Patient Centered Results for Uterine Fibroids

NCT02260752 | Completed

• 2 other identifiers: Pro00057883RFA-HS-14-006
• Study Type: observational
• Target: 3,094
• Locations: 1 country
• Sites: 9

Brief Summary

The overall goal of this project is to better enable patients with uterine fibroids (UF) to make informed decisions about treatment options by leveraging the highest possible evidence of healthcare quality. The foundation of this project will be a multi-site, prospective registry of a diverse group of women who have undergone either medical or surgical treatment for UF. Specifically, the investigators are interested in: comparing management options for symptom relief; comparing management options for preserving reproductive function; and comparing effectiveness among different subpopulations, including consideration of patient needs and preferences of treatment options.

Conditions

Fibroids, Uterine

Outcome Measures

Primary Outcomes (1)

• change in symptom relief (patient interview)

  degree to which bleeding and pain from uterine fibroids is alleviated

  12, 24, 36 months

Secondary Outcomes (1)

• change in preservation reproductive function (patient interview)

  12, 24, 36 months

Study Arms (2)

Medical

Patients who receive medical therapy only for treatment of their uterine fibroids

Drug: Medical Therapy

Procedure

Patients who have a hysterectomy, myomectomy, uterine arterial embolization, endometrial ablation, radiofrequency ablation, or magnetic resonance guided focused ultrasound to treat their UF.

Procedure: hysterectomy; Procedure: Uterine arterial embolization; Procedure: myomectomy; Procedure: endometrial ablation; Procedure: magnetic resonance guided focused ultrasound; Procedure: radiofrequency ablation

Interventions

hysterectomy PROCEDURE

surgical removal of the uterus

Procedure

Uterine arterial embolization PROCEDURE

In uterine artery embolization, doctor uses a slender, flexible tube (catheter) to inject small particles (embolic agents) into the uterine arteries, which supply blood to your fibroids and uterus.the embolic agents are injected into these fibroid blood vessels. The goal is to block the fibroid vessels, starving the fibroids and causing them to shrink and die.

Also known as: UAE

Procedure

myomectomy PROCEDURE

surgical procedure to remove uterine fibroids, but does not remove uterus

Procedure

Medical Therapy DRUG

treatment of uterine fibroids with only medications, no procedure or surgery is used

Medical

endometrial ablation PROCEDURE

surgical procedure that destroys uterine lining via a telescope placed inside the uterus

Also known as: NovaSure, Her Option, HydroTherm

Procedure

magnetic resonance guided focused ultrasound PROCEDURE

procedure that destroys fibroids while inside an MRI machine

Also known as: MRgFUS, ExAblate; Sonalleve

Procedure

radiofrequency ablation PROCEDURE

procedure that uses heat to destroy uterine fibroids

Also known as: Accessa

Procedure

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

10,000 patients diagnosed with UF between the ages of 18 and 54. Patients must have had a menstrual period within the last 12 months. Source documentation of UF must include either imaging or a pathology report.

You may qualify if:

• Diagnosis of UF by imaging or pathology report within 2 years of enrollment initiation.
• Menstrual period within 12 months

You may not qualify if:

• Post-menopausal
• Men
• years old or older

Sponsors & Collaborators

• Duke University: lead

Study Sites (9)

University of California Medical Centers

San Francisco, California, 94143, United States

Location

Uniformed Services University of the Health Sciences

Bethesda, Maryland, 20814, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Inova Health Systems

Falls Church, Virginia, 22042, United States

Location

Related Publications (8)

• Anchan RM, Spies JB, Zhang S, Wojdyla D, Bortoletto P, Terry K, Disler E, Milne A, Gargiulo A, Petrozza J, Brook O, Srouji S, Morton CC, Greenberg J, Wegienka G, Stewart EA, Nicholson WK, Thomas L, Venable S, Laughlin-Tommaso S, Diamond MP, Maxwell GL, Marsh EE, Myers ER, Vines AI, Wise LA, Wallace K, Jacoby VL. Long-term health-related quality of life and symptom severity following hysterectomy, myomectomy, or uterine artery embolization for the treatment of symptomatic uterine fibroids. Am J Obstet Gynecol. 2023 Sep;229(3):275.e1-275.e17. doi: 10.1016/j.ajog.2023.05.020. Epub 2023 May 26.

  PMID: 37244458 DERIVED

• Anchan RM, Wojdyla D, Bortoletto P, Terry K, Disler E, Milne A, Gargiulo A, Petrozza J, Brook O, Srouji S, Morton CC, Greenberg J, Wegienka G, Stewart EA, Nicholson WK, Thomas L, Venable S, Laughlin-Tommaso S, Diamond MP, Maxwell GL, Marsh EE, Myers ER, Vines AI, Wise LA, Wallace K, Jacoby VL, Spies JB. A Comparative Analysis of Health-Related Quality of Life 1 Year Following Myomectomy or Uterine Artery Embolization: Findings from the COMPARE-UF Registry. J Womens Health (Larchmt). 2023 Apr;32(4):423-433. doi: 10.1089/jwh.2022.0133. Epub 2023 Jan 13.

  PMID: 36637808 DERIVED

• Wise LA, Thomas L, Anderson S, Baird DD, Anchan RM, Terry KL, Marsh EE, Wegienka G, Nicholson WK, Wallace K, Bigelow R, Spies J, Maxwell GL, Jacoby V, Myers ER, Stewart EA. Route of myomectomy and fertility: a prospective cohort study. Fertil Steril. 2022 May;117(5):1083-1093. doi: 10.1016/j.fertnstert.2022.01.013. Epub 2022 Feb 23.

  PMID: 35216832 DERIVED

• Wallace K, Stewart EA, Wise LA, Nicholson WK, Parry JP, Zhang S, Laughlin-Tommaso S, Jacoby V, Anchan RM, Diamond MP, Venable S, Shiflett A, Wegienka GR, Maxwell GL, Wojdyla D, Myers ER, Marsh E. Anxiety, Depression, and Quality of Life After Procedural Intervention for Uterine Fibroids. J Womens Health (Larchmt). 2022 Mar;31(3):415-424. doi: 10.1089/jwh.2020.8915. Epub 2021 Jun 8.

  PMID: 34101502 DERIVED

• Wegienka G, Stewart EA, Nicholson WK, Zhang S, Li F, Thomas L, Spies JB, Venable S, Laughlin-Tommaso S, Diamond MP, Anchan RM, Maxwell GL, Marsh EE, Myers ER, Vines AI, Wise LA, Wallace K, Jacoby VL. Black Women Are More Likely Than White Women to Schedule a Uterine-Sparing Treatment for Leiomyomas. J Womens Health (Larchmt). 2021 Mar;30(3):355-366. doi: 10.1089/jwh.2020.8634. Epub 2021 Feb 1.

  PMID: 33524308 DERIVED

• Laughlin-Tommaso SK, Lu D, Thomas L, Diamond MP, Wallace K, Wegienka G, Vines AI, Anchan RM, Wang T, Maxwell GL, Jacoby V, Marsh EE, Spies JB, Nicholson WK, Stewart EA, Myers ER. Short-term quality of life after myomectomy for uterine fibroids from the COMPARE-UF Fibroid Registry. Am J Obstet Gynecol. 2020 Apr;222(4):345.e1-345.e22. doi: 10.1016/j.ajog.2019.09.052. Epub 2019 Oct 31.

  PMID: 31678093 DERIVED

• Nicholson WK, Wegienka G, Zhang S, Wallace K, Stewart E, Laughlin-Tommaso S, Thomas L, Jacoby VL, Marsh EE, Wise L, Borah BJ, Spies J, Venable S, Anchan RM, Larry Maxwell G, Diamond M, Lytle B, Myers ER. Short-Term Health-Related Quality of Life After Hysterectomy Compared With Myomectomy for Symptomatic Leiomyomas. Obstet Gynecol. 2019 Aug;134(2):261-269. doi: 10.1097/AOG.0000000000003354.

  PMID: 31306318 DERIVED

• Stewart EA, Lytle BL, Thomas L, Wegienka GR, Jacoby V, Diamond MP, Nicholson WK, Anchan RM, Venable S, Wallace K, Marsh EE, Maxwell GL, Borah BJ, Catherino WH, Myers ER. The Comparing Options for Management: PAtient-centered REsults for Uterine Fibroids (COMPARE-UF) registry: rationale and design. Am J Obstet Gynecol. 2018 Jul;219(1):95.e1-95.e10. doi: 10.1016/j.ajog.2018.05.004. Epub 2018 May 8.

  PMID: 29750955 DERIVED

Related Links

• COMPARE-UF Registry website
• Additional research study HSRP20194228 "Methods for the Design and Conduct of Subgroup Analysis in Observational Studies"

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood assay

MeSH Terms

Conditions

Leiomyoma

Interventions

Hysterectomy; Uterine Myomectomy; Nutrition Therapy; Endometrial Ablation Techniques; Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Therapeutics; Ablation Techniques; Radiofrequency Therapy

Study Officials

• Evan R Myers, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: October 9, 2014
• Study Start: November 1, 2015
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: November 18, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share

Locations

US (9)