Clinical trial NCT02819609: Comparing Patient-Centered Outcomes After Treatment for Uterine Fibroids
Official title: Comparing Patient-Centered Outcomes After Treatment for Uterine Fibroids
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Fibroids
Lead sponsor: Quintiles, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Center for Medical Technology Policy
name: Duke University
First posted: 2016-06-30
Enrollment: 12234
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


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

Primary outcomes:
measure: 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)
timeFrame: Minimum of two years after index procedure
measure: Time to new or recurrent symptoms after uterus-conserving treatments (myomectomy, endometrial ablation, uterine artery embolization, magnetic resonance imaging [MRI]-guided focused ultrasound ablation)
timeFrame: Minimum of two years after index procedure
measure: 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)
timeFrame: Minimum of two years after index procedure
measure: Time to a subsequent procedure after uterus-conserving treatments (myomectomy, endometrial ablation, uterine artery embolization, magnetic resonance imaging [MRI]-guided focused ultrasound ablation)
timeFrame: Minimum of two years
measure: Effect of stakeholder participation in the research process
timeFrame: From first stakeholder conference (April 2014) to final stakeholder conference (November 2015)
Secondary outcomes:
Other outcomes:
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Study officials:
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