Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives

Study Overview
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Brief Summary
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The purpose of this prospective non-randomised study is to examine whether two different microspheres (Bead-Block and Embosphere) are equally effective in the treatment of the uterine fibroid controlled with contrast-enhanced MR examination. Quantitative MR imaging, including dominant fibroid T1, T2 and contrast enhancement characteristics before intervention and 3 months after interventions will be analysed as a potential predictor of volumetric response after embolization. Another purpose is to determine long-term follow-up in all patient treated in a period from 2001-2011 in OUH analysed retrospectively.

Detailed Description
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Group 1: 26 patient will be treated with Bead-block microspheres - 700-900 µm microspheres or combinations of one vial 2 ml of 500-700 µm microspheres, follow by 700-900 µm microspheres until blood flow stop (  cut the tree appearance). Group 2: 26 patient will be treated with Embosphere; 500-900 µm until near-stasis flow stop in the uterine artery. Clinical and Technical success will be examined, and radiological follow-up 3 and 12 months after embolization using MR contrast-enhanced examination in a Bead Block group and only 3 months control in Embosphere group to assess total fibroid burden infraction degree and eventually residual contracts fibroid enhancement. Quantitative MRI dominant fibroid characteristic for and 3 months after an intervention to examine eventually potential of as a possible predictor of the volumetric response of the uterine fibroid. Retrospective study compromised all patient treated between January 2001 until January 2011 with follow up to January 2014, and re-intervention as well as complications rate analysis.

Official Title
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Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives

Conditions
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Uterine Fibroids, Arterial Embolization

Intervention / Treatment
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* Procedure: embolizations ,uterine fibroid
* Procedure: embolizations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: symptomatic uterus fibroma Exclusion Criteria: pelvic infection (cystitis, oophoritis, salpingitis, abscess, urethritis) gravidity uterus malignancy big subserosal fibroma with stalk diameter of <2 cm menopausal women don,t want to be included into the study concomitant adenomyosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 52 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: embolizations, uterine fibroid<br>embolization interventions with microspheres | Procedure: embolizations ,uterine fibroid<br>* 26 patients will be treat with Bead-block microspheres, 500-700 and 700-900µm until flow stop (  cut the tree appearance) 26 patients will be treat with Embosphere, 500-700µm and /or 700-900 until near stasis  flow stop<br>Procedure: embolizations<br>* comparison between the two microspheres<br>* Other names: microsphere, uterine fibroid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical effect | Primary goal is to achieve release of symptoms after intervention and it would be compared between the two techniques | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reinterventions rate |  | one year |