Heather van Raalte

One-year anatomic and quality-of-life outcomes after the Prolift procedure for treatment of posthysterectomy prolapse

OBJECTIVE To evaluate anatomic and quality-of-life outcomes at 1-year or greater after treatment of posthysterectomy prolapse with the Prolift procedure. STUDY DESIGN A retrospective repeated measures study comparing preoperative and 1-year or greater postoperative outcomes, including Pelvic Organ Prolapse Quantification measurements, Urogenital Distress Inventory, and Incontinence Impact Questionnaire scores. RESULTS Ninety-seven patients were included, with a median follow-up of 19.0 months. Forty-six anterior, 28 posterior, and 23 total Prolift procedures were performed. At 1 year, Pelvic Organ Prolapse Quantification values were significantly improved, as were scores for Incontinence Impact Questionnaire, the Urogenital Distress Inventory, and its subscales, with the greatest improvement seen in the obstructive/discomfort subscale. Anatomical success (</= stage 1 in the treated compartment) was 86.6% at follow-up. Three patients experienced recurrent apical prolapse. An additional 15 patients presented with >/= stage 2 in the untreated vaginal compartment. CONCLUSION Significant anatomic and quality-of-life improvements among patients undergoing the Prolift procedure for posthysterectomy prolapse were demonstrated.

Time to rethink: an evidence-based response from pelvic surgeons to the FDA Safety Communication: "UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse"

In July of 2011 the U.S. Food and Drug Administration (FDA) released a safety communication entitled “UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse.” The stated purpose of this communication is to inform health care providers and patients that serious complications with placement of this mesh are not rare and that it is not clear that these repairs are more effective than nonmesh repair. The comments regarding efficacy are based on a systematic review of the scientific literature from 1996–2011 conducted by the FDA. Our review of the literature during this time yields some different conclusions regarding the safety and efficacy of mesh use in prolapse repair. It may be useful to consider this information prior to making recommendations regarding mesh use in prolapse surgery according to the recent UPDATE.

Vaginal Tactile Imaging

Changes in the elasticity of the vaginal walls, connective support tissues, and muscles are thought to be significant factors in the development of pelvic organ prolapse, a highly prevalent condition affecting at least 50% of women in the United States during their lifetimes. It creates two predominant concerns specific to the biomechanical properties of pelvic support tissues: how does tissue elasticity affect the development of pelvic organ prolapse and how can functional elasticity be maintained through reconstructive surgery. We designed a prototype of vaginal tactile imager (VTI) for visualization and assessment of elastic properties of pelvic floor tissues. In this paper, we analyze applicability of tactile imaging for evaluation of reconstructive surgery results and characterization of normal and pelvic organ prolapse conditions. A pilot clinical study with 13 patients demonstrated that VTI allows imaging of vaginal walls with increased rigidity due to implanted mesh grafts following reconstructive pelvic surgery and VTI has the potential for prolapse characterization and detection.

Quality of life and surgical satisfaction after vaginal reconstructive vs obliterative surgery for the treatment of advanced pelvic organ prolapse

OBJECTIVE We sought to compare quality of life and patient satisfaction after obliterative vs reconstructive surgery. STUDY DESIGN A retrospective cohort study of women who met the following inclusion criteria: age 65 years or older, leading edge of prolapse 4 cm or greater beyond the hymen, and vaginal reconstructive or obliterative surgery. Preoperative responses to the Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7) were collected retrospectively. We then mailed the same questionnaires, and the Surgical Satisfaction Questionnaire (SSQ-8), to these subjects postoperatively. RESULTS Mode of surgery was evenly split (n = 45 per group) between the 90 patients meeting the inclusion criteria. Improvements from the preoperative to postoperative Incontinence Impact Questionnaire and Urogenital Distress Inventory were comparable as were postoperative Surgical Satisfaction Questionnaire scores. CONCLUSION Improvements in condition-specific quality of life and postoperative patient satisfaction measures are comparable in women with prolapse who undergo either reconstructive or obliterative surgery.

Quantifying vaginal tissue elasticity under normal and prolapse conditions by tactile imaging.

Introduction and hypothesisVaginal tactile imaging (VTI) is based on principles similar to those of manual palpation. The objective of this study is to assess the clinical suitability of new approach for imaging and tissue elasticity quantification under normal and prolapse conditions.MethodsThe study subjects included 31 women with normal and prolapse conditions. The tissue elasticity (Young’s modulus) was calculated from spatial gradients in the resulting 3-D tactile images.ResultsAverage values for tissue elasticity for the anterior and posterior compartments for normal conditions were 7.4 ± 4.3 kPa and 6.2 ± 3.1 kPa respectively. For Stage III prolapse the average values for tissue elasticity for anterior and posterior compartments were 1.8 ± 0.7 kPa and 1.8 ± 0.5 kPa respectively.ConclusionsVTI may serve as a means for 3-D imaging of the vagina and a quantitative assessment of vaginal tissue elasticity, providing important information for furthering our understanding of pelvic organ prolapse and surgical treatment.

Characterizing female pelvic floor conditions by tactile imaging

Introduction and hypothesisTactile imaging (TI) is the high-definition pressure mapping technology which allows recording pressure patterns from vaginal walls under applied load and during pelvic floor muscle contraction. The objective of this study was to identify new tactile imaging and muscle contraction markers to characterize female pelvic floor conditions.MethodsThe study subjects included 22 women with normal and prolapse conditions. They were examined by a new vaginal tactile imaging probe that images the entire vagina, the pelvic floor support structures, and pelvic floor muscle contractions.ResultsWe identified 11 parameters as potential markers to characterize the female pelvic floor conditions. These parameters correlate with prolapse conditions, patient age, and parity.ConclusionsOur findings suggest that the tactile imaging markers such as pressure, pressure gradient, and dynamic pressure response during muscle contraction may be used for further quantitative characterization of female pelvic floor conditions.

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.

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.

Quantitative Assessment and Interpretation of Vaginal Conditions

Introduction Few means exist to provide quantitative and reproducible assessment of vaginal conditions from biomechanical and functional standpoints. Aim To develop a new approach for quantitative biomechanical characterization of the vagina. Methods Vaginal tactile imaging (VTI) allows biomechanical assessment of soft tissue and function along the entire length of the anterior, posterior, and lateral vaginal walls. This can be done at rest, with applied vaginal deformation, and with pelvic muscle contraction. Results Data were analyzed for 42 subjects with normal pelvic floor support from an observational case-controlled clinical study. The average age was 52 years (range = 26–90 years). We introduced 8 VTI parameters to characterize vaginal conditions: (i) maximum resistance force to insertion (newtons), (ii) insertion work (millijoules), (iii) maximum stress-to-strain ratio (elasticity; kilopascals per millimeter), (iv) maximum pressure at rest (kilopascals), (v) anterior-posterior force at rest (newtons), (vi) left-right force at rest (newtons), (vii) maximum pressure at muscle contraction (kilopascals), and (viii) muscle contraction force (newtons). We observed low to moderate correlation of these parameters with subject age and no correlation with subject weight. 6 of 8 parameters demonstrated a P value less than .05 for 2 subject subsamples divided by age (≤52 vs >52 years), which means 6 VTI parameters change with age. Conclusions VTI allows biomechanical and functional characterization of the vaginal conditions that can be used for (i) understanding “normal” vaginal conditions, (ii) quantification of the deviation from normality, (iii) personalized treatment (radiofrequency, laser, or plastic surgery), and (iv) assessment of the applied treatment outcome. Egorov V, Murphy M, Lucente V, et al. Quantitative Assessment and Interpretation of Vaginal Conditions. Sex Med 2018;6:39–48.

Biomechanical paradigm and interpretation of female pelvic floor conditions before a treatment

Background Further progress in restoring a woman’s health may be possible if a patient with a damaged pelvic floor could undergo medical imaging and biomechanical diagnostic tests. The results of such tests could contribute to the analysis of multiple treatment options and suggest the optimal one for that patient. Aim To develop a new approach for the biomechanical characterization of vaginal conditions, muscles, and connective tissues in the female pelvic floor. Methods Vaginal tactile imaging (VTI) allows biomechanical assessment of the soft tissue along the entire length of the anterior, posterior, and lateral vaginal walls at rest, with manually applied deflection pressures and with muscle contraction, muscle relaxation, and Valsalva maneuver. VTI allows a large body of measurements to evaluate individual variations in tissue elasticity, support defects, as well as pelvic muscle function. Presuming that 1) the female pelvic floor organs are suspended by ligaments against which muscles contract to open or close the outlets and 2) damaged ligaments weaken the support and may reduce the force of muscle contraction, we made an attempt to characterize multiple pelvic floor structures from VTI data. Results All of the 138 women enrolled in the study were successfully examined with the VTI. The study subjects have had normal pelvic support or pelvic organ prolapse (stages I–IV). The average age of this group of subjects was 60±15 years. We transposed a set of 31 VTI parameters into a quantitative characterization of pelvic muscles and ligamentous structures. Interpretation of the acquired VTI data for normal pelvic floor support and prolapse conditions is proposed based on biomechanical assessment of the functional anatomy. Conclusion Vaginal tactile imaging allows biomechanical characterization of female pelvic floor structures and tissues in vivo, which may help to optimize treatment of the diseased conditions such as prolapse, incontinence, atrophy, and some forms of pelvic pain.