This Post Market study is being conducted to compare the direct and indirect cost of three approaches (GFA, myomectomy, and uterine artery embolization) for the treatment of symptomatic uterine fibroids.
Uterine fibroids are the most common pelvic neoplasms in women; they severely impact quality of life and are the leading indication for hysterectomy. Hysterectomy is the definitive treatment for myomas; however, many patients seek alternative uterine-sparing therapy and desire to conserve their fertility. Myomectomy is a much-reported surgical option for women with symptomatic fibroids and, until recently, the abdominal approach has been the approach of choice for most surgeons. Over time, patients have requested less invasive procedures and minimally invasive, laparoscopic options are becoming more popular among patients and their gynecologists. Standard surgical and interventional treatments for uterine fibroids are costly to society and to the health care system. New technologies such as GFA may offer a low-cost alternative to the standard treatments for symptomatic uterine fibroids in women who desire uterine conservation. This study seeks to evaluate those cost differences between three available uterine-sparing techniques and to explore the qualitative outcomes such as symptom severity, health related quality of life, and overall treatment effect.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
GFA is being used for the treatment of symptomatic uterine fibroids
Myomectomy is a procedure in which uterine fibroids are surgically removed from the uterus.
UAE is a minimally invasive surgical procedure used to treat uterine fibroids.
University of Saskatchewan, Saskatoon City Hospital
Saskatoon, Saskatchewan, Canada
Compare direct cost of GFA compared to those of myomectomy and UAE
To compare medical, surgical, and hospitalization costs (including procedural complication costs) of Global Fibroid Ablation (GFA) compared to those of Myomectomy and Uterine Artery Embolization (UAE)at 3 months post procedure.
Time frame: 3 months post procedure
Compare rates of acute and near-term serious complications to the acute and near-term treatment-related serious adverse events of pivotal study.
Overall rates of acute (within 48 hours post procedure) and near-term (between 2 and 30 days post procedure) serious complications in all GFA subjects compared to the acute and near-term treatment-related serious adverse event rates in the pivotal study.
Time frame: 3 months post procedure
Assess the comparative safety of the three treatment alternatives
Safety measures will be assessed by comparing the complication rate for all three alternatives (GFA, Myomectomy, UAE).
Time frame: 60 Months
Assess factors that influence indirect costs of the three treatment alternatives
Compare incidence costs of post discharge procedure-related complications and re-interventions we well as indirect cost factors defined as days to return-to-work, return to normal activities of daily living, and cost of care up to 60 months post discharge.
Time frame: 60 Months
Assess UFS-QoL pre-treatment to post treatment in all treatment groups
To compare fibroid symptom severity and quality of life scores at 3, 6, 12, 24, 36, 48, and 60 months post procedure as compared to baseline using the Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL0 assessment tool.
Time frame: 60 Months
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Assess subjects menstrual bleeding using the MIQ
Compare subjects menstrual bleeding pre-treatment and up to 3, 6, 12, 24, 36, 48, and 60 months post treatment using the Menorrhagia Impact Questionnaire (MIQ).
Time frame: 60 Months
Assess subject's satisfaction with her treatment
Compare subject's satisfaction and general health outcome at 3, 6, 12, 24, 36, 48, and 60 months post procedure as compared to baseline using the EQ-5D (a standardized instrument for use as a measure of health outcome).
Time frame: 60 Months