Prostaglandin Injection for Myoma Expulsion (PRIME): Case Series of a Novel Approach to Hysteroscopic Resection of FIGO Type 2 Myomas.

STUDY OBJECTIVE: To evaluate the use of dilute carboprost tromethamine injection at the endometrium/myoma junction during hysteroscopy to facilitate myoma expulsion and removal in a single procedure. DESIGN: Case series. SETTING: Single high-volume academic medical center. PATIENTS: Seven patients aged 32 to 51 years old with FIGO type 2 uterine myomas and symptoms of abnormal uterine bleeding or infertility undergoing hysteroscopic resection with a morcellation device from November 2022 to July 2023. INTERVENTION: Dilute injection of carboprost tromethamine (10 µg/mL) at time of hysteroscopic myomectomy. MEASUREMENTS AND MAIN RESULTS: The main outcome measure was ability to complete the hysteroscopic myomectomy in a single procedure using a hysteroscopic morcellator. Secondary outcomes included total operative time, fluid deficit, and postoperative pharmacologic side effects and/or surgical complications. Among our 7 patients, all had successful single procedure complete resections of myomas ranging from 0.9 to 4.6 cm in maximal diameter. Average operative time was 30 minutes, and average fluid deficit was approximately 839 mL. The carboprost dosages used ranged from 30 to 180 µg. One patient experienced prolonged postoperative nausea and vomiting that resolved with antiemetics. One patient experienced postoperative endometritis that improved with antibiotics. CONCLUSION: In this pilot study, injection of dilute carboprost intraoperatively facilitated one-step hysteroscopic myomectomy of FIGO 2 myomas, via enhanced extrusion of the intramural portion of the fibroid into the uterine cavity, with both short operative times and acceptable fluid deficits.

Energy Device Preferences Among Gynecologic Surgeons.

Background and Objectives: Multiple vessel-sealing devices are available for use during laparoscopy. The objective of this study is to determine what surgeon-level and device characteristics influence the choice of advanced energy device during gynecologic laparoscopy. Methods: This is a national cross-sectional study of gynecologic surgeons conducted via social media, utilizing an online, publicly-available, anonymous survey. Gynecologic surgeons who had completed residency training were approached for participation in the survey. Survey completion was voluntary and involved no further follow-ups. The web-based survey consisted of six questions with the option to answer three additional questions if time permitted. The institutional review board determined that this study qualified for exemption. Results: There were 92 respondents who participated in the survey. Of these, 81 completed the survey and were included in the analysis. Female respondents were younger and more frequently reported a glove size of 6.5 or less. Surgeon-level characteristics, including gender, age, glove size, case volume, region, and practice setting, were not significantly associated with preferred energy devices. Device availability in the operating room was the only characteristic associated with preferred energy devices (P-value = .0076). Other device-level characteristics such as optimal thermal spread, reduced plume, ease of use, device reliability, and teachability had no statistically significant association with preferred energy devices. Conclusion: Multiple advanced energy devices are available for use during gynecologic laparoscopy. These devices have varying energy profiles, thermal spread, and device size. Despite this diversity, only device availability in the operating room influenced the surgeon's preferred device selection.

Attitudes and Beliefs about Hysterectomy in Patients with Uterine Fibroids.

STUDY OBJECTIVE: To investigate the attitudes toward and beliefs about hysterectomy that influence the decision of women with symptomatic uterine fibroids regarding hysterectomy. DESIGN: A prospective survey study. SETTING: An outpatient clinic. PATIENTS: Patients in an urban, academic complex gynecology outpatient clinic at the age of 35 years or older with uterine fibroids and without previous hysterectomy were invited to participate. A total of 67 participants were surveyed between December 2020 and February 2022. INTERVENTIONS: Data were collected on demographics, Uterine Fibroid Symptom Health-Related Quality of Life (UFS-QOL) Questionnaire scores, and beliefs regarding hysterectomy via a web-based survey. Participants were posed with clinical scenarios and asked to indicate a preference for hysterectomy or myomectomy and stratified into groups by acceptability of hysterectomy as a treatment option for fibroids. MEASUREMENTS AND MAIN RESULTS: Data were analyzed using chi-square or Fisher exact tests, t tests, or Wilcoxon tests as appropriate. The mean age of participants was 46.2 (SD 7.5) years, and 57% of participants self-identified as White/Caucasian. The mean UFS-QOL symptoms score was 50 (SD 26) and the mean overall health-related quality of life score was 52 (SD 28). Notably, 34% of participants preferred hysterectomy whereas 54% preferred myomectomy assuming equivalent efficacy; 44% of those who preferred myomectomy did not desire future fertility. There were no differences observed in UFS-QOL scores. Participants opting for a hysterectomy believed that it would improve their mood/emptions, relationship with partner, general quality of life, sense of femininity, feeling whole, identity/body image, sexuality, and relationships. Those who opted for a myomectomy believed all those factors would worsen with a hysterectomy, and in addition, it would worsen their vaginal moisture and their partner's experience. CONCLUSION: Many factors affect a patient's decisions regarding hysterectomy for uterine fibroids beyond those related to fertility, including factors related to body image, sexuality, and relationships. Physicians should consider these factors when counseling patients and recognize their importance to facilitate improved shared decision making.

Informational Preferences of Women Seeking Treatment for Symptomatic Uterine Fibroids: A Qualitative Study.

STUDY OBJECTIVE: To establish the informational needs and preferences of women navigating treatment options for symptomatic uterine fibroids. DESIGN: Qualitative study using semistructured interviews. SETTING: Academic institution. PATIENTS: Participants had a diagnosis of symptomatic uterine fibroids with an active treatment plan. INTERVENTIONS: Semistructured video interviews were conducted with female patients undergoing treatment for symptomatic uterine fibroids (n = 20). Women were recruited from the outpatient Center for Complex Gynecology in Chicago, IL. Interviews were recorded and transcribed verbatim. A codebook was developed based on the interview transcripts, and the finalized coding was used to conduct a thematic analysis. MEASUREMENTS AND MAIN RESULTS: Four distinct themes emerged from the interviews: (1) Social supports-including social media-play an important role in informing patients' treatment choices; (2) Patients spend significant energy seeking additional information beyond their obstetrician-gynecologist; (3) Patients prioritize receiving full and complete information from their provider; and (4) Patients experience information-related delays in receiving care. CONCLUSION: Patients seeking care for symptomatic uterine fibroids have strong preferences about both the quality and extent of information they receive from their gynecologists. Physicians treating these conditions must adapt to changing informational desires and consider expanding physician engagement with patients' social media needs.

Improving Colposcopy Education Through Images: A Preliminary Assessment of an Image-Based Mobile App for Colposcopic Education.

OBJECTIVES: Colposcopy is an indispensable part of cervical cancer screening. However, in most training programs, there is little by way of a formalized curriculum. We created an image-based teaching tool and hypothesized that this tool, in a mobile app format, would increase resident comfort with colposcopic practice and quantitatively increase their ability to correlate colposcopic images with impressions. MATERIALS AND METHODS: This was a pilot study conducted among ObGyn residents during March 2021. Thirty-eight residents participated and were randomized to either an app user or an independent study control group. Both groups were surveyed before and after their assigned training and completed a postintervention standardized cognitive examination. The primary end points were subjective improvements in comfort with colposcopy. The secondary end point was performance on a standardized image quiz. RESULTS: Of the 46 targeted residents, 38 participated and 26 completed all elements of the study. On the image examination, app users performed slightly better when compared with the independent study group (mean score, 14.9/25 [SD = 2.15] vs 14.0/25 [SD = 3.27], p = .39). App users also were more likely to be confident in providing an overall colposcopic impression (73% vs 30%, p = .111). One hundred percent of the participants in the app user group said that they would recommend the tool to other residents and residency programs. CONCLUSIONS: Image-based teaching tools, such as the ICE-TI app, are valued by learners and can be a useful adjunct to standardized colposcopy curricula. In addition, making use of a mobile platform facilitated convenience learning.

Female sterilization reversal in the era of in-vitro fertilization.

PURPOSE OF REVIEW: Regret after female sterilization is not uncommon in the United States. Prior to the development of assisted reproductive technology (ART), surgical reversal of sterilization was the only option for patients interested in fertility. First performed in 1972, this procedure has since been refined over the years by gynaecologic surgeons. With in-vitro fertilization (IVF) gaining popularity, interest in sterilization reversal has waned. However, sterilization reversal should remain an important option in patients seeking pregnancy after tubal ligation. RECENT FINDINGS: A direct comparison between IVF and sterilization reversal is challenging due to inherent differences in reporting fertility outcomes. However, sterilization reversal may optimize fertility in younger women, whereas IVF may be more effective in older women. The surgical approach to sterilization reversal can be laparotomic, laparoscopic or robotic. Clinical decision making should include consideration of the risk of ectopic pregnancy, interval from sterilization to reversal, type of sterilization procedure, planned anastomotic site and projected remaining tubal length. SUMMARY: In the era of IVF, sterilization reversal still has a place in the management in restoring fertility. Creating awareness of the role of sterilization reversal is the first step in improving access to adequate training in this procedure for the next generation of reproductive surgeons.

Early Discontinuation, Results Reporting, and Publication of Gynecology Clinical Trials From 2007 to 2020.

OBJECTIVE: To characterize gynecology clinical trials over time, compare gynecology subspecialties, and analyze factors associated with early discontinuation, results reporting, and publication. METHODS: We conducted a cross-sectional analysis of all gynecology trials registered on ClinicalTrials.gov between 2007 and 2020 and their resulting publications. Trials were analyzed with descriptive, multivariable logistic, and Cox regression analyses. Primary exposure variables were trial funding and subspecialty. The three primary outcomes included early discontinuation, results reporting to ClinicalTrials.gov, and publication in a peer-reviewed journal indexed on PubMed. RESULTS: Of 223,690 trials registered on ClinicalTrials.gov between October 2007 and March 2020, only 3.7% focused on gynecology (n=8,174, approximately 3,759,086 participants). Subspecialties included reproductive endocrinology and infertility (n=1,428, 17.5%), gynecologic oncology (n=2,063, 25.2%), urogynecology (n=1,118, 13.7%), family planning (n=648, 7.9%), and other benign gynecology (n=2,917, 35.7%). Only 42.0% of completed trials disseminated results through results reporting and publication. Of all funding types, industry-funded trials were the most likely to be discontinued early (P<.001). Academic-funded trials were the least likely to report results (adjusted odds ratio [aOR] 0.38, 95% CI 0.30-0.50) but the most likely to publish (aOR 1.62, 95% CI 1.24-2.12). The number of reproductive endocrinology and infertility trials increased the most of any subspecialty between 2007 and 2020 (6.4% growth rate). Reproductive endocrinology and infertility and family planning trials were the most likely to be stopped early (reproductive endocrinology and infertility: adjusted hazard ratio [aHR] 2.08, 95% CI 1.59-2.71; family planning: aHR 1.55 95% CI 1.06-2.25). When completed, reproductive endocrinology and infertility trials were the least likely to report results (aOR 0.58, 95% CI 0.38-0.88). No significant differences were seen between subspecialties with respect to publication. CONCLUSION: Gynecology trials comprise only 3.7% of all clinical trials. The paucity of gynecology clinical trials aligns with decades of female underrepresentation in research. When completed, gynecology trials have poor dissemination. Our findings raise concern about bias in the performance, reporting, and publication of gynecology clinical trials.

The power of proximity: Effects of a multidisciplinary fibroid clinic on inter-specialty perceptions and practice patterns.

BACKGROUND: Multidisciplinary collaboration has generally been shown to have positive effects on healthcare but can be difficult to facilitate. This study assessed the effects of a multidisciplinary fibroid clinic on practice patterns and clinician perceptions to better understand drivers of interspecialty collaboration. MATERIALS AND METHODS: Annual rates of hysterectomies, myomectomies, and uterine fibroid embolizations (UFEs) performed in an urban healthcare system were collected from 2012-2019. Rates of each procedure were compared over time before and after launching a multidisciplinary fibroid clinic at the academic medical center. Referral rates were also compared. The gynecologists and interventional radiologists (IRs) involved in the clinic were interviewed 2 years prior to and after the clinic launch about their approaches to fibroids and perceptions of others who treat this condition. A phenomenological approach was used to identify and compare themes within the interviews by two researchers with excellent inter-rater agreement (κ = 0.80). RESULTS AND DISCUSSION: Annual rates of fibroid procedures increased over time (p<0.01) but the relative number of UFEs decreased (p = 0.01). UFE referrals by the clinic gynecologists significantly increased as did the number of combined fibroid procedures (p<0.01). However, the rates of one fibroid procedure relative to others were not different between the clinic and rest of the healthcare system (p = 0.55). Specialty-specific perceptions of fibroid treatments and inter-specialty dynamics did not change. Despite this, clinicians unanimously perceived the clinic and post-clinic practice patterns as positive and distinct from their previous work and relationships between gynecology and IR elsewhere. Limitations of this study included its single clinic design and potential confounder of differences in advertising pre- versus post-clinic. CONCLUSION: Creating the right practice environment may be more important for fostering inter-specialty collaboration and work satisfaction than shared mental models or procedural volumes in certain practice settings.

Magnetic Resonance Imaging in the Evaluation of Female Infertility.

Pelvic MRI plays an important adjunctive role in the clinical workup of female infertility. Hysterosalpingography is the first line imaging modality in evaluation of female infertility, and hysterosalpingo-contrast sonography can also be used to evaluate both the uterine cavity and fallopian tubes. Pelvic MRI can be helpful in the workup of female infertility, particularly in cases of Mullerian duct anomalies, fibroids, adenomyosis, endometriosis, and tubal disease. These conditions and their appearance on imaging will be reviewed in this article.

Body Image and Sexual Function Improve after Both Myomectomy and Hysterectomy for Symptomatic Fibroids.

OBJECTIVES: To determine the factors that influence the choice of myomectomy, uterine fibroid embolization (UFE), or hysterectomy in women with symptomatic uterine fibroids and to assess women's perception of body image and sexual functioning before and after treatment. METHODS: In this prospective observational cohort pilot study, women scheduled to undergo hysterectomy, myomectomy, or UFE were surveyed before surgery and again at 3 to 6 months after their procedure to assess body image and sexual function using the validated 10-item Body Image Scale and 19-item Female Sexual Function Index. Logistic regression was used to determine predictive factors for surgery choice and paired t tests were used to determine changes in perceived sexual function and body image. RESULTS: Of the 71 women surveyed, 69 underwent their scheduled procedure and 68 participants completed the preoperative questionnaire completely (98%). A total of 33 participants completed the postoperative questionnaire (49%). The predictive factor for hysterectomy versus myomectomy/UFE was older age (odds ratio 1.13, P = 0.017, 95% confidence interval [CI] 1.02-1.24). Regardless of surgery type, there were significant improvements in perceived body image and sexual function, including an increase in the overall sexual satisfaction of the participant (mean difference 0.50, P = 0.021, 95% CI 0.92-0.08) and less likely to feel less sexually attractive because of their menstrual bleeding problem (P < 0.0001, 95% CI 0.637-1.675). CONCLUSIONS: Women of older age are more likely to choose hysterectomy over myomectomy or UFE for the treatment of symptomatic uterine fibroids. In addition, women who underwent any treatment for fibroids have increases in perception of body image and sexual functioning after their procedure.

Laparoscopic Major Vascular Injuries in Gynecologic Surgery for Benign Indications: A Systematic Review.

OBJECTIVE: To identify the incidence, location, etiology, and mortality of major vascular injuries in gynecologic laparoscopy for benign indications. DATA SOURCES: A systematic review of PubMed, EMBASE, Cochrane Library, ClinicalTrials.gov, and MEDLINE was conducted. METHODS OF STUDY SELECTION: One thousand ninety-seven studies were screened for inclusion with 147 full-text articles reviewed. Sixty-six studies published between 1978 and 2016 met inclusion criteria, representing 197,062 surgeries. Articles that were included reported the incidence of major vascular injuries during gynecologic laparoscopy for benign indications. Exclusion criteria included surgery for gynecologic malignancy, duplicated data, case series and reports, manuscripts not in English, and studies published only as abstracts. TABULATION, INTEGRATION, AND RESULTS: Injuries to the aorta, inferior vena cava, iliac (common, external, or internal), and inferior epigastric vessels were recorded, as were injuries denoted as major but not otherwise specified. A total of 179 major vascular injuries were reported with an incidence of 0.09% (95% CI 0.08-0.10). The inferior epigastric vessels were the most commonly injured vessel (0.04%, 95% CI 0.03-0.05), comprising 48% (95% CI 40-55) of all injuries. The majority of injuries occurred during abdominal entry (82%, 95% CI 76-89), and the remainder occurred during surgical dissection (18%, 95% CI 11-24). Most injuries were recognized intraoperatively (93%, 95% CI 87-100), and approximately half (55%, 95% CI 46-63) required laparotomy for repair. Only two of the 179 major vascular injuries resulted in death, for an overall mortality rate from vascular injuries of 0.001% (95% CI 0.000-0.004). CONCLUSION: The incidence of major vascular injury during gynecologic laparoscopy found in this review is very low, and the vast majority of injuries did not result in death. Laparoscopy remains a safe surgical technique in relation to vascular injuries when performed for benign gynecologic disease.

A Game Show-Based Curriculum for Teaching Principles of Reproductive Infectious Disease (GBS PRIDE Trial).

OBJECTIVES: The purpose of this study was to evaluate whether a game show-based curriculum improves obstetrics and gynecology (OBGYN) residents' confidence in and understanding of the principles of reproductive infectious disease (RID), clinical manifestations and sequelae of sexually transmitted infection (STI), and management of serious long-term consequences of STIs. METHODS: A game show-based curriculum was developed from the basic principles of RID, which include the following: (1) distinguishing between clinical manifestations of STIs and management of long-term sequelae of STIs; (2) evaluation and management of common gynecologic infectious diseases, including chronic vaginitis, pelvic inflammatory disease, and other pelvic infections; (3) diagnosis and management of perinatal infectious diseases, such as parvovirus, varicella-zoster virus, cytomegalovirus, human immunodeficiency virus, toxoplasmosis, and infection-mediated prematurity; (4) evaluation and management of obstetric and gynecologic postoperative infections; and (5) diagnosis and management of acute and chronic human immunodeficiency virus and hepatitis C virus infections in pregnancy. OBGYN residents at a large urban academic training program were randomized to either a Jeopardy-style educational game show intervention plus a traditional didactic-based curriculum or traditional didactic-based curriculum alone. The study team recruited participants by sending out an e-mail to all of the residents, detailing the study and consent process. Participants from both the intervention and control groups completed confidence and knowledge-based pretests. Posttests were administered 4 weeks after completion of the pretests. Statistical methods were applied to analyze the data. RESULTS: Thirty-eight residents were randomized to a Jeopardy-style game show-based educational intervention (n = 19) or to a traditional didactic-based curriculum (n = 19). All of the participants (100%) completed the pre- and posttests. Pretest median scores were similar between both groups, in which the Jeopardy group had a median score of 48.5 and the traditional group had a median score of 51.4 (P = 0.091). The Jeopardy group median test scores improved between the pretest and posttest (48.5 vs 62.8, P ≤ 0.001). The traditional didactic-based curriculum had a minimal increase in its median posttest scores (51.4 compared with 54.2, P = 0.773). The Jeopardy group had significantly higher posttest median scores and confidence scores than the traditional didactic-based curriculum (Jeopardy = 62.8, traditional = 54.2, P = 0.002). CONCLUSIONS: A game show-based curriculum improves OBGYN residents' confidence and retention of knowledge regarding RIDs, clinical manifestations and sequelae of STIs, and management of serious long-term consequences of STIs. Additional studies that include longer posttest time intervals are needed to assess the longer-term impact of game show-based curriculum on knowledge retention among OBGYN residents.

Essentials in Minimally Invasive Gynecology Manual Skills Construct Validation Trial.

OBJECTIVE: To establish validity evidence for the Essentials in Minimally Invasive Gynecology laparoscopic and hysteroscopic simulation systems. METHODS: A prospective cohort study was IRB approved and conducted at 15 sites in the United States and Canada. The four participant cohorts based on training status were: 1) novice (postgraduate year [PGY]-1) residents, 2) mid-level (PGY-3) residents, 3) proficient (American Board of Obstetrics and Gynecology [ABOG]-certified specialists without subspecialty training); and 4) expert (ABOG-certified obstetrician-gynecologists who had completed a 2-year fellowship in minimally invasive gynecologic surgery). Qualified participants were oriented to both systems, followed by testing with five laparoscopic exercises (L-1, sleeve-peg transfer; L-2, pattern cut; L-3, extracorporeal tie; L-4, intracorporeal tie; L-5, running suture) and two hysteroscopic exercises (H-1, targeting; H-2, polyp removal). Measured outcomes included accuracy and exercise times, including incompletion rates. RESULTS: Of 227 participants, 77 were novice, 70 were mid-level, 33 were proficient, and 47 were experts. Exercise times, in seconds (±SD), for novice compared with mid-level participants for the seven exercises were as follows, and all were significant (P<.05): L-1, 256 (±59) vs 187 (±45); L-2, 274 (±38) vs 232 (±55); L-3, 344 (±101) vs 284 (±107); L-4, 481 (±126) vs 376 (±141); L-5, 494 (±106) vs 420 (±100); H-1, 176 (±56) vs 141 (±48); and H-2, 200 (±96) vs 150 (±37). Incompletion rates were highest in the novice cohort and lowest in the expert group. Exercise errors were significantly less and accuracy was greater in the expert group compared with all other groups. CONCLUSION: Validity evidence was established for the Essentials in Minimally Invasive Gynecology laparoscopic and hysteroscopic simulation systems by distinguishing PGY-1 from PGY-3 trainees and proficient from expert gynecologic surgeons.

Factors that Influence Applicants Pursuing a Fellowship in Minimally Invasive Gynecologic Surgery.

STUDY OBJECTIVE: The Fellowship in Minimally Invasive Gynecologic Surgery (FMIGS) has been the most competitive fellowship in Obstetrics and Gynecology since 2015. Since its inception, it has served to provide advanced endoscopic training and addresses the need for additional proficiency beyond residency. We sought to identify factors that influence applicants in choosing to pursue minimally invasive gynecologic surgery training. DESIGN: Cross-sectional study. SETTING: 2018 FMIGS application cycle. PATIENTS: Not applicable. INTERVENTIONS: A novel, 32-item Web-based survey was distributed to all FMIGS applicants during the 2018 application cycle. MEASUREMENTS AND MAIN RESULTS: Descriptive statistics were used to characterize the applicant sample and responses. Our survey response rate was 47.4% (37/78). Interest in the subject area of minimally invasive gynecologic surgery was the single most influential factor driving applicants to pursue FMIGS, followed by an interest in an academic career. Income level was the least important factor in their decision, with 37.8% rating this as not important. There were no differences in motivational factors between male and female applicants. Few applicants felt "very comfortable" performing laparoscopic hysterectomy (16.2%) or laparoscopic myomectomy (3.0%) on completion of residency training. CONCLUSION: FMIGS applicants are motivated by their interest in minimally invasive gynecologic surgery, academia and research, and the opportunity to increase their proficiency with advanced endoscopic procedures.

The Morcellation "Debate" and the FDA 510(k) Process-A Call for Further Reform.

IMPORTANCE: Few gynecologic surgeons understand the mechanism by which surgical instruments are approved for human use and marketing or do they appreciate the central role they play in postmarket surveillance and reporting after instruments have come to market. OBJECTIVE: Using the experience with the uterine morcellator, this review will detail the Food and Drug Administration (FDA) system for approving surgical instruments and the potential pitfalls of this process. EVIDENCE ACQUISITION: Literature review and public documents from the FDA. RESULTS: The FDA 510(k) approval process for surgical instruments relies largely on postmarket surveillance as exemplified by the uterine power morcellator, which was approved before sufficient evidence was available regarding its potential harms. CONCLUSIONS: The current system currently transfers the responsibility of ensuring safety and efficacy to the public, patients, and providers. To minimize potential harm, the FDA needs to incorporate a greater standard of evidence into its framework for the approval and regulation of medical devices. The burden of these requirements should be borne at least in part by the companies bringing equipment to market. RELEVANCE: It is incumbent on all surgeons to be vigilant in their objective critical assessment of new instrumentation and report their outcomes after they come to market.