Uterine Fibroid Symptom And Quality Of Life Research Articles

Long-term Efficacy of Fibroid Devascularization with Ultrasound-Guided High-Intensity Focused Ultrasound

High-intensity focused ultrasound (HIFU) has been increasingly used for treatment of uterine leiomyoma. The superiority of HIFU therapy targeting uterine leiomyoma blood vessels, however, still needs to be further explored. This study aims to evaluate the long-term efficacy of fibroid devascularization with ultrasound-guided HIFU (USgHIFU) and the effects of treatment on the ovarian reserve and endometrial injury. Fibroid devascularization was assessed with the Adler grade obtained by color Doppler flow imagingand power Doppler imaging (PDI). The targeted vessels were covered and then sonicated by HIFU focal spots. The patients were followed up at 1 month, 3 months, 6 months, 1 year, 2 years and 3 years after treatment. Adverse effects and complications were recorded. The non-perfusion volume rate (NPVR), fibroid volume shrinkage rate (FVSR), Adler Grade, symptom severity score (SSS) and uterine fibroid symptom and quality of life (UFS-QOL) were evaluated. Adverse events (AEs)were recorded. In Center 1, the enrolled patients completed the anti-Müllerian hormone (AMH) test before and at 6 months after treatment. A total of 117 eligible patients were consecutively enrolled to receive interventions and follow-up evaluations of the three centers from January 2019 to May 2023. The 1-month and 6-monthNPVRs were 66.60%±33.14% and 51.12%±39.84%, respectively. The mean FVSRs at 1 month and 6 months after treatment were 38.20% and 43.89%, respectively. No significant difference was observed in AMH levels before and after treatment (p>0.05). No irreversible endometrial injury was observed in MR images after HIFU treatment. No significant difference was observed in both 1-month and 6-monthFVSRs among Center 1, 2 and 3 (p>0.05). No severe AEs occurred. For long-term outcomes, significant differences were observed in Adler grade, FV, FVSR, SSS, reduction in SSSand UFS-QOL before and after treatment (p<0.001) whereas no significant difference was observed in Adler grade among 3 months, 1 year, 2 years and 3 years after treatment (p>0.05). The SSSs were reduced by 33.42% at 1 year, 42.32% at 2 years and 52.46% at 3 years after treatment. For patients with uterine fibroids, USgHIFU-induced devascularization is a safe and effective treatment option. It has little effect on ovarian function and the endometrial injury is reversible, which could be attractive for patients who plan to become pregnant.

Adverse childhood events and health-related quality of life among women undergoing hysterectomy for uterine leiomyoma

Background and Aim Psychosocial stress may increase fibroid risk, but associations with symptom severity, which often influence clinical management decisions, have been underexamined. Our objective is to examine associations between adverse childhood experiences (ACE) and symptom severity and symptom impact on health-related quality of life (HRQL) among women undergoing hysterectomy for treatment of their leiomyomas (fibroids). Methods We recruited 103 premenopausal women into the Fibroids, Observational Research on Genes and the Environment (FORGE) study who were seeking evaluation of fibroids at the Medical Faculty Associates in Washington D.C. and intending to undergo hysterectomy at the George Washington University Hospital. For exposure classification, we assessed eight ACE categories related to child abuse and household challenges. For outcome classification, we used the Uterine Fibroid Symptom and Quality of Life (UFS-QOL). The five-level Likert scale responses were summed to create composite scores; a lower symptom severity score indicated fewer symptoms, while a higher HRQL score indicated better quality of life. We ran quasi-poisson regressions (log-link) to examine associations between ACE scores and UFS-QOL composite scores adjusting for age, race/ethnicity, and education (N=89). Results The majority of participants were Black (73%); about half had private insurance (55%) and a college degree (49%). Cumulative ACE and symptom severity scores were higher among Black compared to non-Black women (p &amp;#x2264; 0.03). History of substance abuse in the household was associated with greater symptom severity (relative risk (RR) = 1.31, 95% CI: 1.07, 1.61), and worse HRQL (RR = 0.74, 95% CI: 0.55, 1.00). History of sexual abuse was also associated with worse HRQL (RR = 0.67, 95% CI: 0.48, 0.92). Conclusions Our study adds to the growing evidence that early life exposures to chronic stress may influence gynecologic health, including symptom-related quality of life. Keywords. Women’s health, gynecological health, health disparities, social-structural stressors

Therapeutic Outcome of MR-Guided High-Intensity Focused Ultrasound (MR-HIFU) in Solitary versus Multiple Uterine Fibroids.

MR-guided high-intensity focused ultrasound (MR-HIFU) is an effective method for treating symptomatic uterine fibroids, especially solitary lesions. The aim of our study was to compare the clinical and morphological outcomes of patients who underwent MR-HIFU due to solitary fibroid (SF) or multiple fibroids (MFs) in a prospective clinical trial. We prospectively included 21 consecutive patients with SF (10) and MF (11) eligible for MR-guided HIFU. The morphological data were assessed using mint Lesion™ for MRI. The clinical data were determined using the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire before and 6 months after treatment. Unpaired and paired Wilcoxon-test and t-tests were applied, and Pearson’s coefficient was used for correlation analysis. A p-value of 0.05 was considered statistically significant. The volume of treated fibroids significantly decreased in both the SF (mean baseline: 118.6 cm3; mean 6-month follow-up: 64.6 cm3) and MF (107.2 cm3; 55.1 cm3) groups. The UFS-QOL showed clinical symptoms significantly improved for patients in both the SF and MF groups regarding concern, activities, energy/mood, and control. The short-term outcome for the treatment of symptomatic fibroids in myomatous uterus by MR-guided HIFU is clinically similar to that of solitary fibroids.

The effect of transcervical resection of submucous fibroids on menstrual blood loss: A prospective cohort study

ObjectivesTranscervical resection of myoma (TCRM) is a widely implemented treatment for submucous fibroids. The aim of this study is to evaluate the effect of TCRM on menstrual bleeding, fibroid related symptoms and quality of life and hemoglobin (Hb) levels. Study designA prospective cohort study was conducted in three teaching hospitals and two academic hospitals in the Netherlands. Patients with HMB (PBAC score > 150) and submucous fibroids (type 0, 1, 2, 3, 4 and hybrid type 2–5) scheduled for TCRM were eligible. At baseline and 3 months after TCRM a Trans Vaginal Ultrasound (TVU) was performed and a Hb sample was taken. Patients filled out the Pictorial Blood Assessment Chart (PBAC) and the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire at baseline and up to 6 months after surgery. Primary outcome was improvement in PBAC score 6 months after surgery. Secondary outcomes were improvement in PBAC score and Hb level 3 months after surgery and UFS-QOL scores 3 and 6 months after surgery. Results126 patients were included and 104 were operated. PBAC were obtained from 98 patients. Six months after surgery, 56.6% of patients went from HMB to normal menstrual bleeding (PBAC < 150). A significant reduction in median PBAC scores of 427 (IQR 198 – 1392) (p <.0001) was found (86% improvement). UFS-QOL scores were obtained from 91 patients. Symptom severity improved from a median of 54 on a scale of 100 (IQR 44–66) at baseline to 22 (IQR 9–41) after 6 months (p <.0001) (59% improvement). Health related quality of life (HRQOL) improved from a median score of 44 on a scale of 100 (IQR 33–62) to 89 (IQR 67–97) 6 months after surgery (p <.0001) (102% improvement). ConclusionTCRM significantly reduces the amount of menstrual bleeding, severity of fibroid related symptoms and improves HRQOL in patients with submucous fibroids.

Uterine artery embolization with highly compressible calibrated microspheres for the treatment of uterine fibroids.

ObjectiveTo evaluate the safety and efficacy of using highly compressible calibrated microspheres in uterine artery embolization (UAE) for the treatment of uterine fibroids.Materials and MethodsThis was a prospective multicenter study. Thirty-two women with symptomatic uterine fibroids were selected for UAE between January 2019 and March 2020. The participants completed the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire, underwent contrast-enhanced pelvic magnetic resonance imaging (MRI), and were submitted to anti-Müllerian hormone measurement, subsequently undergoing UAE with Embosoft microspheres. After six months, the patients again completed the UFS-QOL questionnaire and underwent pelvic MRI.ResultsThe most common symptoms were abnormal uterine bleeding (in 81.3% of the cases), pelvic pain (in 81.3%), and compression (in 46.9%). Of the 32 patients evaluated, 12 (37.5%) had anemia due to abnormal uterine bleeding. Thirty patients completed the study. Among those patients, we observed median reductions of 21.4% in uterine volume and 15.9% in dominant fibroid volume. We identified no adverse events that could be attributed to the material itself, although there were events attributed to the UAE procedure in general.ConclusionFor the treatment of uterine fibroids, UAE using Embosoft microspheres shows satisfactory results, providing reductions in uterine and dominant fibroid volumes, with a low rate of adverse events, and improving patient quality of life, as well as demonstrating safety and efficacy.

Fibroid vascularisation assessed with 3D Power Doppler as predictor for fibroid related symptoms and quality of life; a pilot study.

Uterine fibroids present differently, from well vascularised up to calcified, with some causing heavy menstrual bleeding (HMB). To investigate the association between fibroid vascularisation and HMB, other fibroid related symptoms and quality of life (QOL). A single centre pilot study was carried out in the Netherlands. Women with a maximum of two fibroids who chose expectant management were included. 3D sonography including power doppler was performed at baseline and at 3, 6 and 12 months follow up. Women were asked to complete the Pictorial Blood Assessment Chart (PBAC) and Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaires at every visit. Main outcome measure: The association between fibroid vascularisation and HMB. 53 women were included in the study. Baseline fibroid vascularisation, measured as vascular index (VI) is associated with PBAC score; a 1% higher VI at baseline leads to an 11 point increase in PBAC score over time (RC 10.99, p=0.05, 95% CI -0.15 - 22.12). After correction for the baseline variables ethnicity and fibroid type the association becomes stronger (P<0.05). Fibroid volume at baseline and HMB are also associated: a 1 cm3 larger fibroid leads to 0.6 points increase in PBAC score over time (RC 0.56, p=0.03, 95% CI 0.05 - 1.07). Conclusions: This study highlights that both fibroid vascularisation and fibroid volume may be associated with an increase in menstrual blood loss, other fibroid related symptoms and QOL over time. What is new? We used 3D power doppler to predict symptomatic fibroids.

Durable Improvement in Generic and Fibroid-Specific Quality of Life in Women Treated with the Sonata System after Three Years

<h3>Study Objective</h3> To determine the longitudinal health outcomes of transcervical fibroid ablation (TFA) with the Sonata System on quality of life (QOL) as determined by quality-adjusted life years (QALYs) over 3 years. <h3>Design</h3> Prospective, controlled, multicenter interventional trial. <h3>Setting</h3> 22 Hospitals in the US (21) and Mexico (1). <h3>Patients or Participants</h3> 147 women who underwent TFA with the Sonata® System. <h3>Interventions</h3> TFA was used to ablate fibroids under clinical trial protocol. <h3>Measurements and Main Results</h3> Change in generic health status was assessed with the EQ-5D questionnaire (0 to 1 scale). Fibroid-specific QOL was measured on a 0 to 100 scale using the health-related quality of life (HRQL) subscale of the Uterine Fibroid Symptom and Quality-of-Life (UFS-QOL). We determined the number of QALYs gained relative to baseline by calculating the area under the curve at each follow-up visit over 3 years. We additionally determined cumulative QALYs experienced at each interval during follow-up. The SONATA trial enrolled 147 women at 22 centers who received TFA for symptomatic uterine fibroids. Fibroid-specific QOL increased from 40±21 at baseline to 83±23 at 3 years (p<0.001). Generic QOL increased from 0.72±0.21 at baseline to 0.88±0.16 at 3 years (p<0.001). Comparing outcomes at 3 years relative to baseline, TFA resulted in 1.24±0.64 QALYs gained when calculated using fibroid-specific health utility scores and 0.49±0.61 QALYs gained when calculated using generic health utility scores. Cumulative QALYs experienced at 3 years as a percentage of perfect health were 82% when using fibroid-specific scores and 88% when using generic health scores. <h3>Conclusion</h3> Women treated by TFA with the Sonata System for symptomatic uterine fibroids reported durable improvements in generic and fibroid-specific QOL.

Durable Improvement in Generic and Fibroid-Specific Quality of Life in Women Treated with Transcervical Fibroid Ablation with the Sonata System After Three Years.

Objective:To determine quality-adjusted life years (QALYs) over 3 years after transcervical fibroid ablation (TFA) with the Sonata System.Methods:The SONATA trial was a prospective multicenter interventional trial that assessed the safety and efficacy of TFA for treatment of women with symptomatic uterine fibroids. Change in generic health status was assessed with the EuroQol 5-Dimension questionnaire (0–1 scale). Fibroid-specific quality of life (QOL) was measured on a 0 to 100 scale with the health-related quality of life subscale of the Uterine Fibroid Symptom and Quality-of-Life (UFS-QOL). The number of QALYs gained relative to baseline and cumulative QALYs were calculated using the area under the curve at each follow-up visit over 3 years.Results:Among 147 women receiving TFA, fibroid-specific QOL increased from 40 ± 21 at baseline to 84 ± 19 at 1 year and 83 ± 23 at 3 years (p < 0.001). Generic QOL increased from 0.72 ± 0.21 at baseline to 0.89 ± 0.12 at 1 year and 0.88 ± 0.16 at 3 years (p < 0.001). Over 3 years, TFA resulted in 1.24 ± 0.64 QALYs gained when using fibroid-specific health utility scores and 0.49 ± 0.61 QALYs gained when using generic health utility scores. Cumulative QALYs experienced at 3 years as a percentage of perfect health were 82% with fibroid-specific scores and 88% with generic health scores.Conclusions:Women treated by TFA with the Sonata System for symptomatic uterine fibroids reported durable improvements in generic and fibroid-specific QOL, as well as clinically meaningful increases in QALYs over 3 years. Clinical Trials.gov ID: NCT02228174. (J GYNECOL SURG 38:143)

Uterine-Artery Embolization or Myomectomy for Uterine Fibroids

BackgroundUterine fibroids, the most common type of tumor among women of reproductive age, are associated with heavy menstrual bleeding, abdominal discomfort, subfertility, and a reduced quality of life. For women who wish to preserve their uterus and who have not had a response to medical treatment, myomectomy and uterine-artery embolization are therapeutic options.MethodsWe conducted a multicenter, randomized, open-label trial to evaluate myomectomy, as compared with uterine-artery embolization, in women who had symptomatic uterine fibroids and did not want to undergo hysterectomy. Procedural options included open abdominal, laparoscopic, or hysteroscopic myomectomy. The primary outcome was fibroid-related quality of life, as assessed by the score on the health-related quality-of-life domain of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire (scores range from 0 to 100, with higher scores indicating a better quality of life) at 2 years; adjustment was made for the baseline score.ResultsA total of 254 women, recruited at 29 hospitals in the United Kingdom, were randomly assigned: 127 to the myomectomy group (of whom 105 underwent myomectomy) and 127 to the uterine-artery embolization group (of whom 98 underwent embolization). Data on the primary outcome were available for 206 women (81%). In the intention-to-treat analysis, the mean (±SD) score on the health-related quality-of-life domain of the UFS-QOL questionnaire at 2 years was 84.6±21.5 in the myomectomy group and 80.0±22.0 in the uterine-artery embolization group (mean adjusted difference with complete case analysis, 8.0 points; 95% confidence interval [CI], 1.8 to 14.1; P=0.01; mean adjusted difference with missing responses imputed, 6.5 points; 95% CI, 1.1 to 11.9). Perioperative and postoperative complications from all initial procedures, irrespective of adherence to the assigned procedure, occurred in 29% of the women in the myomectomy group and in 24% of the women in the uterine-artery embolization group.ConclusionsAmong women with symptomatic uterine fibroids, those who underwent myomectomy had a better fibroid-related quality of life at 2 years than those who underwent uterine-artery embolization. (Funded by the National Institute for Health Research Health Technology Assessment program; FEMME Current Controlled Trials number, ISRCTN70772394.)

A Prospective Intervention Trial on Tailored Radiofrequency Ablation of Uterine Myomas.

Background and Objective: Investigating the use of radiofrequency myolysis (RFM) for the treatment of fibroids through less invasive access by combining transvaginal ultrasound, hysteroscopy and laparoscopy. Materials and Methods: Fifty-four premenopausal women with 106 symptomatic uterine myomas. Patients underwent RFM in three ways: Vaginal Ultrasound-guided RFM (VU-RFM), Laparoscopic RFM (L-RFM) and Hysteroscopic-RFM (H-RFM). The mean patient age was 43 years; 52 symptomatic uterine myomas were subserosal, 44 intramural and 10 submucosal. The outcomes evaluated at 1 and 12 months after RFM were myoma size (volume-diameter), “Uterine Fibroid Symptom and Quality of Life (UFS-QOL)” questionnaire and a 10-point Visual Analogue Scale (VAS). The therapy was completed with a single ablation in all patients, no complication was registered. The average number of fibroids treated per intervention was two with the use of different accesses: 64/106 VU-RFMs (60.4%), 32/106 L-RFMs (30.2%) and 10/106 H-RFMs (9.4%). Results: Volume and diameter of fibroids were significantly reduced by, respectively, 51.3% and 20.1% in the first 30 days post-intervention (p < 0.001) up to a maximum of 73.5% and 37.1% after the second follow-up visit at 12 months (p < 0.001). A similar trend was shown in terms of disability with a progressive and significant reduction of symptoms (menorrhagia, dysmenorrhea, dyspareunia and pollakiuria) demonstrated by percentage variation of UFS-QOL Symptom Severity and VAS scores to −74.3% and −45.3% as well as −84.9% and −74.3%, respectively, at 1 and 12 months after RFM (p < 0.001). An overall improvement in the quality of life was also demonstrated by a significant increase in the UFS-QOL total score of +38.2% in the first 30 days post-intervention up to +44.9% after the second follow-up visit at 12 months (p < 0.001). The overall average surgery time of the RFM for each patient was 48 minutes, and the time to treat each fibroid by Vaginal Ultrasound-guided RFM (23 min) was found to be significantly less than those of laparoscopy or hysteroscopy (respectively 35 and 34 min) (p < 0.05). An electromagnetic virtual needle tracking system (VNTS) was successfully tested during the RFM procedures, and real-time contrast-enhanced ultrasound (CEUS) has proven to be effective in determining the duration of myolysis through the identification of eventual residual areas of enhancement within the fibroids. Conclusion: Radiofrequency can be considered a minimally invasive and safe procedure for the treatment of uterine myomas through the customization and possible combination of transvaginal, laparoscopic or hysteroscopic accesses. The standardization of the ablation technique with pre-intervention biopsy and new technologies such as VNTS and CEUS spares healthy uterine tissue and may change the future management of symptomatic uterine fibroids.

Validation of the Spanish version of the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) questionnaire in women with uterine myomatosis

AimTo validate the Spanish version of the Uterine Fibroid Symptom and Quality of Life (UFS-QoL)questionnaire in women with uterine myomatosis, in order to assess severity of symptoms, and their impact on health-related quality of life. Materials and methodsThe participants were recruited in gynaecology clinics. The UFS-QoL questionnaire comprises 37 items, 8 of which assess severity of symptoms, and the remaining 29 assess health-related quality of life in 6 subscales. Internal consistency, concurrent and discriminant validity, test-retest reliability, and the scale’s sensitivity to change were evaluated. ResultsA total of 619 patients with uterine myomatosis, and 57 women without myomatosis, took part in the study. Cronbach’s alpha was 0.97, and the test-retest reliability was 0.90 for the overall scale. TheUFS-QoL not only discriminated between patients and healthy controls but also between patients with different degrees of uterine myomatosis. The scale responded to changes after treatment with an effect size of 1.2. ConclusionsThe Spanish version of the UFs-QoL questionnaire, used in a sample of the Spanish population, proved a valid and reliable tool to differentiate patients with uterine myomatosis and different grades of symptoms, and to evaluate the impact of the severity of these symptoms on health-related quality of life. In addition, the UFs-QoL proved sensitive to the changes generated by myomatosis treatment.

Validación de la versión española del cuestionario Síntomas y Calidad de Vida en los Miomas Uterinos en mujeres con miomatosis uterina

AimTo validate the Spanish version of the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) questionnaire in women with uterine myomatosis, in order to assess severity of symptoms, and their impact on health-related quality of life. Materials and methodsThe participants were recruited in gynaecology clinics. The UFS-QoL questionnaire comprises 37 items, 8 of which assess severity of symptoms, and the remaining 29 assess health-related quality of life in 6 subscales. Internal consistency, concurrent and discriminant validity, test-retest reliability, and the scale's sensitivity to change were evaluated. ResultsA total of 619 patients with uterine myomatosis, and 57 women without myomatosis, took part in the study. Cronbach's alpha was 0.97, and the test-retest reliability was 0.90 for the overall scale. The UFS-QoL not only discriminated between patients and healthy controls but also between patients with different degrees of uterine myomatosis. The scale responded to changes after treatment with an effect size of 1.2. ConclusionsThe Spanish version of the UFS-QoL questionnaire, used in a sample of the Spanish population, proved a valid and reliable tool to differentiate patients with uterine myomatosis and different grades of symptoms, and to evaluate the impact of the severity of these symptoms on health-related quality of life. In addition, the UFS-QoL proved sensitive to the changes generated by myomatosis treatment.

PIH57 THE BLEEDING AND PELVIC DISCOMFORT SCALE: MEASURING PATIENT-REPORTED SYMPTOMS IN UTERINE FIBROIDS

The symptom severity scale of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) instrument contains 8 items and is multi-factorial. The objectives were to determine the subscale (factor) consisting of items relevant to most women with heavy menstrual bleeding (HMB) associated with uterine fibroids (UF), assess its psychometric properties, and determine its responder threshold. Analyses were based on pooled, blinded data from the first one third of patients with HMB enrolled in two Phase 3 studies of relugolix in uterine fibroids (N=254). Factor analyses were done on the UFS-QOL symptom severity scale. The subscale consisting of symptoms experienced by most patients was chosen for further analysis and its psychometric properties were evaluated. The meaningful change threshold was derived by anchor-based methods with change in PGA of symptom severity as an anchor. Within and between anchor group changes in the subscale scores from Baseline to Week 24 were evaluated using pair t-test analysis of variance. Cumulative distribution function and probability density function curves were used as supportive information. Factor analyses revealed that the UFS-QOL symptom severity scale consisted of 3 factors. Factor 1 had three items representing common symptoms of HMB in UF; this factor was named the Bleeding and Pelvic Discomfort (BPD) scale. The BPD scale had no ceiling effects; all response options were used by patients. The items of the BPD scale were found to work cohesively to inform the total score and to adequately distinguish between patients of different severities. Descriptive statistics supported the construct validity and responsiveness. A 20-point change on the BPD scale score (range from 0 - 100) is recommended as the responder threshold. The BPD scale is a short patient-reported outcome measure relevant to patients with HMB due to UF that can be used to assess their symptom burden.

Improvement in health-related quality of life (HRQoL) in women with uterine fibroids (Uf) treated with vilaprisan (VPR): a summary of results from asteroid 1 and 2

To assess the impact of VPR, ulipristal acetate (UPA) and placebo on HRQoL in women with UFs. Two multicenter, double-blind, randomized phase 2 studies examining the efficacy and safety of VPR compared with placebo (ASTEROID 1 and 2), and an active comparator (ASTEROID 2). 309 and 172 women with UFs and heavy menstrual bleeding (HMB) were enrolled in ASTEROID 1 and 2, respectively. In ASTEROID 1, women received oral placebo or VPR 0.5 mg, 1 mg, 2 mg, or 4 mg once daily (OD) for 12 weeks, with follow-up at 24 weeks. In ASTEROID 2, women received VPR 2 mg, UPA 5 mg, or placebo OD for one or two 12-week treatment periods, with 12 weeks’ follow-up. HRQoL was assessed using the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) questionnaire and the Short-Form 36 Health Survey Version 2 (SF-36v2) during baseline (BL), end of treatment (EoT) and end of follow-up (EoFUP) visits. Across treatment groups in ASTEROID 1 at BL, the mean (SD) UFS-QoL total HRQoL scores were between 46.2 (24.1) and 49.9 (25.0)SF-36v2 physical component scores (PCS) were between 45.6 (7.3) and 47.5 (7.8), and SF-36v2 mental component scores (MCS) were between 43.3 (11.5) and 47.5 (8.3). All BL scores were in line with previously published data for women with UFs.1 At EoT, the mean total and subscale UFS-QoL and SF-36v2 scores in all VPR-treated groups increased compared with BL. These increases were greater than those observed with placebo. The mean (SD) UFS-QoL total HRQoL scores increased to 83.2 (19.7) in the highest and 78.3 (24.0) in the lowest VPR dose group, versus 56.2 (24.8) in the placebo group. Mean (SD) SF-36v2 PCS and MCS increased to 51.7 (6.2) and 52.0 (8.9) in the lowest VPR dose group, and 53.7 (6.5) and 51.1 (8.9) in the highest VPR dose group, respectively. By comparison, the mean (SD) PCS and MCS at EoT in the placebo group were 48.4 (7.8) and 43.9 (12.2), respectively. The EoT UFS-QoL and SF-36v2 scores of women that received VPR were in the range of those previously published for healthy women without UFs1. Similar results were observed in ASTEROID 2. Mean UFS-QoL HRQoL and SF-36v2 BL scores increased continuously during treatment with VPR for up to 24 weeks, whereas increased scores were observed for the first 12 weeks with UPA but did not continue to 24 weeks (not statistically tested). The mean (SD) UFS-QoL total HRQoL scores across VPR dosage groups increased from between 78.5 (21.0) and 81.9 (16.4) after 12 weeks, to between 82.4 (17.5) and 85.6 (13.2) after 24 weeks’ treatment. In the UPA group, this score decreased from 75.0 (19.6) at 12 weeks to 73.4 (20.8) at 24 weeks. In general, the mean UFS-QoL total HRQoL and SF-36v2 scores decreased only slightly between treatment cessation and EoFUP across active treatment groups in ASTEROID 1 (6 months) and 2 (3 months). In ASTEROID 1 and 2, increases in mean UFS-QoL and SF-36v2 HRQoL scores were observed alongside reduced HMB in women with UFs during active treatment with VPR and UPA for up to 24 weeks, and were sustained to EoFUP. Furthermore, by EoT, HRQoL scores increased to levels previously published for healthy women without UFs.1

Efficacy and safety of ultrasound-guided high-intensity focused ultrasound for uterine fibroids: a preliminary experience

The objective of this prospective cohort study was to evaluate the therapeutic efficacy and safety of ultrasound-guided high-intensity focussed ultrasound (HIFU) in the treatment of uterine fibroids. Twenty premenopausal women with symptomatic fibroids underwent ultrasound-guided HIFU therapy. Twenty-two fibroids with a median baseline volume of 127.0 cm3 (range 18.5–481.2 cm3) were treated. The percentages fibroid volume reduction were 46.9 (range −8.8–73.1) at 1-month, 57.4 (−51.5–95.2) at 3-month, 60.1 (−18.9–97.8) at 6-month and 75.9 (−33.7–99.3) at 12-month, after treatment. The modified Uterine Fibroid Symptom and Quality of Life (UFS-QOL) scores were reduced by 40.7% (0–59.3%) at 3-month, 45.5% (0–70.4%) at 6-month and 44.9% (0–71.4%) at 12-month after treatment. Three patients required subsequent surgical interventions. No significant complications were encountered. Ultrasound-guided HIFU appears to be effective and safe for the treatment of symptomatic uterine fibroids in selected patients.Impact statementWhat is already known on this subject? Ultrasound-guided high-intensity focussed ultrasound (HIFU) is a relatively new uterine-sparing treatment for fibroids. Most clinical reports are from China, which suggest that this treatment is a safe and effective modality. However, in many other countries, HIFU treatment for fibroids, especially using ultrasound as image guidance, is still considered novel with limited clinical experience.What do the results of this study add? This preliminary report adds to our limited local experience on HIFU and provides reassurance on our continual utilisation of this treatment modality for fibroids. With the increasing demand of uterine-sparing alternatives, experiences shared among different countries are important to make this treatment modality generalisable and universally acceptable.What are the implications of these findings for clinical practice and/or further research?Ultrasound-guided HIFU (USgHIFU) can potential be offered as an alternative treatment modality for women with fibroids.

A retrospective study of ultrasound-guided high intensity focussed ultrasound ablation for multiple uterine fibroids in South Africa

Objective: To evaluate the shrinkage rate, symptom relief and improvement of the quality of life following ultrasound-guided high intensity focussed ultrasound (USgHIFU) for multiple uterine fibroids.Methods: From October 2015 to November 2016, 81 black women with multiple symptomatic fibroids underwent USgHIFU. The number of the fibroids ranged from 3 to 9. The shrinkage rate of fibroids, symptom severity score and quality of life were evaluated following USgHIFU. Magnetic resonance imaging (MRI), the uterine fibroid symptom and quality of life (UFS-QOL) questionnaire were used for evaluation.Results: The mean age of patients was 35.3 ± 5.9 years. The average weight of these patients was 68.4 ± 11.4 kg, with the median abdominal subcutaneous fat thickness of 38.0 ± 11.4 mm. The median fibroid volume was 36.0 (range: 1.8–1220.1) cm³. During HIFU, 60.5% of the patients reported lower abdominal pain, 43.2% sciatic/buttock pain, 60.5% skin “burning” sensation, 6.2% abnormal vaginal discharge and 13.6% transient leg pain. No severe complications were observed. The average volume reduction rate of fibroids in 21 patients who completed the follow-up was 32.5 ± 24.0, 42.3 ± 32.2 and 52.5 ± 36.3% 1, 3 and 6 months after HIFU, respectively. The UFS score decreased and the QOL values significantly increased during the follow-up period. Re-intervention treatment occurred in two of the 21 patients 6 months after HIFU. One patient conceived 3 months after HIFU, and she had a term vaginal delivery without any obstetrical complications.Conclusions: Based on our results, USgHIFU is safe and effective in treating patients with multiple uterine fibroids.

Translation and validation of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire for the Brazilian Portuguese language.

Uterine fibroids (UF), also known as leiomyomas, are the most prevalent gynecological tumors. The Uterine Fibroid Symptoms and Quality of Life (UFS-QOL) is the only specific questionnaire that assesses symptom intensity and quality-of-life issues for women with symptomatic UF; however, it only exists in the English language. Thus, we aimed to translate and culturally validate the UFS-QOL questionnaire for the Brazilian Portuguese language. Cross-sectional study, Department of Gynecology and Obstetrics, FMRP-USP. 113 patients with UF (case group) and 55 patients without UF (control group) were interviewed using the UFS-QOL questionnaire after translation and cultural adaptation. The Short Form-36 questionnaire was used as a control. Demographic and psychometric variables were analyzed. Women with UF presented higher mean age, body mass index, weight, parity and comorbidities than the control group (P < 0.05). The most prevalent complaints were abnormal uterine bleeding (93.8%), pelvic pain (36.3%) and extrinsic compression (10.6%) and these presented adequate construct validity regarding UFS-QOL severity (P < 0.05). The UFS-QOL questionnaire presented good internal consistency regarding symptom severity and quality-of-life-related domains (intraclass correlation coefficient, ICC = 0.82/0.88). Structural validity presented correlation coefficients ranging from 0.59 to 0.91. Test-retest comparison did not show differences among the UFS-QOL subscales. After treatment, women with UF presented improvements on all subscales. The UFS-QOL questionnaire presented adequate translation to the Brazilian Portuguese language, with good internal consistency, discriminant validity, construct validity, structural validity and responsiveness, along with adequate test-retest results.

Uterine artery embolization using progressively larger calibrated gelatin sponge particles

Purpose To assess the effectiveness and safety of uterine artery embolization (UAE) using progressively larger calibrated gelatin sponge particles for symptomatic uterine fibroids. Material and methods Thirty patients with symptomatic uterine fibroids underwent UAE. Calibrated gelatin sponge particles were used in all patients, beginning with 355-500 μm particles, progressively increasing to 500-710 μm and finally to 710-1000 μm particles. Changes in tumor, uterine volume, and tumor infarction rate were assessed using pelvic magnetic resonance imaging (MRI). The level of complication, improvement of clinical symptoms, and Uterine Fibroid Symptom and Quality of Life (UFS-QOL) score were assessed. Results MR imaging revealed the mean largest tumor volume reduction was 56.23 ± 16.25% at three months and 72.61 ± 14.47% at 12 months after the procedure. 100% infarction of the dominant fibroids was 91.27 ± 5.02% at three months and 96 ± 5.20% at 12 months after the procedure. Menorrhagia improved markedly in all 23 patients. Bulk-related symptoms improved in 12 (92.30%) of 13 patients. The baseline UFS-QOL score was 43.13 and improved to 11.88 (p < 0.001). No major complications were observed. Conclusion UAE using progressively larger calibrated gelatin sponge particles is an effective and safe treatment for symptomatic uterine fibroids.

Laparoscopic Myomectomy (LM) Versus Laparoscopic Radiofrequency Volumetric Thermal Ablation (RFVTA) of Symptomatic Myomas: A Randomized Trial of Uterine-Sparing Techniques

To compare RFVTA to LM in the treatment of symptomatic myomas in terms of pain medication use, time to return to normal activities and work, and responses to the validated Uterine Fibroid Symptom and Quality-of-Life (UFS-QOL) questionnaire.

Long-term fertility and bleeding outcomes after robotic, laparoscopic, and abdominal myomectomy

Multiple studies indicate improved short-term outcomes following minimally invasive myomectomy, such as postsurgical pain, blood loss, and length of hospitalization (1-5) However, it is unknown whether long-term outcomes such as fertility and bleeding patterns differ between different approaches to non-hysteroscopic myomectomy. The Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire is validated in assessing bleeding patterns and QOL indicators after myomectomy. Our objective is to determine whether long-term fertility outcomes or UFS-QOL scores differ between robotic, laparoscopic, and abdominal myomectomies.