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.

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.

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.

Length of Stay and 30-Day Postoperative Complications Following Minimally Invasive Apical Prolapse Repair.

IMPORTANCE: Data on the correlation between length of stay and postoperative complications following urogynecologic surgery are limited. OBJECTIVES: The objective of this study was to use a nationwide database to examine the correlation between length of stay and 30-day postoperative complications following minimally invasive apical prolapse repair. STUDY DESIGN: This retrospective cohort study included women in the American College of Surgeons National Surgical Quality Improvement Program database from 2008 to 2018 who underwent laparoscopic/robotic sacrocolpopexy or uterosacral/sacrospinous repair and were discharged on postoperative day 0 (POD0) or 1 (POD1). The primary outcome was 30-day postoperative complication rate. RESULTS: Of the 28,269 women discharged home on POD0/1, 12,663 (45%) underwent laparoscopic/robotic sacrocolpopexy, and 15,606 (55%) underwent uterosacral/sacrospinous repair. Women discharged on POD0 were less likely to be White, less likely to have diabetes or hypertension, had lower mean body mass index, and were less likely to have undergone a hysterectomy ( P < 0.05 for all). Within 30 days of surgery, 7% had a postoperative complication, and 3% had a major complication. Women discharged on POD0 had a lower risk of any complication or any major complication. The most common complication, urinary tract infection, was lower in women discharged on POD0 (3% vs 4%, P < 0.01). Women discharged home on the same day had a higher risk of superficial surgical site infection after undergoing laparoscopic/robotic sacrocolpopexy (1.3% vs 0.5%, P < 0.01) and a higher risk of myocardial infarction/cardiac arrest after uterosacral/sacrospinous repair (0.2% vs 0%, P < 0.04). CONCLUSIONS: In women undergoing minimally invasive reconstructive apical repair, discharge on POD0 is correlated with similar or better (lower) 30-day postoperative complication rates compared with women discharged on POD1.

Investigation of the Association between Surgeon Sex and Laparoscopic Device Ergonomic Strain in Gynecologic Surgery.

STUDY OBJECTIVE: To assess whether female compared with male sex is associated with greater ergonomic strain with the use of 4 advanced energy laparoscopic devices (LigaSure, HALO PKS, ENSEAL, and Harmonic scalpel). DESIGN: Online survey distributed by e-mail using the REDCap platform (Vanderbilt University). All responses were anonymous. SETTING: Nationwide survey in the United States. PARTICIPANTS: Gynecologic surgeons were surveyed through the Society of Gynecologic Surgeons listserv and 4 obstetrics and gynecology departmental listservs. INTERVENTIONS: The survey was distributed between May 1, 2020, and November 1, 2020. The primary outcome was the presence of physical complaints owing to laparoscopic devices. Descriptive statistics compared surgeon characteristics and ergonomic symptoms. Logistic regression was performed, adjusted for surgeon characteristics. MEASUREMENTS AND MAIN RESULTS: The response rate was 39%, comprising 149 women (78%) and 41 men (22%). Women compared with men had a significantly younger age (mean, 34 vs 44 years; p <.01), had smaller glove size (mean, 6.5 vs 7.5; p <.01), had shorter height (median, 66 vs 71 inches; p <.01), and were less frequently in practice for >10 years (19% vs 49%; p <.01). Women significantly more often reported physical complaints related to the use of laparoscopic devices (79% vs 41%; p <.01). Women reported that all devices had too large a fit for appropriate use (p <.01). Women were found to have 5.37 times the odds of physical complaints attributed to the use of laparoscopic instruments (crude oods ratio, 5.37; 95% confidence interval, 2.56-11.25); with adjustment for glove size, age, and laparoscopic case volume and duration, this was no longer significant (adjusted odds ratio, 2.02; 95% confidence interval, 0.59-6.93). CONCLUSION: Women significantly more often report physical complaints and inappropriate fit of the LigaSure, HALO PKS, ENSEAL, and Harmonic scalpel. Female sex is associated with 5-fold greater odds of physical complaints with laparoscopic device use. Further investigation of the surgeon factors underlying device-related strain is a critical next step to understanding and reducing surgeon ergonomic injury.

Disparities in Complications After Prolapse Repair and Sling Procedures: Trends From 2010-2018.

OBJECTIVE: To compare 30-day complication rates after prolapse repair and sling procedures across racial/ethnic groups, and evaluate trends over time. METHODS: We identified female patients in a national outcomes-based database who underwent prolapse repair and/or sling procedures between January 1, 2010 and December 31, 2018, stratified by race and ethnicity, and compared 30-day postoperative complication rates. Multivariable logistic regression adjusted for confounders. Trends in complication rates over time were evaluated using a test for trend (p-trend). RESULTS: We identified 70,540 prolapse repairs and 23,968 sling procedures. Following prolapse repairs, Black women had the highest complication rates (11%, vs 8% for Hispanic and 9% for both White and Other race/ethnicity women, P <0.01). Following sling procedures, there were few differences in complication rates between groups. After adjustments, Black women still experienced higher odds of any complication (aOR 1.15, 95% CI 1.03-1.29), particularly a vascular complication (venous thromboembolism or transfusion) (aOR 2.50, 95% CI 2.05-3.04) following prolapse repair procedures. Hispanic women had higher odds of vascular complications after prolapse repair (aOR 1.47, 95% CI 1.23-1.76) and slings (aOR 2.40, 95% CI 1.53-3.76). Trends from 2010-2018 showed a decrease in vascular complication rates among non-Black women after prolapse repairs, but rates among Black women did not decrease. CONCLUSION: Black women have higher odds of experiencing postoperative complications after prolapse repair procedures, particularly vascular complications. Vascular complication rates after prolapse repair decreased over time for all racial/ethnic groups except Black women. Hispanic women have higher odds of vascular complications after prolapse repair and slings than other racial/ethnic groups.

A mucoadhesive biodissolvable thin film for localized and rapid delivery of lidocaine for the treatment of vestibulodynia.

Vestibulodynia (VBD), an idiopathic pain disorder characterized by erythema and pain of the vulvar vestibule (the inner aspect of the labia minora and vaginal opening), is the most common cause of sexual pain for women of reproductive age. Women also feel discomfort with contact with clothing and tampon use. As most women with this disorder only have pain with provocation of the tissue, topical anesthetics applied to the vestibule are the current first line treatment for temporary pain relief. Treatment options are limited due to anatomical constraints of the vestibular region, poor drug retention time, imprecise dosing, leakage, and overall product messiness. In this study we report a novel approach to treatment of VBD using thin film designed to fit the vulvar vestibule and deliver lidocaine locally. Two use cases for VBD treatment were identified 1) rapid drug release (<5 min), for use prior to intercourse and 2) long-acting release (≥120 min) for prolonged use and relief throughout the day. Cellulose-based mucoadhesive thin films were fabricated using a solvent casting method. Three polymers including hydroxyethylcellulose (HEC), hydroxypropylcellulose (HPC), and hydroxypropylmethycellulose (HMPC), were selected owing to their biocompatibility and ideal properties for film casting. Films casted with HEC, HPC, and HPMC exhibited mucoadhesive properties relative to a control, with the highest mucoadhesive force recorded for films casted with HPC. Effect of media volume, pH, presence of mucin and presence of drug on film dissolution rates were investigated. Dissolution rates were independent of media volume, media pH or drug presence, whereas faster dissolution rates were obtained for all films in presence of mucin. In vitro lidocaine release kinetics were influenced by polymer type, percent drug loading and film casting thickness. Lidocaine release was based on a diffusion mechanism rather than through film dissolution and faster release (∼5 min) was observed for HEC films compared HPC films (∼120 min). Higher drug loading and film thickness resulted in slower and more prolonged release kinetics of lidocaine. All films were biocompatible and exhibited good mechanical properties. Two film formulations (9% w/w HPC with 12% w/w LHC, 5% w/w HEC with 6% w/w LHC) were optimized to meet the two use case scenarios for VBD treatment and moved into in vivo testing. In vivo testing demonstrated the safety of the films in BALB/c mice, and the pharmacokinetic analysis demonstrated the delivery of lidocaine primarily to the vaginal tissue. We demonstrate the ability to develop a mucoadhesive, biodissolvable thin film and fine-tune drug release kinetics to optimize local delivery of lidocaine to the vulva.

Association of Preoperative Depression and Anxiety With Long-term Opioid Use After Hysterectomy for Benign Indications.

OBJECTIVE: To assess whether preoperative depression or anxiety is associated with increased risk of long-term, postoperative opioid use after hysterectomy among women who are opioid-naïve. METHODS: We conducted an observational cohort study of 289,233 opioid-naïve adult women (18 years or older) undergoing hysterectomy for benign indications from 2010 to 2017 using IBM MarketScan databases. Opioid use and refills in the 180 days after surgery and preoperative depression and anxiety were assessed. Secondary outcomes included 30-day incidence of emergency department visits, readmission, and 180-day incidence of opioid complications. The association of depression and anxiety were compared using inverse-probability of treatment weighted log-binomial and proportional Cox regression. RESULTS: Twenty-one percent of women had preoperative depression or anxiety, and 82% of the entire cohort had a perioperative opioid fill (16% before surgery, 66% after surgery). Although perioperative opioid fills were relatively similar across the two groups (risk ratio [RR] 1.07, 95% CI 1.06-1.07), women with depression or anxiety were significantly more likely to have a postoperative opioid fill at every studied time period (RRs 1.44-1.50). Differences were greater when restricted to persistent use (RRs 1.49-2.61). Although opioid complications were rare, women with depression were substantially more likely to be diagnosed with opioid dependence (hazard ratio [HR] 5.54, 95% CI 4.12-7.44), and opioid use disorder (HR 4.20, 95% CI 1.97-8.96). CONCLUSION: Perioperative opioid fills are common after hysterectomy. Women with preoperative anxiety and depression are more likely to experience persistent use and opioid-related complications.

Timing, delays and pathways to diagnosis of endometriosis: a scoping review protocol.

INTRODUCTION: Pathways to diagnosis for women with endometriosis are frequently characterised with delays. Internationally, women face significant barriers and times to diagnosis. The prolonged time without a diagnosis may result in treatment delay, with clinical implications of chronic pain and an unknown effect on fertility outcomes. As delays in diagnosis extend, those suffering from endometriosis incur more cost and frequently experience a reduction in quality of life. The scoping review described in this protocol will (1) map current international scientific peer-reviewed and grey literature investigating pathways, timing, and delay of diagnosis of endometriosis, (2) define common concepts used in the literature, and (3) identify gaps for future examination and intervention development. METHODS AND ANALYSIS: This protocol outlines a scoping review to investigate the current research focused on pathways, timing, and delays in endometriosis diagnosis. The scoping review uses the Joanna Briggs Institute Methodology. The researchers applied the Population, Concept, Context approach to form the research questions. A search string of key terms and Medical Subject Headings will be used to systematically search the PubMed, CINAHL, EMBASE, Web of Science, and Cochrane databases. We will also search ClinicalTrials.gov and grey literature sources. The original search was performed in July 2020, and it will be rerun prior to the manuscript submission. Finally, the reference lists of included works will be reviewed for additional studies. The search results will be screened and reviewed according to predetermined inclusion and exclusion criteria. Data will be extracted from the studies identified for final inclusion using a predetermined tool. The resulting data will be analysed to report the state of the science. ETHICS AND DISSEMINATION: The proposed scoping review does not require review or approval by an ethical board. The researchers will disseminate the study results via conference presentations and publication in a peer-reviewed journal.