Comparing Patient-Centered Outcomes After Treatment for Uterine Fibroids
1 other identifier
observational
12,234
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2014
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 12, 2016
CompletedFirst Posted
Study publicly available on registry
June 30, 2016
CompletedJune 30, 2016
June 1, 2016
2 months
February 12, 2016
June 27, 2016
Conditions
Outcome Measures
Primary Outcomes (5)
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)
Study Arms (4)
Myomectomy
Women with uterine fibroids who underwent myomectomy as their index procedure as part of their routine clinical care
Endometrial ablation
Women with uterine fibroids who underwent endometrial ablation as their index procedure as part of their 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
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
Interventions
Endometrial ablation as part of routine clinical care
Uterine artery embolization as part of routine clinical care
MRI-guided focused ultrasound ablation as part of routine clinical care
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Quintiles, Inc.lead
- Center for Medical Technology Policycollaborator
- Duke Universitycollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Director of Epidemiology and Health Outcomes
Study Record Dates
First Submitted
February 12, 2016
First Posted
June 30, 2016
Study Start
November 1, 2014
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
June 30, 2016
Record last verified: 2016-06