Comparing Patient-Centered Outcomes After Treatment for Uterine Fibroids

Uterine Fibroids Clinical Trial

Official title:

Comparing Patient-Centered Outcomes After Treatment for Uterine Fibroids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02819609
• Other study ID #: CE-12-11-4430
• Status: Completed
• Phase: N/A
• First received: February 12, 2016
• Last updated: June 27, 2016
• Start date: November 2014
• Est. completion date: January 2015

Study information

• Verified date: June 2016
• Source: Quintiles, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12234
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 54 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

Procedure:
• myomectomy
Myomectomy as part of routine clinical care
• endometrial ablation
Endometrial ablation as part of routine clinical care
• uterine artery embolization
Uterine artery embolization as part of routine clinical care
• MRI-guided focused ultrasound ablation
MRI-guided focused ultrasound ablation as part of routine clinical care

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Quintiles, Inc.	Center for Medical Technology Policy, Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Effect of stakeholder participation in the research process		From first stakeholder conference (April 2014) to final stakeholder conference (November 2015)	No