes and consistent with stress shielding. The long-term impact of buckling warrants further investigation.

Defining mechanisms of recurrence following apical prolapse repair based on imaging criteria.

BACKGROUND: Prolapse recurrence after transvaginal surgical repair is common; however, its mechanisms are ill-defined. A thorough understanding of how and why prolapse repairs fail is needed to address their high rate of anatomic recurrence and to develop novel therapies to overcome defined deficiencies. OBJECTIVE: This study aimed to identify mechanisms and contributors of anatomic recurrence after vaginal hysterectomy with uterosacral ligament suspension (native tissue repair) vs transvaginal mesh (VM) hysteropexy surgery for uterovaginal prolapse. STUDY DESIGN: This multicenter study was conducted in a subset of participants in a randomized clinical trial by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Overall, 94 women with uterovaginal prolapse treated via native tissue repair (n=48) or VM hysteropexy (n=46) underwent pelvic magnetic resonance imaging at rest, maximal strain, and poststrain rest (recovery) 30 to 42 months after surgery. Participants who desired reoperation before 30 to 42 months were imaged earlier to assess the impact of the index surgery. Using a novel 3-dimensional pelvic coordinate system, coregistered midsagittal images were obtained to assess study outcomes. Magnetic resonance imaging-based anatomic recurrence (failure) was defined as prolapse beyond the hymen. The primary outcome was the mechanism of failure (apical descent vs anterior vaginal wall elongation), including the frequency and site of failure. Secondary outcomes included displacement of the vaginal apex and perineal body and change in the length of the anterior wall, posterior wall, vaginal perimeter, and introitus of the vagina from rest to strain and rest to recovery. Group differences in the mechanism, frequency, and site of failure were assessed using the Fisher exact tests, and secondary outcomes were compared using Wilcoxon rank-sum tests. RESULTS: Of the 88 participants analyzed, 37 (42%) had recurrent prolapse (VM hysteropexy, 13 of 45 [29%]; native tissue repair, 24 of 43 [56%]). The most common site of failure was the anterior compartment (VM hysteropexy, 38%; native tissue repair, 92%). The primary mechanism of recurrence was apical descent (VM hysteropexy, 85%; native tissue repair, 67%). From rest to strain, failures (vs successes) had greater inferior displacement of the vaginal apex (difference, -12 mm; 95% confidence interval, -19 to -6) and perineal body (difference, -7 mm; 95% confidence interval, -11 to -4) and elongation of the anterior vaginal wall (difference, 12 mm; 95% confidence interval, 8-16) and vaginal introitus (difference, 11 mm; 95% confidence interval, 7-15). CONCLUSION: The primary mechanism of prolapse recurrence following vaginal hysterectomy with uterosacral ligament suspension or VM hysteropexy was apical descent. In addition, greater inferior descent of the vaginal apex and perineal body, lengthening of the anterior vaginal wall, and increased size of the vaginal introitus with strain were associated with anatomic failure. Further studies are needed to provide additional insight into the mechanism by which these factors contribute to anatomic failure.

Methods for the defining mechanisms of anterior vaginal wall descent (DEMAND) study.

INTRODUCTION AND HYPOTHESIS: The protocol and analysis methods for the Defining Mechanisms of Anterior Vaginal Wall Descent (DEMAND) study are presented. DEMAND was designed to identify mechanisms and contributors of prolapse recurrence after two transvaginal apical suspension procedures for uterovaginal prolapse. METHODS: DEMAND is a supplementary cohort study of a clinical trial in which women with uterovaginal prolapse randomized to (1) vaginal hysterectomy with uterosacral ligament suspension or (2) vaginal mesh hysteropexy underwent pelvic magnetic resonance imaging (MRI) at 30-42 months post-surgery. Standardized protocols have been developed to systematize MRI examinations across multiple sites and to improve reliability of MRI measurements. Anatomical failure, based on MRI, is defined as prolapse beyond the hymen. Anatomic measures from co-registered rest, maximal strain, and post-strain rest (recovery) sequences are obtained from the "true mid-sagittal" plane defined by a 3D pelvic coordinate system. The primary outcome is the mechanism of failure (apical descent versus anterior vaginal wall elongation). Secondary outcomes include displacement of the vaginal apex and perineal body and elongation of the anterior wall, posterior wall, perimeter, and introitus of the vagina between (1) rest and strain and (2) rest and recovery. RESULTS: Recruitment and MRI trials of 94 participants were completed by May 2018. CONCLUSIONS: Methods papers which detail studies designed to evaluate anatomic outcomes of prolapse surgeries are few. We describe a systematic, standardized approach to define and quantitatively assess mechanisms of anatomic failure following prolapse repair. This study will provide a better understanding of how apical prolapse repairs fail anatomically.

New Zealand white rabbit: a novel model for prolapse mesh implantation via a lumbar colpopexy.

INTRODUCTION AND HYPOTHESIS: New Zealand white rabbits are an inexpensive large-animal model. This study explored the rabbit as a model for mesh-augmented colpopexy using the intra-abdominal vagina. We hypothesized that polypropylene mesh would negatively impact rabbit vaginal smooth muscle (VSM) morphology and contractile function, similar to the nonhuman primate (NHP)-the established model for prolapse mesh evaluation. METHODS: Restorelle was implanted onto the vagina of ten rabbits via lumbar colpopexy after a hysterectomy. Ten rabbits served as sham. Twelve weeks post-implantation, the vagina was excised and VSM morphology and vaginal contractility were assessed. Outcome measures were compared using independent samples t and Mann-Whitney U tests with a Bonferroni correction, where appropriate. Results from the rabbits were compared with published NHP data. RESULTS: Animals had similar age, parity and BMI. VSM was 18% thinner after Restorelle implantation, P = 0.027. Vaginal contractility was 43% decreased in response to 120 mM KCl (P = 0.003), similar to the 46% reduction observed in the NHP vagina implanted with Restorelle (P = 0.027). Three meshes wrinkled in vivo, resulting in dramatic thinning of the underlying vagina in the area of the mesh causing a mesh exposure. CONCLUSIONS: Polypropylene mesh negatively impacts VSM morphology and vaginal contractility in the rabbit, similar to the NHP, suggesting that the rabbit may serve as an alternative large-animal model. The vaginal thinning and appearance of a mesh exposure in the area of a mesh wrinkle suggest the rabbit may also serve as a model for understanding the pathophysiology of mesh exposure.

Swine Vagina Under Planar Biaxial Loads: An Investigation of Large Deformations and Tears.

Vaginal tears are very common and can lead to severe complications such as hemorrhaging, fecal incontinence, urinary incontinence, and dyspareunia. Despite the implications of vaginal tears on women's health, there are currently no experimental studies on the tear behavior of vaginal tissue. In this study, planar equi-biaxial tests on square specimens of vaginal tissue, with sides oriented along the longitudinal direction (LD) and circumferential direction (CD), were conducted using swine as animal model. Three groups of specimens were mechanically tested: the NT group (n = 9), which had no pre-imposed tear, the longitudinal tear (LT) group (n = 9), and the circumferential tear (CT) group (n = 9), which had central pre-imposed elliptically shaped tears with major axes oriented in the LD and the CD, respectively. Through video recording during testing, axial strains were measured for the NT group using the digital image correlation (DIC) technique and axial displacements of hook clamps were measured for the NT, LT, and CT groups in the LD and CD. The swine vaginal tissue was found to be highly nonlinear and somewhat anisotropic. Up to normalized axial hook displacements of 1.15, no tears were observed to propagate, suggesting that the vagina has a high resistance to further tearing once a tear has occurred. However, in response to biaxial loading, the size of the tears for the CT group increased significantly more than the size of the tears for the LT group (p = 0.003). The microstructural organization of the vagina is likely the culprit for its tear resistance and orientation-dependent tear behavior. Further knowledge on the structure-function relationship of the vagina is needed to guide the development of new methods for preventing the severe complications of tearing.

Deformation of Transvaginal Mesh in Response to Multiaxial Loading.

Synthetic mesh for pelvic organ prolapse (POP) repair is associated with high complication rates. While current devices incorporate large pores (>1 mm), recent studies have shown that uniaxial loading of mesh reduces pore size, raising the risk for complications. However, it is difficult to translate uniaxial results to transvaginal meshes, as in vivo loading is multidirectional. Thus, the aim of this study was to (1) experimentally characterize deformation of pore diameters in a transvaginal mesh in response to clinically relevant multidirectional loading and (2) develop a computational model to simulate mesh behavior in response to in vivo loading conditions. Tension (2.5 N) was applied to each of mesh arm to simulate surgical implantation. Two loading conditions were assessed where the angle of the applied tension was altered and image analysis was used to quantify changes in pore dimensions. A computational model was developed and used to simulate pore behavior in response to these same loading conditions and the results were compared to experimental findings. For both conditions, between 26.4% and 56.6% of all pores were found to have diameters <1 mm. Significant reductions in pore diameter were noted in the inferior arms and between the two superior arms. The computational model identified the same regions, though the model generally underestimated pore deformation. This study demonstrates that multiaxial loading applied clinically has the potential to locally reduce porosity in transvaginal mesh, increasing the risk for complications. Computational simulations show potential of predicting this behavior for more complex loading conditions.

Necking and drawing of rubber-plastic bilayer laminates.

We examine the stretching behavior of rubber-plastic composites composed of a layer of styrene-ethylene/propylene-styrene (SEPS) rubber, bonded to a layer of linear low density polyethylene (LLDPE) plastic. Dog-bone shaped samples of rubber, plastic, and rubber-plastic bilayers with rubber : plastic thickness ratio in the range of 1.2-9 were subjected to uniaxial tension tests. The degree of inhomogeneity of deformation was quantified by digital image correlation analysis of video recordings of these tests. In tension, the SEPS layer showed homogeneous deformation, whereas the LLDPE layer showed necking followed by stable drawing owing to its elastoplastic deformation behavior and post-yield strain hardening. Bilayer laminates showed behavior intermediate between the plastic and the rubber, with the degree of necking and drawing reducing as the rubber : plastic ratio increased. A simple model was developed in which the force in the bilayer was taken as the sum of forces in the plastic and the rubber layers measured independently. By applying a mechanical energy balance to this model, the changes in bilayer necking behavior with rubber thickness could be predicted qualitatively.

Preventing Mesh Pore Collapse by Designing Mesh Pores With Auxetic Geometries: A Comprehensive Evaluation Via Computational Modeling.

Pelvic organ prolapse (POP) meshes are exposed to predominately tensile loading conditions in vivo that can lead to pore collapse by 70-90%, decreasing overall porosity and providing a plausible mechanism for the contraction/shrinkage of mesh observed following implantation. To prevent pore collapse, we proposed to design synthetic meshes with a macrostructure that results in auxetic behavior, the pores expand laterally, instead of contracting when loaded. Such behavior can be achieved with a range of auxetic structures/geometries. This study utilized finite element analysis (FEA) to assess the behavior of mesh models with eight auxetic pore geometries subjected to uniaxial loading to evaluate their potential to allow for pore expansion while simultaneously providing resistance to tensile loading. Overall, substituting auxetic geometries for standard pore geometries yielded more pore expansion, but often at the expense of increased model elongation, with two of the eight auxetics not able to maintain pore expansion at higher levels of tension. Meshes with stable pore geometries that remain open with loading will afford the ingrowth of host tissue into the pores and improved integration of the mesh. Given the demonstrated ability of auxetic geometries to allow for pore size maintenance (and pore expansion), auxetically designed meshes have the potential to significantly impact surgical outcomes and decrease the likelihood of major mesh-related complications.

Female pelvic floor biomechanics: bridging the gap.

PURPOSE OF REVIEW: The pelvic floor is a complex assembly of connective tissues and striated muscles that simultaneously counteracts gravitational forces, inertial forces, and intra-abdominal pressures while maintaining the position of the pelvic organs. In 30% of women, injury or failure of the pelvic floor results in pelvic organ prolapse. Surgical treatments have high recurrence rates, due, in part, to a limited understanding of physiologic loading conditions. It is critical to apply biomechanics to help elucidate how altered loading conditions of the pelvis contribute to the development of pelvic organ prolapse and to define surgeries to restore normal support. RECENT FINDINGS: Evidence suggests the ewe is a potential animal model for studying vaginal properties and that uterosacral and cardinal ligaments experience significant creep, which may be affecting surgical outcomes. A new method of measuring ligament displacements in vivo was developed, and finite element models that simulate urethral support, pelvic floor dynamics, and the impact of episiotomies on the pelvic floor were studied. SUMMARY: The current review highlights some contributions over the past year, including mechanical testing and the creation of models, which are used to understand pelvic floor changes with loading and the impact of surgical procedures, to illustrate how biomechanics is being utilized.

Textile properties of synthetic prolapse mesh in response to uniaxial loading.

BACKGROUND: Although synthetic mesh is associated with superior anatomic outcomes for the repair of pelvic organ prolapse, the benefits of mesh have been questioned because of the relatively high complication rates. To date, the mechanisms that result in such complications are poorly understood, yet the textile characteristics of mesh products are believed to play an important role. Interestingly, the pore diameter of synthetic mesh has been shown to impact the host response after hernia repair greatly, and such findings have served as design criteria for prolapse meshes, with larger pores viewed as more favorable. Although pore size and porosity are well-characterized before implantation, the changes in these textile properties after implantation are unclear; the application of mechanical forces has the potential to greatly alter pore geometries in vivo. Understanding the impact of mechanical loading on the textile properties of mesh is essential for the development of more effective devices for prolapse repair. OBJECTIVE: The objective of this study was to determine the effect of tensile loading and pore orientation on mesh porosity and pore dimensions. STUDY DESIGN: In this study, the porosity and pore diameter of 4 currently available prolapse meshes were examined in response to uniaxial tensile loads of 0.1, 5, and 10 N while mimicking clinical loading conditions. The textile properties were compared with those observed for the unloaded mesh. Meshes included Gynemesh PS (Ethicon, Somerville, NJ), UltraPro (Artisyn; Ethicon), Restorelle (Coloplast, Minneapolis, MN), and Alyte Y-mesh (Bard, Covington, GA). In addition to the various pore geometries, 3 orientations of Restorelle (0-, 5-, 45-degree offset) and 2 orientations of UltraPro (0-, 90-degree offset) were examined. RESULTS: In response to uniaxial loading, both porosity and pore diameter dramatically decreased for most mesh products. The application of 5 N led to reductions in porosity for nearly all groups, with values decreasing by as much as 87% (P < .05). On loading to 10 N of force, nearly all mesh products that were tested were found to have porosities that approached 0% and 0 pores with diameters >1 mm. CONCLUSION: In this study, it was shown that the pore size of current prolapse meshes dramatically decreases in response to mechanical loading. These findings suggest that prolapse meshes, which are more likely to experience tensile forces in vivo relative to hernia repair meshes, have pores that are unfavorable for tissue integration after surgical tensioning and/or loading in urogynecologic surgeries. Such decreases in pore geometry support the hypothesis that regional increases in the concentration of mesh leads to an enhanced local foreign body response. Although pore deformation in transvaginal meshes requires further characterization, the findings presented here provide a mechanical understanding that can be used to recognize potential areas of concern for complex mesh geometries. Understanding mesh mechanics in response to surgical and in vivo loading conditions may provide improved design criteria for mesh and a refinement of surgical techniques, ultimately leading to better patient outcomes.