Appropriateness of Hysterectomy as Treatment for Benign Gynecological Conditions.

Objective: To assess the appropriateness of hysterectomies performed at a large tertiary health system using the 1997 RAND appropriateness classification system and an updated algorithm. Design: We abstracted structured and unstructured data from electronic medical records on patient demographics, primary indication(s) for hysterectomy, diagnosis codes associated with the hysterectomy, previous treatments, and laboratory results. Subjects: Patients aged 18-44 years. Exposure: Receipt of hysterectomy for benign and nonobstetric conditions from October 2014 to December 2017. Main Outcome Measures: Using these data, we provided a RAND-based (dichotomous: inappropriate/appropriate) and Wright-based (3-level: inappropriate/ambiguous/appropriate) appropriateness rating and characterized missing information patterns associated with inappropriate ratings. Results: We analyzed 1,829 hysterectomies across 30 nonmutually exclusive primary indications for surgery. Nearly a third (32.8%) of surgeries had only one primary indication for surgery. Using the RAND-based classifier, 31.3% of hysterectomies were rated as appropriate and 68.7% as inappropriate. Using the Wright-based algorithm, 58.1% of hysterectomies were rated as appropriate, 15.7% as ambiguous, and 26.2% as inappropriate. Missing information on diagnostic procedures was the most common characteristic related to both RAND-based (46.1%) and Wright-based (51.2%) inappropriate ratings. Conclusions: The 1997 RAND classification lacked guidance for several contemporary indications, including gender-affirming care. RAND also has an outdated requirement for diagnostic surgeries such as laparoscopies, which have decreased in practice as diagnostic imaging has improved. Sensitivity analyses suggest that inappropriate surgeries cannot all be attributed to bias from missing electronic medical record data. Accurately documenting care delivery for benign gynecological conditions is key to ensuring quality and equity in gynecological care.

Endometrial Thickness as Diagnostic Triage for Endometrial Cancer Among Black Individuals.

Importance: Poor performance of the transvaginal ultrasonography triage strategy has been suggested as a contributor to racial disparity between Black individuals and White individuals in endometrial cancer (EC) stage at diagnosis in population-level simulation analyses. Objectives: To examine the false-negative probability using ultrasonography-measured endometrial thickness (ET) thresholds as triage for EC diagnosis among Black individuals and assess whether known risk factors of EC modify ET triage performance. Design, Setting, and Participants: This retrospective diagnostic study of merged abstracted electronic health record data and secondary administrative data (January 1, 2014, to December 31, 2020) from the Guidelines for Transvaginal Ultrasound in the Detection of Early Endometrial Cancer sample assessed Black individuals who underwent hysterectomy in a 10-hospital academic-affiliated health care system and affiliated outpatient practices. Data analysis was performed from January 31, 2023, to November 30, 2023. Exposure: Pelvic ultrasonography within 24 months before hysterectomy. Main Outcome and Measures: Ultrasonography performed before hysterectomy as well as demographic and clinical data on symptom presentation, endometrial characterization, and final EC diagnosis were abstracted. Endometrial thickness thresholds were examined for accuracy in ruling out EC diagnosis by using sensitivity, specificity, and negative predictive value. False-negative probability was defined as 1 - sensitivity. Accuracy measures were stratified by risk factors for EC and by factors hypothesized to influence ET measurement quality. Results: A total of 1494 individuals with a uterus (median [IQR] age, 46.1 [41.1-54.0] years) comprised the sample, and 210 had EC. Fibroids (1167 [78.1%]), vaginal bleeding (1067 [71.4%]), and pelvic pain (857 [57.4%]) were the most common presenting diagnoses within 30 days of ultrasonography. Applying the less than 5-mm ET threshold, there was an 11.4% probability that someone with EC would be classified as not having EC (n = 24). At the 4-mm (cumulative) threshold, the probability was 9.5%, and at 3 mm, it was 3.8%. False-negative probability at the 5-mm threshold was similar among EC risk factor groups: postmenopausal bleeding (12.4%; 95% CI, 7.8%-18.5%), body mass index greater than 40 (9.3%; 95% CI, 3.1%-20.3%); and age 50 years or older (12.8%; 95% CI, 8.4%-18.5%). False-negative probability was also similar among those with fibroids on ultrasonography (11.8%; 95% CI, 6.9%-18.4%) but higher in the setting of reported partial ET visibility (26.1%; 95% CI, 10.2%-48.4%) and pelvic pain (14.5%; 95% CI, 7.7%-23.9%). Conclusion and Relevance: These findings suggest that the transvaginal ultrasonography triage strategy is not reliable among Black adults at risk for EC. In the presence of postmenopausal bleeding, tissue sampling is strongly recommended.

Fast, Accurate, and Versatile Data Analysis Platform for the Quantification of Molecular Spatiotemporal Signals.

Optical recording of intricate molecular dynamics is becoming an indispensable technique for biological studies, accelerated by the development of new or improved biosensors and microscopy technology. This creates major computational challenges to extract and quantify biologically meaningful spatiotemporal patterns embedded within complex and rich data sources, many of which cannot be captured with existing methods. Here, we introduce Activity Quantification and Analysis (AQuA2), a fast, accurate, and versatile data analysis platform built upon advanced machine learning techniques. It decomposes complex live imaging-based datasets into elementary signaling events, allowing accurate and unbiased quantification of molecular activities and identification of consensus functional units. We demonstrate applications across a wide range of biosensors, cell types, organs, animal models, and imaging modalities. As exemplar findings, we show how AQuA2 identified drug-dependent interactions between neurons and astroglia, and distinct sensorimotor signal propagation patterns in the mouse spinal cord.

Prevalence of Lower Urinary Tract Symptoms in Women Planning to Undergo Hysterectomy for Uterine Leiomyoma and Abnormal Uterine Bleeding.

Introduction: Leiomyomas are associated with lower urinary tract symptoms (LUTS), but more specific characterization of their impact on LUTS is needed. Methods: This is a retrospective cohort study of 202 participants (101 per group) who underwent hysterectomy for leiomyomas versus abnormal uterine bleeding nonclassified (AUB-N) from July 2015 to May 2019. Baseline demographics, leiomyoma characteristics, and presence of baseline LUTS were collected. The main objective was to compare the prevalence of LUTS between these two groups. Secondary objectives were to analyze the association between leiomyoma characteristics and the prevalence of LUTS. Results: There was no difference in baseline prevalence of LUTS between the hysterectomy for leiomyoma versus AUB-N groups (42.6% vs. 45.5%, p = 0.67). When examining the entire study cohort of participants, irrespective of hysterectomy indication, leiomyoma size >6 cm was associated with an increased prevalence of LUTS when compared with leiomyoma <6 cm (64.9% vs. 40.4%, p = 0.02), and specifically difficulty passing urine (p = 0.02), nocturia (p = 0.04), and urinary frequency (p = 0.04). When controlling for age, body mass index, parity, chronic pelvic pain, and diabetes, leiomyomas >6 cm remained significantly associated with the presence of LUTS (odds ratio 3.1, 95% confidence interval = 1.2-8.3) when compared with leiomyoma <6 cm. Presence of >1 leiomyoma was associated with urinary frequency (67.9% vs. 32.1%, p = 0.02) when compared with ≤1 leiomyoma. Anterior location and uterine volume were not associated with a difference in LUTS. Conclusion: LUTS are prevalent in those planning hysterectomy for leiomyoma and AUB-N. Leiomyomas >6 cm are associated with the presence of LUTS. Future studies should evaluate change in LUTS following hysterectomy for leiomyomas.

Fertility preservation choices and decisional regret after gender-affirming surgery in transgender men or gender nonbinary persons.

Objective: To investigate the prevalence of decisional regret regarding preoperative fertility preservation choices after gender-affirming surgery or removal of reproductive organs. Design: Cross-sectional. Setting: University-based pratice. Patients: A total of 57 survey respondents identifying as transgender men or gender nonbinary with a history of gender-affirming surgery or removal of reproductive organs between 2014 and 2023 with the University of North Carolina Minimally Invasive Gynecology division. Intervention: Survey or questionnaire. Main Outcome Measures: The prevalence and severity of decisional regret regarding preoperative fertility preservation choices were measured with the use of the validated decisional regret scale (DRS) (scored 0-100). Secondary outcomes included patient-reported barriers to pursuing reproductive endocrinology and infertility consultation and fertility preservation treatment. Results: The survey response rate was 50.9% (57/112). "Mild" to "severe" decisional regret was reported by 38.6% (n = 22) of survey respondents, with DRS scores among all respondents ranging from 0-85. Higher median DRS scores were associated with patient-reported inadequacy of preoperative fertility counseling regarding implications of surgery on future fertility or family-building (0 vs. 50) and fertility preservation options (0 vs. 12.5). No desire for future fertility at the time of fertility counseling was the most frequent reason (68.4%) for declining a referral to reproductive endocrinology and infertility for additional fertility preservation discussion. Conclusions: Decisional regret regarding preoperative fertility preservation choices is experienced among transgender men or gender nonbinary persons after gender-affirming surgery or the removal of reproductive organs. Preoperative, patient-centered fertility counseling and fertility preservation treatments should be provided to reduce the risk of future regret.

A Treatment Algorithm for High-Tone Pelvic Floor Dysfunction.

OBJECTIVE: To develop evidence- and consensus-based clinical practice guidelines for management of high-tone pelvic floor dysfunction (HTPFD). High-tone pelvic floor dysfunction is a neuromuscular disorder of the pelvic floor characterized by non-relaxing pelvic floor muscles, resulting in lower urinary tract and defecatory symptoms, sexual dysfunction, and pelvic pain. Despite affecting 80% of women with chronic pelvic pain, there are no uniformly accepted guidelines to direct the management of these patients. METHODS: A Delphi method of consensus development was used, comprising three survey rounds administered anonymously via web-based platform (Qualtrics XM) to national experts in the field of HTPFD recruited through targeted invitation between September and December 2021. Eleven experts participated with backgrounds in urology, urogynecology, minimally invasive gynecology, and pelvic floor physical therapy (PFPT) participated. Panelists were asked to rate their agreement with rated evidence-based statements regarding HTPFD treatment. Statements reaching consensus were used to generate a consensus treatment algorithm. RESULTS: A total of 31 statements were reviewed by group members at the first Delphi round with 10 statements reaching consensus. 28 statements were reposed in the second round with 17 reaching consensus. The putative algorithm met clinical consensus in the third round. There was universal agreement for PFPT as first-line treatment for HTPFD. If satisfactory symptom improvement is reached with PFPT, the patient can be discharged with a home exercise program. If no improvement after PFPT, second-line options include trigger or tender point injections, vaginal muscle relaxants, and cognitive behavioral therapy, all of which can also be used in conjunction with PFPT. Onabotulinumtoxin A injections should be used as third line with symptom assessment after 2-4 weeks. There was universal agreement that sacral neuromodulation is fourth-line intervention. The largest identified barrier to care for these patients is access to PFPT. For patients who cannot access PFPT, experts recommend at-home, guided pelvic floor relaxation, self-massage with vaginal wands, and virtual PFPT visits. CONCLUSION: A stepwise approach to the treatment of HTPFD is recommended, with patients often necessitating multiple lines of treatment either sequentially or in conjunction. However, PFPT should be offered first line.

Endometriosis and Disability: Analysis of Federal Court Appeals of Social Security Disability Insurance and Supplemental Security Income Claims by Individuals Suffering From Endometriosis.

BACKGROUND: Endometriosis, a chronic noncancerous gynecologic condition commonly characterized by disruptive physical and psychosocial symptoms, can be disabling. Individuals in the United States with endometriosis who are unable to work before retirement age can apply for Social Security Disability Insurance (SSDI) and/or Supplemental Security Income (SSI). Given the multi-step process of disability review, it is important to better understand how disability decisions are made. This study aimed to examine approaches and rationales of U.S. federal appeals courts reviewing SSDI and/or SSI claims involving endometriosis-related issues of appeal. METHODS: We searched Westlaw and Nexis Uni records, available as of January 2021, for federal appeals of SSDI and SSI claims including endometriosis as an impairment. Two independent reviewers screened full-text cases and extracted data. Framework Analysis was applied to courts' rationales regarding endometriosis-related issues of appeal. RESULTS: Eighty-seven appeals addressed an endometriosis-related issue. Three themes-evidence, treatment, and time-were identified across the decisions. The courts' discussions across themes exposed rationales and evidentiary requirements that posed challenges for claimants with endometriosis. The courts found subjective reports of symptoms insufficient evidence of impairment and positive responses to treatments to indicate cures or prevent claimants from demonstrating the necessary continuous 12 months of impairment. Some courts expected claimants to use treatments such as contraception or hysterectomy without addressing the risks of such treatments or the fact that they might have been counter to claimants' needs and preferences. CONCLUSIONS: Individuals with endometriosis face evidentiary obstacles and common misconceptions about disease, diagnosis, and treatment in disability claims. SSDI and SSI endometriosis claims are systematically disadvantaged, particularly among those without access to care. The health care, policy, and legal systems can leverage the findings in this study to create a more equitable disability application and review system for those with chronic pain conditions such as endometriosis.

Preferred physical characteristics of lidocaine thin film for women with vestibulodynia.

Introduction: Vestibulodynia (VBD) is the most common cause of sexual pain in the United States, affecting up to 15% of reproductive-aged women during their lifetime with limited treatment options. The purpose of this study was to describe ideal physical characteristics of a vulvar film designed for insertional sexual pain in sexually active women with VBD. Methods: Twenty women were recruited to participant in one of six, semi-structured 60-minute focus group discussions regarding treatment options for VBD. Heterosexual women, aged 18-51 years old with a diagnosis of vulvodynia, vestibulodynia or insertional dyspareunia fit the inclusion criteria. Those who reported no episodes of vaginal intercourse in the prior 18 months were excluded. A new vulvar film technology loaded with 50 mg of 5% lidocaine was introduced to the group. Participants took part in focus groups on a rolling basis depending on availability. Focus group discussions were audio-recorded and transcribed verbatim. Two study investigators coded the transcripts using inductive coding and merged their respective projects to resolve disagreements. We analyzed data related to each code to develop code clusters and higher-level primary topics regarding device preferences. Data related to each of these primary topics was analyzed to assess the range of participant attitudes and preferences and to identify patterns within each primary topic. Results: One hundred and sixteen women were recruited, and twenty women were enrolled. The mean age for the participants was 33.3 years. Most women were educated with at least some college (93%), White (78.6%), married (75%), and had income greater than $100,000 (50%). Analysis of the focus group discussions identified five common topics addressed by participants: desired loaded medication, film size, film shape, film flexibility, and ease and accuracy of use. Concerns across topics included comfort, sexual spontaneity, and efficacy. Interest in loading the device with other acceptable medications or combination with lidocaine was independently noted in 2/6 (33%) of the focus groups. Discussion: Mucoadhesive vulvar thin films may be an acceptable drug delivery system for insertional sexual pain for women with VBD.

Evaluation and Medical Management of Chronic Pelvic Pain.

Chronic pelvic pain (CPP) is a challenging condition affecting an estimated 15% of females in the United States. Multiorgan system dysfunction results in the complex clinical pain presentation. Similar to other chronic pain syndromes, CPP is influenced by biopsychosocial factors and requires a multimodal approach for optimal pain management. This review summarizes the clinical evaluation and medical management of CPP with a comprehensive approach.

Ethnoracial Differences in Premenopausal Hysterectomy: The Role of Symptom Severity.

OBJECTIVE: To evaluate whether greater symptom severity can explain higher hysterectomy rates among premenopausal non-Hispanic Black compared with White patients in the U.S. South rather than potential overtreatment of Black patients. METHODS: Using electronic health record data from 1,703 patients who underwent hysterectomy in a large health care system in the U.S. South between 2014 and 2017, we assessed symptom severity to account for differences in hysterectomy rates for noncancerous conditions among premenopausal non-Hispanic Black, non-Hispanic White, and Hispanic patients. We used Poisson generalized linear mixed modeling to estimate symptom severity (greater than the 75th percentile on composite symptom severity scores of bleeding, bulk, or pelvic pain) as a function of race-ethnicity. We calculated prevalence ratios (PRs). We controlled for factors both contra-indicating and contributing to hysterectomy. RESULTS: The overall median age of non-Hispanic White (n=1,050), non-Hispanic Black (n=565), and Hispanic (n=158) patients was 40 years. The White and Black patients were mostly insured (insured greater than 95%), whereas the Hispanic patients were often uninsured (insured 58.9%). White and Black patients were mostly treated outside academic medical centers (nonmedical center: 63.7% and 58.4%, respectively); the opposite was true for Hispanic patients (nonmedical center: 34.2%). Black patients had higher bleeding severity scores compared with Hispanic and White patients (median 8, 7, and 4 respectively) and higher bulk scores (median 3, 1, and 0, respectively), but pain scores differed (median 3, 5, and 4, respectively). Black and Hispanic patients were disproportionately likely to have severe symptoms documented on two or more symptoms (referent: not severe on any symptoms) (adjusted PR [Black vs White] 3.02, 95% CI 2.29-3.99; adjusted PR [Hispanic vs White] 2.61, 95% CI 1.78-3.83). Although Black and Hispanic patients were more likely to experience severe symptoms, we found no racial and ethnic differences in the number of alternative treatments attempted before hysterectomy. CONCLUSION: We did not find evidence of overtreatment of Black patients. Our findings suggest potential undertreatment of Black and Hispanic patients with uterine-sparing alternatives earlier in their disease progression.

Credentialing and Patient Safety in Robotic Gynecologic Surgery: Changes over the Last Eight Years.

Background and Objectives: Robotic gynecologic surgery has outpaced data showing risks and benefits related to cost, quality outcomes, and patient safety. We aimed to assess how credentialing standards and perceptions of safe use of robotic gynecologic surgery have changed over time. Methods: An anonymous, online survey was distributed in 2013 and in 2021 to attending surgeons and trainees in accredited obstetrics and gynecology residency programs. Results: There were 367 respondents; 265 in 2013 and 102 in 2021. There was a significant increase in robotic platform use from 2013 to 2021. Percentage of respondents who ever having performed a robotic case increased from 48% to 79% and those who performed > 50 cases increased from 25% to 59%. In 2021, a greater percentage of attending physicians reported having formalized protocol for obtaining robotic credentials (93% vs 70%, p = 0.03) and maintaining credentialing (90% vs 27%, p < 0.01). At both time points, most attendings reported requiring proctoring for 1 - 5 cases before independent use. Opinions on the number of cases needed for surgical independence changed from 2013 to 2021. There was an increase in respondents who believed > 20 cases were required (from 58% to 93% of trainees and 29% to 70% of attendings). In 2021, trainees were less likely to report their attendings lacked the skills to safely perform robotic surgery (25% to 6%, p < 0.01). Discussion: Greater experience with robotic platforms and expansion of credentialing processes over time correlated with improved confidence in surgeon skills. Further work is needed to evaluate if current credentialing procedures are sufficient.

Skeletal muscle relaxants for the treatment of myofascial pelvic pain and high tone pelvic floor disorders.

PURPOSE OF REVIEW: Chronic pelvic main is a complex process that includes many causes. In gynecology, the treatment of myofascial pelvic pain and high tone pelvic floor disorders can be managed with skeletal muscle relaxants for select clinical indications. A review of skeletal muscle relaxants will be included for gynecologic indications. RECENT FINDINGS: There are limited studies on vaginal skeletal muscle relaxants, but there can be oral forms used for chronic myofascial pelvic pain. They function as antispastic, antispasmodic, and combination of the two modes of action. Diazepam is the most studied for myofascial pelvic pain in both oral and vaginal formulations. Its use can be combined with multimodal management to optimize outcomes. Other medications have limitations due to dependency and limited studies that demonstrate improvement in pain scales. SUMMARY: Skeletal muscle relaxants have limited high quality studies for chronic myofascial pelvic pain. Their use can be combined with multimodal options to improve clinical outcomes. Additional studies are needed for vaginal preparations and evaluation of safety and clinical efficacy for patient reported outcomes measures in patients living with chronic myofascial pelvic pain.

Racial Disparities in Hysterectomy Route for Benign Disease: Examining Trends and Perioperative Complications from 2007 to 2018 Using the NSQIP Database.

STUDY OBJECTIVE: To examine national trends among race and ethnicity and route of benign hysterectomy from 2007 to 2018. DESIGN: This is a retrospective analysis of the prospective National Surgical Quality Improvement Program cohort program. SETTING: This study included data from the National Surgical Quality Improvement Program database including data from the 2014 to 2018 targeted hysterectomy files. PATIENTS: Adult patients undergoing hysterectomy. INTERVENTIONS: None MEASUREMENTS AND MAIN RESULTS: Current Procedural Terminology codes identified women undergoing benign hysterectomy and perioperative data including race and ethnicity were obtained. To determine relative trends in hysterectomy among race and ethnicity cohorts (White, Black, Hispanic), we calculated the proportion of each procedure performed annually within each race and ethnicity group and compared it across groups. From 2007 to 2018, 269 794 hysterectomies were collected (190 154 White, 45 756 Black, and 33 884 Hispanic). From 2007 to 2018, rates of laparoscopic hysterectomy increased in all cohorts (30.2%-71.6% for White, 23.9%-58.5% for Black, 19.9%-64.0% for Hispanic; ptrend <0.01 for all). For each year from 2007 to 2018, the proportion of women undergoing open abdominal hysterectomy remained twice as high in Black Women compared with White women (33.1%-14.4%, p <.01). Data from the 2014 to 2018 targeted files showed Black and Hispanic women undergoing benign hysterectomy were generally younger, had larger uteri, were more likely to be current smokers, have diabetes and/or hypertension, have higher body mass index, and have undergone previous pelvic surgery (p ≤.01 for all). CONCLUSION: Compared with White women, Black and Hispanic women are less likely to undergo benign hysterectomy via a minimally invasive approach. Although larger uteri and comorbid conditions may attribute to higher rates of open abdominal hysterectomy, the higher prevalence of abdominal hysterectomy among younger Black and Hispanic women highlights potential racial disparities in women's health and access to care.

Trans-segmental imaging in the spinal cord of behaving mice.

Spinal cord circuits play crucial roles in transmitting pain, but the underlying activity patterns within and across spinal segments in behaving mice have remained elusive. We developed a wearable widefield macroscope with a 7.9-mm2 field of view, ~3- to 4-µm lateral resolution, 2.7-mm working distance and <10-g overall weight and show that highly localized painful mechanical stimuli evoke widespread, coordinated astrocyte excitation across multiple spinal segments.

Multiplex translaminar imaging in the spinal cord of behaving mice.

While the spinal cord is known to play critical roles in sensorimotor processing, including pain-related signaling, corresponding activity patterns in genetically defined cell types across spinal laminae have remained challenging to investigate. Calcium imaging has enabled cellular activity measurements in behaving rodents but is currently limited to superficial regions. Here, using chronically implanted microprisms, we imaged sensory and motor-evoked activity in regions and at speeds inaccessible by other high-resolution imaging techniques. To enable translaminar imaging in freely behaving animals through implanted microprisms, we additionally developed wearable microscopes with custom-compound microlenses. This system addresses multiple challenges of previous wearable microscopes, including their limited working distance, resolution, contrast, and achromatic range. Using this system, we show that dorsal horn astrocytes in behaving mice show sensorimotor program-dependent and lamina-specific calcium excitation. Additionally, we show that tachykinin precursor 1 (Tac1)-expressing neurons exhibit translaminar activity to acute mechanical pain but not locomotion.

Dismantling Structural Barriers: Resident Clinics Refocused on Equity.

Disparities in health by race, ethnicity, and socioeconomic status within obstetrics and gynecology are well described and prompt evaluation for structural barriers. Academic medicine has a historical role in caring for marginalized populations, with medical trainees often serving as first-line clinicians for outpatient care. The ubiquitous approach of concentrating care of marginalized patients within resident and trainee clinics raises ethical questions regarding equity and sends a clear message of value that is internalized by learners and patients. A path forward is elimination of the structural inequities caused by maintenance of clinics stratified by training level, thereby creating an integrated patient pool for trainees and attending physicians alike. In this model, demographic and insurance information is blinded and patient triage is guided by clinical acuity and patient preference alone. To address structural inequities in our health care delivery system, we implemented changes in our department. Our goals were to improve access and patient experience and to send a unified message to our patients, learners, and faculty-our clinical staff, across all training levels, are committed to giving the highest standard of care to all people, regardless of insurance status or ability to pay. Academic medical centers must look internally for structural barriers that contribute to health care disparities within obstetrics and gynecology as we aim to make progress toward equity.

Rationale and design of a multicenter randomized clinical trial of vestibulodynia: understanding pathophysiology and determining appropriate treatments (vestibulodynia: UPDATe).

BACKGROUND: Limited data are available to establish evidence-based management protocols for vestibulodynia (VBD), a chronic vulvar pain condition that affects approximately 14 million women in the U.S. For the purposes of the study, our group subdivided VBD subtypes that may benefit from different types of treatment: 1) VBD peripheral (VBD-p), characterized by pain localized to the vulvar vestibule and 2) VBD central (VBD-c), characterized by VBD alongside one or more other chronic overlapping pain conditions (e.g. irritable bowel syndrome, temporomandibular disorder, and fibromyalgia syndrome) that affect remote body regions. Here, we describe the rationale and design of an NIH-funded multicenter clinical trial comparing the effectiveness of topical and/or systemic medication for alleviating pain and normalizing pain- relevant biomarkers among women with VBD-p and VBD-c. METHODS: Participants will be randomly assigned to one of four parallel arms: peripheral treatment with 5% lidocaine + 0.5 mg/ml 0.02% oestradiol compound cream + oral placebo pill, 2) central treatment with the tricyclic antidepressant nortriptyline + placebo cream, 3) combined peripheral cream and central pill treatments, or 4) placebo cream and placebo pill. The treatment phase will last 16 weeks, with outcome measures and biomarkers assessed at 4 time points (0, 8, 16, and 24 weeks). First, we will compare the efficacy of treatments in alleviating pain using standardized tampon insertion with a numeric rating scale and self-reported pain on the short form McGill Pain Questionnaire. Next, we will compare the efficacy of treatments in improving perceived physical, mental, and sexual health using standardized questionnaires. Finally, we will measure cytokines and microRNAs in local vaginal and circulating blood samples using multiplex assays and RNA sequencing, and determine the ability of these biomarkers to predict treatment response. CONCLUSION: This is the first multicenter randomized controlled trial to evaluate the efficacy of peripherally and centrally acting medications currently used in clinical practice for treating unique VBD subtypes based on distinct clinical and biological signatures. ADMINISTRATIVE INFORMATION: Vestibulodynia UPDATe is a multi-centre, two-by-two factorial designed randomized, double-blind, placebo-controlled trial registered at clinical trials.gov (NCT03844412). This work is supported by the R01 HD096331 awarded to Drs. Nackley, Rapkin, Geller and Carey by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).Key messagesPeripheral lidocaine and oestradiol and centrally-targeted nortriptyline medications are used for the treatment of pain in women with VBD, but there is a lack of data from well-powered RCTs.This two-by-two factorial RCT will test the efficacy of these medications in VBD subtypes characterized by distinct clinical characteristics and biomarker profiles.We hope that results will provide clinicians with scientific evidence of therapeutic efficacy in distinct VBD subtypes in an effort to direct and optimize treatment approaches.

Ergonomic Assessment of Surgeon Characteristics and Laparoscopic Device Strain in Gynecologic Surgery.

STUDY OBJECTIVE: To evaluate whether surgeon characteristics, including sex and hand size, were associated with grip strength decline with laparoscopic advanced energy devices. DESIGN: Prospective cohort study. SETTING: Ergonomic simulation at an academic tertiary care site and the Society of Gynecologic Surgeons 47th Annual Meeting. PATIENTS: Thirty-eight participants (19 women and 19 men) were recruited. INTERVENTIONS: Surgeon anthropometric measurements were collected. Each participant completed a 120-second trial of maximum voluntary effort with 3 laparoscopic advanced energy devices (LigaSure, HALO PKS, and ENSEAL). Grip strength was measured using a handheld dynamometer. Subjects completed the NASA Raw Task Load Index scale after each device trial. Grip strengths and ergonomic workload scores were compared using Student t tests and Wilcoxon rank sum tests where appropriate. Univariate and multivariate models analyzed hand size and ergonomic workload. MEASUREMENTS AND MAIN RESULTS: Women had lower baseline grip strength (288 vs 451 N) than men, as did participants with glove size <7 compared with ≥7 (231 vs 397 N). Normalized grip strength was not associated with surgeon sex (p = .08), whereas it was significantly associated with surgeon glove size (p <.01). Grip strength decline was significantly greater for smaller compared to larger handed surgeons for LigaSure (p = .02) and HALO PKS devices (p <.01). The ergonomic workload of device use was significantly greater for smaller compared to larger handed surgeons (p <.01). Surgeon handspan significantly predicted grip strength decline with device use, even after accounting for potential confounders (R2 = .23, ß = .8, p <.01). CONCLUSION: Surgeons with smaller hand size experienced a greater grip strength decline and greater ergonomic workload during repetitive laparoscopic device use. No relationship was found between surgeon sex and grip strength decline or ergonomic workload. Laparoscopic device type was also identified as a significant main effect contributing to grip strength decline. These findings point toward ergonomic strain stemming from an improper fit between the laparoscopic device and the surgeon's hand during device use.