Comparing Patient-Centered Outcomes After Treatment for Uterine Fibroids

Study Overview
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Brief Summary
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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.

Official Title
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Comparing Patient-Centered Outcomes After Treatment for Uterine Fibroids

Conditions
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Uterine Fibroids

Intervention / Treatment
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* Procedure: myomectomy
* Procedure: endometrial ablation
* Procedure: uterine artery embolization
* Procedure: MRI-guided focused ultrasound ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients with a diagnosis of uterine fibroids at any time and at least 1 office visit during study time period At least 1 of the procedures of interest occurring between January 1, 2005 - December 31, 2011 ≥ 18 years and < 55 years of age at the index date Exclusion Criteria: Patients with a diagnosis of gynecologic cancer (ovarian, uterine, cervical) First recorded diagnosis of uterine fibroids occurring beyond four weeks after the Index Date ONLY for patients who underwent endometrial ablation or hysterectomy Patients with a record of any procedures of interest occurring before January 1, 2005

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 54 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Myomectomy<br>Women with uterine fibroids who underwent myomectomy as their index procedure as part of their routine clinical care | Procedure: myomectomy<br>* Myomectomy as part of routine clinical care<br>|
| Endometrial ablation<br>Women with uterine fibroids who underwent endometrial ablation as their index procedure as part of their routine clinical care | Procedure: endometrial ablation<br>* Endometrial ablation as part of routine clinical care<br>|
| Uterine artery embolization<br>Women with uterine fibroids who underwent uterine artery embolization as their index procedure as part of their routine clinical care | Procedure: uterine artery embolization<br>* Uterine artery embolization as part of routine clinical care<br>|
| MRI-guided focused ultrasound ablation<br>Women with uterine fibroids who underwent MRI-guided focused ultrasound ablation as their index procedure as part of their routine clinical care | Procedure: MRI-guided focused ultrasound ablation<br>* MRI-guided focused ultrasound ablation as part of routine clinical care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of uterine fibroids patients who experience new or recurrent symptoms after uterus-conserving treatments (myomectomy, endometrial ablation, uterine artery embolization, magnetic resonance imaging [MRI]-guided focused ultrasound ablation) |  | Minimum of two years after index procedure | 
| Time to new or recurrent symptoms after uterus-conserving treatments (myomectomy, endometrial ablation, uterine artery embolization, magnetic resonance imaging [MRI]-guided focused ultrasound ablation) |  | Minimum of two years after index procedure | 
| Number of uterine fibroids patients who experience a subsequent procedure after uterus-conserving treatments (myomectomy, endometrial ablation, uterine artery embolization, magnetic resonance imaging [MRI]-guided focused ultrasound ablation) |  | Minimum of two years after index procedure | 
| Time to a subsequent procedure after uterus-conserving treatments (myomectomy, endometrial ablation, uterine artery embolization, magnetic resonance imaging [MRI]-guided focused ultrasound ablation) |  | Minimum of two years | 
| Effect of stakeholder participation in the research process |  | From first stakeholder conference (April 2014) to final stakeholder conference (November 2015) |