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1.
J Med Imaging (Bellingham) ; 11(4): 045001, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-39131568

RESUMO

Purpose: The measures that traditionally describe the levator hiatus (LH) are straightforward and reliable; however, they were not specifically designed to capture significant differences. Statistical shape modeling (SSM) was used to quantify LH shape variation across reproductive-age women and identify novel variables associated with LH size and shape. Approach: A retrospective study of pelvic MRIs from 19 nulliparous, 32 parous, and 12 pregnant women was performed. The LH was segmented in the plane of minimal LH dimensions. SSM was implemented. LH size was defined by the cross-sectional area, maximal transverse diameter, and anterior-posterior (A-P) diameter. Novel SSM-guided variables were defined by regions of greatest variation. Multivariate analysis of variance (MANOVA) evaluated group differences, and correlations determined relationships between size and shape variables. Results: Overall shape ( p < 0.001 ), SSM mode 2 (oval to T -shape, p = 0.002 ), mode 3 (rounder to broader anterior shape, p = 0.004 ), and maximal transverse diameter ( p = 0.003 ) significantly differed between groups. Novel anterior and posterior transverse diameters were identified at 14% and 79% of the A-P length. Anterior transverse diameter and maximal transverse diameter were strongly correlated ( r = 0.780 , p < 0.001 ), while posterior transverse diameter and maximal transverse diameter were weakly correlated ( r = 0.398 , p = 0.001 ). Conclusions: The traditional maximal transverse diameter generally corresponded with SSM findings but cannot describe anterior and posterior variation independently. The novel anterior and posterior transverse diameters represent both size and shape variation, can be easily calculated alongside traditional measures, and are more sensitive to subtle and local LH variation. Thus, they have a greater ability to serve as predictive and diagnostic parameters.

2.
JAMA Surg ; 159(8): 845-855, 2024 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-38776067

RESUMO

Importance: The optimal surgical repair of vaginal vault prolapse after hysterectomy remains undetermined. Objective: To compare the efficacy and safety of 3 surgical approaches for vaginal vault prolapse after hysterectomy. Design, Setting, and Participants: This was a multisite, 3-arm, superiority and noninferiority randomized clinical trial. Outcomes were assessed biannually up to 60 months, until the last participant reached 36 months of follow-up. Settings included 9 clinical sites in the US National Institute of Child Health and Human Development (NICHD) Pelvic Floor Disorders Network. Between February 2016 and April 2019, women with symptomatic vaginal vault prolapse after hysterectomy who desired surgical correction were randomized. Data were analyzed from November 2022 to January 2023. Interventions: Mesh-augmented (either abdominally [sacrocolpopexy] or through a vaginal incision [transvaginal mesh]) vs transvaginal native tissue repair. Main Outcomes and Measures: The primary outcome was time until composite treatment failure (including retreatment for prolapse, prolapse beyond the hymen, or prolapse symptoms) evaluated with survival models. Secondary outcomes included patient-reported symptom-specific results, objective measures, and adverse events. Results: Of 376 randomized participants (mean [SD] age, 66.1 [8.7] years), 360 (96%) had surgery, and 296 (82%) completed follow-up. Adjusted 36-month failure incidence was 28% (95% CI, 20%-37%) for sacrocolpopexy, 29% (95% CI, 21%-38%) for transvaginal mesh, and 43% (95% CI, 35%-53%) for native tissue repair. Sacrocolpopexy was found to be superior to native tissue repair (adjusted hazard ratio [aHR], 0.57; 99% CI, 0.33-0.98; P = .01). Transvaginal mesh was not statistically superior to native tissue after adjustment for multiple comparisons (aHR, 0.60; 99% CI, 0.34-1.03; P = .02) but was noninferior to sacrocolpopexy (aHR, 1.05; 97% CI, 0-1.65; P = .01). All 3 surgeries resulted in sustained benefits in subjective outcomes. Mesh exposure rates were low (4 of 120 [3%] for sacrocolpopexy and 6 of 115 [5%] for transvaginal mesh) as were the rates of dyspareunia. Conclusions and Relevance: Among participants undergoing apical repair for vaginal vault prolapse, sacrocolpopexy and transvaginal mesh resulted in similar composite failure rates at study completion; both had lower failure rates than native tissue repair, although only sacrocolpopexy met a statistically significant difference. Low rates of mesh complications and adverse events corroborated the overall safety of each approach. Trial Registration: ClinicalTrials.gov Identifier: NCT02676973.


Assuntos
Histerectomia , Prolapso de Órgão Pélvico , Telas Cirúrgicas , Humanos , Feminino , Prolapso de Órgão Pélvico/cirurgia , Pessoa de Meia-Idade , Histerectomia/métodos , Idoso , Procedimentos Cirúrgicos em Ginecologia/métodos , Complicações Pós-Operatórias/epidemiologia , Resultado do Tratamento , Vagina/cirurgia
3.
Am J Obstet Gynecol ; 231(2): 268.e1-268.e16, 2024 08.
Artigo em Inglês | MEDLINE | ID: mdl-38710268

RESUMO

BACKGROUND: Many clinical trials use systematic methodology to monitor adverse events and determine grade (severity), expectedness, and relatedness to treatments as determined by clinicians. However, patient perspectives are often not included in this process. OBJECTIVE: This study aimed to compare clinician vs patient grading of adverse event severity in a urogynecologic surgical trial. Secondary objectives were to estimate the association of patient grading of adverse events with decision-making and quality of life outcomes and to determine if patient perspective changes over time. STUDY DESIGN: This was a planned supplementary study (Patient Perspectives in Adverse Event Reporting [PPAR]) to a randomized trial comparing 3 surgical approaches to vaginal apical prolapse. In the parent trial, adverse events experienced by patients were collected per a standardized protocol every 6 months during which clinicians graded adverse event severity (mild, moderate, severe/life-threatening). In this substudy, we obtained additional longitudinal patient perspectives for 19 predetermined "PPAR adverse events." Patients provided their own severity grading (mild, moderate, severe/very severe/life-threatening) at initial assessment and at 12 and 36 months postoperatively. Clinicians and patients were masked to each other's reporting. The primary outcome was the interrater agreement (kappa statistic) for adverse event severity between the initial clinician and patient assessment, combining patient grades of mild and moderate. The association between adverse event severity and the Decision Regret Scale, Satisfaction with Decision Scale, the 12-Item Short-Form Health Survey, and Patient Global Impression of Improvement scores was assessed using the Spearman correlation coefficient (ρ) for continuous scales, the Mantel-Haenszel chi-square test for Patient Global Impression of Improvement, and t tests or chi-square tests comparing the assessments of patients who rated their adverse events or symptoms as severe with those who gave other ratings. To describe patient perspective changes over time, the intraobserver agreement was estimated for adverse event severity grade over time using weighted kappa coefficients. RESULTS: Of the 360 randomly assigned patients, 219 (61%) experienced a total of 527 PPAR adverse events (91% moderate and 9% severe/life-threatening by clinician grading). Mean patient age was 67 years; 87% were White and 12% Hispanic. Among the patients reporting any PPAR event, the most common were urinary tract infection (61%), de novo urgency urinary incontinence (35%), stress urinary incontinence (22%), and fecal incontinence (13%). Overall agreement between clinician and participant grading of severity was poor (kappa=0.24 [95% confidence interval, 0.14-0.34]). Of the 414 adverse events that clinicians graded as moderate, patients graded 120 (29%) as mild and 80 (19%) as severe. Of the 39 adverse events graded as severe by clinicians, patients graded 15 (38%) as mild or moderate. Initial patient grading of the most severe reported adverse event was mildly correlated with worse Decision Regret Scale (ρ=0.2; P=.01), 12-Item Short-Form Health Survey (ρ=-0.24; P<.01), and Patient Global Impression of Improvement (P<.01) scores. There was no association between adverse event severity and Satisfaction with Decision Scale score. Patients with an initial grading of "severe" had more regret, lower quality of life, and poorer global impressions of health than those whose worst severity grade was mild (P<.05). Agreement between the patients' initial severity ratings and their ratings at 12 months (kappa=0.48 [95% confidence interval, 0.39-0.58]) and 36 months (kappa=0.45 [95% confidence interval, 0.37-0.53]) was fair. CONCLUSION: Clinician and patient perceptions of adverse event severity are discordant. Worse severity from the patient perspective was associated with patient-centered outcomes. Including the patient perspective provides additional information for evaluating surgical procedures.


Assuntos
Qualidade de Vida , Prolapso Uterino , Humanos , Feminino , Pessoa de Meia-Idade , Prolapso Uterino/cirurgia , Idoso , Procedimentos Cirúrgicos em Ginecologia/efeitos adversos , Procedimentos Cirúrgicos em Ginecologia/métodos , Complicações Pós-Operatórias , Índice de Gravidade de Doença , Medidas de Resultados Relatados pelo Paciente , Satisfação do Paciente
4.
Urogynecology (Phila) ; 30(4): 403-405, 2024 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-38564627
5.
Obstet Gynecol ; 143(6): 767-773, 2024 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-38663014

RESUMO

The female reproductive tract undergoes dynamic changes across the life span. Congenital abnormalities, life events, and medical interventions can negatively affect the structure and function of reproductive tract organs, resulting in lifelong sequelae. The objective of regenerative gynecology is to discover and promote endogenous mechanisms by which a healthy tissue maintains overall tissue integrity after injury, after disease, or with age. In this review, we discuss some of the key state-of-the-art cell-based and scaffolding therapies that have been applied to regenerate gynecologic tissues and organs primarily in animal and tissue culture models. We further discuss the limitations of current technologies, problems of implementation and scalability, and future outlook of the field.


Assuntos
Medicina Regenerativa , Humanos , Medicina Regenerativa/métodos , Feminino , Ginecologia , Engenharia Tecidual/métodos , Animais , Genitália Feminina/fisiologia
6.
Am J Obstet Gynecol ; 231(1): 115.e1-115.e11, 2024 07.
Artigo em Inglês | MEDLINE | ID: mdl-38408622

RESUMO

BACKGROUND: Diabetes is an independent risk factor for mesh complications in women undergoing mesh-augmented surgical repairs of stress urinary incontinence and/or pelvic organ prolapse. The underlying mechanism remains unclear. OBJECTIVE: This study aimed to define the diabetes-associated alterations in the host inflammatory response to mesh and correlate them with perioperative glucose management. STUDY DESIGN: Deidentified demographics and medical records of patients who underwent mesh removal and participated in a mesh biorepository study were reviewed (n=200). In patients with diagnosed diabetes (n=25), blood glucose management before initial mesh implantation and before and after mesh removal was assessed by blood glucose and hemoglobin A1c levels. Age- and body mass index-matched tissue samples excised from patients with and without diabetes were examined. Transcriptomic profiles of immune cell markers, immune mediators, key inflammatory regulators, cell senescence, and epigenetic enzymes were determined by multiplex transcriptomic assays (NanoString). Ratios of apoptotic cells to CD68+ macrophages were examined with immunofluorescence. Protein profiles of 12 molecules involved in apoptotic cell clearance were examined with a multiplex protein assay (Luminex). RESULTS: Demographic and clinical characteristics, including duration between mesh implantation and removal, reason for removal, and type of mesh, etc., were comparable between patients with and without diabetes, except for 11.6% higher body mass index in the former (P=.005). In patients with diabetes, suboptimal management of blood glucose following mesh implantation was observed, with 59% of the patients having loosely or poorly controlled glucose before and after the mesh removal. Ongoing chronic inflammatory response was observed in the excised mesh-tissue complexes in both groups, whereas markers for M2 macrophages (Mrc1 [mannose receptor C-type 1]) and helper T cells (Cd4 [CD4 molecule]) were increasingly expressed in the diabetic vs nondiabetic group (P=.023 and .047, respectively). Furthermore, the gene expressions of proinflammatory Ccl24 (C-C motif chemokine ligand 24) and Ccl13 (C-C motif chemokine ligand 13) were upregulated by 1.5- and 1.8-fold (P=.035 and .027, respectively), whereas that of Il1a (interleukin 1 alpha) was paradoxically downregulated by 2.2-fold (P=.037) in the diabetic vs nondiabetic group. Interestingly, strong positive correlations were found between the expression of Ccl13, Setdb2 (SET domain bifurcated histone lysine methyltransferase 2), and M2 macrophage markers, and between the expression of Il1a, Fosl1 (activator protein-1 transcription factor subunit), and dendritic cell markers, suggesting the involvement of macrophages and dendritic cells in the diabetes-dysregulated proinflammatory response. Supportively, apoptotic cell clearance, which is an important function of macrophages, appeared to be impaired in the diabetic group, with a significantly increased protein level of CALR (calreticulin), an "eat-me" signal on the surface of apoptotic cells (P=.031), along with an increase of AXL (AXL receptor tyrosine kinase) (P=.030), which mediates apoptotic cell clearance. CONCLUSION: Diabetes was associated with altered long-term inflammatory response in complicated mesh implantation, particularly involving innate immune cell dysfunction. Suboptimal blood glycemic control following mesh implantation may contribute to this immune dysregulation, necessitating further mechanistic studies.


Assuntos
Prolapso de Órgão Pélvico , Telas Cirúrgicas , Incontinência Urinária por Estresse , Humanos , Feminino , Pessoa de Meia-Idade , Incontinência Urinária por Estresse/cirurgia , Idoso , Prolapso de Órgão Pélvico/cirurgia , Prolapso de Órgão Pélvico/imunologia , Glicemia/metabolismo , Inflamação , Macrófagos/metabolismo , Macrófagos/imunologia , Apoptose , Hemoglobinas Glicadas/metabolismo , Diabetes Mellitus/imunologia , Antígenos de Diferenciação Mielomonocítica/metabolismo , Complicações Pós-Operatórias/imunologia
7.
Int Urogynecol J ; 35(2): 291-301, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38252279

RESUMO

INTRODUCTION AND HYPOTHESIS: Mixed urinary incontinence (MUI) is defined by the International Urogynecology Association (IUGA) and International Continence Society as the complaint of involuntary leakage of urine associated with urgency and also with exertion, effort, sneezing or coughing. It therefore implies the coexistence of both stress urinary incontinence (SUI) and urgency urinary incontinence (UUI). MUI is a heterogeneous diagnosis that requires an assessment of its individual components of SUI and UUI. Management requires an individualised approach to the symptom components. The aim of this review is to identify the assessment/investigations and management options for MUI. METHODS: A working subcommittee from the IUGA Research & Development (R&D) Committee was created and volunteers invited from the IUGA membership. A literature review was performed to provide guidance focused on the recommended assessment and management of MUI. The document was then evaluated by the entire IUGA R&D Committee and IUGA Board of Directors and revisions made. The final document represents the IUGA R&D Committee Opinion. RESULTS: The R&D Committee MUI opinion paper provides guidance on the assessment and management of women with MUI and summarises the evidence-based recommendations. CONCLUSIONS: Mixed urinary incontinence is a complex problem and successful management requires alleviation of both the stress and urge components. Care should be individualised based on patient preferences. Further research is needed to guide patients in setting goals and to determine which component of MUI to treat first. The evidence for many of the surgical/procedural treatment options for MUI are limited and needs to be explored in more detail.


Assuntos
Incontinência Urinária por Estresse , Incontinência Urinária , Humanos , Feminino , Incontinência Urinária por Estresse/complicações , Incontinência Urinária de Urgência/diagnóstico , Incontinência Urinária de Urgência/terapia , Incontinência Urinária/diagnóstico , Incontinência Urinária/terapia , Incontinência Urinária/complicações , Tosse/complicações
8.
Ann Biomed Eng ; 52(2): 292-301, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37828266

RESUMO

Remodeling of the sacrum and coccyx to accommodate pregnancy and delivery has been hypothesized but not directly quantified. This study aimed to quantify the remodeling of the sacrum and coccyx by comparing midsagittal lengths, angles, curvature, and shape between nulliparous, pregnant, and parous women using both 2 and 3 dimensional measures. Ninety pelvic magnetic resonance images of the pelvis were retrospectively collected and segmented. Twelve length, angle, and curvature measurements were made using definitions from previous literature on the midsagittal plane to define the sacrum, coccyx, and combined sacrum-coccyx shape. These measures were followed by a statistical shape analysis, which returned modes of variation and principal component scores. A separate MANCOVA analysis was conducted for both the 2D and 3D measures. The 2D and 3D analyses agreed that pregnant women had a significantly straighter coccyx and combined sacrum/coccyx than nulliparous (9.1% and 5.6%, respectively) and parous (7.5% and 2.7%, respectively) subjects. All comparisons showed that, on average, a pregnant woman's sacrum and coccyx were significantly straighter than their nulliparous counterparts. Then after delivery, the sacrum/coccyx returned, but not completely back to a more curved configuration.


Assuntos
Cóccix , Sacro , Humanos , Feminino , Gravidez , Estudos Retrospectivos , Pelve , Imageamento por Ressonância Magnética
9.
Urogynecology (Phila) ; 30(2): 132-137, 2024 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-37428878

RESUMO

IMPORTANCE: The health care industry is a leading contributor to solid waste in the United States, and two thirds of a hospital's regulated medical waste is produced from surgery. OBJECTIVE: The primary objective was to assess the utilization of single-use disposable supplies during suburethral sling cases. STUDY DESIGN: We observed suburethral sling plus cystoscopy procedures at an academic medical center. Cases with concomitant procedures were excluded. Our primary outcome was the quantity of wasted supplies, defined as disposable supplies that were opened at the start of the procedure and were unused. Secondarily, we quantified those supplies in both weight and United States dollars. In a subset of cases, we obtained the weight of the total amount of trash generated from the procedure. RESULTS: A total of 20 cases were observed. Most frequently wasted items included an emesis basin, large ring basin, and rectangle plastic tray. Redundant supplies wasted included a 1-L sterile water bottle and, on average, 2.73 (SD, 2.34) blue towels. The sum of the weight of the wasted items among cases was 1.33 lb, associated with $9.50. The average total amount of trash produced from 11 cases was 14.13 lb (SD, 2.27). Removal of the most frequently wasted items would achieve a 9.4% reduction in solid waste produced by the case. CONCLUSIONS: A large waste burden per surgical case was produced by a minor procedure. Removal of frequently wasted items, a reduced number of towels, and smaller cystoscopy fluid bags are simple strategies that would decrease overall waste production.


Assuntos
Resíduos de Serviços de Saúde , Slings Suburetrais , Estados Unidos , Resíduos Sólidos , Centros Médicos Acadêmicos
10.
BJOG ; 131(3): 267-277, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37522240

RESUMO

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.


Assuntos
Prolapso de Órgão Pélvico , Prolapso Uterino , Feminino , Humanos , Estudos Prospectivos , Estudos Transversais , Resultado do Tratamento , Procedimentos Cirúrgicos em Ginecologia/métodos , Vagina/diagnóstico por imagem , Vagina/cirurgia , Histerectomia Vaginal , Prolapso Uterino/cirurgia , Prolapso de Órgão Pélvico/cirurgia
11.
Sci Rep ; 13(1): 21437, 2023 12 05.
Artigo em Inglês | MEDLINE | ID: mdl-38052928

RESUMO

To test the hypothesis that dysregulated wound healing is associated with Urogynecologic mesh complications, we collected vaginal cell secretions using vaginal swabs after polypropylene mesh implantation in patients with (N = 39) and without (N = 40) complication. A customized multiplex immunoassay measured markers of inflammation (MCP-1, IGFBP-1, IL-2, IL-10, IL-17, PDGF-BB, bFGF, IL-1b, IL-6, IL-12p70, TNF-α), neuroinflammation (IL-1RA, TGF-ß, IL-15, IL-18, IL-3, M-CSF), angiogenesis (VEGF), and matrix proteins (fibronectin, tenasin c, thrombospondin-2, lumican) between groups. Patients with complications were younger, heavier, implanted with mesh longer, and more likely to be ever smokers. A 5 kg/m2 BMI increase and ever-smoking were associated with a 2.4-fold and sixfold increased risk of complication, respectively. Patients with the highest tertile of bFGF, fibronectin, thrombospondin-2, TNF-ß, or VEGF had an odds ratio (OR) of 11.8 for having a mesh complication while ≥ 3 elevated had an OR of 237 while controlling for age, BMI, and smoking. The highest tertile of bFGF, thrombospondin-2, and fibronectin together perfectly indicated a complication (P < 0.0001). A receiver-operator curve for high bFGF, thrombospondin-2, and fibronectin showed excellent discrimination between complications and controls (AUC 0.87). These data provide evidence of dysregulated wound healing in mesh complications. Modifiable factors provide potential targets for patient counseling and interventions.


Assuntos
Fibronectinas , Fator A de Crescimento do Endotélio Vascular , Feminino , Humanos , Telas Cirúrgicas/efeitos adversos , Cicatrização , Trombospondinas
12.
Urogynecology (Phila) ; 29(10): 787-799, 2023 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-37733440

RESUMO

OBJECTIVE: The aim of the study was to compare 12-month subjective and objective outcomes between 3 approaches to apical pelvic organ prolapse (POP) surgery in patients presenting with uterovaginal or posthysterectomy vaginal prolapse enrolled in the Pelvic Floor Disorders Registry for Research. STUDY DESIGN: This was an analysis of a multicenter, prospective registry that collected both patient- and physician-reported data for up to 3 years after conservative (pessary) and surgical treatment for POP. Twelve-month subjective and anatomic outcomes for patients who underwent surgical treatment were extracted from the registry for analysis. Pelvic organ prolapse recurrence was defined as a composite outcome and compared between the 3 apical surgery groups (native tissue repair, sacrocolpopexy, colpocleisis) as well as the 2 reconstructive surgery groups (native tissue repair and sacrocolpopexy). RESULTS: A total of 1,153 women were enrolled in the registry and 777 (67%) opted for surgical treatment, of whom 641 underwent apical repair and were included in this analysis (404 native tissue repair, 187 sacrocolpopexy, and 50 colpocleisis). The overall incidence of recurrence was as follows: subjective 6.5%, anatomic 4.7%, retreatment 7.2%, and composite 13.6%. The incidence of recurrence was not different between the 3 surgical groups. When baseline patient characteristics were controlled for, composite POP recurrence between the native tissue and sacrocolpopexy groups remained statistically nonsignificant. Concurrent perineorrhaphy with any type of apical POP surgery was associated with a lower risk of recurrence (adjusted odds ratio, 0.43; 95% confidence interval, 0.25-0.74; P = 0.002) and prior hysterectomy was associated with a higher risk (adjusted odds ratio, 1.77, 95% confidence interval, 1.04-3.03; P = 0.036). CONCLUSION: Pelvic Floor Disorders Registry for Research participants undergoing native tissue apical POP repair, sacrocolpopexy, and colpocleisis surgery had similar rates of POP recurrence 12 months after surgery.


Assuntos
Distúrbios do Assoalho Pélvico , Prolapso de Órgão Pélvico , Prolapso Uterino , Humanos , Feminino , Gravidez , Prolapso Uterino/epidemiologia , Prolapso de Órgão Pélvico/epidemiologia , Sistema de Registros , Colpotomia
13.
J Biomech Eng ; 145(9)2023 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-37216313

RESUMO

Pelvic organ prolapse (POP) is the herniation of the pelvic organs into the vaginal space, resulting in the feeling of a bulge and organ dysfunction. Treatment of POP often involves repositioning the organs using a polypropylene mesh, which has recently been found to have relatively high rates of complications. Complications have been shown to be related to stiffness mismatches between the vagina and polypropylene, and unstable knit patterns resulting in mesh deformations with mechanical loading. To overcome these limitations, we have three-dimensional (3D)-printed a porous, monofilament membrane composed of relatively soft polycarbonate-urethane (PCU) with a stable geometry. PCU was chosen for its tunable properties as it is comprised of both hard and soft segments. The bulk mechanical properties of PCU were first characterized by testing dogbone samples, demonstrating the dependence of PCU mechanical properties on its measurement environment and the effect of print pathing. The pore dimensions and load-relative elongation response of the 3D-printed PCU membranes under monotonic tensile loading were then characterized. Finally, a fatigue study was performed on the 3D-printed membrane to evaluate durability, showing a similar fatigue resistance with a commercial synthetic mesh and hence its potential as a replacement.


Assuntos
Prolapso de Órgão Pélvico , Uretana , Feminino , Humanos , Porosidade , Polipropilenos , Teste de Materiais , Vagina
14.
Am J Obstet Gynecol ; 229(3): 269-274, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37116823

RESUMO

The climate change crisis poses a central threat to public health. The health outcomes of this crisis are well known, but lesser known to medical professionals is the role that healthcare delivery plays in worsening this crisis. The United States healthcare system is responsible for producing 10% of the total greenhouse gases. The adverse health outcomes caused by the overall healthcare system emissions in the United States is estimated to be 470,000 disability-adjusted life years lost, which is commensurate with the 44,000 to 98,000 people who die in hospitals each year in the United States as a consequence of preventable medical errors. Factors that contribute to healthcare greenhouse gas emissions include emissions from our facilities and from the purchase, transport, and use of supplies and waste. In the purview of obstetrics and gynecology, providers should minimize their use of disposable supplies, replace single-use specula with stainless steel specula, and educate themselves and operating room staff about best waste disposal practices. In addition, they can use their individual and collective voice to advocate for sustainable energy and supply practices. A transformation in the way we supply and power our hospitals is needed, and providers should be early adopters of this transformational change. Physician buy-in is essential to decrease the carbon footprint of our care. This narrative is a call to action for obstetricians and gynecologists to reduce our carbon footprint as a public health measure to uphold the quality of care we provide to women.


Assuntos
Gases de Efeito Estufa , Ginecologia , Feminino , Humanos , Gases de Efeito Estufa/análise , Pegada de Carbono , Atenção à Saúde , Salas Cirúrgicas
15.
Ann Biomed Eng ; 51(7): 1461-1470, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-36715838

RESUMO

Specific levator ani muscle imaging measures change with pregnancy and vaginal parity, though entire pelvic floor muscle complex (PFMC) shape variation related to pregnancy-induced and postpartum remodeling has never been quantified. We used statistical shape modeling to compute the 3D variation in PFMC morphology of reproductive-aged nulliparous, late pregnant, and parous women. Pelvic magnetic resonance images were collected retrospectively and PFMCs were segmented. Modes of variation and principal component scores, generated via statistical shape modeling, defined significant morphological variation. Nulliparous (have never given birth), late pregnant (3rd trimester), and parous (have given birth and not currently pregnant) PFMCs were compared via MANCOVA. The overall PFMC shape, mode 2, and mode 3 significantly differed across patient groups (p < 0.001, = 0.002, = 0.001, respectively). This statistical shape analysis described greater perineal and external anal sphincter descent, increased iliococcygeus concavity, and a proportionally wider mid-posterior levator hiatus in late pregnant compared to nulliparous and parous women. The late pregnant group was the most divergent, highlighting differences that likely reduce the mechanical burden of vaginal childbirth. This robust quantification of PFMC shape provides insight to pregnancy and postpartum remodeling and allows for generation of representative non-patient-specific PFMCs that can be used in biomechanical simulations.


Assuntos
Parto , Diafragma da Pelve , Gravidez , Humanos , Feminino , Adulto , Paridade , Diafragma da Pelve/diagnóstico por imagem , Diafragma da Pelve/fisiologia , Estudos Retrospectivos , Parto Obstétrico
16.
Int Urogynecol J ; 33(12): 3355-3364, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-35976420

RESUMO

INTRODUCTION AND HYPOTHESIS: We hypothesized that elective induction of labor (eIOL) at 39 weeks is protective of levator ani muscle injury (LAMI) and is associated with decreased pelvic symptoms at 6 weeks postpartum compared to expectant management of labor. METHODS: Prospective cohort pilot study of uncomplicated, primiparous women with a singleton, vertex gestation enrolled immediately post-vaginal delivery (VD). Subjects were dichotomized into two groups based on labor management: eIOL without complication defined by the ARRIVE trial versus spontaneous VD between 39 weeks0/7 and 42 weeks5/7 or no indication for IOL prior to 40 weeks5/7. The primary outcome was LAMI at 6 weeks postpartum as evidenced by any of the following ultrasound measures: (1) increased levator hiatal area (LHA) > 2500 mm2, (2) increased elasticity index (EI, > 75th quartile) or (3) levator enthesis avulsion. RESULTS: Analysis represents 45/102 consented women from July 2019-October 2020 (eIOL n = 22 and spontaneous VD, n = 23). Neither maternal, clinical, sociodemographic characteristics nor pelvic symptoms differed between groups. Fewer women had LAMI as defined by the primary outcome with eIOL (n = 5, 23.8%) compared to spontaneous VD (n = 15, 65.2%), p = 0.008. Levator enthesis was more deformable (increased EI) with spontaneous VD as compared to the eIOL [10.66 (8.99) vs. 5.68 (2.93), p = 0.046]. On univariate logistic regression women undergoing spontaneous VD had unadjusted OR of 6.0 (1.6-22.5, p = 0.008) of sustaining LAMI compared to those undergoing eIOL. CONCLUSIONS: Composite measures of LAMI though not pelvic floor symptoms were markedly increased in women undergoing spontaneous VD compared to those undergoing eIOL at 39 weeks.


Assuntos
Trabalho de Parto Induzido , Diafragma da Pelve , Feminino , Humanos , Gravidez , Parto Obstétrico , Trabalho de Parto Induzido/efeitos adversos , Diafragma da Pelve/diagnóstico por imagem , Diafragma da Pelve/lesões , Projetos Piloto , Estudos Prospectivos , Ultrassonografia , Ensaios Clínicos como Assunto
18.
Acta Biomater ; 148: 323-335, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-35671876

RESUMO

Polypropylene meshes used in pelvic organ prolapse (POP) repair are hampered by complications. Most POP meshes are highly unstable after tensioning ex vivo, as evidenced by marked deformations (pore collapse and wrinkling) that result in altered structural properties and material burden. By intentionally introducing collapsed pores and wrinkles into a mesh that normally has open pores and remains relatively flat after implantation, we reproduce mesh complications in vivo. To do this, meshes were implanted onto the vagina of rhesus macaques in nondeformed (flat) vs deformed (pore collapse +/- wrinkles) configurations and placed on tension. Twelve weeks later, animals with deformed meshes had two complications, (1) mesh exposure through the vaginal epithelium, and (2) myofibroblast proliferation with fibrosis - a mechanism of pain. The overarching response to deformed mesh was vaginal thinning associated with accelerated apoptosis, reduced collagen content, increased proteolysis, deterioration of mechanical integrity, and loss of contractile function consistent with stress shielding - a precursor to mesh exposure. Regional differences were observed, however, with some areas demonstrating myofibroblast proliferation and matrix deposition. Variable mechanical cues imposed by deformed meshes likely induce these two disparate responses. Utilizing meshes associated with uniform stresses on the vagina by remaining flat with open pores after tensioning is critical to improving outcomes. STATEMENT OF SIGNIFICANCE: Pain and exposure are the two most reported complications associated with the use of polypropylene mesh in urogynecologic procedures. Most meshes have unstable geometries as evidenced by pore collapse and wrinkling after tensioning ex vivo, recapitulating what is observed in meshes excised from women with complications in vivo. We demonstrate that collapsed pores and wrinkling result in two distinct responses (1) mesh exposure associated with tissue degradation and atrophy and (2) myofibroblast proliferation and matrix deposition consistent with fibrosis, a tissue response associated with pain. In conclusion, mesh deformation leads to areas of tissue degradation and myofibroblast proliferation, the likely mechanisms of mesh exposure and pain, respectively. These data corroborate that mesh implantation in a flat configuration with open pores is a critical factor for reducing complications in mesh-augmented surgeries.


Assuntos
Prolapso de Órgão Pélvico , Polipropilenos , Animais , Feminino , Fibrose , Humanos , Macaca mulatta , Dor , Prolapso de Órgão Pélvico/metabolismo , Prolapso de Órgão Pélvico/cirurgia , Polipropilenos/efeitos adversos , Polipropilenos/química , Telas Cirúrgicas/efeitos adversos , Vagina/metabolismo , Vagina/cirurgia
20.
Female Pelvic Med Reconstr Surg ; 28(7): 452-460, 2022 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-35536679

RESUMO

IMPORTANCE: The U.S. Food and Drug Administration uses the Manufacturer and User Facility Device Experience database to evaluate the safety of urogynecologic meshes; however, reports on individual meshes have not been characterized. OBJECTIVE: The aim of the study was to compare complications among available urogynecologic meshes reported to the Manufacturer and User Facility Device Experience database. STUDY DESIGN: This study is a cross-sectional analysis of medical device reports (MDRs) of urogynecologic mesh from January 2004 to March 2019, using the Reed Tech Navigator (LexisNexis), which codes MDRs. The percentage of reports containing specific complaints (not an adverse event rate) were compared with χ 2 tests with Dunn-Sidak correction. Correlations with time on market, mesh weight, stiffness, and porosity were determined. RESULTS: The 34,485 reports examined included 6 transvaginal meshes, 4 sacrocolpopexy meshes, and 10 midurethral slings. Most reported events were pain, erosion, and infection. For transvaginal prolapse, less than 10% of Uphold Lite (Boston Scientific) reports contained pain or erosion versus greater than 90% of Prolift/Prolift+M (Ethicon, P < 0.001). For sacrocolpopexy mesh, greater than 90% of Gynemesh (Ethicon; Prolift in vaginal form) reports included erosion and pain versus less than 60% for Artisyn (Ethicon), Restorelle (Colpoplast), and Upsylon (Boston Scientific, P < 0.0001). For slings, Gynecare TVT Obturator had the highest proportion of erosion and pain complaints. Heavier sling meshes had more reports. When Ascend (Caldera Medical), an outlier with only 5 reports, was excluded, transvaginal mesh stiffness correlated strongly with number of reports. For transvaginal meshes, number of reports correlated with time on market (ρ = 0.8, P = 0.04). CONCLUSIONS: Individual meshes have different properties with different complication profiles, which should inform mesh development and use. Gynemesh MDRs included pain and erosion more frequently than others. Comprehensive registries are needed.


Assuntos
Prolapso de Órgão Pélvico , Slings Suburetrais , Estudos Transversais , Feminino , Humanos , Dor/etiologia , Prolapso de Órgão Pélvico/etiologia , Slings Suburetrais/efeitos adversos , Telas Cirúrgicas/efeitos adversos , Estados Unidos/epidemiologia , United States Food and Drug Administration
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