Radiofrequency ablation for the treatment of uterine fibroids: A systematic review and meta-analysis by the AAGL Practice Committee.

OBJECTIVE: To systematically review clinical and patient-reported outcomes after radiofrequency ablation (RFA) for the treatment of uterine fibroids. DATA SOURCES: We searched Medline, EMBASE, Cochrane Registry of Controlled Trials (CENTRAL) on September 8, 2023, and requested additional data from industry sources. We included published, peer-reviewed studies of patient-centered outcomes of RFA when used for symptomatic fibroids. Abstracts and potentially relevant full-text articles were screened and data were extracted regarding study characteristics, arms, outcomes, and results, together with risk of bias assessment. METHODS OF STUDY SELECTION: We included 30 studies published in 49 articles (3 randomized controlled trials, 1 nonrandomized comparative study, and 26 single-group studies, as well as 4 publications from the TRUST Study) with variable risks of bias. TABULATION, INTEGRATION, AND RESULTS: The study populations were demographically diverse and clinically heterogeneous. Across studies, RFA treatment was associated with fibroid volume reduction of 46.0% (95% confidence interval [CI] 52.1, 40.0; 11 studies) at 3 months and 65.4% (95% CI 74.7, 56.1; 10 studies) at 12 months. All studies reported a decrease in proportion of patients experiencing abnormal, heavy, or prolonged menstrual bleeding, with the most substantial improvement within the first 3 months. Meta-analyses of health-related quality of life (HRQOL) scores demonstrated significant improvements in scores from baseline for Uterine Fibroid Symptoms and Quality of Life [UFS-QOL] (53.4, 95% CI 48.2, 58.5; 19 studies), EuroQol 5 Dimension [EQ-5D] (71.6, 95% CI 65.0, 78.1; 4 studies), and Symptom Severity Score [SSS] (52.2, 95% CI 46.4, 58.1; 17 studies), with a peak at 6 months on the UFS-QOL scale (88.0, 95% CI 83.0, 92.9; 11 studies), a peak at 24 months on the EuroQol-5D scale (88.3, 95% CI 86.0, 90.6; 2 studies), and a trough at 12 months for SSS (12.8, 95% CI 7.0, 18.6; 11 studies). Studies mostly demonstrated return to work and normal activities within 2 weeks. Reported unplanned hospitalizations were infrequent, and durations of hospital stay were generally short. Post-procedure complications were inconsistently reported, but assessed overall to be infrequent. Long-term need for medical and surgical re-intervention varied. Post-RFA hysterectomy rates ranged from 2/205 (1.0%) to 15/62 (24.1%) with variable follow-up periods ranging from 45 days to 74 months. Most studies did not include patients who desired to maintain fertility; thus, reproductive data are insufficient for interpretation. CONCLUSION: There is a paucity of comparative studies, and the small number of RCTs are limited by lack of blinding. Few studies had the long-term follow-up time required to draw definitive conclusions regarding the durability of symptom relief. However, despite these limitations, there is overall agreement on several important clinical measures following RFA, such as decreased fibroid volume, improved uterine bleeding and improved quality of life. Future high quality randomized controlled trials with standardized outcomes measures are required to better characterize the use of RFA among fibroid patients.

Case Series of Reproductive Outcomes after Laparoscopic Radiofrequency Ablation of Symptomatic Myomas.

STUDY OBJECTIVE: To analyze pregnancy delivery and safety outcomes after patient receipt of percutaneous, laparoscopic intra-abdominal ultrasound-guided radiofrequency ablation (Lap-RFA) for symptomatic uterine myomas. DESIGN: Case series (2010-2017); evidence was obtained from 2 randomized, controlled trials (level I), 6 cohort studies (level II-2), and in commercial settings (level II-3). SETTING: Multiple sites in the United States, Canada, Europe, and Latin America (university hospitals, community hospitals, and stand-alone surgery centers). Commercial cases were United States based and followed US Food and Drug Administration clearance of Lap-RFA. PATIENTS: Premenopausal adult women with symptomatic uterine myoma types 1 through 6. INTERVENTIONS: The Lap-RFA procedure was conducted under general anesthesia with laparoscopic and intra-abdominal ultrasound guidance. MEASUREMENTS AND MAIN RESULTS: Safety unknowns included the safety of a full-term pregnancy for mother and baby, rates of spontaneous abortion, preterm delivery, postpartum hemorrhage, placental abnormalities, intrauterine growth restriction, and vaginal versus cesarean delivery. A total of 28 women (mean age = 35.0 ± 3.4 years) conceived a total of 30 times after Lap-RFA, either as part of a clinical study or in commercial settings. The number of myomas treated per patient ranged from 1 to 7. The diameter of treated myomas ranged from 0.9 to 11.0 cm. Most patients had 1 or 2 myomas, and most myomas were ≤5.5 cm in maximal diameter. The 30 pregnancies resulted in 26 full-term live births (86.7%), all healthy infants, with an equal distribution of vaginal and cesarean deliveries. Four (13.3%) spontaneous abortions occurred. No cases of preterm delivery, uterine rupture, placental abruption, placenta accreta, or intrauterine growth restriction were reported. One event each of placenta previa and postpartum hemorrhage were reported. CONCLUSION: Conception and safe, full-term pregnancy are achievable after Lap-RFA of symptomatic myomas. Additional large, rigorous, multivariate prospective studies that adjust for confounders and report pregnancy outcomes after symptomatic myoma treatment are needed.

Norethindrone is superior to combined oral contraceptive pills in short-term delay of menses and onset of breakthrough bleeding: a randomized trial.

BACKGROUND: To determine whether oral norethindrone acetate is superior to combined oral contraceptives (OCP) in delaying menstruation and preventing breakthrough bleeding when started late in the cycle. METHODS: This article comprises of a case control study followed by a pilot randomized controlled study. In the first study, four women who presented late in their cycle and desired avoiding vaginal bleeding within 10 days before a wedding were started on norethindrone 5 mg three times daily and compared to age matched controls started on OCPs. Subsequently, a randomized controlled pilot study (n = 50) comparing OCPs to norethindrone for the retiming of menses was conducted. Percentage of women reporting spotting were compared with level of statistical significance set at p < 0.05. RESULTS: Of the norethindrone treated group, only 2 women (8%) reported spotting compared with 10 women (43%) in the control group (p < 0.01). Norethindrone recipients experienced significant weight gain, which resolved after cessation of therapy and had heavier withdrawal bleed (p < 0.04) when compared to controls. Patient satisfaction was significantly higher in the norethindrone group, with 80% willing to choose this method again. Time to conceive was significantly shorter in the norethindrone group (p < 0.03). CONCLUSIONS: Norethindrone, begun on or before cycle day 12, is superior for women who desire to avoid breakthrough bleeding and maintain fertility when compared to OCPs. It is an ideal approach in patients presenting late in their cycle and who desire delaying menses as well as in circumstances when even minute amounts of breakthrough bleeding cannot be tolerated. TRIAL REGISTRATION: Clinicaltrials.gov NCT03594604 , July 2018. Retrospectively registered.

Reproductive Outcomes in Women Following Radiofrequency Volumetric Thermal Ablation of Symptomatic Fibroids. A Retrospective Case Series Analysis.

OBJECTIVE: To report reproductive outcomes in women who underwent radiofrequency volumetric thermal ablation (RFVTA) of symptomatic uterine fibroids. STUDY DESIGN: Retrospective analysis of fibroid characteristics, treatment parameters, and pregnancy outcomes of 6 subjects in 3 prospective trials of laparoscopic ultrasound-guided RFVTA. RESULTS: Despite the requirement that women enrolled in the RFVTA studies did not desire current or future childbearing and were to continue contraception, 6 subjects conceived at between 3.5 and 15 months postreatment. The number of fibroids treated per patient ranged from 1 to 7, measured between 1.0 cm and 7.6 cm at the greatest diameter, and included multiple types (submucosal, intramural, transmural, and subserosal). Five patients (5/6, 83%) delivered full-term healthy infants: 1 by vaginal delivery and 4 by cesarean section. One patient (1/6, 17%) had a spontaneous miscarriage in the first trimester. CONCLUSION: Viable, full-term pregnancies are possible after RFVTA. Further, in-depth study of pregnancy outcomes following laparoscopic ultrasound-guided radiofrequency, volumetric ablation of fibroids is warranted.

Three-year outcome of the Halt trial: a prospective analysis of radiofrequency volumetric thermal ablation of myomas.

STUDY OBJECTIVE: To analyze the clinical success of radiofrequency volumetric thermal ablation (RFVTA) at 3-year follow-up in terms of subject responses to validated questionnaires and surgical repeat intervention to treat myomas. DESIGN: Prospective follow-up of patients for 36 months after treatment in a multicenter international trial of outpatient, laparoscopic ultrasound-guided RFVTA of symptomatic uterine myomas (Canadian Task Force classification II-1). SETTING: University hospitals and private surgical centers. PATIENTS: One hundred thirty-five premenopausal women (mean [SD] age, 42.5 [4.6] years; body mass index, 30.5 [6.1]) with symptomatic uterine myomas and objectively confirmed heavy menstrual bleeding (≥ 160 to ≤ 500 mL). INTERVENTIONS: Laparoscopic ultrasound-guided RFVTA. MEASUREMENTS AND MAIN RESULTS: One hundred four participants were followed prospectively for 36 months after treatment of myomas via RFVTA. For 104 evaluable participants with 36-month data, change in mean (SD) symptom severity from baseline (60.2 [18.8]) to 36 months was -32.6 (95% confidence interval, -37.5 to -27.8; p < .001). Health-related quality of life also was improved, from the baseline value of 39.2 (19.2) to 38.6 (95% confidence interval, 33.3 to 43.9; p < .001) at 36 months. Patient-reported Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire subscores demonstrated statistically significant improvement from baseline to 36 months in all categories (Concern, Activities, Energy/Mood, Control, Self-consciousness, and Sexual Function) (p < .001). For the 104 participants with 36-month data, mean state of health scores (EuroQOL-5D Health State Index) improved from a baseline value of 71.0 (19.3) to 86.2 (11.7) at 36 months. The cumulative repeat intervention rate of 11% (14 of 135 participants) at 36 months was well below the possible 25% maximum expected at the beginning of the trial. CONCLUSION: RFVTA of uterine myomas resulted in sustained relief from myoma symptoms and continued improvement in health-related quality of life through 36 months after ablation. The low repeat intervention data through 36 months is a positive outcome for patient well-being.

Analysis of the safety and reliability of a hydrothermal ablation system: a multicenter, prospective postmarket study.

OBJECTIVE: To obtain information on practitioner experience in the use of the Genesys HydroThermAblator (HTA) System under normal clinical conditions through documentation of the system's acute safety features, in terms of burn rates, and its technical reliability. STUDY DESIGN: This was a prospective, observational, multicenter, postmarket interventional clinical trial with outcome measures of acute (within 21 days post-procedure) safety, serious adverse device effects, and technical malfunctions in a population of premenopausal women > or = 18 years of age. RESULTS: A total of 992 women (mean age, 41.7 +/- 6.8 years; range, 22-65 years) were enrolled in 18 clinical sites throughout the United States. The Genesys HTA System provided low burn rates in the intent-to-treat (n = 992 [0.4%] [95% CI 0.1-1.0%]) and evaluable (n = 931 [0.2%] [95% CI 0.1-0.8%]) subject populations. Only 1 burn was clinically significant and was defined as a serious adverse device effect (1/992 [0.10%] [95% CI 0.0-0.6%]). Fifty-three (5.1%) technical malfunctions occurred in 44 procedures, and 27 (27/44 [61.4%]) patients completed their procedures after 31 (31/ 53 [58.5%]) technical problems were addressed and resolved. CONCLUSION: The Genesys HTA System delivers a safe and reliable treatment option for premenopausal women with heavy menstrual bleeding.

Sensitivity of myoma imaging using laparoscopic ultrasound compared with magnetic resonance imaging and transvaginal ultrasound.

STUDY OBJECTIVE: To determine the efficacy of laparoscopic ultrasound (LUS) as compared with contrast-enhanced magnetic resonance imaging (CE-MRI) and transvaginal ultrasound (TVUS) in detection of uterine myomas. DESIGN: Retrospective study of imaging methods used in a trial of LUS-guided radiofrequency volumetric thermal ablation in women with symptomatic myomas (Canadian Task Force classification II-2). SETTING: Eleven medical university or private outpatient surgery clinics in the United States (nine sites) and Latin America (two sites). PATIENTS: One hundred thirty-five women with symptomatic myomas and objectively confirmed moderate to severe heavy menstrual bleeding. INTERVENTIONS: LUS-guided radiofrequency volumetric thermal ablation of myomas. MEASUREMENTS AND MAIN RESULTS: Preoperative TVUS scans and CE-MRIs were read at each site, and all CE-MRIs were read by a central reader. LUS-guided scans were obtained intraoperatively by each surgeon by mapping the uterus just before radiofrequency volumetric thermal ablation. The imaging methods and their yields in terms of number of myomas found per subject were as follows: TVUS, 403 myomas (mean [SD] 3 [1.8]; range, 1-8); site CE-MRI, 562 myomas (4.2 [3.8]; range, 1-18); central reader, 619 myomas (4.6 [3.7]; range, 0-20); and LUS, 818 myomas (6.1 [4.9]; range, 1-29) (p < .001). LUS was superior to TVUS, CE-MRI, and the central reader for detection of small (≤1 cm(3)) myomas. Most imaged myomas were intramural: 197 (50.9%) by TVUS, 298 (55.5%) by site CE-MRI, 290 (48.7%) by the central reader, and 386 (48.5%) by LUS. CONCLUSION: Compared with CE-MRI and TVUS, LUS demonstrates the most myomas, regardless of size or type.

Analysis of adverse events with Essure hysteroscopic sterilization reported to the Manufacturer and User Facility Device Experience database.

STUDY OBJECTIVE: The Manufacturer and User Facility Device Experience database may be useful for clinicians using a Food and Drug Administration-approved medical device to identify the occurrence of adverse events and complications. We sought to analyze and investigate reports associated with the Essure hysteroscopic sterilization system (Conceptus Inc., Mountain View, CA) using this database. DESIGN: Retrospective review of the Manufacturer and User Facility Device Experience database for events related to Essure hysteroscopic sterilization from November 2002 to February 2012 (Canadian Task Force Classification III). SETTING: Online retrospective review. PATIENTS: Online reports of patients who underwent Essure tubal sterilization. INTERVENTION: Essure tubal sterilization. MEASUREMENTS AND MAIN RESULTS: Four hundred fifty-seven adverse events were reported in the study period. Pain was the most frequently reported event (217 events [47.5%]) followed by delivery catheter malfunction (121 events [26.4%]). Poststerilization pregnancy was reported in 61 events (13.3%), of which 29 were ectopic pregnancies. Other reported events included perforation (90 events [19.7%]), abnormal bleeding (44 events [9.6%]), and microinsert malposition (33 events [7.2%]). The evaluation and management of these events resulted in an additional surgical procedure in 270 cases (59.1%), of which 44 were hysterectomies. CONCLUSION: Sixty-one unintended poststerilization pregnancies were reported in the study period, of which 29 (47.5%) were ectopic gestations. Thus, ectopic pregnancy must be considered if a woman becomes pregnant after Essure hysteroscopic sterilization. Additionally, 44 women underwent hysterectomy after an adverse event reported to be associated with the use of the device.

Full-term vaginal live birth after laparoscopic radiofrequency ablation of a large, symptomatic intramural fibroid: a case report.

BACKGROUND: This case study describes the first reported vaginal delivery following radiofrequency ablation (RFA) of fibroids. The subject was among a cohort of women seeking treatment for symptomatic fibroids. She was enrolled in a clinical trial studying outcomes of laparoscopic, ultrasound-guided RFA of symptomatic fibroids. CASE: A 38-year-old, G4P3, female was diagnosed with uterine fibroids following a spontaneous abortion and preterm delivery at 21 weeks of a nonviable infant. RFA was performed on 7 fibroids, the largest of which was measured by magnetic resonance imaging (MRI) to be a 6.1-cm, submucosal-intramural, right posterior leiomyoma. The patient conceived approximately 3.5 months after RFA. She had a spontaneous labor at term with an uncomplicated vaginal delivery of a 3,487-g female infant (Apgars: 9, 9). Post-RFA and post-delivery MRI images indicated a myometrial thickness of 9.6 mm throughout, including beneath the ablation site. CONCLUSION: The lack of a uterine defect following RFA in this case may have allowed this patient to progress to term without uterine rupture as has been reported with conventional myomectomy. The use of RFA in infertile women needs further study, and the decision to perform a cesarean section in women who have had RFA needs to be evaluated. The potential to treat many fibroid patients without requirement for subsequent cesarean section also needs further study.

Misdiagnosis of cervical ectopic pregnancy.

PURPOSE: To determine the presenting symptoms as well as the frequency and reasons for the delayed diagnosis of cervical ectopic pregnancy (CEP) in order to increase detection and prevent treatment delay. METHODS: Retrospective case series of 15 women treated for CEP from January 1997 through December 2008 at a university teaching hospital. RESULTS: Fifteen patients were treated for CEP during the study period. Eight patients presented to the emergency department, of which 6 (75%) were initially misdiagnosed. The most common misdiagnosis was threatened miscarriage (n = 5). All patients with accurately diagnosed CEP presented with heavy vaginal bleeding; those misdiagnosed reported mild to moderate vaginal bleeding. Three of six patients misdiagnosed did not have an ultrasound performed upon presentation, and three patients had an ultrasound report not suggestive of CEP. CEP was diagnosed on follow-up ultrasound, delaying treatment 1-4 days. CONCLUSIONS: Misdiagnosis of CEP upon initial presentation is a common occurrence. Transvaginal ultrasound performed by a qualified practitioner may increase detection and prevent treatment delay.

Uterine Fibroids in Black Women: A Race-Stratified Subgroup Analysis of Treatment Outcomes After Laparoscopic Radiofrequency Ablation.

Background: The disease and treatment burden of uterine fibroids (UF) in Black women is substantially greater compared with other racial groups, with higher rates of complications and poorer outcomes with both hysterectomy and myomectomy. The inequities in the access Black women have to minimally invasive routes of surgery contribute to their burden of illness. Laparoscopic radiofrequency ablation (LAP-RFA) is a minimally invasive, safe, and effective uterine-sparing treatment option. Methods: This subgroup analysis of the LAP-RFA Pivotal Trial stratified outcomes by race comparing White women (n = 28, 21%) versus Black women (n = 46, 34%). Results: At baseline, Black women had more fibroids on average (7.3 vs. 3.7; P ≤ 0.001), a greater symptom severity score (SSS) (P ≤ 0.001), and a lower health-related quality of life (HRQoL) score (P = 0.005) than White women. At 36 months post-treatment with LAP-RFA, the statistical differences that existed with baseline SSS and HRQoL score were eliminated between Black and White women. Menstrual blood loss (140.1 mL vs. 127.02 mL; P = 0.44) and mean fibroid volume reduction (47.5 cm3 vs. 36.0 cm3; P = 0.17) were similar between Black and White women at 12 months. Although not statistically significant, the intraoperative total blood loss and uterine blood loss was lower in Black women than White women, despite greater operative time (160 minutes vs. 137 minutes; P = 0.09). Conclusions: These results are promising in providing an alternative uterine-sparing option for Black women and may help to provide a minimally invasive option that can address some of the racial inequities in care for Black women with UF.

Appendectomy in the gynecological setting: intraoperative findings and corresponding histopathology.

BACKGROUND/AIMS: To evaluate the intraoperative findings and corresponding histopathology associated with appendectomies performed during benign gynecological surgery. METHODS: Retrospective case series. RESULTS: Twenty-two appendectomies were performed from 2002 through 2008 at Hutzel Women's Hospital due to intraoperative findings of inflammation or erythema (n = 8), periappendiceal adhesions (n = 5), injury to the appendix or mesoappendix (n = 2), fecalith (n = 2), dilation of the appendix (n = 1), adnexal mass involving the appendix (n = 1), and suspected lipoma (n = 1). Final pathology was consistent with significant findings such as acute inflammation, periappendicitis, and adhesions or endometriosis involving the appendix in 68.2% of cases. CONCLUSION: In the benign gynecological setting, appendectomies were primarily performed due to inflammation or erythema. In the majority of cases, significant appendiceal pathology was confirmed.

Reoperation rates for recurrence of fibroids after abdominal myomectomy in women with large uterus.

BACKGROUND: The population of women undergoing abdominal myomectomy for symptomatic large fibroid uterus is unique. We seek to characterize the timing, risk factors as well as the presenting symptoms which led patients to undergo repeat surgery in this patient population. METHODS AND FINDINGS: We followed 592 patients who underwent an abdominal myomectomy from March 1998 to June 2010 at St. Vincent's Catholic Medical Center and presented later during the study period with a recurrence of symptoms attributable to a reemergence of fibroids and who chose to undergo repeat surgical management. Twelve percent of patients exhibited symptoms of fibroid uterus which led to reoperation within the study period. The mean age at repeat surgery was 44.1 ± 0.6 years old (n = 69) and the mean time between operations was 7.9 ± 0.3 years. Presentation was variable but included bleeding, pain and infertility. Patients presented for surgery with a significantly smaller sized uterus than at their initial surgery. Timing between surgeries correlated with age at initial surgery and uterine size but race, number of fibroids, aggregate weight of fibroids removed, operative time or blood loss at the initial surgery did not correlate. Data is suggestive that intraperitoneal triamcinolone may reduce reoperation rates but not timing of recurrence. CONCLUSION: These results may help in counseling patients, particularly younger women, on the risks of fibroid recurrence necessitating repeat surgery. Further research is necessary to assess if triamcinolone can alter fibroid reurrence in patients who undergo uterus sparing procedures.

Reasons for poststerilization hysterosalpingography noncompliance in a clinic population.

OBJECTIVE: Although hysterosalpingography (HSG) is required 12 weeks after hysteroscopic sterilization, HSG compliance in our clinic population is remarkably low. We were interested in determining the reason(s) for HSG noncompliance in this urban-based patient population. STUDY DESIGN: University Health Center patients who underwent hysteroscopic sterilization between January 1, 2006, and December 31, 2007, and who did not complete HSG were contacted by telephone to elicit the reason(s) for lack of follow-up. RESULTS: Fifty-two patients qualified for inclusion in this study. Consent was obtained from all 14 patients accessible by telephone. Of note, 63.5% of patient-provided phone numbers were not in service at the time contact was attempted (n = 33). Patient-reported reasons for HSG noncompliance included insurance issues (n = 5), failure to remember to schedule HSG (n = 4), HSG scheduling difficulties (n = 2),failure to be informed about the need for HSG (n = 2), and prolonged postoperative vaginal bleeding (n =1). CONCLUSION: Reasons for poststerilization HSG noncompliance varied. However, an insurance issue was the most frequently reported reason for noncompliance. not recalling the need to schedule HSG was another common reason for noncompliance. Approaches to increase compliance with poststerilization HSG are needed, particularly in an urban-based, clinic population.

Placement of a permanent birth control device at a university medical center.

OBJECTIVE: To determine the Essure placement failure rate and analyze factors associated with failure in an urban, nonstudy population at a university medical center. STUDY DESIGN: A retrospective study was conducted of women who underwent attempted Essure hysteroscopic sterilization at the Detroit Medical Center (DMC) from January 1, 2003, to June 30, 2007. RESULTS: There were 316 Essure procedures attempted at the DMC from January 2003 through June 2007. Of the 316 attempted procedures, there were 22 device placement failures and 3 documented post-Essure pregnancies. Of the 22 placement failures, 11 were attributed to difficulty visualizing the tubal ostia. Other causes of failure included device malfunction, uterine perforation, tubal perforation, expulsion of the device, tubal spasm, tubal ostia too large for the device and unspecified. Difficulty visualizing the ostia (p < 0.001) and a longer procedure time (p = 0.008) were significantly associated with failure. CONCLUSION: The rate of successful placement of the Essure permanent birth control device at the DMC is 92.1%, with a post-Essure pregnancy rate of 0.95%. The majority of placement failures may be attributed to difficulty visualizing the tubal ostia.

Complete septate uterus, obstructed hemivagina, and ipsilateral renal anomaly: pregnancy course complicated by a rare urogenital anomaly.

BACKGROUND: Abnormalities of the female reproductive tract are associated with a multitude of intrapartum complications. In the case that follows, we report the complicated pregnancy course of a woman diagnosed postpartum with the uncommon syndrome of obstructed hemivagina and ipsilateral renal anomaly (OHVIRA) associated with a complete septate uterus. CASE: A 19-year-old nulliparous woman with a history of a right nephrectomy secondary to multicystic dysplastic kidney disease presented with premature rupture of membranes at 30 weeks' gestation. After failed induction of labor at 34 weeks' gestation, a uterine anomaly was discovered at the time of cesarean section. Magnetic resonance imaging performed postpartum revealed a complete septate uterus, longitudinal vaginal septum, and obstructed right hemivagina. CONCLUSION: The OHVIRA syndrome is classically associated with uterus didelphys, not complete septate uterus as in this woman. This case illustrates the potential for intrapartum complications in women with abnormalities of the urogenital tract.

Pregnancy following hysteroscopic sterilization at an Urban Abortion Clinic- A case series: Are We looking in the wrong places?

OBJECTIVE: Hysteroscopic sterilization (HS) has become one of the most common permanent contraception methods in the U.S. However, recent evidence suggests that the failure rate may be higher than previously reported. We describe women with a history of HS presenting for abortion at a 3-site urban abortion clinic. STUDY DESIGN: Retrospective case series of patients with previous HS who presented to a 3-site urban abortion clinic for pregnancy termination from October 2012 to February 2015. RESULTS: In 28months, 9 patients with prior HS had failure of the method and then an abortion. CONCLUSIONS: This study identifies a number of failures from a setting previously unaccounted. It suggests that perhaps the failure rate is higher than previously reported. The cases here presented, from a 3-site urban abortion clinic over 28months, almost match and sometimes surpass the number of failures reported in multicenter case series in the literature. Surveys of other abortion clinics in the U.S. and elsewhere might also discover other patients whose HS had failed. IMPLICATIONS: We identified a number of hysteroscopic sterilization failures at termination of pregnancy at a 3-site urban abortion clinic. We hypothesize that the HS failure rate underestimates the true method failure because previous analysis have excluded cases such as these.

Randomized comparative trial of cervical block protocols for pain management during hysteroscopic removal of polyps and myomas.

PURPOSE: To evaluate the efficacy of two cervical block protocols for pain management during hysteroscopic removal of intrauterine polyps and myomas using the MyoSure(®) device. PATIENTS AND METHODS: This was a randomized, comparative treatment trial conducted by five private Obstetrics and Gynecology practices in the USA. Forty premenopausal women aged 18 years and older were randomized to receive either a combination para/intracervical block protocol of 37 cc local anesthetic administered at six injections sites in association with the application of topic 1% lidocaine gel, or an intracervical block protocol of 22 cc local anesthetic administered at three injections sites without topical anesthetic, for pain management during hysteroscopic removal of intrauterine polyps and/or a single type 0 or type 1 submucosal myoma ≤3 cm. The main outcomes were a composite measure of procedure-related pain and pain during the postoperative recovery period, assessed by the Wong-Baker Faces Rating Scale (0= no pain to 10= maximum pain). The lesion characteristics, procedure time, and adverse events were summarized. RESULTS: A total of 17 polyps and eight myomas were removed in the para/intracervical block group, with diameters of 1.3±0.5 cm and 1.8±0.8 cm, respectively. In the intracervical block group, 25 polyps with a mean diameter of 1.2±0.7 cm and 7 myomas with a mean diameter of 1.9±0.9 cm were removed. The mean tissue resection time was 1.2±2.0 minutes and 1.2±1.4 minutes for the para/intracervical and intracervical block groups, respectively. The mean composite procedure-related pain score was low for both cervical block protocols, 1.3±1.4 in the para/intracervical block group vs 2.1±1.5 in the intracervical block group. During the postoperative recovery period, the mean pain scores were 0.3±0.7 vs 1.2±1.7 for the para/intracervical and intracervical block groups, respectively. There were no serious adverse events. CONCLUSION: The MyoSure procedure for removal of polyps and myomas was well tolerated, with low pain scores reported for both the para/intracervical and intracervical block protocols.

Outpatient procedure for the treatment and relief of symptomatic uterine myomas.

OBJECTIVE: To estimate the safety and efficacy of laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation of uterine myomas in symptomatic women. METHODS: A cohort of 135 premenopausal symptomatic women with uterine myomas, uteri 14 weeks of gestation-sized or less with no single myoma exceeding 7 cm, and objectively confirmed heavy menstrual bleeding participated in this prospective, international trial of outpatient laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation. Bleeding outcomes were measured by alkaline hematin analysis at baseline and again at 3, 6, and 12 months posttreatment. Validated quality-of-life and patient satisfaction scales and objective measurements of uterine and myoma volume were conducted at 3, 6, and 12 months. RESULTS: The mean baseline menstrual blood loss of women in the full analysis set (n=127) was 272.7±82.3 mL. At 3-, 6-, and 12-month follow-ups, mean alkaline hematin and associated menstrual blood loss decreased from baseline levels by 31.8%, 40.7%, and 38.3%, respectively (P<.001, paired t test). Symptom severity decreased from a baseline mean transformed score of 61.1 to 26.6 at 12 months postprocedure (P<.001, paired t test). Health-related quality of life improved from a mean transformed score of 37.3 at baseline to 79.5 at 12 months (P<.001, paired t test). At 12 months postprocedure, total mean myoma volume decreased from baseline by 45.1% (measured by magnetic resonance imaging). There was one serious adverse event (one of 135 [0.7%]) requiring readmission 5 weeks postprocedure and one surgical reintervention for persistent bleeding. Ninety-four percent of the women reported satisfaction with the treatment. CONCLUSION: Radiofrequency volumetric thermal ablation of myomas is well tolerated and results in rapid recovery, high patient satisfaction, improved quality of life, and effective symptom relief. CLINICAL TRIAL REGISTRATION: : ClinicalTrials.gov, www.clinicaltrials.gov, NCT00874029. LEVEL OF EVIDENCE: II.

Missing IUD and utilization of fluoroscopy for management: a case report.

INTRODUCTION: A missing intrauterine device (IUD) poses challenges in diagnosis and treatment. Extrauterine placement of IUDs may cause difficulty in localization. We report a case where use of fluoroscopy just prior to laparoscopic intervention to remove the missing IUD was beneficial. CASE: This case report involves a 35-year-old woman who was diagnosed with a missing thread 2 years after insertion of a levonorgestrel IUD (Mirena). Initial diagnostic workup consisting of abdominal X-ray, an ultrasound and diagnostic laparoscopy failed to localize the IUD. We performed an office pelvic ultrasound which confirmed that an IUD was present but could not specifically localize the IUD in the pelvic or abdominal cavity. Hence, we utilized fluoroscopy just prior to laparoscopy to localize and remove the missing device and allow its removal. CONCLUSION: Various imaging modalities aid in detecting a missing IUD, but proper selection of fluoroscopy helped to localize extrauterine placement of an IUD device. We suggest that utilization of this imaging method just prior to laparoscopy may be of value in selected cases.