The Burden of Pain Symptoms in Individuals with Uterine Fibroids-Results from a Prospective Observational Study in the USA.

Purpose: To characterize the burden of uterine fibroids (UF) in individuals experiencing heavy menstrual bleeding (HMB) and moderate-to-severe UF-associated pain in terms of symptoms experienced, impact on work and activities, and pain medication use both on menstrual and non-menstrual days.

Patients and methods: This prospective, real-world, observational study enrolled 350 participants in the USA with a self-reported UF diagnosis, HMB, and moderate-to-severe pain due to UF. Data collection took place from February 9 to July 19, 2021. Over 4 months, participants used an online platform to self-report daily menstrual status, bleeding intensity, UF-associated pain severity, and pain medication use, and to complete weekly work and productivity questionnaires. Results were analyzed descriptively and are reported for the overall population, by pain medication subgroups-defined based on the most potent medication taken-and menstrual versus non-menstrual days/weeks.

Results: The analysis population consisted of 307 participants with ≤5 consecutive missing days of daily survey responses or ≥75% completion rate of the daily surveys. Mean age of participants (standard deviation; SD) was 37.2 (6.3) years. At baseline, 54.1% of participants reported not currently taking medication for treatment of HMB. Over the study period, mean UF-associated pain scores (SD; scale range 0-10) were higher on menstrual days (3.5 [2.7]) than non-menstrual days (1.0 [1.8]), and this was consistent across medication use subgroups. Pain medications were used more frequently on menstrual days than non-menstrual days (22.9% versus 3.7% days of pain medication use, respectively). Participants reported 31.5% work impairment on menstrual weeks versus a 12.7% work impairment on non-menstrual weeks.

Conclusion: In this study, UF-associated pain symptoms coincided with a reduction in individuals' ability to take part in both work and non-work activities and an increase in pain medication use, particularly during menstrual weeks. These results highlight the need for improved diagnosis and pain management strategies in UF.