The Role of Vaginal Mesh Procedures in Pelvic Organ Prolapse Surgery in View of Complication Risk

Synthetic transvaginal mesh has been employed in the treatment of pelvic organ prolapse for more than a decade. As the use of these devices increased during this period so did adverse event reporting. In 2008, the Food and Drug Administration (FDA) Public Health Notification informed physicians and patients of rising concerns with the use of synthetic transvaginal mesh. Shortly thereafter and in parallel to marked increases in adverse event reporting within the Manufacturer and User Device Experience (MAUDE), the FDA released a Safety Communication regarding urogynecologic surgical mesh use. Following this report and in the wake of increased medical industry product withdrawal, growing medicolegal concerns, patient safety, and clinical practice controversy, many gynecologists and pelvic reconstructive surgeons are left with limited long-term data, clinical guidance, and growing uncertainty regarding the role of synthetic transvaginal mesh use in pelvic organ prolapse. This paper reviews the reported complications of synthetic transvaginal mesh with an evidence-based approach as well as providing suggested guidance for the future role of its use amidst the controversy

Menstrual Blood as a Potential Source of Endometrial Derived CD3+ T Cells

Studies of T cell-mediated immunity in the human female genital tract have been problematic due to difficulties associated with the collection of mucosal samples. Consequently, most studies rely on biopsies from the lower female genital tract or remnant tissue from hysterectomies. Availability of samples from healthy women is limited, as most studies are carried out in women with underlying pathologies. Menstruation is the cyclical sloughing off of endometrial tissue, and thus it should be a source of endometrial cells without the need for a biopsy. We isolated and phenotyped T cells from menstrual and peripheral blood and from endometrial biopsy-derived tissue from healthy women to determine the types of T cells present in this compartment. Our data demonstrated that T cells isolated from menstrual blood are a heterogeneous population of cells with markers reminiscent of blood and mucosal cells as well as unique phenotypes not represented in either compartment. T cells isolated from menstrual blood expressed increased levels of HLA-DR, αEβ7 and CXCR4 and reduced levels of CD62L relative to peripheral blood. Menstrual blood CD4+ T cells were enriched for cells expressing both CCR7 and CD45RA, markers identifying naïve T cells and were functional as determined by antigen-specific intracellular cytokine production assays. These data may open new avenues of investigation for cell mediated immune studies involving the female reproductive tract without the need for biopsies

Missing Data Frequency and Correlates in Two Randomized Surgical Trials for Urinary Incontinence in Women

INTRODUCTION AND HYPOTHESIS: Missing data is frequently observed in clinical trials; high rates of missing data may jeopardize trial outcome validity. PURPOSE: We determined the rates of missing data over time, by type of data collected and compared demographic and clinical factors associated with missing data among women who participated in two large randomized clinical trials of surgery for stress urinary incontinence, the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) and the Trial of Midurethral Sling (TOMUS). METHODS: The proportions of subjects who attended and missed each follow-up visit were calculated. The chi-squared test, Fisher\u27s exact test and t test were used to compare women with and without missing data, as well as the completeness of the data for each component of the composite primary outcome. RESULTS: Data completeness for the primary outcome computation in the TOMUS trial (62.3%) was nearly double that in the SISTEr trial (35.7%). The follow-up visit attendance rate decreased over time. A higher proportion of subjects attended all follow-up visits in the TOMUS trial and overall there were fewer missing data for the period that included the primary outcome assessment at 12 months. The highest levels of complete data for the composite outcome variables were for the symptoms questionnaire (SISTEr 100 %, TOMUS 99.8%) and the urinary stress test (SISTEr 96.1%, TOMUS 96.7%). In both studies, the pad test was associated with the lowest levels of complete data (SISTEr 85.1%, TOMUS 88.3%) and approximately one in ten subjects had incomplete voiding diaries at the time of primary outcome assessment. Generally, in both studies, a higher proportion of younger subjects had missing data. This analysis lacked a patient perspective as to the reasons for missing data that could have provided additional information on subject burden, motivations for adherence and study design. In addition, we were unable to compare the effects of the different primary outcome assessment time-points in an identically designed trial. CONCLUSIONS: Missing visits and data increased with time. Questionnaire data and physical outcome data (urinary stress test) that could be assessed during a visit were least prone to missing data, whereas data for variables that required subject effort while away from the research team (pad test, voiding diary) were more likely to be missing. Older subjects were more likely to provide complete data

Functional Status in Older Women Diagnosed with Pelvic Organ Prolapse

Background—Functional status plays an important role in the comprehensive characterization of older adults. Functional limitations are associated with an increased risk of adverse treatment outcomes, but there is limited data on the prevalence of functional limitations in older women with pelvic floor disorders. Objective—The aim of the study was to describe the prevalence of functional limitations based on health status in older women with pelvic organ prolapse. Study Design—This pooled, cross-sectional study utilized data from the linked Health and Retirement Study and Medicare files between 1992 and 2008. The analysis included 890 women ≥65 years with pelvic organ prolapse. We assessed self-reported functional status, categorized in strength, upper and lower body mobility, activities of daily living, and instrumental activities of daily living domains. Functional limitations were evaluated and stratified by respondents self-reported general health status. Descriptive statistics were used to compare categorical and continuous variables, and logistic regression was used to measure differences in the odds of functional limitation by increasing age. Results—The prevalence of functional limitations was 76.2% in strength, 44.9% in upper and 65.8% in lower body mobility, 4.5% in activities of daily living and 13.6% in instrumental activities of daily living. Limitations were more prevalent in women with poor or fair health status than in women with good health status, including 91.5% vs 69.9% in strength, 72.9% vs 33.5% in upper and 88.0% vs 56.8% in lower body mobility, 11.6% vs 0.9% in activities of daily living, and 30.6% vs 6.7% in instrumental activities of daily living, all p Conclusion—Functional limitations, especially in strength and body mobility domains, are highly prevalent in older women with pelvic organ prolapse, particularly in those with poor or fair self-reported health status. Future research is necessary to evaluate if functional status affects clinical outcomes in pelvic reconstructive and gynecologic surgery and whether it should be routinely assessed in clinical decision-making when treating older women with pelvic organ prolapse

Functional Status in Older Women Diagnosed with Pelvic Organ Prolapse

Background—Functional status plays an important role in the comprehensive characterization of older adults. Functional limitations are associated with an increased risk of adverse treatment outcomes, but there is limited data on the prevalence of functional limitations in older women with pelvic floor disorders. Objective—The aim of the study was to describe the prevalence of functional limitations based on health status in older women with pelvic organ prolapse. Study Design—This pooled, cross-sectional study utilized data from the linked Health and Retirement Study and Medicare files between 1992 and 2008. The analysis included 890 women ≥65 years with pelvic organ prolapse. We assessed self-reported functional status, categorized in strength, upper and lower body mobility, activities of daily living, and instrumental activities of daily living domains. Functional limitations were evaluated and stratified by respondents self-reported general health status. Descriptive statistics were used to compare categorical and continuous variables, and logistic regression was used to measure differences in the odds of functional limitation by increasing age. Results—The prevalence of functional limitations was 76.2% in strength, 44.9% in upper and 65.8% in lower body mobility, 4.5% in activities of daily living and 13.6% in instrumental activities of daily living. Limitations were more prevalent in women with poor or fair health status than in women with good health status, including 91.5% vs 69.9% in strength, 72.9% vs 33.5% in upper and 88.0% vs 56.8% in lower body mobility, 11.6% vs 0.9% in activities of daily living, and 30.6% vs 6.7% in instrumental activities of daily living, all p Conclusion—Functional limitations, especially in strength and body mobility domains, are highly prevalent in older women with pelvic organ prolapse, particularly in those with poor or fair self-reported health status. Future research is necessary to evaluate if functional status affects clinical outcomes in pelvic reconstructive and gynecologic surgery and whether it should be routinely assessed in clinical decision-making when treating older women with pelvic organ prolapse

Incontinence pessaries: size, POPQ measures, and successful fitting

The aim of the study was to determine whether successful incontinence pessary fitting or pessary size can be predicted by specific POPQ measurements in women without advanced pelvic organ prolapse. In a multicenter study, women with stress urinary incontinence (SUI) and POPQ stage ≤2 were randomized to three treatment arms: (1) incontinence pessary, (2) behavioral therapy, or (3) both. This study evaluates incontinence pessary size, POPQ measures, and successful fitting in the 266 women assigned to treatment arms 1 and 3. Two hundred thirty-five women (92%) were successfully fitted with an incontinence ring (n = 122) or dish (n = 113). Hysterectomy, genital hiatus (GH), and GH/total vaginal length (TVL) ratios did not predict unsuccessful fitting (p > 0.05). However, mean TVL was greater in women successfully fitted (9.6 vs. 8.8 cm, p < 0.01). Final pessary diameter was not predicted by TVL, point D, or point C (p > 0.05). The vast majority of women with SUI can be successfully fitted with an incontinence pessary, but specific POPQ measures were not helpful in determining incontinence pessary size

Risk Factors for Fecal and Urinary Incontinence After Childbirth: The Childbirth and Pelvic Symptoms Study

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/73402/1/j.1572-0241.2007.01364.x.pd

Racial Differences in Pelvic Anatomy by Magnetic Resonance Imaging

To use static and dynamic magnetic resonance imaging (MRI) to compare dimensions of the bony pelvis and soft tissue structures in a sample of African-American and white women

Prevalence and Trends of Symptomatic Pelvic Floor Disorders in U.S. Women

To estimate the prevalence and trends of these pelvic floor disorders in U.S. women from 2005–2010