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Gynecological Endocrinology : the... Aug 2023In the 24-week, phase 3 LIBERTY 1 (L1) and LIBERTY 2 (L2) trials, relugolix combination therapy (relugolix-CT (relugolix 40 mg, estradiol 1 mg, norethisterone... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
In the 24-week, phase 3 LIBERTY 1 (L1) and LIBERTY 2 (L2) trials, relugolix combination therapy (relugolix-CT (relugolix 40 mg, estradiol 1 mg, norethisterone acetate 0.5 mg)) reduced uterine fibroid (UF)-associated symptoms. This analysis assessed safety and efficacy of relugolix-CT in European women from L1/L2.
METHODS
Premenopausal women (aged 18-50 years) with UF-associated heavy menstrual bleeding (HMB) were randomized 1:1:1 in L1 ( = 388) and L2 ( = 382) to relugolix-CT or placebo for 24 weeks, or delayed relugolix-CT (relugolix 40 mg then relugolix-CT; 12 weeks each). Primary endpoint: proportion of responders (menstrual blood loss (MBL) <80 mL and reduction of ≥50% from baseline MBL volume) over the last 35 days of treatment. Secondary endpoints: MBL volume, amenorrhea, UF-associated pain, symptom severity, distress related to bleeding and pelvic discomfort, health-related quality of life (HRQoL). Safety endpoints included adverse event (AE) reporting and bone mineral density (BMD) assessment.
RESULTS
In European women from L1/L2 ( = 124, 16%), a significantly greater proportion of treatment responders was observed with relugolix-CT vs. placebo (85.4% vs. 19.1%, respectively; nominal < .0001). There were statistically significant improvements with relugolix-CT vs. placebo for several secondary endpoints: reduction in MBL volume, amenorrhea rate, proportion achieving mild-to-no pain, reduction in symptom severity and distress from bleeding and pelvic discomfort, and improvement in HRQoL. Incidence of AEs and percentage changes in BMD from baseline to week 24 were similar for relugolix-CT and placebo.
CONCLUSIONS
In European women with UF and HMB, once-daily relugolix-CT vs. placebo improved UF-associated symptoms and preserved BMD.
Topics: Female; Humans; Amenorrhea; Quality of Life; Menorrhagia; Leiomyoma; Pelvic Pain
PubMed: 37634528
DOI: 10.1080/09513590.2023.2249107 -
Reproductive Biomedicine Online May 2024What is the prevalence of adenomyosis at ultrasonography among adolescents and young women reporting dysmenorrhoea and/or heavy menstrual bleeding (HMB)? (Observational Study)
Observational Study
RESEARCH QUESTION
What is the prevalence of adenomyosis at ultrasonography among adolescents and young women reporting dysmenorrhoea and/or heavy menstrual bleeding (HMB)?
DESIGN
This observational cohort study involved adolescents and young women referred for dysmenorrhoea and/or HMB to the Adolescent Medicine Unit at Careggi University Hospital, Italy. Patients with endometriosis and bleeding disorders were excluded. Transvaginal ultrasonography or transrectal sonography using a transvaginal probe was performed. The myometrium was described according to the Morphological Uterus Sonographic Assessment criteria. Details of baseline characteristics, clinical data and symptoms were collected. The presence of sonographic features of adenomyosis and the association between imaging findings and clinical symptoms were evaluated.
RESULTS
The cohort included 95 patients aged between 13 and 25 years, referred for dysmenorrhoea (88.4%), HMB (23.2%) or both (13.7%). According to the MUSA criteria the sonographic diagnosis of adenomyosis was made in 27.4% of patients, with the diffuse type the most prevalent. Uterine wall asymmetry, hyperechoic intramyometrial islands, translesional vascularity and an interrupted junctional zone were the most common features. Patients with imaging findings of adenomyosis had significantly higher rates of HMB than those with a normal myometrial appearance (38.5% versus 17.4%, P = 0.030). In addition, the coexistence of dysmenorrhoea and HMB was significantly associated with adenomyosis (odds ratio 5.68, 95% confidence interval 1.65-19.5).
CONCLUSIONS
Adenomyosis may be diagnosed among teenagers and young women referred with dysmenorrhoea and/or HMB. The clinical presentation is relevant for the diagnosis, with HMB alone and HMB plus dysmenorrhoea significantly associated with the sonographic identification of adenomyosis.
Topics: Humans; Female; Adenomyosis; Menorrhagia; Dysmenorrhea; Adolescent; Ultrasonography; Adult; Young Adult; Italy; Cohort Studies; Prevalence
PubMed: 38432071
DOI: 10.1016/j.rbmo.2023.103768 -
Reproductive Biomedicine Online Aug 2023Is there association between the presence of a uterine niche and the presence of symptoms?
RESEARCH QUESTION
Is there association between the presence of a uterine niche and the presence of symptoms?
DESIGN
This cross-sectional study was conducted at a single tertiary medical centre. All women who underwent Caesarean section from January 2017 to June 2020 were invited to the gynaecological clinics, and requested to complete a questionnaire regarding symptoms related to the presence of a niche (heavy menstrual bleeding, intermenstrual spotting, pelvic pain, infertility). Transvaginal two-dimensional ultrasonography was performed to assess the uterus and uterine scar characteristics. The primary outcome was defined as the presence of a uterine niche, evaluated by length, depth, residual myometrial thickness (RMT) and ratio between the residual myometrial thickness (RMT) and adjacent myometrial thickness (AMT).
RESULTS
Of 524 women who were eligible and scheduled for evaluation, 282 (54%) completed the follow-up; 173 (61.3%) were symptomatic and 109 (38.6%) asymptomatic. Niche measurements, including RMT/AMT ratio, were comparable between the groups. In a sub-analysis of each symptom, heavy menstrual bleeding and intermenstrual spotting were associated with reduced RMT (P = 0.02 and P = 0.04, respectively) compared with women with normal menstrual bleeding. An RMT less than 2.5 mm was significantly more prevalent in women reporting heavy menstrual bleeding (11 [25.6%] versus 27 [11.3%]; P = 0.01] and new infertility (7 [16.3%] versus 6 [2.5%]; P = 0.001]. In logistic regression analysis, infertility was the only symptom associated with an RMT less than 2.5 mm (B = 1.9; P = 0.002).
CONCLUSIONS
A reduced RMT was found to be associated with heavy menstrual bleeding and intermenstrual spotting, while values below 2.5 mm were also associated with infertility.
Topics: Female; Pregnancy; Humans; Cesarean Section; Cicatrix; Menorrhagia; Cross-Sectional Studies; Uterus; Metrorrhagia; Infertility; Ultrasonography
PubMed: 37277298
DOI: 10.1016/j.rbmo.2023.04.012 -
Journal of Ultrasound in Medicine :... Jun 2024To describe the ultrasonographic appearance of the post-ablative endometrium to improve knowledge of its sonographic findings.
OBJECTIVE
To describe the ultrasonographic appearance of the post-ablative endometrium to improve knowledge of its sonographic findings.
METHODS
This was an Institutional Review Board approved prospective study of patients who underwent second-generation endometrial ablation from 2016 to 2019 at a single health system. Patients had postoperative transvaginal ultrasounds at 2, 6, and 12 months. Ultrasound reports were analyzed for endometrial thickness, description of the endometrium and myometrium, presence of uterine fibroids, and uterine size. Statistical tests for repeated measures were utilized.
RESULTS
There were 68 patients with the average age of 42 (SD 6) years and a BMI of 33 (SD 8). Preoperatively the average endometrial thickness was 10 mm, uterine length was 9.7 cm, and 38.2% had leiomyoma. The average endometrial thickness decreased at each ultrasound: 8.4 mm (SD 3.4), 7.2 mm (SD 3.0), and 5.8 mm (SD 2.5) at 2, 6, and 12 months, respectively. When comparing endometrial thickness postoperatively there was a significant difference at 2 and 12 months (P = .041), and 6 and 12 months (P = .031). There was no change during the postoperative period in the presence of leiomyoma, hyperechoic endometrium, hypoechoic endometrium, heterogeneous endometrium, and cystic endometrium on the ultrasounds.
CONCLUSION
After ablation with a second-generation device, the endometrial thickness on ultrasound decreases with time following surgery. Additional studies correlating these findings to clinical outcomes would be useful.
Topics: Humans; Female; Adult; Endometrium; Prospective Studies; Ultrasonography; Radiofrequency Ablation; Leiomyoma; Middle Aged; Endometrial Ablation Techniques; Uterine Neoplasms
PubMed: 38385632
DOI: 10.1002/jum.16436 -
Gynecologic and Obstetric Investigation Jan 2024To identify an optimal magnetic resonance imaging (MRI)-based classification for the severity of adenomyosis and explore the factors associated with disease severity...
OBJECTIVES
To identify an optimal magnetic resonance imaging (MRI)-based classification for the severity of adenomyosis and explore the factors associated with disease severity (dysmenorrhea or menorrhagia).
DESIGN AND PARTICIPANTS
Several classifications based on MRI have been proposed, and their phenotypes are reported to be associated with the severity of adenomyosis. However, a consensus classification based on MRI findings has not yet been reached. Our study was designed to retrospectively analyze data from a cohort of patients in the Affiliated Nanchong Central Hospital of North Sichuan Medical College from June 2017 to December 2021 before focused ultrasound ablation surgery (FUAS), to identify the optimal classification of adenomyosis severity from different classification criteria and explore factors associated with the presence of symptoms.
METHODS
The proportions of disease severity among different classification groups were compared to obtain the one generating the most considerable chi-square value, which was identified as the optimal classification for informing disease severity. A logistic regression model was constructed to explore factors associated with disease severity.
RESULTS
Classification of Kobayashi H (classification 4) concerning the affected areas and size (volumes of lesions) was recognized as the optimal one, which identified dysmenorrhea (χ2=18.550, p-value=0.002) and menorrhagia (χ2=15.060, p-value=0.010) secondary to adenomyosis. For volumes of uterine wall <2/3, the dysmenorrhea rate in subtype-4 was higher than that in subtype-1 (χ2=4.114, p-value=0.043), and the dysmenorrhea rate in subtype-5 was higher than that in subtype-2 (χ2=4.357, p-value=0.037). Age (OR=0.899, 95%CI=0.810~0.997, p-value=0.044) and external phenotype (OR=3.588, 95%CI=CI 1.018~12.643, p-value=0.047) were associated with dysmenorrhea. Concerning volumes of uterine wall ≥2/3, the menorrhagia rate in subtype-3 remarkably increased compared with that in subtype-6 (χ2=9.776, p-value=0.002), and internal phenotype was identified as an independent factor associated with menorrhagia (OR=1.706, 95%CI=1.131~2.573, p-value=0.011).
LIMITATIONS
Patients in our study were all included before FUAS, which limited our result interpretation for the general patient population.
CONCLUSIONS
MRI-based classification 4 is identified as an optimal classification for informing the severity of adenomyosis. The phenotype of classification is the main characteristic associated with disease severity.
PubMed: 38232715
DOI: 10.1159/000535802 -
Obstetrics and Gynecology Nov 2023To evaluate the safety and efficacy of elagolix 150 mg once-daily monotherapy in patients with heavy menstrual bleeding associated with uterine leiomyomas. (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
To evaluate the safety and efficacy of elagolix 150 mg once-daily monotherapy in patients with heavy menstrual bleeding associated with uterine leiomyomas.
METHODS
A phase 4, randomized, double-blind, placebo-controlled, 6-month treatment study was conducted in premenopausal patients aged 18-51 years with heavy menstrual bleeding (defined as menstrual blood loss greater than 80 mL during one menstrual cycle) associated with uterine leiomyomas. Patients were randomized 2:1 to receive elagolix 150 mg once daily or placebo. The primary endpoint was reduction in menstrual blood loss volume to less than 80 mL at the final month and at least a 50% reduction in menstrual blood loss volume from baseline to the final month.
RESULTS
Of 82 randomized patients, 54 received elagolix 150 mg and 28 received placebo. With elagolix, 49.4% (95% CI 35.1-63.8%) of patients met the primary endpoint, compared with 23.3% (95% CI 7.2-39.5%) of patients who received placebo ( P =.035). Statistically significant differences between elagolix and placebo in mean reduction of menstrual blood loss from baseline were seen as early as month 1 ( P <.05 for months 1-3 and 5). Significantly more patients receiving elagolix experienced suppression of bleeding compared with placebo ( P =.036). Greater improvements were observed in the elagolix group (vs placebo) in the proportion of patients with amenorrhea, in hemoglobin concentrations, and in health-related quality of life. No serious or severe adverse events were reported for elagolix, compared with 7.1% of participants in the placebo group having serious adverse events (coronavirus disease 2019 [COVID-19] n=1, enlarged uvula n=1). Three patients (5.6%) discontinued elagolix due to adverse events.
CONCLUSION
Elagolix 150 mg once-daily monotherapy significantly improved heavy menstrual bleeding associated with uterine leiomyomas compared with placebo in premenopausal patients. Treatment with elagolix 150 mg once daily was generally well-tolerated in this study, with no new safety signals.
FUNDING SOURCE
AbbVie Inc.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov , NCT03886220.
Topics: Female; Humans; Menorrhagia; Uterine Neoplasms; Quality of Life; Gonadotropin-Releasing Hormone; COVID-19; Leiomyoma; Double-Blind Method
PubMed: 37769311
DOI: 10.1097/AOG.0000000000005380 -
Role of ultrasonography in the evaluation of disease severity and treatment efficacy in adenomyosis.Archives of Gynecology and Obstetrics Feb 2024Adenomyosis is a benign disorder characterized by the presence of ectopic endometrial glands and stroma within the myometrium. The main clinical manifestations of... (Review)
Review
BACKGROUND
Adenomyosis is a benign disorder characterized by the presence of ectopic endometrial glands and stroma within the myometrium. The main clinical manifestations of adenomyosis are dysmenorrhea, menorrhagia, and infertility, which affect patients' quality of life. Recently, with advancements in imaging techniques, magnetic resonance imaging, and ultrasonography have become the main diagnostic tools for adenomyosis. In addition to the diagnosis and differential diagnosis of adenomyosis, ultrasonography can also be used to evaluate the severity of adenomyosis. The emergence of new techniques, such as elastography and contrast-enhanced ultrasonography (CEUS), has significantly improved the accuracy of ultrasound-based diagnosis of adenomyosis. These two imaging tools can also be used for the differential diagnosis of adenomyosis and the evaluation of treatment efficacy after medication or ablation procedure.
OBJECTIVE
we review the efficacy of ultrasonography as a diagnostic tool for adenomyosis. We also aim to introduce the potential of ultrasound imaging in the evaluation of the severity of this disease, as well as the application of elastography and contrast-enhanced ultrasonography (CEUS) in its diagnosis.
RESULTS AND CONCLUSION
Our findings reveal the potential value of ultrasonography combined with elastography and/or CEUS as medication guidance and efficacy evaluation tools in the long-term management of adenomyosis.
Topics: Female; Humans; Adenomyosis; Quality of Life; Ultrasonography; Treatment Outcome; Patient Acuity
PubMed: 37115275
DOI: 10.1007/s00404-023-07034-4 -
International Journal of Gynaecology... Oct 2023To provide perspectives on preoperative diagnosis and conservative treatment for diffuse uterine leiomyomatosis (DUL). (Review)
Review
OBJECTIVE
To provide perspectives on preoperative diagnosis and conservative treatment for diffuse uterine leiomyomatosis (DUL).
METHODS
The clinical characteristics, management, and outcome of the five cases diagnosed with DUL receiving surgical treatment at Peking Union Medical College Hospital between January 2010 and December 2021 were retrospectively analyzed.
RESULTS
DUL is a diagnosis based on histopathology. It is a subtype of uterine leiomyoma, characterized by innumerable, poorly circumscribed hypercellular nodules of bland smooth muscle cells with no cytologic atypia diffusely involving the myometrium. Clinical manifestations, including menorrhagia, anemia, and infertility, are similar to those of typical uterine leiomyomas, making a definitive preoperative diagnosis difficult. Magnetic resonance imaging plays an important role in the pre-treatment mapping. Conservative surgery can reduce the uterine volume and improve the contour of the uterine cavity, thereby relieving symptoms of menorrhagia and improving the chance of conception. Gonadotropin-releasing hormone (GnRH) agonist therapy is of great significance for controlling vaginal bleeding, reducing uterine volume, and delaying postoperative recurrence, and can be used alone or as postoperative adjuvant therapy for conservative surgery.
CONCLUSION
The treatment goal for DUL patients with fertility-sparing request should not aim at complete fibroid removal. A successful pregnancy can be achieved following conservative surgery and/or GnRH agonist therapy.
Topics: Pregnancy; Female; Humans; Uterine Neoplasms; Leiomyomatosis; Menorrhagia; Retrospective Studies; Gonadotropin-Releasing Hormone
PubMed: 37014595
DOI: 10.1002/ijgo.14769 -
BMJ Case Reports Aug 2023Pancytopenia due to systemic lupus erythematosus (SLE) is rarely reported, and among those reported, it is mostly due to immunologically mediated cell destruction....
Pancytopenia due to systemic lupus erythematosus (SLE) is rarely reported, and among those reported, it is mostly due to immunologically mediated cell destruction. Pancytopenia due to bone marrow fibrosis secondary to SLE is an extremely rare entity. Myelofibrosis secondary to SLE per se is reported only in 21 cases in the literature. Ours probably is the 22nd case report on SLE with myelofibrosis. Primary presentation of SLE with bleeding manifestation is also a rare phenomenon. Partial to complete regression of myelofibrosis is noted following treatment in secondary myelofibrosis caused by SLE. We report a case of a woman in her late 40s who presented to us with bleeding manifestations of petechial rash and menorrhagia, which on further evaluation showed pancytopenia due to myelofibrosis secondary to SLE. Our case underlines multiple features like primary bleeding manifestation and regression of myelofibrosis following treatment which is rarely reported in association with SLE.
Topics: Female; Humans; Primary Myelofibrosis; Pancytopenia; Lupus Erythematosus, Systemic; Menorrhagia
PubMed: 37591626
DOI: 10.1136/bcr-2023-255229 -
The British Journal of Radiology Nov 2023To evaluate the efficacy and safety of percutaneous microwave ablation (PMWA) for treating adenomyosis in the posterior uterine wall.
OBJECTIVE
To evaluate the efficacy and safety of percutaneous microwave ablation (PMWA) for treating adenomyosis in the posterior uterine wall.
METHODS
Thirty-six patients with symptomatic adenomyosis in the posterior uterine wall who had been subjected to PMWA were retrospectively enrolled in this study. 20 patients who had no ideal transabdominal puncture path due to the retroverted or retroflexed uterine position were treated with PMWA combined with Yu's uteropexy (Group 1). The other 16 patients were treated with PMWA only (Group 2). The non-perfused volume (NPV) ratio, symptomatic relief rate, recurrence rate, changes in clinical symptom scores, economic cost, and complications were compared.
RESULTS
The mean NPV ratio for the 36 patients was 90.2±18.3%, and the percentage of patients who obtained complete relief of dysmenorrhea and menorrhagia was 81.3% (26/32), and 69.6% (16/23) respectively. The recurrence rate was 11.1% (4/36). No major complication was observed. Minor complications included lower abdominal pain, fever, vaginal discharge, nausea, and/or vomiting after ablation, with incidences of 55.6%, 41.7%, 47.2%, and 19.4% respectively. Subgroup analysis showed no significant difference in the median value of NPV ratio, symptomatic relief rate of dysmenorrhea and menorrhagia, changes in clinical symptom scores, recurrence rate and economic cost between the two groups (all > 0.05).
CONCLUSION
PMWA is an effective and safe treatment for adenomyosis in the posterior uterine wall.
ADVANCES IN KNOWLEDGE
This study focused on the ultrasound-guided PMWA treatment for adenomyosis in the posterior uterine wall. Yu's uteropexy, a new ancillary technique allowing safe PMWA for deep posterior uterine wall lesions in retroverted uterus, expanded the indications of PMWA for symptomatic adenomyosis.
Topics: Female; Humans; Adenomyosis; Dysmenorrhea; Retrospective Studies; Menorrhagia; Microwaves; Treatment Outcome
PubMed: 37017557
DOI: 10.1259/bjr.20211301