Long Term Effectiveness of Uterine Sparing Fibroid Treatments

NIH RePORTER · NIH · R01 · $592,123 · view on reporter.nih.gov ↗

Abstract

The lifetime cumulative incidence of uterine leiomyomas (fibroids or UF) is >80% among Black women and ~70% in White women. UF are the most common reason for hysterectomy in the U.S. and can cause heavy menstrual bleeding requiring blood transfusion(s), pelvic pain, urinary and bowel problems, infertility, and substantial impairment of quality of life (QOL). While alternatives to hysterectomy are available including myomectomy (fibroid removal), uterine artery embolization (UAE), endometrial ablation (EA), and radiofrequency ablation (RFA), there are significant knowledge gaps that preclude the development of evidence-based clinical guidelines to select an appropriate UF treatment. Prior studies of UF treatments have several key deficits including limited follow-up time (<2 years) and failure to assess important confounders, such as pre-procedure fibroid characteristics, baseline QOL, and pregnancy intention. Two multisite registries with harmonized data, COMPARE-UF (Myomectomy, EA and UAE patients) and ULTRA (RFA patients), have the capacity to address critical evidence gaps and significantly improve care for women with UF. This project will be led by COMPARE-UF/ULTRA investigators (MPIs) and extend the follow-up of 700 COMPARE-UF and ULTRA participants who have had a uterine-sparing fibroid treatment for up to 10 years after the index procedure. Long term follow-up through menopause is critical to assess the durability of symptom improvement and the rates of hysterectomy or other uterine procedures following the index treatment. Currently, women in COMPARE-UF/ULTRA are followed only for 1-3 years post treatment; the additional follow-up in this proposal, will have a major impact on clinical decision-making, provide relevant data in a racially diverse (>40% Black) population, and include detailed imaging information (UF size, number and location), and self-reported desire for future fertility obtained prior to the index fibroid treatment. Among women who have undergone one of four uterine-sparing procedures (myomectomy, EA, UAE and RFA), validated questionnaires from pre-procedure will be repeated annually up to 10 years post-procedure, to achieve the following: Aim 1: Compare changes in fibroid symptoms and quality of life from pre-procedure up to 10 years post-procedure among four uterine-sparing procedures: myomectomy, EA, UAE, and RFA. Aim 2: Compare the rate of and time until treatment failure up to 10 years after the index treatment among participants who had myomectomy, EA, UAE, and RFA. Aim 3: Identify baseline factors that predict clinical effectiveness after myomectomy, EA, UAE, and RFA and with patient and provider input, create a clinical prediction tool (Fibroid Treatment Calculator) that supports informed decision-making. Our preliminary data demonstrate ongoing active engagement of these participants. This project is a time-limited opportunity that uses two well-designed longitudinal cohorts with comprehensive baseline informatio...

Key facts

NIH application ID
10916217
Project number
5R01HD109127-02
Recipient
HENRY FORD HEALTH SYSTEM
Principal Investigator
Vanessa Jacoby
Activity code
R01
Funding institute
NIH
Fiscal year
2024
Award amount
$592,123
Award type
5
Project period
2023-09-01 → 2027-08-31