Complex obstetrical surgery: building a team and defining roles.

As the number of placenta accreta spectrum cases continues to rise, the gap in surgical skills in labor and delivery units becomes more apparent. Recent scholarly work has highlighted the diminishing advanced surgical skills among obstetrician-gynecologists, particularly among new graduates. Therefore, it has become a practice in many institutions to refer complex cesarean deliveries and obstetrical hysterectomies to subspecialists, specifically gynecologic oncologists. Hence, in this commentary, we propose a process through which key personnel within departments of obstetrics and gynecology are identified and their appropriate level of involvement in cases of complex obstetrical surgery is delineated. In doing so, we describe the surgical skills expected from each provider level so that the cesarean delivery complexity level can be matched with specific surgical expertise. Through this process, an obstetrician-led complex obstetrical surgery team is formed. Ultimately, the goal of this process is 2-fold; first, to return cases with higher levels of surgical complexity back to obstetricians and, second, to reduce the surgical back-up burden from gynecology subspecialists such as gynecologic oncologists.

Gynecology Resident Experience with Office Hysteroscopy Training.

Background: Hysteroscopy is the gold standard for evaluating intrauterine pathology. The majority of physicians currently perform hysteroscopy in the operating room. Lack of training has been cited as a barrier to performing office hysteroscopy; however, resident training in office hysteroscopy has not yet been evaluated. Methods: A prospective cross-sectional survey was performed. A validated 17 question survey tool was sent to 297 program directors of Accreditation Council for Graduate Medical Education accredited obstetrics and gynecology residency programs for distribution to their residents. The survey utilized a Likert scale to assess resident interest in learning office hysteroscopy, satisfaction in training, and perceived self-efficacy to perform office hysteroscopy independently upon graduation. Results: Two hundred and ninety-three obstetrics and gynecology residents responded. Of the respondents, 26.3% reported receiving training in office hysteroscopy. There was no statistically significant difference in training among postgraduate years or program regions. A greater proportion of male residents received training when compared to female residents (42.9% vs. 24.2%, p = 0.019). Ninety-four percent of residents reported interest in learning office hysteroscopy. Satisfaction with hysteroscopy training in the operating room versus the office was 91.1% vs. 11.3% respectively. Of the fourth-year residents, 17.4% felt they could perform office hysteroscopy independently upon graduation and 14.5% reported feeling comfortable performing the procedure. Conclusions: Residency training in office hysteroscopy is lacking and residents are unprepared to perform the procedure after graduation. Enhanced residency training in office hysteroscopy would likely improve resident comfort and ability to perform office hysteroscopy in practice.

Effectiveness of telehealth physical therapy for patients with pelvic floor disorders in a community hospital setting.

PURPOSE: To examine whether there are differences in meeting treatment goals between pelvic floor physical therapy (PFPT) patients who participated in a majority of telehealth visits versus those who participated in mostly traditional office visits at a community hospital. METHODS: Retrospective chart review was performed among patients who received PFPT from April 2019 to February 2021. Cohorts were defined as "Mostly Office Visits" (> 50% office visits) and "Mostly Telehealth" (> / = 50% telehealth visits). Primary outcome measures included demographic data, number/type of visit for each patient, number of no-show/cancelation appointments, and number of patients discharged meeting PFPT goals. Statistical significance was defined as p < 0.05. RESULTS: 234 subjects met criteria for the "Mostly Office Visit" cohort and 48 subjects met criteria for the "Mostly Telehealth" cohort. There were no significant differences observed in age (p = 0.919), BMI (p = 0.817), race/ethnicity (p = 0.170) or insurance type (p = 0.426) between cohorts. There was no significant difference in meeting PFPT goals between the "Mostly Office Visit" cohort (24.4%) and the "Mostly Telehealth" cohort (35.4%) (p = 0.113). There was no difference in the number of canceled visits per patient (mean cancelations "Office visit" 1.98; "Telehealth" 1.63; p = 0.246) and the number of no-show visits per patient (mean no-show's "Office visit" 0.23; "Telehealth" 0.31; p = 0.297) between cohorts. CONCLUSION: There was no difference in meeting discharge goals regardless of whether a patient participated in mostly telehealth visits versus mostly traditional office visits. Therefore, we can conclude that participating in mostly provider-led telehealth visits can be equally efficacious at providing competent PFPT care.

Changes to same day discharge after minimally invasive hysterectomy throughout COVID-19 pandemic.

BACKGROUND: Minimally invasive hysterectomy is a common gynecologic procedure. Numerous studies have found that a same day discharge (SDD) is safe following this procedure. Research has found that SDDs decrease resource strain, nosocomial infections, and financial burden for both the patient and healthcare system. Due to the recent COVID-19 pandemic, the safety of hospital admissions and elective surgeries was called into question. OBJECTIVE: To assess the rates of SDD among patients who underwent a minimally invasive hysterectomy before and during the COVID-19 pandemic. STUDY DESIGN: A retrospective chart review was performed from September 2018 to December 2020 on 521 patients, who met inclusion criteria. Descriptive analysis, chi-square tests of association, and multivariable logistic regression were used for analysis. RESULTS: There was a significant difference between rate of SDDs pre-COVID-19 (12.5%) versus during the COVID-19 period (28.6%) (p < 0.001). Surgical complexity was predictive of not being discharged the same day of surgery (odds ratio [OR] = 4.4, 95% confidence interval [CI] = 2.2-8.8), as was surgical completion time after 4 p.m. (OR = 5.2, 95% CI = 1.1-25.2). There was no difference in readmissions (p = 0.209) and emergency department (ED) visits (p = 0.973) between SDD and overnight stay. CONCLUSION: Rates of SDD for patients undergoing minimally invasive hysterectomy were significantly increased during the COVID-19 pandemic. SDDs are safe; the number of readmissions and ED visits did not increase among patients who were discharged on the same day.

Pressure-Induced Fibroid Ischemia: First-In-Human Experience with a Novel Device for Laparoscopic Treatment of Symptomatic Uterine Fibroids.

The purpose of this study was to assess the feasibility of use of a novel uterine fibroid treatment device hypothesized to cause fibroid infarction by increasing intra-tumoral pressure. Between August 2019 and January 2020, 21 uterine fibroids were treated in 16 symptomatic pre-menopausal black women. Pelvic magnetic resonance imaging was performed before the procedure, a day after the procedure and at 1, 3, 6, and 12 months. The subjects were also followed for clinical outcomes and quality of life up to 12 months at a single investigational site. At 3 months, the mean reduction in the fibroid volume was 36.3% (P = .002). Incremental reduction in volume peaked at the end of the follow-up, at the 12-month mark (60.4%; P = .008). There were no procedures in which the users failed to perform laparoscopic pressure suturing of fibroids with the pressure-induced fibroid ischemia device. Improvement in the quality of life was evident in the Health-Related Quality of Life total, Energy/Mood, Control, and Sexual Function domains of the Uterine Fibroid Symptom and Quality of Life questionnaire at 3 months post-procedure. Unanticipated risks were not identified. Serious adverse events were not identified. The initial clinical assessment of the pressure-induced fibroid ischemia device supports feasibility of the approach and does not reveal serious safety concerns. Trial is currently being registered retrospectively (This was a feasibility study and therefore registration was not mandatory).

Building Blocks for the Long-acting and Permanent Contraceptives Coordinated Registry Network.

Objectives: A multistakeholder expert group under the Women's Health Technology Coordinated Registry Network (WHT-CRN) was organized to develop the foundation for national infrastructure capturing the performance of long-acting and permanent contraceptives. The group, consisting of representatives from professional societies, the US Food and Drug Administration, academia, industry and the patient community, was assembled to discuss the role and feasibility of the CRN and to identify the core data elements needed to assess contraceptive medical product technologies. Design: We applied a Delphi survey method approach to achieve consensus on a core minimum data set for the future CRN. A series of surveys were sent to the panel and answered by each expert anonymously and individually. Results from the surveys were collected, collated and analyzed by a study design team from Weill Cornell Medicine. After the first survey, questions for subsequent surveys were based on the analysis process and conference call discussions with group members. This process was repeated two times over a 6-month time period until consensus was achieved. Results: Twenty-three experts participated in the Delphi process. Participation rates in the first and second round of the Delphi survey were 83% and 100%, respectively. The working group reached final consensus on 121 core data elements capturing reproductive/gynecological history, surgical history, general medical history, encounter information, long-acting/permanent contraceptive index procedures and follow-up, procedures performed in conjunction with the index procedure, product removal, medications, complications related to the long-acting and/or permanent contraceptive procedure, pregnancy and evaluation of safety and effectiveness outcomes. Conclusions: The WHT-CRN expert group produced a consensus-based core set of data elements that allow the study of current and future contraceptives. These data elements influence patient and provider decisions about treatments and include important outcomes related to safety and effectiveness of these medical devices, which may benefit other women's health stakeholders.

Assessing adverse event reports of hysteroscopic sterilization device removal using natural language processing.

OBJECTIVE: To develop an annotation model to apply natural language processing (NLP) to device adverse event reports and implement the model to evaluate the most frequently experienced events among women reporting a sterilization device removal. METHODS: We included adverse event reports from the Manufacturer and User Facility Device Experience database from January 2005 to June 2018 related to device removal following hysteroscopic sterilization. We used an iterative process to develop an annotation model that extracts six categories of desired information and applied the annotation model to train an NLP algorithm. We assessed the model performance using positive predictive value (PPV, also known as precision), sensitivity (also known as recall), and F1 score (a combined measure of PPV and sensitivity). Using extracted variables, we summarized the reporting source, the presence of prespecified and other patient and device events, additional sterilizations and other procedures performed, and time from implantation to removal. RESULTS: The overall F1 score was 91.5% for labeled items and 93.9% for distinct events after excluding duplicates. A total of 16 535 reports of device removal were analyzed. The most frequently reported patient and device events were abdominal/pelvic/genital pain (N = 13 166, 79.6%) and device dislocation/migration (N = 3180, 19.2%), respectively. Of those reporting an additional sterilization procedure, the majority had a hysterectomy or salpingectomy (N = 7932). One-fifth of the cases that had device removal timing specified reported a removal after 7 years following implantation (N = 2444/11 293). CONCLUSIONS: We present a roadmap to develop an annotation model for NLP to analyze device adverse event reports. The extracted information is informative and complements findings from previous research using administrative data.

Evaluation of uterine patency following transcervical uterine fibroid ablation with the Sonata system (the OPEN clinical trial).

OBJECTIVE: Standard transcervical fibroid treatment via hysteroscopic myomectomy can result in a significant rate of intrauterine adhesiogenesis. The primary objective of this study was to document the incidence of de novo uterine adhesions after transcervical fibroid ablation (TFA) of symptomatic uterine fibroids with the Sonata® system. STUDY DESIGN: In this European postmarket prospective, multicenter, single-arm interventional trial, patients were eligible for inclusion if they chose TFA with the Sonata System for symptomatic fibroids and had at least 1 type 1, type 2 or type 2-5 myoma. The presence or absence of intrauterine adhesions was assessed by diagnostic hysteroscopy at baseline and at 6 weeks post-ablation. The hysteroscopy videos were scored by a committee of 3 independent readers. RESULTS: A total of 6 sites enrolled 37 patients. Fifty fibroids with a mean diameter of 3.4 ±â€¯1.8 cm (range 1-8 cm) were ablated. Of the 37 enrolled subjects, 35 completed the study follow-up and 2 electively withdrew from the study prior to the completion of study follow-up. Thirty-four out of 35 pairs of baseline and 6-week hysteroscopies were evaluated by the independent readers with none having de novo adhesions at 6 weeks after treatment with Sonata, including 6 patients with apposing myomata. One patient was excluded from the analysis due to an unevaluable hysteroscopy video. CONCLUSION: Intrauterine adhesiogenesis was not seen post-TFA with the Sonata system. These results suggest the potential for adhesiogenesis after TFA, including in women with apposing submucous and/or transmural myomata, may be minimal.

Seven-Year Outcomes After Hysteroscopic and Laparoscopic Sterilizations.

OBJECTIVE: To evaluate 7-year outcomes after hysteroscopic and laparoscopic sterilizations, including subsequent tubal interventions and hysterectomies. METHODS: This observational cohort study included women undergoing hysteroscopic and laparoscopic sterilizations in outpatient and ambulatory surgical settings in New York State during 2005-2016. We examined subsequent procedures (tubal ligation or resection, and hysterectomy not related to uterine leiomyomas or gynecologic tumors) after the index procedures. After propensity score matching, we used Kaplan-Meier analysis to obtain estimated risks of subsequent procedures within 7 years of index sterilization procedures, and Cox proportional hazard models to compare the differences between groups. RESULTS: We identified 10,143 and 53,206 women who underwent interval hysteroscopic and laparoscopic sterilizations, respectively, in New York State during 2005-2016. The mean age of the cohort was 34.2 years (range 18-80). The propensity score-matched cohort consisted of 10,109 pairs of women. The estimated risk of undergoing an additional tubal ligation or resection within 7 years was higher after hysteroscopic sterilization than it was after laparoscopic sterilization (3.9% vs 1.6%, HR 2.89, 95% CI 2.33-3.57). The difference was most pronounced within the initial year after attempted sterilization (1.5% vs 0.2%; HR 6.39, 95% CI 4.16-9.80). There was no significant difference in the risk of receiving a hysterectomy (0.9% vs 1.2%; HR 0.73, 95% CI 0.53-1.00) between women who underwent hysteroscopic and laparoscopic sterilizations. CONCLUSION: Patients undergoing hysteroscopic sterilization have a higher risk of receiving an additional tubal resection or ligation than those undergoing laparoscopic sterilization, particularly within the first year of the index procedure. There is no difference in undergoing a subsequent hysterectomy between the two groups. With limited evidence of outcomes after hysteroscopic sterilization beyond 7 years and existing reports of removals years after initial implantations, continuous monitoring of long-term outcomes for women who received the device is warranted.

Ultrasound-Guided Transcervical Ablation of Uterine Leiomyomas.

OBJECTIVE: To evaluate the 12-month safety and effectiveness of transcervical ablation for the treatment of symptomatic uterine leiomyomas. METHODS: In this prospective, multicenter, single-arm interventional trial, transcervical ablation was performed on 1-10 leiomyomas per patient with leiomyoma diameters ranging from 1 to 5 cm. Treated leiomyomas included all nonpedunculated types. Coprimary endpoints assessed at 12 months were reduction in menstrual blood loss and absence of surgical reintervention. Additional assessments included symptom severity, quality of life, patient satisfaction, reductions in uterine and leiomyoma volumes, and safety. RESULTS: One hundred forty-seven patients were enrolled and treated in the United States and Mexico. The study met its coprimary endpoints at 12 months (N=143; full analysis set), because 64.8% of patients (95% CI 56.3-72.6%) experienced 50% or greater reduction in menstrual bleeding and 99.3% of patients (95% CI 95.1-99.9%) were free from surgical reintervention. The mean pictorial blood loss assessment chart score decreased by 38.9%, 48.4%, and 51.1% at 3, 6, and 12 months, respectively (P<.001), and 95.1% of patients experienced a reduction in menstrual bleeding at 12 months. There were significant mean improvements in symptom severity and health-related quality of life of 32.1 points and 43.7 points, respectively, at 12 months (all P<.001). Mean maximal leiomyoma volume reduction per patient was 62.4% (P<.001). More than half of patients returned to normal activity within 1 day, 96.3% of patients reported symptom improvement at 12 months, and 97% expressed satisfaction with the treatment at 12 months. There were no device-related adverse events. CONCLUSION: Transcervical ablation was associated with a significant reduction in leiomyoma symptoms with no device-related adverse events and a low surgical reintervention rate through 12 months, demonstrating its potential to safely and effectively treat all nonpedunculated leiomyoma types through a uterus-conserving, incisionless approach. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02228174. FUNDING SOURCE: Supported by Gynesonics, Inc.

A Prospective, Multicenter, Pivotal Trial to Evaluate the Safety and Effectiveness of the AEGEA Vapor Endometrial Ablation System.

STUDY OBJECTIVE: To evaluate the safety and effectiveness of the AEGEA Vapor System (Aegea Medical System, Menlo Park, CA) for the treatment of heavy menstrual bleeding (HMB). DESIGN: A prospective, multicenter, single-arm, open-label, clinical trial. Follow-up assessments were conducted at 24 hours; 2 weeks; and 3, 6, and 12 months after the endometrial ablation procedure (Canadian Task Force Classification II-1). SETTING: A private practice and outpatient and hospital settings at 15 sites in the United States, Canada, Mexico, and the Netherlands. PATIENTS: One hundred fifty-five premenopausal women aged 30 to 50years with HMB as determined by a pictorial blood loss assessment score ≥150. Preoperative evaluation included ultrasound, sonohysterography or hysteroscopy, and endometrial biopsy. Screening inclusion allowed treatment of up to 12-cm uterine sound lengths and nonobstructing myomata. INTERVENTIONS: Endometrial ablation (120-second treatment time) was performed under varying anesthesia regimens using the vapor system from September 2014 to May 2015. MEASUREMENTS AND MAIN RESULTS: The primary effectiveness end point was the reduction of menstrual blood loss to a pictorial blood loss assessment score ≤75. Success was judged based on the Food and Drug Administration's objective performance criteria, derived from the success rates of the first 5 global endometrial ablation pivotal clinical trials. The secondary effectiveness end points included quality of life and patient satisfaction as assessed using the Menorrhagia Impact Questionnaire and the Aberdeen Menorrhagia Severity Score as well as the need for surgical or medical intervention to treat abnormal bleeding at any time within the first 12 months after treatment. All adverse events, including device- and procedure-related events, were recorded. At 12 months, the primary effectiveness end point was achieved in 78.7% of subjects exceeding the OPC (p = .0004); 90.8% of subjects were satisfied or very satisfied with the treatment. Ninety-nine percent of subjects showed improvement in quality of life scores with an average decrease in the Menorrhagia Impact Questionnaire score by 8.1, 72% had less dysmenorrhea, and 85% of women whose sex lives were affected by their menses reported improvement in their sex lives. There were no reported serious adverse device effects or any reported serious adverse events that were procedure related. CONCLUSION: The AEGEA Vapor System is a safe, effective, and minimally invasive option for performing in-office endometrial ablation under minimal anesthesia for the purpose of treating women who suffer from HMB.

Methotrexate Administration to Patients With Presumed Ectopic Pregnancy Leads to Methotrexate Exposure of Intrauterine Pregnancies.

OBJECTIVE: To report clinical experience with methotrexate (MTX) treatment for suspected but not definite ectopic pregnancy (EP). METHODS: This was a retrospective cohort study. All patients treated with MTX for presumed EP between 2000 and 2016 were included. Demographic, clinical, sonographic, and outcome data were collected and analyzed. RESULTS: A total of 820 patients were treated with MTX, 692 (84.4%) of which were lacking definitive features of EP; 155 (22.4%) failed to follow up until complete resolution and were excluded. Retrospective sonographic categorization was applied to 537 patients; of those patients, 393 (73.2%) were categorized as probable EPs, 136 (25.3%) pregnancies of unknown location (PULs), and 8 (1.5%) probable intrauterine pregnancies (IUPs). Sixteen were eventually diagnosed with IUP: 6 from the probable EPs, 9 from the PULs, and 1 from the probable IUP group. Patients with final diagnosis of IUP had higher values of ß-human chorionic gonadotropin as well as lower prevalence of adnexal mass (38% versus 74%; P = .003), higher prevalence of intracavitary fluid (44% versus 9%; P = .0004) and thicker endometrium (17.1 ± 11.8 versus 9.7 ± 5.6; P = .04). None of the sonographic parameters were able to distinguish patients with IUP. One patient of the 16 with IUP was diagnosed with a viable pregnancy, and 7 additional patients had a possible viable pregnancy. None of them elected to continue the pregnancy. CONCLUSIONS: Most patients with suspected EP who are eligible for medical treatment lack definitive sonographic features of EP. Treatment with MTX in such cases should be delayed, as clinically reasonable, to improve the diagnosis and prevent inadvertent administration of MTX to patients with a viable IUP.

Predictors of laparoscopic simulation performance among practicing obstetrician gynecologists.

BACKGROUND: While simulation training has been established as an effective method for improving laparoscopic surgical performance in surgical residents, few studies have focused on its use for attending surgeons, particularly in obstetrics and gynecology. Surgical simulation may have a role in improving and maintaining proficiency in the operating room for practicing obstetrician gynecologists. OBJECTIVE: We sought to determine if parameters of performance for validated laparoscopic virtual simulation tasks correlate with surgical volume and characteristics of practicing obstetricians and gynecologists. STUDY DESIGN: All gynecologists with laparoscopic privileges (n = 347) from 5 academic medical centers in New York City were required to complete a laparoscopic surgery simulation assessment. The physicians took a presimulation survey gathering physician self-reported characteristics and then performed 3 basic skills tasks (enforced peg transfer, lifting/grasping, and cutting) on the LapSim virtual reality laparoscopic simulator (Surgical Science Ltd, Gothenburg, Sweden). The association between simulation outcome scores (time, efficiency, and errors) and self-rated clinical skills measures (self-rated laparoscopic skill score or surgical volume category) were examined with regression models. RESULTS: The average number of laparoscopic procedures per month was a significant predictor of total time on all 3 tasks (P = .001 for peg transfer; P = .041 for lifting and grasping; P < .001 for cutting). Average monthly laparoscopic surgical volume was a significant predictor of 2 efficiency scores in peg transfer, and all 4 efficiency scores in cutting (P = .001 to P = .015). Surgical volume was a significant predictor of errors in lifting/grasping and cutting (P < .001 for both). Self-rated laparoscopic skill level was a significant predictor of total time in all 3 tasks (P < .0001 for peg transfer; P = .009 for lifting and grasping; P < .001 for cutting) and a significant predictor of nearly all efficiency scores and errors scores in all 3 tasks. CONCLUSION: In addition to total time, there was at least 1 other objective performance measure that significantly correlated with surgical volume for each of the 3 tasks. Higher-volume physicians and those with fellowship training were more confident in their laparoscopic skills. By determining simulation performance as it correlates to active physician practice, further studies may help assess skill and individualize training to maintain skill levels as case volumes fluctuate.

Pregnancy Outcomes After Direct Uterine Myoma Thermal Ablation: Review of the Literature.

The objective of this review is to describe the reproductive outcomes of women after radiofrequency volumetric thermal ablation (RFVTA) of myomas or magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU). This is a literature review of the current case reports of reproductive outcomes after direct myoma thermal ablation at multiple academic and private centers throughout the world. A literature search was performed using PubMed and Medline. All publications that included data of women who underwent radiofrequency myoma ablation or MRgHIFU of myomas and subsequently conceived were included. There were 122 pregnancies after direct uterine myoma thermal ablation, and 20 pregnancies were reported after RFVTA. Of these cases, there was 1 spontaneous abortion and 7 elective terminations. The remaining 12 pregnancies went on to have live full-term deliveries, 9 (75%) by cesarean section and 3 (25%) by vaginal delivery. There were no reports of uterine abnormalities at delivery and 1 delayed postpartum hemorrhage with expulsion of a degenerated myoma. There are 102 reported pregnancies after MRgHIFU. There were 21 spontaneous abortions and 22 elective terminations, 48 deliveries, and 11 ongoing pregnancies at the time of report. There was 1 preterm delivery at 36 weeks due to placenta previa, and the remaining deliveries were full term. The complications reported included vaginal spotting (12.5%), delayed placental separation (4%), and placenta previa (4%). There were no cases of uterine rupture. In summary, RFVTA and MRgHIFU are new minimally invasive alternatives for the treatment of myomas. Further investigation into the reproductive outcomes after these myoma therapies is crucial to determine whether these are appropriate treatment options for women with symptomatic myomas who desire future fertility.

The Effects of a Genital Vibratory Stimulation Device on Sexual Function and Genital Sensation.

OBJECTIVE: The aim of this study was to evaluate the effectiveness of a genital vibratory stimulation device in improving sexual function in women with arousal and orgasm disorders. METHODS: In this single-arm, prospective study, baseline and 1- and 3-month assessments were performed to evaluate women with sexual arousal and/or orgasmic disorders, who received therapy using a genital vibratory stimulation device. Sexual function, satisfaction, and distress were evaluated using the Female Sexual Function Index (FSFI), the Female Sexual Distress Scale, and the Female Intervention Efficacy Index questionnaires. Genital sensation was evaluated using quantitative sensory testing. RESULTS: Seventy women, aged 19 to 64 years, were evaluated from October 2009 to August 2013. Forty-seven (67.1%) and 37 (52.9%) women completed 1- and 3-month follow-ups, respectively. The FSFI arousal and orgasm domain scores and total FSFI scores improved at 1 and 3 months (P < 0.001 for all outcomes). Mean (SD) total FSFI scores increased from 20.04 (4.65) (baseline) to 25.03 (5.21) (1 month) to 26.66 (5.42) (3 months; both Ps < 0.0001). Female Sexual Distress Scale scores reflected significantly decreased distress at 1 (P = 0.0006) and 3 (P < 0.0001) months compared with baseline and at 3 months compared with 1 month (P = 0.03). Neurological sensation was increased at all genital sites at 1 and 3 months (P < 0.0001 for all). After adjustment for age, there was a significant interaction between arousal domain scores and clitoral and right labial sensation. At 3 months, perceptions of increased vaginal lubrication, orgasm, and genital sensation were reported by 67.5%, 65.0%, and 82.5% of the participants. No major adverse events were noted. CONCLUSIONS: Genital vibratory stimulation device use resulted in uniform improvements in sexual function, satisfaction, sexually related distress and genital sensation.

Hysteroscopic Essure Inserts for Permanent Contraception: Extended Follow-Up Results of a Phase III Multicenter International Study.

OBJECTIVE: To describe safety, tolerability, and effectiveness results through 5 years of follow-up of a Phase III trial with Essure inserts. DESIGN: Multicenter, nonrandomized, single-arm international study (Canadian Task Force classification II-3). SETTING: Thirteen clinical study centers in the United States, Europe, and Australia. PATIENTS: A total of 518 previously fertile women seeking permanent contraception. INTERVENTION: The objective of the hysteroscopic sterilization procedure was bilateral Essure insert placement (ESS205 model) and tubal occlusion. Women with satisfactory device location and tube occlusion (based on modified hysterosalpingography [HSG]) were instructed to discontinue alternative contraception and to rely on Essure inserts for permanent contraception. MEASUREMENTS AND MAIN RESULTS: The primary endpoint for the Phase III study was the rate of pregnancies occurring during the first year of relying (i.e., HSG-confirmed occlusion) on the Essure inserts for permanent contraception (i.e., 12 months after HSG). For the full 5 years of follow-up (5 years total of relying on the Essure inserts for contraception), the endpoints of interest were safety, prevention of pregnancy, and satisfaction. No pregnancies were reported among women relying on the Essure inserts who completed the full 5 years of follow-up. As of December 5, 2007, 449 women with successful bilateral placement relying on the Essure inserts contributed a total 24 942 woman-months of follow-up for assessing effectiveness. Overall, the Essure inserts were generally well tolerated, with participant comfort rated as "good" to "excellent" by 99% of women (382 of 385) after 5 years of use. Similarly, overall satisfaction was rated as "somewhat" to "very satisfied" by 98% of women (376 of 384) after 5 years of use. The majority of adverse events reported during the 5 years of follow-up were rated as either "mild" or "moderate" in severity. Three severe events (abdominal pain with very heavy periods and irregular menstrual bleeding) were reported in 2 subjects during follow-up as being "possibly" related to the procedure or the inserts. CONCLUSION: The findings from extended follow-up of this Phase III trial with Essure inserts further support the effectiveness, tolerability, and satisfaction of this nonhormonal, nonincisional option for permanent contraception.

Hysteroscopic morcellation: review of the manufacturer and user facility device experience (MAUDE) database.

STUDY OBJECTIVE: To investigate the number and type of adverse events associated with hysteroscopic morcellation of intrauterine disease. DESIGN: Systematic review of Manufacturer and User Device Experience (MAUDE) database from 2005 to June 2014 (Canadian Task Force classification III). SETTING N/A PATIENTS: Women undergoing hysteroscopic surgery for removal of intrauterine polyps or myomas with use of a reciprocating morcellator. INTERVENTIONS: The MAUDE database was searched for the key words "Hysteroscope," "Hysteroscopic reciprocating morcellator," "Interlace," "MyoSure," "Smith & Nephew," and "TRUCLEAR," to identify reported incidences of device malfunction, injury, or death. A total of 119 adverse events were analyzed. Reports were reviewed individually and categorized by date of occurrence, type of morcellation device, type of complication, and a brief description. Each company was contacted to provide an estimate of the number of procedures performed or units sold to date. MEASUREMENTS AND MAIN RESULTS: From 2005 to June 2014, 119 adverse events were reported to the MAUDE database. On the basis of severity, adverse events were categorized as major or minor complications. Major events included intubation/admission to an intensive care unit (n = 14), bowel damage (n = 12), hysterectomy (n = 6), and death (n = 2). Minor events included uterine perforation requiring no other treatment (n = 29), device failure (n = 25), uncomplicated fluid overload (n = 19), postoperative bleeding controlled using noninvasive measures (n = 6), and pelvic infection (n = 4). These events were then categorized according to manufacturer. The number of adverse events reported to the MAUDE database was divided by the total units sold as a surrogate for the estimated number of procedures performed. Understanding the limitation of the numbers used as a numerator and denominator, we concluded that adverse events complicated hysteroscopic morcellation in <0.1% cases. CONCLUSIONS: The suction-based, mechanical energy, rotating tubular cutting system was developed to overcome adverse events that occur during traditional resectoscopy. On the basis of acknowledged limited information from the MAUDE database, it seems that life-threatening complications such as fluid overload, uterine perforation, and bleeding do occur with hysteroscopic morcellation but less frequently than with traditional electrocautery.

Image-guided drainage versus antibiotic-only treatment of pelvic abscesses: short-term and long-term outcomes.

OBJECTIVE: To determine the efficacy of image-guided drainage versus antibiotic-only treatment of pelvic abscesses. DESIGN: Retrospective cohort analysis. SETTING: An academic, inner-city medical center. PATIENT(S): Women ages 11-49, admitted between 1998 and 2008 with ICD9 code 614.x (inflammatory diseases of ovary, fallopian tube, pelvic cellular tissue, and peritoneum). INTERVENTION(S): Medical records search, chart review, and phone survey. MAIN OUTCOME MEASURE(S): Surgical intervention. RESULT(S): We identified 6,151 initial patients, of whom 240 patients met inclusion criteria. Of the included patients, 199 women received antibiotic-only treatment, and 41 received additional image-guided drainage. There was no statistically significant difference between the two groups in terms of age, body mass index, parity, incidence of diabetes, obesity, endometriosis, or history of sexually transmitted infection excluding human immunodeficiency virus (HIV). Abscesses in the drainage cohort were noted to be larger in dimension (5.9 cm vs. 8.5 cm); 16.1% of patients who received antibiotics alone required surgical intervention versus only 2.4% of the drainage cohort. Patients who received drainage had longer hospital stays, but the time from treatment to discharge was similar in both groups (7.4 days vs. 6.7 days). We successfully contacted 150 patients, and the differences in long-term pregnancy outcomes, pain, or infertility were not statistically significant. CONCLUSION(S): Patients who received antibiotics alone were more likely to require further surgical intervention when compared with patients who additionally received image-guided drainage. There were no observable long-term differences.

Role of elevated cancer antigen 19-9 in women with mature cystic teratoma.

The objective of this study was to determine how often an elevated cancer antigen (CA) 19-9 (≥ 37 U/mL) was present during the preoperative evaluation of women with a mature cystic teratoma (MCT). This was a retrospective, consecutive case series (N = 139) of histologically proven MCT treated at Montefiore Medical Center from 1997 to 2008. Data were analyzed for patient and tumor characteristics, tumor markers (CA 19-9, CA 125, and carcinoembryonic antigen [CEA]), preoperative imaging, and procedure. CA 19-9 was elevated in 37.4% of patients. Elevated CA 19-9 was not significantly associated with age, race, CA 125 (≥35 U/mL), CEA (≥5 ng/mL), MCT size, or the presence of bilateral MCTs. Of the patients, 59% were ≥40 years old. Age <40 years was associated with cystectomy rather than oophorectomy (P < .001), regardless of CA 19-9 (P = .09). Elevated preoperative CA 19-9 in patients with MCT was associated with increased preoperative computed tomography (P = .04).