Undiagnosed endometrial abnormalities in women with normal hysterosalpingography scheduled for IVF: prospective evaluation of three-dimensional transvaginal ultrasound versus office hysteroscopy

Objectives: To compare the diagnostic accuracy of three-dimensional transvaginal ultrasound (3D-US) to office hysteroscopy (OH) in the screening of uterine cavity with normal hysterosalpingography (HSG) findings for subtle endometrial abnormalities before in vitro-fertilization (IVF). Methods: A prospective cohort cost-modeling study was carried out in a University hospital. We included 120 infertile women with a normal uterine cavity on HSG scheduled for IVF. All cases were evaluated by 3D-US, and the results were compared with OH findings. Results: OH revealed cavitary endometrial lesions (CLs) in thirty-four women (28.3%). Endometrial polyps were the most common detected lesions (16, 47.1%). 3D-US had 88.2% sensitivity, 96.5% specificity, 90.9% positive predictive value, 95.4% negative predictive value, and 94.2% overall accuracy for CLs. The overall agreement between 3D-US and OH was near-perfect (κ=0.86, 95% CI=0.75-0.96). Irregular menstrual bleeds and prior endometrial procedures were significant predictors for CLs (aOR=24.96, 95% CI=2.71–230.04, P=0.005, aOR=9.16, 95% CI=2.13–39.3, P=0.002, respectively). A selective screening strategy discerning OH to women with these predictors and/or women with abnormal 2D-US would have an NPV of 92.8 % with substantial cost benefits. Conclusions: In the pre-IVF work up, 3D-US, a non-invasive imaging modality, seems to be nearly comparable to OH. Office hysteroscopy screening prioritizing women with abnormal 2D-US, irregular menstrual periods and/or prior endometrial traumatization could yield a satisfactory cost-effective approach for identifying endometrial lesions

Diagnostic delay and health-related quality of life in Egyptian women with endometriosis

Abstract Background Firstly, to measure indicators of health-related quality of life (HRQoL) in Egyptian women with endometriosis; and secondly, to estimate time interval from start of symptoms until endometriosis diagnosis is made (diagnostic delay) in Egyptian women with the disease. Material and methods Before laparoscopy for pelvic pain and/or infertility, eligible Egyptian women completed Global Study of Women’s Health (GSWH) questionnaire and validated Arabic version of Rand SF 36 (SF-36). According to laparoscopic findings, participants were divided to endometriosis group and control women with no pelvic abnormalities. Results Seventy women with endometriosis and 57 symptomatic controls without endometriosis were enrolled. A diagnostic delay of 36 months (IQR 22.5–60) was observed in women with endometriosis while symptomatic controls had a delay of 48 months (IQR 24–84). The difference was not statistically significant (P = 0.08). Bodily pain (BP) scores were significantly lower in women with endometriosis than controls [80.0 (45.0–100.0) versus 100.0 (68.75–100.0) respectively, P is 0.01]. Women with advanced endometriosis had significantly lower scores for physical functioning (PF), role limitation due to physical function (RP), and BP compared to women with mild endometriosis, and to controls. Physical component summary (PCS) scores were significantly lower in women with advanced stage endometriosis [41.51 (34.19–51.54] compared to women with early-stage disease [58.33 (50.98–60.37)] or control group [54.72 (48.81–59.58)]. Patient’s age, intensity of noncyclical pelvic pain, and disease stage are determining factors of HRQoL in women with endometriosis. Conclusions Egyptian women with endometriosis experience relatively short diagnostic delay, poor bodily pain scores, and impaired physical health for which age, disease stage, and non-cyclic pain are determinants. Multi-disciplinary endometriosis centers, educational programs, and patient support groups are needed in Egypt

Fibroid interventions: reducing symptoms today and tomorrow: extending generalizability by using a comprehensive cohort design with a randomized controlled trial.

BackgroundUterine fibroids are an important source of morbidity for reproductive-aged women. Despite an increasing number of alternatives, hysterectomies account for about 75% of all fibroid interventional treatments. Evidence is lacking to help women and their health care providers decide among alternatives to hysterectomy. Fibroid Interventions: Reducing Symptoms Today and Tomorrow (NCT00995878, clinicaltrials.gov) is a randomized controlled trial to compare the safety, efficacy, and economics of 2 minimally invasive alternatives to hysterectomy: uterine artery embolization and magnetic resonance imaging-guided focused ultrasound surgery. Although randomized trials provide the highest level of evidence, they have been difficult to conduct in the United States for interventional fibroid treatments. Thus, contemporaneously recruiting women declining randomization may have value as an alternative strategy for comparative effectiveness research.ObjectiveWe sought to compare baseline characteristics of randomized participants with nonrandomized participants meeting the same enrollment criteria and to determine whether combining the 2 cohorts in a comprehensive cohort design would be useful for analysis.Study designPremenopausal women with symptomatic uterine fibroids seeking interventional therapy at 3 US academic medical centers were randomized (1:1) in 2 strata based on calculated uterine volume (<700 and ≥700 cc(3)) to undergo embolization or focused ultrasound surgery. Women who met the same inclusion criteria but declined randomization were offered enrollment in a parallel cohort. Both cohorts were followed up for a maximum of 36 months after treatment. The measures addressed in this report were baseline demographics, symptoms, fibroid and uterine characteristics, and scores on validated quality-of-life measures.ResultsOf 723 women screened, 57 were randomized and 49 underwent treatment (27 with focused ultrasound and 22 with embolization). Seven of the 8 women randomized but not treated were assigned to embolization. Of 34 women in the parallel cohort, 16 elected focused ultrasound and 18 elected embolization. Compared with nonrandomized participants, randomized participants had higher mean body mass index (28.7 vs 25.3 kg/m(2); P = .01) and were more likely to be gravid (77% vs 47%; P = .003) and smokers (42% vs 12%; P = .003). Age, race, uterine volume, number of fibroids, and baseline validated measures of general and disease-specific quality of life, pain, depression, and sexual function did not differ between the groups. When we performed a comprehensive cohort analysis and analyzed by treatment arm, the only baseline difference observed was a higher median McGill Pain Score among women undergoing focused ultrasound (10.5 vs 6; P = .03); a similar but nonsignificant trend was seen in visual analog scale scores for pain (median, 39.0 vs 24.0; P = .06).ConclusionUsing a comprehensive cohort analysis of study data could result in additional power and greater generalizability if results are adjusted for baseline differences

Periprocedural outcomes comparing fibroid embolization and focused ultrasound: a randomized controlled trial and comprehensive cohort analysis.

BackgroundUterine fibroids are a common problem for reproductive-aged women, yet little comparative effectiveness research is available to guide treatment choice. Uterine artery embolization and magnetic resonance imaging-guided focused ultrasound surgery are minimally invasive therapies approved by the US Food and Drug Administration for treating symptomatic uterine fibroids. The Fibroid Interventions: Reducing Symptoms Today and Tomorrow study is the first randomized controlled trial to compare these 2 fibroid treatments.ObjectiveThe objective of the study was to summarize treatment parameters and compare recovery trajectory and adverse events in the first 6 weeks after treatment.Study designPremenopausal women with symptomatic uterine fibroids seen at 3 US academic medical centers were enrolled in the randomized controlled trial (n = 57). Women meeting identical criteria who declined randomization but agreed to study participation were enrolled in a nonrandomized parallel cohort (n = 34). The 2 treatment groups were analyzed by using a comprehensive cohort design. All women undergoing focused ultrasound and uterine artery embolization received the same postprocedure prescriptions, instructions, and symptom diaries for comparison of recovery in the first 6 weeks. Return to work and normal activities, medication use, symptoms, and adverse events were captured with postprocedure diaries. Data were analyzed using the Wilcoxon rank sum test or χ2 test. Multivariable regression was used to adjust for baseline pain levels and fibroid load when comparing opioid medication, adverse events, and recovery time between treatment groups because these factors varied at baseline between groups and could affect outcomes. Adverse events were also collected.ResultsOf 83 women in the comprehensive cohort design who underwent treatment, 75 completed postprocedure diaries. Focused ultrasound surgery was a longer procedure than embolization (mean [SD], 405 [146] vs 139 [44] min; P <.001). Of women undergoing focused ultrasound (n = 43), 23 (53%) underwent 2 treatment days. Immediate self-rated postprocedure pain was higher after uterine artery embolization than focused ultrasound (median [interquartile range], 5 [1-7] vs 1 [1-4]; P = .002). Compared with those having focused ultrasound (n = 39), women undergoing embolization (n = 36) were more likely to use outpatient opioid (75% vs 21%; P < .001) and nonsteroidal antiinflammatory medications (97% vs 67%; P < .001) and to have a longer median (interquartile range) recovery time (days off work, 8 [6-14] vs 4 [2-7]; P < .001; days until return to normal, 15 [10-29] vs 10 [10-15]; P = .02). There were no significant differences in the incidence or severity of adverse events between treatment arms; 86% of adverse events (42 of 49) required only observation or nominal treatment, and no events caused permanent sequelae or death. After adjustment for baseline pain and uterine fibroid load, uterine artery embolization was still significantly associated with higher opioid use and longer time to return to work and normal activities (P < .001 for each). Results were similar when restricted to the randomized controlled trial.ConclusionWomen undergoing uterine artery embolization have longer recovery times and use more prescription medications, but women undergoing focused ultrasound have longer treatment times. These findings were independent of baseline pain levels and fibroid load

FIRSTT study: randomized controlled trial of uterine artery embolization vs focused ultrasound surgery.

BACKGROUND:Uterine leiomyomas (fibroid tumors) cause considerable symptoms in 30-50% of women and are the leading cause of hysterectomy in the United States. Women with uterine fibroid tumors often seek uterine-preserving treatments, but comparative effectiveness trials are lacking. OBJECTIVE:The purpose of this study was to report treatment effectiveness and ovarian function after uterine artery embolization vs magnetic resonance imaging-guided focused ultrasound surgery from the Fibroid Interventions: Reducing Symptoms Today and Tomorrow study. STUDY DESIGN:The Fibroid Interventions: Reducing Symptoms Today and Tomorrow study, which is a randomized controlled trial of uterine artery embolization vs magnetic resonance imaging-guided focused ultrasound surgery, enrolled premenopausal women with symptomatic uterine fibroid tumors; women who declined randomization were enrolled in a parallel observational cohort. A comprehensive cohort design was used for outcomes analysis. Our target enrollment was 220 women, of which we achieved 41% (n=91) in the randomized and parallel arms of the trial. Primary outcome was reintervention for uterine fibroid tumors within 36 months. Secondary outcomes were change in serum anti-Müllerian hormone levels and standardized measures of fibroid symptoms, quality of life, pain, and sexual function. RESULTS:From 2010-2014, 83 women (mean age, 44.4 years) were treated in the comprehensive cohort design (43 for magnetic resonance imaging-guided focused ultrasound surgery [27 randomized]; 40 for uterine artery embolization [22 randomized]); baseline clinical and uterine characteristics were similar between treatment arms, except for higher fibroid load in the uterine artery embolization arm. The risk of reintervention was higher with magnetic resonance imaging-guided focused ultrasound surgery than uterine artery embolization (hazard ratio, 2.81; 95% confidence interval, 1.01-7.79). Uterine artery embolization showed a significantly greater absolute decrease in anti-Müllerian hormone levels at 24 months compared with magnetic resonance imaging-guided focused ultrasound surgery. Quality of life and pain scores improved in both arms but to a greater extent in the uterine artery embolization arm. Higher pretreatment anti-Müllerian hormone level and younger age at treatment increased the overall risk of reintervention. CONCLUSION:Our study demonstrates a lower reintervention rate and greater improvement in symptoms after uterine artery embolization, although some of the effectiveness may come through impairment of ovarian reserve. Both pretreatment anti-Müllerian hormone level and age are associated with risk of reintervention. CLINICAL TRIAL REGISTRATION NUMBER:NCT00995878, clinicaltrials.gov

Fibroid interventions: reducing symptoms today and tomorrow: extending generalizability by using a comprehensive cohort design with a randomized controlled trial

BACKGROUND: Uterine fibroids are an important source of morbidity for reproductive-aged women. Despite an increasing number of alternatives, hysterectomies account for about 75% of all fibroid interventional treatments. Evidence is lacking to help women and their health care providers decide among alternatives to hysterectomy. Fibroid Interventions: Reducing Symptoms Today and Tomorrow (NCT00995878, clinicaltrials.gov) is a randomized controlled trial to compare the safety, efficacy, and economics of 2 minimally invasive alternatives to hysterectomy: uterine artery embolization and magnetic resonance imaging–guided focused ultrasound surgery. Although randomized trials provide the highest level of evidence, they have been difficult to conduct in the United States for interventional fibroid treatments. Thus, contemporaneously recruiting women declining randomization may have value as an alternative strategy for comparative effectiveness research. OBJECTIVES: To compare baseline characteristics of randomized participants with nonrandomized participants meeting the same enrollment criteria and to determine whether combining the 2 cohorts in a comprehensive cohort design would be useful for analysis. STUDY DESIGN: Premenopausal women with symptomatic uterine fibroids seeking interventional therapy at 3 American academic medical centers were randomized (1:1) in 2 strata based on calculated uterine volume (<700 cc(3) and ≥700 cc(3)) to undergo embolization or focused ultrasound surgery. Women who met the same inclusion criteria but declined randomization were offered enrollment in a parallel cohort. Both cohorts were followed up for a maximum of 36 months after treatment. The measures addressed in this report were baseline demographics, symptoms, fibroid and uterine characteristics, and scores on validated quality-of-life measures. RESULTS: Of 723 women screened, 57 were randomized and 49 underwent treatment (27 with focused ultrasound and 22 with embolization). Seven of the 8 women randomized but not treated were assigned to embolization. Of 34 women in the parallel cohort, 16 elected focused ultrasound and 18 elected embolization. Compared with nonrandomized participants, randomized participants had higher mean body mass index (28.7 vs 25.3 kg/m(2); P=.01) and were more likely to be gravid (77% vs 47%; P=.003) and smokers (42% vs 12%; P=.003). Age, race, uterine volume, number of fibroids, and baseline validated measures of general and disease-specific quality of life, pain, depression, and sexual function did not differ between the groups. When we performed a comprehensive cohort analysis and analyzed by treatment arm, the only baseline difference observed was a higher median McGill Pain Score among women undergoing focused ultrasound (10.5 vs 6; P=.03); a similar but nonsignificant trend was seen in Visual Analog Scale scores for pain (median, 39.0 vs 24.0; P=.06). CONCLUSIONS: Using a comprehensive cohort analysis of study data could result in additional power and greater generalizability if results are adjusted for baseline differences