A simple shot of dexamethasone delivered straight to the uterus could solve the biggest drawback of nonsurgical fibroid treatment: pain following the procedure.

Although uterine fibroid embolization (UFE) offers a minimally invasive alternative to hysterectomy, acute pain after the procedure has limited widespread adoption. A new randomized study suggests a straightforward fix: injecting a corticosteroid through the existing catheter reduced pain at greater levels for up to 96 hours compared to placebo.

“One of the biggest limitations of fibroid embolization is the post-procedural pain,” which occurs even with the use of medicines such as ketorolac, said Prasoon Mohan, MD, medical director of the Florida Interventional Institute in Hollywood, Florida, and an author of the study. “If we can control that pain, that essentially will lead to better patient experience, and eventually more adoption of this nonsurgical, minimally invasive fibroid treatment.”

Uterine fibroids, noncancerous tumors that develop in the uterus, are estimated to occur in over 70% of women by onset of menopause, with approximately 25% experiencing severe symptoms, such as abnormal uterine bleeding and pelvic pain.

Hysterectomy is the definitive treatment but is associated with surgical risks, including excessive bleeding, infection, and loss of fertility. Myomectomy, the removal of individual fibroids, is another surgical option that preserves the uterus.

UFE is among nonsurgical minimally invasive procedures involving injection of small particles into the arteries, which decrease the flow of blood to the uterus, causing fibroids to shrink. Intra-arterial drug delivery has been used in the treatment of diseases such as liver cancer and retinoblastoma.

The use of UFE is limited due to postembolization syndrome, which includes symptoms of pelvic pain, cramping, low-grade fever, and nausea. One study found utilization of UFE was 3.5% compared with hysterectomy (73.4%) and myomectomy (23.1%).

The randomized, double-blind, placebo-controlled clinical trial included 40 women aged 20 to 50 years undergoing UFE at the University of Miami Health System between 2020 and 2023. Following embolization, half received dexamethasone via the femoral artery through a microcatheter while the remaining received a placebo. Women who were pregnant, had diabetes, took a daily steroid, or were attempting to conceive were excluded.

Prior to UFE, all study participants received acetaminophen, ibuprofen, and omeprazole. Following the procedure, they were admitted for observation overnight and received inpatient 30 mg intravenous (IV) ketorolac, as-needed 4 mg IV ondansetron, and 650 mg acetaminophen every 6 hours and 0.2 mg patient-controlled hydromorphone every 10 minutes.

After discharge, patients also took 650 mg acetaminophen and 800 mg ibuprofen orally every 6 hours, 4 mg sublingual ondansetron and 5 mg oxycodone/325 mg acetaminophen every 6 hours as needed, and 100 mg docusate sodium every 12 hours.

Participants assigned their level of pain with scores ranging from 0 to 10. The dexamethasone group had significantly lower mean scores immediately following the procedure (4.0 vs 6.1; P = .04) and through 96 hours (2.4 vs 4.5; P = .02) than the placebo group. The lower pain score among the intervention group was not statistically significant at day 7.

“The magnitude and the duration of the pain control exceeded our expectations,” Mohan said.

Secondary outcomes included symptoms of postembolization syndrome and health-related quality of life, assessed using the UFE-Quality of Life questionnaire at baseline and at 1 and 3 months. Both treatment groups demonstrated significant improvement across all symptom domains at follow-up.

Before the procedure and at the 3-month postprocedure follow-up, MRI imaging was obtained in 26 of the 40 participants. At the 3-month follow-up, the mean uterine volume decreased 37.4% in the dexamethasone group and 29.6% in the placebo group. Both groups demonstrated comparable UFE efficacy.

Mohan said the administration of dexamethasone via catheter is simple, effective, and an “inexpensive way to control the pain and…you already have a small catheter going to the uterine artery.”

Taraneh Shirazian, MD, a gynecologic surgeon and director of the Center for Fibroid Care at NYU Langone Health in New York City, said any new modality that helps patients’ pain is progress.

The question is “how much is the dexamethasone helping patients mobilize and go home or achieve whatever outcome measure would be really helpful to a patient?” she said. “It seems like if there was some standard protocol that every institution was using and then you added this to it, and it really helped patients feel better faster and go home sooner, that could be really valuable.”

The American College of Obstetrics and Gynecologists’ guidelines on management of symptomatic uterine fibroids recommends UFE for patients who desire uterine preservation and are counseled about the limited available data on its effects on fertility and future pregnancy. They note rates of reintervention from regrowth of fibroids as high as 38% have been reported up to 5 years after UFE. Issued in 2021, the guidelines were reaffirmed last year.

Shirazian, a member of the committee that wrote the guidelines, said patients who are closer to menopause, do not want to bear children, and do not have a lot of fibroids, are good candidates for UFE.

Mohan reported no financial conflicts. Shirazian reported being a consultant for Sumitomo Pharma, Hologic, and Channel Medsystems.

Brenda Sandburg is a freelance journalist for Medscape Medical News. She has written about the biopharmaceutical industry and legal issues for the Pink Sheet and American Lawyer Media.