Comparing Patient-Centered Outcomes After Treatment for Uterine Fibroids

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02819609

Enrollment

12234

Registered

2016-06-30

Start date

2014-11-30

Completion date

2015-01-31

Last updated

2016-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Fibroids

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.

Interventions

PROCEDUREmyomectomy

Myomectomy as part of routine clinical care

PROCEDUREendometrial ablation

Endometrial ablation as part of routine clinical care

PROCEDUREuterine artery embolization

Uterine artery embolization as part of routine clinical care

PROCEDUREMRI-guided focused ultrasound ablation

MRI-guided focused ultrasound ablation as part of routine clinical care

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 54 Years

Healthy volunteers

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

Design outcomes

Primary

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)	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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026