A Patient Registry for the Management of Uterine Fibroids in Canada: Protocol for a Multicenter, Prospective, Noninterventional Study

Abstract

Background: Uterine fibroids are the most common benign tumor in women. Among those with fibroids, approximately 30% become symptomatic, with abnormal uterine bleeding, pelvic pain, and bulk symptoms. Despite the high prevalence of fibroids, little information is available regarding symptoms, treatment choices, and outcomes for patients.

Objective: A Canada-wide patient registry was established to understand the real-world practice. This registry included patient presentation and treatment preferences, health care provider attitudes, and clinical outcomes in the management of symptomatic uterine fibroids.

Methods: This study is a prospective, noninterventional, observational patient registry. It will include women diagnosed with uterine fibroids and being managed for symptoms. Participant inclusion criteria were (1) at least 18 years of age, (2) premenopausal with a confirmed diagnosis of uterine fibroids, and associated symptoms, and (3) initiating treatment (drug intervention, procedure intervention, or a combination of both) or watchful waiting. Patients (or legal representative) must understand the nature of the project and provide written informed consent before enrollment. Participant exclusion criteria were (1) they have known or suspected clinically significant pelvic pathology not associated with uterine fibroids, and (2) they are undergoing an emergency hysterectomy at the initial visit. Outcomes will be evaluated in the context of routine clinical practice.

Results: Participant recruitment of this registry began in July 2015. This study currently has a total sample of 1500 patients.

Conclusions: This registry, a first in Canada, will accumulate evidence on the risks and benefits of watchful waiting, and medical and procedural interventions. It will contribute to enhancing access to treatment options for patients.

Trial registration: ClinicalTrials.gov NCT02580578; https://ichgcp.net/clinical-trials-registry/NCT02580578 (Archived by WebCite at http://www.webcitation.org/6yax4Hpvr).

International registered report identifier (irrid): RR1-10.2196/10926.

Keywords: Canada; leiomyoma; registries.

Conflict of interest statement

Conflicts of Interest: MAB has participated in advisory boards for Allergan Canada and AbbVie. PJ is an employee of Allergan. SSS has participated in advisory boards, as a primary investigator, and presented continuing medical education events sponsored by Allergan Canada, Bayer Pharma, and AbbVie.

©Mohamed A Bedaiwy, Peter Janiszewski, Sukhbir S Singh, CAPTURE Steering Committee. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 20.11.2018.