The purpose of this research is to investigate if administration steroids (anti-inflammatory medication) via the uterine arteries during uterine fibroid embolization (A non surgical procedure for treating uterine fibroids by blocking their blood supply) can help reduce the pain, nausea, vomiting, and general feeling of weakness following the procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
42
Dexamethasone delivered to the uterine arterial bed, prior to embolization.
Saline delivered to the uterine arterial bed, prior to embolization.
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Pain Scores Using the VAS Questionnaire
Pain is measured using a modified Visual Analogue Score (VAS), which has a total score ranging from 0 (no pain at all) to 10 (worst pain).
Time frame: Day 7
Severity of Post-embolization Syndrome Symptoms
Post-Embolization Syndrome (PES) was evaluated using a dedicated PES survey. For nausea and vomiting, severity will be scored as follows: 0 - None 1. \- Mild nausea 2. \- Severe nausea requiring antiemetic medication 3. \- Vomiting A score of 0 represents no symptoms (least severe), while a score of 3 represents the most severe symptoms. The scoring range is 0 to 3.
Time frame: Day 7
Change in Symptoms
The Fibroid Symptom Score was assessed using the Uterine Fibroid Embolization (UFE) Quality of Life and Symptomatology Survey. This survey evaluates eight symptoms: 1. Degree of bleeding 2. Presence of clots 3. Variation in the duration of periods 4. Variation in the length of periods 5. Pelvic pain or pressure 6. Frequency of daytime urination 7. Frequency of nighttime urination 8. Fatigue Each symptom is scored from 1 to 5, with higher scores indicating more severe symptoms. The table below presents the mean change in score for each symptom after the intervention, compared to the pre-procedure score. Higher positive numbers indicate greater symptom improvement. In this table, the maximum possible change for an individual symptom is +4, and the minimum is -4.
Time frame: Baseline, 3 months
Change in Quality of Life
Change in participant quality of life was assessed using the Uterine Fibroid Embolization (UFE) Quality of Life and Symptomatology Survey with a total subsection score ranging from 0-6 with the highest score indicating the worst quality of life from fibroid symptoms and vice versa (6=Terrible and 0=Delighted).
Time frame: Baseline, 3 months
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