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Comparing Patient-Centered Outcomes After Treatment for Uterine Fibroids

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ClinicalTrials.gov Identifier: NCT02819609
Recruitment Status : Completed
First Posted : June 30, 2016
Last Update Posted : June 30, 2016
Sponsor:
Collaborators:
Center for Medical Technology Policy
Duke University
Information provided by (Responsible Party):
Priscilla Velentgas, 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.

Condition or disease Intervention/treatment
Uterine Fibroids Procedure: myomectomy Procedure: endometrial ablation Procedure: uterine artery embolization Procedure: MRI-guided focused ultrasound ablation

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Study Type : Observational
Actual Enrollment : 12234 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparing Patient-Centered Outcomes After Treatment for Uterine Fibroids
Study Start Date : November 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Group/Cohort Intervention/treatment
Myomectomy
Women with uterine fibroids who underwent myomectomy as their index procedure as part of their routine clinical care
Procedure: myomectomy
Myomectomy as part of routine clinical care

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

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

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




Primary Outcome Measures :
  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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 54 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patient population for the retrospective data analysis was uterine fibroid patients who have a record of at least 1 of the procedures of interest occurring during the time period of January 1, 2005 - December 31, 2011, with the first instance being designated as the index date. The study time period spanned from January 1, 2004 - December 31, 2013 to allow for 12 months pre-index for evaluating baseline demographic and clinical characteristics and 24 months post-index, ensuring a minimum of 2 years follow-up.
Criteria

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
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Responsible Party: Priscilla Velentgas, Senior Director of Epidemiology and Health Outcomes, Quintiles, Inc.
ClinicalTrials.gov Identifier: NCT02819609    
Other Study ID Numbers: CE-12-11-4430
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: June 30, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases