Intra-Arterial Dexamethasone for the Alleviation of Pain and Postembolization Syndrome Following Uterine Artery Embolization
Phase: PHASE3
Conditions: Leiomyoma
Sponsor: University of Miami

IRB Study Number:
Version: 05282020  
Date: 05/28/2020
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Intra-Arterial Dexamethasone for the Alleviation 
of Pain and Postembolization Syndrome 
Following Uterine Artery Embolization
VERSION #
V09122023
VERSION DATE
09/12/2023
NCT#
NCT04655144
PRINCIPAL INVESTIGATOR (PI)
Prasoon Mohan, MD, 
Associate Professor of Interventional 
Radiology
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Confidentiality Statement: The information contained in this document, especially unpublished 
data, is confidential property.  The information in this document may not be disclosed to others 
unless federal or state law or regulations require such disclosure.  Subject to the foregoing, this 
information may be disclosed only to those persons involved in the study who have a need to know, 
with the obligation not to further disseminate this information.   
TABLE OF CONTENTS 
Contact Information………………………………………………………………...…...3
Investigator Agreement………………………………………………………………….4
Protocol Revision History……………………………………………………………….4
Protocol Synopsis..………………………………………………………...……… ……5
Objectives………………………………………..…………………………..…………..7
Background…………………………………………………………………..…………..7
Inclusion and Exclusion Criteria………………………………………………….…….10
Number of Subjects…………………………………………………………………..…10
Study-Wide Recruitment Methods…………………………………………………...…10
Study Timelines………….…………………………………………………………...…11
Study Endpoints…………………………………………………………………………11
Procedures Involved……………….……………………………………………………12
Data and Specimen Banking………………………………………………………….…15
Data Management……………………………………………………………….………15
Provisions to Monitor the Data to Ensure the Safety of Subjects………………….……16
Withdrawal of Subjects……………………………………………………………...…..17
Risks to Subjects……………………………………………………………………...…17
Potential Benefits to Subjects…………………………………………..………….……18
Vulnerable Populations………………………………..……………………………...…18
Multi-Site Research………………………………………………………………….…..18
Community Based Participatory Research………………………………………………18
Sharing of Results with Subjects………………………………………………...………18
Setting……………………………………………………………………………………18
Resources Available………………………………………………………………..……19
Prior Approvals…………………………..………………………………………………20
Recruitment Methods………………………………………………………….…………20
Local Number of Subjects……………………………………………………………..…21
Confidentiality……………………………………………………………………………21
Provisions to Protect the Privacy Interests of Subjects……………………………….….22
Compensation for Research-Related Injury……………………………………………...22
Economic Burden to Subjects…………………………………………………………....22
Consent Process……………………………………………..……………………...……22
Process to Document Consent in Writing…………………………..……………………23
Authorization for Use and Disclosure of Protected Health Information……………...….23
Drugs or Devices………………………………………………………………..………..24
References……………………………………...……………………………..……….…25
Appendix:
a.
Consent Form
b.
Pain and PES Survey
c.
QOL Survey  
d.
General Trial Protocol                                                                    
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2.
CONTACT INFORMATION
PRINCIPAL INVESTIGATOR
Prasoon Mohan, MD, MRCS (Eng.)
Associate Professor of Interventional 
Radiology
Address: 1475 NW 12 Ave Miami, FL 
33136
Telephone: 305-243- 2067
Email: pxp136@med.miami.edu 
CLINICAL RESEARCH COORDINATOR
Lia Quezada
Clinical Research Coordinator
Telephone: 305-243-2210
Email: lquezada@med.miami.edu  
*Primary study contact
Co-INVESTIGATORS(S) 
Ira Karmin, MD
Asst. Professor, Obstetrics and Gynecology
Shivank Bhatia, MD
Chairman, Department of Interventional 
Radiology (IR)
Issam Kably, MD
Associate Professor, IR
Zoe Miller, MD 
Asst. Professor, IR
Shree Venkat, MD
Asst. Professor, IR
Andres, Krauthamer, MD
Asst. Professor, IR
Kenneth Briley, MD, PhD
PGY2 IR/DR Resident
Elvira A. Allakhverdieva, MD
PGY2 Radiology resident
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BIOSTATISTICIAN
Yalda Zarnegarnia, PhD.
Division of biostatistics,
Miller School of Medicine
Telephone: 305-972- 1841
Email: yzarnegarnia@miami.edu
CLINICAL TRIAL MANAGEMENT
Ricardo Aleman
Director, Research Support
Telephone: 305-243-6053
Email: rla90@miami.edu 
FUNDING SOURCE
Internal funding from the Department of 
Vascular and Interventional Radiology 
+
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3.
INVESTIGATOR AGREEMENT
I confirm that I have read this protocol, I understand it, and I will work according to this protocol 
and to the ethical principles stated in the latest version of the Declaration of Helsinki, the applicable 
ICH guidelines for good clinical practices, and the applicable federal, state, and local laws, rules, 
and regulations relating to the conduct of the protocol.  
I have read and understand the information in the Investigators’ Brochure (and/or other such 
pertinent safety information) regarding the risks and potential benefits.  
I agree to inform all those who assist/collaborate with me in the conduct of this study of their 
responsibilities and obligations. 
Once the protocol has been reviewed and approved by the Institutional Review Board (IRB) I 
understand that any change(s) made during the course of the study must also (first) be approved 
by the IRB prior to implementation, except when such modification is made to remove any 
immediate hazard(s) to the subject(s).  
I certify that I and the study staff responsible have received the requisite training to conduct this 
research protocol.  
I agree to maintain adequate and accurate records in accordance with the University of Miami 
policies, federal, state and local laws and regulations.  
I agree to maintain the confidentiality of all information received and/or developed in connection 
with this protocol.
eProst Number:
Protocol Version Number: 09122023
Protocol Version Date: 09/12/2023
Signature of Investigator:
Date: 09/12/2023
Name of Investigator (printed): Prasoon Mohan, MD
Institution: University of Miami
4.
PROTOCOL REVISION HISTORY 
Version #
Summary of Changes
Version Date
05282020
Initial Submission
07/09/2020
09122023
Revision
09/12/2023
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5.
PROTOCOL SYNOPSIS
Protocol Title
Intra-Arterial Dexamethasone for the Alleviation of Pain and 
Postembolization Syndrome Following Uterine Artery 
Embolization (UFE).
Targeted Patient 
Population
Women aged 20-50 years with symptomatic uterine fibroids.
Study Design
Randomized double blind placebo control trial.
Treatment Schema
Direct intra-arterial dexamethasone delivery to the uterine 
arteries at the time of embolization for minimizing the post 
embolization pain, narcotic use, nausea and vomiting and 
hospital stay. 
Duration of Treatment
Intra-arterial dexamethasone will be administered during  
standard UFE procedure protocol 
Follow-up Required Post-
Treatment
To evaluate specific aim 1: 
Pain will be assessed using 11 point visual analog scale as 
below:
The visual analog pain score will be documented as follows:
o
Time 0 Immediately prior to the procedure
o
1 hour intervals for the first 3 hours
o
3 hour intervals for the next 9 hours 
o
6 hour intervals for the next 12 hours
o
Daily, for the next 3 days 
o
Once at day 7
First 3 of those surveys will be done in the recovery area
The amount of narcotic use from PCA pump will also be 
recorded.
To evaluate specific aim 2: 
Post embolization syndrome will be assessed as reporting of 
nausea, vomiting and pain scores, that will be assessed at least 
twice during the day of the procedure and then daily for the next 
3 days and then at 7 days. We will utilize our previously 
mentioned UFE Pain and PED Survey.
To evaluate specific aim 3: 
Symptom relief and patient satisfaction will be measured 
through the completion of a UFE health-related quality of life 
(QOL) survey, UFE QOL Survey, prior to the procedure and 
then at 1 month and 3 month after procedure.
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Uterine fibroid volume change will be measured by comparing 
the pre procedure and 3 month post procedure MRI using 
volumetric software.
Objectives
SA1: Assess the efficacy of intra-arterially delivered 
dexamethasone for the alleviation of post-procedural pain 
following UFE.
SA2: Assess the efficacy of intra-arterially delivered 
dexamethasone for the alleviation of post embolization 
syndrome in UFE. 
SA3: Compare the fibroid volume change, symptom relief and 
patient satisfaction from UFE between patients who received 
steroids versus those who did not.  
Expected Number of 
Patients
Approximately 42 patients
Expected Number of 
Centers
University of Miami Health Towers
University of Miami Hospital and Clinics
Lennar Foundation Medical center
Expected Duration of the 
Study
2 years
Inclusion Criteria
Women aged 20-50 years undergoing UFE for symptomatic 
fibroids
Exclusion Criteria
Women aged <20 or >50 years, those 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, and prisoners.
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6.
Objectives* 
Uterine fibroid embolization (UFE) is a proven minimally invasive and uterine 
sparing technique for the treatment of symptomatic fibroids. The procedure is 
associated with significant post procedure cramping along with nausea and vomiting 
which require a high dose of non-steroidal anti-inflammatory medications (NSAID) 
and IV patient controlled analgesia with opioids. This can sometimes translate to 
increased length of hospital stay, and the possibility of readmission [1, 2]. Recently, 
a study by Kim, et. al., has shown that the use of preprocedural oral dexamethasone 
decreases these clinically apparent side effects seen following UFE [3].  
 
In this proposed randomized double blind placebo control trial, we propose the use 
of intra-arterial dexamethasone, delivered directly to the uterine arteries at the time 
of embolization for the treatment of post-UFE pain and post-embolization syndrome. 
We hypothesize that the anti-inflammatory effects from the high dose of steroids 
delivered directly to the uterus, bypassing the first pass metabolism and systemic 
dilution, will lead to lower pain scores, decline in narcotic use, lower incidence of 
nausea and vomiting and shorter hospital stay.
The specific aims of the study are:
1. To assess the efficacy of intra-arterially delivered dexamethasone for the 
alleviation of post-procedural pain following UFE.
2. To assess the efficacy of intra-arterially delivered dexamethasone for the 
alleviation of post embolization syndrome in UFE. 
3. To compare the fibroid volume change, symptom relief and patient 
satisfaction from UFE between patients who received steroids versus those 
who did not.  
7.
Background*
Occurring in over half of all women, uterine fibroids are the most common tumor of 
the female reproductive tract [4]. While most women remain asymptomatic, those 
with symptomatic uterine fibroids suffer from pain, pelvic pressure, menorrhagia, 
urinary frequency and infertility [5]. Not surprisingly, such women have 
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significantly lower health-care quality of life scores [6, 7]. Current management 
options include medical, surgical, and minimally invasive procedures. 
The initial medical management of symptomatic fibroids is pharmacologic, with the 
first-line treatment being oral contraceptives (OCPs). However, these are generally 
used to regulate menstrual cycles and have not been shown to reduce the overall 
volume of the fibroid [8]. In fact, 25% of women with symptomatic fibroids who are 
medically managed will go on to have a hysterectomy [9]. Gonadotropin-releasing 
hormone agonists (GnRHa) inhibits the production of estrogen and can shrink 
fibroids, but they are associated with serious side effects such as menopause like 
symptoms, osteoporosis and hirsutism. When GnRHa are stopped, the fibroids 
normally grow back [10].
Hysterectomy is considered the definitive treatment for symptomatic uterine 
fibroids. In 2005, of all the hysterectomies performed in the United States 
(~200,000) in women less than 45 years, 25% were for fibroids. Surgery is of course 
not without risk and two thirds of hysterectomies performed are still performed via 
open surgery [11]. Hysterectomy is also associated with significant morbidity and 
longer recovery period. Infection, abdominal herniation, injuries to the bowel or 
urinary system, hormonal changes that effect mood/weight, the possibility of 
hirsutism if an oophorectomy is included, and the inability to conceive are all 
associated complications. 
Since it was first introduced into the United States in the late 90’s, UFE has presented 
women with a non-surgical, minimally invasive, and uterine-sparing option for the 
treatment of their symptomatic fibroids [12]. Since then, multiple randomized 
controlled trials (RCTs) have shown similar efficacy of UFE compared to 
hysterectomy. One of the initial studies, the EMbolization versus hysterectoMY 
(EMMY) trial, found that patients recovered and returned to work significantly 
sooner in the UFE cohort, and that there was no difference in symptom relief at 2 
years between the two groups [13-15]. Other studies, such as the Randomized Trial 
of Embolization versus Surgical Treatment for Fibroids (REST) found that UFE 
patients recovered more quickly and had less pain than surgery patients. At 1 year, 
both groups had similar degrees of improvement in health-related qualify of life and 
had similar levels of satisfaction. A third study, found that patients who underwent 
UFE rather than hysterectomy additionally had a shorter hospital stay, thus 
highlighting some of the financial benefits of UFE [16]. Further, several clinical 
trials have shown an increased complication rate and lower patient satisfaction 
scores for those women who underwent hysterectomy for the treatment of their 
fibroids, as opposed to Uterine Artery Embolization (UFE) [17, 18].
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One of the major side effects of UFE is the pain and cramping that patients 
experience after the procedure, which is most pronounced in the first 12-24 hours. 
Therefore, much interest has been placed on determining what causes pain following 
UFE and how best to alleviate it. Some studies have addressed the timing and nature 
of post-UFE pain, with a finding that the initial pain is due to uterine myometrial 
ischemia [19, 20]. Later at about 72 hours, some patients begin to report loss of 
appetite, nausea, vomiting, and fatigue - a constellation of symptoms termed post-
embolization syndrome (PES). PES can lead to readmission in up to 10% of patients 
[2]. Hence, there appears to be two distinct phases of pain in the post-UFE patient: 
1. The immediate ischemic pain, and later, 2. The PES symptom constellation. 
Treatment of post-UFE pain and PES has largely focused on the use of non-steroidal 
anti-inflammatory medications (NSAIDs), narcotics, antiemetics, intra-arterially 
delivered lidocaine, and most recently with dexamethasone. It is this last option that 
has shown a decrease in both pain scores and biomarkers of inflammation [21]. In 
this study by Kim, et. al., significant reductions in post-procedural pain were 
achieved with a single intravenous dose of 10mg of dexamethasone in without any 
reported complications [3]. Our hypothesis is primarily based on this Randomized 
study. Instead of giving the steroid orally, administration into uterine artery will lead 
to a high dose of drug reaching the myometrium, bypassing the first pass metabolism 
and systemic drug dilution. We hypothesize that the anti-inflammatory effects of the 
high dose dexamethasone will have a significant beneficial effect on the post 
procedural pain and PES.
As a single administration, even at high doses, dexamethasone has very favorable 
efficacy and side effect profiles for the treatment of a wide range of conditions, 
including inflammation, pain, and nausea [22]. In fact, a recent study involving a 
single IV dose of dexamethasone was shown to significantly decrease PES following 
embolization of liver tumors [23]. 
Delivering dexamethasone directly to the uterus during a UFE has several 
advantages: bypassing of the first-pass metabolism, the lack of systemic dilution, 
and importantly, the direct delivery to the targeted region of ischemia and source of 
pain- i.e. the same tissue receiving embolic agent will also receive dexamethasone.  
This will also be administered as a single dose, eliminating the need for a steroid 
taper. This is a relatively cheap intervention (cost of Dexamethasone $1.22 USD per 
dose) which could potentially save money by decreasing the length of hospital stay 
and transitioning of UFE to an ambulatory/outpatient procedure. Additionally, a 
concurrent decrease in the incidence of PES should translate to a lower readmission 
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rate. If true, this work may also have a social impact in that fewer narcotics would 
be required to control pain. Here we propose a clinical trial designed to address these 
questions, and if proven true, could be adopted as a standard of practice to this 
uterine-sparing minimally-invasive procedure.
8.
Inclusion and Exclusion Criteria*
All eligible women, in whom UFE is not inherently contraindicated, will be screened 
based on the following Inclusion/Exclusion criteria during their initial clinic 
appointment to discuss UFE. This will consist of a standardized questionnaire 
administered with participation from the primary physician and utilize standardized 
teach-back techniques to ensure patient understanding [24]. 
Inclusion: Women aged 20-50 years, undergoing UFE for symptomatic fibroids.  
Exclusion: Women aged <20 or >50 years, those 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, and prisoners.
9.
Number of Subjects*
The power calculation is primarily based on the paper from Kim et al, which 
evaluated the effect of IV dexamethasone for treatment of post UFE pain and PES 
[3]. Based on this study, the mean Visual Analogue Scale for the Dexamethasone 
group was 2.89 (SD 1.09) compared to 3.91 (SD 2) for controls. However, in 
contrast to the reference study, the proposed study utilizes intraarterial drug 
delivery directly into uterus instead of IV routedrug , which results in higher 
concentration in the uterus [25-27]. For a low flow organ such as uterus, 
intraarterial delivery of a low clearance drug such as dexamethasone will result in a 
regional advantage of 10-25 times compared to IV or oral delivery as shown by 
Daemen et al. [25]. Given the significantly enhanced organ drug concentration in 
the uterus, an increase in effect size of at least 50% is expected with intraarterial 
drug administration compared to IV route. To detect a difference 50% larger 
between control group and intervention group, using a two-sample t test with 
significance level of 0.05, sample size of 21 per group will provide us with 86% 
statistical power to detect such an effect size.
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10. Study-Wide Recruitment Methods*
As with the discussion of Inclusion/Exclusion criteria, participants will be 
introduced to the study at the time of their initial clinical visit (referred for UFE 
through typical channels), and once they have already met criteria for undergoing a 
UFE for symptomatic fibroids. The patients will not be actively recruited for this 
study, per say, but will be offered admission to it providing they meet criteria. 
11. Study Timelines*
We intend to start the study by 10/2020 and to complete recruitment in 2 years, 
completing in 10/2022
Unless a patient chooses to opt-out of the study, a participant’s duration will be 
limited to a total of 15 days beyond the procedural date. This will include periodic 
assessments of a subjective and objective measure, as outlined later in this proposal. 
Enrollment and data analysis will be conducted on a rolling basis and deemed 
complete upon either meeting the primary endpoints (detailed below) or in the face 
of severe adverse events related to the procedural modification (detailed below).  
12. Study Endpoints*
Primary end point of this study is post procedure pain. As such, pain is measured 
using a modified Visual Analogue Score (VAS), a numerical rating system that each 
patient assigns to their level of pain, at a particular time [28]. The study endpoints 
will include qualitative and quantitative collection of data. Pain following UFE is 
subjective and unique to each patient and can be based on the location, number of 
the fibroid(s) and the volume of fibroid(s). A modified VAS, termed UFE Pain and 
PES Survey, will be utilized to assess pain prior to and following the procedure (Pre, 
immediately after the procedure, and periodically for the next 13 days, as described 
below). Our primary endpoint will be a 3-point decrease in the UFE Pain & PES 
score between test and controls. 
Secondary endpoints will include assessment of PES based on the measurement of 
nausea, vomiting, subjective fevers or chills, subjective data obtained from return to 
work times and readmission rates. This will be assessed in part using our UFE Pain 
and PES Survey, which includes a previously validated numerical scoring system 
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(0-3) to categorize nausea and vomiting, as well as a “Yes” or “No” scoring system 
to evaluate subjective fevers or chills.  
13. Procedures Involved*
The Uterine Artery Embolization procedure with the proposed intervention is 
detailed below, italicized section denotes the interventions which are additions to the 
standard of care. The procedure is separated into Pre-Procedure Assessment and 
Imaging, Uterine Artery Embolization Procedure, and Post-Procedure Assessment 
and Imaging. 
Pre-Procedure Assessment and Imaging:
●
All accepted UFE study participants will be initially assessed using the attached UFE Pain 
& PES Survey to ascertain their current baseline pain. 
●
Current medication requirements (e.g. OCPs, NSAIDs, narcotics, anti-emetics) will also 
be assessed at this time. 
●
Basic laboratory studies will be conducted at this time. This will include a Complete 
Metabolic Panel (CMP), Complete Blood Counts (CBC), Hemoglobin A1c, and qualitative 
urine pregnancy test (UPT).  
●
Each patient will further undergo (or have recent) pre-procedural imaging to determine 
fibroid burden, approximate volume, and arterial anatomy. This should be an MRI of the 
pelvis.  
Uterine Embolization Procedure:
No changes are proposed to the standard UFE procedure except for the intraarterial 
delivery of dexamethasone. 
Post-
procedural 
Evaluations
Outpatient  
Survey Phase: 
7d
Inpatient 
Survey Phase: 
24h
Uterine Artery 
Embolization
Initial Clinical 
Evaluation
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Pre-UFE patients will receive the following medications for conscious sedation, pain 
control and nausea/vomiting during the procedure as per the standard departmental 
protocol, unless contraindicated: 
●
50-300 mg IV Fentanyl 
●
0.5- 3.0 mg IV Versed 
●
30 mg IV Toradol 
●
1 g IV acetaminophen
Procedure technique:
No changes are proposed to the standard UFE procedure except for the intraarterial 
delivery of dexamethasone. 
Common femoral or radial artery access is used for the procedure. Using a 
combination of base catheters, microcatheters and different wires, each uterine artery 
is catheterized and angiograms are performed. Following this, prior to embolization, 
5 mg of IV dexamethasone or placebo are injected via the microcatheter placed in 
the uterine artery. This is followed by particle embolization using particles of size 
ranging from 500-1000µM, until near stasis as per standard technique. The same 
procedure is then repeated on the contralateral uterine artery. Finally, catheters and 
sheaths will be removed and hemostasis achieved at the access sites using closure 
device or manual compression. Patients will be admitted to the general medicine 
ward for overnight observation.
Post-UFE patients will receive the following pain/anti-emetic regimen post 
procedure: 
Inpatient Medications
●
30 mg IV Ketorolac q6h
●
650 mg PO Acetaminophen q6h (continued for 4 days post procedure)
●
0.2 mg demand dose, 10 minute lockout, 1.2 mg/hour, Hydromorphone PCA 
●
4 mg IV Ondansetron q6h PRN
Discharge Medications
●
650 mg PO Acetaminophen q6h (4 days post procedure, then q12h)
●
800 mg PO Ibuprofen q6h (4 days post procedure, then q12h)
●
5/325 mg PO Percocet q6h PRN
●
100 mg PO Docusate Sodium (Colace) q12h (4 days post procedure, then PRN)
●
4 mg SL Ondansetron q6h PRN
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Post-Procedure Assessment and Imaging:
●
Pain, nausea, vomiting and fever will be documented using the visual analog score and 
nausea and vomiting score at:
o
Time 0 Immediately prior to the procedure
o
1 hour intervals for the first 3 hours
o
3 hour intervals for the next 9 hours 
o
6 hour intervals for the next 12 hours
o
Daily, for the next 3 days 
o
Once at day 7
●
Each patient will complete uterine fibroid symptom & health-related quality of life 
questionnaire prior to the procedure and then 1 month and 3 month after.
●
Each patient will undergo post-procedural MRI imaging to determine residual fibroid 
burden and approximate volume at 3 months in order to gauge treatment response.   
●
PCA usage statistics.
Study Design: 
This study is designed as a double blinded, placebo controlled randomized control 
trial. As previously mentioned, the study will divide the patients into two groups. 
The test group will receive intra-procedural intra-arterial dexamethasone and the 
control group, a saline placebo. Block randomization (Size: 8) will be done using a 
random number generator. 
The drug or placebo will be prepared by research pharmacy and be delivered to the 
Interventional Radiology Department in identical containers with specific serial 
numbers. The physician performing the UFE, the patient and the research team will 
be unaware of the nature of the administered drug/placebo or the patient grouping. 
The drug preparation will be coordinated by the University of Miami Pharmacy 
Department’s Research Coordinator, Daniel W. Nobel. Once the uterine artery is 
catheterized, the drug or placebo will be injected intra-arterially. Embolization is 
then performed as usual. 
Following UFE, all patients will be admitted to the general inpatient unit for 
observation, as is standard of care for all UFE patients. Following this observation 
period, patients will be discharged with appropriate instructions of when and how to 
follow-up with the treatment team. This will include explicit instructions to self-
monitoring for unusual bleeding, swelling, bruising at the femoral artery access site, 
abnormal uterine bleeding, cramping, extended bouts of nausea, vomiting, fever, 
chills, and malaise. All patients will be given the number of an on-call physician for 
questions and concerns they may have. As mentioned above, all patients will be 
telephoned daily by a member of the research team on day 2, 3, 4, and 7 post-UFE.
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All patients will have a routine 2 week post-procedural phone call to review their 
symptoms, 1 month clinic visit and then 3 month clinic visit after MRI imaging. 
All data collected from the Surveys will be stored and analyzed as described 
elsewhere in this proposal. Again, we expect that this study will reach its recruitment 
goal and Primary Endpoint in approximately 2 years.
To evaluate specific aim 1: 
Pain will be assessed using 11 point visual analog scale as below:
The visual analog pain score will be documented as follows:
o
Time 0 Immediately prior to the procedure
o
1 hour intervals for the first 3 hours
o
3 hour intervals for the next 9 hours 
o
6 hour intervals for the next 12 hours
o
Daily, for the next 3 days 
o
Once at day 7
First 3 of those surveys will be done in the recovery area. The amount of narcotic 
use from PCA pump will also be recorded.
To evaluate specific aim 2: 
Post embolization syndrome will be assessed as reporting of nausea, vomiting and 
pain scores, that will be assessed at least twice during the day of the procedure and 
then daily for the next 3 days and then at 7 days. We will utilize our previously 
mentioned UFE Pain and PED Survey.
To evaluate specific aim 3: 
Symptom relief, patient satisfaction and fibroid volume change will be measured 
through the completion of a UFE health-related quality of life (QOL) survey, UFE 
QOL Survey, prior to the procedure and then at 1 month and 3 month after procedure.
Uterine volume will be compared from the pre-procedure and 3 month post 
procedure MRI using volumetric software.
14. Data and Specimen Banking*
No specimen will be collected or stored. Data will be kept in password protected, 
HIPAA compliant University approved Box folder, accessible only to investigators.
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15. Data Management*
All data will be stored, accessed, and analyzed utilizing server and computer 
workstations previously approved as HIPAA compliant. Data will be kept in 
password protected, HIPAA compliant University approved Box folder, accessible 
only to investigators. Anonymized data will include age, pre and post MRI imaging, 
UFE Pain & PES Survey, narcotic use, vital signs, subjective reports of nausea, 
vomiting, daily dietary intake, bowel movements, length of hospital stay, 
readmission rate, and days to return to baseline.  
A single computer system managed by the Pharmacology Research Coordinator, 
Daniel W. Nobel, will be maintained to ensure blinding of the cohorts. Collected 
data will be analyzed by Prasoon Mohan, MD, and done so prior to unblinding.  
16. Provisions to Monitor the Data to Ensure the Safety of 
Subjects*
All data will be analyzed as it arrives and on a rolling basis by the primary physicians 
and researchers directly involved in this study, to ensure that the clinical findings 
and participant reported responses to the Pain & UFE Survey are not deviating in a 
way that could lead to undue harm. 
As stated previously, all participants will be admitted to the hospital for observation 
for the first 24 hours and discharged with 2-week clinical follow-up in place and the 
contact information of a research team member. All participants will be contacted 
daily for the first 3 days, then at 7 and 14 days following the procedure. Any adverse 
effects of safety issues would be discovered in this follow up.
At 6 months we will analyze the interim data for any difference in the efficacy of 
treatment between the groups. All data will be analyzed using IBM SPSS software. 
We will use Student’s T test for analysis of continuous variables, Chi square test for 
categorical variables with significance level set at two tailed p value of <0.05. 
Although we expect that this trial exposes the participants to minimal risk, we 
consider the following statistically-significant differences between the two arms to 
be grounds for immediate trial termination: excessive abnormal uterine bleeding, 
infection, and sepsis.    
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17. Withdrawal of Subjects*
Subjects will be immediately withdrawn if it is deemed at any time prior to the 
procedure date that they fall into any of the previously outlined Exclusion criteria, 
suffer an intra-procedural adverse reaction to the use of dexamethasone, or willingly 
choose to leave the trial at any time. 
Once terminated from the trial, a subject can continue to undergo a UFE if they both 
meet the previously prescribed criteria and choose to do so. If a subject chooses to 
withdrawal post-UFE, a termination letter will be issued to their current address and 
all attained medical documents will be delivered through standard channels to their 
Primary Care Provider / referring physician. They can continue to receive standard 
post-UFE follow-up care through the University of Miami Interventional Radiology 
Department, if they so choose and without any punitive consequences. This is 
outlined in the Study Consent Form.    
18. Risks to Subjects*
In this study, patients will be asked to assume the standard risks associated with 
UFE. These include known complications of bleeding, infection, adverse reaction to 
contrast agent, pain, need for further intervention/embolization. Further, there is a 
additional risk with the addition of a single dose of dexamethasone, as below which 
will be explained to patients. 
Even at large doses, dexamethasone is known to have an excellent safety profile, 
with few adverse effects. Of those reported, anaphylaxis is exceedingly rare 
(incidence of ~ 0.1%) and the risk of transient hyperglycemia should be mitigated 
by the exclusion of pre-diabetic and diabetic patients (Determined by Hemoglobin 
A1c percentage) [29, 30]. It is important to note that there is no increased risk for 
delayed wound healing or infection in surgical patients receiving a single dose of 
dexamethasone [30]. Further, as a single dose will be administered, there is no need 
for a dedicated taper as suppression of the hypothalamic-pituitary-adrenal axis does 
not occur until weeks of steroid therapy.     
 
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19. Potential Benefits to Subjects*
If observed, the major benefit to women participating in the dexamethasone arm of 
this study will be a fall in pain level and PES following UFE. Other benefits may be 
a faster recovery and faster return to work or baseline activity. 
20. Vulnerable Populations*
N/A
21. Multi-Site Research*
N/A
22. Community-Based Participatory Research*
N/A
23. Sharing of Results with Subjects*
All imaging findings, diagnostic studies, complications, and follow-up treatments 
will be shared with both patient and their appointed primary care/obstetrics 
physicians. However, the study will remain blinded to both patient and clinician until 
the study is deemed closed, an adverse event occurs, or the study is prematurely 
terminated for any of the reasons previously stated. Any shared health information 
will be done so utilizing HIPAA-compliant channels.  
24. Setting
Recruitment will occur in our already-established Interventional Radiology clinics 
located at University of Miami, at the professional arts center (PAC). Likewise, UFE 
procedures will be carried out at University of Miami Health Towers or University 
of Miami Hospital and Clinics or Lennar Foundation Medical center, utilizing 
similar or identical equipment and the previously stated methods. Data analysis will 
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be carried out on University of Miami computer systems on a rolling basis to ensure 
participants are not placed at undue risk.    
25. Resources Available
The below members will meet monthly and on an as-needed basis, share all data via 
a University-approved means, a shared Box folder. This will include this IRB 
proposal, the Study Consent Form, the Patient Information Packet, and a data 
spreadsheet to compile the UFE Pain & PES Survey scores. The Principal 
Investigator shall have the responsibility of coordinating the study effort, and 
together with the Participating Physicians shall be responsible for the UFE 
procedures and the monitoring of study participants to ensure safety. This will 
include coordination between the Advanced Care Practitioners and the Research 
Coordinator to monitor for any participant adverse events. The Clinical Pharmacist 
will be responsible for compounding the Dexamethasone and Saline placebo, as well 
as blinding the study by assigning serial numbers to the medicine vials.
Principal Investigator:
Prasoon Mohan, MD 
Associate Professor - Clinical Interventional Radiology
Program Director for the Interventional Radiology Residency and Fellowship
Co-investigators:
Shivank Bhatia, MD
Chairman, Department of Vascular and Interventional Radiology 
Associate Professor of Interventional Radiology and Urology
Issam Kably, MD
Associate Professor of Vascular and Interventional Radiology
Ira Karmin, MD
Assistant Professor, Department of Obstetrics and Gynecology  
Zoe Miller, MD
Assistant Professor of Vascular and Interventional Radiology 
Associate Program Director of the Interventional Radiology Residency and Fellowship Programs
Shree Ramanan Venkat, MD
Assistant Professor of Vascular and Interventional Radiology 
Andres Krauthamer, MD
Assistant Professor of Vascular and Interventional Radiology
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Kenneth Briley, MD, PhD
Vascular and Interventional Radiology Resident
Elvira A. Allakhverdieva, MD
Diagnostic Radiology Resident
Other research personnel:
Jeremy Deni PharmD, BCPS
Clinical Research Pharmacist
University of Miami Sylvester Comprehensive Center
Arais Cavada, APRN
Vascular and Interventional Radiology 
Lia Quezada
Research Coordinator 
Vascular and Interventional Radiology 
26. Prior Approvals
All approvals have been granted by the Vascular and Interventional Radiology 
Department at the University of Miami for this study. This includes funding for a 
dedicated Research Coordinator and the costs associated with compounding the 
materials required in the study. 
27. Recruitment Methods
Recruitment will occur at the first clinical encounter between Physician and Patient 
in the IR clinic. Patients considering UFE generally placed in contact with the 
Vascular and Interventional Radiology team through a standard physician referral 
system. Referring physicians typically include Obstetric/Gynecologic specialists, 
Hospitalist, Emergency Physicians, and Primary Care Practitioners. Patients are seen 
in clinic prior to determining candidacy for the procedure and it is at this time that 
the research is introduced. If deemed a candidate for a UFE (please see listing of 
Inclusion/Exclusion Criteria), participants will be introduced to the study utilizing 
the same simplified language and pelvic models currently utilized to describe the 
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procedure, and the risks and benefits associated with such. As mentioned, standard 
teach-back techniques will be employed to gauge participant understanding.  
28. Local Number of Subjects
We anticipate that there will be approximately 21 local participants in each arm of 
this trial. As described above, this number appears to be the minimum required to 
ensure adequate statistical power. We anticipate to take approximately 2 years to 
recruit the patients.
29. Confidentiality
 X  On a University of Miami electronic device (e.g. encrypted, password-protected 
computer).
X   On a cloud-based storage system that is approved by the University of Miami.
  
X   JHS Secured SharePoint.
X   The Investigator (or research staff) will record (e.g. write down, abstract) data 
collected in a manner that does not include any indirect or direct identifiers and 
the recorded data will not be linked to the individual’s identity.  
X   The investigator (or research staff) will record (e.g. write down, abstract) the 
data collected in a manner that does not include any direct identifiers of the 
subject. The investigator will assign a code to each subject and link the code to 
the subject’s identity.  The research team will maintain the link to the subject’s 
identity on a document separate from the research data.  Both documents will 
be stored in separate files on a University of Miami encrypted device or on a 
University of Miami approved cloud storage system. The research team will 
destroy the identifiers at the earliest opportunity.
X   The research team will maintain the research data incompliance with applicable 
regulatory requirements and University of Miami data retention requirements 
as described in the Investigator Handbook.  
X   Bio-Specimens obtained for this research will be stored without any direct or 
indirect identifiers.  
X   Bio-Specimens obtained for this research will be stored in a de-identified coded 
manner.  
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X  When required to transport data or bio-specimens for this research, the research 
team will transport the data and bio-specimens in a de-identified (or 
anonymous) manner with a link to the individual subject’s identity maintain 
separately from the data and/or bio-specimen.
30. Provisions to Protect the Privacy Interests of Subjects
All aforementioned members of this clinical trial hold certain responsibilities to the 
privacy and comfort of the participants. As such, real-time transparency of incoming 
clinical data and patient concerns will be compiled in a shared, password protected 
University Box Folder for monitoring by all. However, some members will be 
restricted in their access to HIPAA-protected materials. This will include Ancillary 
Staff members and those not directly involved in the daily care of the participant. 
The topics of Privacy, Comfort, and Patient Rights will be explicitly discussed 
during every patient encounter to ensure that ongoing participant-membership 
remains voluntary in the eyes of the patient. This will include a discussion about the 
right to withdrawal from the study without penalization.    
31. Compensation for Research-Related Injury
N/A
32. Economic Burden to Subjects
N/A
33. Consent Process
Participants will be introduced to the study at the time of their initial clinical visit, 
and a standardized questionnaire will be administered by the primary physician with 
standardized teach-back techniques to ensure patient understanding of the risks and 
benefits of the altered procedure [24]. Participants will not be obligated to enter into 
the study at this time, and can do so, at any time prior to the procedure. 
The patient will be given the following documents, which are included in this 
proposal, during the initial visit: 
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1. Procedural Consent Form (IMed UFE Consent Form)
2. Study Informed Consent
3. Study Timeline Graphic 
4. Adverse Event Reporting Form (FDA Form 3500)
5. UFE Pain & PES Survey
6. QOL Survey
        Non-English Speaking Subjects
●Spanish
●Portuguese
●French 
●French Creole (French and Haitian)
●Chinese (Mandarin and Cantonese)
All participants will be consented and instructed by a certified native linguist or translation phone 
line, used by the University of Miami Hospital System.
34. Process to Document Consent in Writing
We will utilize the consent form attached at the end of this document, Study Consent 
Form, a derivative of HRP-502a.
35. Authorization for Use and Disclosure of Protected 
Health Information (HIPAA) 
Type of Request:
X   Waiver of Authorization for access to medical record for subject identification/recruitment.
X   Waiver of Authorization for access to medical record to obtain data for the research.
Confirm that you will destroy or de-identify the information you collect at the earliest opportunity. 
    X  I confirm
Confirm that the information you collect will not be reused or disclosed to any other person or 
entity, except as required by law, for authorized oversight of the research study or for other 
research for which the use or disclosure of PHI is permissible.           
    X  I confirm         
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36. Drugs or Devices
          All vials/syringes of dexamethasone or saline will be compounded by the 
Pharmacology Research Coordinator, Daniel W. Nobel, PharmD, BCOP, 
BCPS, at University of Miami Hospital. 8 mg dexamethasone intravenous 
preparation or placebo will be dispensed in identical vials or syringes with 
unique serial numbers. A log of the serial numbers will be kept in the 
pharmacy. The medication will be delivered to the IR Angiography suite and 
will be administered by the interventional radiologist performing the 
procedure. Storage is not required as the drug is prepared and administered 
the same day. 
Applicable to:
FDA Regulation
IND Studies
IDE studies
Abbreviated 
IDE studies
21 CFR 11
X
X
21 CFR 54
X
X
21 CFR 210
X
21 CFR 211
X
21 CFR 312
X
21 CFR 812
X
X
21 CFR 820
X
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Kim, S.Y., et al., The effects of single-dose dexamethasone on inflammatory response and 
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Baird, D.D., et al., High cumulative incidence of uterine leiomyoma in black and white 
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