Comparing Patient-Centered Outcomes After Treatment for Uterine Fibroids

June 27, 2016 updated by: Priscilla Velentgas, Quintiles, Inc.
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

12234

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 54 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The patient population for the retrospective data analysis was uterine fibroid patients who have a record of at least 1 of the procedures of interest occurring during the time period of January 1, 2005 - December 31, 2011, with the first instance being designated as the index date. The study time period spanned from January 1, 2004 - December 31, 2013 to allow for 12 months pre-index for evaluating baseline demographic and clinical characteristics and 24 months post-index, ensuring a minimum of 2 years follow-up.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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)
Time Frame: Minimum of two years after index procedure
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
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
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
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)
From first stakeholder conference (April 2014) to final stakeholder conference (November 2015)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quintiles, Inc.

Collaborators

Duke University
Center for Medical Technology Policy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

February 12, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (Estimate)

June 30, 2016

Study Record Updates

Last Update Posted (Estimate)

June 30, 2016

Last Update Submitted That Met QC Criteria

June 27, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE-12-11-4430

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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