Uncovering Surface Penetration by Enterococci From Urinary Tract Infection Patients.

IMPORTANCE: The relationship between Enterococcus faecalis vaginal colonization and urinary tract infections (UTIs) remains uncertain. OBJECTIVE: We aimed to evaluate the surface invasion capability of E faecalis isolates from patients with and without UTIs as a potential readout of pathogenicity. STUDY DESIGN: Participants were females from urogynecology clinics, comprising symptomatic UTI and asymptomatic non-UTI patients, categorized by the presence or absence of E faecalis-positive cultures identified via standard urine culture techniques. Vaginal and urine samples from patients were plated on enterococci selective medium, and E faecalis isolates detected in both cohorts were species specific identified using 16S rRNA sequencing. Clinical isolates were inoculated on semisolid media, and both external colonies and underneath colony prints formed by agar-penetrating enterococci were imaged. External growth and invasiveness were quantified by determining colony-forming units of the noninvading and agar-penetrating cells and compared with the E faecalis OG1RF. RESULTS: We selected E faecalis isolates from urine and vaginal samples of 4 patients with and 4 patients without UTIs. Assays demonstrated that most isolates formed similarly sized external colonies with comparable colony-forming unit. Surface invasion differed across patients and isolation sites compared with OG1RF. The vaginal isolate from UTI patient 1, who had the most recurrences, exhibited significantly greater agar-invading capacity compared with OG1RF. CONCLUSIONS: Our pilot study indicates that ex vivo invasion assays may unveil virulence traits in E faecalis from UTI patients. Enhanced enterococcal surface penetration could increase urogenital invasion risk. Further research is needed to correlate penetration with disease severity in a larger patient group.

Sensitivity of the NIH Toolbox to Detect Cognitive Change in Individuals With Intellectual and Developmental Disability.

BACKGROUND AND OBJECTIVE: Individuals with intellectual disability (ID) experience protracted cognitive development compared with typical youth. Sensitive measurement of cognitive change in this population is a critical need for clinical trials and other intervention studies, but well-validated outcome measures are scarce. This study's aim was to evaluate the sensitivity of the NIH Toolbox Cognition Battery (NIHTB-CB) to detect developmental changes in groups with ID-fragile X syndrome (FXS), Down syndrome (DS), and other ID (OID)-and to provide further support for its use as an outcome measure for treatment trials. METHODS: We administered the NIHTB-CB and a reference standard cross-validation measure (Stanford-Binet Intelligence Scales, Fifth Edition [SB5]) to 256 individuals with FXS, DS, and OID (ages 6-27 years). After 2 years of development, we retested 197 individuals. Group developmental changes in each cognitive domain of the NIHTB-CB and SB5 were assessed using latent change score models, and 2-year growth was evaluated at 3 age points (10, 16, and 22 years). RESULTS: Overall, effect sizes of growth measured by the NIHTB-CB tests were comparable with or exceeded those of the SB5. The NIHTB-CB showed significant gains in almost all domains in OID at younger ages (10 years), with continued gains at 16 years and stability in early adulthood (22 years). The FXS group showed delayed gains in attention and inhibitory control compared with OID. The DS group had delayed gains in receptive vocabulary compared with OID. Unlike the other groups, DS had significant growth in early adulthood in 2 domains (working memory and attention/inhibitory control). Notably, each group's pattern of NIHTB-CB growth across development corresponded to their respective pattern of SB5 growth. DISCUSSION: The NIHTB-CB is sensitive to developmental changes in individuals with ID. Comparison with levels and timing of growth on the cross-validation measure shows that the NIHTB-CB has potential to identify meaningful trajectories across cognitive domains and ID etiologies. Sensitivity to change within the context of treatment studies and delineation of clinically meaningful changes in NIHTB-CB scores, linked to daily functioning, must be established in future research to evaluate the battery more completely as a key outcome measure.

Therapeutic components of digital counseling for chronic heart failure.

Background: Task force statements support the use of cognitive behavioral therapy (CBT) and motivational interviewing (MI) to promote self-care in chronic heart failure (CHF) patients. Digital counseling interventions have the potential to complement conventional programs. However, therapeutic components of digital programs associated with improved outcomes are not clearly established. Objective: Identify therapeutic components of the Canadian e-Platform to Promote Behavioral Self-Management in Chronic Heart Failure (CHF-CePPORT) protocol that were associated with improved health-related quality of life (HRQL). Materials and methods: Ordinal logistic regression was used to identify therapeutic components of the CHF-CePPORT protocol. The primary outcome was the 12-month Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) tertile. Logistic regressions determined the association between 12-month KCCQ-OS tertile, using logon hours for key segments of the protocol, modality of content delivery, and clinical themes. Results: A total of 117 patients were enrolled in the e-Counseling arm of the CHF-CePPORT trial. Median age was 60 years (IQR 52-69). Total logon hours in the initial 4-month segment of CHF-CePPORT (Sessions 1-16) was associated with increased 12-month KCCQ-OS tertile (Odds Ratio, OR = 1.31, 95% CI, 1.1-1.5, P = 0.001). Within sessions 1-16, improved KCCQ-OS was associated with logon hours for self-assessment tools/trackers (OR = 1.49, 95% CI, 1.1-2.0, P = 0.007), and videos (OR = 1.57, 95% CI, 1.03-2.4, P = 0.04), but not for CHF information pages. Conclusion: This study highlights the importance of using evidence-based guidelines from CBT and MI as core components of digital counseling, delivered through videos and interactive tools/trackers, to improve HRQL with CHF.

Remodeling of the Enterococcal Cell Envelope during Surface Penetration Promotes Intrinsic Resistance to Stress.

Enterococcus faecalis is a normal commensal of the human gastrointestinal tract (GIT). However, upon disruption of gut homeostasis, this nonmotile bacterium can egress from its natural niche and spread to distal organs. While this translocation process can lead to life-threatening systemic infections, the underlying mechanisms remain largely unexplored. Our prior work showed that E. faecalis migration across diverse surfaces requires the formation of matrix-covered multicellular aggregates and the synthesis of exopolysaccharides, but how enterococcal cells are reprogrammed during this process is unknown. Whether surface penetration endows E. faecalis with adaptive advantages is also uncertain. Here, we report that surface penetration promotes the generation of a metabolically and phenotypically distinct E. faecalis population with an enhanced capacity to endure various forms of extracellular stress. Surface-invading enterococci demonstrated major ultrastructural alterations in their cell envelope characterized by increased membrane glycolipid content. These changes were accompanied by marked induction of specific transcriptional programs enhancing cell envelope biogenesis and glycolipid metabolism. Notably, the surface-invading population demonstrated superior tolerance to membrane-damaging antimicrobials, including daptomycin and ß-defensins produced by epithelial cells. Genetic mutations impairing glycolipid biosynthesis sensitized E. faecalis to envelope stressors and reduced the ability of this bacterium to penetrate semisolid surfaces and translocate through human intestinal epithelial cell monolayers. Our study reveals that surface penetration induces distinct transcriptional, metabolic, and ultrastructural changes that equip E. faecalis with enhanced capacity to resist external stressors and thrive in its surrounding environment. IMPORTANCE Enterococcus faecalis inhabits the GIT of multiple organisms, where its establishment could be mediated by the formation of biofilm-like aggregates. In susceptible individuals, this bacterium can overgrow and breach intestinal barriers, a process that may lead to lethal systemic infections. While the formation of multicellular aggregates promotes E. faecalis migration across surfaces, little is known about the metabolic and physiological states of the enterococci encased in these surface-penetrating structures. The present study reveals that E. faecalis cells capable of migrating through semisolid surfaces genetically reprogram their metabolism toward increased cell envelope and glycolipid biogenesis, which confers superior tolerance to membrane-damaging agents. E. faecalis's success as a pathobiont depends on its antimicrobial resistance, as well as on its rapid adaptability to overcome multiple environmental challenges. Thus, targeting adaptive genetic and/or metabolic pathways induced during E. faecalis surface penetration may be useful to better confront infections by this bacterium in the clinic.

Rare complications of pessary use: A systematic review of case reports.

Introduction: Pessaries are desirable for its overall safety profiles. Serious complications have been reported; however, there is little summative evidence. This systematic review aimed to consolidate all reported serious outcomes from pessaries usage to better identify and counsel patients who might be at higher risk of developing these adverse events. Methods: We performed a systematic literature review using search terms such as 'prolapse', 'stress urinary incontinence' and 'pessary or pessaries or pessarium' on PubMed, Embase and CINAHL. A total of 36 articles were identified. Patient-level data were extracted from case reports to further describe complications on an individual level. Results: Overall median age of the patients was 82 years (range 62-98). The most frequent complications were vesicovaginal fistula (25%, n = 9/36), rectovaginal fistula (19%, n = 7/36), vaginal impaction (11%, n = 4/36) and vaginal evisceration of small bowel through vaginal vault (8%, n = 3/36). In the vesicovaginal fistula cohort, none of the patients had a history of radiation, and two had histories of total abdominal hysterectomy (22%). In the rectovaginal fistula cohort, one patient had a history of pelvic radiation for rectal squamous cell carcinoma, and another had a history of chronic steroid use for rheumatoid arthritis. No other risk factors were reported in the other groups. Ring and Gellhorn were the most represented pessary types among the studies, 16 (44%) and 12 (33%), respectively. No complications were reported with surgical and non-surgical treatment of the complications. Conclusion: Pessaries are a reasonable and durable treatment for POP with exceedingly rare reports of severe adverse complications. The ideal candidate for pessary should have a good self-care index. Studies to determine causative factors of the more serious adverse events are needed; however, this may be difficult given the long follow-up that is required.

Role of Pessaries in the Treatment of Pelvic Organ Prolapse: A Systematic Review and Meta-analysis.

OBJECTIVE: To evaluate the existing evidence on the efficacy of pessaries in improving quality of life when used for the treatment of pelvic organ prolapse (POP). DATA SOURCES: We searched for the terms "pelvic organ prolapse" and "pessar/y/ies/ium or vaginal support device," and "safety or safe or outcome or complication or efficacy or effective or effectiveness" in PubMed, EMBASE, and CINAHL on March 16, 2020. A search was also performed on ClinicalTrials.gov , with no studies fitting our strict inclusion and exclusion criteria. METHODS OF STUDY SELECTION: Studies that reported pretreatment and posttreatment mean scores and SDs after pessary treatment for standardized questionnaires were included. Studies performed in pediatric populations, pregnancy, and use of pessaries not for prolapse were excluded. Three reviewers independently screened studies. TABULATION, INTEGRATION, AND RESULTS: Data abstraction was performed according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Data were pooled for meta-analysis when reported by at least three studies. The primary study outcome was change in mean pretreatment and posttreatment questionnaire scores, which included those for the PFDI-20 (Pelvic Floor Distress Inventory- Short Form 20), PFIQ-7 (Pelvic Floor Impact Questionnaire - Short Form 7), and subscale POPIQ (Pelvic Organ Prolapse Impact Questionnaire Long Form). A random-effects model was used to combine estimates and capture between-study heterogeneity using the I 2 -statistic. Eight studies including 627 patients were included for systematic review. The mean (SD) age was 63.0±12.2 years, and the majority of patients had stage III prolapse (48.1%) followed by stage II prolapse (43.2%) when reported. Although variable, the majority of studies conducted 3-month follow-up. A negative change in pretreatment and posttreatment scores was noted, signifying improvement after pessary use: PFDI-20 mean change -46.1 (95% CI -65.4 to -26.8); PFIQ-7 mean change -36.0 (95% CI -46.0 to -26.0); POPIQ-7 (Pelvic Organ Prolapse Impact Questionnaire-7) mean change -16.3 (95% CI -26.8 to -5.7). No significant heterogeneity was found. CONCLUSION: Based on improvements in standardized questionnaire scores, pessaries are effective treatment options for POP. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42020172618.

Implementation of international guidelines for polycystic ovary syndrome: barriers and facilitators among gynecologists and primary care providers.

Objective: To identify barriers and facilitators to the implementation of evidence-based guidelines among gynecologists and primary care physicians (PCPs) caring for women with polycystic ovary syndrome (PCOS). Design: Qualitative semi-structured interview study. Setting: Academic medical center. Patients: None. Interventions: None. Main Outcome Measures: Barriers and facilitators in the diagnosis and management of PCOS. Results: We interviewed 10 gynecologists and 8 PCPs to reach thematic saturation using a thematic analysis approach. Four themes were identified: diagnostic considerations, treatment of symptoms of PCOS, screening for long-term complications of PCOS, and counseling on long-term complications. Many gynecologists did not perform the recommended metabolic screening and were uncomfortable managing metabolic complications of PCOS. They uniformly counseled patients on the risk of endometrial hyperplasia and infertility. PCPs expressed the lack of familiarity with diagnostic criteria and often did not complete a comprehensive workup before making a diagnosis of PCOS. However, they routinely counseled patients on cardiometabolic risk and were familiar with managing the related long-term complications. Common barriers to comprehensive care delivery included the lack of knowledge and inadequate time and resources. Important facilitators included the overlap between the management of PCOS and other conditions such as obesity and abnormal uterine bleeding. Conclusions: Our study highlights the need for interventions that target the barriers identified among gynecologists and PCPs in implementing guidelines for diagnosing and managing PCOS. In conjunction with prior studies, our findings support a multidisciplinary care model for women with PCOS. Future studies should focus on implementation strategies to facilitate evidence-based care.

Adverse Events for Overactive Bladder Medications From a Public Federal Database.

IMPORTANCE: Clinical data on the use of overactive bladder (OAB) medications are limited by the physician interpretation of adverse effects rather than those that are patient reported. OBJECTIVE: The aim of the study was to evaluate the association between OAB medications and adverse drug events (ADEs) through the self-reporting U.S. Food and Drug Administration Adverse Event Report System database. STUDY DESIGN: The U.S. Food and Drug Administration Adverse Event Report System (FAERS) database was queried from 2004 to 2019. Adverse drug events were recategorized. Disproportionality analysis was used to detect the risk signals for each OAB medication and ADEs. χ 2 values were calculated to assess the association between ADEs and dosage. RESULTS: A total number of 14,102 reports were identified. The most frequently reported OAB medications were mirabegron (35%), transdermal oxybutynin (27%), and solifenacin (25%). Neuropsychiatric (NP) ADEs were highest with tolterodine and fesoterodine usage (16% and 15.6%, respectively) and transdermal oxybutynin had the lowest (6.5%). Increasing the dose of tolterodine or fesoterodine was not associated with increased NP ADEs. Oxybutynin had the highest risk of affect/mood disorder, agitation, and balance/movement disorder; however, it had the lowest risk of headache/migraine compared with all OAB medications. Mirabegron compared with all other OAB medications had the lowest risk of affect/mood disorder and agitation; however, it had the highest risk of headache and migraines. CONCLUSIONS: The FAERS database not only is a repository of ADEs but also may represent evolving prescribing habits for OAB medications. Transdermal oxybutynin had the lowest NP ADEs and may be appropriate for selected individuals.

The Role of Pessaries in the Treatment of Women With Stress Urinary Incontinence: A Systematic Review and Meta-Analysis.

IMPORTANCE: Pessaries are an important conservative therapy for stress urinary incontinence (SUI), but few studies have comprehensively evaluated their utility. OBJECTIVE: The objective of this study is to evaluate the existing evidence on the efficacy and safety of pessaries for the treatment of SUI. STUDY DESIGN: We searched for the terms "stress urinary incontinence" and "pessar/y/ies/ium" in PubMed, Embase, and Cinhal on June 10, 2020. Studies that characterized subjective and/or objective data were included. Studies performed in pediatric populations, pregnancy, and use of pessaries not for SUI were excluded. Two reviewers independently screened and assessed data quality and risk of bias according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. RESULTS: Ten studies, including 376 patients, were included. In terms of subjective outcomes, 76% of 72 patients reported feeling continent after pessary treatment compared with 0% of 86 patients surveyed before pessary use (P < 0.0001). Both Urinary Distress Inventory and Incontinence Impact Questionnaire scores decreased significantly by 46.7% (n = 155 baseline, n = 139 follow-up; P < 0.0001) and 67.8% (n = 139 baseline, n = 107 follow-up; P < 0.0001), respectively. Significant objective measures associated with pessary use included increased urethral closure pressure (n = 122; g = 0.56; 95% confidence interval [CI], -0.66 to 1.77; P < 0.049) and decreased pad weight (n = 129 baseline; n = 118 follow-up; g = -0.89; 95% CI, -1.986 to 0.19; P = 0.009). Adverse events significantly decreased at greater than 6 months follow-up compared with less than 6 months follow-up, including pain (31.5%, n = 29/92 vs 14.3%, n = 5/35; P = 0.0513) and discomfort (50%, n = 46/92 vs 29.3%, n = 12/41; P = 0.0268). CONCLUSIONS: Based on both subjective and objective measures, pessaries are an effective conservative treatment option for SUI. This supports pessary use, though larger studies with longer-term follow-up are warranted.

Can Women Accurately Predict Their Voided Volumes?

IMPORTANCE: Voiding diaries can be onerous, we sought to investigate if some women can predict their voided volumes. OBJECTIVES: The objective of this study is to determine the accuracy of estimated voided volumes and characteristics most predictive of accuracy. STUDY DESIGN: We prospectively collected data on 101 women undergoing urodynamics for lower urinary tract symptoms and/or prolapse at a tertiary care facility. Data collection included postvoid residual volume, urodynamic diagnosis, flow time and rate, and a 1-time measurement of voided volume into a blinded uroflow. Linear and logistic regression analyses were performed to examine predictors of estimated voided volume (mL). RESULTS: Mean age was 58.2 years (standard deviation, 12.8 years). The median estimated voided volume and actual voided volume were 240 and 215 mL, respectively. The average percent error was 15% (63% of patients being within a 30% margin of error and 32.7% being within a 20% margin of error). On linear regression analysis, smaller voids of 101 to 200 mL were associated with greater accuracy (R2 = 0.37 P = 0.001) and diagnosis of anxiety was associated with a higher voided volume percent error (P = 0.028). Logistic regression analysis revealed that for every 1 year increase in age, there was a 3% decrease in odds of predicting voiding volume within 30% (odds ratios, 0.97; P = 0.041). CONCLUSIONS: Nearly two-thirds of women estimated their voided volume within 30% of the actual void and one-third of women could predict within 20%. This should be taken into consideration when obtaining patient history, particularly with age and diagnosis of anxiety, and may substantiate use of voiding diaries for accurate measurement in specific populations.

No pelvic exam, no problem: patient satisfaction following the integration of comprehensive urogynecology telemedicine.

INTRODUCTION AND HYPOTHESIS: The COVID-19 pandemic revolutionized the practice of medicine, requiring rapid adoption of telemedicine. However, patient satisfaction has not been well characterized for telemedicine visits for a broad range of urogynecologic conditions. METHODS: We performed a cross-sectional survey study following a retrospective review of all urogynecologic telemedicine visits from March 1, 2020, to March 31, 2021, at a tertiary care center. The survey queried patient satisfaction using the Likert scale. Descriptive statistics and Fisher's exact analyses were performed. RESULTS: There were 256 telemedicine visits at our institution during the study period, and 88 patients (34% unadjusted response rate) completed the survey. The average age of study participants was 55 (SD 17; 24, 84) years old. The majority of patients were white (69%), lived within the five boroughs of NYC (81%), and had higher levels of education (72% with a bachelor's or professional degree). Most visits were for urinary complaints (68%), with those patients reporting greater fulfillment of urogynecologic needs compared to patients presenting with pelvic complaints (p = 0.02). There were no significant differences in satisfaction among other demographics (p > 0.05). Altogether, high satisfaction rates were noted for scheduling (99%), technology (90%), provider interaction (96%), fulfillment of personal needs (91%), and overall satisfaction (94%). CONCLUSIONS: We demonstrate high patient satisfaction for telemedicine visits in a tertiary urogynecology clinic for a variety of indications, with greater fulfillment of urogynecologic needs observed for those visits which may not necessitate an in-person exam (e.g., urinary complaint).

Characterizing Adverse Events Reporting for an Over-the-Counter Disposable Intravaginal Support Device for Stress Urinary Incontinence.

OBJECTIVES: In recent years, new intravaginal support devices for stress urinary incontinence have been introduced to the market. Although studies have demonstrated their safety and efficacy, few studies have examined adverse events attributed to their use. The objective of this study was to characterize reported adverse events for an over-the-counter intravaginal support device and determine whether further medical treatment was necessary to manage the adverse event. METHODS: We searched the Manufacturer and User Device Experience database from January 2015 to September 2020 for pertinent reported adverse events, which included the unique report key, event date, report date, event text descriptions, and resulting course of treatment. Per Manufacturer and User Device Experience database mandatory requirements, all reports were submitted by the manufacturer within 30 days of receiving the consumer's voluntary submission. RESULTS: A total of 257 reports were included for analysis. The most common reported adverse event was related to the string of the device, which broke with either removal or insertion of the device (230 of 257 [89.5%]). The majority of patients who required medical attention (133 of 257 [51.8%]) were evaluated and managed in the office setting (85 of 133 [63.9%]), whereas 37% (95 of 257) of patients were able to self-treat. CONCLUSIONS: Most complications attributed to device use were self-managed or managed in the outpatient setting. No emergent hospitalizations or deaths were attributed to their use, supporting their generally low-risk profile and high tolerability. Limitations of this review include the inability to decipher a denominator for these reported adverse events and the potential bias attributed to voluntary consumer reporting.

Incarcerated ventral wall hernia after robotic urogynecologic surgery: A case report.

Trocar site hernia is a rare complication of minimally invasive surgery, with incidence estimates varying widely. Studies have demonstrated rates of up to 1.2% in patients undergoing gynecologic surgery. Yet, little is known about hernia risk in the urogynecologic patient population who undergo robotic reconstructive surgery. Risk factors for the development of trocar site hernia include both incisional risk factors (trocar placement location, trocar diameter, intraoperative trocar manipulation) and patient risk factors (obesity, pelvic organ prolapse or other hernia). This report presents a case of large incarcerated small bowel hernia at a trocar site following robotic urogynecologic surgery and the resulting interventions, including repeat surgery, to reduce the hernia. This case should prompt urogynecologic surgeons to check port sites after extensive dissections to assess if large peritoneal or fascial defects need additional closure.

Is Nocturia Associated With Detrusor Underactivity?

OBJECTIVES: Detrusor underactivity (DU) is diagnosed using urodynamic testing. We hypothesized that nocturia is associated with detrusor underactivity. METHODS: We performed a retrospective chart review of all women who underwent urodynamic testing at our institution between 2016 and 2018. Uroflowmetry and pressure-flow study parameters were compared between women with nocturia (≥2 voids/night) and without nocturia (0-1 void/night). Detrusor underactivity was diagnosed using 3 different criteria: (1) bladder voiding efficiency (BVE) of <90%, (2) bladder contractility index of <100, and (3) a composite of three urodynamic measures (Gammie criteria). RESULTS: Of 358 women, 172 (48%) were in the nocturia group and 186 (52%) were in the no nocturia group. On uroflowmetry, median postvoid residual volume was similar (20 mL) in both groups. Median maximum flow rate (15 vs 17 mL/s, P < 0.05) and average flow rate (6 mL/s vs 7 mL/s, P < 0.05) were significantly lower in the nocturia group compared with the no nocturia group. During pressure-flow study, a significantly greater proportion of women with nocturia were unable to void around the catheter (30% vs 27%, P < 0.01). The overall rate of DU varied with the criteria used: BVE (54%), bladder contractility index (41%), and Gammie criteria (7%). The rate of DU using the BVE criteria was significantly higher in the nocturia group (63% vs 48%, P < 0.01), but no significant differences were noted using the other criteria. CONCLUSIONS: Nocturia is associated with reduced voiding efficiency in women. The diagnosis of DU using urodynamics is challenging.

Detection of COVID-19 in a Vulvar Lesion.

As new information about coronavirus disease 2019 (COVID-19) is rapidly discovered, clinicians are better equipped to make informed decisions for their patients. While current research suggests COVID-19 viral antigen is not found in vaginal secretions, its detectability in the female lower genital tract may have clinical implications for obstetric and gynecologic care for women. We present a case of a woman at 31 weeks' gestation with simultaneous upper respiratory symptoms and vulvovaginitis. She was found to have a vulvar lesion positive for severe acute respiratory syndrome-COVID by viral swab. This case shows that COVID-19 is detectable in the vulva. This may have implications for health care workers' exposure and personal protective equipment needs. While vertical transmission has largely not been reported, the presence of detectable virus in the female lower genital tract makes this a continued possibility and area of study. KEY POINTS: · COVID-19 is detectable in the female lower genital tract.. · The detection of COVID-19 in the vulva may have implications for personal protective equipment use.. · The detection of COVID-19 in vulvovaginal lesions makes vertical transmission a continued possibility..

Validation of the NIH Toolbox Cognitive Battery in intellectual disability.

OBJECTIVE: To advance the science of cognitive outcome measurement for individuals with intellectual disability (ID), we established administration guidelines and evaluated the psychometric properties of the NIH-Toolbox Cognitive Battery (NIHTB-CB) for use in clinical research. METHODS: We assessed feasibility, test-retest reliability, and convergent validity of the NIHTB-CB (measuring executive function, processing speed, memory, and language) by assessing 242 individuals with fragile X syndrome (FXS), Down syndrome (DS), and other ID, ages 6 through 25 years, with retesting completed after 1 month. To facilitate accessibility and measurement accuracy, we developed accommodations and standard assessment guidelines, documented in an e-manual. Finally, we assessed the sensitivity of the battery to expected syndrome-specific cognitive phenotypes. RESULTS: Above a mental age of 5.0 years, all tests had excellent feasibility. More varied feasibility across tests was seen between mental ages of 3 and 4 years. Reliability and convergent validity ranged from moderate to strong. Each test and the Crystallized and Fluid Composite scores correlated moderately to strongly with IQ, and the Crystallized Composite had modest correlations with adaptive behavior. The NIHTB-CB showed known-groups validity by detecting expected executive function deficits in FXS and a receptive language deficit in DS. CONCLUSION: The NIHTB-CB is a reliable and valid test battery for children and young adults with ID with a mental age of ≈5 years and above. Adaptations for very low-functioning or younger children with ID are needed for some subtests to expand the developmental range of the battery. Studies examining sensitivity to developmental and treatment changes are now warranted.

Risk of Contamination of Voided Urine Specimen in Women With Pelvic Organ Prolapse.

OBJECTIVES: The primary aim of this study was to determine if urine cultures are more likely to be contaminated in women with pelvic organ prolapse (POP). The secondary aim was to evaluate the test characteristics of a urine dipstick in women with POP. METHODS: A retrospective cohort study was conducted of women who presented to the urogynecology clinic between September 1, 2017, and August 31, 2018. Associations between the presence of POP and contaminated urine culture results were estimated using univariable and multivariable analyses. The sensitivity and specificity of a urine dipstick in women with POP were calculated. RESULTS: We included 351 women (143 with and 208 without POP). Women with POP were older (65.4 ± 15.8 vs 60.7 ± 11.0 years, P < 0.01), had a lower body mass index (26.6 ± 4.8 vs 29.2 ± 7.7 kg/m, P < 0.01), and were less likely to have recurrent urinary tract infections (3.5% vs 9.6%, P=0.03). Women with POP were more likely to have a contaminated urine culture than women without POP (55.9% vs 40.9%, P < 0.01). Rates of contaminated urine culture were higher in women with stage 3 and 4 prolapse than in women with stage 2 prolapse (59.6% vs 41.0%, P < 0.01). On multivariate analysis, the odds of contaminated urine culture remained higher in women with POP (odds ratio, 1.89; 95% confidence interval, 1.20-2.99). In women with POP, the sensitivity (23.5%) and positive predictive value (66.7%) of a urine dipstick were poor. CONCLUSIONS: Women with POP are more likely to provide a contaminated urine culture when collecting a midstream urine specimen.

Effects of mavoglurant on visual attention and pupil reactivity while viewing photographs of faces in Fragile X Syndrome.

BACKGROUND: Numerous preclinical studies have supported the theory that enhanced activation of mGluR5 signaling, due to the absence or reduction of the FMR1 protein, contributes to cognitive and behavioral deficits in patients with fragile X syndrome (FXS). However multiple phase 2 controlled trials in patients with FXS have failed to demonstrate efficacy of compounds that negatively modulate mGluR5, including two phase 2b randomized controlled trials (RCT) of mavoglurant (AFQ056, Novartis Pharma AG), when the primary measures of interest were behavioral ratings. This has cast some doubt onto the translation of the mGluR5 theory from animal models to humans with the disorder. METHODS: We evaluated social gaze behavior-a key phenotypic feature of the disorder-and sympathetic nervous system influence on pupil size using a previously-validated eye tracking paradigm as a biobehavioral probe, in 57 adolescent or adult patients with FXS at baseline and following three months of blinded treatment with one of three doses of mavoglurant or placebo, within the context of the AFQ056 RCTs. RESULTS: Patients with FXS treated with mavoglurant demonstrated increased total absolute looking time and number of fixations to the eye region while viewing human faces relative to baseline, and compared to those treated with placebo. In addition, patients had greater pupil reactivity to faces relative to baseline following mavoglurant treatment compared to placebo. DISCUSSION: The study shows that negative modulation of mGluR5 activity improves eye gaze behavior and alters sympathetically-driven reactivity to faces in patients with FXS, providing preliminary evidence of this drug's impact on behavior in humans with the disorder.