Uterine Fibroid Symptom-Quality Of Life Research Articles

Treatment Goals and Symptoms of Patients Presenting to a Center for Fibroid Care [ID 2683523

INTRODUCTION: Multidisciplinary fibroid centers represent a new model of fibroid care. We evaluated the goals and symptoms of patients presenting to our center. METHODS: This is a retrospective cohort study of patients presenting between June 2022 and June 2023. Patients were sent the Uterine Fibroid Symptom Quality of Life (UFS-QOL) survey and a goals questionnaire prior to first appointment. Patients who completed both were included. We obtained age, race, most recent hemoglobin level (Hgb), largest fibroid type on most recent imaging, composite symptom severity score (SS), and health-related QOL score (HRQL). This study met IRB exemption criteria. RESULTS: Of 581 patients, 326 (56%) completed both surveys. Mean age was 43.0 years (SD 8.0). Patients identified as Black (35.3%), White (24.8%), Asian (8.9%), and other/multiple race (7.7%). Most patients' largest fibroid was subserosal (37%), followed by intramural (28.7%), submucosal (5.9%), and combined type (28.3%). There was no difference in SS (P=.307) or HRQL (P=.504) between these groups. Most patients (60.7%) selected a top goal of symptom elimination, followed by treating anemia (21.2%) and becoming pregnant (18.1%). Almost a quarter (26.4%) reported difficulty conceiving, and they had higher SS (mean difference [MD] −6.1; 95% CI, −12.1, −0.6) and lower HRQL (MD 7.2; 95% CI, 0.4, 14.0). Patients with Hgb below 12 had higher SS (MD −8.6; 95% CI, −14.6, −2.7) and lower HRQL (MD 8.0; 95% CI, 1.1, 15.0). CONCLUSION: Most patients reported a primary goal of symptom elimination. Difficulty conceiving and low Hgb were associated with worse symptoms, yielding insight into treatment opportunities affecting QOL.

Efficacy and safety of transvaginal high-intensity focused ultrasound therapy in women with symptomatic uterine leiomyomas: A clinical trial

ObjectiveTo evaluate the efficacy and safety of transvaginal high-intensity focused ultrasound (vHIFU) therapy in women with symptomatic uterine leiomyomas. MethodsThis first-in-human, two-center, prospective, unblinded, single-arm trial was performed in the Republic of Korea from December 2017 to February 2019. Premenopausal women with symptomatic, contrast-enhanced uterine leiomyomas with a diameter ≤5 cm were eligible. Under sedation or monitored anesthesia, leiomyomas were ablated with vHIFU under ultrasound guidance. The primary endpoint was the non-perfused volume (NPV) ratio measured immediately after therapy. Secondary endpoints were changes in Uterine Fibroid Symptom-Quality of Life (UFS-QOL) scores, dysmenorrhea visual analog scale (VAS), uterine leiomyoma volume, rate of subsequent therapy, and treatment-emergent adverse events (TEAE). ResultsThirty-five women were screened; 13 women were enrolled and underwent vHIFU therapy for 33 uterine leiomyomas. NPV ratios were 0.76 ± 0.27 (mean ± SD); the lower limit of a one-sided 97.5 % confidence interval was 0.67, surpassing the non-inferiority cut-off of 0.50. UFS-QOL scores (symptom severity score, median, baseline: 66.60, 3-month follow-up: 32.85; p = 0.0010; health related quality of life score, median, baseline: 41.40, 3-month follow-up: 73.30; p = 0.0010) and dysmenorrhea VAS (mean, baseline: 50.92, 3-month follow-up: 20.67; p = 0.0019) improved significantly. Volume of uterine leiomyoma was reduced (median, baseline: 8.10 cm3, 3-month follow=-up: 5.30 cm3; p < 0.0001), and none received subsequent therapy. Twenty-six TEAEs from 8 participants were observed, and all TEAEs were resolved without sequelae. ConclusionvHIFU therapy exhibited promising efficacy and safety and might be considered as a treatment option for women with symptomatic uterine leiomyomas.Registration: This trial was registered at: www.clinicaltrial.gov (NCT03328260)

Quality of Life Outcomes in Treatments for Symptomatic Uterine Fibroids: A Systematic Literature Review

Study Objective To conduct systematic literature review (SLR) on quality of life (QoL) outcomes of treatments for symptomatic uterine fibroids (UF). Design A systematic review was conducted using MEDLINE, Embase, PubMed and Google Scholar to identify studies published since database inception and May 1, 2020. Prospective and retrospective studies with at least ten patients were considered eligible if they included treatment of symptomatic UF patients and reported QoL measures using the uterine fibroid symptom quality of life (UFS-QoL) questionnaire. The baseline, post baseline and change from baseline (CFB) UFS-QoL scores for overall and subscales were extracted for each time point reported in the study. Setting N/A Patients or Participants N/A Interventions N/A Measurements and Main Results Of 746 search results, 64 references for 60 studies were included: 42 prospective studies, 9 retrospective studies, 3 post hoc analyses and 6 other studies. A total of 8,047 patients were included, with a median study size of 66 patients. The baseline and post-baseline median health-related quality of life (HRQoL) scores were 46.6 and 82.0, respectively (Mean scores were 49.8 and 82.4 respectively). The median improvement in HRQoL score was 34.2 (Mean 31.8, N=7,261 pts). The baseline and post-baseline median symptom severity scores (SSS) were 55.9 and 22.3, respectively (Mean scores were 54.0 and 21.3 respectively). The median improvement in SSS was -32.6 (Mean -31.7, N=7,380 patients). Similar range of improvements were observed for other subscales of UFS-QoL. Conclusion To our knowledge, this study is one of the first and the most comprehensive systematic review on quality of life outcomes of treatments for symptomatic UF patients. An on-going meta-analysis is warranted to provide a more quantitative overview of QoL outcomes.

Uterine Fibroid Symptom - Quality of Life questionnaire translation and validation into Brazilian Portuguese.

Purpose To translate into Portuguese, culturally adapt and validate the Uterine Fibroid Symptom - Quality of Life (UFS-QoL) questionnaire for Brazilian women with uterine leiomyoma. Methods Initially, the UFS-QoL questionnaire was translated into Brazilian Portuguese in accordance with international standards, with subsequent cultural, structural, conceptual and semantic adaptations, so that patients were able to properly answer the questionnaire. Fifty patients with uterine leiomyoma and 19 patients without the disease, confirmed by abdominal pelvic examination and/or transvaginal ultrasound, were selected at the outpatient clinics of the Department of Gynecology of the Universidade Federal de São Paulo (Unifesp). The UFS-QoL questionnaire was administered to all women twice on the same day, with two different interviewers, with an interval of 15 minutes between interviews. After 15 days, the questionnaire was re-administered by the first interviewer. Reliability (internal consistency and test-retest), construct and discriminative validity were tested to ratify the questionnaire. Results The reliability of the instrument was assessed by Cronbach's α coefficient with an overall result of 0.97, indicating high reliability. The survey results showed a high correlation (p = 0.94; p ≤ 0.001). Conclusion The UFS-QoL questionnaire was successfully adapted to the Brazilian Portuguese language and Brazilian culture, showing reliability and validity.

The FAST-EU trial: 12-month clinical outcomes of women after intrauterine sonography-guided transcervical radiofrequency ablation of uterine fibroids.

The FAST-EU Trial was designed to establish the effectiveness and confirm the safety of transcervical intrauterine sonography-guided radiofrequency ablation with the VizAblate™ System in the treatment of symptomatic uterine fibroids. This was a multicenter, prospective, single-arm trial involving academic and community hospitals in the United Kingdom, the Netherlands, and Mexico. Women with qualifying uterine fibroids and heavy menstrual bleeding underwent intrauterine sonography-guided transcervical radiofrequency ablation (RFA) with the VizAblate System; anesthesia was individualized. Patients were required to have up to five fibroids from 1 to 5 cm in diameter. The primary trial endpoint was the percentage change in perfused fibroid volume, as assessed by contrast-enhanced MRI at 3 months by an independent core laboratory. Secondary endpoints, evaluated at 6 and 12 months, included safety, percentage reductions in the Menstrual Pictogram (MP) score, and the Symptom Severity Score (SSS) subscale of the Uterine Fibroid Symptom-Quality of Life (UFS-QOL) questionnaire, along with the rate of surgical reintervention for abnormal uterine bleeding and the mean number of days to return to normal activity. Additional assessments included the Health-Related Quality of Life (HRQOL) subscale of the UFS-QOL, nonsurgical reintervention for abnormal uterine bleeding, anesthesia regimen, patient satisfaction, and pain during the recovery period. An additional MRI study was performed at 12 months on a subgroup of patients. Fifty patients (89 fibroids) underwent transcervical radiofrequency ablation with the VizAblate System. At 3 and 12 months, perfused fibroid volumes were reduced from baseline by an average of 68.1 ± 28.6 and 67.4 ± 31.9 %, respectively, while total fibroid volumes were reduced from baseline by an average of 54.7 ± 37.4 and 66.6 ± 32.1 %, respectively (all P < .001 compared with baseline; Wilcoxon signed-rank test). At 12 months, mean MP score and SSS decreased by 53.8 ± 50.5 and 55.1 ± 41.0 %, respectively; the mean HRQOL score increased by 277 ± 483 %. There were four surgical reinterventions (8 %) within 12 months. This is the first report of the 12-month follow-up for patients in the FAST-EU Trial. In concert with previously reported 3- and 6-month endpoint data, the 12-month results of the FAST-EU Trial suggest that in addition to substantially reducing the perfused and total volume of targeted uterine fibroids, the VizAblate System is safe and effective through 12 months in providing relief of abnormal uterine bleeding associated with submucous, intramural, and transmural fibroids.

Twelve-Month Outcomes for Patients Undergoing Hysteroscopic Morcellation of Uterine Polyps and Myomas in an Office or Ambulatory Surgical Center

Study ObjectiveTo examine efficacy of hysteroscopic removal of polyps and myomas on health-related quality of life and symptom severity at 1-year postprocedure. DesignRandomized, prospective, comparative setting clinical trial (Canadian Task Force classification II-2). SettingNine outpatient obstetrics and gynecology practices and hospitals in the United States. PatientsWomen 18 to 55 years of age with polyps and/or type 0 or I myomas ≥1.5 and ≤3.0 cm. InterventionsTreatment of polyps and fibroids with the MyoSure device. Measurements and Main ResultsA total of 118 lesions (76 polyps, 42 myomas) were removed. Among the 118 pathologies removed, 53 were removed in an office setting (28 myomas, 25 polyps), and 55 were removed in an ambulatory surgical center (ASC) setting (14 myomas, 41 polyps). The mean percentage of pathology removed was 95.9 ± 6.8% for fibroids and 99.9 ± 0.7% for polyps. Symptom severity as measured by the Uterine Fibroid Symptom-Quality of Life (UFS-QOL) scale improved significantly (p < .01) between baseline (mean score of 67.5 ± 15.4) and 12 months postprocedure (mean score of 22.3 ± 22.6). The Health-Related Quality of Life (HRQOL) scale also improved significantly (p < .01) between baseline (mean score 38.7 ± 23.3) and 12 months postprocedure (mean score of 83.9 ± 24.4). Both the office and ASC groups demonstrated a statistically significant (p < .01) improvement in UFS-QOL and HRQOL. ConclusionFor women with intrauterine polyps and/or myomas who experienced abnormal uterine bleeding, hysteroscopic morcellation with the MyoSure device provided significant, durable health-related, quality-of-life improvements up to 12 months postprocedure. These findings were the same for patients treated in both an office-based setting and ASCs.