Ulipristal Acetate Therapy Versus Uterine Artery Embolization in Management of Uterine Fibroids
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Ain Shams Maternity Hospital
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Decline in dominant fibroid volume (in cubic centimeters).
Study Overview
Brief Summary
Study objective: To prove that Ulipristal acetate is an effective line of management for uterine fibroids by causing a significant decline in fibroid volumes resulting in a substantial relief of fibroid-related symptoms, and to compare its results with those of uterine artery embolization.
Design: A randomized control trial. Setting: Maternity Hospital, Ain Shams University.
Patients: Women with symptomatic uterine fibroids.
Interventions: 70 women were randomly assigned to either Ulipristal Acetate (UA) group or uterine artery embolization (UAE) group (35 in each group). Both groups were followed up to detect the decline in fibroid size as well as the improvement of symptoms.
Detailed Description
Inclusion Criteria:
Women with symptomatic uterine fibroids were recruited into the study after fulfilling the following criteria:
- Their age should range from 35 to 50 years.
- Their body mass index (BMI) should range from 18 to 35 Kg/m2.
- The presence of multiple symptomatic type 2, 3, 4, 5, or 6 uterine fibroids according to the FIGO classification.
- The dominant fibroid diameter should range from 4 to 8 cm as assessed by ultrasound.
- They should not be seeking future fertility.
- They should be refusing any surgical intervention whether myomectomy or hysterectomy.
Exclusion Criteria:
- Post-menopausal status or premature ovarian failure.
- Type 0, 1 and 7 uterine fibroids according to FIGO classification.
- Previous myomectomy or any uterine surgery.
- Previous or ongoing hormonal treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Their age should range from 35 to 50 years.
- •Their body mass index (BMI) should range from 18 to 35 Kg/m
- •The presence of one or more symptomatic type 2, 3, 4, 5, or 6 uterine fibroids according to the FIGO classification.
- •The dominant fibroid diameter should range from 4 to 8 cm as assessed by ultrasound.
- •They should not be seeking future fertility.
- •They should be refusing any surgical intervention whether myomectomy or hysterectomy.
Exclusion Criteria
- •Post-menopausal status or premature ovarian failure.
- •Type 0, 1 and 7 uterine fibroids according to FIGO classification.
- •Previous myomectomy or any uterine surgery.
- •Previous or ongoing hormonal treatment.
Arms & Interventions
Group A "Ulipristal Acetate (UA) - Fibristal group" (n=35)
Patients within this group received oral Ulipristal Acetate (Fibristal ©) 5 mg / day starting from the first day of menstrual bleeding, and for 3 months (period of the study).
Intervention: Ulipristal Oral Tablet (Drug)
Group B "Uterine artery embolization (UAE) group" (n=35)
Patients within this group underwent bilateral selective uterine artery embolization, during which polyvinyl alcohol (PVA) particles was administered via a catheter followed by capping with a plug of gelatin sponge. The end point for embolization is to have a static column of contrast in the uterine artery, with only a stump filling when the internal iliac artery was injected. The gelatin sponge cap was thought to both complete the occlusion of the uterine artery and to prevent PVA particles from being drawn out of the uterine artery by the Venturi effect, which would result in non-target embolization.
Intervention: Uterine artery embolization (Procedure)
Outcomes
Primary Outcomes
Decline in dominant fibroid volume (in cubic centimeters).
Time Frame: 3 months
measured by transvaginal ultrasound.
Secondary Outcomes
- Relief of abnormal uterine bleeding.(3 months)
- Relief of pelvic pain.(3 months)
- Relief of pelvic pressure symptoms.(3 months)
- Adverse effects.(6 months)
Investigators
Paula Naseef
Principal Investigator
Ain Shams Maternity Hospital