Leiomyoma
Conditions
Keywords
Fibroids, Leiomyoma, post-embolization pain, dexamethasone
Brief summary
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.
Interventions
DRUGDexamethasone
Dexamethasone delivered to the uterine arterial bed, prior to embolization.
DRUGSaline
Saline delivered to the uterine arterial bed, prior to embolization.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Women who meet criteria to undergo uterine fibroid embolization for symptomatic fibroids.
Exclusion criteria
* Currently pregnant or actively attempting to conceive * Those deemed mentally impaired to make their own medical decisions * Previous documented allergy to dexamethasone * Those currently taking daily steroids for any reason * Those with diabetes or deemed to be pre-diabetic * Those with contraindications for angiography * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores Using the VAS Questionnaire | Day 7 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Post-embolization Syndrome Symptoms | Day 7 | 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. |
| Change in Symptoms | Baseline, 3 months | 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. |
| Change in Quality of Life | Baseline, 3 months | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexamethasone Arm A total of 5mg dexamethasone will be administered into each uterine artery (10mg total) prior to uterine artery embolization.
Dexamethasone: Dexamethasone delivered to the uterine arterial bed, prior to embolization. | 21 |
| Saline Arm A volume of normal saline, equal to the total volume delivered in the Dexamethasone Arm, will be administered into each uterine artery prior to uterine artery embolization.
Saline: Saline delivered to the uterine arterial bed, prior to embolization. | 21 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Consumed THC | 1 | 0 |
| Overall Study | Unilateral embolization | 0 | 1 |
Baseline characteristics
| Characteristic | Dexamethasone Arm | Saline Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 21 Participants | 42 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 9 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 8 Participants | 15 Participants |
| Race (NIH/OMB) White | 7 Participants | 4 Participants | 11 Participants |
| Sex: Female, Male Female | 21 Participants | 21 Participants | 42 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 21 |
| other Total, other adverse events | 1 / 21 | 1 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexamethasone Arm | Pain Scores Using the VAS Questionnaire | Immediate | 4 score on a scale | Standard Deviation 3.2 |
| Dexamethasone Arm | Pain Scores Using the VAS Questionnaire | 12 Hours | 4.3 score on a scale | Standard Deviation 3.3 |
| Dexamethasone Arm | Pain Scores Using the VAS Questionnaire | 2 Hours | 5.45 score on a scale | Standard Deviation 2.9 |
| Dexamethasone Arm | Pain Scores Using the VAS Questionnaire | 24 Hours | 2.5 score on a scale | Standard Deviation 2.4 |
| Dexamethasone Arm | Pain Scores Using the VAS Questionnaire | 3 Hours | 5 score on a scale | Standard Deviation 2.8 |
| Dexamethasone Arm | Pain Scores Using the VAS Questionnaire | 48 Hours | 2.7 score on a scale | Standard Deviation 3.2 |
| Dexamethasone Arm | Pain Scores Using the VAS Questionnaire | Preprocedural | 0.8 score on a scale | Standard Deviation 1.5 |
| Dexamethasone Arm | Pain Scores Using the VAS Questionnaire | 72 Hours | 3.42 score on a scale | Standard Deviation 2.9 |
| Dexamethasone Arm | Pain Scores Using the VAS Questionnaire | 6 Hours | 4.6 score on a scale | Standard Deviation 2.5 |
| Dexamethasone Arm | Pain Scores Using the VAS Questionnaire | 96 Hours | 2.35 score on a scale | Standard Deviation 2.4 |
| Dexamethasone Arm | Pain Scores Using the VAS Questionnaire | 1 Hour | 6 score on a scale | Standard Deviation 3.3 |
| Dexamethasone Arm | Pain Scores Using the VAS Questionnaire | 168 Hours | 1.7 score on a scale | Standard Deviation 2.6 |
| Dexamethasone Arm | Pain Scores Using the VAS Questionnaire | 9 Hours | 4.4 score on a scale | Standard Deviation 3 |
| Saline Arm | Pain Scores Using the VAS Questionnaire | 168 Hours | 2.9 score on a scale | Standard Deviation 2.4 |
| Saline Arm | Pain Scores Using the VAS Questionnaire | Preprocedural | 1.3 score on a scale | Standard Deviation 2.1 |
| Saline Arm | Pain Scores Using the VAS Questionnaire | Immediate | 6.1 score on a scale | Standard Deviation 3.1 |
| Saline Arm | Pain Scores Using the VAS Questionnaire | 1 Hour | 6.3 score on a scale | Standard Deviation 3.2 |
| Saline Arm | Pain Scores Using the VAS Questionnaire | 3 Hours | 4.9 score on a scale | Standard Deviation 3.2 |
| Saline Arm | Pain Scores Using the VAS Questionnaire | 6 Hours | 5.9 score on a scale | Standard Deviation 3.2 |
| Saline Arm | Pain Scores Using the VAS Questionnaire | 9 Hours | 5.9 score on a scale | Standard Deviation 2.9 |
| Saline Arm | Pain Scores Using the VAS Questionnaire | 12 Hours | 4.5 score on a scale | Standard Deviation 3.2 |
| Saline Arm | Pain Scores Using the VAS Questionnaire | 24 Hours | 4.2 score on a scale | Standard Deviation 2.9 |
| Saline Arm | Pain Scores Using the VAS Questionnaire | 48 Hours | 5.1 score on a scale | Standard Deviation 3 |
| Saline Arm | Pain Scores Using the VAS Questionnaire | 72 Hours | 4.7 score on a scale | Standard Deviation 3 |
| Saline Arm | Pain Scores Using the VAS Questionnaire | 96 Hours | 4.5 score on a scale | Standard Deviation 3.2 |
| Saline Arm | Pain Scores Using the VAS Questionnaire | 2 Hours | 5.8 score on a scale | Standard Deviation 3.1 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexamethasone Arm | Change in Quality of Life | Baseline | 5.2 score on a scale | Standard Deviation 1.4 |
| Dexamethasone Arm | Change in Quality of Life | 3 Month | 2.5 score on a scale | Standard Deviation 2 |
| Saline Arm | Change in Quality of Life | Baseline | 5.5 score on a scale | Standard Deviation 1 |
| Saline Arm | Change in Quality of Life | 3 Month | 1.3 score on a scale | Standard Deviation 1.8 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexamethasone Arm | Change in Symptoms | Bleeding | 2.4 score on a scale | Standard Deviation 1.5 |
| Dexamethasone Arm | Change in Symptoms | Clots | 1.7 score on a scale | Standard Deviation 1.3 |
| Dexamethasone Arm | Change in Symptoms | Fluctuation | 1.9 score on a scale | Standard Deviation 1.2 |
| Dexamethasone Arm | Change in Symptoms | Length | 1.6 score on a scale | Standard Deviation 1.1 |
| Dexamethasone Arm | Change in Symptoms | Pain | 1.8 score on a scale | Standard Deviation 1.2 |
| Dexamethasone Arm | Change in Symptoms | Polyuria | 2.3 score on a scale | Standard Deviation 1.5 |
| Dexamethasone Arm | Change in Symptoms | Nocturia | 2.3 score on a scale | Standard Deviation 1.6 |
| Dexamethasone Arm | Change in Symptoms | Fatigue | 2.5 score on a scale | Standard Deviation 1.4 |
| Saline Arm | Change in Symptoms | Fatigue | 1.9 score on a scale | Standard Deviation 1.4 |
| Saline Arm | Change in Symptoms | Bleeding | 2.3 score on a scale | Standard Deviation 1.4 |
| Saline Arm | Change in Symptoms | Pain | 2.0 score on a scale | Standard Deviation 1.2 |
| Saline Arm | Change in Symptoms | Clots | 1.8 score on a scale | Standard Deviation 0.91 |
| Saline Arm | Change in Symptoms | Nocturia | 2.1 score on a scale | Standard Deviation 1.5 |
| Saline Arm | Change in Symptoms | Fluctuation | 1.9 score on a scale | Standard Deviation 1.1 |
| Saline Arm | Change in Symptoms | Polyuria | 2.2 score on a scale | Standard Deviation 1.5 |
| Saline Arm | Change in Symptoms | Length | 1.9 score on a scale | Standard Deviation 1.1 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexamethasone Arm | Severity of Post-embolization Syndrome Symptoms | 1 Hour | 0.3 score on a scale | Standard Deviation 0.8 |
| Dexamethasone Arm | Severity of Post-embolization Syndrome Symptoms | 12 Hour | 0.6 score on a scale | Standard Deviation 0.9 |
| Dexamethasone Arm | Severity of Post-embolization Syndrome Symptoms | 3 Hour | 0.4 score on a scale | Standard Deviation 0.8 |
| Dexamethasone Arm | Severity of Post-embolization Syndrome Symptoms | 24 Hour | 0 score on a scale | Standard Deviation 0 |
| Dexamethasone Arm | Severity of Post-embolization Syndrome Symptoms | Immediate Postprocedural | 0.1 score on a scale | Standard Deviation 0.3 |
| Dexamethasone Arm | Severity of Post-embolization Syndrome Symptoms | 48 Hour | 0.2 score on a scale | Standard Deviation 0.4 |
| Dexamethasone Arm | Severity of Post-embolization Syndrome Symptoms | 6 Hour | 0.7 score on a scale | Standard Deviation 1 |
| Dexamethasone Arm | Severity of Post-embolization Syndrome Symptoms | 72 Hour | 0.3 score on a scale | Standard Deviation 0.7 |
| Dexamethasone Arm | Severity of Post-embolization Syndrome Symptoms | 2 Hour | 0.4 score on a scale | Standard Deviation 0.8 |
| Dexamethasone Arm | Severity of Post-embolization Syndrome Symptoms | 96 Hour | 0.1 score on a scale | Standard Deviation 0.4 |
| Dexamethasone Arm | Severity of Post-embolization Syndrome Symptoms | 9 Hour | 0.8 score on a scale | Standard Deviation 1.2 |
| Dexamethasone Arm | Severity of Post-embolization Syndrome Symptoms | 168 Hour | 0.2 score on a scale | Standard Deviation 0.5 |
| Dexamethasone Arm | Severity of Post-embolization Syndrome Symptoms | Preprocedural | 0 score on a scale | Standard Deviation 0 |
| Saline Arm | Severity of Post-embolization Syndrome Symptoms | 168 Hour | 0.1 score on a scale | Standard Deviation 0.2 |
| Saline Arm | Severity of Post-embolization Syndrome Symptoms | Preprocedural | 0 score on a scale | Standard Deviation 0 |
| Saline Arm | Severity of Post-embolization Syndrome Symptoms | Immediate Postprocedural | 0.2 score on a scale | Standard Deviation 0.5 |
| Saline Arm | Severity of Post-embolization Syndrome Symptoms | 1 Hour | 0.4 score on a scale | Standard Deviation 0.7 |
| Saline Arm | Severity of Post-embolization Syndrome Symptoms | 2 Hour | 0.5 score on a scale | Standard Deviation 0.8 |
| Saline Arm | Severity of Post-embolization Syndrome Symptoms | 3 Hour | 0.6 score on a scale | Standard Deviation 1 |
| Saline Arm | Severity of Post-embolization Syndrome Symptoms | 6 Hour | 1.1 score on a scale | Standard Deviation 1.2 |
| Saline Arm | Severity of Post-embolization Syndrome Symptoms | 9 Hour | 1 score on a scale | Standard Deviation 1.2 |
| Saline Arm | Severity of Post-embolization Syndrome Symptoms | 12 Hour | 0.4 score on a scale | Standard Deviation 0.6 |
| Saline Arm | Severity of Post-embolization Syndrome Symptoms | 24 Hour | 0.2 score on a scale | Standard Deviation 0.5 |
| Saline Arm | Severity of Post-embolization Syndrome Symptoms | 48 Hour | 0.4 score on a scale | Standard Deviation 0.7 |
| Saline Arm | Severity of Post-embolization Syndrome Symptoms | 72 Hour | 0.8 score on a scale | Standard Deviation 1.1 |
| Saline Arm | Severity of Post-embolization Syndrome Symptoms | 96 Hour | 0.4 score on a scale | Standard Deviation 0.7 |