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OpenTrials
Completed

NCT Number: NCT02819609

Comparing Patient-Centered Outcomes After Treatment for Uterine Fibroids

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.

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Key information

Conditions

Uterine Fibroids Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

18 year–54 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Myomectomy

Procedure

Myomectomy as part of routine clinical care

Endometrial ablation

Procedure

Endometrial ablation as part of routine clinical care

Uterine Artery Embolization

Procedure

Uterine artery embolization as part of routine clinical care

MRI-Guided Focused Ultrasound Ablation

Procedure

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

Primary outcomes

  1. 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)

    Time frame: Minimum of two years after index procedure

  2. Time to new or recurrent symptoms after uterus-conserving treatments (myomectomy, endometrial ablation, uterine artery embolization, magnetic resonance imaging [MRI]-guided focused ultrasound ablation)

    Time frame: Minimum of two years after index procedure

  3. 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)

    Time frame: Minimum of two years after index procedure

  4. Time to a subsequent procedure after uterus-conserving treatments (myomectomy, endometrial ablation, uterine artery embolization, magnetic resonance imaging [MRI]-guided focused ultrasound ablation)

    Time frame: Minimum of two years

  5. Effect of stakeholder participation in the research process

    Time frame: From first stakeholder conference (April 2014) to final stakeholder conference (November 2015)

Sponsors and collaborators

Lead sponsor

Quintiles, Inc.

Industry

Collaborators

  • Center for Medical Technology Policy
  • Duke University

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 30, 2016
Registry last updated
Jun 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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