Comparing endometrial biopsy results with hysteroscopic pathology in women presenting with abnormal and postmenopausal uterine bleeding.

OBJECTIVE: To compare pathology results after office-based blind endometrial biopsy and pathology results from hysteroscopy in women presenting with abnormal uterine bleeding (AUB). METHODS: A retrospective cohort study of biologic women presenting with AUB at a tertiary care referral care center. Patients were included if they underwent evaluation with blind endometrial biopsy performed in the office followed by hysteroscopy within one year. Hysteroscopic findings and pathology were correlated with index endometrial biopsy findings. RESULTS: 689 patients met inclusion criteria. The mean age and BMI were 49 (±10) years and 31 (±8) kg/m2. The median duration of bleeding leading up to presentation was of 3.5 (1.5-9) months. Of the patients who had operative hysteroscopic pathology demonstrating endometrial polyp, 30.6 % (81) had a polyp detected on office endometrial biopsy. Of the patients who had hysteroscopic pathology demonstrating intracavitary fibroids, 0 % (0) were detected on endometrial biopsy. Of the patients who had hyperplasia without atypia on hysteroscopy, 28.6 % (4) were detected or suspected on endometrial biopsy. Of the patients who had hyperplasia with atypia on hysteroscopy, 5.9 % (1) were detected or suspected on endometrial biopsy. There were 12 cases of confirmed or suspected malignancy on hysteroscopy, of which 8.3 % (1) were detected on endometrial biopsy. CONCLUSION: Concordance between focal findings on office hysteroscopy and endometrial biopsy is low. Endometrial biopsy when malignancy is suspected has been shown to be of benefit, but in the setting of suspected benign focal pathology, blind assessment of the endometrial cavity for definitive diagnosis should be abandoned. In women with symptomatic uterine bleeding, hysteroscopic visualization is associated with increased sensitivity in identifying intrauterine pathology.

Implementation of Office Hysteroscopy for the Evaluation and Treatment of Intrauterine Pathology.

Hysteroscopy provides a minimally invasive strategy to evaluate intrauterine pathology and manage conditions such as abnormal uterine bleeding, infertility, intrauterine adhesions, müllerian anomalies, and intrauterine foreign bodies. Increasing access to hysteroscopy procedures in the office has the potential to improve patient care by minimizing financial and logistical barriers, aiding in streamlined diagnosis and treatment planning, and potentially averting unnecessary operative procedures and anesthesia. Office hysteroscopy refers to procedures performed in outpatient settings where pain management involves no medications, oral nonsedating medications, local anesthetic agents, or oral or inhaled conscious sedation. We present best practices for the implementation of hysteroscopy in an office setting. These include appropriate patient selection, optimal procedural timing, cervical preparation for patients at highest risk of cervical stenosis or pain with dilation, individualized pain-management strategies, use of distension media, and video monitoring to engage patients in the procedure. We describe miniaturized equipment for use in the office setting and "no-touch" vaginoscopic approaches to limit patient discomfort. With appropriate training and experience, office hysteroscopy presents a simple and cost-effective modality for optimizing gynecologic care for our patients.

Racial and ethnic disparities in surgical care for endometriosis across the United States.

BACKGROUND: Despite an estimated 10% prevalence of endometriosis among reproductive-age women, surgical population-based data are limited. OBJECTIVE: We sought to investigate racial and ethnic disparities in surgical interventions and complications among patients undergoing endometriosis surgery across the United States. STUDY DESIGN: We performed a retrospective cohort study of American College of Surgeons National Surgical Quality Improvement Program data from 2010 to 2018 identifying International Classification of Diseases, Ninth/Tenth Revision codes for endometriosis We compared procedures, surgical routes (laparoscopy vs laparotomy), and 30-day postoperative complications by race and ethnicity. RESULTS: We identified 11,936 patients who underwent surgery for endometriosis (65% White, 8.2% Hispanic, 7.3% Black or African American, 6.2% Asian, 1.0% Native Hawaiian or Pacific Islander, 0.6% American Indian or Alaska Native, and 11.5% of unknown race). Perioperative complications occurred in 9.6% of cases. After adjusting for confounders, being Hispanic (adjusted odds ratio, 1.31; 95% confidence interval, 1.06-1.64), Black or African American (adjusted odds ratio, 1.71; confidence interval, 1.39-2.10), Native Hawaiian or Pacific Islander (adjusted odds ratio, 2.08; confidence interval, 1.28-3.37), or American Indian or Alaska Native (adjusted odds ratio, 2.34; confidence interval, 1.32-4.17) was associated with surgical complications. Hysterectomies among Hispanic (adjusted odds ratio, 1.68; confidence interval, 1.38-2.06), Black or African American (adjusted odds ratio, 1.77; confidence interval, 1.43-2.18), Asian (adjusted odds ratio, 1.87; confidence interval, 1.43-2.46), Native Hawaiian or Pacific Islander (adjusted odds ratio, 4.16; confidence interval, 2.14-8.10), and patients of unknown race or ethnicity (adjusted odds ratio, 2.07; confidence interval, 1.75-2.47) were more likely to be open. Being Hispanic (adjusted odds ratio, 1.64; confidence interval, 1.16-2.30) or Black or African American (adjusted odds ratio, 2.64; confidence interval, 1.95-3.58) was also associated with receipt of laparotomy for nonhysterectomy procedures. The likelihood of undergoing oophorectomy was increased for Hispanic and Black women (adjusted odds ratio, 2.57; confidence interval, 1.96-3.37 and adjusted odds ratio, 2.06; confidence interval, 1.51-2.80, respectively), especially at younger ages. CONCLUSION: Race and ethnicity were independently associated with surgical care for endometriosis, with elevated complication rates experienced by Hispanic, Black or African American, Native Hawaiian or Pacific Islander, and American Indian or Alaska Native patients.

Reduction of Heavy Menstrual Bleeding in Women Not Designated as Responders to Elagolix Plus Add Back Therapy for Uterine Fibroids.

Objective: To assess outcomes of women with uterine fibroids (UFs) and heavy menstrual bleeding (HMB) treated with 300 mg elagolix twice daily plus add-back therapy (E2 1 mg/NETA 0.5 mg once daily) or placebo who were not considered responders in pooled analysis of two phase 3, 6-month randomized clinical trials (Elaris UF-1 and UF-2). Methods: Responders were defined as women who met both primary end point bleeding criteria (<80 mL menstrual blood loss [MBL] during the final month and ≥50% reduction in MBL from baseline to the final month) and either completed the study or discontinued due to predefined reasons. Thus, women termed nonresponders who were analyzed in this study who met neither or one bleeding end point or met both criteria but prematurely discontinued treatment because of adverse events, perceived lack of efficacy, or required surgical or interventional treatment for UFs were analyzed in this study. This post hoc analysis assessed mean changes from baseline in MBL, as well as adverse events. Results: Among 367 women receiving elagolix with add-back with observed data, 89 (24%) were not considered responders. Within this subset, 17 (19%) women met both bleeding criteria but prematurely discontinued treatment for the reasons mentioned above, while 23 (26%) met one bleeding criterion and 49 (55%) met neither bleeding criteria, regardless of discontinuation status. Among all nonresponders, a numerical trend toward greater mean reductions in MBL was observed in those receiving elagolix with add-back, compared with placebo group nonresponders. No differences in adverse events were observed between responders and nonresponders. Conclusion: Forty of 89 (45%) women with HMB and UFs who were classified as nonresponders in the UF-1 or UF-2 trials may have had a clinically meaningful response to elagolix with add-back therapy because they met at least one of the objective bleeding criteria. Clinical Trial Registration: Clinicaltrials.gov, NCT02654054 and NCT02691494. (NEJM 2020; 382:328-340) DOI: 10.1056/NEJMoa1904351.

Efficacy and safety of elagolix with add-back therapy in women with uterine fibroids and coexisting adenomyosis.

OBJECTIVE: To determine if coexisting adenomyosis limits the efficacy of elagolix, an oral gonadotropin-releasing hormone antagonist, with hormonal add-back therapy in reducing heavy menstrual bleeding in women with uterine fibroids. DESIGN: Pooled analysis of two identical, double-blind, randomized, placebo-controlled, 6-month phase 3 trials (Elaris Uterine Fibroids [UF]-1 and UF-2). SETTING: A total of 153 gynecological clinical care settings in the United States and Canada. PATIENTS: Premenopausal women (18-51 years) with >80 mL of menstrual blood loss (MBL)/cycle and uterine fibroids with and without coexisting adenomyosis diagnosed by ultrasound and/or magnetic resonance imaging at baseline. INTERVENTIONS: Participants were randomized 1:1:2 to placebo, elagolix 300 mg twice daily alone, or elagolix 300 mg twice daily with estradiol 1 mg/norethindrone acetate 0.5 mg once daily. MAIN OUTCOME MEASURES: The primary endpoint was the proportion of women who had <80 mL of MBL during the final month and ≥50% reduction in MBL from baseline to the final month. Adverse events were monitored. RESULTS: Of 786 women treated across the two trials, 16% (126 women) had coexisting adenomyosis. Among this subset, a significantly greater proportion of women who received elagolix with add-back therapy (77.1% [95% confidence interval, 66.2, 88.0]) met both primary endpoint criteria compared with women who received placebo (12.2% [95% confidence interval, 1.0, 23.4]). Adverse events most frequently reported in the elagolix with add-back adenomyosis subset were hot flushes (18.3%), nausea (11.7%), and night sweats (8.3%). CONCLUSIONS: Elagolix with add-back therapy significantly reduced heavy menstrual bleeding in women with uterine fibroids and coexisting adenomyosis, suggesting that elagolix efficacy was not adversely affected by the presence of adenomyosis (Elaris UF-1 and UF-2 Clinical-Trials.gov numbers, NCT02654054 and NCT02691494).

Elagolix Treatment for Up to 12 Months in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas.

OBJECTIVE: To investigate the safety and efficacy of elagolix, an oral gonadotropin-releasing hormone antagonist, with hormonal add-back therapy for up to 12 months in women with heavy menstrual bleeding associated with uterine leiomyomas. METHODS: Elaris UF-EXTEND was a phase 3 extension study that evaluated an additional 6 months (up to 12 months total) of elagolix 300 mg twice daily with hormonal add-back therapy (estradiol 1 mg and norethindrone acetate 0.5 mg once daily) in women who completed an initial 6 months of the same treatment in one of two preceding phase 3 studies. The primary endpoint was the percentage of women with both less than 80 mL menstrual blood loss during final month and a 50% or greater reduction in menstrual blood loss from baseline to final month. Safety evaluations included adverse events and bone mineral density changes. The planned sample size of UF-EXTEND was based on estimated rollover and discontinuation rates in the two preceding studies. RESULTS: From September 2016 to March 2019, 433 women were enrolled in UF-EXTEND. Of these women, 218 received up to 12 months of elagolix with add-back therapy; the mean±SD age of this group was 42.4±5.4 years and 67.3% were black. The percentage of women who met the primary endpoint in this elagolix with add-back group was 87.9% (95% CI [83.4-92.3]). The most frequently reported adverse events with up to 12 months of elagolix plus add-back therapy were hot flush (6.9%), night sweats (3.2%), headache (5.5%), and nausea (4.1%). Mean percent decreases in bone mineral density from baseline to extension month 6 were significantly less with elagolix plus add-back therapy than with elagolix alone {between-group difference in lumbar spine: -3.3 (95% CI [-4.1 to -2.5])}. CONCLUSION: Up to 12 months of elagolix with add-back therapy provided sustained reduction in menstrual blood loss in women with uterine leiomyomas, with the addition of add-back therapy attenuating the hypoestrogenic effects of elagolix alone. No new or unexpected safety concerns were associated with an additional 6 months of elagolix with addback therapy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02925494. FUNDING SOURCE: AbbVie Inc funded this study.

Use of hysteroscopy in diagnosis and follow-up of acquired uterine enhanced myometrial vascularity.

OBJECTIVE: To describe the role of hysteroscopy in diagnosis and subsequent follow-up of uterine enhanced myometrial vascularity (EMV). Uterine EMV, previously known as arteriovenous malformation (AVM), is a rare but cannot-miss finding often associated with prior pregnancy or uterine surgery and is typically suspected when a vascular mass is found on ultrasound. Color Doppler imaging will demonstrate high-velocity, low-impedance flow, with more significant shunts demonstrating higher peak systolic velocity (PSV). If not already diagnosed by ultrasound, accurate recognition during hysteroscopy is mandatory prior to any uterine instrumentation, as biopsy or curettage can lead to unanticipated massive hemorrhage. While many cases of EMV may resolve spontaneously, actively bleeding patients may require treatment with embolization, a procedure that may decrease ovarian reserve and impair fertility, though favorable reproductive outcomes have been reported. Others have reported success with hysteroscopic management using a bipolar electrosurgical loop. DESIGN: Case report. SETTING: Academic hospital system. PATIENT(S): We describe a 22-year-old G2P1011 who presented to the emergency department with heavy vaginal bleeding and a negative urine human chorionic gonadotropin 9 weeks following a first-trimester termination of pregnancy. Her ultrasound demonstrated a heterogeneous 2.6×2.3×2.6 cm vascular mass in the endometrial canal that was initially interpreted as retained products of conception. Unfortunately, PSV in the lesion was not measured. During observation, bleeding continued, and her hemoglobin dropped from 8.3 g/dL to 6.9 g/dL the next morning. She was transfused 2 units of blood and taken to the operating room for hysteroscopic evaluation and possible uterine curettage. INTERVENTION(S): Hysteroscopy revealed a large pulsating 2cm bluish vascular mass that was recognized as a uterine EMV and the procedure was terminated with the plan for embolization. Given fertility concerns, the diagnosis was confirmed with MRI/MRA, which identified a 2.7cm mass-like process with early post-contrast enhancement in the arterial phase. An angiogram demonstrated bilaterally enlarged tortuous uterine arteries perfusing a hypervascular EMV that was treated with selective bilateral uterine artery embolization. MAIN OUTCOME MEASURE(S): Further bleeding or evidence of EMV. RESULT(S): Follow-up office hysteroscopy at 2 weeks demonstrated a 2 cm raised area of tissue without pulsations. At 6 weeks post-procedure, bleeding had ceased, and office hysteroscopy revealed only a small 0.5 cm calcified nodule with a circumferential pseudo-decidual reaction. CONCLUSION(S): Hysteroscopy may be used to diagnose EMV when ultrasound is not conclusive. Recognition of the pulsating vascular appearance of EMV on hysteroscopy is critical in preventing hemorrhage from inappropriate curettage. Resolution of the lesion following embolization can be readily demonstrated with office hysteroscopy.

Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids.

BACKGROUND: Uterine fibroids are hormone-responsive neoplasms that are associated with heavy menstrual bleeding. Elagolix, an oral gonadotropin-releasing hormone antagonist resulting in rapid, reversible suppression of ovarian sex hormones, may reduce fibroid-associated bleeding. METHODS: We conducted two identical, double-blind, randomized, placebo-controlled, 6-month phase 3 trials (Elaris Uterine Fibroids 1 and 2 [UF-1 and UF-2]) to evaluate the efficacy and safety of elagolix at a dose of 300 mg twice daily with hormonal "add-back" therapy (to replace reduced levels of endogenous hormones; in this case, estradiol, 1 mg, and norethindrone acetate, 0.5 mg, once daily) in women with fibroid-associated bleeding. An elagolix-alone group was included to assess the impact of add-back therapy on the hypoestrogenic effects of elagolix. The primary end point was menstrual blood loss of less than 80 ml during the final month of treatment and at least a 50% reduction in menstrual blood loss from baseline to the final month; missing data were imputed with the use of multiple imputation. RESULTS: A total of 412 women in UF-1 and 378 women in UF-2 underwent randomization, received elagolix or placebo, and were included in the analyses. Criteria for the primary end point were met in 68.5% of 206 women in UF-1 and in 76.5% of 189 women in UF-2 who received elagolix plus add-back therapy, as compared with 8.7% of 102 women and 10% of 94 women, respectively, who received placebo (P<0.001 for both trials). Among the women who received elagolix alone, the primary end point was met in 84.1% of 104 women in UF-1 and in 77% of 95 women in UF-2. Hot flushes (in both trials) and metrorrhagia (in UF-1) occurred significantly more commonly with elagolix plus add-back therapy than with placebo. Hypoestrogenic effects of elagolix, especially decreases in bone mineral density, were attenuated with add-back therapy. CONCLUSIONS: Elagolix with add-back therapy was effective in reducing heavy menstrual bleeding in women with uterine fibroids. (Funded by AbbVie; Elaris UF-1 and Elaris UF-2 ClinicalTrials.gov numbers, NCT02654054 and NCT02691494.).

Clinical Performance of Radiofrequency Ablation for Treatment of Uterine Fibroids: Systematic Review and Meta-Analysis of Prospective Studies.

Background: Radiofrequency ablation (RFA) has emerged as a safe and effective treatment option for women with symptomatic uterine fibroids and can be delivered by laparoscopic, transvaginal, or transcervical approaches. The evidence regarding typical patient outcomes with RFA has not previously been examined in a comprehensive fashion. Materials and Methods: We performed a systematic review of prospective studies for treatment of uterine fibroids with RFA. Main outcomes were procedure time, patient recovery metrics, change in fibroid volume, symptom severity score (SSS), health-related quality of life (HRQL), and reinterventions. Data were analyzed with random effects meta-analysis and metaregression. Results: We identified 32 articles of 1283 unique patients (median age: 42 years) treated with laparoscopic RFA (19 articles), transvaginal RFA (8 articles), or transcervical fibroid ablation (5 articles). Mean procedure time was 49 minutes, time to discharge was 8.2 hours, time to normal activities was 5.2 days, and time to return to work was 5.1 days. At 12 months follow-up, fibroid volume decreased by 66%, HRQL increased by 39 points, and SSS decreased by 42 points (all P < .001 versus baseline). The annual cumulative rate of reinterventions due to fibroid-related symptoms was 4.2%, 8.2%, and 11.5% through 3 years. Conclusions: RFA of uterine fibroids significantly reduces fibroid volume, provides significant durable improvements in fibroid-related quality of life, and is associated with favorable reintervention rates.

Vilaprisan in women with uterine fibroids: the randomized phase 2b ASTEROID 1 study.

OBJECTIVES: To assess the safety and efficacy of four vilaprisan doses (0.5-4.0 mg) in women with uterine fibroids. DESIGN: Randomized, double-blind, placebo-controlled, multicenter trial. SETTING: Ninety-eight centers in 12 countries. PATIENT(S): Women aged 18-50 years with uterine fibroids and heavy menstrual bleeding were randomized equally to oral vilaprisan at 0.5, 1.0, 2.0, or 4.0 mg or placebo once daily. INTERVENTION(S): Treatment for 12 weeks, 24-week follow-up. MAIN OUTCOME MEASURE(S): Primary end point was absence of scheduled or unscheduled bleeding/spotting. Key secondary efficacy end points included volume of menstrual blood loss and change in fibroid volume. RESULT(S): A total of 309 patients were randomized, and 300 received treatment. Complete absence of bleeding/spotting was observed in 30%, 56%, 54%, and 60% of patients in the vilaprisan 0.5, 1.0, 2.0, and 4.0 mg groups, respectively, versus 1.7% with placebo. After 12 weeks, >83% of women achieved amenorrhea (<2 mL/28 days) with ≥1.0 mg vilaprisan versus 9% with placebo. Heavy menstrual bleeding stopped (but returned at a lower volume after treatment cessation) with ≥1.0 mg vilaprisan treatment. Reductions in fibroid volume of up to 41% were observed. Most patients receiving vilaprisan reported improvements in symptom severity. No safety concerns were identified in general safety, endometrial safety (by biopsy), laboratory values, and ultrasound examinations. CONCLUSION(S): ASTEROID 1 supports the efficacy of vilaprisan for the treatment of heavy menstrual bleeding associated with uterine fibroids. Daily oral treatment with vilaprisan 0.5-4.0 mg was well tolerated, and vilaprisan 2.0 mg once daily has been selected for further investigation. CLINICAL TRIAL REGISTRATION NUMBER: NCT02131662.

ACR Appropriateness Criteria® Radiologic Management of Uterine Leiomyomas.

Uterine fibroids, also known as leiomyomas, are the most common benign tumor in women of reproductive age. When symptomatic, these patients can present with bleeding and/or bulk-related symptoms. Treatment options for symptomatic uterine leiomyomas include medical management, minimally invasive treatment such as uterine artery embolization, and surgical options, such as myomectomy. It is important to understand the role of these treatment options in various clinical scenarios so that appropriate consultation is performed. Furthermore, patients should be presented with the outcomes and complications of each of these treatment options. A summary of the data and clinical trials of the treatment options for symptomatic uterine leiomyomas is outlined in this article. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment.

Hysteroscopy for Abnormal Uterine Bleeding and Fibroids.

Operative hysteroscopy is a safe and effective minimally invasive treatment option for submucosal and intramural leiomyomas. We discuss preoperative evaluation, fluid management, postoperative complications, preventative measures, and hysteroscopic outcomes. Technical instructions and tips for successful hysteroscopy, as well as the various equipment options most commonly utilized in the United States, are also reviewed.

The medical management of abnormal uterine bleeding in reproductive-aged women.

In the treatment of women with abnormal uterine bleeding, once a thorough history, physical examination, and indicated imaging studies are performed and all significant structural causes are excluded, medical management is the first-line approach. Determining the acuity of the bleeding, the patient's medical history, assessing risk factors, and establishing a diagnosis will individualize their medical regimen. In acute abnormal uterine bleeding with a normal uterus, parenteral estrogen, a multidose combined oral contraceptive regimen, a multidose progestin-only regimen, and tranexamic acid are all viable options, given the appropriate clinical scenario. Heavy menstrual bleeding can be treated with a levonorgestrel-releasing intrauterine system, combined oral contraceptives, continuous oral progestins, and tranexamic acid with high efficacy. Nonsteroidal antiinflammatory drugs may be utilized with hormonal methods and tranexamic acid to decrease menstrual bleeding. Gonadotropin-releasing hormone agonists are indicated in patients with leiomyoma and abnormal uterine bleeding in preparation for surgical interventions. In women with inherited bleeding disorders all hormonal methods as well as tranexamic acid can be used to treat abnormal uterine bleeding. Women on anticoagulation therapy should consider using progestin-only methods as well as a gonadotropin-releasing hormone agonist to treat their heavy menstrual bleeding. Given these myriad options for medical treatment of abnormal uterine bleeding, many patients may avoid surgical intervention.

Further validation of the uterine fibroid symptom and quality-of-life questionnaire.

OBJECTIVE: To further examine the reliability, validity and responsiveness of the uterine fibroid symptom and quality-of-life (UFS-QOL) questionnaire among women with and without uterine fibroids. METHODS: A multicenter, non-randomized, prospective study was conducted with women undergoing treatment for uterine fibroids (fibroid treatment group [FTG]) and normal controls (normal control group [NCG]). Women in the FTG were recruited when they were scheduled for treatment; women in the NCG were recruited during their annual exam. Participants completed the UFS-QOL and a short form 36 health survey (SF-36) at enrollment and at 6 and 12 months. Descriptive statistics, Cronbach's alpha, Spearman's correlations, t tests, and general linear models were used to analyze the internal consistency and test-retest reliability, concurrent and discriminant validity, and responsiveness of the UFS-QOL. RESULTS: There were 89 NCG and 234 FTG women who completed the study. Mean age was 43.1 years for FTG and 40.8 for NCG (P < 0.001). The FTG reported significantly greater symptom severity and worse health-related quality of life (HRQL) than the NCG (all UFS-QOL subscales P < 0.001). The UFS-QOL subscales were significantly correlated in the expected direction and magnitude with each SF-36 subscale in the FTG, indicating acceptable concurrent validity. Cronbach's alphas were 0.73 to 0.97, reflecting adequate internal consistency. Each UFS-QOL subscale was responsive to changes after treatment in the FTG with effect sizes ranging between 1.1 and -2.35. The UFS-QOL remained stable in the NCG during the 1 year follow-up. CONCLUSION: The UFS-QOL is a valid and reliable measure to assess symptoms and HRQL in women with uterine fibroids and is highly responsive to treatment-related changes.

Diagnosis of abnormal uterine bleeding with biopsy or hysteroscopy.

Abnormal uterine bleeding in women is a common cause for gynecologic consultation. Physicians must maintain a low threshold for endometrial assessment in abnormal uterine bleeding. Accurately determining the etiology of the bleeding permits appropriate treatment, minimizes unnecessary delays in therapy, and prevents needless worry in women. There are few national consensus guidelines, best practice guidelines, or treatment algorithms that provide gynecologists with scrupulous data to make concise decisions for the utilization of technology such as endometrial biopsy, transvaginal ultrasound, saline infusion sonography, or hysteroscopy in the evaluation of menstrual aberrations. Using technology that has a high sensitivity to detect a disease allows a physician to make concise decisions for proceeding with minimally invasive procedures or reliance on medical therapies that will probably be effective.

Outcomes from leiomyoma therapies: comparison with normal controls.

OBJECTIVE: To assess the severity of symptoms caused by uterine leiomyomas, their effect on health-related quality of life, and the change after treatment compared with a normal control group. METHODS: A multicenter nonrandomized prospective study was completed assessing 12-month outcomes from three leiomyoma treatments. Outcome measures included the Uterine Fibroid Symptom and Quality of Life and the Short Form 36 questionnaires. Women scheduled for hysterectomy, myomectomy, or uterine artery embolization were recruited, as well as normal control group members. Questionnaires were completed at baseline and at 6 and 12 months posttreatment. Baseline characteristics were summarized using descriptive statistics. General linear models were used to examine differences among the patient groups. RESULTS: A total of 375 patients completed baseline enrollment: 101 normal, 107 embolization, 61 myomectomy, and 106 hysterectomy. At baseline, the mean Uterine Fibroid Symptom and Quality of Life Symptom Severity score for women in the normal control group was 15.3 (+/-14.5) and 64.8 (+/-20) for the leiomyoma patients (P<.001). At 6 and 12 months, the mean Symptom score for women in the normal control group was unchanged, while the leiomyoma treatment group score reduced to a mean of 17.8 (+/-17.5) at 12 months. Similar magnitude changes occurred among the Uterine Fibroid Symptom and Quality of Life health-related quality of life subscale scores for the normal control group members and leiomyoma patients. At 12 months, the hysterectomy group reported significantly lower symptoms and better health-related quality of life than the other two therapies (P<.001). CONCLUSION: At 12 months after treatment, all three leiomyoma therapies resulted in substantial symptom relief, to near normal levels, with the greatest improvement after hysterectomy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00390494. LEVEL OF EVIDENCE: II.