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INTRODUCTION AND HYPOTHESIS: The objective was to evaluate the safety and effectiveness of an intrapartum electromechanical pelvic floor dilator designed to reduce the risk of levator ani muscle (LAM) avulsion during vaginal delivery. METHODS: A multicenter, randomized controlled trial enrolled nulliparous participants planning vaginal delivery. During the first stage of labor, participants were randomized to receive the intravaginal device or standard-of-care labor management. The primary effectiveness endpoint was the presence of full LAM avulsion on transperineal pelvic-floor ultrasound at 3 months. Three urogynecologists performed blinded interpretation of ultrasound images. The primary safety endpoint was adverse events (AEs) through 3 months. RESULTS: A total of 214 women were randomized to Device (n = 113) or Control (n = 101) arms. Of 113 Device assignees, 82 had a device placed, of whom 68 delivered vaginally. Of 101 Control participants, 85 delivered vaginally. At 3 months, 110 participants, 46 Device subjects who received full device treatment, and 64 Controls underwent ultrasound for the per-protocol analysis. No full LAM avulsions (0.0%) occurred in the Device group versus 7 out of 64 (10.9%) in the Control group (p = 0.040; two-tailed Fisher's test). A single maternal serious AE (laceration) was device related; no neonate serious AEs were device related. CONCLUSIONS: The pelvic floor dilator device significantly reduced the incidence of complete LAM avulsion in nulliparous individuals undergoing first vaginal childbirth. The dilator demonstrated an acceptable safety profile and was well received by recipients. Use of the intrapartum electromechanical pelvic floor dilator in laboring nulliparous individuals may reduce the rate of LAM avulsion, an injury associated with serious sequelae including pelvic organ prolapse.
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INTRODUCTION AND HYPOTHESIS: Predictors of surgical outcomes in patients with an obstetric fistula who have been operated before should be identified in order to guide surgical strategy and optimize counseling of the patient. METHODS: This retrospective study is aimed at identifying predictors of outcomes for repeat surgery in 346 patients who had been operated on before for an obstetrics fistula at the Fistula Care Center (FCC) in Lilongwe, Malawi. Repeat cases were only undertaken by advanced and expert surgeons. The primary outcome was successful anatomical closure, based on a negative postoperative dye test. The secondary outcomes involved urinary continence, based on a patient-reported questionnaire and an objective 1-h pad weight test. Logistic regression models were used to test the predictors for statistical significance. RESULTS: Successful fistula closure was achieved in 288 (83%) patients and continence was achieved in 185 (64%) patients after the first repeat attempt at the FCC. Lack of urethral involvement (Goh classification: proximity to the urethra) was shown to be a good predictor of the outcomes: fistula closure and subjective and objective continence. CONCLUSIONS: Absence of urethral involvement is an independent predictor for successful outcomes in repeat surgery for obstetric fistulas. Even in the hands of an expert surgeon, the risk of another failure in achieving anatomical closure or subjective or objective continence is between 4 and 5 times higher than when the urethra is not involved.
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Fístula Vesicovaginal , Gravidez , Feminino , Humanos , Estudos Retrospectivos , Fístula Vesicovaginal/cirurgia , Reoperação , Modelos Logísticos , Uretra , Resultado do TratamentoRESUMO
Urinary tract infections (UTIs) are one of the most common infections in women. The only proven preventive strategy for recurrent UTIs is prophylactic antibiotics. Given growing antibiotic resistance, the use of probiotics has been proposed as an alternative to antibiotics. Herein, we discuss the current evidence to support the possibility that exogenous lactobacilli may limit the pathogenicity of uropathogens such as E. coli. Probiotics appear to have a significant potential in prevention of recurrent UTI, however, additional data are needed to understand how they can be effectively used in clinical practice.
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Infecções por Escherichia coli , Probióticos , Infecções Urinárias , Escherichia coli , Infecções por Escherichia coli/prevenção & controle , Feminino , Humanos , Lactobacillus , Infecções Urinárias/prevenção & controleRESUMO
BACKGROUND: Robotic-assisted gynecologic surgery is common, but requires unique training. A validated assessment tool for evaluating trainees' robotic surgery skills is Robotic-Objective Structured Assessments of Technical Skills. OBJECTIVE: We sought to assess whether crowdsourcing can be used as an alternative to expert surgical evaluators in scoring Robotic-Objective Structured Assessments of Technical Skills. STUDY DESIGN: The Robotic Training Network produced the Robotic-Objective Structured Assessments of Technical Skills, which evaluate trainees across 5 dry lab robotic surgical drills. Robotic-Objective Structured Assessments of Technical Skills were previously validated in a study of 105 participants, where dry lab surgical drills were recorded, de-identified, and scored by 3 expert surgeons using the Robotic-Objective Structured Assessments of Technical Skills checklist. Our methods-comparison study uses these previously obtained recordings and expert surgeon scores. Mean scores per participant from each drill were separated into quartiles. Crowdworkers were trained and calibrated on Robotic-Objective Structured Assessments of Technical Skills scoring using a representative recording of a skilled and novice surgeon. Following this, 3 recordings from each scoring quartile for each drill were randomly selected. Crowdworkers evaluated the randomly selected recordings using Robotic-Objective Structured Assessments of Technical Skills. Linear mixed effects models were used to derive mean crowdsourced ratings for each drill. Pearson correlation coefficients were calculated to assess the correlation between crowdsourced and expert surgeons' ratings. RESULTS: In all, 448 crowdworkers reviewed videos from 60 dry lab drills, and completed a total of 2517 Robotic-Objective Structured Assessments of Technical Skills assessments within 16 hours. Crowdsourced Robotic-Objective Structured Assessments of Technical Skills ratings were highly correlated with expert surgeon ratings across each of the 5 dry lab drills (r ranging from 0.75-0.91). CONCLUSION: Crowdsourced assessments of recorded dry lab surgical drills using a validated assessment tool are a rapid and suitable alternative to expert surgeon evaluation.
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Crowdsourcing , Avaliação Educacional/métodos , Procedimentos Cirúrgicos em Ginecologia/educação , Procedimentos Cirúrgicos Robóticos/educação , Treinamento por Simulação , Competência Clínica , Procedimentos Cirúrgicos em Ginecologia/normas , Humanos , Índia , Modelos Lineares , México , Variações Dependentes do Observador , Procedimentos Cirúrgicos Robóticos/normas , Estados Unidos , Gravação em VídeoRESUMO
BACKGROUND: Optimal glycemic control is vital in decreasing the risk of congenital birth defects and perinatal complications in women with diabetes. Although frequent blood glucose (BG) monitoring is essential during pregnancy, studies have highlighted poor compliance and falsification of glucose readings. We designed this study to assess whether a web-based glucose monitor improves compliance, glycemic control, and patient satisfaction. METHODS: This was a prospective study of 30 women with pre-gestational diabetes. After 4 weeks of using paper logs, patients were given a web-based glucose monitor. The primary outcome of interest was the average number of BG readings prior to and during web-based implementation. Secondary outcomes included glycemic control and patient satisfaction as determined by a pre- and post-study survey. RESULTS: The number of BG readings after 2 months using the web-based meter was similar to baseline. Hemoglobin A1c (HbA1c) significantly improved and there was a trend toward improved overall glycemic values. Survey results demonstrated satisfaction with the new system, although 20% of patients felt uncomfortable with glucose values being available to providers in real time. CONCLUSIONS: Compliance with BG monitoring was similar when comparing a web-based system with written logs. Since other studies have highlighted that some glucose data from written logs are falsified, actual compliance using the web-based monitor may be improved. This study demonstrates potential patient concerns using a web-based system. Further studies should explore patient reactions to providers having real-time access to online glycemic data given our survey results.
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Automonitorização da Glicemia , Diabetes Mellitus , Feminino , Humanos , Gravidez , Automonitorização da Glicemia/métodos , Glicemia , Gestantes , Estudos Prospectivos , Satisfação Pessoal , Satisfação do Paciente , Hemoglobinas Glicadas/análise , Cooperação do Paciente , InternetRESUMO
We compared the effect of commercial vaginal douching products on Lactobacillus crispatus, L. jensenii, L. gasseri, L. iners, E. coli, and immortalized vaginal epithelial cells (VK2). All studied douching products (vinegar, iodine and baking soda based) induced epithelial cell death, and all inhibited growth of E. coli. Co-culture of vaginal epithelial cells with any of the lactobacilli immediately following exposure to douching products resulted in a trend to less human cell death. However, co-culture of epithelial cells with L. iners was associated with higher production of IL6 and IL8, and lower IL1RA regardless of presence or type of douching solution. Co-culture with L. crispatus or L. jensenii decreased IL6 production in the absence of douches, but increased IL6 production after exposure to vinegar. Douching products may be associated with epithelial disruption and inflammation, and may reduce the anti-inflammatory effects of beneficial lactobacilli.
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Epitélio/efeitos dos fármacos , Epitélio/microbiologia , Escherichia coli/efeitos dos fármacos , Lactobacillus/efeitos dos fármacos , Ducha Vaginal/efeitos adversos , Ácido Acético , Sobrevivência Celular , Técnicas de Cocultura , Citocinas/metabolismo , Feminino , Humanos , Concentração de Íons de Hidrogênio , Sistema Imunitário , Interleucina-6/biossíntese , Interleucina-8/biossíntese , Iodo , Lactobacillus crispatus , Lactobacillus gasseri , Testes de Sensibilidade Microbiana , Risco , Bicarbonato de Sódio , Infecções Urinárias/etiologia , Infecções Urinárias/prevenção & controle , Vagina/efeitos dos fármacosRESUMO
Half of postmenopausal women experience genitourinary syndrome of menopause, for which many use lubricating vaginal products. The effect of vaginal products on uropathogenic and commensal vaginal bacteria is poorly understood. We evaluated the effect of five common vaginal products (KY Jelly, Replens Silky Smooth lubricant, coconut oil, Replens Long-Lasting moisturizer or Trimo-San) on growth and viability of Escherichia coli and Lactobacillus crispatus. Bacteria were co-cultured products alone and in the presence of both vaginal epithelial cells and selected products. Bacterial growth was compared between conditions using an unpaired t-test or ANOVA, as appropriate. All products except for coconut oil significantly inhibited growth of laboratory and clinical strains of Escherichia coli (p < 0.02). Only two products (Replens Long-Lasting moisturizer and Trimo-San) significantly inhibited growth of Lactobacillus crispatus (p < 0.01), while the product Replens Silky Smooth stimulated growth (p < 0.01). Co-culture of selected products in the presence of vaginal epithelial cells eliminated the inhibitory effects of the products on E. coli. In conclusion, in vitro exposure to vaginal moisturizing and lubricating products inhibited growth of Escherichia coli, though the inhibition was mitigated by the presence of vaginal epithelial cells. Lactobacillus crispatus demonstrated less growth inhibition than Escherichia coli.
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Escherichia coli/efeitos dos fármacos , Escherichia coli/crescimento & desenvolvimento , Lactobacillus crispatus/efeitos dos fármacos , Lactobacillus crispatus/crescimento & desenvolvimento , Lubrificantes/farmacologia , Vagina/microbiologia , Aderência Bacteriana/efeitos dos fármacos , Escherichia coli/fisiologia , Feminino , Humanos , Lactobacillus crispatus/fisiologia , Viabilidade Microbiana/efeitos dos fármacos , Vagina/efeitos dos fármacosRESUMO
PURPOSE: To determine the impact of a structured multi-disciplinary management strategy on clinical outcomes in women with invasive placental disease (IPD). MATERIALS AND METHODS: This was a retrospective cohort study of consecutive women having peripartum hysterectomies with IPD over seven years. For the most recent three years, a structured multidisciplinary team (MDT) reviewed each suspected case, created a management plan, and implemented that plan. Outcomes were compared between cases delivered prior to and after the MDT process was started. RESULTS: There were 47 pregnancies with IPD, of which 31 (66.0%) were suspected antenatally and 40 (85.1%) had a prior uterine surgery. An MDT approach was performed in 19 (40.4%) cases. In the MDT group, there were longer operative times (260 min versus 181 min, p = 0.0001), less blood loss (1200 mL versus 2500 mL, p = 0.009), less administration of blood products (47.4% versus 85.7%, p = 0.005), and higher intraoperative lowest mean arterial pressures (MAPs) (57 mmHg versus 48 mmHg, p = 0.002, when compared to the No-MDT (n = 28) approach. No differences were found for other outcomes. CONCLUSION: Clinically meaningful improvements of less blood loss, fewer transfusions, and higher intraoperative MAPs suggest that MDT cases were more stable intraoperatively, which over a larger number of patients, should translate into improved outcomes.
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Equipe de Assistência ao Paciente/organização & administração , Doenças Placentárias/terapia , Adulto , Perda Sanguínea Cirúrgica/estatística & dados numéricos , Estudos de Casos e Controles , Feminino , Humanos , Histerectomia/efeitos adversos , Duração da Cirurgia , Equipe de Assistência ao Paciente/normas , Doenças Placentárias/diagnóstico , Gravidez , Estudos RetrospectivosRESUMO
Most proteins are in equilibrium with partially and globally unfolded conformations. In contrast, kinetically stable proteins (KSPs) are trapped by an energy barrier in a specific state, unable to transiently sample other conformations. Among many potential roles, it appears that kinetic stability (KS) is a feature used by nature to allow proteins to maintain activity under harsh conditions and to preserve the structure of proteins that are prone to misfolding. The biological and pathological significance of KS remains poorly understood because of the lack of simple experimental methods to identify this property and its infrequent occurrence in proteins. Based on our previous correlation between KS and a protein's resistance to the denaturing detergent SDS, we show here the application of a diagonal 2D (D2D) SDS/PAGE assay to identify KSPs in complex mixtures. We applied this method to the lysate of Escherichia coli and upon proteomics analysis have identified 50 nonredundant proteins that were SDS-resistant (i.e., kinetically stable). Structural and functional analyses of a subset (44) of these proteins with known 3D structure revealed some potential structural and functional biases toward and against KS. This simple D2D SDS/PAGE assay will allow the widespread investigation of KS, including the proteomics-level identification of KSPs in different systems, potentially leading to a better understanding of the biological and pathological significance of this intriguing property of proteins.