Comparing Patient-Centered Outcomes After Treatment for Uterine Fibroids

N/ACompletedNCT02819609

Quintiles, Inc.12,234 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

12,234

Conditions

Uterine Fibroids

Interventions

myomectomyPROCEDURE

Myomectomy as part of routine clinical care

endometrial ablationPROCEDURE

Endometrial ablation as part of routine clinical care

uterine artery embolizationPROCEDURE

Uterine artery embolization as part of routine clinical care

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 54 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: Minimum of two years

Effect of stakeholder participation in the research process

Time frame: From first stakeholder conference (April 2014) to final stakeholder conference (November 2015)

Data from ClinicalTrials.gov

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