Comparing Patient-Centered Outcomes After Treatment for Uterine Fibroids

Completed

• Conditions: Uterine Fibroids
• Interventions: Procedure: MRI-guided focused ultrasound ablation; Procedure: myomectomy; Procedure: uterine artery embolization; Procedure: endometrial ablation

• Registration Number: NCT02819609
• Lead Sponsor: Quintiles, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Study First Submitted: 2016-02-12
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-27
• Last Update Submitted: 2016-06-27
• Study First Posted: 2016-06-30
• Last Update Posted: 2016-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12234

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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)