A Multicenter Prospective Non-Interventional Study Assessing the Management of Canadian Women With Uterine Fibroids

A Multicentre Prospective Non-interventional Study Assessing the Management of Canadian Women With Uterine Fibroids, a Patient Registry

This study will characterize the treatments and outcomes associated with different uterine fibroid treatments in Canada, to understand patients' preferences and satisfaction with different medical and procedural interventions. The study will also assess the effectiveness of ulipristal acetate (Fibristal®) in controlling bleeding, reducing fibroid volume and symptoms, and improvement in patient's quality of life.

Study Overview

• Status: Completed
• Conditions: Leiomyoma
• Intervention / Treatment: Other: No Intervention

• Study Type: Observational
• Enrollment (Actual): 1500

Contacts and Locations

Study Locations

• Canada
  • Québec, Canada, G1V 4G2
    • CHU de Quebec-Universite Laval
  • Alberta
    • Calgary, Alberta, Canada, T2E 7W7
      • Peter Lougheed Centre/University of Calgary
    • Edmonton, Alberta, Canada, T5T 1L6
      • Urestky Edmonton Clinic
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E1
      • Sanders Vancouver Clinic
    • Vancouver, British Columbia, Canada, V6H 3N1
      • Children's and Women's Health Centre of British Columbia - The University of British Columbia
    • White Rock, British Columbia, Canada, V4B 5C9
      • Southern Health Centre
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 6H5
      • Landau Fredericton Clinic
  • Newfoundland and Labrador
    • St. John, Newfoundland and Labrador, Canada, L6G 0B5
      • Strand Clinic
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • IWK Healtch Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4K1
      • Hamilton Health Sciences
    • London, Ontario, Canada, N6A 5W9
      • Minimally Invasive Gynecology Clinic
    • Ottawa, Ontario, Canada, K1H 7W9
      • Ottawa Hospital Research Institute
    • Toronto, Ontario, Canada, M5G 1Z5
      • Mount Sinai Hospital
    • Toronto, Ontario, Canada, M5C 2T2
      • St. Micheals Hospital
    • Windsor, Ontario, Canada, N9C 1X2
      • South Windsor Women's Health
  • Quebec
    • Lasalle, Quebec, Canada, H8N 1T9
      • Centre Gynécologie et Maternité
    • Montreal, Quebec, Canada, H3S 1Y9
      • Jewish General Hospital
    • Montreal, Quebec, Canada, J4N 1C2
      • Clinique de Gynécologie & Obstétrique Pierre Boucher
    • Saint-Laurent, Quebec, Canada, H4R 0B7
      • Complexe Medical Saint-Laurent
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4S 6X3
      • University of Saskatchewan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Patients diagnosed with uterine fibroids treated as per standard of care in clinical practice.

Description

Inclusion Criteria:

-Pre-menopausal adult women with confirmed diagnosis and symptoms associated with uterine fibroids who are initiating treatment.

Exclusion Criteria:

-Significant pelvic pathology not associated with uterine fibroids.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All Participants; Female patients who are diagnosed and treated for symptoms associated with their uterine fibroids per routine clinical practice. No intervention is administered in this study.	Other: No Intervention; No intervention is administered in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Uterine Fibroid Symptom Quality of Life 37-Item Questionnaire (UFS QoL)	24 Months
Ruta Menorrhagia (Bleeding) 15-Item Questionnaire	24 Months
Number of Participants with Adverse Drug Reactions	24 Months

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: Carmen Enciu, Allergan

Publications and helpful links

General Publications

• Bougie O, Bedaiwy MA, Laberge P, Lebovic G, Leyland N, Atri M, Murji A; CAPTURE Steering Committee. Quality of ultrasonography reporting and factors associated with selection of imaging modality for uterine fibroids in Canada: results from a prospective cohort registry. CMAJ Open. 2020 Aug 12;8(3):E506-E513. doi: 10.9778/cmajo.20200004. Print 2020 Jul-Sep.
• Bedaiwy MA, Janiszewski P, Singh SS; CAPTURE Steering Committee. A Patient Registry for the Management of Uterine Fibroids in Canada: Protocol for a Multicenter, Prospective, Noninterventional Study. JMIR Res Protoc. 2018 Nov 20;7(11):e10926. doi: 10.2196/10926.

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2015
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: October 19, 2015
• First Submitted That Met QC Criteria: October 19, 2015
• First Posted (Estimate): October 20, 2015

Study Record Updates

• Last Update Posted (Actual): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 26, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: CMO-CAN-WH-0412

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No