Comparing Patient-Centered Outcomes After Treatment for Uterine Fibroids

Quintiles

Status: Completed

Conditions: Uterine Fibroids

Treatments: Procedure: MRI-guided focused ultrasound ablation; Procedure: uterine artery embolization; Procedure: myomectomy; Procedure: endometrial ablation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02819609

CE-12-11-4430

Details and patient eligibility

About

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.

Enrollment: 12,234 patients

Sex: Female

Ages: 18 to 54 years old

Volunteers: No 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

Trial design

12,234 participants in 4 patient groups

Myomectomy

Description:

Women with uterine fibroids who underwent myomectomy as their index procedure as part of their routine clinical care

Treatment:

Procedure: myomectomy

Endometrial ablation

Description:

Women with uterine fibroids who underwent endometrial ablation as their index procedure as part of their routine clinical care

Treatment:

Procedure: endometrial ablation

Uterine artery embolization

Description:

Women with uterine fibroids who underwent uterine artery embolization as their index procedure as part of their routine clinical care

Treatment:

Procedure: uterine artery embolization

MRI-guided focused ultrasound ablation

Description:

Women with uterine fibroids who underwent MRI-guided focused ultrasound ablation as their index procedure as part of their routine clinical care

Treatment:

Procedure: MRI-guided focused ultrasound ablation