Comparing Patient-Centered Outcomes After Treatment for Uterine Fibroids
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Uterine Fibroids
- Sponsor
- Quintiles, Inc.
- Enrollment
- 12234
- Primary Endpoint
- 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)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Priscilla Velentgas
Senior Director of Epidemiology and Health Outcomes
Quintiles, Inc.
Eligibility Criteria
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)