Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Women with uterine fibroids who underwent myomectomy as their index procedure as part of their routine clinical care

Women with uterine fibroids who underwent endometrial ablation as their index procedure as part of their routine clinical care

Women with uterine fibroids who underwent uterine artery embolization as their index procedure as part of their routine clinical care

Women with uterine fibroids who underwent MRI-guided focused ultrasound ablation as their index procedure as part of their routine clinical care

Myomectomy as part of routine clinical care

myomectomy

Endometrial ablation as part of routine clinical care

endometrial ablation

Uterine artery embolization as part of routine clinical care

uterine artery embolization

MRI-guided focused ultrasound ablation as part of routine clinical care

MRI-guided focused ultrasound ablation

The purpose of this observational, retrospective database study of patients with uterine fibroids is to compare the durability of symptom relief after uterus-conserving treatments for symptomatic fibroids in terms of incidence of, and time to, new or recurrent symptoms and subsequent procedures and evaluate the effect stakeholder participation had on the research process.

Comparing Patient-Centered Outcomes After Treatment for Uterine Fibroids

Center for Medical Technology Policy

Duke University

Quintiles, Inc.

Senior Director of Epidemiology and Health Outcomes

Behaviors and Mental Disorders

Quality of Life

The patients who desire for future pregnancy will enroll into this arm , and will be divided into UAE group and SURGERY group.

The patients who don't desire for reserving uterus and/ or future pregnancy will enroll into this arm , and will be divided into UAE group and SURGERY group.

Uterine artery embolization will be done for the patients who enroll into UAE group and desire for future pregancy and reserving uterus.Myomectomy will be performed for the patients who enroll into SURGERY group and desire for future pregancy and reserving uterus.Hysterectomy will be done for the patients who enroll into SURGERY group and don't desire for reserving uterus and/or future pregnancy.

Interventional radiological or surgical management

Hong Shan, M.D., PHD.

The efficacy and safety of uterine artery embolization, as compared with standard surgical methods, for the treatment of symptomatic uterine fibroids remain uncertain. The purpose of this trial is to evaluate the uterine volume and tumor size reduction, symptomatic relief, complication, fertility, ovarian function and quality of life with uterine artery embolization for uterine fibroids comparing with standard surgical methods.

Clinical Trial of Uterine Artery Embolization for Uterine Leiomyoma

Multi-Center Clinical Trial of Uterine Artery Embolization Treatment of Uterine Leiomyoma

Sun Yat-sen University

Hong Shan

Femoral arterial puncture for the uterine fibroid embolization procedure

Radial arterial puncture for the uterine fibroid embolization procedure

Arterial access

John Kachura

Randomized trial comparing uterine fibroid embolization patient satisfaction and quality of life with femoral versus radial arterial access

1:1 randomized trial comparing patient satisfaction and quality of life with femoral versus radial arterial access for uterine fibroid embolization

Satisfaction of Patients With Trans-Arterial Radial Access: Quality of Life in Uterine Fibroid Embolization Trial

Based on visual analog scale (min 0, max 10; higher score indicates better outcome)

Complications categorized based on the Society of Interventional Radiology Standards of Practice Guideline

Fluoroscopy time used during the procedure

Cost of disposable equipment used for the procedure

Health related quality of life short form-8 questionnaire (raw score converted to standardised score min 0, max 100; higher score indicates better outcome)

Mount Sinai Hospital, Canada

Interventional Radiologist; Associate Professor of Medical Imaging

Infections

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Communicable Diseases

Urinary Tract Infections

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Matthew Barber, MMD

To the investigators knowledge there is no research data published to date regarding the lower urinary tract symptoms in women with leiomyomas. The primary aims of this study are:

1. To determine prevalence of lower urinary tract symptoms in patients who present for care for symptomatic leiomyomata.
2. To compare change in lower urinary tract symptoms within treatment groups measured by the UDI-6 total before and at six months after three common treatments for symptomatic uterine fibroids including: hysterectomy, myomectomy, or uterine artery embolization.

The study proposed here will hopefully answer the question if one particular therapy is appropriate to treat fibroids and relieve lower urinary tract symptoms.

1. Uterine fibroids Uterine leiomyomas or fibroids are one of the most common conditions affecting women of reproductive age. They account for approximately a third of all hysterectomies performed. Symptoms often attributed to uterine leiomyomas include excessive menstrual bleeding, dysmenorrhea, pelvic pain, and so called "bulk symptoms," or symptoms related to pressure on adjacent organs such as ureteral obstruction, urinary frequency and urgency, rectal pressure, pelvic pressure and increasing abdominal girth. Current treatment for symptomatic uterine fibroids includes hysterectomy, myomectomy and uterine fibroid embolization.
2. Lower urinary tract symptoms Although, urinary symptoms like frequency, urgency, incontinence, and voiding dysfunction are often attributed to fibroids, the relationship between fibroids and lower urinary tract symptoms (LUTS) has been poorly studied. The public health burden of fibroids has been studied before and after radical hysterectomy, supracervical hysterectomy, and total abdominal hysterectomy.(1-3) What is missing in the literature is a comparison of traditional and non-traditional surgical fibroid techniques in a prospective fashion. Moreover, there are no studies evaluating the relationship between anatomic factors like uterine size or fibroid number or location and the presence of LUTS.

Lower Urinary Tract Infection (UTI) Evaluation in Women With Uterine Leiomyomata

Lower UTI Evaluation in Women With Uterine Leiomyomata

The Cleveland Clinic

Adenomyosis

Menorrhagia

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Hemorrhage

Uterine Hemorrhage

Menstruation Disturbances

Uterine Artery Embolization

Richard S Boroditsky, MD

This study will evaluate the safety, efficacy , quality of life and patient satisfaction of uterine artery embolization for the treatment of symptomatic uterine fibroids. It will provide useful information in the development od guidelines in patient selection, procedural management and subsequent follow up.

Uterine Artery Embolization for Symptomatic Fibroids

Short and Long Term Outcomes of Uterine Artery Embolization.

University of Manitoba

Percutaneous or vaginal application of microwave antenna with microwave treatment of fibroma

Microwave treatment

Percutaneous applicaiton of a catheter into the femoral artery and embolization of uterine artery or branches thereof

Helena Kopp Kallner, MD; PhD

Helena Kopp Kallner, MD, PhD

Uterine fibroids are benign tumors that occur most commonly in women of reproductive age. Symptoms of uterine fibroids may be heavy menstrual bleeding which may lead to anemia, pressure symptoms, bowel symptoms or urinary urgency. In recent years, increasing attention has been paid to the study of minimally invasive methods for treatment. Microwave ablation of myomas and endometrium has been shown to have good effect and acceptability has been high. This study aims to compare the effectiveness, feasibility and acceptability of percutaneous or per vaginal microwave ablation and uterine artery embolization for the treatment of uterine myomas in a randomized single blind study.

Primary outcome

1. Volume reduction 6 months post treatment (+/- 15 days) compared to pre treatment measured as mean volume reduction of the 3 largest fibroids evaluated by magnetic

Power calculation

To be able to show a difference between the groups in myoma shrinkage at 6 months of 75% in microwave ablation and 50%\[11\] in the embolization group with a standard deviation of 25% with a alpha of 0.05 and a power of 80% we would need 16 women in each group and thus need to randomize 32 women.

In order to compensate for loss to follow-up or drop out a total of 36 women will be randomized.

Patients and investigators will not be blinded. The MRI will be performed and evaluated by a blinded radiologist.

After having signed informed consent but before randomization patients will undergo MRI of the uterine fibroids. Patients with a single fibroid measuring more than mean diameter 8cm will be excluded from further participation in the study.

All women included in the study after MRI examination will fill in a PBAC evaluation\[7\] during the menses preceding treatment. Women will fill a VAS for maximal pain during 1 month prior to treatment.

Microwave ablation will be performed percutaneously or vaginally using a Covidien Emprint microwave ablation system. Embolization will be performed in conscious women with an epidural catheter for pain relief.

At follow up visit 1, 3 months and 6 months post treatment acceptability will be assessed as overall satisfaction of treatment on a scale from 1-7 and if the woman would recommend the treatment to a friend.

A new MRI scan will be performed 6 months post treatment (+/-15 days).

Background

Uterine fibroids are benign tumors that occur most commonly in women of reproductive age. Symptoms of uterine fibroids may be heavy menstrual bleeding which may lead to anemia, pressure symptoms, bowel symptoms or urinary urgency. Hysterectomy remains the reference standard in the treatment of uterine fibroids. However, it may cause long-term side effects such as pain and genitovaginal prolapse. It also carries a substantial risk of short term complications such as infections and organ damage. Myomectomy is another conventional treatment, but it is associated with a recurrence rate as high as 20% according to literature. It carries the same short term risks of complications as hysterectomy but at a lower frequency.

In recent years, increasing attention has been paid to the study of minimally invasive or non-invasive therapies with uterine preservation such as uterine arterial embolization (UAE), radiofrequency (RF), microwave treatment and high intensity focused ultrasound (HIFU). RF ablation often requires the aid of a laparoscopic procedure, which is invasive. HIFU is effective in small myomas, but can be time consuming in large myomas with treatments for several hours. Ultrasound or computer tomography guided percutaneous microwave thermal ablation is minimally invasive, has low time requirements, is easy to perform, and has been broadly used for the treatment of solid tumours in organs other than the uterus with favourable effects.

Microwave ablation of myomas and endometrium has been performed in China and Japan. The effect and acceptability has been high. The research team in this study has been to China to study the treatment. We have visited the clinic and studied the procedure as well as talked to patients pre- and post operatively . The equipment at Danderyd Hospital has the same output effects as the equipment in China. Danderyd Hospital as approved the method for use in uterine myomas. However, no randomized comparative study of other minimally invasive methods has been performed.

This study aims to compare the effectiveness, feasibility and acceptability of percutaneous CT- or ultrasound guided microwave ablation and uterine artery embolization for the treatment of uterine myomas in a randomized single blind study.

Power calculation

To be able to show a difference between the groups in myoma shrinkage at 6 months of 75% in microwave ablation and 50% in the embolization group with a standard deviation of 25% with a alpha of 0.05 and a power of 80% we would need 16 women in each group and thus need to randomize 32 women.

In order to compensate for loss to follow-up or drop out a total of 36 women will be randomized.

Recruitment and Randomization

Women fulfilling inclusion criteria and without exclusion criteria will be identified at the outpatient clinic of Danderyds Hospital. Advertisement may be placed in local newspapers or on social media (Facebook and Instagram) and relevant webpages or in gynecological clinics.

Women will be randomized after having been informed orally and in written and after having signed informed consent and after fulfilling inclusion and exclusion criteria after MRI-examination. Randomization will be in random permuted blocks of 6 at a ratio of 1:1. The randomization will be according to a computer generated randomization sequence. After patients have signed informed consent and fulfill inclusion without exclusion criteria after the initial magnetic resonance imaging they will be allocated to an intervention by consecutive opening of sealed opaque envelopes containing the randomization code.

Blinding

Patients and investigators will not be blinded. The MRI will be performed and evaluated by a blinded radiologist.

Method

Pre randomization evaluation

After having signed informed consent but before randomization patients will undergo MRI of the uterine fibroids. Patients with a single fibroid measuring more than 6cm will be excluded from further participation in the study.

All women included in the study after MRI examination will fill in a PBAC evaluation during the menses preceding treatment. Women will fill a VAS for maximal pain during 1 month prior to treatment. In addition a full blood panel will be evaluated.

As for uterine artery embolization no pathologist report will be performed before any treatment.

Microwave ablation

Microwave ablation will be performed percutaneously using a Covidien Emprint microwave ablation system with a 30-90 Watts effect in 14-16 gauge needle with a ceramic tip using computer tomography with fusion technique or ultrasound for myoma imaging and needle guidance. After identification of the needle path with CT or peroperative ultrasound local anaesthesia (carbocain 1% with 0,05mg/ml adrenaline) will be given along the needle path and a small skin incision using a scalpel will made for the needle entry. Patients will be given intravenous anesthesia with spontaneous breathing or general anesthesia during treatment to minimize movement during ablation.

Uterine artery embolization

Embolization will be performed in conscious women with an epidural catheter for pain relief. A catheter will be inserted in the femoral artery to access the uterine artery during x-ray monitoring and during administration of contrast to visualize the fibroma and its supporting arterial supply. When the supporting arterial branch has been identified polyvinyl alcohol particles are released into the bloodstream. These particles cause a thrombosis in the vessel.

Evaluation post treatment

Women will estimate VAS maximum postoperative pain day of surgery and the following 7 days. In addition they will note how many days passed before all pain subsided, use of pain medication will be noted and period until resuming normal daily activities. The period of hospitalization will be noted. Menstrual blood loss (PBAC) will be noted the first menstruation, menstruation number 3 and 5 post treatment. PBAC is a validated instrument for menstrual blood loss quantification.

Follow-up visits will be after first menstruation at approximately 1 month and at 3 and 6-7 months post-treatment.

At follow up visit 1, 3 months and 6 months post treatment acceptability will be assessed as overall satisfaction of treatment on a scale from 1-7 and if the woman would recommend the treatment to a friend.

A new MRI scan will be performed 6 months post treatment (+/-15 days). Women will then be asked to participate in a long-term follow up with evaluation of fibroma growth using ultrasound and recurrence of symptoms using PBAC yearly until retraction of consent.

Clinicial significance

Uterine myomas are a benign disease but have a significant impact on the lives of women. As many as 70% of women have myomas. However, the self-reported frequency of uterine myomas differs between countries and ranges from 4% to 15% in some countries- probably depending on the use of ultrasound in gynecological practice and the information given to women. Women with self reported uterine myomas are much more likely to report on symptoms which are known to be caused by myomas such as heavy menstrual bleeding, pressure symptoms, urinary urgency and pain (dysmenhorrea and dyspareunia). Myomas remain the leading cause of hysterectomies in most western countries. As hysterectomy is a highly invasive procedure with cost for women in terms of absence from work and short and long term complications, finding new minimally invasive treatments should remain a focus of health care.

Study of Volume Reduction of Uterine Fibroids After Embolization or Microwave Treatment

Single Blinded Randomized Study of Volume Reduction of Uterine Fibroids After Uterine Artery Embolization Versus Computer Tomography or Ultrasound Guided Percutaneous Microwave Ablation Evaluated by Magnetic Resonance Imaging

Volume reduction 6 months post treatment (+/- 15 days) compared to pre treatment measured as mean volume reduction of the 3 largest fibroids evaluated by magnetic resonance imaging (MRI)

Pain (measures as visual analogue scale, VAS)- maximum postoperative pain day of surgery and following 7 days)

Reduction of symptoms as pressure, urgency and coital pain, score in UFS-QoL questionnaire

Generic drug name, number of milligrams consumed

time away from work after treatment in both groups

number of days of menstrual bleeding divided into fresh bleeding and spotting

Menstrual blood loss score evaluated by the validated Pictorial Bleeding assessment chart

Quality of life evaluated by score in the validated questionnaire Uterine Fibroid Symptoms. Quality of Life (UFS-QoL)

Any complication occurring in women will be recorded and judged by the principal investigator as related, probably related, probably not related or not related

Karolinska Institutet

Senior consultant, PhD

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

hysterectomy

J.A. Reekers, MD, PhD

The Emmy trial is set up to evaluate the safety and efficacy of uterine artery embolization (UAE) in comparison to hysterectomy for the treatment of symptomatic uterine fibroids. UAE was considered equivalent to hysterectomy when at least 75% of patients had normalization of heavy menstrual blood loss after treatment.

Uterine Artery Embolization (UAE) is a new treatment for heavy menstrual bleeding caused by uterine fibroids. UAE is already being performed on a regular basis, without profound evidence: no good quality randomized controlled trials have been conducted. The EMMY trial evaluates the safety and efficacy of UAE in a randomized comparison to hysterectomy. Patients were included when they had uterine fibroids and menorrhagia, and were eligible for hysterectomy. The primary endpoint is the elimination of menorrhagia after a two-year follow-up period. Secondary endpoints comprise: effect on complaints of pain and pressure, quality of life issues, uterine volume reduction, effect on ovarian function and cost-effectiveness. Patients were randomly assigned to either UAE or hysterectomy (1:1). All patients were followed for two years after treatment. Whether UAE can be an alternative to hysterectomy as treatment of first choice depends on the balance of efficacy, costs, and quality of life.

Emmy Trial: Uterine Artery Embolization (UAE) Versus Hysterectomy for Uterine Fibroids

EMMY Trial: a Randomized Comparison of Uterine Artery Embolization and Hysterectomy for the Treatment of Symptomatic Uterine Fibroids

Boston Scientific Corporation

ZonMw: The Netherlands Organisation for Health Research and Development

The leiomyomas were evaluated individually. MR was used to evaluate morphology: the radiological dimension(s) of the leiomyoma and uterus and the volume. The number of leiomyoma fibroid, and their location in the myometrium was classified. Perfusion and the characterization of the T2 signal were also evaluated.

The leiomyomas were evaluated individually. MR was used to evaluate morphology: the radiological dimension(s) of the leiomyoma and uterus and the volume. The number of leiomyoma fibroids was determined, and their location in the myometrium. Perfusion and the characterization of the T2 signal were also evaluated.

Magnetic Resonance Image

Eduardo Zlotnik

The purpose of this study is to determine predictive factors in the pelvic magnetic resonance in the response of arterial embolization of uterine leiomyoma.

This study followed symptomatic premenopausal women with uterine leiomyoma who underwent uterine artery embolization (UAE). Treatment was accompanied by magnetic resonance imaging of both the volume of the entire uterus and the leiomyomas one month before and six months after UAE. This patients were treated at the Uterine Leiomyoma Sector of the Department of Obstetrics and Gynecology, Medicine College of the University of São Paulo. In this study, the investigators examined 179 leiomyomas in 50 patients.

Predictive Factors of Pelvic Magnetic Resonance in the Response of Arterial Embolization of Uterine Leiomyoma

Use the magnetic resonanse to evaluate factors that predicted leiomyoma reduction in patients who underwent uterine artery embolization

University of Sao Paulo

Hospital Israelita Albert Einstein

Principal Investigator

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Reproductive Control Agents

Ethanol

Progesterone

Ulipristal acetate

Contraceptive Agents

Contraceptive Agents, Hormonal

Contraceptive Agents, Female

Patients within this group received oral Ulipristal Acetate (Fibristal ©) 5 mg / day starting from the first day of menstrual bleeding, and for 3 months (period of the study).

Patients within this group underwent bilateral selective uterine artery embolization, during which polyvinyl alcohol (PVA) particles was administered via a catheter followed by capping with a plug of gelatin sponge. The end point for embolization is to have a static column of contrast in the uterine artery, with only a stump filling when the internal iliac artery was injected. The gelatin sponge cap was thought to both complete the occlusion of the uterine artery and to prevent PVA particles from being drawn out of the uterine artery by the Venturi effect, which would result in non-target embolization.

A selective progesterone receptor modulator (SPRM), as a medical line of treatment for uterine fibroids. Due to its selective anti-proliferative and pro-apoptotic action, Ulipristal Acetate (UA) is assumed to be effective in reducing abnormal uterine bleeding (AUB) and fibroid size.

Ulipristal Oral Tablet

Selective embolization of uterine arteries bilaterally, using polyvinyl alcohol (PVA) particles administered via a catheter followed by capping with a plug of gelatin sponge. The end point for embolization is to have a static column of contrast in the uterine artery, with only a stump filling when the internal iliac artery was injected.

Uterine artery embolization

Study objective: To prove that Ulipristal acetate is an effective line of management for uterine fibroids by causing a significant decline in fibroid volumes resulting in a substantial relief of fibroid-related symptoms, and to compare its results with those of uterine artery embolization.

Design: A randomized control trial. Setting: Maternity Hospital, Ain Shams University.

Patients: Women with symptomatic uterine fibroids.

Interventions: 70 women were randomly assigned to either Ulipristal Acetate (UA) group or uterine artery embolization (UAE) group (35 in each group). Both groups were followed up to detect the decline in fibroid size as well as the improvement of symptoms.

Inclusion Criteria:

Women with symptomatic uterine fibroids were recruited into the study after fulfilling the following criteria:

* Their age should range from 35 to 50 years.
* Their body mass index (BMI) should range from 18 to 35 Kg/m2.
* The presence of multiple symptomatic type 2, 3, 4, 5, or 6 uterine fibroids according to the FIGO classification.
* The dominant fibroid diameter should range from 4 to 8 cm as assessed by ultrasound.
* They should not be seeking future fertility.
* They should be refusing any surgical intervention whether myomectomy or hysterectomy.

Exclusion Criteria:

1. Post-menopausal status or premature ovarian failure.
2. Type 0, 1 and 7 uterine fibroids according to FIGO classification.
3. Previous myomectomy or any uterine surgery.
4. Previous or ongoing hormonal treatment.

Sampling Method:

The study sample will be a "convenient sample" where women fulfilling the inclusion criteria and consenting to participate in the study will be recruited.

Sample Size justification:

The study will include 70 women with symptomatic uterine fibroids who will be randomized into two groups with 35 women in each group.

The required sample size has been calculated using the PASS 15 Power Anal-ysis and Sample Size Software (PASS©) version 15 (2017); NCSS, LLC. Kaysville, Utah, USA.

The main outcome measure is the reduction in fibroid volume. The secondary outcome measures are symptoms relief and improvement in quality of life.

A previous study reported that Ulipristal Acetate (UA) was comparable to uterine artery embolization (UAE) as regards the percentage of reduction in fibroid volume with median (interquartile range) percentage reduction of 48.1 (24.8 - 66) % versus 47.3 (29.5 - 69.5) % for UPA and UAE respectively (Czuczwar et al., 2015).

Using the methods described by Wan et al (2014) and Luo et al (2018), we calculated that the mean ± SD percentage of reduction in fibroid volume was 44.0 ± 28.5 % versus 48.9 ±32.3 % for UPA and UAE respectively, with mean difference of 4.9 % and common within group SD of 30.5%.

Taking into consideration a "drop-out rate" of about 10%, due to loss of follow up or withdrawal from the study, it is estimated that a sample size of 35 patients per group achieves 80% power using a one-sided equivalence test with a significance level of 5% (alpha-error = 0.05), when the difference between the two means is 4.9 %, common within group SD is 30.5 %, and equivalence limits are -25% and 25%.

On the other hand, this sample size achieves a power of 82% to detect a statistically significant difference between the two groups as regards the symptoms scores and measures of ovarian reserve (AFC and AMH) for an effect size equivalent to a Cohen's d of 0.75 (i.e., 0.75 common SD) using a two-sided unpaired t-test with the same significance level of alpha = 0.05.

These equivalence limits and effect size have been targeted, as they may be considered clinically important.

Informed consent:

The nature and scope of the clinical study will be explained in an understand-able way to the patients and an informed consent form, in Arabic language, including all the study procedures, advantages and possible risks and specifying who informed the patient, will be provided and the patient must sign on it before participation. The study protocol and patient informed consent will be reviewed and approved by the Ethics Committee of the Obstetrics and Gynecology Department, Ain Shams University.

Funding:

This study will be funded by the researcher himself and Ain Shams University

Randomization and Allocation concealment:

The participants will be randomly assigned into one of the two study groups using a computer random sequence generator. The randomization will be made using sequentially numbered, opaque sealed envelopes; each envelope contains the method of intervention according to the random sequence and will be opened just before the intervention.

Study Procedures:

All participants will undergo full assessment before starting either treatment options. This assessment will include:

Detailed History:

* Personal history: including patient's full name, age, marital status, parity, occupation and residence will be recorded.
* Menstrual history: including age of menarche, D/C, amount of menstrual flow and associated dysmenorrhea.
* Contraceptive history: to exclude other causes for uterine bleeding.
* Past medical history of Diabetes Mellitus, hypertension, bronchial asthma, cardiac diseases, anemia, etc.
* Past surgical history of uterine surgeries.
* History of present illness with detailed analysis of each patient's complaint whether abnormal uterine bleeding, dysmenorrhea and pelvic pressure symptoms such as urinary urgency or constipation.

Physical Examination:

* General examination including: Pulse, blood pressure, temperature, body mass index (BMI), auscultation of lungs and heart, and complex-ion as pallor due to anemia caused by heavy bleeding.
* Abdominal examination: inspection for any scar, palpation of the abdomen for any tenderness and for pelviabdominal masses.
* Pelvic examination: complete bimanual examination for uterine size, mobility and palpable uterine fibroids.

Investigations:

* Baseline hemoglobin, hematocrit, and blood grouping.
* Blood chemistry: AST, ALT, serum creatinine and RBS.
* Trans-vaginal ultrasound for uterine volume and fibroid location, volume and maximum diameter. Uterine volume (expressed in cubic centimeters) will be calculated by measuring the maximum length, antero-posterior and transverse diameters of the uterine corpus, using the US device software formula for calculation of the uterine volume. Myoma volumes will be measured by using the existing 2-dimensional US methods. The FIGO classification system (figure 1) will be used for defining the myoma location.

Study groups:

Patients recruited in this study will be randomized into one of the following study groups:

1. Group A "Ulipristal Acetate (UA) - Fibristal group" (n=35):

   Patients within this group will receive oral Ulipristal Acetate (Fibristal ©) 5 mg / day starting from the first day of menstrual bleeding, and for 3 months (period of the study).
2. Group B "Uterine artery embolization (UAE) group" (n=35):

Patients within this group will undergo bilateral selective uterine artery embolization, during which polyvinyl alcohol (PVA) particles will be administered via a catheter followed by capping with a plug of gelatin sponge. The end point for embolization is to have a static column of contrast in the uterine artery, with only a stump filling when the internal iliac artery was injected. The gelatin sponge cap was thought to both complete the occlusion of the uterine artery and to prevent PVA particles from being drawn out of the uterine artery by the Venturi effect, which would result in non-target embolization.

Follow up:

Each patient within both groups will be subjected to follow-up trans-vaginal ultrasound (US) 3 months after Ulipristal acetate (UA) therapy or after uterine artery embolization (UAE) session to detect the decline in uterine fibroid volumes in comparison to their baseline. To reduce inter-observer variability associated with ultrasound imaging, measurements will be always taken by the same sonographer.

Each patient within both groups will be evaluated clinically for the symptoms reported at least 1 month before starting the treatment (baseline) and 3 months after Ulipristal acetate (UA) therapy or after uterine artery embolization (UAE) session. Durability of the used treatment line will be tested by follow up after one year from initiating therapy.

Fibroid-related heavy menstrual bleeding (HMB) will be evaluated by the pictorial blood assessment chart score (figure 2). This instrument is a self-administered pictorial chart that takes account of the number of sanitary pads and tampons used, presence of blood clots, and episodes of bleeding. The 1-month pictorial blood assessment chart score was calculated from the addition of daily scores for 28 days. A score of higher than 100 during the first 8 days of menstruation will be defined as heavy menstrual bleeding (HMB).

Subjective feelings of pelvic pressure, urinary urgency, and constipation will be recorded on a simplified questionnaire containing 2 categories defined as "absent "and "present." The visual analog scale (VAS) pain score (figure 3) will be used to determine the presence or absence of pelvic pain.

Statistical Methods:

Data will be analyzed using Intention to treat (ITT) analysis. According to Fisher et al (1990), the ITT analysis includes all randomized patients in the groups to which they were randomly assigned, regardless of their adherence with the entry criteria, regardless of the treatment they actually received, and regardless of subsequent withdrawal from treatment or deviation from the protocol.

In other words, ITT analysis includes every subject who is randomized according to randomized treatment assignment. It ignores non-compliance, protocol deviations, withdrawal, and anything that happens after randomization. ITT analysis is usually described as "once randomized, always analyzed".

ITT analysis avoids overoptimistic estimates of the efficacy of one of the two interventions resulting from the removal of non-compliers by accepting that noncompliance and protocol deviations are likely to occur in actual clinical practice.

Efficacy of the two study interventions will be compared using Odds ratio (OR), Relative risk (RR), Number needed to treat (NNT) and Number needed to harm (NNH).

Data will be analyzed using IBM© SPSS© Statistics version 23 (IBM© Corp., Armonk, NY). Normally distributed numerical data will be presented as mean and SD, and skewed data as median and interquartile range. Qualitative data will be presented as number and percentage. Normally distributed numerical data will be compared using the unpaired t test and skewed data using the Mann-Whitney test. Categorical data will be compared using the Pearson chi-squared test or Fisher's exact test, if appropriate. A two-sided p-value \<0.05 will be considered statistically significant.

UA Versus UAE in Treatment of Fibroids

Ulipristal Acetate Therapy Versus Uterine Artery Embolization in Management of Uterine Fibroids

measured by reduction in Pictorial Blood Loss Assessment Chart Score.

measured by reduction in Visual Analogue Scale Score.

Subjective feelings of pelvic pressure symptoms including urinary urgency, and constipation was recorded using a simplified questionnaire containing 2 categories defined as "absent "and "present."

resulting from either treatment options within the 2 arms of the study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparing Patient-Centered Outcomes After Treatment for Uterine Fibroids	NCT02819609	Uterine Fibroid...	myomectomy endometrial abl... uterine artery ... MRI-guided focu...	18 Years - 54 Years	Quintiles, Inc.
Clinical Trial of Uterine Artery Embolization for Uterine Leiomyoma	NCT00821275	Leiomyoma	Interventional ...	20 Years - 50 Years	Sun Yat-sen University
Satisfaction of Patients With Trans-Arterial Radial Access: Quality of Life in Uterine Fibroid Embolization Trial	NCT03021720	Uterine Fibroid	Arterial access	18 Years -	Mount Sinai Hospital, Canada
Lower Urinary Tract Infection (UTI) Evaluation in Women With Uterine Leiomyomata	NCT01123603	Urinary Tract I... Leiomyoma		18 Years -	The Cleveland Clinic
Lower Urinary Tract Infection (UTI) Evaluation in Women With Uterine Leiomyomata	NCT01123603	Urinary Tract I... Leiomyoma		18 Years -	The Cleveland Clinic
Uterine Artery Embolization for Symptomatic Fibroids	NCT00354471	Uterine Fibroid... Menorrhagia Adenomyosis	Uterine Artery ...	18 Years - 60 Years	University of Manitoba
Study of Volume Reduction of Uterine Fibroids After Embolization or Microwave Treatment	NCT02942537	Uterine Fibroid...	Microwave treat... uterine artery ...	30 Years - 55 Years	Karolinska Institutet
Emmy Trial: Uterine Artery Embolization (UAE) Versus Hysterectomy for Uterine Fibroids	NCT00100191	Menorrhagia Leiomyoma Uterine Neoplas...	uterine artery ... hysterectomy	18 Years -	ZonMw: The Netherlands Organisation for Health Research and Development
Predictive Factors of Pelvic Magnetic Resonance in the Response of Arterial Embolization of Uterine Leiomyoma	NCT01468402	Exposure to Mag... Uterine Leiomyo...	Magnetic Resona...	18 Years - 45 Years	Hospital Israelita Albert Einstein
UA Versus UAE in Treatment of Fibroids	NCT04832906	Uterine Fibroid	Ulipristal Oral... Uterine artery ...	35 Years - 50 Years	Ain Shams Maternity Hospital
UA Versus UAE in Treatment of Fibroids	NCT04832906	Uterine Fibroid	Ulipristal Oral... Uterine artery ...	35 Years - 50 Years	Ain Shams Maternity Hospital

Spots Global Cancer Trial Database for uterine artery embolization