Uterine Fibroid Volume Research Articles

Multicenter, prospective, single-arm clinical study to investigate the efficacy and safety of Zoladex (Goserelin acetate) 10.8 mg prior to surgery in Chinese premenopausal women with symptomatic uterine fibroids

Objectives To assess the effect and safety of Zoladex (Goserelin acetate) 10.8 mg in patients with uterine fibroids. Methods Fifty-three patients received Goserelin acetate 10.8 mg once and surgery was conducted at 12 weeks ± 7 days after drug injection. All assessments form baseline to week12/before surgery were carried out: fibroids volume, uterine volume, serum hormone (E2, FSH, LH), hemoglobin concentration, uterine arterial resistance index (UA-RI), fibroid arterial RI (FA-RI) and improvements of symptoms (Uterine Fibroid Symptom and Quality of Life (UFS-QOL) and Health-Related Quality of Life (HRQL) scores). Adverse events (AEs) were recorded to evaluate the safety. Results After 12 weeks of treatment, the volume of uterine fibroids was significantly smaller than before (249.19 ± 297.04 vs. 195.77 ± 418.27 cm3, p < 0.0001). The volume of the uterus was also smaller than before (372.02 vs. 263.58 cm3, p < 0.0001). Serum levels of E2, FSH, and LH showed significant decreasing trend (61.13 pmol/L, 5.23 IU/L and 4.75 IU/L respectively, p < 0.0001) and hemoglobin levels were increased significantly (108.30 ± 26.28 VS. 134.90 ± 9.21g/L, p < 0.0001). Left and right UA-RI showed slight increase of 0.04 and 0.02 respectively from baseline without significance. Mean FA-RI showed slight decrease of 0.03 from baseline (p = 0.22). Patient symptoms were alleviated after treatment. In addition, AEs occurred in 81.1% of enrolled patients and all AEs were well tolerably. Conclusions Goserelin acetate 10.8 mg pretreatment can effectively reduce the volume of uterine fibroids and uterus, lower estrogen levels and improve anemia symptoms. It could also improve the quality of life of patients, showing good safety and tolerance. This pretreatment was effective, safe, and generally well tolerated.

Effect of dienogest treatment on uterine fibroid volume in patients with endometriosis or adenomyosis complicated by uterine fibroids.

Currently, the use of dienogest in clinical practice has increased significantly, and many studies have focused on its effectiveness and safety in the treatment of endometriosis and adenomyosis; however, the effects of treatment with dienogest on uterine fibroid size in patients with endometriosis or adenomyosis have not been investigated. To explore changes in fibroid size in patients with concomitant uterine fibroids undergoing dienogest treatment for endometriosis or adenomyosis and to evaluate the effectiveness and safety of the drug. The clinical data of patients with uterine fibroids treated with dienogest for endometriosis or adenomyosis at Peking University First Hospital from January 2021 to January 2023 were retrospectively analyzed. The maximum uterine fibroid diameter and volume increased after 3 months, 6 months and 1 year of dienogest treatment compared with those before treatment (P < 0.01). The maximum diameter and volume of the uterine adenomyoma increased after 3 months of dienogest treatment but decreased after 6 months and 1 year of treatment compared with those before treatment, but the difference was not significant (P > 0.05). Endometrial thickness and antigen 125 levels were significantly thinner and decreased, respectively, after dienogest treatment (P < 0.01). Pearson's correlation analysis revealed that the increase in uterine fibroid volume after 3 months of dienogest treatment was positively correlated with the basic uterine fibroid volume (r = 0.792, P < 0.01). Among 64 patients with dysmenorrhea, 63 experienced significant relief of dysmenorrhea after 6 months of treatment with dienogest, and all patients experienced significant relief of dysmenorrhea after 12 months. Patients were able to tolerate the drugs, with an average drug tolerance score of 8.73. The use of dienogest in patients with endometriosis or adenomyosis combined with uterine fibroids can effectively relieve the patient's pain symptoms and significantly reduce the sizes of ovarian endometriotic cysts, but it cannot inhibit uterine fibroid growth.

Multiparametric quantitative magnetic resonance imaging of uterine fibroids for prediction of growth rate-a pilot study.

Uterine fibroid (UF) growth rate and future morbidity cannot be predicted. This can lead to sub-optimal clinical management, with women being lost to follow-up and later presenting with severe disease that may require hospitalization, transfusions, and urgent surgical interventions. Multi-parametric quantitative magnetic resonance imaging (MRI) could provide a biomarker to predict growth rate facilitating better-informed disease management and better clinical outcomes. We assessed the ability of putative quantitative and qualitative MRI predictive factors to predict UF growth rate. Twenty women with UFs were recruited and completed baseline and follow-up MRI exams, 1-2.5 years apart. The subjects filled out symptom severity and health-related quality of life questionnaires at each visit. A standard clinical pelvic MRI non-contrast exam was performed at each visit, followed by a contrast-enhanced multi-parametric quantitative MRI (mp-qMRI) exam with T2, T2*, and apparent diffusion coefficient (ADC) mapping and dynamic contrast-enhanced MRI. Up to 3 largest fibroids were identified and outlined on the T2-weighted sequence. Fibroid morphology and enhancement patterns were qualitatively assessed on dynamic contrast-enhanced MRI. The UFs' volumes and average T2, T2*, and ADC values were calculated. Pearson correlation coefficients were calculated between UF growth rate and T2, T2*, ADC, and baseline volume. Multiple logistic regression and receiver operating characteristic (ROC) analysis were performed to predict fast-growing UFs using combinations of up to 2 significant predictors. A significance level of alpha =0.05 was used. Forty-four fibroids in 20 women had growth rate measurement available, and 36 fibroids in 16 women had follow-up quantitative MRI available. The distribution of fibroid growth rate was skewed, with approximately 20% of the fibroids exhibiting fast growth (>10 cc/year). However, there were no significant changes in median baseline and follow-up values of symptom severity and health-related quality of life scores. There was no change in average T2, T2*, and ADC at follow-up exams and there was a moderate to strong correlation to the fibroid growth rate in baseline volume and average T2 and ADC in slow-growing fibroids (<10 cc/year). A multiple logistic regression to identify fast growing UFs (>10 cc/year) achieved an area under the curve (AUC) of 0.80 with specificity of 69% at 100% sensitivity. The mp-qMRI parameters T2, ADC, and UF volume obtained at the time of initial fibroid diagnosis may be able to predict UF growth rate. Mp-qMRI could be integrated into the management of UFs, for individualized care and improved clinical outcomes.

Laparoscopic continuous seromuscular circumsuture for myomectomy: a real-world, retrospective, East-Asian cohort study

ObjectiveThis study aimed to introduce a novel laparoscopic haemostasis for myomectomy and investigate the independent risk factors for uterine fibroid recurrence.DesignA retrospective cohort study.SettingFollowing strengthening the reporting of observational studies...

To Evaluate the Efficacy and Safety of Mifepristone in Reducing the Size & Symptoms of Uterine Leiomyoma/Fibroids.

Uterine leiomyomas, or fibroids, are prevalent benign gynecological tumors affecting many women during their reproductive years. While surgical excision has long been the gold standard for fibroid treatment, the pharmacological management, including progesterone receptor modulators like mifepristone (RU 486), has garnered attention due to the reduced surgical approaches. However, there is a notable paucity of research on the effectiveness of mifepristone, on the same. This study seeks to evaluate the safety and efficacy of mifepristone in reducing uterine leiomyoma size and alleviating associated symptoms. Conducted prospectively, the study enrolled 20 pre-menopausal women, aged 18years or older, from Nanavati Max Super Speciality Hospital Mumbai, Maharashtra, India. Participants were selected based on specific inclusion criteria, including the presence of at least one uterine myoma with a minimum diameter of 2.5cm as confirmed by ultrasound. Participants had an average age of 39.75years and an average BMI of 27.58kg/m2. The study found that mifepristone significantly reduced uterine volume by 75%, with hemoglobin levels substantially improving from 9 gm/dL initially to 12.51 gm/dL after six months. Pain intensity, assessed using the Visual Analog Scale (VAS) score, gradually decreased from baseline to three-month, with all 20 patients reporting the complete absence of pelvic pain by six months. This prospective study highlights mifepristone's promise as a non-surgical approach to effectively reduce uterine fibroid volume, improve hemoglobin levels, and mitigate uterine blood loss in patients.

Efficacy of uterine artery embolization (UAE) for uterine fibroids according to FIGO classification: a single-center experience.

This study aims to retrospectively evaluate the outcomes of uterine artery embolization (UAE) for uterine fibroids (UFs), specifically submucosal UFs, according to the International Federation ofGynecologyand Obstetrics (FIGO) classification of UFs. Forty-two patients with symptomatic UFs underwent UAE with Embosphere® between July 2016 and November 2021. MRI was performed before, at 3and 6months after the UAE. At each examination, the volume of UF was measured, and the percentage volume reduction rate (VRR) was calculated. The technical success rate (TSR), symptom improvement rate (SIR), regrowth rate (RR) after 6months, and adverse events (AEs) were examined; VRR was compared between patients with submucosal UFs (FIGO types 0-2, group A), those with submucosal contacts (FIGO type 3, group B), and those without submucosal UFs (FIGO types 4-7, group C). Statistical analysis was performed on the difference in VRR between groups A, B, and C at 3 and 6months after UAE. The relationship with hormone levels before UAE and VRR was evaluated. Thirty-seven of the 42 patients were evaluated. Overall, VRR was 37.0% at 3months and 52.1% at 6months; TSR, SIR, and RR were 100%, 95.2%, and 5.4%, respectively; VRR at 6months was 80.7% for group A (n = 7), 57.8% for group B (n = 13), and 37.1% for group C (n = 17). Significant differences were found between A and C (p < 0.001) and B and C (p = 0.023). Hormone levels before UAE had no effect on VRR. There was no significant AEs other than grade 3 pulmonary embolism in one patient. UAE was effective for submucosal FIGO types 0-3. UAE was especially useful as an option for FIGO type 3 with a low protrusion rate that is difficult to treat with transcervical resection.

Can an apparent diffusion coefficient of uterine fibroid before uterine artery embolization predict potential fibroid response?

ACOG guidance confirms the use of uterine artery embolisation (UAE) as an alternative to hysterectomy or myomectomy. The main objective of this article is to evaluate the ability of preoperative magnetic resonance ımaging (MRI) to study the relationship between uterine fibroid reduction and diffusion coefficient (ADC) value after UAE. This is a relevant topic with the growing interest in using ADC as a noninvasive imaging biomarker for monitoring tissue changes and predicting uterine fibroid response to UAE over the past years. In this prospective controlled non-randomized trial; uterine fibroid volume, fibroid diameter, uterine volume, fibroid ADC and normal myometrium ADC were recorded before and after UAE. Wilcoxon test was used in the analysis of the dependent quantitative data. Pearson correlation coefficients were calculated between post-UAE uterine volume, fibroid volume, and average fibroid diameter reduction and the patient's age, parity, gravidity, fibroid ADC and myometrial ADC before UAE. The mean fibroid volume reduction was 36.0% (range between 17.3-77.7%). Mean fibroid diameter, fibroid volume, uterine volume, and myometrium ADC values after UAE were significantly lower than before the procedure (p = 0.002, < 0.001, 0.001, 0.006 respectively), but the decrease in fibroid ADC is not significant. As a result decrease in fibroid volume was greater as pre-UAE fibroid ADC values increased, and that finding may contribute to the selection of the patients for the procedure. The ADC value before UAE was positively correlated with fibroid volume reduction.

Efficacy and safety of vilaprisan in women with uterine fibroids: data from the ASTEROID 3 randomized controlled trial

Vilaprisan is a highly potent selective progesterone receptor modulator shown to reduce heavy menstrual bleeding, induce amenorrhea, and diminish uterine fibroid volume in phase 2 studies. The objective of ASTEROID 3 was to demonstrate the superiority of vilaprisan compared with placebo in the treatment of heavy menstrual bleeding in women with uterine fibroids. Randomized, double-blind, placebo-controlled, multicenter phase 3 study. Hospitals and medical centers. Women with ≥1 uterine fibroid of ≥3 cm and heavy menstrual bleeding of >80 mL/cycle. Women were randomly assigned to 1 of 4 treatment arms, which were planned to comprise 2 treatment periods of 12 weeks, each with vilaprisan (2 mg/d) or placebo that were continuous or separated by a break of one bleed. Amenorrhea (primary end point; <2 mL in the last 28 days of treatment) and heavy menstrual bleeding response (key secondary end point; <80 mL/cycle and >50% reduction in bleeding from baseline) were measured with the alkaline hematin method. Change in volume of the 3 largest fibroids from baseline to end of treatment was assessed by ultrasound. Safety was monitored throughout the study. Overall, 75 women completed the first 12 weeks of treatment. Statistically significant and clinically meaningful differences were observed between the vilaprisan- and placebo-treated groups in both the full analysis and per-protocol sets. In the per-protocol set (n = 36 and n = 12 for the vilaprisan and placebo groups, respectively), amenorrhea was observed more frequently in women treated with vilaprisan than in those who received placebo (83.3% vs. 0%, P<.0001), with a median time to onset of 3 days in the vilaprisan group. Similarly, more vilaprisan- than placebo-treated women achieved a response in heavy menstrual bleeding (91.7% vs. 25.0%, P<.0001). Serious adverse events were reported for 22 (27.8%) of 79 women and were evenly distributed among the 4 groups receiving vilaprisan and/or placebo. None of these events led to study discontinuation or were related to the liver, and no new safety findings were identified compared with the earlier phase 2 ASTEROID studies. Vilaprisan is efficacious and well tolerated over 12 weeks in the treatment of heavy menstrual bleeding associated with uterine fibroids. Further investigations of the long-term efficacy and safety of vilaprisan are warranted. NCT03400943 (ClinicalTrials.gov).

O-191 Effects of relugolix combination therapy (Relugolix-CT) on uterine fibroid (UF) and uterine volume through 52 weeks: post hoc analysis of the LIBERTY Long-Term Extension study

Abstract Study question How does baseline UF and uterine volume impact the proportion of women achieving meaningful UF and uterine volume reductions with Relugolix-CT through 52 weeks? Summary answer Women with larger UF and uterine volumes at baseline may be more likely to experience clinically meaningful reductions of UF and uterine volume with Relugolix-CT. What is known already In the randomised, Phase 3 LIBERTY 1 and 2 pivotal studies, the efficacy and safety of once-daily Relugolix-CT (relugolix 40 mg, estradiol 1 mg, norethisterone acetate 0.5 mg) were demonstrated in premenopausal women (aged 18–50 years), with a significant reduction in UF-associated heavy menstrual bleeding (HMB) vs placebo, and preserved bone mineral density (BMD) through 24 weeks. The open-label, 28-week LIBERTY Long-Term Extension (LTE) study continued to demonstrate sustained menstrual blood loss reductions and preservation of BMD, alongside reductions in UF and uterine volume. Study design, size, duration The LIBERTY 1 and 2 studies of Relugolix-CT were conducted in 770 premenopausal women with UF-associated HMB. Women were randomised 1:1:1 to receive Relugolix-CT or placebo for 24 weeks, or delayed Relugolix-CT (relugolix 40 mg alone for 12 weeks, then Relugolix-CT for 12 weeks). Women who completed the pivotal trials were eligible to participate in the LIBERTY LTE study, receiving open-label Relugolix-CT for an additional 28 weeks. Participants/materials, setting, methods Endpoints of the LTE included change from baseline to Week 52 in UF and uterine volume. This post hoc analysis assessed the proportion of women who experienced a clinically meaningful reduction in UF or uterine volume of &amp;gt; 25% or &amp;gt; 50% through 52 weeks of Relugolix-CT. Subgroup analyses were performed to descriptively summarise the impact of UF and uterine volume at baseline (&amp;lt;25cm3 or ≥ 25cm3; &amp;lt;300cm3 or ≥ 300cm3, respectively) on change in UF and uterine volume. Main results and the role of chance In total, 477 women enrolled in the LTE, 363 completed 52 weeks of treatment, and 163 received Relugolix-CT continuously up to 52 weeks. At baseline, the mean (standard deviation) volume of the largest UF was 80.0 (145.1) cm3; mean (SD) uterine volume was 386.7 (320.5) cm3 in the Relugolix-CT group. At Week 24, 52.6% and 30.3% of women in the Relugolix-CT group experienced &amp;gt;25% and &amp;gt;50% reduction in UF volume, respectively. These proportions increased to 61.1% and 36.6%, respectively, at Week 52. For uterine volume, 36.1% and 4.5% experienced a &amp;gt; 25% and &amp;gt;50% reduction at Week 24, increasing to 41.2% and 9.6% at Week 52. At Week 52, of 81 women with a baseline UF volume of &amp;lt; 25cm3, 52.4% and 27.0% experienced a &amp;gt; 25% and &amp;gt;50% reduction in UF volume, respectively; 69.1% and 45.6% of 81 women with a baseline UF volume of ≥ 25cm3 experienced &amp;gt;25% and &amp;gt;50% reductions in UF volume, respectively. At Week 52, of 96 women with a baseline uterine volume of &amp;lt; 300cm3, 38.5% and 6.4% experienced a &amp;gt; 25% and &amp;gt;50% reduction in uterine volume; 44.8% and 13.8% of 67 women with a baseline uterine volume of ≥ 300cm3 experienced &amp;gt;25% and &amp;gt;50% reductions in uterine volume. Limitations, reasons for caution The study was conducted as an open-label study without a control group over the 28 weeks of the extension period. The present data are from a post hoc analysis of LIBERTY data without predefined criteria. Wider implications of the findings Treatment with Relugolix-CT led to a substantial reduction of UF and uterine volume in a large proportion of women with UF-associated HMB. Women with larger UF and uterine volume at baseline may be more likely to experience substantial reductions of UF and uterine volume. Trial registration number NCT03049735, NCT03103087, NCT03412890

Occurrence of adverse events after magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) therapy in symptomatic uterine fibroids—a retrospective case-control study

Objectives Our study aims at the comprehensive analysis of adverse events (AEs) in patients with symptomatic uterine fibroids (UFs) who underwent magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) in the last 6 years in one of the major Polish centers performing this type of therapy. Methods The presented retrospective case-control study was conducted in the Department of Obstetrics and Gynecology, Pro-Familia Hospital, Rzeszów in cooperation with the Second Department of Obstetrics and Gynecology, Center of Postgraduate Medical Education, Warsaw. The study enrolled 372 women with symptomatic UFs who underwent MR-HIFU and reported AEs during or after the procedure. The occurrence of particular AEs was analyzed. Statistical comparison of two cohorts (patients with and without AEs) was conducted based on epidemiological factors, UF characteristics, fat layer thickness, the presence of abdominal scars and technical parameters of the procedure. Results The overall mean occurrence rate of AEs was 8.9% (n = 33). No major AEs were reported. The only statistically significant risk factor of AEs was the treatment of type II UFs according to Funaki (OR 2.12, CI 95%, p = 0.043). Other investigated factors did not have a statistically significant influence on AE occurrence. Abdominal pain was the most common AE. Conclusion Our data showed that MR-HIFU seemed to be a safe procedure. The AE rate after the treatment is relatively low. According to the obtained data it seems that the occurrence of AEs does not depend on the technical parameters of the procedure and the volume, position and location of UFs. Further prospective, randomized studies and with long follow-up are necessary to confirm the final conclusions.

Measurement of changes in uterine and fibroid volume during treatment of heavy menstrual bleeding (HMB).

Does application of an unbiased method for analysis of magnetic resonance (MR) images reveal any effect on uterine or fibroid volume from treatment of heavy menstrual bleeding (HMB) with three 12-week courses of the selective progesterone receptor modulator ulipristal acetate (SPRM-UPA)? Application of an unbiased method for analysis of MR images showed that treatment of HMB with SPRM-UPA was not associated with a significant reduction in the volume of the uterus or in the volume of uterine fibroids. SPRM-UPA shows therapeutic efficacy for treating HMB. However, the mechanism of action (MoA) is not well understood and there have been mixed reports, using potentially biased methodology, regarding whether SPRM-UPA has an effect on the volume of the uterus and fibroids. In a prospective clinical study (with no comparator), 19 women with HMB were treated over a period of 12 months with SPRM-UPA and uterine and fibroid size were assessed with high resolution structural MRI and stereology. A cohort of 19 women aged 38-52years (8 with and 11 without fibroids) were treated with three 12-week courses of 5 mg SPRM-UPA given daily, with four weeks off medication in-between treatment courses. Unbiased estimates of the volume of uterus and total volume of fibroids were obtained at baseline, and after 6 and 12 months of treatment, by using the Cavalieri method of modern design-based stereology in combination with magnetic resonance imaging (MRI). Bland-Altman plots showed good intra-rater repeatability and good inter-rater reproducibility for measurement of the volume of both fibroids and the uterus. For the total patient cohort, two-way ANOVA did not show a significant reduction in the volume of the uterus after two or three treatment courses of SPRM-UPA (P = 0.51), which was also the case when the groups of women with and without fibroids were considered separately (P = 0.63). One-way ANOVA did not show a significant reduction in total fibroid volume in the eight patients with fibroids (P = 0.17). The study has been performed in a relatively small cohort of women and simulations that have subsequently been performed using the acquired data have shown that for three time points and a group size of up to 50, with alpha (Type I Error) and beta (Type II Error) set to 95% significance and 80% power, respectively, at least 35 patients would need to be recruited in order for the null hypothesis (that there is no significant reduction in total fibroid volume) to be potentially rejected. The imaging protocol that we have developed represents a generic paradigm for measuring the volume of the uterus and uterine fibroids that can be readily incorporated in future studies of medical treatments of HMB. In the present study, SPRM-UPA failed to produce a significant reduction in the volume of the uterus or the total volume of fibroids (which were present in approximately half of the patients) after either two or three 12-week courses of treatment. This finding represents a new insight in respect of the management of HMB using treatment strategies that target hormone-dependence. The UPA Versus Conventional Management of HMB (UCON) trial was funded by the EME Programme (Medical Research Council (MRC) and National Institutes of Health Research (NIHR)) (12/206/52). The views expressed in this publication are those of the authors and not necessarily those of the Medical Research Council, National Institute for Health Research, or Department of Health and Social Care.Medical Research Council (MRC) Centre grants to the Centre for Reproductive Health (CRH) (G1002033 and MR/N022556/1) are also gratefully acknowledged. H.C. has clinical research support for laboratory consumables and staff from Bayer AG and provides consultancy advice (All paid to Institution) for Bayer AG, PregLem SA, Gedeon Richter, Vifor Pharma UK Ltd, AbbVie Inc., and Myovant Sciences GmbH. H.C. has received royalties from UpToDate for an article on abnormal uterine bleeding. L.W. has received grant funding from Roche Diagnostics (Paid to Institution). All other authors have no conflicts to declare. The study reported here is an embedded mechanism of action study (no comparator) within the UCON clinical trial (registration ISRCTN: 20426843).

Uterine fibroid volume is not associated with blood pressure

Background: Females with uterine fibroids (UF), benign tumors of the myometrium, have a higher risk of hypertension than females without UF. The relationship between UF and hypertension is not fully understood. Case studies have reported hypertension in patients with large UF that compress the ureters, resulting in hydronephrosis. However, this pathophysiology is not present in all females with UF and hypertension. It is unknown if UF volume is correlated with blood pressure in the absence of renal compromise. Therefore, the goal of this study was to determine the potential associations between blood pressure and 1) volume of the largest UF and 2) volume of the uterus (a surrogate for total UF volume) in females with UF. Methods: We utilized the Mayo Clinic Data Explorer to identify patients, who had pelvic ultrasound or magnetic resonance imaging (MRI) studies performed at Mayo Clinic-Rochester in 2021 that reported the presence of UF, and who were ages 18-65 years old. From this system, we collected brachial blood pressure data (systolic, diastolic, and mean), assessed in the outpatient setting within 14 days of imaging. For each patient, dimensions of the largest UF and the uterus were abstracted from radiology reports. The largest UF was assessed, as it reliably had all three dimensions reported. Volume of the uterus was used as a surrogate for total UF volume to consider the possibility of multiple UF that were not detailed in the radiology report. Volumes of the largest UF and uterus were each calculated as for ellipsoid structures, (length✕depth✕width)✕0.523 in cm 3 . The Pearson correlation coefficient (r) was calculated to assess the linear relationship between blood pressure and largest UF volume, and blood pressure and uterine volume. A p-value &lt;0.05 denoted statistical significance. Results: One hundred thirteen females (48±9 years old) were included in the analysis, 88 with ultrasound and 25 with MRI reports. Average blood pressures were as follows, systolic: 121±16 mmHg (range: 92-185 mmHg), diastolic: 76±9 mmHg (52-101 mmHg), and mean: 91±11 mmHg (67-129 mmHg). Twenty-nine females (25.7%) had a diagnosis of hypertension. Hydronephrosis was not reported in any of the imaging reports. A mean of 2±2 UF were present per uterus (range: 1-15). Average volume of the largest UF was 75.0±115.9 cm 3 . Largest UF volume was not associated with systolic (r=0.023, p=0.812), diastolic (r=-0.040, p=0.677), or mean (r=-0.014, p=0.881) blood pressures. Average volume of the uterus was 219.6±215.6 cm 3 . Volume of the uterus was not associated with systolic (r=0.040, p=0.688), diastolic (r=0.102, p=0.305), or mean (r=0.071, p=0.475) blood pressures. Conclusion: In females with UF, blood pressure is not associated with the largest UF or uterine volumes. These data suggest that in the absence of hydronephrosis, the association between UF and blood pressure is not related to UF size. It is unknown if these findings differ based on factors, such as race. AHA 898649, NIH K01 HL1148144 This is the full abstract presented at the American Physiology Summit 2023 meeting and is only available in HTML format. There are no additional versions or additional content available for this abstract. Physiology was not involved in the peer review process.

Low Serum Level of Vitamin D is Associated with Uterine Leiomyoma in the Chinese Population

Background: The goal of this work was to compare the serum vitamin D level in women with uterine leiomyoma to that of controls, and to examine its association with the etiopathogenesis of this disease. Methods: This case-control study included 110 premenopausal women referred to a university hospital from January 2020 to December 2020. The study group consisted of 55 cases who underwent surgery for uterine fibroids, while the control group was comprised of 55 subjects without uterine fibroids. The number and volume of existing fibroids in each subject was assessed by transvaginal ultrasonography. Serum vitamin D status was determined by radioimmunoassay for 25-hydroxyvitamin D. Results: Average serum 25-hydroxyvitamin D levels in patients with uterine fibroids (20.52 ± 6.17 ng/mL) were significantly lower than in controls (24.18 ± 6.88 ng/mL; p = 0.004). Deficiency in 25-hydroxyvitamin D (i.e., &lt;20 ng/mL) was more frequent in women with uterine fibroids (28/55, 50.91%) compared to controls (13/55, 23.64%; p = 0.001). A trend for negative correlation was found between serum 25-hydroxyvitamin D levels and total uterine fibroid volume (r = –0.18) in the study group (p = 0.20). No significant associations were found between serum 25-hydroxyvitamin D level and the number of fibroids (p = 0.38) or their location (p = 0.89). Conclusions: The serum vitamin D concentration is lower in Chinese women with uterine leiomyomas compared to controls. Vitamin D deficiency could therefore be a risk factor for uterine leiomyoma in the Chinese population.

Use of Non-Contrast-Enhanced MR Angiography to Assess Recanalization after Uterine Artery Embolization

The purpose of this study was to examine the use of non-contrast-enhanced MR angiography (MRA) for assessing recanalization of uterine arteries (UAs) after uterine artery embolization (UAE) for symptomatic fibroids. Pre-procedural and follow-up unenhanced MRA images of 30 patients were reviewed, and the extent to which the UAs could be visualized was classified on a 4-point scale. An increase in the score between consecutive time points indicates that a previously inconspicuous segment of the UA became visible on follow-up images. Patients were divided into two groups according to the presence (or absence) of recanalization. The median UA visualization score at each follow-up was significantly lower than that at baseline (p < 0.01), but there was no significant difference between the scores of the follow-up images. Recanalization was detected in 63% (19/30) of patients. In these patients, the mean decrease in uterine and largest fibroid volume at 12 months after UAE was inferior to the mean decrease in patients for whom recanalization was not detected. Based on MRA assessment, recanalization after UAE occurred in 63% of patients but did not compromise the reduction in uterine and dominant fibroid volumes within 12 months after UAE.

The efficacy and safety of Chinese herbal medicine Guizhi Fuling capsule combined with low dose mifepristone in the treatment of uterine fibroids: a systematic review and meta-analysis of 28 randomized controlled trials

ObjectiveGuizhi Fuling Capsule (GZFL), a classic traditional Chinese medicine prescription, is often recommended for the treatment of uterine fibroids (UFs). However, the efficacy and safety of GZFL in combination with low-dose mifepristone (MFP) remains controversial.Materials and methodsWe searched eight literature databases and two clinical trial registries for randomized controlled trials (RCTs) of the efficacy and safety of GZFL combined with low-dose MFP in the treatment of UFs from database inception to April 24, 2022. Data analysis was performed using the Meta package in RStudio and RevMan 5.4. GRADE pro3.6.1 software was used for the assessment of evidence quality.ResultsTwenty-eight RCTs were included in this study, including a total of 2813 patients. The meta-analysis showed that compared with low-dose MFP alone, GZFL combined with low-dose MFP significantly reduced follicle stimulating hormone (p < 0.001), estradiol (p < 0.001), progesterone (p < 0.001), luteinizing hormone (p < 0.001), uterine fibroids volume (p < 0.001), uterine volume (p < 0.001), menstrual flow (p < 0.001) and increased clinical efficiency rate (p < 0.001). Meanwhile, GZFL combined with low-dose MFP did not significantly increase the incidence of adverse drug reactions compared with low-dose MFP alone (p = 0.16). The quality of the evidence for the outcomes ranged from “very low” to “moderate.”ConclusionThis study suggests that GZFL combined with low-dose MFP is more effective and safe in the treatment of UFs, and it is a potential treatment for UFs. However, due to the poor quality of the included RCTs formulations, we recommend a rigorous, high-quality, large-sample trial to confirm our findings.

Effects of long-term intermittent pharmacological therapy with ulipristal acetate on reducing the volume of uterine fibroids and relieving symptoms.

The aim of this study was to compare the effects of a 12-week course and four repeated 12-week courses of daily 5 mg ulipristal acetate (UPA) on reducing the volume and relieving symptoms of uterine fibroids. From 2016 to 2019, 287 female patients with uterine fibroids diagnosed using ultrasonography were recruited. The patients received four 12-week course treatments of daily UPA administration in the first and fourth sessions, respectively. During the first and fourth courses of UPA, we measured the volume of the fibroids using ultrasonography to study the effect on volume reduction. The measured outcomes included symptomatic relief and adverse effects. After the first UPA treatment course, menorrhagia was improved in 82.2% of patients. A total of 59.5% of patients were responsive to treatment, and the volume of the three largest fibroids decreased from 160.9 cm3 to 104.6 cm3. After the fourth treatment course, 87.4% of patients reported decreased bleeding. A total of 67.2% of patients were responsive to treatment, and the volume of the three largest fibroids decreased from 171.7 cm3 to 106.5 cm3. In 64 (38.1%) patients in group A and 36 (30.3%) in group B, the fibroid volume increased. Among them, 72% of patients showed improved symptoms. Uterine bleeding, pain, and reduced fibroid volume were adequately regulated in patients with symptomatic fibroids with four repeated 12-week courses of daily UPA.

Association between serum vitamin D level and uterine fibroid in premenopausal women in Indian population.

We aim to evaluate the association between serum 25-hydroxyvitamin D3 levels and total number, volume and location of uterine fibroids (UFs) in premenopausal women in North Indian population. This case control study was undertaken in 310 women between 18 years and 45 years of age. Cases comprised of 102 women with fibroid lesion and the control group included 208 women with normal uterine morphology on ultrasonography. Blood samples were taken for measuring 25-hydroxyvitamin D3 levels. The mean serum 25-hydroxyvitamin D3 level in the study and control group was 14.52 ± 7.89 ng/mL and 26.6 ± 14.36 ng/mL respectively (p < 0.05). There was significant inverse correlation between serum 25-hydroxyvitamin D3 levels and total volume of fibroids (p = 0.000) while none between 25-hydroxyvitamin D3 levels with location, number of fibroids. 25-hydroxyvitamin D3 deficiency was more common in the study group (54.90%) compared to healthy controls (6.7%) while sufficiency was more common among controls (67.8% vs. 27.45) (p < 0.05). Women with deficient 25-hydroxyvitamin D3 levels have an odds of 18.36 for developing uterine fibroid. Women with low parity, those belonging to higher socioeconomic status and having less than 1-hour sun exposure per day were independently found to have high risk for development of UFs. Vitamin D may have a role in growth of UFs. Women not able to get adequate sun exposure due to indoor working conditions may need evaluation and supplementation as prophylaxis for development of fibroid.

Randomised Controlled Trial of Particles Used in Uterine fibRoid Embolisation (PURE): Non-Spherical Polyvinyl Alcohol Versus Calibrated Microspheres

PurposeThe PURE study is a randomised controlled trial (RCT) comparing the clinical and MRI outcomes of patients treated with non-spherical polyvinyl alcohol, ns-PVA (Contour PVA–Boston Scientific–355–500 & 500–700 microns) versus calibrated hydrogel microspheres (Embozene–Varian Inc–700 & 900 microns) for symptomatic uterine fibroids.Materials and MethodsProspective, ethically approved non-sponsored RCT in 84 patients in a single UK tertiary IR unit, ISRCTN registry trial number ISRCTN18191539 in 2013 and 2014. All patients with symptomatic fibroid disease were eligible. UAE followed a standardised protocol with UFS-QOL and contrast-enhanced MRI before and 6 months post UAE. Outcome measures included: (1) Uterine Fibroid Symptom and Quality of Life questionnaire (UFS-QOL). (2) Percentage total and dominant fibroid infarction. (3) Uterine and dominant fibroid volume reduction. (4) Volume of embolics.ResultsSixty-three patients completed the QOL follow-up (33 ns-PVA vs 30 Embozenes), the groups were equivalent at baseline. Patients were followed up for 6 months following UAE. There was no significant difference in symptom scores or HR-QOL between ns-PVA and Embozenes, p = 0.67 and 0.21, respectively. 92.7% of patients treated with ns-PVA achieved > 90% dominant fibroid infarction versus 61.8% treated with Embozenes (p = 0.0016). 66% of patients treated with ns = PVA achieved > 90% total fibroid percentage infarction compared with 35% in the Embozene group (p = 0.011). The mean vials/syringes used were 5.2 with Embozenes versus 4.1 using PVA (p = 0.08).ConclusionThe PURE study informs IRs regarding the efficacy of embolic agents in UAE, with superior fibroid infarction on MRI using ns-PVA versus Embozenes however no significant difference in clinical outcomes at 6 months after UAE.

Long Term and Low Dose Mifepristone in The Treatment of Uterine Leiomyoma

To explore the long-term effect of low-dose mifepristone in the treatment of uterine leiomyoma. Methods: 90 cases of hysteromyoma treated in our hospital from December 2018 to May 2019 were randomly divided into control group and observation group, 45 cases in each group. The control group was treated with conventional dose (25mg / D) of mifepristone, and the observation group with low dose (12.5mg / D) of mifepristone. The uterine volume, uterine fibroid volume, hormone level, therapeutic effect and adverse reactions were compared between the two groups. Results: After treatment, the volume of uterus and hysteromyoma in the two groups decreased significantly, but there was no significant difference between the observation group and the control group (P &gt; 0.05); the level of E2, P, FSH in the two groups decreased, but there was no significant difference between the observation group and the control group (P &gt; 0.05); the treatment effect of the observation group and the control group was no significant difference (P &gt; 0.05); the adverse reactions of nausea, anorexia, hot flashes and fatigue in the observation group The birth rate was significantly lower than that of the control group (P &lt; 0.05). Conclusion: Low dose mifepristone can also effectively reduce the level of estrogen and progesterone in patients with uterine leiomyoma, reduce the volume of leiomyoma, reduce the incidence of adverse reactions, with high safety, which is worthy of clinical application.

Efficacy and Safety of the Two Ayurveda Drug Regimens in Uterine Fibroids: A Randomized Single-Blind Clinical Trial.

This study aims to assess the efficacy and safety of two Ayurveda drug regimens for the treatment of uterine fibroids (UF) in a randomized single-blind clinical trial. 120 participants with UF (volume ≥ 2 cm3) were randomly allocated at a 1 : 1 : 1 ratio to 2 experimental groups and the control group. The 12-week intervention period was followed by 12-week follow-up. The primary efficacy endpoint was the change of the largest UF volume. The secondary efficacy endpoints were assessed by the pictorial bleeding assessment score (PBAC), UF symptoms, and quality of life score. The safety endpoints were changed in hepatic and renal safety parameters and patients experiencing adverse effects. Significant decrease was observed in the volume of UF in the arm II but not in arm I, while a significant increase was observed in the volume of the largest UF in the control group at 12th week. The PBAC score remained stable in all groups. Further mean value of the intervention arms symptom severity subscale (SSS) was significantly reduced compared to the control arm. Health-related quality of life (HRQL) value improved in 12th week of both experimental arms compared to baseline. Control arm HRQL value was reduced compared to baseline. The volume of the largest UF and both SSS and HRQL values remained stable within the follow-up period in the tested arms. The findings of this study demonstrated the safety and efficacy of selected two Ayurveda drug regimens in reducing the volume of UF and related symptoms and improving quality of life.